Federal Register / Vol. 87, No. 137 / Tuesday, July 19, 2022 / Proposed Rules 42973 

1Agricultural water for produce subject to the 

requirements of part 112 (covered produce) other 

than sprouts, using a direct application method 

during growing activities are commonly referred to 

as ‘‘pre-harvest agricultural water.’’ The produce 

safety regulation refers to pre-harvest agricultural 

water used during sprout production as ‘‘sprout 

irrigation water.’’ 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 112 

[Docket No. FDA–2021–N–0471] 

RIN 0910–AI49 

Standards for the Growing, Harvesting, 

Packing, and Holding of Produce for 

Human Consumption Relating to 

Agricultural Water 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; supplemental 

notice of proposed rulemaking. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is proposing dates for compliance 

with the pre-harvest agricultural water 

provisions for covered produce other 

than sprouts in the ‘‘Standards for the 

Growing, Harvesting, Packing, and 

Holding of Produce for Human 

Consumption Relating to Agricultural 

Water’’ proposed rule. We also are 

specifying the duration of the period 

during which we intend to exercise 

enforcement discretion for the harvest 

and post-harvest agricultural water 

requirements for covered produce other 

than sprouts in the produce safety 

regulation to provide covered farms, 

regulators, educators, and other 

stakeholders additional time to facilitate 

compliance with those provisions. The 

proposed compliance dates for preharvest agricultural water requirements 

and our exercise of enforcement 

discretion for the harvest and postharvest agricultural water provisions are 

intended to facilitate successful 

implementation and optimize public 

health protections. We are reopening the 

comment period only with respect to 

the compliance dates for the proposed 

pre-harvest agricultural water 

provisions for covered produce other 

than sprouts. 

DATES: Either electronic or written 

comments on the proposed rule must be 

submitted by September 19, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

September 19, 2022. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–N–0471 for ‘‘Standards for the 

Growing, Harvesting, Packing, and 

Holding of Produce for Human 

Consumption Relating to Agricultural 

Water.’’ Received comments, those filed 

in a timely manner (see ADDRESSES), 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Samir Assar, Center for Food Safety and 

Applied Nutrition (HFS–317), Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–1636, 

samir.assar@hhs.fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Purpose of the Supplemental Notice 

of Proposed Rulemaking 

This supplemental notice of proposed 

rulemaking proposes compliance dates 

for the pre-harvest agricultural water 1

provisions for covered produce other 

than sprouts in the proposed rule, 

‘‘Standards for the Growing, Harvesting, 

Packing, and Holding of Produce for 

Human Consumption Relating to 


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2Agricultural water used during harvesting, 

packing, and holding activities are commonly 

referred to as ‘‘harvest and post-harvest agricultural 

water.’’ 

3The produce safety regulation refers to preharvest agricultural water used during sprout 

production as ‘‘sprout irrigation water.’’ 

Agricultural Water’’ (86 FR 69120, 

December 6, 2021) (2021 agricultural 

water proposed rule) and announces our 

intent to continue the policy of 

enforcement discretion for the relevant 

subpart E requirements in the produce 

safety regulation until this rulemaking is 

completed. Additionally, we are 

specifying the duration of our intended 

enforcement discretion policy for the 

harvest and post-harvest agricultural 

water 2 requirements for covered 

produce other than sprouts in the 

produce safety regulation. 

In light of the revisions we are 

proposing to certain pre-harvest 

agricultural water requirements for 

covered produce (other than sprouts) in 

the 2021 agricultural water proposed 

rule, we are proposing to establish dates 

for compliance with the pre-harvest 

agricultural water provisions for 

covered produce other than sprouts as 

follows: 2 years and 9 months after the 

effective date of a final rule for very 

small businesses; 1 year and 9 months 

after the effective date of a final rule for 

small businesses; and 9 months after the 

effective date of a final rule for all other 

businesses (see table 3). 

We are not proposing a compliance 

date extension for the harvest and postharvest agricultural water requirements 

for covered produce other than sprouts 

because we did not propose to change 

those provisions. However, we are 

specifying the duration of our intended 

enforcement discretion policy for the 

harvest and post-harvest agricultural 

water provisions for covered produce 

other than sprouts in the produce safety 

regulation until January 26, 2025, for 

very small businesses; January 26, 2024, 

for small businesses; and January 26, 

2023, for all other businesses (see table 

3). 

B. Summary of the Major Provisions of 

the Supplemental Notice of Proposed 

Rulemaking 

The 2021 agricultural water proposed 

rule, if finalized, would revise certain 

provisions in the produce safety 

regulation applicable to pre-harvest 

agricultural water.3 The 2021 

agricultural water proposed rule would 

not substantively alter the standards 

established in part 112, subpart E, for 

agricultural water used for sprouts, for 

which the compliance dates have 

passed, or for harvest and post-harvest 

agricultural water, or for treatment of 

agricultural water. 

We are reopening the comment period 

on the 2021 agricultural water proposed 

rule to seek public comment on the 

proposed compliance dates for the preharvest agricultural water provisions for 

covered produce other than sprouts. We 

are proposing to establish dates for 

compliance with the pre-harvest 

agricultural water provisions for 

covered produce other than sprouts as 

follows: 2 years and 9 months after the 

effective date of a final rule for very 

small businesses; 1 year and 9 months 

after the effective date of a final rule for 

small businesses; and 9 months after the 

effective date of a final rule for all other 

businesses. We are proposing these 

compliance dates in light of the 

proposed revisions to certain preharvest agricultural water requirements 

for covered produce (other than 

sprouts). 

As the 2021 agricultural water 

proposed rule did not propose to change 

the requirements of the produce safety 

regulation that apply to harvest and 

post-harvest agricultural water for 

covered produce other than sprouts, we 

are not proposing a compliance date 

extension for those provisions. 

However, we are specifying the duration 

of our intended enforcement discretion 

policy for the harvest and post-harvest 

agricultural water provisions for 

covered produce other than sprouts in 

the produce safety regulation to provide 

covered farms, regulators, educators, 

and other stakeholders additional time 

to facilitate compliance with those 

requirements. (The compliance dates for 

harvest and post-harvest requirements 

are likely to occur before we complete 

this rulemaking, in which we have 

proposed to reorganize and replace 

subpart E in its entirety. In this 

document we refer to those provisions 

according to the section numbers in the 

produce safety regulation, recognizing 

that subpart E may be reorganized 

subsequently through this rulemaking.) 

We recognize that prior to the 

publication of the 2021 agricultural 

water proposed rule, stakeholders did 

not have clarity on whether additional 

substantive changes for the harvest and 

post-harvest agricultural water 

provisions would be proposed. In 

addition, we recognize that the intended 

benefits of the harvest and post-harvest 

requirements may not be fully realized 

unless accompanied by adequate 

training, technical assistance, and other 

preparations to support effective 

implementation by all parties. 

Therefore, we intend to exercise 

enforcement discretion for the harvest 

and post-harvest agricultural water 

provisions for covered produce other 

than sprouts in the produce safety 

regulation until January 26, 2025, for 

very small businesses; January 26, 2024, 

for small businesses; and January 26, 

2023, for all other businesses. 

The proposed compliance dates for 

pre-harvest agricultural water 

provisions in the 2021 agricultural 

water proposed rule and enforcement 

discretion policy for the harvest and 

post-harvest agricultural water 

provisions in the produce safety 

regulation are intended to optimize 

public health by allowing for the proper 

foundation to be established for 

successful implementation. 

Additionally, these dates are informed 

by experience, information, and 

feedback on the inherent 

implementation challenges with 

agricultural water requirements given 

the scale and diversity of the produce 

sector and agricultural water systems 

and with a long-term view toward 

improving public-health outcomes. 

At this time, we are not seeking 

comment on any other provisions of the 

previously published proposed rule that 

are not identified for public comment in 

this document. We will complete our 

review of public comments received 

thus far, and take into account 

comments received on the proposed 

compliance dates in response to this 

document, in issuing a final rule. 

C. Legal Authority 

The proposed compliance dates for 

certain agricultural water provisions 

discussed in this document are 

consistent with our authority in sections 

402, 419, and 701(a) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 342, 350h, and 371(a)) 

and sections 311, 361, and 368 of the 

Public Health Service Act (PHS Act) (42 

U.S.C. 243, 264, and 271). We discuss 

our legal authority in greater detail in 

the 2021 agricultural water proposed 

rule (86 FR 69128–69129). 

D. Costs and Benefits 

We have examined the impacts of this 

supplemental proposed rule. 

Annualized at either 3 percent or 7 

percent, our primary estimates for the 

costs of this supplemental proposed rule 

are $ 0.1 million. The benefit of this 

supplemental proposed rule is clarity to 

stakeholders about the proposed 

compliance dates for the pre-harvest 

agricultural water provisions for 

covered produce other than sprouts 

described in the 2021 agricultural water 

proposed rule. 


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4Under the produce safety regulation, a farm is 

a very small business if, on a rolling basis, the 

average annual monetary value of produce it sold 

during the previous 3-year period is no more than 

$250,000. A farm is a small business if, on a rolling 

basis, the average annual monetary value of 

produce it sold during the previous 3-year period 

is no more than $500,000, and the farm is not a very 

small business. See § 112.3. 

II. Background 

This pre-harvest agricultural water 

compliance dates proposal concerns one 

of the seven foundational rules that we 

have established as part of our 

implementation of section 105 of the 

FDA Food Safety Modernization Act 

(FSMA; Pub. L. 111–353): the 

‘‘Standards for the Growing, Harvesting, 

Packing, and Holding of Produce for 

Human Consumption’’ rule (80 FR 

74354, November 27, 2015) (2015 

produce safety final rule) (codified in 21 

CFR part 112). FSMA, which was signed 

into law on January 4, 2011, is intended 

to allow FDA to better protect public 

health by helping to ensure the safety 

and security of the food supply. 

In the preamble of the 2015 produce 

safety final rule, we stated that the 

regulation would be effective on January 

26, 2016, and provided for compliance 

dates of 1 to 6 years from the effective 

date depending on farm size, 

commodity, and provision(s) (see table 

entitled ‘‘compliance dates’’ in the 

preamble of the 2015 produce safety 

final rule, 80 FR 74354 at 74357, as 

corrected in a technical amendment at 

81 FR 26466, May 3, 2016). (Some of the 

compliance dates identified in the 

technical amendment fall on weekends 

(i.e., January 26, 2019, is a Saturday and 

January 26, 2020, is a Sunday) and 

should therefore be read as referring to 

the next business day (i.e., January 28, 

2019, and January 27, 2020, 

respectively). We use the latter dates 

throughout this document.) 

For the majority of agricultural water 

provisions in subpart E (and for most of 

the other provisions in the rule), with 

respect to covered produce other than 

sprouts, we provided compliance 

periods of 4 years from the effective date 

of the rule for very small businesses, 3 

years for small businesses, and 2 years 

for all other businesses.4 We provided 

an additional 2 years beyond those 

compliance periods for certain water 

quality requirements in § 112.44 and 

related provisions in §§ 112.45 and 

112.46. See table 1. 

TABLE 1—AS STATED IN THE 2015 PRODUCE SAFETY FINAL RULE (80 FR 74461), COMPLIANCE DATES FOR REQUIREMENTS IN SUBPART E (AGRICULTURAL WATER) FOR COVERED ACTIVITIES INVOLVING COVERED PRODUCE (EXCEPT

SPROUTS SUBJECT TO SUBPART M) 

Compliance dates of 2–4 years applicable to the farm based on its size Extended compliance date of additional 2 years beyond the compliance 

date based on size of farm 

§ 112.41. 

§ 112.42. 

§ 112.43. 

§ 112.45(a) with respect to safe and adequate standard. 

§ 112.46(a). 

§ 112.46(b)(1) with respect to untreated surface water. 

§ 112.47. 

§ 112.48. 

§ 112.49. 

§ 112.50. 

§ 112.44. 

§ 112.45(a) with respect to § 112.44(a) criterion. 

§ 112.45(b). 

§ 112.46(b)(1) with respect to untreated ground water. 

§ 112.46(b)(2) and (b)(3). 

§ 112.46(c). 

In a final rule, ‘‘The Food and Drug 

Administration Food Safety 

Modernization Act: Extension and 

Clarification of Compliance Dates for 

Certain Provisions of Four 

Implementing Rules’’ (81 FR 57784, 

August 24, 2016) we also extended the 

compliance date for certain ‘‘customer 

provisions’’ in four of the seven 

foundational rules that we have 

established as part of our 

implementation of FSMA, including the 

2015 produce safety final rule 

(§ 112.2(b)(3)). In that final rule, we also 

clarified the compliance dates for 

certain agricultural water testing 

provisions as originally established in 

the 2015 produce safety final rule. 

In 2017, we issued a proposed rule, 

‘‘Standards for the Growing, Harvesting, 

Packing, and Holding of Produce for 

Human Consumption; Extension of 

Compliance Dates for Subpart E’’ (82 FR 

42963, September 13, 2017) (2017 

proposed compliance date extension), in 

which we proposed to extend, for 

covered produce other than sprouts, the 

dates for compliance with the preharvest, harvest, and post-harvest 

agricultural water provisions contained 

in subpart E of the 2015 produce safety 

final rule. We proposed to extend the 

compliance dates, which we later 

finalized in a final rule (84 FR 9706, 

March 18, 2019) (2019 final compliance 

date extension), to address questions 

about the practical implementation of 

compliance with certain provisions and 

to consider how we might further 

reduce the regulatory burden or increase 

flexibility while continuing to protect 

public health. In that final rule we also 

finalized a uniform compliance date 

structure such that all the compliance 

dates for subpart E provisions as applied 

to non-sprout covered produce would 

occur at the same time, retaining datestaggering based on farm size. That final 

rule extended the compliance dates for 

the agricultural water requirements in 

subpart E for non-sprout covered 

produce to January 26, 2024, for very 

small businesses; January 26, 2023, for 

small businesses; and January 26, 2022, 

for all other businesses. See table 2. 

TABLE 2—AS STATED IN THE FINAL RULE EXTENDING COMPLIANCE DATES FOR SUBPART E (84 FR 9706), COMPLIANCE

DATES FOR REQUIREMENTS IN SUBPART E FOR COVERED ACTIVITIES INVOLVING COVERED PRODUCE (EXCEPT

SPROUTS SUBJECT TO SUBPART M) 

Size of covered farm Compliance date 

Very Small Business ................................................................................ January 26, 2024. 

Small Business ......................................................................................... January 26, 2023. 


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5See ‘‘FDA-State Produce Safety Implementation 

Cooperative Agreement Program at https://

www.fda.gov/federal-state-local-tribal-andterritorial-officials/grants-and-cooperativeagreements/fda-state-produce-safetyimplementation-cooperative-agreement-program. 

TABLE 2—AS STATED IN THE FINAL RULE EXTENDING COMPLIANCE DATES FOR SUBPART E (84 FR 9706), COMPLIANCE

DATES FOR REQUIREMENTS IN SUBPART E FOR COVERED ACTIVITIES INVOLVING COVERED PRODUCE (EXCEPT

SPROUTS SUBJECT TO SUBPART M)—Continued 

Size of covered farm Compliance date 

All Other Businesses ................................................................................ January 26, 2022. 

The 2021 agricultural water proposed 

rule explains that we intend to exercise 

enforcement discretion for these 

requirements while working to address 

compliance dates in a targeted manner 

through the rulemaking process, with 

the goal of completing the rulemaking as 

quickly as possible (86 FR 69147). At 

public meetings to discuss the proposed 

rule, we reiterated our commitment to 

work diligently to address the 

agricultural water compliance dates for 

covered produce other than sprouts. The 

comment period for the 2021 

agricultural water proposed rule closed 

on April 5, 2022. 

The proposed pre-harvest agricultural 

water compliance dates and 

enforcement discretion policy for 

harvest and post-harvest requirements 

are intended to optimize public health 

by allowing for the proper foundation to 

be established for successful 

implementation that will benefit all 

stakeholders, as described in sections III 

and IV. These dates are informed by 

experience with produce safety rule 

implementation, together with 

information and stakeholder feedback 

on the inherent implementation 

challenges with agricultural water 

requirements given the scale and 

diversity of the produce sector and 

agricultural water systems and with a 

long-term view toward improving 

public-health outcomes. Fully realizing 

the anticipated benefits to consumers of 

the agricultural water requirements 

(including the pre-harvest requirements, 

if finalized) will require a solid 

foundation for implementation to 

ensure that regulators and industry are 

adequately trained and understand how 

to apply the agricultural water 

requirements effectively on individual 

covered farms and, for regulators, also 

necessitates ensuring that the 

requirements are applied consistently. 

We note that the compliance dates for 

provisions of the produce safety 

regulation not related to agricultural 

water have passed, and all compliance 

dates for provisions related to sprouts, 

including for agricultural water have 

passed (see table entitled ‘‘Compliance 

Dates for the Produce Safety Regulation 

Under this Final Rule (21 CFR part 

112)’’ in the 2019 final compliance date 

extension at 84 FR 9709). 

III. Proposed Pre-Harvest Agricultural 

Water Compliance Dates for Covered 

Produce Other Than Sprouts 

In the 2021 agricultural water 

proposed rule, we proposed to revise 

certain provisions in the produce safety 

regulation applicable to pre-harvest 

agricultural water for covered produce 

other than sprouts. In the proposed rule, 

we did not propose to revise the 

requirements established for harvest and 

post-harvest agricultural water. 

Specifically, the proposed rule would 

replace the microbial criteria and testing 

requirements for pre-harvest agricultural 

water for covered produce (other than 

sprouts) with provisions for systemsbased agricultural water assessments 

that are designed to be more feasible to 

implement across the wide variety of 

agricultural water systems, uses, and 

practices, while also being adaptable to 

future advancements in agricultural 

water quality science, and achieving 

improved public health protections. 

Additionally, we proposed to require 

expedited mitigation for hazards related 

to certain activities associated with 

adjacent and nearby lands, in light of 

findings from several recent produce 

outbreak investigations. The proposed 

revisions in the 2021 agricultural water 

proposed rule are intended to address 

stakeholder concerns about complexity 

and practical implementation 

challenges with certain agricultural 

water provisions while more 

comprehensively addressing a known 

route of contamination that can lead to 

preventable foodborne illness that is a 

significant public health problem. 

We recognize that covered farms will 

likely need time to prepare for 

compliance with the provisions we 

proposed to revise, if finalized. We also 

recognize that regulators, educators, and 

other stakeholders may also need time 

to develop education and outreach, 

training, and other tools to facilitate 

understanding and compliance by 

covered farms. FSMA acknowledges the 

importance of education and outreach 

in obtaining compliance with the 

produce safety rule, which established 

the first-of-its-kind Federal produce 

safety requirements. A key pillar of 

FSMA implementation has been to 

ensure that industry has the appropriate 

knowledge and training to effectively 

comply, making it important for 

compliance dates to account for 

remaining outreach, education, and 

training needs. 

FSMA further recognizes a critical 

role for FDA’s State regulatory partners 

in enforcing the regulation in 

coordination with FDA. To this end, 

FDA has established the FDA-State 

Produce Safety Implementation 

Cooperative Agreement Program 5 (FDAState Produce CAP), through which 

most states have developed produce 

safety programs. The FDA-State CAP 

has various program objectives— 

including assessment and planning to 

guide the development of produce 

programs; providing education, 

outreach, and technical assistance to 

produce farms; developing inspection 

regulatory programs; and establishing 

compliance and enforcement 

programs—all of which can take 

significant time, resources, and 

planning to successfully administer. 

Due to the valuable role of FDA’s State 

regulatory partners in the integrated 

food safety system—in particular, their 

essential participation in produce safety 

rule education and enforcement under 

section 419(b)(2)(A) of the FD&C Act— 

we recognize that States need adequate 

time to fully prepare for implementation 

of their program components and that 

coordination efforts are taken between 

state and Federal regulators to ensure 

consistent implementation across all 

regulated industry. Therefore, we 

consider it appropriate to propose 

compliance dates for the proposed preharvest agricultural water requirements 

for covered produce other than sprouts 

and to exercise enforcement discretion 

for the relevant pre-harvest 

requirements in the produce safety 

regulation until this rulemaking is 

completed in order to give covered 

farms and other stakeholders adequate 

time to prepare for compliance. 

This supplemental notice of proposed 

rulemaking does not address the 

underlying requirements in subpart E, 

and we are reopening the comment 


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period only with respect to the preharvest agricultural water compliance 

dates identified in this document. 

In this supplemental notice of 

proposed rulemaking, we are proposing 

compliance dates for the pre-harvest 

agricultural water provisions for 

covered produce other than sprouts, in 

the 2021 agricultural water proposed 

rule. We are not proposing to extend the 

compliance dates for the harvest and 

post-harvest agricultural provisions that 

we are not proposing to change, 

although we intend to exercise 

enforcement discretion for those 

requirements in the produce safety 

regulation (see section IV) for covered 

produce (other than sprouts). We also 

propose that any final rule establishing 

the compliance dates for the pre-harvest 

agricultural water requirements for 

covered produce (other than sprouts) 

would become effective 60 days after 

the date of publication of the final rule 

in the Federal Register. 

Specifically, we are proposing 

compliance dates for the pre-harvest 

agricultural water provisions for 

covered produce other than sprouts 

such that the subpart E compliance 

dates for non-sprout covered produce 

would be those in table 3. 

TABLE 3—COMPLIANCE DATES FOR REQUIREMENTS IN SUBPART E FOR COVERED ACTIVITIES INVOLVING COVERED

PRODUCE (EXCEPT SPROUTS SUBJECT TO SUBPART M) 

Size of covered farm 

Provisions related to harvest and postharvest agricultural water Provisions related to pre-harvest agricultural water 

Compliance date Proposed compliance date 

Very Small Business ............................... January 26, 2024 ................................... 2 years and 9 months after the effective date of a final rule. 

Small Business ....................................... January 26, 2023 ................................... 1 year and 9 months after the effective date of a final rule. 

All Other Businesses .............................. January 26, 2022 ................................... 9 months after the effective date of a final rule. 

We recognize that stakeholders may 

benefit from additional clarity to aid in 

their understanding of the compliance 

date structure in table 3. As such, table 

4 summarizes the subpart E provisions 

as stated in the 2021 agricultural water 

proposed rule that would apply for 

agricultural water used during growing 

and during harvesting, packing, or 

holding for covered produce (other than 

sprouts). (As discussed above, the 

compliance dates for harvest and postharvest requirements are likely to occur 

before we complete this rulemaking, in 

which we have proposed to reorganize 

and replace subpart E in its entirety. 

While the discussion regarding our 

intended exercise of enforcement 

discretion for the harvest and postharvest requirements refers to those 

provisions according to section numbers 

in the produce safety regulation, table 4 

reflects the relevant proposed provision 

numbers in the 2021 agricultural water 

proposed rule.) 

TABLE 4—SUMMARY OF THE PROVISIONS IN SUBPART E THAT WOULD APPLY FOR AGRICULTURAL WATER USED DURING

GROWING ACTIVITIES AND DURING HARVESTING, PACKING, OR HOLDING ACTIVITIES FOR COVERED PRODUCE OTHER

THAN SPROUTS

If you use agricultural water for 

this covered activity for covered 

produce other than sprouts 

Then you must meet these requirements If applicable, you also must meet these requirements 

Pre-harvest activities .................... § 112.41 ............ (quality standard) ......................... § 112.43(d) ........ (testing for assessment purposes). 

§ 112.42 ............ (inspections and maintenance) .... § 112.45 ............ (measures). 

§ 112.43 ............ (agricultural water assessment) ... § 112.46 ............ (treatment). 

§ 112.50 ............ (records) ....................................... § 112.47 ............ (who may test). 

§ 112.161 .......... (records review) ........................... § 112.151 .......... (test methods). 

§ 112.12 ............ (alternatives). 

Harvest and post-harvest activities.§ 112.41 ............ (quality standard) ......................... § 112.44(b) ........ (testing untreated ground water). 

§ 112.42 ............ (inspections and maintenance) .... § 112.45 ............ (measures). 

§ 112.44(a) ........ (microbial quality criterion) ........... § 112.46 ............ (treatment). 

§ 112.44(d) ........ (additional management and 

monitoring).

§ 112.47 ............ (who may test). 

§ 112.50 ............ (records) ....................................... § 112.151 .......... (test methods). 

§ 112.161 .......... (records review) ........................... § 112.12 ............ (alternatives). 

We acknowledge that some 

requirements that apply for pre-harvest 

agricultural water (for example, 

§ 112.42, which includes requirements 

for inspections and maintenance of 

agricultural water sources and 

distribution systems) remain unchanged 

in the 2021 agricultural water proposed 

rule. However, we anticipate that 

maintaining compliance dates for all 

pre-harvest agricultural requirements on 

the same interval would be important 

for effective implementation of the 

systems-based approach we are 

proposing for pre-harvest agricultural 

water. To bifurcate compliance dates for 

the pre-harvest agricultural water 

requirements based on whether changes 

have been proposed would result in a 

compliance date structure similar to that 

originally established in the 2015 

produce safety final rule—i.e., based on 

specific provisions of subpart E, as 

opposed to being based on the covered 

activity that agricultural water is being 

used for (compare table 1 with table 3). 

In consideration of the feedback 

received from stakeholders during 

rulemaking for the 2019 final 

compliance date extension, we do not 


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consider that this would be a wise or 

workable approach to pursue. 

Accordingly, we are proposing to 

maintain compliance dates for all preharvest agricultural water requirements 

on the same interval, regardless of 

whether changes have been proposed. 

As the comment period for the 2021 

agricultural water proposed rule closed 

on April 5, 2022, we are reopening the 

comment period solely to request 

comments on the proposed compliance 

dates for the proposed pre-harvest 

agricultural water provisions for 

covered produce other than sprouts. 

This action does not seek comment on 

other provisions of the previously 

published proposed rule. 

Our goal is to complete this 

rulemaking as quickly as possible, and 

in the meantime, we intend to exercise 

enforcement discretion for the preharvest agricultural water requirements 

in the produce safety regulation for 

covered produce other than sprouts. We 

note that produce remains subject to the 

other applicable provisions of the 

produce safety regulation and the 

applicable provisions of the FD&C Act 

notwithstanding this proposed 

compliance date extension. The Agency 

encourages farms to focus their attention 

on good agricultural practices to 

maintain and protect the quality of their 

water sources. (See, e.g., FDA’s ‘‘Guide 

to Minimize Microbial Food Safety 

Hazards for Fresh Fruits and 

Vegetables,’’ at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/guidanceindustry-guide-minimize-microbialfood-safety-hazards-fresh-fruits-andvegetables). 

IV. Intended Enforcement Discretion for 

the Harvest and Post-Harvest 

Agricultural Water Requirements for 

Covered Produce Other Than Sprouts 

As we are not proposing to change the 

requirements that apply for harvest and 

post-harvest agricultural water through 

this rulemaking, we are not proposing a 

compliance date extension for those 

provisions for covered produce other 

than sprouts. However, we recognize 

that prior to the publication of the 2021 

agricultural water proposed rule, 

stakeholders did not have clarity on 

whether FDA would be proposing 

substantive changes to requirements 

that apply for agricultural water used 

during harvest and post-harvest 

activities. Because the intended benefits 

of the harvest and post-harvest 

requirements may not be fully realized 

unless accompanied by adequate 

training, technical assistance, and other 

preparations to support effective 

implementation by all parties, we are 

specifying the duration of our intended 

exercise of enforcement discretion with 

an understanding that covered farms 

will likely need this additional time to 

prepare for compliance with the harvest 

and post-harvest agricultural water 

provisions, and that regulators, 

educators, and other stakeholders may 

also need time to develop education and 

outreach, training, and other tools to 

facilitate understanding and compliance 

by covered farms. Moreover, due to the 

valuable role of FDA’s State regulatory 

partners in the integrated food safety 

system—in particular, their essential 

participation in produce safety rule 

education and enforcement under 

section 419(b)(2)(A) of the FD&C Act— 

we recognize that States may need the 

additional time to prepare for 

implementation of their program 

components, and that coordination 

efforts are taken between State and 

Federal regulators to provide for 

consistent implementation across all 

regulated industry. (See also discussion 

in section III of this document). We 

understand that some of these parties 

may have been awaiting FDA action 

before developing or deploying such 

training, technical assistance, or other 

implementation materials. 

Additionally, we recognize that many 

covered farms may already be aware of, 

and have received education and 

training on, the harvest and post-harvest 

agricultural water requirements 

established in the produce safety 

regulation, which we are not proposing 

to change. (See, for example, the 

standardized curriculum developed by 

the Produce Safety Alliance, which 

covers fundamental food safety topics as 

they relate to produce and the 

requirements of the produce safety 

regulation, including those for 

agricultural water used during 

harvesting, packing, and holding of 

covered produce.) However, we 

understand that even with education 

and training on these requirements, 

covered farms will still need to apply 

the knowledge to their operations by 

taking steps to implement those 

requirements on-farm, such that covered 

farms may need additional time to come 

into compliance with those provisions. 

In light of these considerations, we 

intend to exercise enforcement 

discretion for the harvest and postharvest agricultural water provisions in 

the produce safety regulation for 

covered produce other than sprouts 

until January 26, 2025, for very small 

businesses; January 26, 2024, for small 

businesses; and January 26, 2023, for all 

other businesses. In the meantime, 

covered farms (other than sprout 

operations) should focus their attention 

on good agricultural practices to 

maintain and protect the quality of their 

water source. (See, e.g., FDA’s ‘‘Guide to 

Minimize Microbial Food Safety 

Hazards for Fresh Fruits and 

Vegetables,’’ at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/guidanceindustry-guide-minimize-microbialfood-safety-hazards-fresh-fruits-andvegetables). We note that produce 

remains subject to the other applicable 

provisions of the produce safety 

regulation and the applicable provisions 

of the FD&C Act. 

V. Preliminary Economic Analysis of 

Impacts 

We have examined the impacts of the 

supplemental proposed rule to the 2021 

proposed rule, ‘‘Standards for the 

Growing, Harvesting, Packing, and 

Holding of Produce for Human 

Consumption related to Agricultural 

Water’’ (Docket No. FDA–2021–N–4071; 

hereafter ‘‘2021 Agricultural Water 

Proposed Rule’’) under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). 

Executive Orders 12866 and 13563 

direct us to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Office of Information and Regulatory 

Affairs in the Office of Management and 

Budget determined that the 2021 

Agricultural Water Proposed Rule is a 

significant regulatory action as defined 

by Executive Order 12866. This 

supplemental NPRM has also been 

designated as a significant regulatory 

action under E.O. 12866. 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. We 

previously concluded that the 2021 

Agricultural Water Proposed Rule 

would not have a significant economic 

impact on a substantial number of small 

entities. Because this supplemental 

proposed rule proposes compliance 

dates without imposing additional costs 

to farms (except reading the rule), we 

anticipate this supplemental proposed 

rule will not change that conclusion. If 

the 2021 Agricultural Water Proposed 

Rule as amended by this supplement is 

finalized, we may, if appropriate, certify 

that the final rule does not have a 

significant impact on a substantial 

number of small entities. 


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Federal Register / Vol. 87, No. 137 / Tuesday, July 19, 2022 / Proposed Rules 42979 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any rule that includes any Federal 

mandate that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

one year.’’ The current threshold after 

adjustment for inflation is $165 million, 

using the most current (2021) Implicit 

Price Deflator for the Gross Domestic 

Product. The 2021 Agricultural 

Proposed Rule as amended by this 

supplemental proposed rule would not 

result in an expenditure in any year that 

meets or exceeds this amount. 

We have developed a comprehensive 

Preliminary Economic Analysis of 

Impacts (PRIA) that assesses the impacts 

of the supplemental proposed rule (Ref. 

1). We estimate costs and benefits of the 

2021 agricultural water proposed rule in 

the ‘‘Standards for the Growing, 

Harvesting, Packing and Holding of 

Produce for Human Consumption 

Relating to Agricultural Water; 

Preliminary Regulatory Impact 

Analysis’’ (2021 agricultural water 

PRIA) (Ref. 2). This supplemental 

proposed rule makes no substantive 

changes to the provisions in the 2021 

Agricultural Water Proposed Rule. 

Rather, this supplemental proposed rule 

proposes compliance dates for the preharvest agricultural water provisions for 

covered produce other than sprouts, 

which are not specified in the 2021 

Agricultural Water Proposed Rule. The 

costs of the supplemental proposed rule 

are the costs of reading this rule. 

Annualized at either 3 percent or 7 

percent, our primary estimates of this 

supplemental proposed rule are $0.1 

million. The benefit of this 

supplemental proposed rule is clarity to 

stakeholders about the proposed 

compliance dates for the pre-harvest 

agricultural water provisions for 

covered produce other than sprouts 

described in the 2021 agricultural water 

proposed rule. The full preliminary 

analysis of economic impacts is 

available in the docket for this proposed 

rule and at https://www.fda.gov/aboutfda/reports/economic-impact-analysesfda-regulations. 

VI. Analysis of Environmental Impact 

The Agency has carefully considered 

the potential environmental effects of 

this action. FDA has concluded that the 

action will not have a significant impact 

on the human environment, and that an 

environmental impact statement is not 

required. The Agency’s finding of no 

significant impact, including a 

supplement to the finding of no 

significant impact, and the evidence 

supporting that finding may be seen in 

the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday (Refs. 3 to 5). 

Under FDA’s regulations implementing 

the National Environmental Policy Act 

(21 CFR part 25), an action of this type 

would require an EA under 21 CFR 

25.31a(a). 

VII. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

supplemental notice of proposed 

rulemaking contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

VIII. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed rule 

does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

conclude that the proposed rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

IX. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have tentatively determined that the 

rule does not contain policies that 

would have a substantial direct effect on 

one or more Indian Tribes, on the 

relationship between the Federal 

Government and Indian Tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. The 

Agency solicits comments from tribal 

officials on any potential impact on 

Indian Tribes from this proposed action. 

X. References 

The following reference is on display 

at the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. FDA has verified 

the website address, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. FDA, ‘‘Supplemental Notice of Proposed 

Rulemaking: Standards for the Growing, 

Harvesting, Packing, and Holding of 

Produce for Human Consumption 

Relating to Agricultural Water; 

Preliminary Regulatory Impact 

Analysis,’’ 2022. Available at: https://

www.fda.gov/about-fda/reports/ 

economic-impact-analyses-fdaregulations. 

2. FDA, ‘‘Standards for the Growing, 

Harvesting, Packing, and Holding of 

Produce for Human Consumption 

Relating to Agricultural Water; 

Preliminary Regulatory Impact 

Analysis,’’ 2021. Available at: https://

www.fda.gov/about-fda/reports/ 

economic-impact-analyses-fdaregulations. 

3. FDA, ‘‘Environmental Assessment for the 

Proposed Rule: Standards for the 

Growing, Harvesting, Packing, and 

Holding of Produce for Human 

Consumption Relating to Agricultural 

Water,’’ November 9. 2021. 

4. FDA, ‘‘Standards for the Growing, 

Harvesting, Packing, and Holding of 

Produce for Human Consumption 

Relating to Agricultural Water: Finding 

of No Significant Impact,’’ November 9, 

2021. 

5. FDA, ‘‘Standards for the Growing, 

Harvesting, Packing, and Holding of 

Produce for Human Consumption 

Relating to Agricultural Water: 

Supplement to the Finding of No 

Significant Impact.’’ 

Dated: July 11, 2022. 

Robert M. Califf, 

Commissioner of Food and Drugs. 

[FR Doc. 2022–15134 Filed 7–18–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–945] 

Schedules of Controlled Substances: 

Removal of Fenfluramine From Control 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Drug Enforcement 

Administration proposes to remove 

fenfluramine (chemical name: N-ethyla-methyl-3- 

(trifluoromethyl)phenethylamine), 

including its salts, isomers, and salts of 

isomers whenever the existence of such 

salts, isomers, and salts is possible, from 

the schedules of the Controlled 

Substances Act (CSA). This scheduling 

action is pursuant to the CSA which 


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