Things to Consider Before Launching a Feed Ingredient in Aquaculture
During the last three decades, world aquaculture production increased more than tenfold, reaching 73.8 million tons in 2014 (FAO 2016). Globally, fish currently represent about 16.6 percent of animal protein supply and 6.5 percent of all protein for human consumption. It is predicted that aquaculture will provide the most reliable and sustainable supply of seafood (i.e., marine-derived food) in the future (Hixson, 2014). However, there are a number of difficult issues associated with producing an aquaculture feed ingredient that is permitted for use in the United States.
Historically, a new feed ingredient may be approved for use via three routes: (1) a food (i.e., feed) additive petition for approval by FDA; (2) a new ingredient definition petition submitted for approval by the American Association of Feed Control Officials (AAFCO) and; (3) the Generally Recognized As Safe (GRAS) process. Regardless of the route, the safety of feed of a feed ingredient must be demonstrated either by the history of use prior to 1958 (in GRAS process) or by scientific procedures (in all three routes). Because the FDA food additive petition route is very cumbersome and lengthy and, because the AAFCO definition route is not compliant with federal law, therefore, in this article, the author will focus on GRAS. The FDA’s final rule on GRAS (including the Center of Veterinary Medicine (CVM)) on how to determine the GRAS status of a feed ingredient was finalized in August, 2016 (Federal Register 81:54960, August 17, 2016).
To demonstrate safety, toxicity tests are required for a GRAS to show that the feed ingredient is safe for the target animal. These tests may include, but are not necessarily limited to: (1) a demonstration of the biochemical fate of a substance; (2) a repeated-dose study, such as a 90-day toxicity study; (3) a possible test for reproductive effects and, (4) most always, tests for genotoxicity and mutagenicity. However, special circumstances must be considered when applying these aforementioned tests in aquaculture.
First, extra stability studies may be required to assess the stability of the ingredient in the feed because, after all, aquaculture diets are consumed in the water not as dry substances in a rodent feeder. Particularly troublesome circumstances are presented by the slow-feeding or bottom-feeding aquaculture species, where the diet pellet must retain its form and nutrient content until the pellet is consumed. For example, it is possible for water-soluble nutrients to dissolve out of the pellet before consumption, preventing the aquaculture animals from accessing all the required nutrients (FDA, 2016).