As initially announced last week by outgoing Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., the compliance dates for FDA’s agricultural water quality requirements under the “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption” rule (Produce Rule) are being extended. Today, FDA published a final rule in the Federal Register that the requirements’ (21 C.F.R. Part 112, Subpart E) compliance date will be extended by two years. This extension is based – in large part – on the complexity of implementing sampling and testing regimes in the agricultural water requirements.
This extension finalizes FDA’s September 2017 proposal to extend the compliance dates for these requirements. The extension applies to all covered produce, except sprouts. The new compliance dates are as follows:
- January 26, 2024, for very small businesses,
- January 26, 2023, for small businesses, and
- January 26, 2022, for all other businesses.
This final rule does not change the compliance dates for sprouts (which have already passed), as the agricultural water requirements for sprouts are different from the requirements for other produce commodities (compare §§ 112.44(a)(1) and 112.44(b)). Moreover, the final rule does not change the substance of the agricultural water requirements, or address substantive comments that requested technical clarification.
Since the Produce Rule was published in November 2015, FDA received feedback from numerous stakeholders raising issues regarding the practicality of some of the agricultural water requirements. Many of these concerns related to the testing requirements for pre-harvest agricultural water, which are different for sprouts than they are for other types of covered produce. FDA is extending the compliance date so the agency has additional time to consider how to approach these issues.
FDA will continue to pursue a rigorous stakeholder engagement plan in the coming months as the agency considers the “practical implementation” of the agricultural water requirements. At the same time, Congressional interest in the Produce Rule’s implementation is unabated and many food safety proponents continue to press the agency for swifter action. While the delay means that produce growers will not be saddled with what some view as unclear or unworkable rules anytime soon, how the final rules governing agricultural water sampling and testing will work is still unclear. We will provide further updates on this blog as FDA issues clarification on the agricultural water requirements.