How FDA's 2018 Guidance on Food Facility Registration Clarified the Farm Exemption

In 2018, FDA issued a final guidance document titled 'Questions and Answers Regarding Food Facility Registration' — commonly called the Food Facility Registration Q&A Guidance. This guidance was issued to clarify who must register their food facility under FSMA's Preventive Controls for Human Food rule, with particular focus on the farm exemption and the boundary between exempt and non-exempt operations. For foreign manufacturers, the document's clarifications are directly relevant: they define the categories that trigger a registration requirement and the categories that are explicitly excluded.

The farm exemption and why it matters for manufacturers

FSMA exempts farms from the food facility registration requirement when they are engaged in primary production activities — growing crops, raising livestock, harvesting, and certain post-harvest activities. The exemption exists because farms are subject to a separate FSMA rule (the Produce Safety Rule) and because requiring every farm to register would create an enormous administrative burden. However, the exemption has a defined boundary. A farm that begins processing food — cooking, manufacturing, transforming raw agricultural commodities into processed products — may cross into 'farm mixed-type facility' territory, which requires registration. A farm packing facility that sorts, sizes, or labels produce generally remains within the farm exemption. A facility that takes farm products and converts them into shelf-stable products, sauces, or ready-to-eat items generally does not.

What 'farm mixed-type facility' means

A farm mixed-type facility is an operation that conducts both farm activities (growing, harvesting) and non-farm activities (manufacturing, processing) at the same physical location. The 2018 guidance added a definition of this term near the beginning of the document — a clarification that had been absent from the draft guidance — so that operations could more easily determine whether they fell into this category. Farm mixed-type facilities are required to register with FDA. The key test is whether the operation conducts activities that go beyond the farm definition. If a farm grows olives and also produces olive oil at the same location, the olive oil production is a non-farm activity, and the entire operation may be a farm mixed-type facility that must register.

The retail food establishment exemption

The 2018 guidance also added a definition of 'retail food establishment' at the point where the term is first used, making it easier for businesses to determine whether they qualify for that exemption. Retail food establishments — grocery stores, restaurants, and similar businesses that sell food directly to the final consumer — are generally exempt from registration. The exemption applies when the majority of the facility's food sales are directly to consumers. A foreign manufacturer that produces food and sells it entirely through wholesale channels to US importers does not qualify for the retail food establishment exemption regardless of the terminology used to describe the business.

Clarifications on placing labels on raw agricultural commodities

One of the specific clarifications in the 2018 guidance addressed whether placing labels on raw agricultural commodities (RACs) or on boxes containing RACs constitutes 'manufacturing or processing' for registration purposes. FDA confirmed that this activity — applying a label directly to a RAC or its container without otherwise processing the commodity — does not trigger a registration requirement. This is relevant for foreign packers who grade and label fresh produce for US export without performing any processing step. Labeling in this limited sense keeps the operation within the farm/packing exemption.

What has changed since 2018 and what remains relevant

The 2018 guidance did not change the underlying regulatory requirements — it clarified how FDA interprets them. Those interpretations remain in effect. Since 2018, FDA has published additional guidance on the supplemental farm definition issues that were not fully resolved in the 2018 document. For foreign manufacturers who are uncertain whether their operation requires FDA registration, the most reliable approach is to describe the operation's activities in detail — what comes in, what steps are performed, what goes out — and map those activities against FDA's definitions. FDABridge can conduct this analysis as part of a pre-registration consultation. Visit fdabridge.com/food-facility-registration or fdabridge.com/contact to start the conversation.