Differences From the Proposed Preventive Control Rule for Human Food
FDA is proposing different annual gross sales levels for the three definition options of very small business for animal food facilities than proposed for human food facilities. In the proposed rule for preventive controls for human food (78 FR 3646), FDA proposed three options for annual gross sales levels for very small business. Option 1 would be $250,000, Option 2 would be $500,000, and Option 3 would be $1 million. For the proposed rule for preventive controls for animal food, FDA is proposing three different options for annual gross sales levels for very small business. Option 1 would be $500,000, Option 2 would be $1 million, and Option 3 would be $2.5 million. In general, the animal food industry sector is more heavily weighted toward the medium and larger facilities, when based on gross annual sales, than is the human food industry sector. For example, facilities producing livestock or poultry feed often buy and sell product measured in tons, resulting in high annual gross sales. Though the annual gross sales levels would be higher for each option in the proposed animal food rule, the percent of facilities and percent of sales exempted would be comparable to the annual gross sales levels for the three options for the proposed rule for human food.
C. Proposed SEC 507.5--Exemptions
1. Proposed SEC 507.5(a)--Exemption Applicable to Establishments Not Required To Register Under Section 415 of the FD&C Act
Proposed SEC 507.5(a) would exempt establishments not required to register under section 415 of the FD&C Act. According to section 415(c)(1) of the FD&C Act, establishments that are not required to register include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in 21 CFR 123.3(k)). The Agency has interpreted these terms in SEC 1.227. For example, in the animal food context, a "restaurant" includes pet shelters, kennels, and veterinary facilities in which food is provided to animals. A "retail food establishment" is an establishment that sells food directly to consumers as their primary business function, where the term "consumer" does not include a business. A grocery store, including the pet food aisle, would be an example. In addition, the Agency has interpreted "nonprofit food establishment" to include a charitable entity that provides food or meals for consumption by animals in the United States. To be considered a nonprofit food establishment, the establishment must meet the terms of section 501(c)(3) of the U.S. Internal Revenue Code. Certain nonprofit wildlife rehabilitation centers would likely fall into this category.
In section VIII.B of the document for the proposed rule for preventive controls for human food (78 FR 3646), FDA proposed to further clarify the scope of the definition of "farm" for the purposes of section 415 of the FD&C Act to mean a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. The term "farm" would include: (1) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership and (2) facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership. Because this definition of "farm" reflects the Agency's interpretation of the term in section 415 of the FD&C Act, establishments that meet this definition would not be required to register under section 415 of the FD&C Act and would therefore be excluded from the scope of this rulemaking under proposed SEC 507.5(a). For example, a farm that manufactures/processes food, e.g., by using mobile equipment to mix grain and forage with a commercially produced protein/mineral supplement into a total-mixed ration to feed to dairy cattle on its farm, or another farm under the same ownership, would be exempt from this proposed rule. As another example, a crop farm that grows, harvests, and stores agronomic crops such as alfalfa hay, corn, and other feed grains for distribution into commerce as animal food would be exempt from the proposed rule.