
[Federal Register Volume 82, Number 176 (Wednesday, September 13, 2017)]
[Proposed Rules]
[Pages 42963-42968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19434]


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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-ZA50


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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
proposing to extend, 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 proposing to extend 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 achieve 
our regulatory objectives, in keeping with the Administration's 
policies.

DATES: Submit either electronic or written comments on this proposed 
rule by November 13, 2017.

ADDRESSES: You may submit comments on the extension of the compliance 
period as follows. Please note that late, untimely filed comments will 
not be considered. Electronic comments must be submitted on or before 
November 13, 2017. The https://www.regulations.gov electronic filing 
system will accept comments until midnight Eastern Time at the end of 
November 13, 2017. Comments received by mail/hand delivery/courier (for 
written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is 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

[[Page 42964]]

identified, as confidential, if submitted as detailed in 
``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0921 for ``Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption; Extension of Compliance 
Dates for Subpart E.'' 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.
     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.gpo.gov/fdsys/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.

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: 

I. Background

    This proposed 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) 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).
    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. 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 1.
    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 the produce safety regulation (Sec.  112.2(b)(3)) and 
clarified the compliance dates for certain agricultural water testing 
provisions as originally established in the produce safety regulation.

  Table 1--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
                  size                               of 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 safe    Sec.   112.46(b)(1) with
 and adequate standard.                   respect to untreated ground
                                          water.
Sec.   112.46(a).......................  Sec.   112.46(b)(2) and (b)(3).
Sec.   112.46(b)(1) with respect to      112.46(c).
 untreated surface water.
Sec.   112.47..........................
Sec.   112.48..........................
Sec.   112.49..........................
Sec.   112.50..........................
------------------------------------------------------------------------


[[Page 42965]]

II. Proposed Extension of Subpart E Compliance Dates for Produce Other 
Than Sprouts

    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 proposing this extension in light of the feedback we have 
received and under Executive Orders 13777, 13771, and 13563. Additional 
time would allow us to consider approaches to address these issues, as 
well as opportunities there may be to reduce the cost and enhance the 
flexibility of these requirements beyond those reflected in the final 
rule.
    As part of this proposed extension, we also propose to simplify the 
subpart E compliance period structure such that all the compliance 
dates for subpart E provisions as applied to non-sprout produce would 
occur at the same time, retaining date staggering based on farm size. 
Accordingly, covered farms would 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 propose to extend the 
compliance dates for provisions in the first column of table 1 by 4 
years, and propose to extend the compliance dates for provisions in the 
second column of table 1 by 2 years, so that the compliance dates for 
non-sprout covered produce for all provisions of subpart E would be 
those in table 2.

  Table 2--Proposed Compliance Dates for Requirements in Subpart E for
 Covered Activities Involving Covered Produce (Except Sprouts Subject to
                               Subpart M)
------------------------------------------------------------------------
                                 Proposed time periods starting from the
                                effective date of the November 27, 2015,
                                 produce safety final rule (January 26,
     Size of covered farm                         2016)
                               -----------------------------------------
                                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.
------------------------------------------------------------------------

    We believe the simpler compliance date structure would alleviate 
confusion, and because we are proposing it as part of a proposal to 
provide additional time for compliance with all of the provisions, we 
expect it to alleviate burden. We do not anticipate that the change 
would result in any practical or logistical compliance challenges. We 
request comment on whether this change to the compliance date structure 
would be helpful.
    This proposed rule is limited in scope to extending the compliance 
dates for covered produce other than sprouts. The proposed 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 will continue to work with stakeholders on the issues 
raised regarding the agricultural water requirements.
    Our goal is to complete this rulemaking as quickly as possible. 
However, we are aware that many farms have been working well in advance 
of their compliance dates to come into compliance. As we continue to 
work with stakeholders on issues raised regarding the agricultural 
water requirements, we intend to exercise enforcement discretion for 
covered produce other than sprouts relative to the agricultural water 
provisions in subpart E of the produce safety regulation. This means 
that while we are considering these issues, we do not intend to enforce 
the requirements in subpart E of the regulation for covered produce 
other than sprouts. Thus, by announcing we intend to exercise 
enforcement discretion for covered produce other than sprouts relative 
to the agricultural water provisions in subpart E, farms may choose to 
continue with their current water testing programs or allocate their 
resources differently to avoid incurring additional costs based on our 
proposal to extend the agricultural water compliance dates. And, as 
explained above, when we finalize compliance dates, we intend to 
continue to work with stakeholders to address agricultural water 
questions and with farms to prepare for compliance.
    This proposed rule also would 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. Because sprouts present a unique safety 
risk, 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)). Moreover, based on the 
information available to us, many sprout farms use municipal water for 
growing activities; and under the produce safety regulation, covered 
farms are not required to test water from a public supply when certain 
conditions are met (see 21 CFR 112.46(a)(1) and (2)). We also 
established earlier compliance dates for sprouts than for other covered 
produce, and the first compliance date for covered sprout farms 
(January 26, 2017) has already passed. We have not received any 
significant feedback from sprout farms that subpart E has posed 
particular challenges. Accordingly, we are proposing to take no action 
with regard to compliance dates for activities involving sprouts and 
thus the compliance dates for covered farms with respect to sprouts are 
the original compliance dates, including for the agricultural water 
provisions in Subpart E.
    Table 3 summarizes the compliance dates for the produce safety 
regulation as they would be if this proposed rule is finalized. Time 
periods start from effective date of the produce safety rule (January 
26, 2016) except as otherwise specified.

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III. Economic Analysis of Impacts

    We have examined the impacts of this proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4), and Executive Order 13771 on Reducing Regulation and Controlling 
Regulatory Costs (January 30, 2017). 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 13563 states the 
importance of quantifying costs and benefits, reducing costs and 
burdens, and harmonizing rules. We conclude that this proposed rule 
would not increase compliance costs and would instead reduce compliance 
costs by delaying certain compliance dates. Moreover, it would serve an 
important purpose of providing us an opportunity to consider how to 
reduce burdens on the public. We conclude that this proposed rule is an 
economically

[[Page 42967]]

significant regulatory action as defined by Executive Order 12866.
    This rule would extend, 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, would not change. However, because the compliance 
dates for certain provisions would be extended, the discounted value of 
both total costs and total benefits would decrease.
    There would be 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 would 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 start-up costs and recurring costs would 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 percent over 10 years, would decrease by about 3 
percent from $404 million to $392 million, resulting in a savings of 
$12 million. No additional costs would be incurred by state, local, and 
tribal governments or the private sector as a result of this proposed 
rule.
    There would be a reduction in benefits associated with extending 
the compliance dates as described previously. Consumers eating non-
sprout covered produce would 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 percent over 10 
years, would decrease by $108 million from $1.033 billion to $925 
million. Estimated changes in benefits and costs as a result of this 
proposed extension are summarized in the following table.

   Table 4--Summary of the Changes in Benefits and Costs as a Result of This Proposed Rule, Annualized Over 10
                                       Years, in Millions of 2016 Dollars
----------------------------------------------------------------------------------------------------------------
                                                                                                    Benefits of
                                                                     Costs to       Benefits of    reduced risk
                                                     Costs to      industry with   reduced risk     of illness
                                                  industry under   the proposed     of illness       with the
                                                    2015 final      compliance      under 2015       proposed
                                                       rule          extension      final rule      compliance
                                                                                                     extension
----------------------------------------------------------------------------------------------------------------
Annualized 3%...................................            $404            $392          $1,033            $925
Annualized 7%...................................             382             370             983             874
Net Present Value 3%............................           3,443           3,340           8,811           7,886
Net Present Value 7%............................           2,681           2,598           6,901           6,143
----------------------------------------------------------------------------------------------------------------

    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities when ``the agency publishes a general notice of proposed 
rulemaking.'' (5 U.S.C. 601(2)). We have analyzed this proposed rule 
under the Regulatory Flexibility Act and determined that, because it 
would only extend certain compliance dates for agricultural water 
provisions in the produce safety regulation, it would 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 issuing ``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 $148 
million, using the most current (2016) Implicit Price Deflator for the 
Gross Domestic Product. We have determined that this proposed rule 
would not result in an expenditure in any year that meets or exceeds 
this amount.
    Executive Order 13771, entitled Reducing Regulation and Controlling 
Regulatory Costs, was issued on January 30, 2017. Section 2(a) of 
Executive Order 13771 requires an agency, unless prohibited by law, to 
identify at least two existing regulations to be repealed when the 
agency publicly proposes for notice and comment or otherwise 
promulgates a new regulation. In furtherance of this requirement, 
section 2(c) of Executive Order 13771 requires that the new incremental 
costs associated with new regulations shall, to the extent permitted by 
law, be offset by the elimination of existing costs associated with at 
least two prior regulations. This proposed rule is expected to be an 
Executive Order 13771 deregulatory action. Details on the estimated 
cost savings of this proposed rule can be found in the rule's economic 
analysis.
    For interested persons, the detailed preliminary regulatory impact 
analysis 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.

IV. 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.

V. Paperwork Reduction Act of 1995

    This proposed 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.

VI. 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

[[Page 42968]]

the Executive order and, consequently, a federalism summary impact 
statement is not required.

VII. Executive Order 13175

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have determined that 
the proposed 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 
proposed 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.

VIII. References

    The following references are on display in 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; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites 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, ``Preliminary Regulatory Impact Analysis, Preliminary 
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; Proposed Rule,'' 2017. Available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

    Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19434 Filed 9-12-17; 8:45 am]
 BILLING CODE 4164-01-P


