This provision would exempt, for example, facilities that only store whole grains (such as corn, wheat, barley, oats, and soybeans) for animal food from subpart C. This would include facilities such as grain elevators provided that such facilities do not conduct other activities subject to section 418 of the FD&C Act. Outbreaks of illness associated with feeding RACs to animals have not been traced back to storage facilities solely engaged in the storage of RACs. In addition, facilities that are solely engaged in the storage of RACs are exempt from the current part 110 CGMP regulations for human food, and
While outbreaks of illness associated with feeding RACs to animals have not been traced back to storage facilities solely engaged in the storage of RACs,
While the Agency tentatively concludes that animal food facilities such as grain elevators that are solely engaged in the storage of grains that are raw agricultural commodities should be exempt from proposed subpart B and proposed subpart C, the Agency does have some concerns. One of those concerns is the potential for mycotoxins, such as aflatoxins, fumonisins, and DON, to be present in RACs obtained by farms and fed to animals. This concern is largely mitigated for RACs intended for human food because RACs for human food routinely undergo further processing and are rarely consumed in the "raw" state.
Mycotoxins are toxic by-products of mold that can develop in certain agricultural commodities pre-harvest or post-harvest while in storage. Mycotoxins can reduce animal productivity, cause sudden death if fed in large quantities, and can become a component of milk and eggs intended for human consumption.
Mycotoxin contamination varies greatly from year to year and by geographic region of the country, depending on weather conditions that stress crops and predispose to mold growth. In regions of the country where conditions tend to favor mold growth, grain elevators and other buyers routinely monitor for this hazard and turn away producers whose crops exceed
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