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FSMA Produce Safety Rule or GAPs

FSMA Produce Safety Rule



FSMA Produce Safety Rule or GAPs?

The FSMA Produce Safety Rule compliance dates began January 26, 2018 for most requirements, except the agricultural water related requirements. The largest farm businesses have to meet this earliest compliance date, with small and very small farm businesses having an additional one year, and two years (respectively) for most requirements.

Now that the first wave of produce farm businesses are becoming regulated for the very first time, I thought it might be good to look at the differences between the FSMA Produce Safety Rule and GAPs (good agricultural practices).

Some questions might be…

Does the Produce Safety Rule replace GAPs?

As a farm, do I have to do both?

Do they work together?

Naturally, the answer to each of these questions is not so straightforward. First, lets look at a summary of both the FSMA Produce Safety Rule and GAPs:


FSMA Produce Safety Rule

This is a newly mandated program that governs the on-farm practices of growing certain fruits and vegetables. The list of covered crops is long, but basically any produce crop that is likely to be eaten raw is covered.

The Produce Safety Rule is a science- and risk-based approach that aims to minimize or prevent contamination of produce instead of react to an outbreak after the fact. It covers 5 identified contamination routes:

  • worker health and hygiene
  • agricultural water
  • soil amendments of animal origin
  • wildlife and domestic animals
  • sanitation of tools, equipment and buildings

Baseline criteria and standards are prescribed, however, each farm has the flexibility to determine how they will comply, based on their specific farm operations. Food safety plans are NOT required, but the Produce Safety Rule requires records to be kept.

Some farm operations may be exempt from the Produce Safety Rule, but all farms are encouraged to comply with the standards to improve the quality of the US food supply.

GAPs (Good Agricultural Practices)

Prior to FSMA, the FDA and USDA developed the Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, (released 1998). The common name is GAPs (Good Agricultural Practices ) and GAPs are voluntary guidelines for those grow, harvest, pack and transport produce. Guidance is given for the following points of contamination:

  • agricultural water
  • worker health and hygiene
  • soil amendments
  • sanitary facilities -restrooms and handwashing for workers, volunteers and customers
  • field sanitation – harvest bins, totes, knives and equipment
  • pack facility sanitation – sorting tables, bins, equipment, and pest control
  • transport – growers, packers, distributors, wholesalers, etc.
  • traceback


GAPs Audits

Although voluntary, GAPs compliance is also market and consumer driven. Buyers, farmers market organizations, school districts and consumers may require a farmer have a GAP audit as a condition of purchase, or presence at a farmers market.

Audits are conducted by 3rd party organizations (both government and private sector organizations), usually at a cost to the grower. In preparation for the audit, it is generally necessary for a farm to have a written food safety plan and at least one growing season of documentation for an audit to be performed.

As a grower in need of a GAPs audit, make sure to ask questions of your buyer(s) before hand and research the type of audit you need.

The USDA Produce GAPs Harmonized Standards  is a combination of the official two separate Produce GAPs Harmonized Food Safety Standards posted on the United Fresh website.

The ‘Harmonized GAPs’ standards (generally meaning GAPs) are designed to meet the majority of buyer requirements (with riders added as necessary). Just know if you need a ‘Field Operations and Harvest’ focused audit or a ‘Post Harvest Operations’ focused audit, or if you want both.


Produce Safety Rule or GAPs?

At the beginning of this article, we posed potential questions about compliance with the Produce Safety Rule or GAPs. Let’s review potential answers.

Does the Produce Safety Rule replace GAPs?

No. The Produce Safety Rule should be considered a baseline level of produce safety. GAPs are market driven, and buyers or consumers may ask for a written food safety plan or audit as a condition of sale.

As a farm, do I have to do both?

It depends. A farm’s business size (as defined in the Produce Safety Rule) and the crops grown will determine if they are regulated by the produce safety rule. As an additional standard, a farm’s buyer(s) may require them to have a written food safety plan only, or perhaps a food safety plan and GAPs audit.

Do they work together?

Probably, but at this writing, it’s not clear the exact extent. The Produce Safety Rule requires certain recordkeeping, but not an actual food safety plan. That recordkeeping will be a good start on a food safety plan but additional documentation is probably required.


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