81 FR 26466 - Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Technical Amendment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 85 (May 3, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 85 (May 3, 2016)
| Page Range | 26466-26468 | |
| FR Document | 2016-09768 |
[Federal Register Volume 81, Number 85 (Tuesday, May 3, 2016)] [Rules and Regulations] [Pages 26466-26468] From the Federal Register Online [www.thefederalregister.org] [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
![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
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W BND ......................................................................................... 5,000
§ 95.6394 VOR Federal Airway V394 is Amended to Read in Part
Daggett, CA VORTAC .................................................................. * Oasys, NV FIX ........................................................................... ** 12,000
*10,400—MCA
Oasys, NV FIX, SW BND
** 9,500—MOCA
** 10,000—GNSS MEA
Oasys, NV FIX .............................................................................. Las Vegas, NV VORTAC ............................................................ 9,000
[FR Doc. 2016–10009 Filed 5–2–16; 8:45 am] amending a final rule that published in FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4910–13–P the Federal Register of November 27, Samir Assar, Center for Food Safety and
2015. That final rule established Applied Nutrition (HFS–317), Food and
science-based minimum standards for Drug Administration, 5100 Paint Branch
DEPARTMENT OF HEALTH AND the safe growing, harvesting, packing, Pkwy., College Park, MD 20740, 240–
HUMAN SERVICES and holding of produce, meaning fruits 402–1636.
and vegetables grown for human
Food and Drug Administration consumption. The rule sets forth SUPPLEMENTARY INFORMATION: In the
procedures, processes, and practices Federal Register of Friday, November
21 CFR Part 112 that minimize the risk of serious adverse 27, 2015 (80 FR 74354), FDA published
health consequences or death, including the final rule ‘‘Standards for the
[Docket No. FDA–2011–N–0921]
those reasonably necessary to prevent Growing, Harvesting, Packing, and
RIN 0910–AG35 Holding of Produce for Human
the introduction of known or reasonably
foreseeable biological hazards into or Consumption’’ with some editorial and
Standards for the Growing, Harvesting, inadvertent errors. This action is being
Packing, and Holding of Produce for onto produce and to provide reasonable
assurances that the produce is not taken to correct inadvertent errors in the
Human Consumption; Technical
adulterated on account of such hazards. preamble to the final rule and to
Amendment
FDA established these standards as part improve the accuracy of the provisions
AGENCY: Food and Drug Administration, of our implementation of the FDA Food added to the Code of Federal
HHS. Safety and Modernization Act. The final Regulations.
Final rule; technical
ACTION: rule published with some editorial and On page 74357, the table with the
amendment. inadvertent errors. This document heading ‘‘COMPLIANCE DATES’’ is
corrects those errors. corrected to read as follows:
SUMMARY: The Food and Drug
Administration (FDA or we) is DATES: Effective May 3, 2016.
COMPLIANCE DATES
Covered activities involving all Farms eligible for a qualified exemption
Covered other covered produce (if applicable)
activities (i.e., subject to part 112, except
involving subpart M) Compliance
sprouts
Size of covered date for Compliance
covered under
farm Compliance retention of date for Compliance date for all other
subpart M Compliance
date for certain records modified requirements in §§ 112.6 and
(i.e., subject to date for all
specified agri- supporting requirement in 112.7
all requirements other
cultural water eligibility in § 112.6(b)(1)
of part 112) requirements
requirements § 112.7(b)
Time periods starting from the effective date of this Time periods starting from the
rule effective date of this rule
Very small busi- 3 years (Janu- 6 years (Janu- 4 years (Janu- Effective date of January 1, 2020 4 years for farms not producing
ness. ary 26, 2019). ary 26, 2022). ary 26, 2020). rule (January sprouts (January 26, 2020)/3
26, 2016). years for farms producing
sprouts (January 26, 2019).
Small business .. 2 years (Janu- 5 years (Janu- 3 years (Janu- .......................... .......................... 3 years for farms not producing
ary 26, 2018). ary 26, 2021). ary 26, 2019). sprouts (January 26, 2019)/2
Lhorne on DSK30JT082PROD with RULES
years for farms producing
sprouts (January 26, 2018).
All other busi- 1 year (January 4 years (Janu- 2 years (Janu- .......................... .......................... N/A.
nesses. 26, 2017). ary 26, 2020). ary 26, 2018).
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![26468 Federal Register / Vol. 81, No. 85 / Tuesday, May 3, 2016 / Rules and Regulations
commodity from the crop plant and DEPARTMENT OF HOMELAND without prior notice and opportunity to
removing or trimming part of the raw SECURITY comment when the agency for good
agricultural commodity (e.g., foliage, cause finds that those procedures are
husks, roots or stems). Examples of Coast Guard ‘‘impracticable, unnecessary, or contrary
harvesting also include cooling, field to the public interest.’’ Under 5 U.S.C.
coring, filtering, gathering, hulling, 33 CFR Part 165 553(b)(B), the Coast Guard finds that
shelling, sifting, threshing, trimming of [Docket Number USCG–2016–0109]
good cause exists for not publishing a
outer leaves of, and washing raw Notice of Proposed Rulemaking (NPRM)
RIN 1625–AA00 with respect to this rule because doing
agricultural commodities grown on a
farm. so would be impracticable and contrary
Safety Zone; Hudson River, Jersey to the public interest. The event sponsor
* * * * * City, NJ, Manhattan, NY was late in submitting the marine event
Packing means placing food into a AGENCY: Coast Guard, DHS. application. This late submission did
container other than packaging the food not give the Coast Guard enough time to
ACTION: Temporary final rule.
and also includes re-packing and publish an NPRM and solicit comments
activities performed incidental to SUMMARY: The Coast Guard is from the public before establishing a
packing or re-packing a food (e.g., establishing a temporary safety zone on safety zone. The nature of the Louis
activities performed for the safe or the navigable waters of the Hudson Vuitton America’s Cup World Series
effective packing or re-packing of that River in the vicinity of Manhattan, NY, New York 2016 requires the immediate
food (such as sorting, culling, grading, and Jersey City, NJ for the Louis Vuitton establishment of a safety zone.
and weighing or conveying incidental to America’s Cup World Series New York Publishing an NPRM and delaying the
packing or re-packing)), but does not 2016 regatta. This temporary safety zone effective date of this rule to await public
include activities that transform a raw is necessary to protect all participating comment inhibits the Coast Guard’s
and spectator vessels from the hazards ability to fulfill its statutory mission to
agricultural commodity into a processed
associated with regattas in high traffic protect ports, waterways, and the
food as defined in section 201(gg) of the
areas. This rule is intended to restrict all maritime public. We are issuing this
Federal Food, Drug, and Cosmetic Act. rule, and under 5 U.S.C. 553(d)(3), the
vessels from a portion of the Hudson
* * * * * Coast Guard finds that good cause exists
River during the event.
Small business means a farm that is for making it effective less than 30 days
DATES: This rule is effective from 11:30
subject to any of the requirements of after publication in the Federal
a.m. on Friday, May 6, 2016 through Register. The rule must become
this part and, on a rolling basis, the 5:00 p.m. on Sunday, May 8, 2016. This
average annual monetary value of effective on the date specified in order
rule will be enforced between 11:30 a.m. to provide for the safety of spectators
produce (as defined in this section) the to 5:00 p.m. from Friday, May 6, 2016
farm sold during the previous 3-year and vessels operating in the area near
through Sunday, May 8, 2016. this event. Delaying the effective date of
period is no more than $500,000; and ADDRESSES: To view documents this rule would be contrary to the public
the farm is not a very small business as mentioned in this preamble as being interest and would expose spectators
defined in this section. available in the docket, go to http:// and vessels to the hazards associated
* * * * * www.regulations.gov, type USCG–2016– with the regattas. The sponsor advised
Very small business means a farm that 0109 in the ‘‘SEARCH’’ box and click that any change to the date of the event
is subject to any of the requirements of ‘‘SEARCH.’’ Click on Open Docket would cause economic hardship on the
this part and, on a rolling basis, the Folder on the line associated with this event sponsor, negatively impacting
average annual monetary value of rule. other activities being held in
produce (as defined in this section) the FOR FURTHER INFORMATION CONTACT: If conjunction with the event.
farm sold during the previous 3-year you have questions about this proposed III. Legal Authority and Need for Rule
period is no more than $250,000. rulemaking, call or email LTJG
Christopher Dunn, Sector New York The Coast Guard is issuing this rule
* * * * * under the authority in 33 U.S.C. 1231.
Waterways Management Division, U.S.
■ 3. In § 112.55, revise paragraph (b) to Coast Guard; telephone 718–354–4012, The Louis Vuitton America’s Cup World
read as follows: email christopher.e.dunn@uscg.mil. Series 2016, is planned to take place
over a 3 day period between the dates
SUPPLEMENTARY INFORMATION:
§ 112.55 What microbial standards apply of May 6–8, 2016, on the Hudson River
to the treatment processes in § 112.54? I. Table of Abbreviations in the vicinity of Manhattan, NY. The
* * * * * Series is composed of daily racing of
CFR Code of Federal Regulations
DHS Department of Homeland Security
high-speed, high-performance sailing
(b) Salmonella species are not vessels. The racing of these vessels on
detected using a method that can detect FR Federal Register
NPRM Notice of proposed rulemaking the Hudson River along Manhattan, NY
three MPN Salmonella species per 4 § Section is expected to generate national and
grams (or milliliter, if liquid is being U.S.C. United States Code international media coverage, and
sampled) of total solids; and less than attract spectators on a number of
1,000 MPN fecal coliforms per gram (or II. Background Information and
recreational vessels and excursion
milliliter, if liquid is being sampled) of Regulatory History
vessels.
total solids. The Coast Guard is issuing this The Coast Guard is proposing
Lhorne on DSK30JT082PROD with RULES
Dated: April 21, 2016. temporary rule without prior notice and establishing this safety zone, in
opportunity to comment pursuant to conjunction with the Louis Vuitton
Leslie Kux,
authority under section 4(a) of the America’s Cup World Series 2016, to
Associate Commissioner for Policy. Administrative Procedure Act (APA) (5 ensure the protection of the maritime
[FR Doc. 2016–09768 Filed 5–2–16; 8:45 am] U.S.C. 553(b)). This provision public and event participants from the
BILLING CODE 4164–01–P authorizes an agency to issue a rule hazards associated with large-scale
VerDate Sep<11>2014 13:43 May 02, 2016 Jkt 238001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\03MYR1.SGM 03MYR1](https://thefederalregister.org/doc/81_FR_26551/page/3.svg)
Document Created: 2016-05-03 00:30:59
Document Modified: 2016-05-03 00:30:59
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; technical amendment. | |
| Dates | Effective May 3, 2016. | |
| 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. | |
| FR Citation | 81 FR 26466 | |
| RIN Number | 0910-AG35 | |
| CFR Associated | Foods; Fruits and Vegetables; Incorporation by Reference; Packaging and Containers; Recordkeeping Requirements and Safety |
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