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Bill Marler

FDA Compliance

Is the FDA Creating a HACCP Program for Produce?

New FDA rule proposes that farms conduct water assessments rather than previously required tests

Published: Wednesday, January 19, 2022 - 13:02

Although the announcement, “FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce,” is a bit to fully digest in one sitting, I’m intrigued by the FDA’s focus on pre-harvest risk assessment of water risk as opposed to water testing for pathogens generally.

The FDA’s requirement of an annual water-risk assessment by farms to “determine whether corrective or mitigation measures are reasonably necessary to reduce the potential for contamination” arguably creates a hazard analysis and critical control point (HACCP) for produce. This requires that produce growers take stock of what pathogen risks surround them on nearby lands, like cattle operations or wild animal populations, that might impact water quality, and take measures to protect produce consumers from possible infection from a deadly pathogen.

With respect to risky adjacent land operations, it’s unclear at this point what a grower can do to mitigate those risks short of relocating, or treating or testing water. However, this rule seems to remove certain water-testing requirements. One method of confirming if HACCP is working is science-based  testing to help understand if the mitigation measures are in fact working.

So, in my view the jury is still out on:
1. Will eliminating water testing and increasing assessments make for a safer product?
2. Shouldn’t the FDA recognize that produce is essentially a ready-to-eat product grown outside with the risks inherent from what’s directly around it or what might blow or flow to it?
3. Wouldn’t a broader environmental approach be required to ensure produce safety?

Here’s the FDA’s press release with links:

Today, the U.S. Food and Drug Administration (FDA) issued a proposed rule that aims to enhance the safety of produce. It proposes to require farms to conduct comprehensive assessments that would help them identify and mitigate hazards in water used to grow produce. This is the latest step in the agency’s implementation of the FDA Food Safety Modernization Act (FSMA), and it proposes to replace some of the existing requirements for agricultural water in the Produce Safety Rule (PSR).

“There have been far too many foodborne illness outbreaks possibly linked to pre-harvest agricultural water in recent years, including water coming from lands nearby produce farms,“ says Frank Yiannas, FDA deputy commissioner for food policy and response. “As a federal government agency charged with protecting public health, the FDA is committed to implementing effective modern, science-based measures designed to prevent these outbreaks from occurring in the future. The proposed rule is the latest action taken by the FDA to continue working toward implementation of key provisions of FSMA. If finalized, we’re confident this proposal would result in fewer outbreaks in the U.S. related to produce, protecting public health and saving lives. This proposed rule is a monumental step towards further improving the safety of the fruits and vegetables Americans serve their families every day, and the FDA looks forward to engaging with stakeholders on the proposed changes.”

The proposed rule, if finalized, would change certain pre-harvest agricultural water requirements for produce and farms subject to the PSR, other than sprouts operations. Key provisions in the proposed rule include:

• A requirement for farms to manage their agricultural water quality based on the results of a comprehensive systems assessment (“agricultural water assessment”) that is adaptable to the wide variety of water sources and uses,  and future scientific advancements.

• An annual assessment by farms of their pre-harvest agricultural water to identify any conditions likely to introduce hazards into, or onto, covered produce or food-contact surfaces. Based on these assessments, farms would then determine whether corrective or mitigation measures are reasonably necessary to reduce the potential for contamination. The assessment would include an evaluation of the farm’s water system, agricultural water-use practices, crop characteristics, environmental conditions, and other relevant factors, such as the results of any testing conducted to inform the assessment.

• A requirement that farms implement expedited mitigation measures for hazards related to certain activities associated with adjacent and nearby lands, to protect the quality of the water used on produce. This is being included following several recent outbreak investigations on produce that revealed potential routes of contamination, including activities and conditions such as animal grazing and the presence of livestock and wildlife on land adjacent to, or near, produce farms or their water sources.

• The removal of certain testing requirements for pre-harvest agricultural water and replacing them with the agricultural water assessments identified above. The proposed revisions are intended to address stakeholder concerns about complexity and practical implementation challenges while protecting public health.

The FDA intends to continue working closely with stakeholders and our state and tribal partners to provide necessary training, technical assistance, education, and outreach. The agency will hold two virtual public meetings to discuss the proposal and hear feedback, and more details will be announced in a forthcoming Federal Register notice. In addition, the agency is also developing an online tool to assist growers in understanding agricultural water assessments.

Recognizing that the current agricultural water compliance dates for covered produce other than sprouts under the PSR are set to begin in January 2022, the agency intends to exercise enforcement discretion for those agricultural water requirements while pursuing another proposed rule to extend the compliance dates for all of the agricultural water requirements in the PSR for such covered produce. More information on the proposed compliance date extension will be announced in a forthcoming Federal Register notice.

The FDA’s proposal is one of the critical remaining pieces of working toward FSMA implementation. The FDA has taken many important steps to achieve the food safety goals envisioned by Congress when FSMA was established in 2011, such as implementing seven foundational rules. The FDA also has developed multiple action plans to address specific food-safety issues and has further built on the foundation under FSMA through the New Era of Smarter Food Safety initiative.

Related information:
FDA Proposes Changes to Agricultural Water Requirements in the Produce Safety Rule
FSMA Proposed Rule on Agricultural Water
FDA Food Safety Modernization Act

First published Dec. 3, 2021, on Food Safety News.


About The Author

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Bill Marler

Bill Marler is an accomplished personal injury lawyer and national expert on foodborne illness litigation. He began representing victims of foodborne illness in 1993, when he represented Brianne Kiner, the most seriously injured survivor of the Jack in the Box E. coli O157:H7 outbreak, resulting in her landmark $15.6 million settlement. Marler founded Food Safety News in 2009.