356 



Register of February 2, 1967 and is herewith attached to this appendix as 1. A 

 typical sample contains the following major components : 



Protein, 75 to 85 percent. 



Fat, 0.3 to 0.5 percent. 



Ash, 9 to 15 percent (mostly calcium and phosphorus). 



Carbohydrates, 0.1 to 0.4 percent. 



II. SPECIFICATIONS WAIVED 



The AID procured FPO is subjected to rigid inspection and conforms to all but 

 two provisions of the above mentioned regulations. These concern packaging and 

 fluoride level (refer to Sections 121.1202(c) (6) ; (d) ; (e) ; (f ) (2) ). Specifically, 



A. The requirement for packages not to exceed one pound net weight reflects 

 a domestic matter, does not relate to any public health aspect, and is not germane 

 or pertinent to overseas use. 



B. The FDA requirement for fluoride level is a maximum of 100 ppm. AID has 

 set, after consultation with experts, a permissible maximum fluoride level of 

 250 ppm. 



III. BACKGROUND ON FLUORIDE CHANGE 



The level of 100 ppm of fluoride, which can be attained only by expensive 

 deboning, was determined administratively by the FDA on the basis of a possible 

 cosmetic affect from long-term feeding of high levels of FPO. There was no 

 concern about any possible toxic effect. 



If a child is fed FPC as 10% of its total protein intake daily from the age of 

 six months to 12 years, and assuming a level of 250 ppm of fluoride in the FPO, 

 the amount of available fluoride ingested per day during this period will be from 

 3 to 5 mgs per day. At this level of intake, there may be some slight mottling of 

 teeth after several years continuous feeding. The letter from the Food and 

 Nutrition Board of the National Research Council attached to this appendix as 2 

 summarizes the opinion of a special expert committee ; namely, that as much as 

 8 mg. of fluoride per day for a life time will have no serious effect, and on the 

 contrary may be regarded as beneficial. 



IV. A LEGAL REQUIREMENT 



Despite the lack of hazard associated with these changes the fact that they differ 

 from the FDA standard necessitates that in any country in which the FPC will 

 be used, A.I.D. must ascertain that written approval has been obtained from the 

 appropriate Ministry before shipment can be made. 



V. USE OF FPC IN FOODS 



FPO can be added to a variety of foods. The amount needed to supplement a 

 protein deficient diet depends ui)on the composition of the diet itself. In general, 

 an inclusion of 10-20 grams of FPO per day will greatly improve the quality of 

 the diet. 



Adding FPO at levels of 5-10% of the flour used in cereal foods and at similar 

 levels in other food, has no discernible effect on flavor and texture. FPC fortifica- 

 tion recognizes the persistence of food habits and is used only to improve food 

 nutritionally while at the same time retaining the conventional taste, color, and 

 textured qualities of the food fortified. 



Some examples: 



(A) Pasta products. — ^All forms of pasta products, spaghetti, macaroni and 

 noodles, etc., can be supplemented with FPC. The proportion of FPC to flour per 

 kilogram of mixture is given in the following table : 



[in grams] 



