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HRD-78-9 1 (1977-11-02)

handle is hein.gao/gaobaawfh0001 and id is 1 raw text is: DLCUNEIT RESUME /-ci'7 04045 -- [B30743273 Food Additive. Acrylonitrile, Banned in Beverage Containers. 4RD-78-9; B-164031(2). Noveaber 2# 1977. Released November 9, 1977. 17 pp. Report to Rep. Toby Moffett; by Paul G. Dembling, Acting Comptroller General. Issue Area: Food (1700) ; Consumer and Vorker Prtection: Safety of Food Additives (905). Contact: Human Resources Div. Budget Function: Health: Preventj.oa and Control of Health Problems (553). Orqanization Concerned: Food and Drug Administration. Congressional Relevance: Rep. Toby Moffett. Authority: Food, Drug, and Cosmetic Act, as amended; Focd Additives Amendment of 1958 (21 O.S.C. 348). 21 C.F.B. 170.3(e). 21 C.F.R. 170.22. Acrylonitrile is a volatile, clear liquid, which c.-n be formed into more complex compounds known as polymers that are used to make various plastic articles. Beverage bottles made of acrylonitrile copolymers are lightweight, do not cause injury if broker,, and are, therefore, desirable to consumers. A characteristic of such bottles, however, is that afte,. polymerization, a small anoant of -residual acrylcnitrile that has not combined with other monomers remains in the plastic and may become part of the substance in the bottle. Some acrylonitrile copolymers also depolymerize tc some ext4ent, allowinq additional acrylonitrile to migrate to the rood. Findings/Cunclusions: In January 1977, Food aLd Drug Administration (FDA) officials decided that the use cf acrylonitrile in making plastic bottles for carbonated beverages and beer should be banned avd that all other acrylcnitrile uses should be restricted to a maximum petissible migration level off 0.05 ppm. on March 7, 1977, Monsanto Coapaay filed a moticu in the U.S. court of appeals requestinq a review of FDA's suspension of its regulati-n authorizing the use of acrylonitrile in bottles intended to hold soft drinks. In its notion, Monsanto Company maintained that PEA had not followed the procedures required by section 4C9 of the Federal Food, Drug, and Cosmetic Act in suspending the regulation. The primary issue of this motion was whether FDA could remove a previously lawful product from the market without notice and opportanicy for affected parties to contest the action. The ccurt ordered that FDA's suspension of the regulation be lifted until Kay Ia, 1977, and that FDA hold the required public hearing Froaptly. The outc*me was that acrylonitrile copolymers used to takricate beverage containers were judged to be food additives Ln1 were not safe for use in food. FDA terEinated all regqlations that permit acrylonitrile in beverage containezs. (SW)

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