FSMA Produce Safety Rule: Agricultural Water System Inspection is Different from the Proposed Agricultural Water Assessment

FSMA Produce Safety Rule: Agricultural Water System Inspecon

is Dierent from the Proposed Agricultural Water Assessment

Don Stoeckel, Donna Clements, Thais Ramos, Tommy Saunders, Mariana Villarreal, Elizabeth A. Bihn

May 2023

This fact sheet provides informaon about the

dierences between an Agricultural Water System

Inspecon (§ 112.42) and the proposed Agricultural

Water Assessment (AgWA) from the Food Safety

Modernizaon Act (FSMA) Produce Safety Rule (PSR).

This informaon is based on the current FSMA PSR

requirements for agricultural water

as well as proposed

revisions to the current requirements that were

published in 2021

Subpart E of the FSMA PSR for fruit and vegetables

producers can be grouped into requirements related to:

• Growing covered produce other than sprouts

(producon/ pre-harvest water)

• Harvesng and packing covered produce other than

sprouts (harvest/ postharvest water)

Dierences between FSMA PSR Requirements

for Agricultural Water System Inspecon and

Agricultural Water Assessment

The Agricultural Water System Inspecon is a

requirement in the FSMA PSR

, with enforcement dates

phased in (according to business size class) beginning

in January 26, 2023 for harvest/ postharvest water.

This requirement will eventually include all agricultural

water systems at covered farms, including those used

for producon/ pre-harvest and harvest/ postharvest

agricultural water, but currently only apply to harvest/

postharvest water unl the nal producon/pre-harvest

standards are published. The requirement covers

agricultural water systems to the extent that they are

under the farm’s control, but requires consideraon

of o-site inuences that could introduce human

pathogens to water and the use of pracces that reduce

these risks.

The inspecon must be done at least once per year, to

idenfy condions that may introduce hazards (e.g.,

human pathogens) to covered produce or food-contact

surfaces through water. Observaons made during the

inspecon are used to guide the implementaon of

pracces such as system repairs, maintenance, or other

acons that reduce the idened risks. The ndings

of the inspecon must be documented in the farm’s

record. The PSA Records Required by the FSMA Produce

Safety Rule fact sheet

provides a template to aid in

recordkeeping.

The Agricultural Water Assessment (AgWA) is a

proposed requirement

, subject to change unl it is

nalized. This requirement would be in addion to the

Agricultural Water System Inspecon. The AgWA is

specic to producon/ pre-harvest agricultural water

that is used to grow covered produce. The AgWA is

proposed to be completed at least once per year, to

idenfy condions that may result in contaminaon of

the water source or otherwise increase the likelihood

of human pathogens being in the water. In contrast to

the Agricultural Water System Inspecon which focuses

on the physical agricultural water system, the AgWA

requires consideraon of crops being grown, weather

impacts, adjacent land uses, and other things that can

inuence risks to fruits and vegetables being produced.

Observaons made during the AgWA enable a farm to

reduce risks by determining what uses are appropriate

for the water source, including applicaon of measures

that may be necessary to reduce produce safety risks.

The ndings of the AgWA, and any correcve measures

or migaon measures applied as an outcome of the

assessment, must be documented in the farm’s record.

The table on the following page provides a more detailed

comparison of the two requirements.

Agricultural water system means a source of agricultural water, the water distribuon system, any building or

structure that is part of the water distribuon system (such as a well house, pump staon, or shed), and any

equipment used for applicaon of agricultural water to covered produce during growing, harvesng, packing,

or holding acvies

V1 • 5/10/23

Characterisc Agricultural Water System Inspecon Agricultural Water Assessment (proposed)

Regulatory

requirement

FSMA Produce Safety Rule

21 Code of Federal Regulaons (CFR) 112.42

Proposed revision to 21 CFR Subpart E

Compliance date Started January 26, 2022

• Inially under enforcement discreon

• Phased in by business size class

Proposed to begin 9 months aer the eecve date of the nal revised 21 CFR Subpart E

• Phased in by business size class

Scope of

requirement

For all agricultural water systems on covered farms, to the extent

under the farm’s control. Applies to water used during growing,

harvest, and postharvest acvies

Applies to agricultural water used during growing acvies (producon/ pre-harvest

water) on covered farms

Frequency FSMA PSR § 112.42: "At the beginning of a growing season, as

appropriate, but at least once annually"

Proposed § 112.43: "Based in part on the results of any inspecons and maintenance

you conducted under § 112.42, at least once annually you must prepare a wrien

agricultural water assessment for water that you apply to covered produce (other than

sprouts) using a direct applicaon method during growing acvies."

Evaluaon

parameters

Abridged quote from FSMA PSR § 112.42:

"... Idenfy condions that are reasonably likely to introduce

known or reasonably foreseeable hazards into or onto covered

produce or food contact surfaces in light of your covered produce,

pracces, and condions, including consideraon of the following:

(1) The nature of each agricultural water source (for example,

ground water or surface water);

(2) The extent of your control over each agricultural water source;

(3) The degree of protecon of each agricultural water source;

(4) Use of adjacent and nearby land; and

(5) The likelihood of introducon of known or reasonably

foreseeable hazards to agricultural water by another user of

agricultural water before the water reaches your covered farm."

Paraphrased from proposed § 112.43(a):

• Water system characteriscs: mostly informaon carried over from the Agricultural

Water System Inspecon

• Agricultural water pracces: how the water is used

• Crop characteriscs: such as those related to adhesion or internalizaon

• Environmental condions: including potenal for water source contaminaon related

to runo

• Other factors: including tesng results

Outcome Maintain water sources and distribuon systems to reduce the

potenal for pathogens in the water.

Paraphrased from proposed § 112.43(c):

• Determine whether either of the following is reasonably necessary based on ndings

of the AgWA:

(a) disconnuaon of use pending correcve measures, or

(b) implementaon of migaon measures

• Record the determinaon

• Take necessary and appropriate acon

Documentaon

required

FSMA PSR § 112.50(b)(1): “You must establish and keep the

following records: The ndings of the inspecon of your agricultural

water system in accordance with the requirements of § 112.42(a)”

Abridged quote from proposed § 112.50(b)(2):

"Your wrien agricultural water assessments, including descripons of factors evaluated

and wrien determinaons..."

Abridged quote from proposed § 112.50(b)(7):

"Documentaon of acons you take in accordance with § 112.45..." (e.g.,

disconnuaon of use pending correcve measures, implementaon of migaon

measures)

Compliance and Enforcement Dates

The FSMA PSR was published in its nal form in

December, 2015

. Farms growing covered produce other

than sprouts were not inspected against the agricultural

water requirements in Subpart E up unl January 2023.

This is because FDA both extended relevant compliance

dates

and announced policies to exercise enforcement

discreon (i.e., inspectors do not enforce those

requirements) in order to “allow me for the agency to

consider how best to address stakeholder concerns while

protecng public health.”

In December 2021, FDA published a proposed rule in the

Federal Register to revise Subpart E

. FDA followed up

in July 2022 with a proposed rule for producon/ pre-

harvest water compliance dates

and in January 2023

with a fact sheet

, both stang that the policy to exercise

enforcement discreon for requirements related to

harvest/ postharvest water would end in January 2023.

The updated policy results in enforcement for covered

farms selling more than $500,000 of produce per year

(3-year average) rst, with enforcement dates that are

phased in for other business size classes.

Business

Size Class

Compliance dates

(enforcement dates)

for harvest/

postharvest water

Compliance dates

for producon/

pre-harvest water

(proposed)

All other

businesses

(> $500,000

annual produce

sales*)

January 26, 2022

(January 26, 2023)

9 months aer

eecve date of

nal revised rule

Small businesses

($250,000 to

$500,000 annual

produce sales)

January 26, 2023

(January 26, 2024)

1 year, 9 months

aer eecve date

of nal revised

rule

Very small

businesses

(< $250,000

annual produce

sales)

January 26, 2024

(January 27, 2025)

2 years, 9 months

aer eecve date

of nal revised

rule

*Annual produce sales are calculated on a rolling three-year

average basis and are not adjusted for inaon.

What Subpart E Requirements Apply Now?

• Covered farms that use agricultural water in covered

acvies during and aer harvest (i.e., harvesng,

packing, holding) must follow the relevant 2015

Produce Safety Rule requirements in Subpart E

including the Agricultural Water System Inspecon

when their business becomes subject to the rule

(see table to the le).

• Requirements for agricultural water used during

producon/pre-harvest are currently (Spring 2023) at

the proposed stage, and do not apply unl publicaon

of the nal rule and compliance dates arrive.

Supporng Guidance and Fact Sheets

The preamble to the FSMA PSR

is valuable for

understanding the basis for current requirements.

FDA also summarized the requirements for harvest/

postharvest agricultural water in a fact sheet released in

January 2023

The preamble to the proposed revision to Subpart E

provides a basis for understanding what is currently

proposed for producon/ pre-harvest agricultural water.

In addion, FDA has described proposed revisions to

Subpart E producon/ pre-harvest requirements in a fact

sheet

and an Agricultural Water Assessment Builder

tool

which provide insight into what compliance with

the future requirement may look like.

The PSA Team used these FDA documents along with

insights from collaborang subject maer experts

to create a template for the required record of the

Agricultural Water System Inspecon

. PSA also created

a fact sheet and a decision tree to aid in lling out the

record and navigang the Agricultural Water System

Inspecon process

PSA plans to update this fact sheet with future versions

as FDA publishes new guidance and tools, and as the

nalized Subpart E revision arrives.

References

1. U.S. Food and Drug Administraon 2015. Standards for the Growing, Harvesng, Packing, and Holding of

Produce for Human Consumpon. (Final Rule). Federal Register November 27, 2015. 80(228):747354-74568.

Accessed March 2023.

2. U.S. Food and Drug Administraon 2021. Standards for the Growing, Harvesng, Packing, and Holding of

Produce for Human Consumpon Relang to Agricultural Water. (Proposed Revisions to Subpart E). Federal

Accessed March 2023.

3. K. Woods, D. Pahl, D. Stoeckel, B. Fick, G. Wall, and E.A. Bihn 2020. Water System Inspecon Record Template.

Page 2 in Records Required by the FSMA Produce Safety Rule. Fact Sheet. Produce Safety Alliance, Cornell

University. Revision in preparaon March 2023.

Accessed March 2023.

4. U.S. Food and Drug Administraon 2019. Standards for the Growing, Harvesng, Packing, and Holding of

Produce for Human Consumpon; Extension of Compliance Dates for Subpart E. Federal Register March 18,

2019. 84(52) 9706-9714.

Accessed March 2023.

5. U.S. Food and Drug Administraon 2021. FDA Proposes Changes to Agricultural Water Requirements in the

Produce Safety Rule. Constuent Update.

Accessed March 2023.

6. U.S. Food and Drug Administraon 2022. Standards for the Growing, Harvesng, Packing, and Holding of

Produce for Human Consumpon Relang to Agricultural Water. (Proposed Compliance Dates for Subpart E

Revisions). Federal Register July 19, 2022. 87(137):42937-42979.

Accessed March 2023.

7. U.S. Food and Drug Administraon 2023. End of Intended Enforcement Discreon for Subpart E Requirements

for Harvest and Post-Harvest Agricultural Water for Covered Produce Other than Sprouts - Beginning January 26,

2023. Fact Sheet.

Accessed March 2023.

8. U.S. Food and Drug Administraon 2021. Agricultural Water Proposed Rule. Fact Sheet.

Accessed March 2023.

9. U.S. Food and Drug Administraon 2021. Agricultural Water Assessment Builder. Online tool.

Accessed March 2023.

10. Produce Safety Alliance In Preparaon. Agricultural Water System Inspecon Fact Sheet and Decision Tree.