
[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Rules and Regulations]
[Pages 74669-74672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28161]



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Vol. 80

Friday,

No. 228

November 27, 2015

Part V





 Department of Health and Human Services





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Food and Drug Administration





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21 CFR Part 112





 Final Environmental Impact Statement and Record of Decision for the 
Standards for the Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption; Availability; Final Rule

  Federal Register / Vol. 80 , No. 228 / Friday, November 27, 2015 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2014-N-2244]
RIN 0910-AG35


Final Environmental Impact Statement and Record of Decision for 
the Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) has made 
available for public review the Final Environmental Impact Statement 
(EIS) and Record of Decision (ROD) for the standards for the growing, 
harvesting, packing, and holding of produce for human consumption. FDA 
prepared the Final EIS after taking into account public comment 
received on the corresponding Draft EIS and is publishing the ROD at 
the time of our decision. The Final EIS and ROD documents are available 
in Docket No. FDA-2014-N-2244.

DATES: FDA announces the availability of the EIS and ROD on November 
27, 2015.

FOR FURTHER INFORMATION CONTACT: Annette McCarthy, Center for Food 
Safety and Applied Nutrition (HFS-205), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1057.

SUPPLEMENTARY INFORMATION: 

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), 
signed into law by President Obama on January 4, 2011, enables FDA to 
better protect public health by helping to ensure the safety and 
security of the food supply. FSMA amends the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) to establish the foundation of a 
modernized, prevention-based food safety system. As part of our 
implementation of FSMA, we published the proposed rule: Standards for 
the Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption (hereafter referred to as ``the 2013 proposed rule'') on 
January 16, 2013, to establish science-based minimum standards for the 
safe growing, harvesting, packing, and holding of produce (78 FR 3504). 
On September 29, 2014, FDA issued a supplemental notice of proposed 
rulemaking (``the supplemental proposed rule''), amending certain 
specific provisions of the 2013 proposed rule (79 FR 58434). Taken 
together, these publications constitute FDA's proposed standards for 
the growing, harvesting, packing, and holding of produce for human 
consumption (``the Produce Safety proposed rule'').
    FDA announced a ``Notice of Intent'' (NOI) to prepare an EIS to 
evaluate the potential environmental effects of the Produce Safety 
Proposed Rule in the Federal Register on August 19, 2013 (78 FR 50358). 
In the NOI, FDA also announced the beginning of the scoping process and 
solicited public comments to identify issues to be analyzed in an EIS. 
The NOI asked for public comment by November 15, 2013, and FDA later 
extended the deadline for the comment period to March 15, 2014 (78 FR 
69006; November 18, 2013), and then April 18, 2014 (79 FR 13593; March 
11, 2014).
    A public scoping meeting was held on April 4, 2014, in College 
Park, MD. FDA prepared a Draft EIS for the Produce Safety proposed rule 
and, on January 14, 2015, published a ``Notification of public 
meeting'' in the Federal Register to: (1) Announce the availability of 
the Draft EIS for public review and comment and (2) announce a public 
meeting to inform the public of the findings in the Draft EIS, provide 
information about the EIS process, solicit oral stakeholder and public 
comments on the Draft EIS, and provide clarification, as needed, about 
the contents of the Draft EIS (80 FR 1852). The public meeting was held 
on February 10, 2015, in College Park, MD. The comment period on the 
Draft EIS closed on March 13, 2015. FDA is now announcing the 
availability of the Final EIS, which FDA prepared, taking into account 
public comment received on the Draft EIS, and the ROD, which details 
FDA's final decision, taking into account the findings of the Final EIS 
and the Agency's stated purpose and need.
    In the Produce Safety proposed rule, FDA proposed science-based 
minimum standards for the safe production and harvesting of produce. As 
discussed in the Final EIS (Ref. 1), out of these standards, we 
identified four provisions that could potentially significantly affect 
the quality of the human environment, if finalized (hereinafter 
referred to as ``potentially significant provisions''). For each of the 
potentially significant provisions, FDA then identified alternative 
provisions to consider. The potentially significant provisions are: (1) 
Standards directed to agricultural water, (2) standards directed to 
biological soil amendments (BSA) of animal origin, (3) standards 
directed to domesticated and wild animals, and (4) general provisions 
(i.e., cumulative impacts). Additionally, an overarching ``No Action'' 
alternative was considered for the purpose of evaluating conditions in 
the absence of any final rule.
    For standards directed to agricultural water, we considered the 
following alternatives: (1) As proposed by FDA, i.e., a statistical 
threshold value (STV) not exceeding 410 colony forming units (CFU) of 
generic Escherichia coli per 100 milliliters (ml) of water and a 
geometric mean (GM) not exceeding 126 CFU of generic E. coli per 100 ml 
of water, along with options to achieve the standard by applying either 
a time interval between last irrigation and harvest using a microbial 
die-off rate of 0.5 log per day and/or a time interval between harvest 
and end of storage using an appropriate microbial die-off or removal 
rates, including during activities such as commercial washing (proposed 
21 CFR 112.44(c)); (2) a microbial quality standard of no more than 235 
CFU (or most probable number (MPN), as appropriate) generic E. coli per 
100 ml for any single sample or a rolling GM (n=5) of more than 126 CFU 
(or MPN, as appropriate) per 100 ml of water, as was proposed in the 
2013 proposed rule; (3) as proposed (i.e., Alternative 1), but with an 
additional criterion establishing a maximum generic E. coli threshold; 
and (4) for each of the previous alternatives, consider the 
environmental impacts if each alternative includes root crops that are 
irrigated using low-flow methods.
    For standards directed to BSAs of animal origin, FDA considered 
standards for both untreated and treated BSAs. For untreated BSAs of 
animal origin, the alternatives considered included a range of minimal 
application intervals (the time between application and harvest) when 
the BSA is applied in a manner that does not contact covered produce 
during application and minimizes the potential for contact with covered 
produce after application. The alternative application intervals 
evaluated were: (1) 9 months; (2) 0 months; (3) 90 and 120 days; 
consistent with the National Organic Program's regulations in 7 CFR 
205.203(c)(1); (4) 6 months; and (5) 12 months. For standards directed 
to treated BSAs, the alternatives considered included a range of 
application intervals when the BSA is composted in accordance with the 
requirements proposed in Sec.  112.54(c) and applied in a manner that 
minimizes the potential for contact with covered produce during and 
after application.

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The application intervals evaluated were: (1) As proposed by FDA, 0 
days (proposed Sec.  112.56(a)(4)(i)); (2) 45 days; and (3) 90 days.
    For standards directed at domesticated animals, we considered 
alternatives under which, if working animals are used in a growing area 
where a crop has been planted, measures would be required to prevent 
the introduction of known or reasonably foreseeable hazards into or 
onto covered produce with the waiting period between grazing and 
harvesting varying by alternative. The following alternatives were 
evaluated: (1) As proposed by FDA, an adequate waiting period between 
grazing and harvesting for covered produce in any growing area that was 
grazed to ensure the safety of the harvested crop (proposed Sec.  
112.82(a)); (2) a minimum waiting period of 9 months; and (3) a minimum 
waiting period of 90 days and 120 days before harvest, depending upon 
whether the edible portion of the crop contacts the soil (applying the 
timeframes for raw manure set forth in the National Organic Program's 
regulations in 7 CFR 205.203(c)(1)). For standards directed to wild 
animals, we considered alternatives to the proposed requirement that 
under circumstances when there is a reasonable probability that animal 
intrusion will contaminate covered produce, the grower would be 
required to monitor those areas that are used for a covered activity 
for evidence of animal intrusion: (1) As needed during the growing 
season based on (i) the grower's covered produce and (ii) the grower's 
observations and experience; and (2) immediately prior to harvest. The 
alternatives evaluated were: (1) As proposed by FDA, if animal 
intrusion occurs--as made evident by observation of significant 
quantities of animals, animal excreta, or crop destruction via 
grazing--the grower must evaluate whether the covered produce can be 
harvested in accordance with the requirements of proposed Sec.  112.112 
(proposed Sec.  112.83(a) and (b)); and (2) if animal intrusion is 
reasonably likely to occur, the grower must take measures to exclude 
animals from fields where covered produce is grown.
    The cumulative impacts of the proposed rule were considered using a 
range of alternatives to the general provision in proposed Sec.  112.4, 
which would specify the farms that would be covered under the rule 
based on the farm's annual sales of produce. The alternatives evaluated 
were to cover those farms that have: (1) As proposed by FDA, an average 
annual monetary value of produce sold during the previous 3-year period 
of more than $25,000 (on a rolling basis) (proposed Sec.  112.4); (2) 
an average annual monetary value of food sold during the previous 3-
year period of more than $50,000 (on a rolling basis); (3) an average 
annual monetary value of food sold during the previous 3-year period of 
more than $100,000 (on a rolling basis); and (4) an average annual 
monetary value of covered produce sold during the previous 3-year 
period of more than $25,000 (on a rolling basis).
    In the Final EIS, FDA identifies the ``Agency's preferred 
alternative,'' i.e., the alternative which the Agency believes will 
fulfill its statutory mission and responsibilities for this rulemaking, 
giving consideration to economic, environmental, technical, and other 
factors. Slight modifications to the preferred alternative were made in 
the ROD to reflect the Agency's final action. The Agency's preferred 
alternative, as described in the ROD, is comprised of the following 
alternatives for each of the potentially significant provisions listed 
previously:
    For agricultural water and including root crops irrigated using 
low-flow methods, generic E. coli: GM of 126 CFU/100 ml and STV of 410 
CFU/100 ml, with additional flexibility for microbial die-off and/or 
removal (Sec. Sec.  112.44(b) and 112.45(b));
    For treated biological soil amendments of animal origin, 0 day 
application interval (Sec.  112.56(a)(2)); and
    For domesticated animals (grazing and working) and animal 
intrusion, visual assessment for significant evidence of animal 
potential contamination as needed during the growing season to identify 
and not harvest produce that is or is likely to be contaminated 
(Sec. Sec.  112.83, 112.84, and 112.112).
    As discussed in the supplemental proposed rule, FDA has chosen to 
defer decision on a minimum application interval for untreated BSAs of 
animal origin that are applied in a manner that does not contact 
covered produce during application and minimizes the potential for 
contact with covered produce after application (79 FR 58434) and, 
therefore, has not identified an alternative that would best meet the 
statutory mission and responsibilities. For the purpose of the 
aggregate environmental impact analysis in the Final EIS, in the 
absence of a decision on the alternative that would fulfill the 
statutory mission, the impacts associated with the 0-day application 
interval were included as the environmental impacts associated with 
this alternative.
    FDA has made the Final EIS and ROD available for public review in 
Docket No. FDA-2014-N-2244 (see Ref. 1 and 2).

Waiver of 30-Day Review of Final EIS

    Under CEQ regulation 40 CFR 1506.10(b)(2), no decision on the 
proposed action shall be made or recorded by a Federal Agency under 40 
CFR 1505.2 until 30 days after publication of the notice for a Final 
EIS. However, 40 CFR 1506.10(b)(2) also provides the following 
exception from the rules of timing: An agency engaged in rulemaking 
under the Administrative Procedure Act or other statute for the purpose 
of protecting the public health or safety, may waive the time period in 
paragraph (b)(2) and publish a decision on the final rule 
simultaneously with publication of the notice of the availability of 
the final environmental impact statement.
    Consistent with the circumstances in 40 CFR 1506.10(b)(2) under 
which a waiver may be used, FDA is waiving the 30-day time period 
between the publication of the Final EIS and FDA's decision on the 
Produce Safety final rule. FDA is publishing this notice of 
availability of the Final EIS simultaneously with the publication of 
the Produce Safety final rule and ROD. FDA considers the use of the 
waiver to be appropriate, in order to enhance food safety and protect 
public health, consistent with the purpose of FSMA and the Produce 
Safety final rule and the urgency for its release. We explain our 
reasons as follows:
    The Produce Safety final rule establishes standards to minimize the 
risk of serious adverse health consequences or death (SAHCOD) resulting 
from contaminated produce. This rule implements section 419 of the FD&C 
Act (21 U.S.C. 350h), which requires FDA to adopt a final produce 
safety regulation based on known safety risks, that sets forth 
procedures, processes, and practices to minimize the risk of serious 
adverse health consequences or death, including those that are 
reasonably necessary to prevent the introduction of known or reasonably 
foreseeable hazards into produce and to provide reasonable assurances 
that produce is not adulterated under section 402 of the FD&C Act (21 
U.S.C. 342).
    The history of foodborne illness outbreaks, including outbreaks 
resulting in severe illnesses and death associated with contaminated 
produce, make clear that produce-related outbreaks are a serious and 
ongoing food safety problem. From 1996 to 2010, approximately 131 
produce-related reported outbreaks occurred, resulting in 14,132 
outbreak-related illnesses; 1,360 hospitalizations; and 27 deaths.

[[Page 74672]]

These outbreaks were associated with approximately 20 different produce 
commodities (Ref. 3). Even after enactment of FSMA outbreaks from 
produce continue to occur, between January 2011 and 2014, there were 44 
outbreaks; 3,120 illnesses; 735 hospitalizations; and 42 deaths 
associated with produce (Ref. 4). These outbreaks were associated with 
approximately 10 different produce commodities. The illness numbers 
cited previously are the reported illnesses; the Centers for Disease 
Control estimates that only a fraction of foodborne illness is reported 
(http://www.cdc.gov/foodborneburden/estimates-overview.html).
    This history of produce-related outbreaks was the impetus for 
Congress, in FSMA, to require Federal produce safety standards to 
establish requirements for prevention-focused regulation in a sector of 
the food industry that had previously seen little Federal food safety 
oversight and underscores the urgent public health need for 
implementation of FDA produce safety standards to begin. Annualizing 
benefits over the first 10 years after publication of the rule, we 
expect benefits of the Produce Safety final rule to be approximately 
362,059 illnesses averted per year, valued at $976 million annually 
(see the Regulatory Impact Analysis accompanying the rule for 
additional information (Ref. 5)).
    There is a public health need to publish the Produce Safety final 
rule and begin implementation of the produce safety standards. Congress 
conveyed its sense of urgency in the timeframes established in FSMA for 
the Produce Safety final rule: 1 year after enactment of FSMA for a 
proposed rule (section 419(a)(1)(A) of the FD&C Act) and 1 year after 
the close of the comment period for a final rule (section 419(b)(1) of 
the FD&C Act). Congress recognized the urgent need to establish 
standards for produce safety to prevent SAHCOD hazards and, therefore, 
included specific timeframes for issuance of the proposed and final 
produce safety rules within the statute. Although FDA was unable to 
meet these statutory timeframes, FDA has nonetheless acted as swiftly 
as possible to complete the rulemaking process to establish the produce 
safety regulation in 21 CFR part 112.
    Formulating the produce safety standards involved highly complex 
scientific, regulatory, and practical considerations. For example, 
establishing the appropriate microbial quality criteria for 
agricultural water that is used during growing activities involved 
extensive review of scientific literature on pathogen presence, 
transmission, and survival under various conditions; other relevant 
national and international standards; diverse uses and methods of 
application of water; and the wide array of commodities and practices 
that affect potential risk of contamination of produce. As another 
example, we considered various options before adopting a regulatory 
framework that is based on practices, procedures, and processes 
associated with growing, harvesting, packing, and holding of all 
covered produce, rather than one that (based solely on a history of 
outbreaks or illnesses associated with the commodity) would be 
applicable to individual commodities or classes of commodities. FDA's 
integrated approach to produce safety standards draws on our past 
experiences and appropriately reflects the need to tailor requirements 
to specific on-farm routes of contamination. Through this rule (along 
with other FSMA rules) FDA is putting in place a framework for food 
safety that is modern and brings to bear the most recent science on 
provisions to enhance food safety, that is risk-based and focuses 
effort where the hazards are reasonably likely to occur, and that is 
flexible and practical given our current knowledge of food safety 
practices.
    The rule notably sets standards in an area that is extremely 
diverse. Therefore, FDA has spent considerable time to achieve the 
right balance in establishing standards that would adequately protect 
public health and yet be flexible and practicable to be implemented 
successfully by the highly diverse produce industry. This necessitated 
enormous outreach, including numerous farm visits all over the United 
States, throughout the rulemaking process, to solicit and consider 
stakeholder input in preparing the final rule. We believe we have acted 
responsibly in taking the time to craft a regulation that provides 
critical public health protection and also is implementable by the 
produce industry. Implementation of the produce safety standards by 
covered farms engaged in the growing, harvesting, packing, and/or 
holding of produce is critical to achieve the public health goals set 
out in FSMA and, therefore, we set reasonable timeframes for compliance 
with the rule. It is important for FDA to finalize the rule as quickly 
as possible to enable farmers, packers, handlers, and others covered 
under the rule to begin taking the steps that will safeguard public 
health and safety.

II. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) 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 http://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. Final Environmental Impact Statement for the Proposed Rule: 
Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption, http://www.fda.gov/food/guidanceregulation/fsma/ucm396564.htm.
2. Record of Decision. Final Environmental Impact Statement--
Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption, October 2015.
3. D'Lima, C., K. Vierk, and FDA, ``Memorandum to the Record'', 
2011.
4. Merriweather, C., T. C. Cloyd, C. Robinson, D. Gubernot, and FDA, 
2011-2014 Produce Related Outbreaks and Illnesses [Memorandum]. May 
8, 2015.
5. FDA, ``Final Regulatory Impact Analysis: Standards for the 
Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption,'' http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm.

    Dated: October 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28161 Filed 11-13-15; 8:45 am]
 BILLING CODE 4164-01-P


