at deciding on a few of the most promising 

 processes and developing these through the experi- 

 mental stage into pilot production. The purpose of 

 the exercise was to develop processes and engi- 

 neering designs sufficiently detailed to permit 

 private enterprise to undertake commercial pro- 

 duction with no more than the normal business 

 risks associated with a new product. 



Unfortunately, progress has been slowed by a 

 series of disputes and misunderstandings. Coopera- 

 tion between the commercial developer of FPC 

 and the Bureau's staff was less than ideal; and both 

 were hampered severely by the intransigent atti- 

 tude of the Food and Drug Administration toward 

 fish protein concentrates made from whole fish. 



After a long series of meetings, agreements, and 

 formal actions, during which the developers of 

 FPC met one objection by FDA after another, 

 approval was granted to both the private firm and 

 the BCF for commercial production with their 

 respective processes. But this approval was tied to 

 a requirement that the product could be sold in 

 the United States only in one pound packages for 

 home consumption. 



The panel does not propose to pass judgment 

 on the basis for this decision; it can only point out 

 the effect of it. We now allow agencies of the 

 United States to use fish protein concentrate for 

 direct human consumption in public health pro- 

 grams outside the United States while continuing, 

 for all practical purposes, the prohibition on its 

 use for these purposes within the United States. 

 No one can say with certainty that there exists a 

 substantial market for fish protein concentrate in 

 the United States. There has been enough ex- 

 pression of interest by food manufacturers to 

 warrant the conclusion that the market should be 

 tested, in the traditional fashion, by allowing food 

 producers to use it in any way they see fit, as long 

 as the strict Food and Drug Administration re- 

 quirements with respect to process and product 

 are adhered to rigidly. There can be no doubt that 

 the speed with which the necessary technology, 

 marketing techniques and channels, and families of 

 end products and processes will be developed by 

 industry is materially reduced by this restriction 

 on package size. 



The most important use for fish protein con- 

 centrate will doubtless be as a dietary supplement 

 in areas where proteins in general, and animal 



proteins in particular, are chronically below mini- 

 mum nutrition requirements. Unfortunately, these 

 are the very low income areas where sophisticated 

 market development techniques and organization 

 are scarce, and where demand for "medicine" is 

 particularly difficult to develop. It is likely, 

 therefore, that for some time to come, the product 

 must perform its very promising role in alleviating 

 protein malnutrition on an institutional basis, with 

 primary financial support from recipient govern- 

 ments and the United States. This does not, 

 however, rule out the need for careful studies of 

 socioeconomic conditions in the needy countries 

 that bear on dietary habits and marketing arrange- 

 ments. It is vital to the success of any major use of 

 FPC as a pubUc health measure that the best use 

 be made of existing institutions, both Government 

 and private business. 



Pressure to undertake this worthwhile inter- 

 national program has resulted in commitments 

 that may be very difficult to meet. Neither the 

 commercial firm nor the BCF have yet resolved all 

 the technical problems that must be settled before 

 commercial production can be undertaken at 

 prices that would make FPC attractive relative to 

 other protein additives. Both processes still require 

 the development of some technique for efficient 

 recovery of the solvent used; otherwise, the cost 

 becomes prohibitive. It is likely that such a system 

 is in sight. In addition, both of the methods 

 approved thus far by the Food and Drug Adminis- 

 tration involve denaturation of the protein to an 

 extent that limits the functional properties of the 

 resulting product. This means, in turn, that the 

 flexibility with which fish protein concentrate can 

 be blended with formulated foods is reduced 

 substantially. 



Neither of these limitations constitutes an 

 insuperable barrier to the widespread use of fish 

 protein concentrate. It does mean, however, that 

 the starvation budget provided to the BCF pro- 

 gram for FPC must be supplemented sufficiently 

 to permit completion of the projected pilot plant, 

 resolution of the solvent recovery problem, and 

 effective transfer of the whole body of informa- 

 tion to private firms for commercial production. 



There is also urgent need for adequate funding 

 of work required to adapt the process to fatty fish, 

 since a majority of the very cheap and abundant 

 species that will eventually form the backbone of a 



VII-59 



