Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  
  
 
 
Classification of Activities as Harvesting, 
Packing, Holding, or 
Manufacturing/Processing for Farms and 
Facilities:  
Guidance for Industry  
 
Draft Guidance
 
This guidance is being distributed for comment purposes only. 
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure 
that FDA considers your comment on this draft guidance before we begin work on the final 
version of the guidance, submit either electronic or written comments on the draft guidance 
within 180 days of publication in the Federal Register of the notice announcing the availability 
of the draft guidance.  Submit electronic comments to http://www.regulations.gov.  Submit 
written comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should be 
identified with the docket number FDA-2016-D-2373 listed in the notice of availability that 
publishes in the Federal Register.  
For questions regarding this draft document contact the Center for Food Safety and Applied 
Nutrition (CFSAN) at 240-402-1700. 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
August 2016 
    Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Table of Contents  
 
I. Introduction
   
II. Background on Farm-Related Definitions
   
A.  Rulemaking to Revise Farm-Related Definitions 
B.  Definitions of Farm and Mixed-Type Facility 
C.  Definitions of Harvesting, Packing, Packaging, Holding, and 
Manufacturing/Processing 
D.  Manufacturing/Processing Activities That Are Allowed Within the 
Farm Definition 
E.  Packing, Packaging, and Stickering/Labeling Activities That Are 
Allowed Within the Farm Definition 
F.  Distinguishing Blending Activities from Mixing Activities 
III. Discussion
   
A.  Significance of Activity Classification 
B.  Activities Classified as Harvesting 
C.  Activities Classified as Packing or Packaging 
D.  Activities Classified as Holding 
E.  Activities Classified as Manufacturing/Processing 
F.  Activities Classified in More Than One Way 
G.  Activity Classification on a Farm Mixed-Type Facility that Grows, 
Harvests, Packs, and Processes Lettuce 
H.  Activity Classification in the Production of Walnuts 
I.  Activity Classification in the Production of Tomatoes 
 
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Classification of Activities as Harvesting, 
Packing, Holding, or 
Manufacturing/Processing for Farms and 
Facilities:  
1
Guidance for Industry 
 
   
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration's (FDA or we) on this topic.  It does not establish any rights for any person and is 
not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance as listed on the title page.  
 
 
 
I.  Introduction  
The purpose of this guidance is to help you to determine whether the activities that you perform 
are within the farm definition.  The regulatory framework for determining whether your 
business is a farm depends in large part on certain definitions (i.e., the definitions for farm, 
mixed-type facility (including a farm mixed-type facility), harvesting, packing, 
packaging, holding and manufacturing/processing) that are established in our regulation 
for Registration of Food Facilities (21 CFR part 1, subpart H).2 For your convenience, we copied 
these definitions that are established in 21 CFR 1.227 into sections II.B and II.C of this guidance.  
The guidance includes several examples of hypothetical operations that conduct various 
activities. We developed the hypothetical examples to make certain points about the regulatory 
framework for determining whether the activities that you perform are within the farm 
definition.  To make these points, in some cases our hypothetical examples describe activities 
that may not be common in todays farming operations.  It would not be possible to address 
every conceivable circumstance that may be relevant to determining whether the activities that 
                                                 
1 This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and Applied Nutrition 
in cooperation with the Office of Surveillance and Compliance in the Center for Veterinary Medicine at the U.S. 
Food and Drug Administration.   
2 The definition of manufacturing/processing includes packaging as an example of a 
manufacturing/processing activity.  In this guidance, we often discuss packaging separately from 
manufacturing/processing even though packaging is a manufacturing/processing activity. This is because 
packaging is common on farms and the farm definition specifically provides for packaging as a 
manufacturing/processing activity that is within the farm definition. 
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you perform are within the farm definition.  However, our intent was to provide information 
that will be helpful to you in evaluating your own operations.  
Determining whether the activities you perform are within the farm definition plays a key role 
in determining whether your business is exempt from registration as a food facility under Section 
415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350d) and 21 CFR  
1.226(b) because your business is a farm.3  Farms are not subject to the requirements for 
hazard analysis and risk-based preventive controls (in 21 CFR part 117 for human food and in 21 
CFR part 507 for animal food), which apply only to facilities required to register. 4  Some key 
provisions in our regulation for Registration of Food Facilities applicable to determining whether 
your operation is a facility that is required to register are: 
  21 CFR 1.225  Who must register under this subpart? 
  21 CFR 1.226  Who does not need to register under this subpart? 
  21 CFR 1.227  What definitions apply to this subpart?  
 
We intend to provide additional guidance relating to our regulation for Registration of Food 
Facilities in the near future. 
This guidance is also intended for you if your business is a farm mixed-type facility required to 
register, to help you determine which activities that you perform are outside the farm 
definition and therefore potentially subject to the requirements for hazard analysis and risk-based 
preventive controls (in 21 CFR part 117 for human food and in 21 CFR part 507 for animal 
food)4 and/or the requirements for Mitigation Strategies to Protect Food Against Intentional 
Adulteration (21 CFR 121). 
This guidance is also intended for you if you need to determine whether you are exempt from: 
  Current good manufacturing practice (CGMP) requirements for human food (in 21 CFR 
Part 117, Subpart B) or for animal food (21 CFR Part 507, Subpart B), based on:  
  the exemptions for farms and the activities of farm mixed-type facilities that fall 
o
within the definition of farm in 21 CFR 117.5(k)(1)(i) (as limited by 21 CFR 
117.5(k)(2)), 21 CFR 117.5(k)(1)(iv), and 21 CFR 507.5(a); 
  the exemptions for establishments that are solely engaged in the holding and/or 
o
transportation of one or more raw agricultural commodities (RACs) in 21 CFR 
117.5(k)(iii) and 21 CFR 507.5(h)(1);  
  the exemptions for establishments that are solely engaged in hulling, shelling, 
o
drying, packing, and/or holding nuts (without additional 
manufacturing/processing, such as roasting nuts) in 21 CFR 117.5(k)(1)(v) and 
21 CFR 507.5(h)(2);  
                                                 
3 There are other exemptions from the facility registration requirement in addition to the exemption for farms.  See 
21 CFR  1.226.  The applicability of these other exemptions are outside the scope of this guidance, which relates 
only to the exemption for farms in  1.226(b).   
4 There are various exemptions from the hazard analysis and preventive controls requirements potentially available 
to facilities required to register.  See 21 CFR  117.5, 117.7, 507.5, 507.10, and 507.12).  The applicability of many 
of these exemptions is outside the scope of this guidance.   
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  the exemption for establishments that are solely engaged in ginning of cotton 
o
(without additional manufacturing/processing, such as extracting oil from cotton 
seed) in 21 CFR 507.5(h)(3); and/or  
  Requirements for hazard analysis and risk-based preventive controls in 21 CFR Part 117, 
Subparts C and G (for human food) or 21 CFR Part 507, Subparts C and E (for animal 
food), and certain modified requirements (such as 21 CFR 117.201 or 21 CFR 507.7) 
based on the exemptions for:  
  on-farm packing or holding of food by a small or very small business, if the only 
o
packing and holding activities subject to section 418 of the FD&C Act that the 
business conducts are identified low-risk activity/food combinations in 21 CFR 
117.5(g) and 21 CFR 507.5(e); 
  on-farm manufacturing/processing of food for distribution into commerce by a 
o
small or very small business, if the only manufacturing/processing activities 
subject to section 418 of the FD&C Act that the business conducts are identified 
low-risk activity/food combinations in 21 CFR 117.5(h) and 21 CFR 507.5(f); 
  facilities that are solely engaged in the storage of RACs (other than fruits and 
o
vegetables) intended for further distribution or processing in 21 CFR 117.5(j) and 
21 CFR 507.5(g); and/or 
  facilities that are solely engaged in the storage of unexposed packaged food 
o
(with modified requirements where the food requires time/temperature control to 
significantly minimize or prevent the growth of, or toxin formation by, 
pathogens) in 21 CFR 117.7 and 21 CFR 507.10.  
 
In general, this guidance is directed at classification of activities associated with crops (plants or 
plant products) rather than with animal products. However, some of the information in this 
guidance may be of interest to you if you produce shell eggs. For example, you may find it useful 
to know that washing can be classified as a harvesting, packing, or 
manufacturing/processing activity.  Likewise, some of the information in this guidance may be 
of interest to you if you raise game animals. For example, you may find it useful to know that we 
classify slaughtering and smoking as manufacturing/processing activities.   
This guidance is intended to help you determine which activities that you perform are within the 
farm definition. It is not directed to interpreting other aspects of the farm definition (such as 
an interpretation of under one management or in one general (but not necessarily contiguous) 
physical location), or other definitions in our regulation for Registration of Food Facilities (such 
as retail food establishment), even though these other aspects and definitions may be relevant 
to determining whether your business must register as a food facility and the applicability of 
other requirements, such as those in 21 CFR Parts 112, 117, and 507.  Certain aspects of the 
farm definition, such as under one management and in one general (but not necessarily 
contiguous) physical location, are very fact-specific, and therefore we are not issuing guidance 
focused on these topics at this time but are instead addressing them on a case-by-case basis.  
However, some of the examples we provide in this document do describe operations in terms of 
both management and/or location.  You may find these examples helpful in understanding these 
aspects of the farm definition.  
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
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viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required.  
II.  Background on Farm-Related Definitions 
A.  Rulemaking to Revise Farm-Related Definitions 
Section 103(c) of the FDA Food Safety Modernization Act (FSMA) directed us to conduct 
rulemaking to clarify the on-farm activities that would, in part, determine when an establishment 
is required to register with us as a facility, or is not required to register with us because the 
establishment is a farm.  To do so, we conducted rulemaking to revise and add farm-related 
definitions to our existing regulation for Registration of Food Facilities in the same rulemaking 
documents that we issued to establish Part 117, containing the CGMP and preventive controls 
requirements for human food.  (See the final rule at 80 FR 55908, September 17, 2015.)  For the 
purposes of this guidance, we call that rulemaking the farm definition rulemaking. The farm 
definition rulemaking: 
  Revised the farm definition to provide for two types of farms: 
  Primary production farms; and 
o
  Secondary activities farms;  
o
  Revised three definitions associated with the farm definition (i.e., the definitions of 
packing, holding, and manufacturing/processing) and added more examples of 
activities in each of these definitions; and  
  Established a new definition associated with the farm definition (i.e., the definition of 
harvesting) and included examples of harvesting activities in the definition.      
 
B.  Definitions of Farm and Mixed-Type Facility 
The following definitions of farm and mixed-type facility are excerpts from our updated 
regulation for Registration of Food Facilities as published in the Title 21 of the Code of Federal 
Regulations, part 1, subpart H (21 CFR 1.227). The farm definition is formatted according to 
styles associated with the Code of Federal Regulations, including numbering styles not otherwise 
associated with this document.  
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 
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(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 paragraph (1)(ii) and (iii) of this 
definition. 
Mixed-type facility means an establishment that engages in both activities that are exempt from 
registration under section 415 of the Federal Food, Drug, and Cosmetic Act and activities that 
require the establishment to be registered.  An example of such a facility is a farm mixed-type 
facility, which is an establishment that is a farm, but also conducts activities outside the farm 
definition that require the establishment to be registered. 
We note that one result of the farm definition rulemaking is that there are two types of farms  
primary production farm and secondary activities farm.  We provided for these two types of 
farms to reflect the current reality of what it means to be a farm. For example, the two types of 
farms provide for a packinghouse that is managed by a business entity (such as a cooperative) 
that is different from the business entity growing crops (such as individual primary production 
farms) to be within the farm definition under certain circumstances.  For a fuller discussion of 
our reasons for revising the farm definition to provide for two types of farms, see Comment 
and Response 25 in the farm definition rulemaking (80 FR 55908 at 55927-55929).  
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C.  Definitions of Harvesting, Packing, Packaging, Holding, and 
Manufacturing/Processing 
The following definitions of harvesting, packing, packaging, holding, and 
manufacturing/processing are excerpts from our updated regulation for Registration of Food 
Facilities as published in the Title 21 of the Code of Federal Regulations, part 1, subpart H (21 
CFR 1.227). 
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 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-repacking 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, as defined in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act, into a processed food as defined in section 201(gg) of the Federal 
Food, Drug, and Cosmetic Act.   
Packaging (when used as a verb) means placing food into a container that directly contacts the 
food and that the consumer receives. 
Holding means storage of food and also includes activities performed incidental to storage of a 
food (e.g., activities performed for the safe or effective storage of that food, such as fumigating 
food during storage, and drying/dehydrating raw agricultural commodities when the 
drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or 
alfalfa)).  Holding also includes activities performed as a practical necessity for the distribution 
of that food (such as blending of the same raw agricultural commodity and breaking down 
pallets)), 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.  
Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, 
and liquid storage tanks. 
Manufacturing/processing means making food from one or more ingredients, or synthesizing, 
preparing, treating, modifying or manipulating food, including food crops or ingredients. 
Examples of manufacturing/processing activities include:  Baking, boiling, bottling, canning, 
cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a 
distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, 
eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, 
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labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, 
peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing.  For farms 
and farm mixed-type facilities, manufacturing/processing does not include activities that are part 
of harvesting, packing, or holding. 
D.  Manufacturing/Processing Activities That Are Allowed Within the 
Farm Definition 
A key factor in whether your business is a farm is whether the activities you perform fall 
within the activities that we included in the farm definition.  You can do the following 
manufacturing/processing activities and still be within the farm definition, as long as you dont 
do manufacturing/processing that goes beyond these activities: 
  Drying/dehydrating raw agricultural commodities (RACs) to create a distinct commodity 
(such as drying/dehydrating fresh herbs to produce dried herbs), and packaging and 
labeling the dried/dehydrated commodities, without additional manufacturing/processing 
activities (such as chopping or slicing the fresh or dried herbs);  
  Treatment to manipulate the ripening of RACs (such as by treating produce with ethylene 
gas), and packaging and labeling the treated RACs, without additional 
manufacturing/processing activities (such as by chopping or slicing the untreated or 
treated RACs); and 
  Packaging and labeling RACs, without additional manufacturing/processing activities 
(such as by irradiating the RACs or packaged RACs). 
 
E.  Packing, Packaging, and Stickering/Labeling Activities That Are 
Allowed Within the Farm Definition 
Note that our definitions distinguish between packing and packaging.  The first key 
distinction is that we use the term packaging to mean placing food into a container that directly 
contacts the food and that the consumer5 receives, but we use the term packing when food is 
placed into containers that are not consumer containers.  For example, placing strawberries into 
consumer containers that directly contact the food (e.g., plastic clamshells) is packaging, but 
placing apples into boxes and sending them to distribution centers or retailers is packing.  The 
second key distinction is that we classify packaging as a manufacturing/processing activity, 
but we do not classify packing as a manufacturing/processing activity.   
Importantly, one of the changes we made during the farm definition rulemaking is to allow 
packaging RACs to be within the farm definition even though packaging is a 
manufacturing/processing activity.  As a result, if you place RACs into a container, it makes no 
difference whether that activity is packing or packaging the RACs  for the purpose of 
determining whether your business is a farm, you can do either.  Refer to section II.B of this 
guidance for the farm definition at (1)(i) (packing RACs); (1)(iii)(B)(3) (packaging RACs); 
                                                 
5 The term consumer does not include businesses.  For example, pet owners and other individuals purchasing 
animal food from a retail facility are consumers but a farm operation purchasing animal food for its livestock is not a 
consumer.  See 68 FR 58894 at 58914. 
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and (2) (Secondary Activities Farms may pack RACs and conduct the same additional activities 
in (1)(iii) as a Primary Production Farm). 
Similarly, we consider labeling, including stickering, to be a manufacturing/processing 
activity.  However, you can also place labels (e.g., stickers) directly on RACs, on boxes or other 
containers holding packed RACs, or on consumer packages containing RACs, and still be within 
the farm definition. See farm definition at (1)(iii)(B)(3) (labeling RACs). 
By contrast, however, packaging and labeling of processed foods is manufacturing/processing 
that is not specifically included within the farm definition (see farm definition at (1)(iii)(B)) 
unless done for consumption on farm (see farm definition at (1)(iii)(A)) or performed on 
certain types of dried/dehydrated processed foods specified in the farm definition (see farm 
definition at (1)(iii)(B)(1)).  Also, only certain packing of processed foods is within the farm 
definition.  See farm definition at (1)(ii) (packing of processed foods limited to processed 
foods consumed on that farm or another under the same management, and processed foods 
identified in (1)(iii)(B)(1)).  See Table 1 for a summary of those packing, packaging, and 
stickering/labeling activities that are within the farm definition and those packing, 
packaging, and stickering/labeling activities that are not within the farm definition.   
Table 1. Summary of Packing, Packaging, and Stickering/Labeling Activities  
  Packing  Packaging  Stickering/labeling 
RAC  Within the farm  Within the farm  Within the farm 
definition  definition  definition 
Processed  Not within the  Not within the farm  Not within the farm 
food  farm definition,  definition, unless  definition, unless 
unless consumed  consumed on that farm or  consumed on that farm or 
on that farm or  another farm under the  another farm under the 
another farm  same management, or is  same management, or is 
under the same  performed on processed  performed on processed 
management, or is  food identified in  food identified in 
performed on  (1)(iii)(B)(1) with no  (1)(iii)(B)(1) with no 
processed food  additional  additional 
identified in  manufacturing/processing  manufacturing/processing 
(1)(iii)(B)(1) 
 
F.  Distinguishing Blending Activities from Mixing Activities 
For the purposes of this guidance, we use the term blending when the foods involved are the 
same.  One example of a type of food that is blended is grain, such as wheat.  For example, we 
consider the activity of blending different lots of wheat to meet a customers quality 
specifications to be a practical necessity for product distribution and, thus, to be within the 
definition of holding (see 79 FR 58524 at 58537, and 80 FR 55908 at 55933).  Holding RACs 
is within the farm definition (see farm definition at (1)(i) and (2)) and therefore blending lots 
of the same RAC on a farm does not make an operation a facility required to register. 
For the purposes of this guidance, we use the term mixing when the foods involved are 
different. Depending on the circumstances, mixing can be classified in different ways. 
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For example, we consider the activity of mixing corn and oats in the production of animal 
food, or mixing various seeds to produce bird food, to be manufacturing/processing, because the 
animal food produced by mixing ingredients is a processed food (see 79 FR 58524 at 58537, and 
80 FR 55908 at 55933).  Because this type of manufacturing/processing is not specifically 
included in the farm definition (see farm definition at (1)(iii)(B)), this kind of mixing makes 
an operation a facility required to register (unless an exemption applies).  
On the other hand, when mixing different intact RACs together does not create a processed food, 
we classify such mixing as part of packing, packaging, or holding, as applicable.  For 
example, we classify the activity of mixing intact produce RACs (such as oranges and grapefruit) 
in a packing container such as a box for further distribution as packing the RACs.  We classify 
mixing intact produce RACs (such as apples, oranges, and tangerines) in a net bag that directly 
contacts the food and that a consumer would receive, and mixing three different colored intact 
bell pepper RACs in a plastic bag that directly contacts the food and that a consumer would 
receive, packaging the RACs.  These activities are within the farm definition and therefore 
these kinds of mixing of RACs on a farm do not make an operation a facility required to register. 
III.  Discussion  
A.  Significance of Activity Classification 
The regulatory text of each definition associated with the farm definition includes examples of 
activities included within that definition.  Importantly, the fact that we included a particular 
activity in one definition does not mean that it cannot also be included as an example in another 
definition.  Depending on the circumstances, activities may be classified in different ways, and 
there may even be more than one possible classification of an activity for a single circumstance.  
We recommend that, in considering classification of an activity, businesses consider first 
whether the activity is growing (for farms) or fits the definition of harvesting, packing, or 
holding.  If the activity is not growing and does not fall within one or more of the  
harvesting, packing, or holding definitions, the activity is likely to be 
manufacturing/processing.  There are various limitations on growing, harvesting, packing, and 
holding.  By contrast, the definition of manufacturing/processing is very broad, capturing 
anything that does not fall within one or more of the other definitions.  The limitations on 
growing, harvesting, packing, and holding, compared to the breadth of 
manufacturing/processing, help explain why some activities may be classified in different ways 
depending on the specific situation.   
For example, we included trimming of outer leaves as an example in the definition of 
harvesting, but we also included trimming as an example in the definition of 
manufacturing/processing.  This is because trimming RACs can be harvesting when done on a 
farm (whether this is done in the growing area or elsewhere on a farm, such as in a packing 
house), or can be manufacturing/processing, for example, when done during the production of 
processed produce (such as fresh-cut mixed salad greens) in a food processing facility.  We also 
consider that trimming can in some cases fit the definition of packing, both on and off-farm, 
when trimming is incidental to packing (i.e., when it is done for the purpose of safe or effective 
packing of food).  This is true even though we did not include trimming as an example of a 
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packing activity in the definition.  For example, if a RAC must be trimmed before the RAC is 
packed in a container to remove damaged portions that could promote pathogen growth, or if part 
of the RAC (e.g., foliage, husks, roots or stems) must be removed to pack only the desired RAC 
in the container, such trimming may be incidental to packing. On the other hand, if an operation 
trims a RAC such as a head of lettuce to remove damaged portions before the operation washes 
the lettuce, chops it, bags the chopped lettuce in consumer packages, and then packs the bags 
into shipping boxes, the trimming in this case would not be incidental to packing. Other activities 
performed by the operation after the trimming make clear that the purpose of the trimming is not 
merely for safe or effective packing.  For example, the intervening chopping, which is a 
manufacturing/processing activity, prevents the trimming from being considered incidental to 
packing. 
The definition of manufacturing/processing specifies that, [f]or farms and farm mixed-type 
facilities, manufacturing/processing does not include activities that are part of harvesting, 
packing, or holding.  This means that because trimming on a farm may be harvesting or (in 
some cases) packing, it is not manufacturing/processing in such cases.  Off-farm, trimming 
may be packing as described above, and is otherwise likely to be manufacturing/processing 
when it does not fit the definition of packing.   
For a farm mixed-type facility, activity classification is relevant to determining which activities 
are within the farm definition, and which activities are not within the farm definition and 
therefore make an operation a facility required to register (unless an exemption applies), and 
which may in turn be subject to CGMP and/or preventive controls requirements (as applicable) 
under Parts 117 or 507.  For example, if you grow apples for human food, harvest the apples, and 
manufacture/process the apples by slicing them, your operation is a farm mixed-type facility 
and you must register as a food facility (unless an exemption applies) because you are 
performing manufacturing/processing that is outside the farm definition (i.e., slicing apples).  
The growing and harvesting activities are within the farm definition and, thus, are not subject 
to the preventive controls requirements in Part 117 (see 78 FR at 3677 (Jan. 16, 2013), and 21 
CFR 117.5(f), (g)(1), and (h)(1)).  In addition, those activities are exempt from the CGMP 
requirements in Part 117 (Subpart B) under 21 CFR 117.5(k)(1)(iv).  On the other hand, your 
apple growing and harvesting activities are potentially subject to the produce safety requirements 
in Part 112 (as applicable).  In addition, the manufacturing/processing activity of slicing the 
apples is potentially subject to the CGMP and preventive controls requirements of Part 117 (as 
applicable). Apple culls and cores resulting from the production of human food that are by-
products for animal food use may be subject to the CGMP and preventive controls requirements 
of Part 507 (or the holding and distribution provision of 21 CFR 117.95, if the by-product meets 
the requirements of 21 CFR 507.12).   
For an establishment (such as a warehouse) that performs activities on RACs but is not a farm, 
the activity classification can have important consequences beyond making the establishment a 
facility required to register.  For example, under 21 CFR 117.5(j) and 507.5(g) for human food 
and animal food, respectively, a facility that is solely engaged in the storage of RACs (other than 
fruits and vegetables) intended for further distribution or processing is not subject to the 
requirements for hazard analysis and risk-based preventive controls in those regulations.  In this 
case, the facility would need to determine whether all the activities it performs fall within the 
definition of holding.  As an example, depending on the activities performed at the facility, as 
discussed in section II.F of this guidance, the difference between blending (which is an 
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example of a holding activity), mixing that creates a processed food (which is an example of 
a manufacturing/processing activity), and mixing that does not create a processed food 
(which may be packaging, packing, or holding, depending on the circumstances) could be 
relevant in determining whether the requirements for hazard analysis and risk-based preventive 
controls are applicable.  As another example, an establishment can be exempt from CGMP 
requirements if it is solely engaged in hulling, shelling, drying, packing, and/or holding nuts6 
(without additional manufacturing/processing, such as roasting nuts) (21 CFR 117.5(k)(1)(v) and 
507.5(h)(2) for human and animal food, respectively).  In this case, to determine whether the 
CGMP requirements apply, the facility would need to determine whether the activities it 
performs (in addition to hulling, shelling, and drying) are included in the definitions of packing 
or holding.    
Some farm operations use different terms (such as post-harvest, pre-packing, or post-
packing) for some of the activities we classify as harvesting, packing, packaging, or 
holding.   While farms may classify activities for their own purposes, our definitions for 
regulatory purposes may not align with how farms think of various activities for non-regulatory 
purposes.  In particular, our definition of harvesting may be broader than what many farms or 
other businesses think of as harvesting.  Our definition of harvesting is not limited to the act of, 
for example, gathering RACs from a growing area (e.g., picking apples off of trees), but also 
includes activities traditionally performed on farms for purposes of removing RACs from the 
place they were grown or raised and preparing them for use as food.  This breadth is intended to 
reflect the reality of what it means to be a farm.  See section III.B of this guidance for examples 
of activities that can be classified as harvesting.   On the other hand, our definitions of 
packing and holding may be narrower than what some businesses consider to be packing or 
holding.   Our emphasis on the definitions we have established in the relevant regulations is 
important to preserve the intended scope and applicability of various regulatory requirements.   
During the farm definition rulemaking, we received comments asking us to classify several 
specific activities so that an operation that performs these activities can determine whether 
performing that specific activity is within the farm definition.  To address these questions, in 
the remainder of this guidance we: 
  Provide examples of harvesting, packing, packaging, holding, and 
manufacturing/processing activities in addition to those examples established in the 
definitions in our regulation for Registration of Food Facilities;  
  Explain why some activities (such as washing RACs) are classified in more than one 
way;  
  Provide some examples explaining which activities would be within the farm 
definition, and which activities would not,  for hypothetical farms, farm mixed-type 
facilities, and facilities conducting various activities. 
 
                                                 
6 For animal food, the exemption in 21 CFR 507.5(h)(2) includes hulling, shelling, drying, packing, and/or holding 
nuts and hulls. 
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B.  Activities Classified as Harvesting 
Note that the definition of harvesting makes this definition applicable only to farms and farm 
mixed-type facilities.   
Importantly, as defined, harvesting relates to a place where RACs were grown or raised.  The 
examples in this section are primarily intended to demonstrate how the definition of harvesting 
requires connection to such a place, and the type and degree of connection that is sufficient.  The 
examples in this section focus on a single activity  washing apples  to illustrate the impact of 
changes to the type and degree of the connection to a place where RACs were grown or raised.  
As we noted in section III.A, activities may be classified in different ways, and there may even 
be more than one possible classification of an activity for a single circumstance.  In this section 
of this document, we focus on circumstances in which an activity could be classified as 
harvesting, even if the activity could also be classified another way under the same 
circumstances (for example, as packing, as shown in these examples). 
  Operation A grows and harvests apples in one general physical location, so Operation A 
is a primary production farm.  Operation A also washes the apples as they are removed 
from the trees, in the growing area.  The washing can be classified as harvesting 
because it is occurring on a farm in the same general physical location as where the 
apples were grown.  (In addition, if some or all of Operation As washing is performed 
for the safe or effective packing of the apples (e.g., to prevent unwanted debris from 
being packed along with the apples), the washing may also be classified as packing.  
Because both harvesting RACs and packing RACs are inside the farm definition, the 
overlap has no practical consequence for Operation As regulatory status.) 
  Operation B grows and harvests apples in one general physical location, so Operation B 
is a primary production farm.  Operation B also washes the apples in a packing house that 
is separate from the growing area but still on the same farm.  The washing can be 
classified as harvesting because it is occurring on a farm in the same general physical 
location as where the apples were grown.  (In addition, if some or all of Operation Bs 
washing is performed for the safe or effective packing of the apples, the washing may 
also be classified as packing.) 
  Operation C grows and harvests apples in one general physical location, so Operation C 
is a primary production farm.  Operation C also washes the apples in a packing house that 
is separate from the growing area but still on the same farm.  It also receives apples from 
another farm under separate management and washes those apples in the same packing 
house.  The washing can be classified as harvesting. For the apples the operation grew, 
this is because the washing is occurring on a farm in the same general physical location 
as where the apples were grown. For the other farms apples, this is because the washing 
is occurring on a farm in the same general physical location where the farms own RACs 
were grown or raised, and we have removed distinctions from the farm definition that 
limited what activities farms could perform on RACs from other farms.  An activity a 
farm performs on others RACs can be classified the same way as the same activity 
would be classified when performed on the farms own RACs. (In addition, if some or all 
of Operation Cs washing is performed for the safe or effective packing of the apples, the 
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washing may also be classified as packing.  This is true for both the apples Operation C 
grew and those received from other farms.) 
  Operation D does not grow any apples (or grow/raise any other RACs) but receives 
apples from multiple farms under separate management and washes them.  The operation 
is majority owned by the primary production farms that grow the majority of the apples it 
washes.  Operation D is a secondary activities farm.  While the washing in this case does 
not take place in the same general physical location as where any of the apples (or any 
other RACs) were grown, this is the type of arrangement FDA intended to establish as 
within the farm definition through the addition of secondary activities farms to that 
definition.  Thus, we consider that in such cases, the criteria in the secondary activities 
farm definition linking the farms where the RACs were grown to the secondary activities 
farm (through both the RACs themselves and the majority ownership requirement) make 
it appropriate to classify such an operations washing of apples as harvesting even 
though it is not done in the same general physical location as where the apples (or any 
other RACs) were grown. (In addition, if some or all of Operation Ds washing is 
performed for the safe or effective packing of the apples, the washing may also be 
classified as packing.) 
  Operation E does not grow any apples (or grow/raise any other RACs) but receives 
apples from multiple other farms under separate management and washes them.  The 
operation is not majority owned by the primary production farms that supply the apples it 
washes and therefore Operation E is not a secondary activities farm.  In this case, the 
washing cannot be classified as harvesting because it is not performed on a farm in the 
same general physical location as where the apples or other RACs were grown or raised, 
and the criteria in the secondary activities farm definition that might otherwise satisfy the 
needed connection are not met.  If some or all of Operation Es washing is performed for 
the safe or effective packing of the apples, the washing may be classified as packing.  
Otherwise, this washing should be classified as manufacturing/processing. Regardless 
of whether the washing is classified as packing or manufacturing/processing, 
Operation E is a facility that is required to register (unless an exemption applies), and it 
may be subject to Part 117 (unless an exemption applies).  Also, this operation is not a 
primary production farm that only harvests apples based on an argument that washing can 
be classified as harvesting in some cases where washing is not done in the same 
general physical location as where those specific RACs were grown or raised (such as for 
Operations C and D above).  FDA considers harvesting to be limited to the general 
physical locations of farms (and farm mixed-type facilities) where RACs are grown or 
raised, except for operations meeting the specific criteria required to be secondary 
activities farms.  The definition of harvesting is not so limited that it applies only to the 
specific RACs grown on a single farm (see Operation C above), but it is not so extensive 
as to allow any activity that might be considered harvesting on a farm to bring an 
operation that does not grow crops/raise animals, or harvest RACs in the same general 
physical location where they were grown or raised, into the farm definition. 
  Operation F travels to farms under separate management to wash apples on-site at the 
growing farm.  Sometimes the washing is done in the field where the apples were grown, 
and sometimes it is done elsewhere on the growing farm (not in the growing area but still 
in the same general physical location where the apples were grown).  Operation F is not 
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majority owned by the primary production farms that supply the apples it washes and 
therefore Operation F is not a secondary activities farm.  In this case, the washing can be 
classified as harvesting because it is performed on farms (the growing farms) in the 
same general physical locations as where the apples were grown.  Operation F is a 
primary production farm that harvests, but does not grow, the apples.  Operation F is a 
different type of primary production farm than Operations A, B, and C, because 
Operation F is a primary production farm that harvests, but does not grow or raise, RACs. 
(In addition, if some or all of Operation Fs washing is performed for the safe or effective 
packing of the apples, the washing may also be classified as packing.)   
  Operation G travels to farms under separate management to pick apples from trees, and 
then takes the apples off-site to a different location under its own management to be 
washed. While the washing location is not on any of the growing farms, it is half a mile 
down the road -  near enough that it is still in the same general physical location as those 
farms.  In this case, picking apples from the trees where they were grown can be 
classified as harvesting.  Performing this activity makes Operation G a primary 
production farm (or a farm mixed-type facility, depending on the scope of activities it 
performs).  Like Operation F, Operation G is a primary production farm that harvests, but 
does not grow or raise, RACs. The washing in this case can also be classified as 
harvesting even though it is not performed on the growing farms.  As for Operation C 
above, this is because the washing is occurring on a farm (in this case, Operation G) in 
the same general physical location as where the apples were grown, and we have 
removed distinctions from the farm definition that limited what activities farms could 
perform on RACs from other farms.  An activity a farm performs on others RACs can be 
classified the same way as the same activity is classified when performed on the farms 
own RACs. (In addition, if some or all of Operation Gs washing is performed for the 
safe or effective packing of the apples, the washing may also be classified as packing.)      
  Operation H travels to farms under separate management to pick apples from trees, and 
then takes the apples off-site to a separate location under its own management to be 
washed. In this case the washing location is not on any of the growing farms, and is not 
in the same general physical location as those farms  it is in a different region of the 
country.  Because a primary production farm is limited to one general (but not 
necessarily contiguous) physical location, the washing location is not considered to be 
part of the same operation that picked the apples (regardless of the fact that common 
management controls Operation Hs picking and washing).  Thus, the washing operation 
should be separately analyzed from the picking operation. In this case, just as for 
Operation G, picking apples from the trees where they were grown can be classified as 
harvesting.  Performing this activity makes the picking operation a primary production 
farm (or a farm mixed-type facility, depending on the scope of activities it performs).  
Like Operations F and G, Operation Hs picking operation is a primary production farm 
that harvests, but does not grow or raise, RACs. In this case, the picking operation (which 
is a primary production farm) owns a majority interest in the washing operation and the 
picking operation supplies all of the washing operations apples.  Thus, the washing 
operation meets the criteria to be a secondary activities farm.  We consider that in such 
cases, the criteria in the secondary activities farm definition linking the farm where the 
RACs were harvested to the secondary activities farm (through both the RACs 
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themselves and the majority ownership requirement) make it appropriate to classify such 
an operations washing of apples as harvesting even though it is not done in the same 
general physical location as where the apples (or any other RACs) were grown. (In 
addition, if some or all of Operation Hs washing is performed for the safe or effective 
packing of the apples, the washing may also be classified as packing.) 
   
The examples above demonstrate how harvesting relates to a place where RACs were grown 
or raised. To summarize, we interpret harvesting to occur only (1) in the same general physical 
location as where RACs are grown or raised (though the RACs grown/raised in that location 
need not be the same RACs, or same type(s) of RACs, harvested in that location); or (2) at 
operations that meet the criteria in the secondary activities farm definition linking the farm where 
the RACs were harvested to the secondary activities farm (through both the RACs themselves 
and the majority ownership requirement).  
The examples above also illustrate how some activities may be classified in more than one way 
depending on the facts, and why they are, for example, provided both as examples of 
harvesting and as examples of manufacturing/processing in those definitions.  Some 
activities, such as washing RACs, may be classified as harvesting on a farm or farm mixed-
type facility but manufacturing/processing when performed elsewhere.  Some activities, such 
as washing RACs, can also be classified as packing both on- and off-farm under appropriate 
circumstances (i.e., when performed for the safe or effective packing of a food).  Some activities, 
such as washing RACs, may be simultaneously classified in two or more different ways (e.g., 
washing RACs can simultaneously be both harvesting and packing if both definitions fit).  
Washing RACs is only an example of one such activity. There are other activities, such as 
trimming RACs, that have the same or similar properties.   
Also, as mentioned earlier, our classifications for regulatory purposes may not always align with 
how farms think of various activities for non-regulatory purposes.  We consider that many 
activities on farms and farm mixed-type facilities can be classified as harvesting even though 
they may not be performed in the growing area itself (provided, as illustrated above, that there is 
a sufficient connection to the growing area) or at the same time that the crop is removed from the 
plant.  Thus, we consider that both Operation As washing apples and Operation Bs washing 
apples (see above) can be classified as harvesting, even though Operation Bs washing occurs 
in a packing house that is on the same farm (and therefore in the same general physical location 
as the growing area) but separate from the growing area.  Moreover, the amount of time that has 
passed since the apples were removed from the growing area is not, in and of itself, 
determinative.  Thus, for example, it does not matter to the outcome for Operation B whether the 
apples are washed right after being picked and then packed into boxes, or if the apples are 
washed weeks after they are picked, just before they are packed into boxes.  In either case, we 
still consider that the washing can be classified as harvesting because it is performed on RACs 
on a farm, does not transform those RACs into processed food, and is an activity farms have 
traditionally performed for the purpose of removing RACs from the place they were grown and 
preparing them for use as food.  Some farms may consider Operation Bs washing to be 
packing considering the on-farm packing house location or temporal connection to packing.  
As described above, if some or all of Operation Bs washing is performed for the safe or 
effective packing of the apples (e.g., to prevent unwanted debris from being packed along with 
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the apples), the washing may also be classified as packing (in addition to harvesting).  
Because both harvesting RACs and packing RACs are inside the farm definition, the overlap has 
no practical consequence for Operation Bs regulatory status.  On the other hand, if an operation 
were to wash apples, slice them, and then pack the sliced apples, the washing could not be 
considered incidental to packing because the circumstances demonstrate that the washing is not 
merely for the purpose of safe or effective packing of the apples.  The intervening slicing, which 
is a manufacturing/processing activity, prevents the washing from being considered part of the 
later packing activity.         
See the first column in Table 2 for examples of activities that we included in the definition of 
harvesting in our regulation for Registration of Food Facilities.  See the second column in 
Table 2 for additional examples of activities that can be classified as harvesting on farms and 
farm mixed-type facilities, even though we did not include the activity in the definition of 
harvesting.   
Table 2. Examples of Harvesting Activities 
Examples of Harvesting Activities  Additional Examples of Harvesting 
Included in the Definition  Activities 
  Cutting (or otherwise separating) the    Aging/curing/fermenting/oxidizing that 
edible portion of the RAC from the  occurs passively over time, e.g., cocoa 
crop plant  beans, coffee beans, and vanilla beans 
  Removing or trimming part of the RAC    Blending (e.g., blending different lots 
(e.g., foliage, husks, roots, or stems)   of the same RAC together)  
  Cooling    Braiding (e.g., garlic) 
  Field coring    Bunching (e.g., garlic, onions) 
  Filtering    Cleaning seeds that are the harvested 
  Gathering  crop including removal of leaves, 
  Hulling   stems, and husks, such as for flax seeds 
  Shelling     Drying/dehydrating RACs when the 
  Sifting   drying/dehydrating does not create a 
  Threshing   distinct commodity (such as 
drying/dehydrating grains in the 
  Trimming of outer leaves  
growing area)  
  Washing  
  Hydro-cooling and icing   
  Maintaining hydration  
  Sorting/culling/grading  
  Trimming the tops or roots of bunches 
of allium crops (such as leeks, chives, 
or garlic) and root crops (such as 
carrots, beets, turnips, parsnips)  
  Using pesticides in wash water  
 
 
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C.    Activities Classified as Packing or Packaging 
See the first column in Table 3 for examples of activities that we included in the definition of 
packing in our regulation for Registration of Food Facilities.  See the second column in Table 
3 for additional examples of activities that can be classified as packing even though we did not 
include the activity in the definition of packing.   
Although packaging RACs is within the farm definition, packaging is distinct from 
packing.  We consider packaging to be manufacturing/processing, but we have 
specifically provided that packaging and labeling RACs, when this activity does not involve 
additional manufacturing/processing, is within the farm definition.  See farm definition at 
(1)(iii)(B)(3) and (2)).  See Table 4 for examples of activities that can be classified as 
packaging.  Note that the definition of packaging in our regulation for Registration of Food 
Facilities does not include any examples of packaging activities.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 3. Examples of Packing Activities 
Examples of Packing Activities Included  Additional Examples of Packing Activities 
in the Definition 
  Activities performed incidental to    Blending different lots of the same food 
packing or re-packing a food - e.g.,  together for the purpose of safe or 
activities performed for the safe or  effective packing of that food (e.g., 
effective packing of that food  combining lots of the same food to fill 
  Sorting   a packing container with the desired 
o
  Culling   amount of food) 
o
  Grading     Cooling (including hydro-cooling and 
o
  Weighing or conveying   icing) for safe/effective packing 
o
  Filtering for safe/effective packing 
(e.g., filtering honey to remove hive 
debris) 
  Mixing intact RACs in a packing 
container without creating a processed 
food (such as putting intact oranges and 
grapefruits together into a box for 
further distribution) 
  Hulling for safe/effective packing (such 
as hulling walnuts to pack only the 
desired part of the RAC) 
  Removing or trimming parts of  RACs 
for safe/effective packing (e.g., 
removing stems/husks, trimming outer 
leaves, trimming tops or roots of 
bunches of allium crops (such as leeks, 
chives, or garlic) and root crops (such 
as carrots, beets, turnips, parsnips)) 
  Shelling for safe/effective packing 
(such as shelling walnuts to pack only 
the desired part of the RAC) 
  Sifting for safe/effective packing (such 
as sifting grains to remove plant debris 
such as pieces of stalks to pack only the 
desired grain) 
  Washing for safe/effective packing 
(e.g., washing RACs to remove dirt, 
including using pesticides in wash 
water) 
 
 
 
 
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Table 4. Examples of Packaging Activities 
Examples of Packaging Activities 
  Putting strawberries into clamshells that directly contact the food and that the consumer 
receives 
  Putting cilantro into plastic bags that directly contact the food and that the consumer 
receives 
  Putting apples into plastic bags that directly contact the food and that the consumer 
receives 
  Putting citrus fruit into net bags that directly contact the food and that the consumer 
receives 
  Putting bell peppers into plastic bags that directly contact the food and that the consumer 
receives 
  Putting three different colored bell peppers into plastic bags that directly contact the food 
and that the consumer receives (mixing the different colored bell peppers in the 
package) 
  Putting tree nuts into plastic or net bags that directly contact the food and that the 
consumer receives 
 
D.  Activities Classified as Holding 
1.  Activities performed incidental to storage of a food (e.g., for safe or effective 
storage of the food) 
The definition of holding provides that holding includes activities performed incidental to 
storage of a food (e.g., activities performed for the safe or effective storage of that food, such as 
fumigating food during storage, and drying/dehydrating raw agricultural commodities when the 
drying/dehydrating does not create a distinct commodity)... 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. Below, we add as additional examples of activities 
performed for the safe or effective storage of food that do not transform a RAC into processed 
food, which may therefore be classified as holding: 
  aeration for safe or effective storage (e.g., to manipulate grain temperatures);  
  coating RACs for safe or effective storage (e.g., coating grains with diatomaceous 
earth to control insects during storage, coating fruits and vegetables with 
wax/oil/resin for safe or effective storage (including using wax as a carrier of 
fungicides or anti-oxidants for safe or effective storage));  
  cooling (e.g., refrigerating, maintaining already-frozen food in a frozen state) for 
the purpose of safe/effective storage (including to preserve quality);  
  heat treatment for purposes of pest control (i.e., for safe/effective storage) that 
does not change a RAC into processed food (e.g., heating mangoes by immersion 
in hot water for a specified time as a quarantine treatment for fruit flies; heating 
already dried herbs to control insects); and 
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  turning for safe or effective storage (e.g., turning grain to monitor grain condition 
and quality, turning grain to manage grain temperature and moisture). 
 
2.  Activities performed as a practical necessity for distribution of a food 
In addition to including activities incidental to storage (e.g., performed for safe or effective 
storage of food), the definition of holding provides that [h]olding also includes activities 
performed as a practical necessity for the distribution of that food (such as blending of the same 
raw agricultural commodity and breaking down pallets)), 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.  We emphasize that activities performed as a 
practical necessity for the distribution of [a] food are limited to only those activities that are 
truly necessary, as a practical matter, to any holding and distribution of the food in question.  It 
would not be appropriate to consider activities optionally performed to add value to a food 
product as holding on this basis, because such activities are not truly necessary to the 
distribution of the food.  
Further, any activity that changes a RAC into processed food is explicitly excluded from 
holding.   
In keeping with these limitations, we have identified only a few activities as examples of 
holding based on a conclusion that they are practical necessities for distribution of certain 
foods.  For example, we consider that blending of the same RAC (e.g., blending different lots of 
the same grain to meet a customers quality specifications), and breaking down pallets (e.g., 
unwrapping and disassembling a pallet containing multiple cartons of food so that the cartons 
may be stored and/or sold separately) may be practical necessities for distribution of foods.  
Below, we add as additional examples of this kind: 
  aging/curing/fermenting/oxidizing that occurs passively over time, e.g., cocoa beans, 
coffee beans, and vanilla beans;  
  loading food into a vehicle, or placing food in a building or its associated fixtures or 
equipment as a practical necessity for distribution of the food; 
  sampling food (such as sugar) for grading or quality control purposes as a practical 
necessity for distribution of the food;  
  screening grain (e.g., using scalpers and shakers to remove rocks and other extraneous 
material) as a practical necessity for distribution of the food; 
  sorting/culling/grading as a practical necessity for distribution of the food; and  
  weighing or conveying as a practical necessity for distribution of the food (e.g., to hold 
only a given weight in a storage bin or to distribute a given weight of food). 
We note that we are not including in this list of examples repacking and blast freezing... when 
product is not exposed to the environment, despite our statement in the farm definition 
rulemaking that such activities would be considered practical necessities for distribution and 
therefore holding.  See 80 FR at 55934 (Comment/Response 44) and 80 FR at 56192 
(Comment/Response 39).  Our prior statements were incorrect and we hereby withdraw them.  
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Neither repacking nor blast freezing should be considered a holding activity.  We have 
thought more about what should be considered a practical necessity and are explaining our 
thinking more here.  
Repacking is packing.  Packing has a separate definition from holding and is not within the 
definition of holding.  We understand, however, that some activities that industry might think of 
as putting food in a container are practical necessities for distributing food, and we wish to 
clarify that some such activities are considered holding for our purposes.  We do not consider 
placing food inside a building, or its associated fixtures or equipment, to be packing.  For 
example, we consider placing grain in a silo to be a practical necessity for distribution of the 
grain, and therefore holding grain.  Placing grain in a silo is not packing grain, even though a 
silo might in some sense be considered a container.   Similarly, we consider that loading food 
into a vehicle is not packing, even though a vehicle might in some sense be considered a 
container.  Loading food into a vehicle as a practical necessity for distribution of the food is 
holding (regardless of whether the food being loaded is in a container(s), or is loaded directly 
into the vehicle in bulk). 
Blast freezing, to the extent this activity involves freezing food that is not already frozen, is 
manufacturing/processing.  Freezing changes RACs into processed food and therefore cannot be 
holding, because the definition of holding excludes activities that change RACs to processed 
food.  However, as noted above, maintaining already-frozen food in a frozen state (such as by 
holding such food in a freezer) is holding because it is performed for the safe or effective 
storage of the already-frozen food. 
3.  Examples of activities that are not holding 
We consider that the following activities may not be classified as holding, even though they do 
not necessarily transform RACs into processed food, because they are not incidental to storage 
(e.g., for safe or effective storage) and they are not practical necessities for distribution of food: 
  filtering;  
  hulling;  
  labeling (including stickering); 
  mixing two different foods together;  
  packing or re-packing; 
  packaging; 
  removing or trimming parts of RACs;  
  shelling;  
  sifting; and  
  washing. 
This list is not exhaustive.  For example, any activity that transforms a RAC into processed food 
may not be classified as holding, because as noted above, the definition of holding excludes 
activities that change RACs to processed food. 
 
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4.  Summary 
See the first column in Table 5 for examples of activities that we included in the definition of 
holding in our regulation for Registration of Food Facilities.  See the second column in Table 5 
for additional examples of activities that can be classified as holding even though we did not 
include the activity in the definition of holding. 
Table 5. Examples of Holding Activities 
Examples of Holding Activities Included  Additional Examples of Holding Activities 
in the Definition 
  Storing food    Aeration for safe or effective storage 
  Activities performed incidental to  (e.g., to manipulate grain temperatures)  
storage of a food - e.g., activities    Aging/curing/fermenting/oxidizing that 
performed for the safe or effective  occurs passively over time, e.g., cocoa 
storage of that food  beans, coffee beans, and vanilla beans 
  Fumigating food during storage    Coating RACs for safe or effective 
o
  Drying/dehydrating RACs when  storage  (e.g., coating grains with 
o
the drying/dehydrating does not  diatomaceous earth to control insects 
create a distinct commodity  during storage, coating fruits and 
(such as drying/dehydrating hay  vegetables with wax/oil/resin for safe 
or alfalfa)    or effective storage (including using 
  Activities performed as a practical  wax as a carrier of fungicides or anti-
necessity for the distribution of that  oxidants for safe or effective storage)) 
food    Cooling (e.g., refrigerating, maintaining 
  Blending of the same RAC   already-frozen food in a frozen state) 
o
  Breaking down pallets  for the purpose of safe/effective storage 
o
(including to preserve quality) 
  Heat treatment for purposes of pest 
control (i.e., for safe/effective storage) 
that does not change a RAC into 
processed food (e.g., heating mangoes 
by immersion in hot water for a 
specified time as a quarantine treatment 
for fruit flies; heating already dried 
herbs to control insects) 
  Loading food into a vehicle, or placing 
food in a building or its associated 
fixtures or equipment as a practical 
necessity for distribution of the food 
  Sampling food (such as sugar) for 
grading or quality control purposes as a 
practical necessity for distribution of 
the food 
  Screening grain (e.g., using scalpers 
and shakers to remove rocks and other 
extraneous material) as a practical 
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Examples of Holding Activities Included  Additional Examples of Holding Activities 
in the Definition 
necessity for distribution of the food 
  Sorting/culling/grading as a practical 
necessity for distribution of the food 
  Turning for safe or effective storage 
(e.g., turning grain to monitor grain 
condition and quality, turning grain to 
manage grain temperature and 
moisture) 
  Weighing or conveying as a practical 
necessity for distribution of the food 
(e.g., to hold only a given weight in a 
storage bin or to distribute a given 
weight of food) 
 
E.  Activities Classified as Manufacturing/Processing 
See the first column in Table 6 for examples of activities that we included in the definition of 
manufacturing/processing in our regulation for Registration of Food Facilities.  See the second 
column in Table 6 for additional examples of activities that can be classified as 
manufacturing/processing even though we did not include the activity in the definition of 
manufacturing/processing.  A given activity may be manufacturing/processing but not 
transform a RAC into a processed food.  As discussed in the farm definition rulemaking, the 
activities that transform a RAC into a processed food are not coextensive with the definition of 
manufacturing/processing.  Transforming a RAC into processed food involves altering the 
general state of the commodity, sometimes referred to as transformation of the RAC into a new 
or distinct commodity.  Examples of activities that may be manufacturing/processing without 
transforming a RAC into a processed food include coloring, washing, and waxing.  See 78 FR 
3646 at 3679 (Jan. 16, 2013) (proposed rule). On the other hand, because any activity that does 
transform a RAC into processed food is explicitly excluded from the definitions of harvesting, 
packing, and holding, such activities are always classified as manufacturing/processing.  
Manufacturing/processing is outside the farm definition except as specifically provided in the 
farm definition (see farm definition at (1)(iii) and (2)). 
 
 
 
 
 
 
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Table 6. Examples of Manufacturing/Processing Activities 
Examples of Manufacturing/Processing  Additional Examples of 
Activities Included in the Definition  Manufacturing/Processing Activities 
  Baking     Bleaching (e.g., walnuts) 
  Boiling     Chopping 
  Bottling     Coating for purposes other than 
  Canning   storage/transport (e.g., coating 
  Cooking   strawberries with chocolate) 
  Cooling     Coloring (e.g., adding color to the skin 
  Cutting   of oranges) 
  Distilling     Coring (e.g., in the production of fresh-
  Drying/dehydrating RACs to create a  cut lettuce)  
distinct commodity (such as    Cracking (e.g. corn) 
drying/dehydrating grapes to produce    Crushing 
raisins)*     Extracting oils 
  Evaporating     Extruding 
  Eviscerating     Fermenting fruits and vegetables 
  Extracting juice     Flaking 
  Formulating     Hulling 
  Freezing     Infusing 
  Grinding     Mashing 
  Homogenizing     Pearling 
  Irradiating     Pelleting 
  Labeling*     Pitting 
  Milling     Roasting 
  Mixing     Salting 
  Packaging (including modified    Shelling 
atmosphere packaging)*     Shredding 
  Pasteurizing     Sifting 
  Peeling     Slaughtering and post-slaughter 
  Rendering   operations 
  Treating to manipulate ripening*     Slicing 
  Trimming     Smoking 
  Washing     Sorting, culling, grading (e.g., as an 
  Waxing  initial step in a processing facility before 
canning)  
  Using pesticides in wash water (e.g., in 
the production of fresh-cut lettuce) 
  Wafering 
  Weighing or conveying ingredients to be 
used during manufacturing/processing at 
the same facility (e.g., weighing 
ingredients to be used in the facilitys 
production of baked goods) 
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*At least some types of the listed manufacturing/processing activity are specifically allowed 
within the farm definition as manufacturing/processing (i.e., such activities are within the farm 
definition even though they are not otherwise classified as growing, harvesting, packing, or 
holding). 
F.  Activities Classified in More Than One Way 
If you compare Table 2, Table 3, Table 5, and Table 6, you will see that several activities can be 
classified in more than one way. See Table 7 for examples of activities that may be classified in 
more than one way.  Please note that, as discussed above, in some cases these examples overlap 
(i.e., an activity can simultaneously be classified in more than one way, such as being both 
harvesting and packing when performed on a farm), and that these are only examples (not an 
exhaustive list of possibilities). 
Table 7. Examples of Activities That May Be Classified in More Than One Way 
Activity  Classifications    Discussion 
Aging/curing/    Harvesting     Aging/curing/fermenting/ 
fermenting/    Holding  oxidizing that occurs passively 
oxidizing that  over time, e.g., cocoa beans, 
occurs  coffee beans, and vanilla beans 
passively over  on a farm is a harvesting 
time, e.g.,  activity. 
cocoa beans,    Aging/curing/fermenting/ 
coffee beans,  oxidizing that occurs passively 
and vanilla  over time, e.g., cocoa beans, 
beans  coffee beans, and vanilla beans 
during storage is a holding 
activity. 
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Activity  Classifications    Discussion 
Blending (the    Harvesting    Blending different lots of the 
same food)    Packing  same RAC together on a farm is 
  Holding  a harvesting activity. 
  Manufacturing/processing    Blending different lots of the 
same food together for the 
purpose of safe or effective 
packing of that food (e.g., 
combining lots of the same food 
to fill a packing container with 
the desired amount of food) is a 
packing activity. 
  Blending different lots of the 
same grain to meet a customers 
quality specifications as a 
practical necessity for product 
distribution is a holding activity. 
  Blending that does not fall into 
harvesting, packing, or holding 
(e.g., combining lots of the same 
flour at a facility that uses the 
flour to bake bread) is a 
manufacturing/processing 
activity. 
Coating     Holding     Coating for safe or effective 
  Manufacturing/processing  storage  (e.g., coating grain 
RACs with diatomaceous earth 
to control insects during storage, 
coating fruits and vegetables 
with wax/oil/resin for safe or 
effective storage, including 
using wax as a carrier of 
fungicides or anti-oxidants for 
safe or effective storage) is a 
holding activity.  
  Coating in the production of 
chocolate-covered strawberries 
or caramel-coated apples is a 
manufacturing/processing 
activity. 
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Activity  Classifications    Discussion 
Cooling    Harvesting     Cooling RACs on a farm (e.g., 
  Packing  hydro-cooling cherries as they 
  Holding   are picked in the growing area, 
  Manufacturing/processing  hydro-cooling cantaloupes in an 
on-farm packing house) is a 
harvesting activity. 
  Cooling (including hydro-
cooling and icing (e.g., hydro-
cooling broccoli)) for the 
purpose of safe/effective 
packing is a packing activity. 
  Cooling (e.g., refrigerating, 
maintaining already-frozen food 
in a frozen state) during storage 
for the purpose of safe/effective 
storage (including to preserve 
quality) is a holding activity. 
  Cooling that does not fall into 
harvesting, packing, or holding 
(e.g., a cooling step in a 
production process used to 
remove heat from a cooked food 
prior to packaging) is a 
manufacturing/processing 
activity. 
Coring    Harvesting     Field coring on a farm (e.g., 
  Manufacturing/processing  removing the core from lettuce 
at the same time that the stem is 
cut and wrapper leaves removed) 
is a harvesting activity. 
  Coring lettuce at a facility that 
chops the lettuce to produce 
fresh-cut lettuce is a 
manufacturing/processing 
activity. 
Cutting    Harvesting     Cutting (or otherwise separating) 
  Manufacturing/processing  the edible portion of the RAC 
from the crop plant on a farm is 
a harvesting activity. 
  Cutting lettuce in the production 
of fresh-cut lettuce is a 
manufacturing/processing 
activity. 
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Activity  Classifications    Discussion 
Drying/    Harvesting     Drying/dehydrating RACs on a 
dehydrating    Holding   farm when the 
RACs    Manufacturing/processing  drying/dehydrating does not 
create a distinct commodity 
(such as drying/dehydrating 
grains in the growing area on a 
farm) is a harvesting activity. 
  Drying/dehydrating RACs for 
purposes of safe or effective 
storage when the 
drying/dehydrating does not 
create a distinct commodity 
(such as drying/dehydrating hay 
or alfalfa) is a holding activity. 
  Drying/dehydrating RACs to 
create a distinct commodity 
(such as drying/dehydrating 
grapes to produce raisins) is a 
manufacturing/processing 
activity. 
Filtering    Harvesting     Filtering RACs (e.g., filtering 
  Packing  raw milk to remove straw, hair, 
etc.) on a farm is a harvesting 
activity. 
  Filtering RACs for safe/effective 
packing (e.g., filtering honey to 
remove hive debris) is a packing 
activity. 
Hulling    Harvesting     Hulling RACs on a farm is a 
  Packing   harvesting activity. 
  Manufacturing/processing    Hulling for safe/effective 
packing (such as hulling walnuts 
to pack just the desired part of 
the RAC) is a packing activity.  
  Hulling walnuts at a facility that 
chops the walnuts is a 
manufacturing/processing 
activity. 
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Activity  Classifications    Discussion 
Mixing    Packing      Mixing intact RACs in a packing 
(different    Manufacturing/processing  container without creating a 
foods)  processed food (e.g., placing 
three different colored bell 
peppers in a box for further 
distribution) is a packing 
activity.   
  Mixing intact RACs in a 
container that directly contacts 
the food and that the consumer 
receives without creating a 
processed food (e.g., placing 
three different colored bell 
peppers directly into a plastic 
bag that the consumer receives) 
is packaging, which is a 
manufacturing/processing 
activity.  
  Mixing different RACs together 
in a manner that creates a 
processed food (e.g., mixing 
corn and oats in the production 
of animal food) is a 
manufacturing/ processing 
activity. 
  Mixing performed on processed 
foods (e.g., mixing roasted nuts, 
chocolate, and dried fruits to 
make trail mix) is a 
manufacturing/processing 
activity. 
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Activity  Classifications    Discussion 
Removing or    Harvesting     Removing or trimming parts of 
trimming    Packing   RACs (e.g., removing 
parts of RACs    Manufacturing/processing  stems/husks, trimming outer 
leaves, trimming tops or roots of 
bunches of allium crops (such as 
leeks, chives, or garlic) and root 
crops (such as carrots, beets, 
turnips, parsnips)) on a farm is a 
harvesting activity. 
  Removing or trimming parts of 
RACs for safe/effective packing 
is a packing activity.  
  Removing or trimming parts of 
RACs at a facility that chops the 
RACs to produce a fresh-cut 
salad mix is a 
manufacturing/processing 
activity. 
Shelling    Harvesting    Shelling RACs on a farm is a 
  Packing  harvesting activity. 
  Manufacturing/processing    Shelling for safe/effective 
packing (such as shelling 
walnuts to pack just the desired 
part of the RAC) is a packing 
activity.  
  Shelling walnuts at a facility that 
chops the walnuts is a 
manufacturing/processing 
activity. 
Sifting    Harvesting    Sifting RACs (e.g., hand 
  Packing  threshing of wheat) on a farm is 
  Manufacturing/processing  a harvesting activity. 
  Sifting for safe/effective packing 
(such as sifting grains to remove 
plant debris such as pieces of 
stalks to pack only the desired 
grain) is a packing activity.  
  Sifting flour as part of making 
baked goods is a 
manufacturing/processing 
activity. 
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Activity  Classifications    Discussion 
Sorting,    Harvesting     Sorting, culling, and grading 
culling, and    Packing   RACs on a farm are harvesting 
grading    Holding   activities. 
  Manufacturing/processing    Sorting, culling, and grading 
performed for the safe or 
effective packing of the food 
incidental to packing are packing 
activities. 
  Sorting, culling, and grading 
performed as a practical 
necessity for distribution of the 
food are holding activities. 
  Sorting, culling and grading that 
does not fall into harvesting, 
packing, or holding (e.g., when 
performed as an initial step in a 
processing facility before 
canning) are 
manufacturing/processing 
activities. 
Washing    Harvesting     Washing RACs on a farm (e.g., 
(including    Packing   washing RACs to remove dirt, 
using    Manufacturing/processing  including using pesticides in 
pesticides in  wash water) is a harvesting 
wash water)  activity. 
  Washing for safe/effective 
packing (e.g., washing RACs to 
remove dirt, including using 
pesticides in wash water) is a 
packing activity. 
  Washing at a facility before 
canning fruit or vegetables, or 
during the production of a fresh-
cut salad mix, including using 
pesticides in wash water, is a 
manufacturing/processing 
activity. 
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Activity  Classifications    Discussion 
Weighing or    Packing    Weighing for the purpose of safe 
conveying    Holding  or effective packing (e.g., to 
  Manufacturing/processing  pack items of a similar weight) 
is a packing activity 
  Weighing as a practical 
necessity for distribution of food 
(e.g., to hold only a given weight 
in a storage bin or to distribute a 
given weight of food) is a 
holding activity 
  Weighing ingredients to be used 
during processing at the same 
facility (e.g., weighing 
ingredients to be used in the 
facilitys production of baked 
goods) is a 
manufacturing/processing 
activity 
 
The following examples describe the practical implications for some situations in which 
activities can be classified in more than one way, including whether the specific classification of 
an activity is likely to matter.     
  If all of the activities you perform are within the farm definition, it generally makes no 
difference whether you classify an activity as harvesting, packing, or holding, or as one 
of the manufacturing/processing activities (such as packaging) listed in the farm 
definition.  Thus, for example, if it might be possible to consider a particular activity that 
you perform on a particular food to be either harvesting or packing within the 
meaning of those definitions, the decision is unlikely to affect your operations regulatory 
status in a meaningful way.   
  If your business is a primary production farm or a secondary activities farm, but you 
also perform at least one activity that falls outside the farm definition, your business is 
a farm mixed-type facility and you may be required to register as a food facility (see 21 
CFR 1.225 and 1.226).  The activities that trigger the registration requirement (those that 
are not within the farm definition) may be subject to the requirements of 21 CFR Part 117 
or 507 (for human food or animal food, respectively) as applicable.   
  If your operation is not a primary production farm or a secondary activities farm, you 
may be required to register as a food facility (see 21 CFR 1.225 and 1.226). All of the 
activities you perform are potentially subject to the requirements of 21 CFR Part 117 or 
507 (for human food or animal food, respectively), or Part 121, as applicable.       
 
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G.  Activity Classification on a Farm Mixed-Type Facility that Grows, 
Harvests, Packs, and Processes Lettuce 
Business I grows lettuce and other types of salad greens and harvests lettuce and other types of 
salad greens from the field by cutting the stems, field coring the lettuce, trimming outer leaves of 
the lettuce/greens, and washing the intact lettuce/greens.  The business then packs some of the 
lettuce in an intact form for distribution, and also produces some fresh-cut lettuce/greens (e.g., by 
chopping a single variety of lettuce and bagging it or by chopping and bagging mixes of salad 
greens).  The business also stores all of its products (intact and fresh-cut lettuce/greens) for at 
least some time in refrigerated storage. 
  Business Is growing and harvesting operations (growing the lettuce/greens, cutting the 
stems, field coring the lettuce, trimming outer leaves of the lettuce/greens, and washing 
the intact lettuce/greens) are within the farm definition.  Business Is packing of RACs 
(packing intact lettuce for distribution) and storing of RACs (storing intact lettuce/greens 
under refrigeration) are also within the farm definition.  These activities are not subject 
to the requirements of Part 117 or Part 507.  Because these activities are performed on a 
farm on produce RACs, they may be subject to the requirements of Part 112 (the produce 
safety rule), as applicable.  
  When Business I chops lettuces/salad greens to create fresh-cut lettuce/greens, this 
changes the intact RACs into distinct commodities, which means they become processed 
foods and are no longer RACs.  This is a manufacturing/processing activity (note that the 
definitions of harvesting, packing, and holding all explicitly exclude activities that 
change RACs into processed foods, which leaves only manufacturing/processing as an 
appropriate classification for such activities).  This manufacturing/processing activity is 
not specifically included in the farm definition (see farm definition at (1)(iii)(B)) unless 
done for consumption on farm (see farm definition at (1)(iii)(A)).  In this example, the 
chopped lettuce/greens are for distribution into commerce and not for on-farm 
consumption, so this activity is outside the farm definition.  Assuming that no exemptions 
from the registration requirement apply (see 21 CFR 1.225 and 1.226), Business I is 
required to register as a food facility.  Because Business I is a farm (see paragraph 
above), but also conducts some activities outside the farm definition that require it to be 
registered, Business I is a farm mixed-type facility.  Business Is chopping of 
lettuce/greens is potentially subject to the requirements of Part 117 or Part 507 (for 
human food or animal food, respectively), as applicable. 
  Business I also packages the chopped lettuces/greens by placing them in bags that 
directly contact the food and that the consumer receives (whether as a single chopped 
lettuce variety or as a mix of chopped salad greens).  This is packaging, which is a 
manufacturing/processing activity, and it is performed on a processed food.  This 
manufacturing/processing activity (packaging a processed food) is not specifically 
included in the farm definition (see farm definition at (1)(iii)(B)) unless done for 
consumption on farm (see farm definition at (1)(iii)(A)) or performed on certain types of 
dried/dehydrated processed foods specified in the definition (see farm definition at 
(1)(iii)(B)(1)).  In this example, the chopped lettuce/greens are for distribution into 
commerce and not for on-farm consumption, so this activity is outside the farm definition 
and as discussed above, Business I is a farm mixed-type facility.  Business Is 
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packaging of chopped lettuce/greens is potentially subject to the requirements of Part 117 
or Part 507 (for human food or animal food, respectively), as applicable.     
  Business I also stores its chopped, bagged lettuce/greens for at least some time in 
refrigerated storage.  This is a holding activity, and it is performed on a processed food.  
This holding activity (holding a processed food) is only within the farm definition if done 
for consumption on farm or performed on certain types of dried/dehydrated processed 
foods specified in the definition (see farm definition at (1)(ii)).  In this example, the 
chopped lettuce/greens are for distribution into commerce and not for on-farm 
consumption, and they are not the dried/dehydrated processed foods specified in the farm 
definition, so this activity is outside the farm definition. As discussed above, Business I is 
a farm mixed-type facility.  Business Is holding of chopped, bagged lettuce/greens is 
potentially subject to the requirements of Part 117 or Part 507 (for human food or animal 
food, respectively), as applicable. 
H.  Activity Classification in the Production of Walnuts 
Business J grows and harvests walnuts, holds them, and ships them in bulk (loading walnuts 
directly into trucks) to Business K.  Business K hulls and dries the walnuts, holds them, and 
ships them in bulk to Businesses L and M.  Business L and Business M shell walnuts, but also 
have manufacturing/processing operations that bleach in-shell walnuts and chop shelled walnuts.  
Businesses L and M also pack and hold the in-shell bleached walnuts, shelled walnuts, and 
shelled chopped walnuts for distribution (into large fabric bags and boxes used as shipping 
containers, which consumers do not receive).  Business J owns a majority interest in Businesses 
K and L, but does not own a majority interest in Business M.  More than half of the walnuts that 
Business K hulls and dries are grown by Business J.  More than half of the walnuts that Business 
L shells are grown by Business J.  Business M buys walnuts to shell from several different farms 
including Business J. 
 
   
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Figure 1.Schematic Representation of the Business Relationship Between Walnut 
Businesses J, K, L, and M 
 
 
Business J 
 
 
  Grows, Harvests, and Holds 
Other suppliers  Walnuts 
 
 
Walnuts 
 
 
Business K 
  (Majority owned by J; 
Majority of walnuts from J) 
 
 
  Other suppliers  Other suppliers 
Hulls, Dries, and Holds 
  Walnuts 
 
  Walnuts  Walnuts 
 
 
Business L  Business M 
 
(Majority owned by J;   
  Majority of walnuts from J)  Bleaches In-Shell Walnuts 
  Shells Walnuts 
 
Bleaches In-Shell Walnuts  Chops Shelled Walnuts 
 
Shells Walnuts  Packs and Holds: 
  Chops Shelled Walnuts   In-Shell Bleached 
Packs and Holds:  Walnuts;  
 
 In-Shell Bleached   Shelled Walnuts; and 
  Walnuts;    Shelled Chopped 
 Shelled Walnuts;  Walnuts 
 
and   
   Shelled Chopped 
  Walnuts 
 
 
  Business J is a primary production farm. Business Js bulk shipping of walnut RACs 
(loading the walnuts into trucks) is a holding activity.  Its growing, harvesting, and 
holding of walnut RACs are all within the farm definition, and are therefore not subject 
to the requirements in 21 CFR Parts 117 or 507 (for human or animal food, respectively). 
Because these activities are performed on a farm on produce RACs, they may be subject 
to the requirements of Part 112 (the produce safety rule) as applicable. 
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  Business K is majority owned by Business J, which is a primary production farm, and 
gets more than half of its RACs from Business J.  Business K hulls and dries walnuts 
(drying which does not create a distinct commodity).  While these activities occur in a 
different physical location from where the walnuts were grown, the ownership and 
product connection of Business K to the primary production farm (Business J) means that 
these activities of Business K may be considered harvesting activities.  It may also be 
reasonable to consider Business Ks drying of walnuts to be a holding activity because 
the drying is for the purpose of safe or effective storage of the walnuts.  Regardless of 
whether the drying is classified as a harvesting activity or a holding activity, Business K 
is a secondary activities farm that harvests and holds walnut RACs and meets the 
ownership and product criteria in the secondary activities farm definition. Business Ks 
bulk shipping of walnut RACs (loading the walnuts into trucks) is a holding activity.  Its 
hulling, drying, and holding of walnut RACs are all within the farm definition, and are 
therefore not subject to the requirements in 21 CFR Parts 117 or 507 (for human or 
animal food, respectively). Because these activities are performed on a farm on produce 
RACs, they may be subject to the requirements of Part 112 (the produce safety rule) as 
applicable. 
  Business L is majority owned by Business J, which is a primary production farm, and 
gets more than half of its RACs from Business J (via Business K).  Business Ls walnut 
shelling occurs in a different physical location from where the walnuts were grown, but 
as for Business K, the ownership and product connection of Business L to the primary 
production farm (Business J) means that the walnut shelling activities of Business L may 
be considered harvesting activities.  Business L is a secondary activities farm that shells 
walnut RACs (which may be considered, in this case, a harvesting activity) and meets the 
ownership and product criteria in the secondary activities farm definition.  Business Ls 
shelling of walnuts, and its packing and holding of shelled (not chopped) walnuts, are 
inside the farm definition and are therefore not subject to the requirements in 21 CFR 
Parts 117 or 507 (for human or animal food, respectively). Because these activities are 
performed on a farm on produce RACs, they may be subject to the requirements of Part 
112 (the produce safety rule), as applicable.  However, Business L also conducts some 
activities that are not within the farm definition.  Its walnut bleaching and chopping are 
manufacturing/processing activities. It also packs and holds shelled chopped walnuts, 
which are a processed food.  These packing and holding activities (packing and holding a 
processed food) are only within the farm definition if done for consumption on farm or 
performed on certain types of dried/dehydrated processed foods specified in the 
definition (see farm definition at (1)(ii)).  In this example, the chopped walnuts are for 
distribution into commerce and not for on-farm consumption, and they are not the 
dried/dehydrated processed foods specified in the farm definition, so these activities are 
outside the farm definition. Business L also packs and holds in-shell bleached walnuts.  
The bleaching step, as described above, is outside the farm definition, making Business 
Ls later packing and holding of the in-shell bleached walnuts also outside the farm 
definition.  Assuming that no exemptions from the registration requirement apply (see 21 
CFR 1.225 and 1.226), Business L is required to register as a food facility.  Because 
Business L is a farm (see above), but also conducts some activities outside the farm 
definition that require it to be registered, Business L is a farm mixed-type facility.  
Business Ls bleaching, chopping, packing, and holding of the bleached in-shell walnuts 
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and the shelled chopped walnuts are potentially subject to the requirements of Part 117 or 
Part 507 (for human food or animal food, respectively), as applicable. 
  Business M does not meet the ownership or product criteria in the secondary activities 
farm definition, so its shelling of walnuts is not harvesting because it is not performed on 
a farm in the same general physical location as where the walnuts or other RACs were 
grown or raised, and the criteria in the secondary activities farm definition that might 
otherwise satisfy the needed connection are not met.  This businesss shelling can be 
classified in different ways depending on its specific purpose.  When Business M shells 
walnuts and packs the shelled walnuts for distribution, the shelling might reasonably be 
classified as a packing activity because it is done for the safe/effective packing of the 
shelled walnuts (to pack only the desired portion of the RAC).  The same shelling might 
also reasonably be classified as manufacturing/processing activity.  On the other hand, 
when Business M shells walnuts, chops the shelled walnuts, and packs the shelled 
chopped walnuts, the shelling is not merely for the purpose of safe/effective packing and 
therefore may not be considered packing.  The intervening chopping, which is a 
manufacturing/processing activity, prevents this shelling from being considered 
packing.  This shelling is therefore only reasonably classified as a 
manufacturing/processing activity.  Business Ms bleaching and chopping of walnuts are 
also manufacturing/processing activities.  Business M also packs and holds all the 
products described here.  Assuming that no exemptions from the registration requirement 
apply (see 21 CFR 1.225 and 1.226), Business M is required to register as a food facility. 
Business M is not a farm mixed-type facility.  All of its activities are packing, holding, or 
manufacturing/processing activities that are potentially subject to the requirements of Part 
117 or Part 507 (for human food or animal food, respectively), as applicable. 
I.  Activity Classification in the Production of Tomatoes 
 
In this example, we first describe five different businesses (Business N, O, P, Q, and R) and then 
explain how each business is classified (as a primary production farm, secondary activities farm, 
or a facility).  
1.  Description of the businesses 
  Business N packs and holds tomatoes grown and harvested from its own fields in the 
same general physical location as the packing house and also packs and holds tomatoes 
that it buys from other tomato farms, Business O and Business P.     
  Businesses O and P are two separate operations that grow, harvest, and hold tomatoes, 
but do not pack tomatoes. 
  Business Q packs and holds only tomatoes grown and harvested by Business O and 
Business P, and Businesses O and P together own more than 50 percent of Business Q.     
  Business R buys tomatoes from several farms (Business O, Business P and others), and 
packs and holds those tomatoes.  Business R does not grow any tomatoes and is not 
owned by the farms that supply the tomatoes it packs.   
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2.   Classification of the business 
 
  Business N is a primary production farm. Its growing, harvesting, packing and holding of 
tomatoes are within the farm definition, and are therefore not subject to the 
requirements of Part 117 or Part 507 (for human food or animal food, respectively). 
Because these activities are performed on a farm on produce RACs, they may be subject 
to the requirements of Part 112 (the produce safety rule) as applicable. 
  Businesses O and P are each primary production farms.  Their growing, harvesting, and 
holding of tomatoes are within the farm definition, and are therefore not subject to the 
requirements of Part 117 or Part 507 (for human food or animal food, respectively). 
Because these activities are performed on a farm on produce RACs, they may be subject 
to the requirements of Part 112 (the produce safety rule) as applicable. 
  Business Q is a secondary activities farm because it is majority owned by primary 
production farms (Businesses O and P) and all of the tomatoes packed by Business Q 
come from the primary production farms.  Business Qs packing and holding of tomatoes 
are therefore not subject to the requirements of Part 117 or Part 507 (for human food or 
animal food, respectively). Because these activities are performed on a farm on produce 
RACs, they may be subject to the requirements of Part 112 (the produce safety rule) as 
applicable. 
  Business R is not a farm.  Business R is a facility and, assuming that no exemptions from 
the registration requirement apply (see 21 CFR 1.225 and 1.226), it is required to register 
as a food facility.  Its packing and holding of tomatoes are potentially subject to the 
requirements of Part 117 or Part 507 (for human food or animal food, respectively). 
 
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