The FSMA 204 Final Rule on Pre-Harvest Agricultural Water: how will it affect your business?

In May the FDA published its long-awaited Pre-Harvest Agricultural Water Final Rule. We analyse what it means for the food industry.

Introduced to improve the safety of water used by US farms to grow agricultural produce, the Pre-Harvest Agricultural Water Final Rule forms part of sweeping changes brought about under the Food Safety Modernization Act (FSMA) Section 204(d) (FSMA 204) – which collectively require far more stringent record-keeping by all supply chain stakeholders.

With wide-reaching implications for distributors, retailers and restaurants, as well as some 70,000 US farms, the clock is ticking for industry to get itself ready for the change.

Here’s everything they need to know.

What is the Pre-Harvest Agricultural Water Final Rule?

Simply put, the Pre-Harvest Agricultural Water Final Rule - aka Final Rule - requires affected producers to carry out systems-based, pre-harvest assessments of agricultural water in order to identify likely hazards, improve risk management and reduce the odds of contamination.

Up until now regulations around pre-harvest water use have been limited. Though there’s been a general understanding around the importance of clean water for crop irrigation, specific guidelines and standards haven’t been widely implemented and this element of production has existed largely unregulated.

In recent years, attitudes have changed however, with a number of food safety incidents related to pre-harvest water use and the recognition that pathogens such as E. coli, salmonella and Listeria can pose a serious risk of contamination during irrigation.

The US first addressed this in 2015 via the Produce Safety Rule set out in the FDA’s FSMA, which set standards for water quality used, but the Final Rule updates these requirements further and adds an additional need to carry out proactive assessments.

Who is affected by the Final Rule?

Any farm subject to the existing Produce Safety Rule 2015 within the Food Safety Modernization Act is likely to be affected by the updated legislation, other than those growing sprouts which have separate more stringent requirements.

If you are not sure if a farm is subject to the Produce Safety Rule, take a look at the FDA’s Coverage and Exemptions Flowcharts for further guidance.

What's the deadline?

The rule will be effective 60 days after May 2, 2024. However, compliance timelines from this date vary depending on the size of the farm.

Very small businesses (having, on a rolling basis, an average annual value of food sold during the previous three years of no more than $250,000): 2 years, nine months.

Small businesses (having, on a rolling basis, an average annual value of food sold during the previous three years of no more than $500,000): 1 year, nine months

All other businesses: Nine months

What are the requirements of the Final Rule?

The Final Rule requires affected US farms to carry out annual assessments of agricultural water use, in order to monitor and evaluate out a number of different factors that could increase contamination risks.

These assessments must take into account a number of different elements, including but not limited to:

Whether the water system used is ground vs surface, open vs closed to the environment

Water-use practices, sprinkler or spray; drip vs furrow

Any impacts from adjacent or nearby land, such as animal activity or other water sources
Environmental conditions, such as average air temperature, the occurrence of extreme weather events

Based on these assessments, farms will then need to decide if corrective action or mitigation measures are required to eliminate any risks of contamination. The former is applicable where agricultural water is not safe or is not of adequate sanitary quality for intended use, and the latter where there is one or more reasonably foreseeable hazards highlighted in the assessment.

To understand the specific actions required, in what timeframes, businesses should refer to the FDA’s factsheet here.

Is there a wider impact across the food industry?

Yes, absolutely.

Though affected farms must carry out assessments and ensure corrective action is taken where appropriate, the Final Rule has implications that go far beyond the farmgate.

FSMA 204, of which the Final Rule is part, places responsibility on all supply chain stakeholders involved in the distribution, preparation and sales of affected produce to ensure records are adequately kept detailing assessments carried out and any actions taken.

This is to ensure compliance and facilitate quick and accurate identification of any products involved in food safety recalls.

The required records must be kept for at least two years and be made available to the US FDA upon request within 24 hours in an electronic spreadsheet at minimum.

There are a few exceptions. For example, where produce is sourced from a local or small farm and shipped directly to a retailer or restaurant, it isn’t necessary to track these items (though businesses must keep a record of the name and address of that farm for 180 days).

In the vast majority of cases however, each food businesses will need to step up current protocols around record-keeping or risk falling foul of the rules.

How prepared is the sector?

In many cases, there’s more work that affected farms and food businesses need to do ahead of the deadlines for compliance with the Final Rule.

For example, though our recent whitepaper revealed that 68% of US businesses think they are ready for the regulation roll-out, half still aren’t using a digital system to manage their food safety, quality and traceability requirements.

That could be a problem. With the introduction of the Final Rule – and FSMA 204 more broadly – food traceability requirements will need to be more detailed, more rigorous and – critically – available in formats that can be swiftly shared with both other stakeholders and regulators. Manual systems could therefore make compliance a challenge.

In the coming months all affected businesses will need to consider the following:

Identification: Which products in their supply chain will be impacted by the Final Rule? Which may be high risk and require further action? For retailers and restaurants, how they can they support affected producers/suppliers with assessments?

Capture: Which systems do they have in place to capture Key Data Elements (KDEs) for each Critical Tracking Event (CTE) detailed in FSMA 204? How is data exchanged between supply chain partners? At what speed could it be shared with the FDA, if requested?

Education: Pre-harvest agricultural water is an element of the supply chain that has existed largely free from regulatory oversight until now. The changes introduced by the Final Rule may therefore require business leaders to consider additional education for employees to make clear the role of pre-harvest water in contamination and any changes to protocols put in place as a result.

How can Foods Connected help?

At Foods Connected, we can support you in your preparations for the Final Rule.

Our award-winning suite of software solutions specialises in traceability and supply chain management, and our platform includes digital record-keeping solutions that can be easily used to fulfil any requirements regarding KDEs and CTEs.

Our end-to-end traceability insights can be shared across the supply chain in real-time - giving companies confidence that they are ‘data ready’ for deadline.

Make no mistake either, that deadline is fast-approaching.

Now is the time to ensure your business understands exactly how the Final Rule could affect your business, how it fits into the wider requirements of FSMA 204 and that you have the systems in place to capture, share and evaluate critical data on food safety.

You can read more about managing transparency and compliance in the supply chain in the whitepaper below. Alternatively, if you think that Foods Connected can help you prepare for FSMA 204, request a demo of our food traceability software today.