The Agency is proposing to define the term "water activity (aw)" to mean a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.
2. Food Processing Sector Study and the Definitions of "Small Business" and "Very Small Business"
FDA conducted a Food Processing Sector Study as required by section 418(l)(5) of the FD&C Act (Ref. 16). The purpose of that study was to make determinations in five areas as required by section 418(l)(5)(A) of the FD&C Act and to use the results of the study in defining the terms "small business" and "very small business." These areas include, in part: (1) Distribution of food production by type and size of operation, (2) the proportion of food produced by each type and size of operation, (3) the number and types of food facilities co-located on farms, (4) the incidence of foodborne illness originating from each size and type of operation, and (5) the effect on foodborne illness risk associated with certain activities regarding food. The Food Processing Sector Study provides information on the number of establishments and average sales per establishment by industry and size of operation.
Section 418(l)(5)(B) of the FD&C Act required consideration of harvestable acres, income, the number of employees, and the volume of product in defining the terms "small business" and "very small business." The Food Processing Sector Study (Ref. 16) concluded that there was no consistent pattern across food categories, including the pet food and animal feed categories, in terms of which sizes of establishments contribute most to foodborne illness risk. "Harvestable acres," "income," "the number of employees," and "the volume of food harvested" are all ways to measure the size of an operation. Income does not appear to be the most relevant measure, since facility income may be derived from multiple sources, many of which are not food-related. "Harvestable acres" and "volume of food harvested" are similar measures that appear primarily relevant to the growing and harvesting of crops, which are activities not subject to this regulation. Harvestable acres and volume of food harvested do not provide a meaningful measure with respect to the risk from pet food or animal feed produced by a farm mixed-type facility (a pet food or animal feed facility co-located on a farm subject to this regulation); the Agency's qualitative risk assessment of manufacturing, processing, packing, and holding activities conducted in a facility co-located on a farm showed that risk was related to activity/animal food combinations; these animal foods could be harvested from large or small farms (see section VII.B for a discussion of that qualitative risk assessment). A high risk activity/animal food combination (i.e., a not low-risk activity/food combination) could be conducted on a farm with many harvestable acres or very few harvestable acres. For example, an on-farm facility mixing and/or blending for the purpose of making a complete animal food (which would not be considered a low-risk activity/food combination) could be one that has very few acres, or the mixing and/or blending for the purpose of making a complete animal food could be a small component of a large farm operation.
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