February 24, 2017
Over two years ago, the National Sustainable Agriculture Coalition (NSAC) reported on a proposed rule by the Food and Drug Administration (FDA) that would impact whether local food businesses and value-added producers had to register with FDA as “food facilities.” Since that time, FDA has finalized two rules under the Food Safety Modernization Act (FSMA) that affect registration requirements, one for produce farms and one for food processors. The question of which farms might have to register with FDA, unfortunately, continues to confuse and confound farmers and processors.
If you recall from past posts, the two main reasons why farms might not have to register with FDA is (1) because they satisfy FDA’s definition of “farm” or (2) they satisfy FDA’s definition a “retail food establishment.”
These definitions are nuanced, and there are still a lot of questions and grey areas, particularly concerning FSMA’s “farm” definition. In recognition of this persistent confusion, FDA has issued several draft guidance documents. The first draft guidance, issued over the summer, provides additional details on the types of activities that are allowable under the “farm definition.” A second draft guidance was issued this winter, which provides questions and answers related to facility registration, including which entities have to register and what to do if you need to register or cancel a registration. Below, we provide a summary of this guidance, including some of the most relevant questions and answers for farms and local food producers.
Extended Compliance Dates for Preventive Controls Rule
Before we get into the Q&A, it’s important to note that FDA has extended the Preventive Controls Rule compliance dates for operations that just barely do not meet the farm definition (often because of the ownership criteria). You can read more about the extension here. FDA also acknowledges this action in the Registration Q&A:
In a final rule published in the Federal Register of August 24, 2016 (81 FR 57784), FDA extended the date for certain facilities to comply with some or all requirements for hazard analysis and risk-based preventive controls in some circumstances. These facilities include certain facilities that would qualify as secondary activities farms except for the ownership of the facility, certain facilities that color RACs, and facilities solely engaged in the ginning of cotton. For some of these issues, FDA stated that it was considering whether future rulemaking to modify the “farm” definition is appropriate to address the issue. FDA does not intend to prioritize enforcing the registration requirement for these businesses. (emphasis added)
If you meet these criteria, you can wait for an individualized response from FDA via the Technical Assistance Network, or wait for more guidance from FDA on the other aspects of the farm definition (like ownership). As noted above, FDA is considering future rulemaking to address the ambiguity of the farm definition, or – at the very least – additional guidance to support producers. If someone comes on your farm and tells you that you have to register, but you disagree, direct them to these statements from FDA and let NSAC or your local farm membership organization know too. NSAC is continually compiling stories and information from farm operations that either do not neatly fit the farm definition, or are experiencing pressure to register, so that we can address problems and questions as they arise.
Basic Information on Registration
The Q&A provides a clear statement that farms that aggregate produce from other farms do not have to register.
B.1.9 Does a farm that packs fresh produce from other farms have to register?
No. According to the definition of “farm,” an establishment devoted to the growing of crops, the harvesting of crops, the raising of animals, or any combination of these activities, would remain within the “farm” definition if it packs or holds [raw agricultural commodities], RACs, regardless of whether the farm packs or holds RACs grown on that farm, RACs grown on a another farm under the same management, or RACs grown on another farm under different management. Any such operation that meets the “farm” definition is not subject to the requirement to register under section 415 of the FD&C Act.
Q&A: Retail Food Establishment
The draft guidance provides additional clarity on the retail food establishment definition with the following examples:
[A]n establishment located on a farm that sells apples it grows and apple pies it manufactures directly to consumers at a farmer’s market would consider those sales in determining its primary function [i.e. whether the majority of its sales are direct to consumers].
[I]f a farmer manufactures or manages the manufacturing of jellies from the apples that he grows at an off-farm location, such as an incubator kitchen, and sells those jellies directly to consumers at a farmer’s market, the jelly-making operation would be a farm-operated business and may consider those sales in determining its primary function.
The draft guidance also addresses shared kitchens, where multiple value-added businesses may rent space, and makes it clear that if multiple farm businesses are using a shared kitchen space:
The ownership of the physical building, e.g., the ownership of the shared kitchen, where the manufacturing/processing occurs is not relevant. Thus, if an apple grower leases space at an off-farm incubator kitchen to manufacture apple jellies, ownership of the incubator kitchen building would not be relevant. Because the apple farmer manages the off-farm apple jelly manufacturing operation, the apply jelly manufacturing operation is a farm-operated business and eligible for the retail food establishment exemption from registration [assuming the majority of its sales are direct to consumer].
Additional clarity on the retail food establishment definition is contained in the following sections:
B.2.9 Is there a limitation on the distance of roadside stands or farmers’ markets from the farms on which the food is produced?
No. For purposes of the definitions for farmers’ markets and roadside stands, as used in the definition of “retail food establishment” in 21 CFR 1.227, there is no limitation on the distance between the farmers’ market or roadside stand and the farms on which the food is produced.
B.2.10 What does “community supported agriculture program” mean for purposes of the “retail food establishment” definition?
The term “community supported agriculture (CSA) program,” which is used in the definition of “retail food establishment” in 21 CFR 1.227, 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 consolidates their crops at a central location for distribution to shareholders or subscribers.
B.2.11 For purposes of the “retail food establishment” definition, can CSAs sell food other than crops?
Yes. CSA activities are not limited to only selling “crops.” For example, a farm mixed-type facility may sell strawberries it grows and strawberry jam that it manufactures directly to consumers through a CSA. Whether the on-farm manufacturing establishment is a retail food establishment, and thus exempt from registration, would depend on whether its primary function is to sell food directly to consumers [i.e. at least 50.1% of all food sales].
B.2.12 May sales from my on-farm manufacturing operation that are made via mail, catalog or Internet order, or through online farmers’ markets or online grocery delivery be considered sales of food directly to consumers?
Yes. Sales of food directly to consumers from an establishment located on a farm or from a farm- operated business includes sales by such establishments directly to consumers at such direct-to- consumer platforms as mail, catalog, and Internet order, including online farmers markets and online grocery delivery.
B.2.14 For purposes of the “retail food establishment” definition, can sales at produce auctions, food hubs, and buying clubs be considered sales that are directly to consumers?
Sales at such platforms can be to different types of entities. In some cases, sales may be to consumers. However, sales may also be to restaurants, wholesalers and other businesses. An establishment’s direct sales to individual consumers at these platforms can be counted as sales to consumers. However, a direct sale to a business at these platforms cannot be counted as sales to consumers. Furthermore, a direct sale to a separate business that runs these platforms, rather than to specific buyers, would not be counted as sales to consumers because businesses (including businesses that run produce auctions) are not consumers.
B.2.15 Is there an income limitation included in the “retail food establishment” definition?
No. There is no income limitation for establishments to qualify as retail food establishments. As long as an establishment’s primary function is to sell food directly to consumers, it is a retail food establishment. 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 Q&A also makes it clear that beekeepers producing raw honey are not required to register, but beekeepers that pasteurize their honey do have to register.
B.1.21 Am I required to register if I extract and bottle honey produced on my farm (i.e., remove the wax seal and spin the honey out of the honeycomb, then bottle the honey)?
No. Many activities associated with beekeeping and honey production are within the “farm” definition and therefore do not require registration. In this case, extracting honey is considered harvesting and bottling honey is packaging a RAC (raw agricultural commodity), which is a type of manufacturing/processing included within the “farm” definition.
C.4.4 Am I required to register if I use heat to pasteurize the honey I produce on my farm?
Under 21 CFR 1.227, heating honey for pasteurization is considered manufacturing/processing. Therefore, if you use heat to pasteurize the honey you produce on your farm, you must register unless: (1) all the honey that has undergone manufacturing/processing is consumed on your farm or another farm under the same management, or (2) your manufacturing/processing operation meets the definition of a retail food establishment.
Q&A: Maple Syrup
If you are making maple syrup from sap, then you have to register with FDA, unless you are a retail food establishment (meaning the majority of your sales are direct to individual consumers).
B.1.15 Are maple syrup producers “farms” and, thus, exempt from registering?
The response to this question depends upon the activities of the maple syrup producer. The activities of maple syrup producers customarily consist of two types: gathering sap from sugar maple trees and concentrating the sap through the application of heat to make syrup. Gathering sap is “harvesting,” which is included in the definition of “farm.” Therefore, the farm is exempt from registration. However, concentrating sugar maple sap by heating is a form of “manufacturing/processing.” Accordingly, a facility that concentrates sugar maple sap is performing a “manufacturing/processing” activity and is required to register, unless all of the concentrated sap is consumed on the farm or another farm under the same management.
Q&A: Hay vs. Haylage/Silage
Farms that sell hay to other farms are not required to register, because making hay is not a manufacturing/processing activity. However, farms that ensile hay for sale as animal feed are required to register, because ensiling is a manufacturing/processing activity.
B.1.24 If a farmer makes silage and sells that silage to another farmer for use as animal food, would the farmer be required to register?
Silage is a processed food made by fermenting (ensiling) green vegetation (e.g., alfalfa, clover, corn). A farm may manufacture/process food and remain within the “farm” definition, if all the food that is manufactured/processed is consumed on that farm or another farm under the same management. If the processed food is consumed on a farm under different management, then the farm manufacturing the food becomes a farm mixed-type facility and is required to register. Therefore, in this example, the silage farmer would be required to register because the farmer is selling silage to another farm under different management.
Still have questions?
This post only contains a select few of the most common questions and answers from the guidance. We strongly encourage any operation that has questions about registration to review the entire document. You can download the full draft guidance here. Keep in mind that it is a draft, so the information may change in the final Q&A based on public input. If still have questions or additional input after reading the guidance, you can submit comments to FDA. You can do so anytime, but it is recommended that you submit comments here prior to March 27, 2017 in order to have your feedback integrated in the final Q&A.
You can also submit specific scenarios and questions on an ongoing basis via FDA’s Technical Assistance Network.
NSAC is happy to submit questions and scenarios anonymously on your behalf. To do so, contact us via email@example.com.
You may also be interested in our Special Reports on the FSMA Rules, or our Am I Affected? Flowchart, which walks farmers and food businesses through a series of questions to help determine whether and to what extent you might be covered by the two main FSMA Rules.
Categories: Food Safety