Document DvMY5wOD08KKRX2DrzNZ1rQ2B

FILE NAME Talc TALC DATE 1975 Mar 17 DOC TALC089 DOCUMENT DESCRIPTION Article from Food Chemical News - FDA Delays Action on Containing Talc in Food me March 17 1975 Page 53 FOOD CHEMICAL NEWS mo FDA DELAYS ACTION ON CONTAINING TALC IN FOOD March 14 said that available information The Food and Drug Administration on talc in foods acknowledging that it will does not warrant a ban on containing delay any action on its pending proposal to institute such a ban See FOOD CHEMICAL NEWS Oct. 1 1973 Page 37 to At the same time FDA withdrew its proposal to tie the generally use of talc in packaging paper and paperboard the absence particles The agency also reaffirmed its decision not to propose of containing filters in food and beverage processing recognized as safe of asbestos limitations on use dealing with asbestos particles in drugs for The agency did issue a regulation discussed at length the comments filed on injection and at the same time FOOD CHEMICAL parenteral with talc in food drugs and in packaging See its propoOscatl.s 2d2eal1i9ng73 Page 18 Dec. 3 1973 Page 2 Dec. 10 1973 Page 3 Dec. and Feb. 18 NEWS 24 1973 Page 20 Jan. 7 1974 Page 30 Jan. 14 1974 Page 30 1974 Page 16 with other agencies extensive experiments FDA noted that it plans in conjunction asbestos fibers represents a definitive to determine if long term exposure to ingested other data are available the hazard to human health Until the study is completed or containing filters in the concluded that a prohibition of the use of agency talc as a food or food processing of food and beverages and oifs cunowanrrtanateidndi uentg o lack of sufficient data additive or in drugs or drug ingredients Industry Investigations Urged by FDA all means of eliminating the use of However FDA urged manufacturers to investigate in formulation and such filters and talc and to keep the FDA informed about changes " processing of this type final regulations for talc until an acceptable As expected FDA decided to delay any be developed for this method for determining the presence of asbestos particles can said it is substance See FOOD CHEMICAL NEWS Feb. 17 Page 32 The agency actively pursuing research on methodology that the designated optical crystallographic method FDA did not agree with comments " but did recognize that an is unreliable when used by those experienced inuttihleityaratnd acceptance than indicated effective compliance method must have greater by the comments on the proposed method Most of those who commented did not actually use the proposed method FDA said or a personal but reflected their general experience with optical crystamleltohgordapwhays supported in none preference for other analytical methods The proposed the difficulty in using the Most expressed objection was a of the comments of one trade association resulted in incon- method A collaborative study by members the method the agency sistent results and four of the ten participants could not use said Page 55 FOOD Page NEWS March March 17 of ash FOOD CHEMICAL CHEMICAL NEWS by the bulk from milk, rice, Although detection detection limited by bulk ash recovered products as fresh was limited packaged macaroni macaroni other such such flakes comment frozen meat products dried and and corn also demonstrated demonstrated these than than p.p.b. asbestos comment of FDA said said the salt represents a practical upper of migration migration Concluding Concluding that upper practical practical to represents asbestos contact paper represents asbestos consideration paper paperboard paperboard explained explained explained that migration as the conclusion conclusion "ag is based consideration extreme abrasive salt to tremolitic other dry foods and unusually the levels high tremolitic asbestos content test ( % compared compared reported paperboard paperboard of use of asbestos on the prohibition delayed promulgation any regulation prohibition of asbestos asbestos can promulgation nonparenteral filters delayed preparation foods and prohibition reliable data data can filters filters for preparation nonparenteral nonparenteral drugs more and obtained on background concentration asbestos drinking water be obtained the addition of asbestos of asbestos filters filters regard regard had decided not to issue a regulation agency stated stated its proposal that it regulation regulation issue governing governing filters in food and beverage Some comments comments governing the use asbestos urged the basis of a beverage processing processing be regulated on lack of the ingestion ingestion use filters of asbestos is safe the ingestion ingestion small amounts that uniform and consistent regulations Commissioner agrees industry basis should be adopted on an method- this the lack of available reproducible method- ology ology determining fibers beverages beverages other foods determining asbestosto propose the regulation regulation of before before handling Commissioner other related matters any event the comment comment handling the Commissioner has decided to delay becomerumloiontg soinnctaelc a direct direct food or ingredient ingredient ingredient a final " municipal or drug ingredient. fibers fibers foods and and available data the addition addition and nonparenteral nonparenteral nonparenteral drugs use asbestos filters the data on the asbestos asbestos controls water are sufficiently sufficiently reliable regulatory regulatory permit permit promulgation controls at time Noting Noting asbestoassbersetloisabcolntenet some municipal watersuppcloimpeasrasbailde the the a Canadian Canadian indicated indicated content beverages beverages comparacbomplaraeble levels areas the asbestos a background of the U. S. Noting levels in areas the contro- contro- demonstrate hazard the methodology methodology ingestion of evidence evidence demonstrate health presented presented ingestion expected OF the nature evidence expected asbestos asbestos fibers normally talc used in food or drugs or food amounts containing talc or in beverages and nonparentera nonparentera drugs prepared drug packaging foods , FDA concluded asbestos filters prepared with concluded concluded -- -~ in drugs or of asbestos filters drugs ... promulgation the use talc the preparation OF asbestos filters for foods prohibition nonparenteral the amount amount preparation nonparenteral nonparenteral nonparenteral nonparenteral drugs which asbestos and drugs drugs which food of asbestos fibers in food and drugs or which asbestos fibers in tale for use