Advancing the science of risk-based criteria for agricultural water quality:  Industry perspectives on the use of risk-based approaches

Jennifer McEntire, PhD

VP, Food Safety

United Fresh Produce Association

FVIAC

Aug 14, 2019

1

Key Points

Everyone knows ag water quality is important to food safety

Regulatory requirements are on pause

Industry mindset around managing risk has shifted

Leafy greens producers

Breadth of produce industry

Next steps

Continue to support science

Support science & risk based regulation

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Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, current Subpart E

“all agricultural water must be safe and of adequate sanitary quality for its intended use” (§ 112.41)

water that is intended to, or is likely to, contact the harvestable portion of covered produce or food-contact surfaces (§ 112.3(c))

Requirements on inspection/maintenance of ag water sources and systems, microbial quality, and record-keeping

Microbial limits are specified

Specifies generic E. coli as the indicator organism

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PSR Requirements

Microbial water quality profile (MWQP)

rolling 4-year data set of water testing results

 geometric mean (GM) of 126 or less CFU generic E. coli/100 mL water 

statistical threshold value (STV) of 410 or less CFU generic E. coli/100 mL water

“Die off” provision

The requirement for agricultural water used during and after harvest is no detectable generic E. coli in 100 mL of water. 

Challenges

The math

The logistics

The method

Is it the right standard?

Recreational water

Other hazards

Delay of Ag Water Compliance

“The extension is designed to provide additional time to ensure the FDA applies the best thinking to clarify standards for pre-harvest microbial water quality and to continue working closely with produce farmers on sensible approaches to protect consumers”

March 15, 2019 Statement from former-Commissioner Gottlieb   

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633586.htm

FDA needs time to compile and interpret the science

Opportunity for industry to provide input and support

Rulemaking required if updates made to the standards

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February 2018 “Water Summit”

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Industry Response(s)

April 2019 – update to LGMA guidelines

Covers ~90% of leafy greens grown in US

Emphasis on evaluating ag water risk based on:

Source, storage, and conveyance

Water use/application

Timing of application

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Categorizes water into types: A, B, and BA (treated)

Defines acceptable uses of water categories

**Open source water must be treated (verified method) if applying overhead within 21 days of harvest

CA-LGMA currently working on guidance to help growers validate ag water treatment systems  

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Harmonized Ag Water Working Group

Initiated in 2018 to mitigate varying interpretations on how to conduct a risk assessment

Basic risk assessment ‘decision tree’ based on:

Crop use 

Water source

Water delivery system

Application method

Detailed hazard mitigation table 

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Center for Produce Safety

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Industry Needs

More science; communicate what we already know

CPS, PSA, etc.

Continued collaboration with FDA 

United Fresh shared risk assessment guidance

Developing position statement as FDA reevaluates Subpart E

Be proactive – don’t wait for FDA

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