[Federal Register Volume 81, Number 85 (Tuesday, May 3, 2016)]
[Rules and Regulations]
[Pages 26466-26468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09768]


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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-AG35


Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending a 
final rule that published in the Federal Register of November 27, 2015. 
That final rule established science-based minimum standards for the 
safe growing, harvesting, packing, and holding of produce, meaning 
fruits and vegetables grown for human consumption. The rule sets forth 
procedures, processes, and practices that minimize the risk of serious 
adverse health consequences or death, including those reasonably 
necessary to prevent the introduction of known or reasonably 
foreseeable biological hazards into or onto produce and to provide 
reasonable assurances that the produce is not adulterated on account of 
such hazards. FDA established these standards as part of our 
implementation of the FDA Food Safety and Modernization Act. The final 
rule published with some editorial and inadvertent errors. This 
document corrects those errors.

DATES: Effective May 3, 2016.

FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety 
and Applied Nutrition (HFS-317), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1636.

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, November 
27, 2015 (80 FR 74354), FDA published the final rule ``Standards for 
the Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption'' with some editorial and inadvertent errors. This action 
is being taken to correct inadvertent errors in the preamble to the 
final rule and to improve the accuracy of the provisions added to the 
Code of Federal Regulations.
    On page 74357, the table with the heading ``COMPLIANCE DATES'' is 
corrected to read as follows:

                                                                    Compliance Dates
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Covered activities involving all      Farms eligible for a qualified exemption (if applicable)
                                 Covered activities   other covered produce (i.e., subject -------------------------------------------------------------
                                  involving sprouts      to part 112, except subpart M)
                                    covered under   ---------------------------------------  Compliance date
      Size of covered farm        subpart M (i.e.,     Compliance date                       for retention of   Compliance date     Compliance date for
                                   subject to all        for certain      Compliance date        records          for modified    all other requirements
                                   requirements of        specified        for all other        supporting       requirement in    in Sec.  Sec.   112.6
                                      part 112)      agricultural water     requirements      eligibility in          Sec.               and 112.7
                                                        requirements                         Sec.   112.7(b)      112.6(b)(1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                   Time periods starting from the effective date of this                                          Time periods starting
                                                            rule                                                                   from the effective
                                                                                                                                   date of this rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Very small business............  3 years (January    6 years (January    4 years (January   Effective date of  January 1, 2020..  4 years for farms not
                                  26, 2019).          26, 2022).          26, 2020).         rule (January                         producing sprouts
                                                                                             26, 2016).                            (January 26, 2020)/3
                                                                                                                                   years for farms
                                                                                                                                   producing sprouts
                                                                                                                                   (January 26, 2019).
Small business.................  2 years (January    5 years (January    3 years (January   .................  .................  3 years for farms not
                                  26, 2018).          26, 2021).          26, 2019).                                               producing sprouts
                                                                                                                                   (January 26, 2019)/2
                                                                                                                                   years for farms
                                                                                                                                   producing sprouts
                                                                                                                                   (January 26, 2018).
All other businesses...........  1 year (January     4 years (January    2 years (January   .................  .................  N/A.
                                  26, 2017).          26, 2020).          26, 2018).
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 26467]]

    Section 112.3 is revised to collapse paragraphs (a), (b), and (c) 
into a single paragraph.
    The definition of ``farm'' is revised to use the same indent 
numbering as in the definition of ``farm'' under 21 CFR 1.227 
established in the final rule, ``Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' 
(80 FR 55908; September 17, 2015).
    The definition of ``covered activity'' is revised to replace the 
reference to 21 CFR part 110 with a reference to 21 CFR part 117.
    The definition of ``harvesting'' is revised consistent with the 
revision to the definition of ``harvesting'' in Sec.  1.227 as 
published in ``Current Good Manufacturing Practice, Hazard Analysis, 
and Risk-Based Preventive Controls for Human Food; Technical 
Amendment'' (81 FR 3714; January 22, 2016).
    The definition of ``packing'' is revised to remove a duplicative 
reference to section 201(r) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321(r)) and to add the term ``re-packing'' in multiple 
places, so that the definition is consistent with the definition of 
``packing'' in Sec.  117.3 as published in ``Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human 
Food; Technical Amendment'' (81 FR 3714);
    The definitions of ``small business'' and ``very small business'' 
are revised to remove paragraph references that are no longer needed 
due to the rearrangement of Sec.  112.3 into a single section and to 
follow the structure of the other definitions in Sec.  112.3.
    In the definition of ``qualified end-user,'' paragraphs (i) and 
(ii) are redesignated as paragraphs (1) and (2).
    Section 112.55(b) is revised to add a liquid weight basis for 
sampling, consistent with table 18 in the final rule ``Standards for 
the Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption'' (80 FR 74354 at 74475) and discussion under Comment 291 
in the same document (80 FR 74354 at 74472 to 74473).

List of Subjects in 21 CFR Part 112

    Foods, Fruits and vegetables, Incorporation by reference, Packaging 
and containers, Recordkeeping requirements, Safety.

PART 112--STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND 
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

0
1. The authority citation for 21 CFR part 112 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 
264, 271.


0
2. Amend Sec.  112.3 by:
0
a. Removing paragraphs (a) and (b) and (c) introductory text and adding 
introductory text;
0
b. In the definition of ``Qualified end-user'', redesignating 
paragraphs (i) and (ii) as paragraphs (1) and (2);
0
c. Revising the definitions of ``Covered activity'', ``Farm'', 
``Harvesting'', and ``Packing''; and
0
d. Adding in alphabetical order the definitions of ``Small business'' 
and ``Very small business''.
    The revisions and additions read as follows:


Sec.  112.3  What definitions apply to this part?

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this part. The following definitions also apply:
* * * * *
    Covered activity means growing, harvesting, packing, or holding 
covered produce on a farm. Covered activity includes manufacturing/
processing of covered produce on a farm, but only to the extent that 
such activities are performed on raw agricultural commodities and only 
to the extent that such activities are within the meaning of ``farm'' 
as defined in this chapter. Providing, acting consistently with, and 
documenting actions taken in compliance with written assurances as 
described in Sec.  112.2(b) are also covered activities. This part does 
not apply to activities of a facility that are subject to part 117 of 
this chapter.
* * * * *
    Farm means:
    (1) Primary production farm. A primary production farm is an 
operation under one management in one general (but not necessarily 
contiguous) physical location devoted to the growing of crops, the 
harvesting of crops, the raising of animals (including seafood), or any 
combination of these activities. The term ``farm'' includes operations 
that, in addition to these activities:
    (i) Pack or hold raw agricultural commodities;
    (ii) Pack or hold processed food, provided that all processed food 
used in such activities is either consumed on that farm or another farm 
under the same management, or is processed food identified in paragraph 
(1)(iii)(B)(1) of this definition; and
    (iii) Manufacture/process food, provided that:
    (A) All food used in such activities is consumed on that farm or 
another farm under the same management; or
    (B) Any manufacturing/processing of food that is not consumed on 
that farm or another farm under the same management consists only of:
    (1) Drying/dehydrating raw agricultural commodities to create a 
distinct commodity (such as drying/dehydrating grapes to produce 
raisins), and packaging and labeling such commodities, without 
additional manufacturing/processing (an example of additional 
manufacturing/processing is slicing);
    (2) Treatment to manipulate the ripening of raw agricultural 
commodities (such as by treating produce with ethylene gas), and 
packaging and labeling treated raw agricultural commodities, without 
additional manufacturing/processing; and
    (3) Packaging and labeling raw agricultural commodities, when these 
activities do not involve additional manufacturing/processing (an 
example of additional manufacturing/processing is irradiation); or
    (2) Secondary activities farm. A secondary activities farm is an 
operation, not located on a primary production farm, devoted to 
harvesting (such as hulling or shelling), packing, and/or holding of 
raw agricultural commodities, provided that the primary production 
farm(s) that grows, harvests, and/or raises the majority of the raw 
agricultural commodities harvested, packed, and/or held by the 
secondary activities farm owns, or jointly owns, a majority interest in 
the secondary activities farm. A secondary activities farm may also 
conduct those additional activities allowed on a primary production 
farm as described in paragraphs (1)(ii) and (iii) of this definition.
* * * * *
    Harvesting applies to farms and farm mixed-type facilities and 
means activities that are traditionally performed on farms for the 
purpose of removing raw agricultural commodities from the place they 
were grown or raised and preparing them for use as food. Harvesting is 
limited to activities performed on raw agricultural commodities, or on 
processed foods created by drying/dehydrating a raw agricultural 
commodity without additional manufacturing/processing, on a farm. 
Harvesting does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of 
harvesting include cutting (or otherwise separating) the edible portion 
of the raw agricultural

[[Page 26468]]

commodity from the crop plant and removing or trimming part of the raw 
agricultural commodity (e.g., foliage, husks, roots or stems). Examples 
of harvesting also include cooling, field coring, filtering, gathering, 
hulling, shelling, sifting, threshing, trimming of outer leaves of, and 
washing raw agricultural commodities grown on a farm.
* * * * *
    Packing means placing food into a container other than packaging 
the food and also includes re-packing and activities performed 
incidental to packing or re-packing a food (e.g., activities performed 
for the safe or effective packing or re-packing of that food (such as 
sorting, culling, grading, and weighing or conveying incidental to 
packing or re-packing)), but does not include activities that transform 
a raw agricultural commodity into a processed food as defined in 
section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
* * * * *
    Small business means a farm that is subject to any of the 
requirements of this part and, on a rolling basis, the average annual 
monetary value of produce (as defined in this section) the farm sold 
during the previous 3-year period is no more than $500,000; and the 
farm is not a very small business as defined in this section.
* * * * *
    Very small business means a farm that is subject to any of the 
requirements of this part and, on a rolling basis, the average annual 
monetary value of produce (as defined in this section) the farm sold 
during the previous 3-year period is no more than $250,000.
* * * * *

0
3. In Sec.  112.55, revise paragraph (b) to read as follows:


Sec.  112.55  What microbial standards apply to the treatment processes 
in Sec.  112.54?

* * * * *
    (b) Salmonella species are not detected using a method that can 
detect three MPN Salmonella species per 4 grams (or milliliter, if 
liquid is being sampled) of total solids; and less than 1,000 MPN fecal 
coliforms per gram (or milliliter, if liquid is being sampled) of total 
solids.

    Dated: April 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09768 Filed 5-2-16; 8:45 am]
BILLING CODE 4164-01-P