The Regulatory Citation and How It Applies:
“Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for the use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.” [§46.104(d)(6)]
SPECIAL INFORMATION
Taste and food quality evaluation studies conducted under this exemption may not involve the consumption of any type or volume of food that would present any risk to the subjects and should fall into what would be considered reasonable eating behaviors by the subject.
Research involving the consumption of alcohol, vitamins, and nutritional supplements does not qualify for exempt status because these items are not considered “foods.”
This category may be applied to research involving children; however, written parental consent to include children in taste testing studies is required. Inclusion of children in Food Quality and Consumer Acceptance Studies may pose greater than minimal risk to participants and may require Expedited or Full IRB review.
EXAMPLES
- A taste-test on different varieties of a fruit to determine customer preference, when the fruits do not have any additives and subjects are asked to indicate which fruit they prefer.
- A study that involves taste-testing of various beef products from cattle that have been given feed with a chemical additive. If the researcher can document that the amount of the additive was at or below the levels approved by the USDA, the research may qualify for an exemption.
- Consumer acceptance study of various brands of frozen meals that could be readily purchased.