Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Technical Amendment, 26466-26468 [2016-09768]
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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
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§ 95.6394
VOR Federal Airway V394 is Amended to Read in Part
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** 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 ..
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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).
..........................
..........................
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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
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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
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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
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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
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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?
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*
*
*
*
*
(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
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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]
=======================================================================
-----------------------------------------------------------------------
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