The standards proposed in subpart E of the rule are directed to agricultural water only. Indirect water application methods where water is not intended to, and is not likely to, contact the harvestable or harvested part of the crop would not be subject to the requirements of proposed subpart E of the rule. As proposed, “agricultural water” would not include indirect water application methods used during growing. For example, generally, the water used for drip or furrow irrigation in apple orchards would not be considered agricultural water because the water is unlikely to contact the harvestable portion of the crop. FDA is proposing to distinguish between water that is intended to, or is likely to, contact produce or food-contact surfaces and water that is not intended to, and is not likely to, contact produce or food-contact surfaces based on the relative likelihood of contamination from water that contacts produce and the need for measures to minimize such likelihood.
While indirectly applied water is unlikely to contact produce or food-contact surfaces, we recognize that it presents the possibility of produce contamination. For example, use of contaminated water in drip or furrow irrigation may still serve as a vehicle for bringing contaminants into the growing environment which may potentially be transferred to produce by rain splash, workers, or equipment; use of contaminated water for dust abatement on farm roads may also be transferred to produce by run-off, rain splash, workers, or equipment.
Indirect water application methods would remain subject to Section 402(a)(4) of the FD&C Act. That is, indirect water application may adulterate produce if, considering the water quality and the manner of its application, the use of the water causes produce to be prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. Moreover, if a pathogen is detected in or on produce, such produce would be considered adulterated under Section 402(a)(1) of the FD&C Act, in that it contains a poisonous or deleterious substance which may render it injurious to health. Therefore, we have tentatively concluded that indirect water application methods do not need to be covered within the scope of “agricultural water” for the purposes of the proposed rule. We are seeking public comment on our proposed limited scope of “agricultural water.”
