FSMA harvest, post-harvest ag water requirements for large farms in full force (Ag Law)
(Editor’s note: Nicole Cook is an environmental and agricultural faculty legal specialist at the University of Maryland Eastern Shore. This column should not be interpreted as legal or financial advice for the reader.)
On Jan. 26, the Food and Drug Administration’s enforcement discretion period ended, and “large” operations that are covered by the FSMA Produce Safety Rule are expected to be in full compliance with the rule’s harvest and post-harvest agricultural water requirements.
What Are The PSR Harvest
and Post-Harvest Agricultural Water Requirements?
The harvest and post-harvest ag water requirements are in Section E of the PSR.
They cover water used in harvesting, packing, and holding activities like water used to prevent dehydration, water used to clean equipment or food contact surfaces, water used in transporting covered produce, and water used in cooling or washing covered produce.
It also includes water used to make ice that contacts covered produce, and water used for handwashing.
It does not include “pre-harvest” water, which is water that’s used during growing activities like water used in crop irrigation or crop protection sprays.
Compliance dates for the harvest and post-harvest provisions are as follows:
• Jan. 26, 2023 for large businesses (average produce sales from the past three years above $584,908);
• Jan. 26, 2024 for small businesses (average produce sales from the past three years between $250,000 and $584,908); and
• Jan. 26, 2025 for very small businesses (average produce sales from the past three years between $29,245 and $250,000).
The FDA has said that it intends to take an “educate while we regulate” approach to the rule for the first year, however, the agency will expect to see that establishments have undertaken or are well on their way to compliance with the harvest and post-harvest requirements.
You can find a link to a new FDA fact sheet, entitled Requirements for Harvest and Post-Harvest Agricultural Water in Subpart E for Covered Produce Other than Sprouts, on FDA’s website.
You can also find a link to the fact sheet in my March 28, 2023, blog post at umagrisk.org. The fact sheet details compliance requirements and the agency’s intended activities.
With the PSR’s basic requirement that “all agricultural water must be safe and of adequate sanitary quality for its intended use,” the requirements include provisions related to inspections and maintenance of ag water systems, water treatment, microbial quality standards, testing and monitoring of agricultural water, and recordkeeping.
Here’s an overview of the requirements:
• If the water used during and/or after harvest is determined to be out of compliance, the farm must immediately discontinue its use. Before resuming use, the farm must reinspect the entire affected agricultural water system and make necessary changes or treat the water according to section § 112.45(a).
• When the water needs to be treated, the selected method must effectively make the water safe and of adequate sanitary quality for its intended use and/or meet the microbial criteria of no detectable generic E. coli per 100 mL of water. And, it must be monitored to ensure the water consistently meets the criteria.
• Testing is not required if the water is from a public water system or supply or is treated in accordance with § 112.43. Untreated ground water (e.g., wells), however, is required to be tested initially at least four times during the growing season or during the first year, then tested annually thereafter.
If the water does not meet acceptable levels (no detectable generic E. coli), the farm must stop using the source and determine the cause, make corrections and then return to testing four times. Remember untreated surface water cannot be used for harvest or post-harvest activities.
• Other harvest/post-harvest requirements include water management, water quality monitoring, and water temperature monitoring and maintenance (as detailed in § 112.48).
• Among the records required to be maintained are those pertaining to agricultural water system inspections, test results, water treatment, methods, corrective actions, and public water systems (if applicable), as well as the PSR’s general recordkeeping requirements (in Subpart O).
If you have not addressed these areas in your harvest and post-harvest agricultural water activities, now is the time to do it.
What About Pre-Harvest Agricultural Water Requirements?
In July 2022, the FDA extended the dates for compliance with the PSR’s pre-harvest agricultural water provisions. It is not yet known when the pre-harvest ag water rule will be finalized, but once it is, it will require farms to conduct an annual, systems-based agricultural water assessment to determine and guide measures to minimize potential risks associated with pre-harvest agricultural water. When the rule is finalized, FDA proposes the following compliance dates:
• Two years, nine months after the effective date for very small businesses;
• One year, nine months after the effective date for small businesses; and
• Nine months after the effective date for all other businesses.
Although the rule is still in proposed stages, all farms except small and very small businesses will have only nine months following the effective date of the final rule to come into compliance. ‘That means now is a good time to make sure you are implementing pre-harvest ag water practices and managing risks appropriately.
What Can I Do To Make Sure My Farm Is Ready For Inspection?
With the end of the enforcement discretion period, the FDA will be starting routine inspections that include harvest and post-harvest ag water use assessments.
In its educate while regulating approach, the agency will work with state and industry partners in training, technical assistance, educational visits, and on-farm readiness reviews.
Information about on-farm readiness reviews in Maryland is available at the Maryland Department of Agriculture’s website.
You can also contact Molly Gillingham, MDA’s Program Manager for Food Quality Assurance, at 410-841-5769, or e-mail email@example.com.