Today the Food and Drug Administration (FDA) announced a new proposed revision to Subpart E (Agricultural Water) of the Food Safety Modernization Act Produce Safety Rule. This portion of the rule was placed on hold in 2017.

There will be a 120-day comment period and two virtual public meetings will be held in 2022. The timing for these meetings will be announced later. Please note this is a proposed rule and has not been finalized yet.

What is in the Proposed Revision?

• The proposed revision replaces the microbial quality criteria and testing requirements currently in §§ 112.44(b) and 112.46(b) with new provisions for conducting pre-harvest agricultural water assessments (proposed § 112.43) for hazard identification.
• Farms can still elect to test their pre-harvest agricultural water to help inform their agricultural water assessments.
• New options for mitigation measures have been added and expedited implementation of mitigation measures for known ore reasonably foreseeable hazards related to certain adjacent and nearby land uses.
• Management review is required for pre-harvest agricultural water assessments.
• New definitions of “agricultural water assessment” and “agricultural water system”

When do Farms Need to Comply?

The proposed rule does not delay the first compliance dates set to begin in January 2022. However, the FDA will be using Enforcement Discretion while it proposes another new rule to postpone these compliance dates.

What is Agricultural Water?

As defined in the rule under §§112.3: Agricultural water means water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food contact surfaces, including water used in growing activities (including irrigation water applied using direct water application methods, water used for preparing crop sprays, and water used for growing sprouts) and in harvesting, packing, and holding activities (including water used for washing or cooling harvested produce and water used for preventing dehydration of covered produce). 

Useful Links

FDA Proposes Changes to FSMA Agricultural Water Used on Produce: https://www.fda.gov/news-events/press-announcements/fda-proposes-changes-food-safety-modernization-act-rule-enhance-safety-agricultural-water-used

FSMA Proposed Rule on Agricultural Water: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-proposed-rule-agricultural-water

 

For More Information

Please contact the Produce Safety Program at produce.safety@oda.oregon.gov or 971-283-4749.