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Defining Food Establishments—Amend Section 1-201.10(B)

The FDA Food Code recognizes that food establishments should be maintained to ensure sanitary conditions free of rodents, insects, and other pests. The 2013 Food Code, however, defines "food establishments" subject to the code to exclude establishments that offer only prepackaged, shelf-stable foods. States that have adopted the 2013 Food Code's definition of food establishments may not ensure that stores selling only prepackaged, shelf-stable foods meet basic sanitation requirements.

Proper handling, storage, and display of prepackaged foods is necessary to safeguard public health. Establishments that are typically not in the business of selling food -- such as home goods, hardware, clothing, party supply, and office supply stores -- should be defined as "food establishments" and required to meet basic sanitation standards. Jurisdictions that inspect such stores have found numerous sanitation violations including the presence of insects, rat and mouse droppings, the presence of a trapped mouse, gnawed food bags, the presence of live birds and a pet dog, improper storage of toxic chemicals, and spoiled food (documentation attached).

Risks posed to consumers may be high for ready-to-eat foods, such as candy bars and chips. These foods are typically eaten directly out of the packaging, with consumers' hands touching both the packaging and the food itself, increasing the likelihood that excrement or toxic chemicals present on the packaging could contaminate the food consumed.

that a letter be sent to the FDA requesting the definition of Food Establishments in the 2013 Food Code section 1-201.10(B) be amended as follows (new language is underlined; language to be deleted is in strikethrough format):

1-201.10 Statement of Application and Listing of Terms

(B) Terms Defined. As used in this Code, each of the terms listed in ¶ 1-201.10(B) shall have the meaning stated below.

Food Establishment.

(3) "Food establishment" does not include:

(a) An establishment that offers only prePACKAGED FOODS that are not TIME/TEMPERATURE CONTROL FOR SAFETY FOODS;

(ba) A produce stand that only offers whole, uncut fresh fruits and vegetables;

(cb) A FOOD PROCESSING PLANT; including those that are located on the PREMISES of a FOOD ESTABLISHMENT

(dc) A kitchen in a private home if only FOOD that is not TIME/TEMPERATURE CONTROL FOR SAFETY FOOD, is prepared for sale or service at a function such as a religious or charitable organization's bake sale if allowed by LAW and if the CONSUMER is informed by a clearly visible placard at the sales or service location that the FOOD is prepared in a kitchen that is not subject to regulation and inspection by the REGULATORY AUTHORITY;

(ed) An area where FOOD that is prepared as specified in Subparagraph (3)(dc) of this definition is sold or offered for human consumption;

(fe) A kitchen in a private home, such as a small family day-care provider; or a bed-and-breakfast operation that prepares and offers FOOD to guests if the home is owner occupied, the number of available guest bedrooms does not exceed 6, breakfast is the only meal offered, the number of guests served does not exceed 18, and the CONSUMER is informed by statements contained in published advertisements, mailed brochures, and placards posted at the registration area that the FOOD is prepared in a kitchen that is not regulated and inspected by the REGULATORY AUTHORITY; or

(gf) A private home that receives catered or home-delivered FOOD.