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How to Manage Growers: FSMA Produce Safety Rule for Processors

Safety Rule for Processors

Let’s face it, all of our food comes from farms. When it comes to plant-based food there’s always a grower (or many growers!) involved.

Here at Safe Food Alliance, we work to, help growers implement processes to ensure compliance with the FSMA Produce Safety rule (FSMA is the FDA’s “Food Safety Modernization Act”). Many of our customers are also processors who buy a raw agricultural commodity (‘RAC’) from growers, and are reevaluating how they “manage” these growers as part of their supplier approval/ supplier management program.

As it stands, if you are a processor that purchases directly from growers you should be considering a review of your company’s grower management programs, with the following objectives in mind:

  1. Meeting FSMA regulatory requirements
  2. Meeting your customer requirements and food safety audit requirements
  3. Protecting your operation by reducing risk

Assessing Risk & Defining Controls

At the most basic level, any food processor should be making sure that their suppliers and the products purchased comply with current regulations and are safe. This includes packaging suppliers, ingredient suppliers, and raw materials like agricultural commodities. This doesn’t mean that you have to physically audit all of your suppliers; it doesn’t even mean that you have to get a copy of a third-party audit from all of them. Food safety is always based on risk, so as a processor, you need to determine the level of risk posed by the raw material, then based on that assessment determine what controls are needed.

If this sounds a lot like HACCP or Preventive Controls, that’s because it is. Based on your hazard analysis you determine what needs to be done to reduce risk and help ensure the safety of your products, and to ultimately protect the future of your company.

With produce, processors should always identify the risk of pathogens in their hazard analysis. Remember that any produce may bear this risk, since it’s grown outside. Additionally, there may be physical hazards that a company will have to contend with in its internal operations. Lastly, an assessment of likely chemical risks, such as pesticides, has to be done.

Evaluating Each Type of Risk


Products that are higher risk will require the highest level of verification to help minimize any risk. High-risk products might include anything such as  an annual crop grown directly on the ground, or anything eaten fresh without a processing step that would significantly reduce pathogens. Imported items may also bear a higher risk, depending on the country of origin and their local practices and regulations, and may need extra verification activities.

Examples: Leafy greens, fresh fruit, some imported items

Potential Controls: Third-party GAP audit, or full on-site review of programs conducted by your company. Confirm compliance with FSMA Produce Safety rule, as well as industry best practices, potentially to include review of growers’ records. Sampling and testing of product on a defined schedule will generally need to be conducted as well.


Tree crops or other items grown off the ground, and items with no history of past recalls.  Other factors to consider: local or domestically grown items, or crops over which the processor has direct oversight (vertically integrated companies) may have lower risk.

Examples: Dried fruit or other items with minimal past food safety issues, some tree nuts, items that are always heat treated or processed in some way prior to consumption. In some cases, these items may qualify for an exemption from FSMA (see below).

Potential Controls: Grower completes a questionnaire or your employee works with them to complete one; review of the grower’s food safety plan; short on-site visit to review practices / observe.

Exempt: There are a few exemptions built into the FSMA Produce Safety rule. For these items, an exemption may be taken per the regulation, or they can be treated as low risk as outlined above.  These include:
1. Produce on the “rarely consumed raw” list
2. Produce on individual consumption or on-farm consumption (not for sale)
3. Produce the receives a commercial processing step which would significantly reduce pathogens

Examples: Tomatoes for paste or canning, peaches or olives for canning, California-grown almonds treated per the marketing order, wine grapes used for wine (not eaten).

Potential Controls: Documentation to demonstrate qualification for exemption.  This implicitly requires that the processing step be validated as a “kill step”, it can’t just be assumed that it is effective.

FDA’s Focus Areas for Risk Management in Produce

There are a few specific focus areas built into the rule, where the FDA and industry working groups have identified potential risks related to agricultural products. These are the focus areas of the Produce Safety rule that can be reviewed with growers you purchase from:

  1. Personnel training and qualification: This section is mainly focused on personal hygiene, harvesting activities, handling product, and relevant employee training.
  2. Agricultural water quality: The most controversial section, this one is still under review by FDA for discussion with the industry as they consider potential changes. Requires growers to establish and maintain a “microbial water quality profile”, utilizing specific test methods for generic E. coli.  Compliance dates for these requirements are delayed for a few more years.
  3. Soil amendments: Focuses mainly on soil amendments of animal origin, and controlling associated risks. This control can be achieved through treatment of those amendments, or timing of application of raw amendments well in advance of harvest.  No soil amendments should ever come into contact with the harvestable portion of the crop.
  4. Domesticated and wild animals: Requires monitoring for animal activity which may put product at risk, and taking appropriate actions if observed.
  5. Growing, harvesting, packing and holding activities: Focused on how activities are carried out related to product risk, such as handling practices.
  6. Equipment, tools, buildings, and sanitation for processing operations: Design and maintenance of equipment, tools and facilities; cleaning and sanitation; pest control; etc.

Low-Cost Training Available

If you are responsible for purchasing raw agricultural commodities, or handle the “grower relations” function, consider attending the official one-day produce safety course and become familiar with the requirements of the rule. After attending the course you’ll receive an official certificate from AFDO.  Safe Food Alliance currently offers this course in various locations at low cost this spring.

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