CPG Sec. 555.750 Seeds for Sprouting Prior to Food Use, i.e., Dried Mung Beans, Alfalfa Seeds, Etc.
An advisory opinion issued January 18, 1982 (Docket No. 80A-0518/AP), responded to the following issues:
- Whether mung beans used exclusively for the purpose of growing bean sprouts should be regulated as "food," and
- Whether, regardless of their ultimate classification, rodent-defiled mung beans to be used solely for growing bean sprouts may be exempt from sanitation inspections, seizure, and condemnation as an adulterated food.
The advisory opinion, although it specifically addressed mung beans, applies to other seeds that are used for producing sprouts for food use. The FDA has long held that mung beans are food. The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 (f)) defines "food" as (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such articles. Mung beans whether to be consumed in bean form or to be germinated to produce bean sprouts, are considered to be food. Although mung beans are not always consumed in bean form, they are still considered to be food if they are intended to be processed into food. USDA's classification of mung beans as seeds, not food, is not relevant to FDA's regulation of food under the act. FDA regulates many commodities as foods that are also used as seeds in growing crops. Corn, wheat, and dried beans, for example, have this dual identity, but these products are still regulated as foods. FDA is of the opinion that all seeds used for sprouting are foods.
FDA has, in the past, made some exemptions for foods used solely for seed purposes. Mercury-treated wheat is a case in point. A mercurial fungicide is permitted on wheat used for seed purposes only. However, in this case, the product of the growing process is separated from the seed by a complete maturation process that results in a separate food--the harvested wheat. Some similar exemption could be applied to mung beans used solely for the purpose of developing mature plants in order to harvest a crop of mung beans. However, seeds used for sprouting are too closely associated with the finished food (sprouts) to allow for an exemption of this type. In many instances, the spent bean hull is not even separated from the sprout before the sprouts are offered for sale as a finished food.
For the reasons stated above, FDA will regulate seeds used for producing sprouts for food and mung beans used exclusively for seed purposes, as food and cannot exempt them from sanitation inspections, seizure, and condemnation as adulterated food.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.