
[Federal Register Volume 84, Number 52 (Monday, March 18, 2019)]
[Rules and Regulations]
[Pages 9706-9714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04652]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2011-N-0921]
RIN 0910-AH93


Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption; Extension of Compliance Dates for 
Subpart E

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
extending, for covered produce other than sprouts, the dates for 
compliance with the agricultural water provisions in the ``Standards 
for the Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption'' rule. We are extending the compliance dates 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.

DATES: As of March 18, 2019 the compliance dates for the agricultural 
water provisions (subpart E) in the Standards for the ``Growing, 
Harvesting, Packing, and Holding of Produce for Human Consumption'' 
rule (November 27, 2015, 80 FR 74354), for covered produce other than 
sprouts, are delayed to January 26, 2024, for very small businesses, 
January 26, 2023, for small businesses, and January 26, 2022, for all 
other businesses.

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.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
II. Background
III. Analysis and Response to Public Comments
IV. Economic Analysis of Impacts
V. Analysis of Environmental Impact
VI. Paperwork Reduction Act of 1995
VII. Federalism
VIII. Consultation and Coordination With Indian Tribal Governments
IX. References

I. Executive Summary

    The final rule extends, for covered produce other than sprouts, the 
dates for compliance with the agricultural water provisions in the 
``Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption'' rule. The agricultural water provisions 
are contained in subpart E of that rule. We are also simplifying the 
compliance date structure under subpart E as applied to non-sprout 
covered produce, while retaining date-staggering based on size. The new 
compliance dates for the agricultural water requirements in subpart E 
for non-sprout covered produce are January 26, 2024, for very small 
businesses; January 26, 2023, for small businesses; and January 26, 
2022, for all other businesses.
    The final rule does not alter the requirements in subpart E and 
therefore the estimated costs and benefits accrued in any given year of 
compliance with the produce safety regulation, relative to the first 
year of compliance, do not change. However, because the compliance 
dates for the agricultural water provisions are extended, the 
discounted value of both total costs and total benefits decrease.
    The impact of this final rule is summarized in the following table.

                 Table 1--Summary of Changes to Benefits and Costs as a Result of the Final Rule
----------------------------------------------------------------------------------------------------------------
                                                                                       Units
                                                      Primary    -----------------------------------------------
                    Category                         estimate                      Discount rate
                                                                   Year dollars         (%)       Period covered
----------------------------------------------------------------------------------------------------------------
Forgone Benefits:

[[Page 9707]]

 
    Annualized..................................             $96            2017               7       2016-2025
    Monetized $millions/year....................             104            2017               3       2016-2025
Forgone Costs:
    Annualized..................................              10            2017               7       2016-2025
    Monetized $millions/year....................              12            2017               3       2016-2025
----------------------------------------------------------------------------------------------------------------

II. Background

    This extension of compliance dates concerns one of the seven 
foundational rules that we have established in Title 21 of the Code of 
Federal Regulations (21 CFR), Part 112 as part of our implementation of 
the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353): 
``Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption'' (the produce safety regulation, 
published in the Federal Register of November 27, 2015, 80 FR 74354) 
(https://www.fda.gov/fsma). We proposed this extension in a proposed 
rule published on September 13, 2017 (82 FR 42963). We have reviewed 
the comments submitted in response to the proposed rule, and we respond 
to those comments in section II. In this final rule we are extending 
the compliance dates as proposed.
    In the preamble of the final rule establishing the produce safety 
regulation, we stated that the produce safety 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 final rule establishing the produce safety regulation, 
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 at 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.\1\ We 
provided an additional 2 years beyond those compliance periods for 
certain water quality requirements in Sec.  112.44 and related 
provisions in Sec. Sec.  112.45 and 112.46. See table 2.
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    \1\ Under 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 21 CFR 112.3.
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    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 
produce safety regulation (Sec.  112.2(b)(3)). In that final rule, we 
also clarified how we interpret the compliance dates for certain 
agricultural water testing provisions established in the produce safety 
regulation.

  Table 2--As Stated in Produce Safety Regulation, Compliance Dates for
  Requirements in Subpart E (Agricultural Water) for Covered Activities
     Involving Covered Produce (Except Sprouts Subject to Subpart M)
------------------------------------------------------------------------
                                         Extended compliance date of
   Compliance dates of 2-4 years        additional 2 years beyond the
applicable to the farm based on its    compliance date based on size of
                size                                 farm
------------------------------------------------------------------------
Sec.   112.41.                       Sec.   112.44.
Sec.   112.42.                       Sec.   112.45(a) with respect to
                                      Sec.   112.44(a) criterion.
Sec.   112.43.
Sec.   112.45(b).
Sec.   112.45(a) with respect to     Sec.   112.46(b)(1) with respect to
 safe and adequate standard.          untreated ground water.
Sec.   112.46(a).                    Sec.   112.46(b)(2) and (b)(3).
Sec.   112.46(b)(1) with respect to  Sec.   112.46(c).
 untreated surface water.
Sec.   112.47.
Sec.   112.48.
Sec.   112.49.
Sec.   112.50.
------------------------------------------------------------------------

    FDA has received feedback from numerous stakeholders raising issues 
regarding the practicality of some of the agricultural water 
requirements in the produce safety regulation as applied to covered 
produce other than sprouts. Many of these concerns relate to the 
testing requirements for pre-harvest agricultural water, which are 
different for sprouts than they are for other types of covered produce. 
We are extending these compliance dates in light of the feedback we 
have received. Additional time allows us to consider how to approach 
these issues.

[[Page 9708]]

    As part of this extension, we are simplifying the subpart E 
compliance period structure such that all the compliance dates for 
subpart E provisions as applied to non-sprout covered produce will 
occur at the same time, retaining date-staggering based on farm size. 
Accordingly, covered farms will have 2 years beyond the previously 
published compliance dates for the water quality requirements in Sec.  
112.44 and related provisions in Sec. Sec.  112.45 and 112.46, to 
comply with all of subpart E. Put another way, we are extending the 
compliance dates for provisions in the first column of table 2 by 4 
years and extending the compliance dates for provisions in the second 
column of table 2 by 2 years, so that the compliance dates for non-
sprout covered produce for all provisions of subpart E are those listed 
in table 3.

Table 3--Compliance Dates for Requirements in Subpart E for Covered Activities Involving Covered Produce (Except
                                          Sprouts Subject to Subpart M)
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                                         Time periods starting from the effective date of the November 27, 2015,
                                                      produce safety final rule (January 26, 2016)
         Size of covered farm          -------------------------------------------------------------------------
                                                 Compliance period                     Compliance date
----------------------------------------------------------------------------------------------------------------
Very Small Business...................  8 years............................  January 26, 2024.
Small Business........................  7 years............................  January 26, 2023.
All Other Businesses..................  6 years............................  January 26, 2022.
----------------------------------------------------------------------------------------------------------------

    This rule is limited in scope to extending the compliance dates for 
covered produce other than sprouts. The rule does not address the 
underlying requirements in subpart E, but only the compliance dates for 
those requirements (for covered produce other than sprouts).
    We conducted a qualitative assessment of risk of hazards associated 
with produce production during the produce safety rulemaking, which 
indicates that agricultural water is a potential route of contamination 
of produce during growing, harvesting, and on-farm postharvest 
activities and that use of poor agricultural practices could lead to 
contamination and illness even where the potential for contamination is 
relatively low. We remain firmly committed to science-based minimum 
standards directed to agricultural water to minimize the risk of 
serious adverse health consequences or death from the use of, or 
exposure to, covered produce, including those reasonably necessary to 
prevent the introduction of known or reasonably foreseeable hazards 
into covered produce, and to provide reasonable assurances that the 
produce is not adulterated under section 402 of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 342). To that end, we have been 
pursuing and will continue to pursue a rigorous stakeholder engagement 
plan in the coming months as we consider the practical implementation 
of the agricultural water requirements and how to best achieve these 
important public health objectives. Along with farmers and others in 
the produce industry, in February 2018 we participated in a summit at 
which participants proposed and discussed potential approaches to 
addressing concerns with the existing agricultural water requirements. 
We are also continuing visits to farms throughout the country to 
further refine our understanding of the myriad variations in 
agricultural water sources and uses. We will continue to consult with 
experts in produce safety, water systems, and water microbiology, from 
both the public and private sectors, to take advantage of the very 
latest scientific developments and conclusions, particularly around 
water quality criteria, sampling, and testing.
    This rule does not change the compliance dates for sprouts. In the 
final produce safety regulation, we provided staggered compliance 
periods based on farm size for covered activities involving sprouts. 
The compliance date for activities involving sprouts for very small 
businesses is January 28, 2019. The compliance date for activities 
involving sprouts for small businesses is January 26, 2018. The 
compliance date for activities involving sprouts for all other 
businesses is January 26, 2017. The final produce safety regulation 
established sprout-specific requirements on multiple topics, including 
agricultural water. The agricultural water requirements for sprouts are 
different from the agricultural water requirements for other produce 
commodities (compare Sec. Sec.  112.44(a)(1) and 112.44(b)). We have 
not received any significant feedback from sprout farms that subpart E 
has posed particular challenges. Accordingly, as proposed, we are not 
taking action with regard to compliance dates for activities involving 
sprouts.
    Table 4 summarizes the compliance dates for the produce safety 
regulation based on this final rule. Time periods start from the 
effective date of the produce safety rule (January 26, 2016) except as 
otherwise specified.
BILLING CODE 4164-01-P

[[Page 9709]]

[GRAPHIC] [TIFF OMITTED] TR18MR19.000

BILLING CODE 4164-01-C

III. Analysis and Response to Public Comments

    In response to the proposed rule, we received comments from covered 
farms, consumer protection groups, groups representing these 
stakeholders, and state governments. Many of the comments were 
supportive of the proposed extension and simplification of compliance 
dates. In this final rule, we respond to comments related to whether 
FDA should extend the compliance dates and simplify the compliance date 
structure for the agricultural water requirements for covered produce 
other than sprouts. We did not consider and do not address comments 
that raised issues beyond the narrow scope of the proposed rule, 
including comments related to withdrawal or modifications to subpart E 
or comments related to broader policy issues. FDA will take these 
additional comments into consideration as we consider approaches to 
address agricultural water requirements. In this final rule we also do 
not address specific questions on the produce safety regulation, but 
the Technical Assistance Network remains an available resource for such 
questions (https://www.fda.gov/food/guidanceregulation/fsma/ucm459719.htm). We have summarized the relevant comments received and 
provided our responses below.
    (Comment 1) Many comments supported the proposed extension of 
compliance dates for the agricultural water provisions for covered 
produce other than sprouts. One comment stated that the extension would 
allow covered farms an opportunity to continue a dialogue with FDA 
around the best

[[Page 9710]]

approaches to implementing the agricultural water provisions. An 
association said it ``strongly supported'' the proposed extension, that 
the agricultural water provisions are very complex, and explained it 
had been working to educate its members about the requirements but 
found that developing practical advice was a challenge given the 
complexity. Another organization expressed its support for the proposed 
extension and stated that the agricultural water provisions are 
complicated and difficult to understand. Another individual wrote in 
support of the extension, contending that covered farms and other 
stakeholders have been confused by the requirements, and opined that an 
extension would be particularly helpful to smaller covered farms that 
could use the additional time to understand and implement these 
provisions.
    (Response 1) These comments are consistent with the feedback we 
have been receiving on the complexity of the agricultural water 
provisions from stakeholders since the produce safety final rule 
published in 2015. We have repeatedly heard the message relayed in 
these comments--that the requirements of subpart E, particularly the 
sampling and testing provisions, are complicated to understand, and 
questions remain about how to implement them in a practical manner. 
Accordingly, we have decided to finalize the extension as proposed.
    (Comment 2) Some comments opposed FDA's proposal to extend the 
compliance dates because they did not believe we had sufficiently 
justified the proposed delay, or its length. These comments noted that 
the compliance dates for certain agricultural water testing 
requirements were already later than the compliance dates for the rest 
of the produce safety regulation. These comments also stated that FDA 
had already sufficiently addressed stakeholder concerns through the 
rulemaking process, noting that we revised the agricultural water 
requirements as a result of comments on the proposed and supplemental 
rules. Some comments also encouraged the Agency to withdraw the 
proposed rule and focus on implementing the produce safety regulation 
on time; these comments also noted the public health benefits of the 
produce safety regulation.
    (Response 2) While we share the goal of public health expressed in 
these comments, we believe that a delay is necessary and justified for 
reasons different than those set out in the final rule for the changes 
to the agricultural water requirements. The feedback we have received 
since the final rule was published about the complexity and the 
attendant challenges with the produce safety regulation's agricultural 
water requirements has been frequent and consistent and has come from 
growers of many commodities in many regions. This feedback is new and 
is in addition to the comments on the proposed rule. Since the final 
rule was published, many covered farms, both individually and in groups 
via associations, have strenuously expressed concerns, particularly 
around the complexity of the sampling and testing provisions. On 
numerous farm visits and industry gatherings across the country, 
stakeholders have frequently communicated to us that they view the 
agricultural water regulatory scheme as too complex and too burdensome, 
and have objected that it does not sufficiently allow for a variety of 
water uses and availabilities. In the face of these widespread and 
steady concerns, including new concerns that were not expressed in 
response to the proposed rule, we proposed this compliance date 
extension, for the purpose of further engaging stakeholders and 
determining what can be done to consider and address the concerns we 
have heard. Many comments to this docket repeat and reinforce what we 
have been hearing. We therefore conclude it is in the public's interest 
for us to institute this delay so that we may further collaborate with 
an array of stakeholders and pursue solutions that will allow us to 
achieve the shared goal of improved produce safety in a way that is 
more workable for covered farms.
    The length of this delay in compliance dates was chosen to allow us 
sufficient time to explore these challenges with stakeholders and 
experts, and pursue solutions that improve the workability of these 
provisions. Covered farms also need a significant amount of time to 
prepare for compliance after the solutions are determined. A shorter 
time period would not have been sufficient for both robust stakeholder 
engagement and for covered farms to transition to implementation.
    (Comment 3) Some comments opposed FDA's proposal to extend the 
agricultural water compliance dates, in general because they concluded 
the extension would harm consumers more than it would help covered 
farms. Some of these comments noted that FDA's cost-benefit analysis 
indicates that this delay would impose a burden on consumers that 
outweighs any gains that may accrue to producers. Some comments 
contended that the extension has the potential to increase the risk of 
illness and death by potentially more than 730,000 additional cases of 
foodborne illness. Some comments noted that the proposed compliance 
date extension would mean covered farms would not be required to comply 
with these provisions until 11-13 years after FSMA was enacted, thereby 
delaying benefits to the public.
    (Response 3) FDA remains committed to ensuring that the produce 
safety rule addresses the risks associated with agricultural water. We 
note that produce remains subject to the adulteration provisions of the 
FD&C Act during this extension of the compliance dates, and 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/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm064574.htm). We have, however, determined that it will serve the 
public health best to take time now to engage stakeholders and discern 
how best to achieve public health protections in the covered produce 
agricultural water arena. FDA believes that ignoring the widespread 
concerns raised about complexity and serious questions about how the 
requirements can be implemented in practical ways on farms is also 
likely to reduce the estimated public health benefits of the 
agricultural water provision of the rule. Farms that cannot understand 
the requirements and determine how to implement the requirements are 
not likely to be realizing full food safety measures. We thus believe 
it is critical to address the issues we have heard about the complexity 
of the final rule and the diversity of use and source of agricultural 
water, and the variety of factors that impact agricultural water. The 
agency also believes that further collaboration with stakeholders to 
understand the source of the complexity and develop practical solutions 
is necessary to best allow us to achieve the shared goal of improved 
produce safety in a way that is more workable for covered farms.
    The economic analysis we conducted for the produce safety final 
rule, in keeping with our standard practice, evaluated the costs and 
benefits of the rule in its first 10 years, or 2016-2025. We analyzed 
the costs and benefits of this extension over the same time horizon 
(2016-2025). We estimated that this extension would translate to a 
savings of $12 (10) million for covered farms (annualized at 3 (7) 
percent over

[[Page 9711]]

those 10 years), because we estimated covered farms would delay making 
additional investments to initially comply with the agricultural water 
provisions until the arrival of the extended compliance dates. Because 
our economic analysis spans ten years starting with the produce safety 
rule effective date, the delay in those initial investments shows as a 
savings over those 10 years, but over the longer term may be viewed as 
costs deferred rather than saved. Using the same time horizon (2016-
2025), we also estimated that this extension would reduce expected 
benefits from the rule as a whole during those 10 years from $800 
($740) million to $696 ($644) million, annualized at 3 percent (7 
percent) over those 10 years.
    We do not know how the commenter arrived at the estimate that this 
extension could contribute to more than 730,000 additional cases of 
foodborne illness. We estimate that approximately 31,300 illnesses 
would not be prevented during the specified 10-year time horizon as a 
result of this extension.\2\ Because we have not yet decided how to 
address the concerns that have been raised about the practicality of 
the requirements, we cannot estimate the economic impact or the effect 
on foodborne illness rates of any solutions that we might implement in 
the future.
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    \2\ We arrive at this estimate by taking the decrease in the 
annualized benefits between the original produce safety rule and the 
rule with this extension (about $104 million and $96 million at 3 
percent and 7 percent, respectively, over 10 years) and dividing it 
by the average cost per foodborne illness associated with covered 
produce other than sprouts. We estimate that approximately 30,103 
and 32,554 illnesses annualized at 3 percent and 7 percent, 
respectively, that we estimate would not be prevented during the 
specified 10-year time horizon.
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    With the delay of the compliance dates, we intend to lay the 
groundwork for a successful implementation, which will benefit all 
stakeholders. We will use this time to engage with all stakeholders and 
consult with experts to determine how to implement, explain, and/or 
revise the agricultural water provisions in ways that reduce complexity 
and improve their workability for covered farms while still attaining 
for the public the benefits of science-based agricultural water 
standards for covered produce. We will also use the time to continue 
our outreach and educational efforts, so that the myriad types of 
covered farms will have the opportunity to prepare for successful 
implementation.
    (Comment 4) Some comments opposed FDA's proposal to extend 
compliance dates because they felt that the proposed rule was too broad 
in that it extends the compliance date for other agricultural water 
provisions in subpart E that are not dependent on an analysis of 
multiyear water profile (e.g., requirement for growers to inspect and 
repair water distribution infrastructure, monitor for the buildup of 
organic material in wash tanks and coolers, maintain and monitor the 
temperature of water to minimize microbiological risk, and keeping 
records of the scientific support for food safety interventions). 
Comments argued that some subpart E requirements are not complex, and 
it would not be difficult for covered farms to comply with such 
requirements by the original compliance dates. Comments also noted some 
third-party audits require compliance with standards that are similar 
to parts of subpart E, implying that some covered farms are already 
complying with similar provisions for that purpose.
    (Response 4) FDA considered proposing to extend just the provisions 
in subpart E that, under the produce safety final rule, had a 
compliance date 2 years later than the rest of subpart E (see table 2), 
but we determined that there were other provisions in subpart E that 
were equally complex and challenging for stakeholders, particularly 
other sampling and testing provisions (see, e.g., Sec.  112.46(b)(1) 
(testing requirement originally subject to the ``earlier'' compliance 
date in the context of untreated surface water)). Accordingly, 
retaining the original bifurcated structure was not an option. We have 
heard repeatedly from stakeholders that the compliance date structure 
under subpart E is confusing, so extending compliance dates for both a 
subset of the originally-not-extended provisions of subpart E, together 
with the originally-extended provisions of subpart E, would mean adding 
another layer of confusion to the subpart E compliance date situation, 
and that did not seem wise or workable.
    Some third-party audits include agricultural water requirements 
with which farms must comply to obtain a passing audit or 
certification, and some of those requirements may be similar to 
provisions in subpart E. Although some segments of the industry do 
undergo third-party audits, that fact did not dissuade us from the 
conclusion that there is a need to extend the compliance date for all 
of subpart E (for covered produce other than sprouts), which is based 
on significant feedback received from stakeholders since publication of 
subpart E in the produce safety final rule as well as comments on the 
extension proposed rule.
    (Comment 5) Some comments argued that FDA failed to explain the 
nature of the confusion over the rule's compliance date structure that 
caused us to propose a simplification to that structure.
    (Response 5) As evidenced by other comments, there was confusion 
over the compliance dates in subpart E and some stakeholders found it 
challenging to discern exactly which regulatory requirements were 
subject to the longer compliance period. One comment noted that simply 
determining the relevant compliance date is a challenge and said 
simplifying the compliance date structure would help. Other comments 
noted being confused by the existing compliance date structure. We 
conclude there is sufficient justification for us to simplify the 
subpart E compliance date structure.
    (Comment 6) Even with the compliance date extension and 
simplification we proposed in September 2017 and are finalizing here, 
some comments expressed confusion about the meaning of the compliance 
date with respect to initiating sampling versus completing the 
microbial water quality profile (MWQP). One comment specifically 
requested that the new compliance dates mean the dates on which farms 
must start to conduct the initial survey to develop the MWQP.
    (Response 6) Farms are not required to have completed a MWQP by 
their compliance date. A farm's compliance date means the date on which 
the farm must begin sampling a water source for its initial survey, 
which will eventually result in a MWQP.
    We note that this issue was addressed in the 2016 final rule that 
extended and clarified compliance dates for certain FSMA provisions (81 
FR 57784 at 57793-94). However, we recognize that there is still 
confusion about when the MWQP must be completed under the simplified 
compliance date structure we are finalizing here. We are therefore 
clarifying that farms are not required to have already developed a 
completed MWQP as of their new compliance date. Rather, farms must 
begin sampling and testing their untreated water sources in accordance 
with Sec.  112.46(b)(1), as applicable, by their compliance date. If 
the compliance date is not an appropriate time to engage in the 
relevant sampling and testing activities--for example, because of the 
requirement in Sec.  112.46(b)(1)(ii) that samples be representative of 
your use of the water--then compliance must begin by the first relevant 
time period that occurs after the compliance date.
    To elaborate on what this would mean in practical terms, for a farm 
that is not small or very small, compliance must begin by the first 
relevant time period that occurs on or after January 26, 2022.

[[Page 9712]]

For example, if a farm that is not small or very small only uses an 
untreated water source for agricultural water in May, a compliance date 
of January 26, 2022, would indicate that sample collection under Sec.  
112.46(b)(1) must take place in May 2022, as that is the time in which 
water samples collected would be representative of their use of the 
water. Farms that wish to develop or begin developing their MWQP prior 
to their compliance date are welcome to do so; but in the above 
example, FDA would not expect sample collection to have begun prior to 
May 2022.
    To provide a few examples related to the number and timing of 
samples, all of the following possible approaches are acceptable for 
farms that are not small or very small:
     Beginning in 2022, conducting an initial survey of an 
untreated surface water source by taking 10 samples per year over 2 
years (10 in 2022 and 10 in 2023) for a total of 20 samples in 
accordance with Sec.  112.46(b)(1)(i)(A); calculating the MWQP for the 
first time upon completing the 20-sample data set in 2023; and applying 
any necessary corrective actions under Sec.  112.45(b) as soon as 
practicable and no later than the following year (e.g., during the 2024 
growing season).
     Beginning in 2022, conducting an initial survey of an 
untreated surface water source by taking 5 samples per year over 4 
years (5 in 2022, 5 in 2023, 5 in 2024, and 5 in 2025) for a total of 
20 samples, in accordance with Sec.  112.46(b)(1)(i)(A); calculating 
the MWQP for the first time upon completing the 20-sample data set in 
2025; and applying any necessary corrective actions under Sec.  
112.45(b) as soon as practicable and no later than the following year 
(e.g., during the 2026 growing season).
     Beginning in 2022, conducting an initial survey of an 
untreated ground water source by taking 4 samples during the 2022 
growing season in accordance with Sec.  112.46(b)(1)(i)(B); calculating 
the MWQP for the first time upon completing the 4-sample data set at 
the end of the 2022 growing season; and applying any necessary 
corrective actions under Sec.  112.45(b) as soon as practicable and no 
later than the following year (e.g., during the 2023 growing season).
    (Comment 7) Some comments requested additional outreach and 
education as FDA explores modifications to the agricultural water 
testing provisions.
    (Response 7) FDA intends to continue to work with an array of 
stakeholders to explore and address the concerns around subpart E. As 
described above, we will be implementing a rigorous stakeholder 
engagement plan over the course of several months. If we determine that 
changes to subpart E are necessary, that would require notice and 
comment rulemaking and thus the public would have an opportunity to 
comment on any proposed changes. If we determine that we can address 
concerns through guidance, such a guidance would be considered ``Level 
1'' and would be subject to the notice and comment procedures outlined 
in Sec.  10.115(g), which is part of FDA's Good Guidance Practices 
regulations. We also remain committed to working with covered farms to 
prepare for compliance, through outreach, training and education, and 
other collaboration.
    (Comment 8) Some comments stated the proposed extension is contrary 
to Congress' intent and the plain language of FSMA, noting that the 
statute included a deadline for the produce safety final rule.
    (Response 8) We do not agree that delaying the compliance date for 
subpart E is contrary to Congress's intent or the plain language of the 
statute. FSMA required FDA to establish science- and risk-based minimum 
standards for the safe production and harvesting of produce for human 
consumption (see section 419(a)(1)(A) of the FD&C Act (21 U.S.C. 
350h(a)(1)(A))), which we have done by promulgating the produce safety 
regulation. Extending the compliance dates for subpart E (for covered 
produce other than sprouts) will allow us to evaluate how we can either 
improve the requirements or implement them in a way that is less 
confusing and more workable for covered farms, in light of the feedback 
we have received about subpart E, while still protecting the public 
health.
    Although FSMA includes deadlines for issuing the proposed and final 
rules, there is nothing in the language or spirit of the statute that 
is contrary to FDA doing its due diligence to examine how we can 
achieve the public health regulatory objectives contained in the rule 
in a way that is more practical for covered farms. We reiterate that we 
are not changing the compliance dates for the entire produce safety 
regulation, just subpart E for covered produce other than sprouts.
    (Comment 9) Comments stated that FDA should clearly communicate its 
expectations of agricultural water users during the extension.
    (Response 9) With this final rule, we are extending the compliance 
dates for subpart E of the produce safety regulation for covered 
produce other than sprouts. FDA will therefore not expect growers of 
covered produce (other than sprouts) to implement subpart E until the 
new compliance dates. In the meantime, farms should 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/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm064574.htm). Farms currently 
testing their water may choose to continue with their current water 
testing programs, and farms that are not currently testing their water 
may choose to begin doing so.

IV. Economic Analysis of Impacts

    We have examined the impacts of this rule under Executive Order 
12866, Executive Order 13563, Executive Order 13771, the Regulatory 
Flexibility Act (5 U.S.C. 601612), 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). Executive Order 13771 requires that the costs associated 
with significant new regulations ``shall, to the extent permitted by 
law, be offset by the elimination of existing costs associated with at 
least two prior regulations.'' We believe that this final rule is an 
economically significant regulatory action as defined by Executive 
Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that will minimize any significant impact of a rule 
on small entities. Because this final rule only extends the compliance 
dates for certain provisions of the produce safety regulation, we 
certify that this final rule will not have a significant economic 
impact on a substantial number of small entities.
    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

[[Page 9713]]

adjustment for inflation is $150 million, using the most current (2017) 
Implicit Price Deflator for the Gross Domestic Product. This final rule 
will not result in an expenditure in any year that meets or exceeds 
this amount.
    This rule extends, for non-sprout covered produce, the compliance 
date for all of the provisions of subpart E to 4 years after the 
relevant farm's compliance date for all other provisions of the produce 
safety regulation (which varies based on establishment size). The 
estimated costs and benefits accrued in any given year of compliance 
with the produce safety regulation, relative to the first year of 
compliance, do not change. However, because the compliance dates for 
certain provisions are extended, the discounted value of both total 
costs and total benefits decrease.
    In the final regulatory impact analysis of subpart E of the produce 
safety regulation, we only considered Sec. Sec.  112.42, 112.44, 
112.45(a)(2), 112.45(b)(3), 112.46(b), and 112.46(c) to result in a 
cost. Therefore, while subpart E has other provisions, only the 
aforementioned provisions are relevant to and addressed in this cost 
and benefit analysis.
    There is a reduction in costs (i.e., cost savings) associated with 
extending, for non-sprout covered produce, the compliance date for all 
of the provisions of subpart E to 4 years after the relevant farm's 
compliance date for the rest of the produce safety regulation. With 
respect to their non-sprout covered produce, covered farms have 4 years 
from the compliance date for the other provisions of produce safety 
regulation to comply with the provisions in subpart E. Thus, while all 
initial startup costs and recurring costs remain the same as estimated 
in the final regulatory impact analysis for the produce safety 
regulation (Ref. 1), the annualized total costs, discounted at 3 (7) 
percent over 10 years, decrease from $291 ($265) million to $280 ($254) 
million, resulting in a savings of $12 ($10) million.\3\ The present 
value of total costs, discounted at 3 (7) percent over 10 years, 
decreases from about $2.5 ($1.9) billion to about $2.4 ($1.8) billion, 
resulting in a savings of about $99 ($74) million. No additional costs 
would be incurred by state, local, and tribal governments or the 
private sector as a result of this rule.
---------------------------------------------------------------------------

    \3\ The $12 million and $10 million figures are rounded. The 
costs decrease from $291.5 ($264.8) million to $279.8 ($254.3) 
million, resulting in a savings of $11.6 ($10.5) million.
---------------------------------------------------------------------------

    There is a reduction in benefits associated with extending the 
compliance dates as described previously. Consumers eating non-sprout 
covered produce will not enjoy the potential health benefits (i.e., 
reduced risk of illness) provided by the provisions of subpart E until 
2 to 4 years (depending on the specific provision) later than 
originally established in the produce safety regulation. Thus, the 
annualized total benefits to consumers, discounted at 3 (7) percent 
over 10 years, decrease by $104 ($96) million from $800 ($740) million 
to $696 ($644) million. The present value of total benefits, discounted 
at 3 (7) percent over 10 years, decreases from about $6.8 ($5.2) 
billion to about $5.9 ($4.5) billion. Estimated changes in benefits and 
costs as a result of this extension are summarized in the following 
table.

                 Table 5--Summary of Changes to Benefits and Costs as a Result of the Final Rule
----------------------------------------------------------------------------------------------------------------
                                                                                       Units
                                                      Primary    -----------------------------------------------
                    Category                         estimate                      Discount rate
                                                                   Year dollars         (%)       Period covered
----------------------------------------------------------------------------------------------------------------
Forgone Benefits:
    Annualized..................................             $96            2017               7       2016-2025
    Monetized $millions/year....................             104            2017               3       2016-2025
Forgone Costs:
    Annualized..................................              10            2017               7       2016-2025
    Monetized $millions/year....................              12            2017               3       2016-2025
----------------------------------------------------------------------------------------------------------------

    In line with Executive Order 13771, in table 6 we estimate present 
and annualized values of costs and cost savings over an infinite time 
horizon. Based on these cost-savings, this final rule will be 
considered a deregulatory action under Executive Order 13771.

    Table 6--Executive Order 13771 Summary Table (in $ Millions 2016
                 Dollars, Over an Infinite Time Horizon)
------------------------------------------------------------------------
                                              Primary         Primary
                  Item                     estimate (7%)   estimate (3%)
------------------------------------------------------------------------
Present Value of Cost Savings...........             $72             $97
Annualized Cost Savings.................               5               3
------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic 
impacts is available in the docket for this rule (Ref. 2) at https://www.regulations.gov, and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

V. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(j) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    This rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

[[Page 9714]]

VII. Federalism

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13132. FDA has determined that the 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 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.

VIII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects 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. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive order and, consequently, a 
tribal summary impact statement is not required.

IX. References

    The following references are on display in the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852 and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.
    1. FDA, ``Final Regulatory Impact Analysis, Standards for the 
Growing, Harvesting, Packing and Holding of Produce for Human 
Consumption.'' November 2015. Available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm472310.htm.
    2. FDA, ``Final Regulatory Impact Analysis, Final Regulatory 
Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for the 
Standards for the Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption; Extension of Compliance Dates for Subpart E; 
Final Rule,'' 2019. Available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

    Dated: March 6, 2019.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-04652 Filed 3-15-19; 8:45 am]
BILLING CODE 4164-01-P


