PENNSYLVANIA FLUOROCARBON CO., INC

it is not an additive and is exempt from provisions of the Amendment. This clause is the basis for FDA's issuance ofGRAS (generally recog- nized as sa...
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REPORT FOR ANALYTICAL CHEMISTS NO MOLDS-NO WASTENO MACHINING

EXTRUDED

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TEFLON SHAPES Reduce Cost of Components for chemical applications

Some of the many shapes extruded by Pennsylvania Fluorocarbon for the chemical and mechanical industries include: fluid separators, feeding tubes for small parts, channels and seals. These shapes offer: • the widest service temperature range of any plastic (-450°F. to + 500°F.) • complete chemical inertness • lowest coefficient of friction of any solid material • very l o w permeability

Extreme Dimensional Accuracy Assured On A n y Appropriate Design PF extruded shapes made from Teflon allow design engineers to incorporate the chemical inertness and low coefficient of friction of Teflon into their products, economically. PF extrudes intricate Teflon shapes to extremely close tolerances, cuts them to lengths, post forms to requirements and performs any auxiliary machining steps. Molds are eliminated, there is no waste of Teflon and, frequently, no additional finishing operations are necessary. Result? Teflon components of extreme accuracy at lower cost. Write, wire or call for a quotation on your particular Teflon component requirements, regardless of the intricacy of the shape. Shapes ranging from 2500 feet per pound to 6 feet per pound can be extruded.

PENNSYLVANIA FLUOROCARBON CO., INC. 1115 N. 38th Street, Philo. 4, Pa. EVergreen 6-0603 TWX: PH 252 *DuPont registered trademark

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Circle No. 7 on Readers' Service Card · ANALYTICAL CHEMISTRY

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$20,000. These are average examples of some of the costs, and they can v a r y widely, depending upon the circumstances of a particular additive. T h u s , extremely large expenditures could be needed to see a project through to filing of a petition with F D A . Regardless of scope, the completed studies will have utilized the services of several scientific disciplines. Analytical chemists, bacteriologists, pharmacologists, physiologists, veterinarians—all these and more m a y be involved. The analytical chemist m a y be called in a t the very beginning when it must be decided whether a particular substance actually is a food additive. H e m a y still find himself involved after the petition has been filed, now defending the analytical procedures he has developed. Between these two extremes there is little likelihood t h a t he will ever be far removed from the over-all project, even with regard to those phases not primarily concerned with analytical chemistry. Direct and Indirect Additives T h e Amendment says t h a t a food additive is any substance which becomes p a r t of a food or which affects the food's characteristics, directly or indirectly. I t then makes certain exceptions. If the substance is generally recognized by qualified experts as having been shown to be safe in its intended use, it is not an additive and is exempt from provisions of the Amendment. This clause is the basis for F D A ' s issuance of G R A S (generally recognized as safe) lists, previously mentioned. If it is a pesticide chemical in or on a raw agricultural commodity, or used for production, storage, or transportation of a raw agricultural commodity, it is regulated under the Miller Amendment and is therefore not considered a food additive as defined. Finally, if the substance has gained approval previously under terms of the M e a t Inspection Act, the P o u l t r y Products Inspection Act, or the Food, D r u g , and Cosmetic Act, it is considered to have "prior sanction" and does not come under the jurisdiction of the Food Additives Amendment. This essentially is the legal defi-

nition of a food additive. There would seem to be little cause for confusion as to whether a given substance is an additive in the eyes of the law. Aside from some initial confusion over the G R A S classification, such is indeed the case where direct additives are concerned. These are deliberately added by t h e manufacturer for a specific purpose—to add flavor, to improve nutrient value, to help preserve the food, or for numerous other reasons. H e knows w h a t he is putting in, he knows w h a t his intended purpose is, and with some degree of effort he can probably become aware of all aspects of the n a t u r e of the substance and devise a method for its rapid determination. T h u s , he can determine quite readily in most cases whether it is legally a food additive; and in planning prerequisite research for filing a petition he has pretty good ideas upon which to base his course of action. N o t so with indirect additives. These are not deliberately added in a t t e m p t s to improve the food's quality and appeal. They just h a p pen to be there as a result of some operation anywhere along the line t h a t stretches from the raw commodity t o the finished, packaged food on the kitchen table. T h i n k of the infinite number of possibilities here. The additive might be a compound formed by a chemical reaction during manufacture. I t might be a substance t h a t has migrated to the food from some factory equipment such as belting or hoses. I t might have migrated from the packaging materials— paper, plastic, cotton, burlap, adhesives, inks, and innumerable others. I t could be a substance which, having been added to boilers to inhibit corrosion, has been picked up by the steam, later to come into contact with the food. I t might be the chemicals put on boxes by fruit pickers to prevent mold, or the fumigant used on flour or dried fruit. I t might result from the drugs used on animals as medical t r e a t m e n t or for promoting growth. These are some of the things t h a t are causing sleepless nights among manufacturers and making analytical researchers out of analytical chemists. The range of possibilities is al-