NC State Extension

Definition of a Farm

Why is it important to review the definition of a farm?

As the Food Safety Modernization Act (FSMA) was developed FDA revised the definition of a “farm”. This new definition differentiates between farming operations that grow, pack, harvest and hold raw agricultural commodities (produce) and those that are further processing or manufacturing, for example, farms that are slicing, chopping or processing produce. This revision has important implications for the produce industry as the definition of a “farm” lists specific activities that determine whether the farming operation will be regulated under FSMA’s Produce Safety Rule, or if a farming operation may be considered a farm-mixed type facility and may also have to comply with portions of FSMA’s Preventative Controls for Human Food Rule.

This page contains information published in the Food Safety Modernization Act (FSMA) Produce Safety Rule and two published draft-guidance documents from FDA. The draft Guidance documents are Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities published in August 2016 and Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) – Revised published in December 2016. FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidance documents describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidance documents means that something is suggested or recommended, but not required. For the purposes of this document when information from guidance documents is provided, it will be cited as such.

Objectives for this publication

  • To define the activities allowed under the “farm” definition for produce farms.
  • To define a “mixed-type facility”.
  • To define what farming operations need to register as a food facility with FDA.
  • To outline the process for food facility registration and for farms that have erroneously registered with FDA to cancel their food facility registration.

Relevant definition

Raw agricultural commodity (RAC) means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.

To get started, the definition of a “farm” as defined in the Produce Safety Rule is outlined. This definition allows for a farm to have multiple locations, lists activities that are allowed (growing, harvesting, packing, holding and limited processing/manufacturing activities) and discusses ownership of produce when produce is held or packed for other growers. Note that produce (fruits and vegetables) are considered raw agricultural commodities (RACs).

Defining a “Farm”

A farm as defined in the Produce Safety Rule can be either a Primary production farm or a Secondary activities farm.

(i)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, harvesting of crops, raising of animals (including seafood), or any combination of these activities.

The term farm includes operations that, in addition to these activities:

(A) Pack or hold raw agricultural commodities;

(B) 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 handled in a manner identified in (C); and

(C) Manufactured/processed food, provided that:

  1. All food used in such activities is consumed on that farm or another farm under the same management; or
  2. 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 or dehydrating fresh herbs to produce dried herbs), 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

(ii) 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 in paragraphs (B) and (C).

Important note about the definition of a farm: Certain aspects of the farm definition, statements such as “under one management” and “in one general (but not necessarily contiguous) physical location,” are very fact-specific, and therefore FDA did not issue guidance focused on those topics but is instead addressing them on a case-by-case basis.

Activities allowed under the Farm definition

It is important to understand what specific activities are allowed when harvesting, packing, packaging and holding produce.

Harvesting

Harvesting applies to activities conducted at 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. 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 include cooling, field coring, filtering, gathering, hulling, removing stems and husks from, shelling, sifting, threshing, trimming of outer leaves of, and washing raw agricultural commodities grown on a farm.

Harvesting does not include activities that transform a raw agricultural commodity into a processed food. ‘‘Processed food’’ means any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydration, or milling.

The first column in Table 1 provides examples of activities that FDA included in the definition of harvesting in the Produce Safety Rule. The second column provides additional examples of activities that can be classified as “harvesting” on farms and farm mixed-type facilities that FDA has provided in guidance documents.

Table 1. Examples of harvesting activities.

Harvesting activities included in the PSR Rule definition Additional examples of harvesting activities offered in guidance

· Cutting (or otherwise separating) the edible portion of the RAC from the crop plant.

· Removing or trimming part of the RAC (e.g., foliage, husks, roots, or stems).

· Cooling.

· Field coring.

· Filtering.

· Gathering.

· Hulling.

· Shelling.

· Sifting.

· Threshing.

· Trimming of outer leaves.

· Washing.

· Aging/curing/fermenting/oxidizing that occurs passively over time, e.g., cocoa beans, coffee beans, and vanilla beans.

· Blending (e.g., blending different lots of the same RAC together).

· Braiding (e.g., garlic).

· Bunching (e.g., garlic, onions).

· Cleaning seeds that are the harvested crop including removal of leaves, stems, and husks, such as for flax seeds.

· Drying/dehydrating RACs when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating grains in the growing area).

· 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.

Source:  Classification of activities as harvesting, packing, holding, or manufacturing/processing for farms and facilities draft- guidance (2016).

Packing

Packing means placing food into a container other than packaging the food and also includes activities performed incidental to packing a food (e.g., activities performed for the safe or effective packing of that food such as sorting, culling, grading, and weighing or conveying incidental to packing or re- packing), but does not include activities that transform a raw agricultural commodity into a processed food.

Table 2. Examples of Packing Activities.

 “Packing” Activities Included in the PSR Definition Additional examples of packing activities offered in guidance 

Activities performed incidental to packing or re-packing a food – e.g., activities performed for the safe or effective packing of that food.

o Sorting
o Culling
o Grading
o Weighing or conveying

 

· 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).

· Cooling (including hydro-cooling and icing) for safe/effective packing.

· 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).

Source:  Classification of activities as harvesting, packing, holding, or manufacturing/processing for farms and facilities draft-guidance (2016).

Packaging

Packaging means placing food into a container that directly contacts the food and the consumer receives.

Table 3. 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.

Source:  Classification of activities as harvesting, packing, holding, or manufacturing/processing for farms and facilities draft–guidance (2016).

Holding

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. 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. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.

Table 4. Examples of holding activities.

Holding activities included in the PSR definition Additional examples of holding activities offered in guidance

·    Storing food.

·    Activities performed incidental to storage of a food – e.g., activities performed for the safe or effective storage of that food.

o Fumigating food during storage.

o Drying/dehydrating RACs when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa).

o     Activities performed as a practical necessity for the distribution of that food such as:

Blending of the same RAC or breaking down pallets.

· Aeration for safe or effective storage (e.g., to manipulate grain temperatures).

· Aging/curing/fermenting/oxidizing that occurs passively over time, e.g., cocoa beans, coffee beans, and vanilla beans.

· 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).

· 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.

· 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).

Source:  Classification of activities as harvesting, packing, holding, or manufacturing/processing for farms and facilities draft- guidance (2016).

What is a farm mixed-type facility?

Farm mixed-type facilities are farms that further process produce or do other activities (not listed in the farm definition) that require them to register with FDA as a “food facility” (unless an exemption applies).

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, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing.

Depending on the processing/manufacturing activities being conducted at a farm mixed-type facility, the operation may have to comply with portions of the Preventative Controls for Human Food Rule also commonly referred to as the “PC Rule”. For example, if a farm grows apples for human food, harvest the apples, and manufactures/ process the apples by slicing them, the operation is a “farm mixed-type facility” and must register as a food “facility” (unless an exemption applies) because the farm is performing manufacturing/processing that is outside the “farm” definition (i.e., slicing apples). The growing and harvesting activities are within the “farm” definition and are subject to the Produce Safety rule requirements. The manufacturing/processing activity of slicing the apples is potentially subject to the CGMP and preventive controls requirements of the Preventative Control Rule for Human Food.

If after reviewing the definition of a farm and the activities allowed you realize that your farm operation is a farm mixed-type facility, review the guidelines for food facility registration and determine whether your operation needs to register or not. If you need help with this step, please contact your local Extension Agent and they will get you in contact with a member of the NCSU’s food safety team.

Understanding the basics: Food Facility Registration 

To better understand food facility registrations, it is important to discuss what FDA considers a facility and then discuss where farms fall under this regulation and what steps a farm must take in case it has mistakenly registered with FDA.

According to FDA’s regulation on food facilities a facility means any establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/ processes, packs, or holds food for consumption in the United States. Transport vehicles are not facilities if they hold food only in the usual course of business as carriers. A facility may consist of one or more contiguous structures, and a single building may house more than one distinct facility if the facilities are under separate ownership. The private residence of an individual is not a facility. Non-bottled water drinking water collection and distribution establishments and their structures are not facilities.

Who must register under the food facility registration requirements?

If you are the owner, operator, or agent in charge of either a domestic or foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States, you must register with FDA, unless you are exempt from the requirement to register.

Are farms exempt from registering as a food facility with FDA?

Farms are exempt from registration. However, if the farm is a “farm mixed-type facility,” then it must register.

What facilities are exempt from registration as a food facility with FDA?

The following facilities are exempt from registering as a food facility:

Farms

Retail food establishments *

Restaurants**

Nonprofit food establishments***

Fishing vessels

Facilities regulated exclusively by the USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act or the Egg Products Inspection Act.

Private residences

*A retail food establishment means an establishment that sells food products directly to consumers as its primary function. The term ‘‘retail food establishment’’ includes facilities that manufacture, process, pack, or hold food if the establishment’s primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. A retail food establishment’s primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The term ‘‘consumers’’ does not include businesses. A ‘‘retail food establishment’’ includes grocery stores, convenience stores, and vending machine locations. A ‘‘retail food establishment’’ also includes certain farm-operated businesses selling food directly to consumers as their primary function.

(1) Sale of food directly to consumers from an establishment located on a farm includes sales by that establishment directly to consumers:

(i) At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers’ market (a location where one or more local farmers assemble to sell food from their farms directly to consumers);

(ii) Through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer’s crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and

(iii) At other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmer’s markets and online grocery delivery; religious or other organization bazaars; and State and local fairs.

(2) Sale of food directly to consumers by a farm-operated business includes the sale of food by that farm-operated business directly to consumers:

(i) At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers’ market (a location where one or more local farmers assemble to sell food from their farms directly to consumers);

(ii) Through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer’s crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and

(iii) At other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online grocery delivery; religious or other organization bazaars; and State and local fairs.

(3) For the purposes of this definition, ‘‘farm-operated business’’ means a business that is managed by one or more farms and conducts manufacturing/ processing not on the farm(s).

**Restaurant means a facility that prepares and sells food directly to consumers for immediate consumption. Restaurant does not include facilities that provide food to interstate conveyances, central kitchens, and other similar facilities that do not prepare and serve food directly to consumers.

Restaurants are:

(1) Entities in which food is provided to humans, such as cafeterias, lunchrooms, cafes, bistros, fast food establishments, food stands, saloons, taverns, bars, lounges, catering facilities, hospital kitchens, day care kitchens, and nursing home kitchens are restaurants; and

(2) Pet shelters, kennels, and veterinary facilities in which food is provided to animals are restaurants.

***Non-profit food Establishments:  means a charitable entity that prepares or serves food directly to the consumer or otherwise provides food or meals for consumption by humans or animals in the United States. The term includes central food banks, soup kitchens, and nonprofit food delivery services. To be considered a nonprofit food establishment, the establishment must meet the terms of section 501(c)(3) of the U.S. Internal Revenue Code.

How do I register a food facility?

A facility must be registered before manufacturing/processing, packing, or holding operations begin. Facilities are required to renew their registrations every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year.

Facilities may register through the FDA and more information can be found at: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/. Registration is free.

When will registration close?

A new facility can register at any time, registration does not close for new facilities. However, required biennial renewal occurs during even-numbered years between October 1 and December 31.

What if a farm registered erroneously with FDA as a food facility, can the farm cancel the registration?

Some farms that have been undergoing voluntary third-party food safety audits had to register their packing houses with FDA as a food facility. This was a requirement that some third-party auditing companies had in their guidelines. With the new guidance that FDA has published over the past year, it is evident that farms should not be registered as food facilities. If after reviewing this document, it is determined that a farm has erroneously registered as a food facility it is important to cancel the food facility registration as soon as possible and save the cancellation notice with the farm’s records. If a farm does not cancel the registration it may be possible that state or federal inspectors show up to inspect the facility for compliance with guidelines under the Preventative Controls for Human Food Rule.

Canceling a food facility registration can be done online or by mail. For directions on how to cancel a food facility registration online go to: https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm084398.htm#changereg

Alternatively, a paper copy of the cancellation (Form FDA 3537a) can be used to fax or mail the cancellation to FDA. Beginning January 4, 2020, cancellations must be submitted electronically, unless FDA has granted a waiver. If FDA has granted a waiver, a cancellation form may be submitted by mail or fax. The paper copy can be found at: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM072017.pdf

The paper form can be submitted by fax to 301-436-2804 or by mail to: U.S. Food and Drug Administration Food Facility Registration (HFS-681) 5001 Campus Dr., College Park, MD 20740.

The cancellation for a facility’s registration must include the following information:

  • The facility’s registration number;
  • Whether the facility is domestic or foreign;
  • The facility name and address;
  • The name, address, and email address (if available) of the individual submitting the cancellation;
  • For registration cancellations not submitted by the owner, operator, or agent in charge of the facility, the email address of the individual who authorized submission of the registration cancellation, unless FDA has granted a waiver under 21 CFR 1.245; and
  • A statement certifying that the information submitted is true and accurate, and that the person submitting the cancellation is authorized by the facility to cancel its registration.

When will a food facility registration be considered canceled?

For electronic cancellations, once a farm completes the electronic cancellation, FDA will provide an electronic confirmation of your cancellation. The registration will be considered cancelled once FDA sends the cancellation confirmation. For cancellations submitted by mail or fax, the registration will be considered cancelled once FDA enters the facility’s cancellation data into the registration system. FDA will send the registrant a cancellation confirmation.

For registration cancellations not submitted by the owner, operator, or agent in charge of the facility, after submission of the registration cancellation, FDA will verify that the individual identified as having authorized submission of the cancellation in fact authorized the submission on behalf of the facility. FDA will not confirm the registration cancellation until that individual confirms that he or she authorized the registration cancellation.

Summary

This document provides a summary of the activities that are conducted at a farm based on the revised definition of a farm. If you need further explanation about activities and examples at different farms refer to the guidance documents listed below. If you operate a farm mixed-type facility it is also important that you understand what portions of the Preventative Controls for Human Food Rule apply to your facility. Finally, this document discussed food facility registrations from the standpoint of produce (fruit and vegetable) farms. Farm operators need to be aware that farms are exempt from this requirement. Food facility registrations trigger a set of different rules for facilities that do not apply to farms.

For more information on this topic and to read the full draft guidance documents see:

Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities Draft guidance. (August 2016).

https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM517575.pdf

Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) – (December 2016).

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm331959.htm

Produce Safety Rule – Final Rule

https://www.fda.gov/food/guidanceregulation/fsma/ucm334114.htm

Written By

Photo of Elena Rogers, N.C. Cooperative ExtensionElena RogersArea Specialized Agent, Agriculture - Food Safety - Fresh Produce Western NC Serves 49 Counties and EBCIBased out of Horticultural Science(828) 352-2519 elena_rogers@ncsu.eduHorticultural Science - NC State University
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