Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Technical Amendment, 26466-26468 [2016-09768]

Download as PDF 26466 Federal Register / Vol. 81, No. 85 / Tuesday, May 3, 2016 / Rules and Regulations REVISIONS TO IFR ALTITUDES & CHANGEOVER POINT—Continued [Amendment 526 effective date May 26, 2016] From To MEA E BND .......................................................................................... W BND ......................................................................................... § 95.6394 VOR Federal Airway V394 is Amended to Read in Part Daggett, CA VORTAC .................................................................. *10,400—MCA Oasys, NV FIX, SW BND ** 9,500—MOCA ** 10,000—GNSS MEA Oasys, NV FIX .............................................................................. [FR Doc. 2016–10009 Filed 5–2–16; 8:45 am] BILLING CODE 4910–13–P 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. Final rule; technical amendment. ACTION: The Food and Drug Administration (FDA or we) is SUMMARY: 9,000 5,000 * Oasys, NV FIX ........................................................................... ** 12,000 Las Vegas, NV VORTAC ............................................................ 9,000 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: 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. 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: SUPPLEMENTARY INFORMATION: Effective May 3, 2016. COMPLIANCE DATES Size of covered farm Covered activities involving sprouts covered under subpart M (i.e., subject to all requirements of part 112) Covered activities involving all other covered produce (i.e., subject to part 112, except subpart M) Compliance date for certain specified agricultural water requirements Compliance date for all other requirements Farms eligible for a qualified exemption (if applicable) Compliance date for retention of records supporting eligibility in § 112.7(b) Compliance date for modified requirement in § 112.6(b)(1) Compliance date for all other requirements in §§ 112.6 and 112.7 Time periods starting from the effective date of this rule Time periods starting from the effective date of this rule 3 years (January 26, 2019). 6 years (January 26, 2022). 4 years (January 26, 2020). Effective date of rule (January 26, 2016). January 1, 2020 Small business .. Lhorne on DSK30JT082PROD with RULES Very small business. 2 years (January 26, 2018). 5 years (January 26, 2021). 3 years (January 26, 2019). .......................... .......................... All other businesses. 1 year (January 26, 2017). 4 years (January 26, 2020). 2 years (January 26, 2018). .......................... .......................... VerDate Sep<11>2014 18:19 May 02, 2016 Jkt 238001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\03MYR1.SGM 4 years for farms not producing sprouts (January 26, 2020)/3 years for farms producing sprouts (January 26, 2019). 3 years for farms not producing sprouts (January 26, 2019)/2 years for farms producing sprouts (January 26, 2018). N/A. 03MYR1 Federal Register / Vol. 81, No. 85 / Tuesday, May 3, 2016 / Rules and Regulations 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 § 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 § 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 § 112.3 into a single section and to follow the structure of the other definitions in § 112.3. In the definition of ‘‘qualified enduser,’’ 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 Lhorne on DSK30JT082PROD with RULES 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 1. The authority citation for 21 CFR part 112 continues to read as follows: ■ VerDate Sep<11>2014 13:43 May 02, 2016 Jkt 238001 Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271. 2. Amend § 112.3 by: a. Removing paragraphs (a) and (b) and (c) introductory text and adding introductory text; ■ b. In the definition of ‘‘Qualified enduser’’, redesignating paragraphs (i) and (ii) as paragraphs (1) and (2); ■ c. Revising the definitions of ‘‘Covered activity’’, ‘‘Farm’’, ‘‘Harvesting’’, and ‘‘Packing’’; and ■ d. Adding in alphabetical order the definitions of ‘‘Small business’’ and ‘‘Very small business’’. The revisions and additions read as follows: ■ ■ § 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 § 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 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 26467 (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 E:\FR\FM\03MYR1.SGM 03MYR1 26468 Federal Register / Vol. 81, No. 85 / Tuesday, May 3, 2016 / Rules and Regulations 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. * * * * * 3. In § 112.55, revise paragraph (b) to read as follows: ■ § 112.55 What microbial standards apply to the treatment processes in § 112.54? Lhorne on DSK30JT082PROD with RULES * * * * * (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 VerDate Sep<11>2014 13:43 May 02, 2016 Jkt 238001 DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG–2016–0109] RIN 1625–AA00 Safety Zone; Hudson River, Jersey City, NJ, Manhattan, NY Coast Guard, DHS. Temporary final rule. AGENCY: ACTION: The Coast Guard is establishing a temporary safety zone on the navigable waters of the Hudson River in the vicinity of Manhattan, NY, and Jersey City, NJ for the Louis Vuitton America’s Cup World Series New York 2016 regatta. This temporary safety zone is necessary to protect all participating and spectator vessels from the hazards associated with regattas in high traffic areas. This rule is intended to restrict all vessels from a portion of the Hudson River during the event. DATES: This rule is effective from 11:30 a.m. on Friday, May 6, 2016 through 5:00 p.m. on Sunday, May 8, 2016. This rule will be enforced between 11:30 a.m. to 5:00 p.m. from Friday, May 6, 2016 through Sunday, May 8, 2016. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov, type USCG–2016– 0109 in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open Docket Folder on the line associated with this rule. FOR FURTHER INFORMATION CONTACT: If you have questions about this proposed rulemaking, call or email LTJG Christopher Dunn, Sector New York Waterways Management Division, U.S. Coast Guard; telephone 718–354–4012, email christopher.e.dunn@uscg.mil. SUPPLEMENTARY INFORMATION: SUMMARY: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 without prior notice and opportunity to comment when the agency for good cause finds that those procedures are ‘‘impracticable, unnecessary, or contrary to the public interest.’’ Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a Notice of Proposed Rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The event sponsor was late in submitting the marine event application. This late submission did not give the Coast Guard enough time to publish an NPRM and solicit comments from the public before establishing a safety zone. The nature of the Louis Vuitton America’s Cup World Series New York 2016 requires the immediate establishment of a safety zone. Publishing an NPRM and delaying the effective date of this rule to await public comment inhibits the Coast Guard’s ability to fulfill its statutory mission to protect ports, waterways, and the maritime public. We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. The rule must become effective on the date specified in order to provide for the safety of spectators and vessels operating in the area near this event. Delaying the effective date of this rule would be contrary to the public interest and would expose spectators and vessels to the hazards associated with the regattas. The sponsor advised that any change to the date of the event would cause economic hardship on the event sponsor, negatively impacting other activities being held in conjunction with the event. III. Legal Authority and Need for Rule The Coast Guard is issuing this rule under the authority in 33 U.S.C. 1231. The Louis Vuitton America’s Cup World Series 2016, is planned to take place over a 3 day period between the dates of May 6–8, 2016, on the Hudson River in the vicinity of Manhattan, NY. The Series is composed of daily racing of high-speed, high-performance sailing vessels. The racing of these vessels on the Hudson River along Manhattan, NY is expected to generate national and international media coverage, and attract spectators on a number of recreational vessels and excursion vessels. The Coast Guard is proposing establishing this safety zone, in conjunction with the Louis Vuitton America’s Cup World Series 2016, to ensure the protection of the maritime public and event participants from the hazards associated with large-scale E:\FR\FM\03MYR1.SGM 03MYR1

Agencies

[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.

-----------------------------------------------------------------------

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
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