Use of Blending as a Method to Bring Filth Content Within Defect Action Levels: An Idea Whose Time Has Come?

Abstract

This paper begins with a brief discussion, for illustrative purposes, of the evolution of regulations for reconditioning in the food salvage industry, and present requirements for reconditioning adulterated food. It then describes the current FDA policy with regard to blending, and the theory behind the prohibition of this particular method of reconditioning adulterated food. Part B shows the application of the rule against blending to individual cases. It begins with several cases in which the general rule was followed and blending was not allowed. It then dexcribes a case in which FDA discretion to prohibit blending was questioned in the context of exports. Part C describes a situation which occurred in the late 1970s, when corn produced in the southeastern part of the country became widely contaminated with aflatoxin, a carcinogen. FDA made an exception to the blending policy in the aflatoxin case, allowing contaminated corn to be blended with pure corn for feeding to animals. This ignited a controversy which still exists today. Part D takes a more detailed look at the increasing controversy over the blending policy, and its effect on the perception of FDA regulations. Courts have concluded that FDA has the power to grant such exceptions, but the prospect of case by case analysis has prompted strenuous arguments for change. Some have called for an end to DALs, or at the very least some clarity as to the meaning of compliance guidelines. Others have argued that regardless of whether FDA's power to grant exceptions in individual cases may be deemed arbitrary, it may be more important to look at procedures for blending so that food will not be wasted when so many are starving around the world.