Who does not have to register?

• Farms
• Private residences of individuals
• Retail food establishments
• Restaurants
• Non-profit establishments that prepare food for, or serve food directly to, consumers
• Transport vehicles that hold food only in the usual course of their business as carriers.
• Facilities regulated exclusively throughout the entire facility by the U.S. Department of Agriculture
• Fishing vessels not engaged in processing
• Non-bottled water, drinking water collection and distribution establishments and structures, such as municipal water systems

Criteria for Exemption from Registration

Farms are exempt if

• the farm is in one general physical location,
• it is devoted to growing, harvesting, washing, trimming of outer leaves, and/or cooling of produce,
• it involves raising animals (including seafood) for human or animal consumption (FDA considers activites such as milking cows and collecting eggs from chickens to be ''harvesting'' when applied to animals, because these activities are similar to harvesting crops) and/or,
• foods that are manufactured or processed are exclusively consumed on that farm or another farm under the same ownership.

• Farm-operated roadside stands that sell food directly to consumers as its primary function are exempt from registration.

Packers

• Packers of fruits, vegetables, and mushrooms are considered farms and are exempt if: All food used is grown, raised, or consumed on the owner's farm or another farm under the same ownership

• Packers of fruits, vegetables, and mushrooms are not exempt and must register if: they pack or hold food crops that have been grown on farms owned by someone else

• Warehouses or produce auctions are operations that hold food for resale are not exempt and must register.


Animal feed

• Feed mills and pet food manufacturers, process, pack, or hold feed for animal consumption are not exempt and must register.

Private residences of individuals

• A food manufacturing business that operates from within a private home is exempt and does not have to register even though food may be manufactured/processed, packed, or held there.
• see Guidance and Requirements for Pennsylvania Home Food Processors for more information on home food businesses.

Retail food establishments

• Groceries, delis, and roadside stands, that sell food directly to consumers as their primary function, meaning that annual sales directly to consumers are of greater dollar value than annual sales to other buyers are exempt and not required to register.
• Farm-operated roadside stands that sell food directly to consumers as its primary function are exempt from registration.

Restaurants

• Operations that prepare and sell food directly to consumers for immediate consumption are exempt.
• Central kitchens are not exempt if they do not prepare and serve food directly to consumer and must register.
• Facilities that provide food to interstate conveyances, such as to commercial aircraft are not exempt and must register.


Non-profit establishments that prepare food for, or serve food directly to, consumers

• Charitable entities that meet the terms of of the Internal Revenue Code 501(c)(3) and that prepare or serve food directly to the consumer or otherwise provide food or meals for consumption by humans or animals in the U.S are exempt.
• Examples of nonprofit food establishments include central food banks, soup kitchens, and nonprofit food delivery services.

Transport vehicles that hold food only in the usual course of their business as carriers.

• trucks or other motor carriers are exempt.
• However, truck or marine terminals or freight forwarders are not exempt and must register because they hold food.
• If a vehicle such as a railcar is used as a storage bin for a manufacturing plant, it would be "holding'' food, not transporting it, and would not be exempt and must register.
• The regulaton does not exempt facilities based on how long they hold food. 


Facilities regulated exclusively throughout the entire facility by the U.S. Department of Agriculture

• Facilities handling only meat, poultry, or egg products are exempt.

Fishing vessels not engaged in processing

• Those that harvest and transport fish and that may engage in practices such as heading, eviscerating, or freezing fish solely to prepare the fish for holding on board the vessel are exempt.

Non-bottled water, drinking water collection and distribution establishments and structures

• i.e. municipal water systems are exempt.

FDA's discussion of exemption criteria can be accessed in the online version of the interim final rule.

Registration is easy, free, and required by law.
For help with registration, contact FDA 
In the U.S call 1-800-216-7331 or 301-575-0156 
From elsewhere call 301-575-0156 
Fax questions to 301-210-0247 
Email questions to furls@fda.gov

Luke LaBorde
Assistant Professor of Food Science
Penn State University
lfl5@psu.edu