Consistent with this approach, the Agency conducted a qualitative risk assessment (Ref. 33) ("section 103(C)(1)(C) draft RA") related to activity/animal food combinations for the purpose of determining which activity/animal food combinations would be considered low risk. The Agency focused on activity/animal food combinations that were identified as being conducted on farms (and, thus, might be conducted by farm mixed-type facilities), but the Agency did not consider activity/animal food combinations that would be solely within the farm definition (such as the growing and harvesting of crops) and, thus, are not relevant to the requirements of section 103 of FSMA. The Agency focused on considering the risk of activity/animal food combinations rather than separately considering the risk of specific animal food categories because doing so better enabled the Agency to focus on whether a specific manufacturing, processing, packing, or holding activity conducted on animal food by a farm mixed-type facility warranted an exemption from, or modified requirements for, the provisions of section 418 of the FD&C Act.
Elsewhere in this issue of the
C. Results of the Qualitative Risk Assessment
In this section, the Agency reports the results of the section 103(C)(1)(C) draft RA, arranged in three lists. References to "farms" in these lists should be understood to include farm mixed-type facilities. The lists are shaped by the proposed definitions for harvesting, manufacturing/processing, packing, or holding in the section 415 registration regulations (discussed in section VIII.E of the document for the proposed rule for preventive controls for human food (78 FR 3646), the organizing principles (discussed in section VIII.D of the document for the proposed rule for preventive controls for human food) that form the basis for those proposed definitions, and the examples of activity classifications. As discussed in section VIII.E of the document for the proposed rule for preventive controls for human food, the same activity may be classified differently (among the categories of harvesting, manufacturing/processing, packing, or holding) depending on whether the animal food being operated upon is a RAC and whether the RAC was grown or raised on the farm or farm mixed-type facility performing the activity or a farm under the same ownership and whether the animal food is consumed on the farm that produced it or another farm under the same ownership. The Agency requests comment on the lists in sections VII.C.1, VII.C.2, and VII.C.3.
For purposes of this document, grains are the small, hard fruits or seeds of arable crops, or the crops bearing these fruits or seeds, that are grown and processed for use as meal, flour, baked goods, and cereals (including cereal grains, pseudo cereals, pulses, and other plants used in the same fashion) to be used in animal food. Examples of animal food grains include barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, and buckwheat. Oilseeds are the small, hard fruits or seeds of arable crops that are grown and processed mainly for the oil that is extracted from them. Examples of animal food oilseeds include soybean, cottonseed, and rapeseed. Grains and oilseeds are field-dried before harvest. Post-harvest drying or dehydrating that further reduces the moisture content of harvested grains and oilseeds for the purpose of storage or transportation is considered an activity separate from field drying done before harvest. In the lists that follow, the terms grain and oilseed are used in a general sense while the terms dried grain and dried oilseed are used to designate specifically those harvested grains and oilseeds that have been further dried or dehydrated for the purpose of storage or transportation.
Most Popular Stories
- American Airlines, US Airways Complete Merger
- ACA Delay Stresses Small Businesses
- Unemployed Wait as Lawmakers Debate
- Saab Gets Back into the Game; U.S. Auto Sales Soar
- Dell Offers Undisclosed Number of Employee Buyouts
- Questions Remain in Jenni Rivera's Death
- General Dynamics Plans 200 New Jobs in N.M.
- Authorities Close to Deal with JPMorgan Chase over Madoff Response
- Harley Issues Motorcycle Recall
- Auto Dealer Builds Big Solar Project