FDA indecision on additive criticized - C&EN Global Enterprise (ACS

Nov 3, 1975 - The General Accounting Office has charged that the Food & Drug Administration is exposing the public to unnecessary risks by permitting ...
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Tunney: mountain of testimony

nomic impact than the original bill. This is because "sweeping, discre­ tionary powers" given EPA include a mandate to list not less than 300 chemical substances (other than new chemical substances) with the highest priority for testing. Dominguez also detailed the findings of an industry-sponsored survey conducted by Foster D. Snell Inc. that indicates that, de­ pending on how EPA interprets the law, cost to the chemical industry could range from $358 million to $1.3 billion. This probably came as no surprise to the two subcommittee members at the hearing—Sen. Tunney and Sen. Wendell H. Ford (D.-Ky.)—or the subcommittee staff. MCA had submitted copies of the Snell report to the subcommit­ tee months ago and presented the study's findings at a House hearing on toxic substances. D

FDA indecision on additive criticized The General Accounting Office has charged that the Food & Drug Administration is exposing the public to unnecessary risks by permitting the continued use of Red No. 2, a food color additive. And GAO recommends that the Secretary of Health, Education & Welfare direct the FDA Commis­ sioner to either establish the safety of the additive or prevent its use in food, drugs, and cosmetics. Red No. 2, according to GAO, has been shown to cause cancer, fetal deaths, and chromosome changes in test animals. Generically known as amaranth, the dye is used to improve the appearance of a number of items, including hot dogs, ice cream, and candies. In 1973 about 1.1 million lb, valued at $2.9 million, were sold in the U.S. Under 1960 amendments to the

Food, Drug & Cosmetic Act, con­ tinued use of commercial color additives was permitted until their safety could be reviewed and regu­ lations issued for their use. All reviews were to be completed by January 1963. Extensions were to be permitted only for completing scientific investigations of a sub­ stance's safety. However, GAO points out, a final determination on Red No. 2's safety has been delayed 14 times in the past 12 years at the requests of manufacturers or industry asso­ ciations. In some cases, GAO says, these requests did not say what in­ vestigations were being conducted or when they would be completed. These delays, GAO says, oc­ curred in spite of FDA's concern about the safety of the additive. In July 1972, FDA published a pro­ posal that would have reduced substantially human exposure to the additive. But as of September 1975, this proposal still had not been acted on. FDA now says, in response to GAO's findings, that its evaluation of existing data in­ dicates that Red No. 2 poses no risk to consumers and that there is no evidence that it causes cancer in humans or poses a risk to de­ veloping babies. But FDA still has not made any move to officially recognize Red No. 2 as safe. FDA agrees with GAO that a final determination should be made whether the additive should be listed permanently as an acceptable food color additive. To this end, it has referred all data on the additive to a newly formed toxicology ad­ visory committee that will begin an independent evaluation of the data Nov. 21. FDA, by law, must report in writing to the House and Senate Government Operations Commit­ tees on what actions it has taken in response to the GAO recommenda­ tion no later than January 1976. D

FMC wants to sell its fiber operations FMC's agony in synthetic fibers, principally rayon, may be coming to an end. After several years of at­ tempting to stimulate performance in this area with a mixture of prun­ ing and new investment, the com­ pany finally has decided to try to sell the business. In the company's otherwise favorable third-quarter earnings report last week, chairman Robert H. Malott put fibers up for sale. "As part of FMC's program to re­ deploy capital to those operations

of the company having the highest growth potential for FMC, the com­ pany intends to explore the possi­ bility of selling its fiber division. Although the company will consider offers and will be contacting pro­ spective buyers, there are no nego­ tiations now in progress. It is our objective to sell the division as an operating unit to a purchaser who will continue the division's opera­ tions and maintain its employee and customer relations." FMC's fibers history has been one of a brief success and a subsequent long decline. After acquiring in 1963 American Viscose, the domi­ nant U.S. rayon producer, FMC cashed in handsomely for four years. The new division's cash flow fully repaid the initial investment dur­ ing this period. But beginning in 1968, fibers per­ formance began to deteriorate. Re­ turns declined to very low levels and then sank into the red in 1974. That year, fibers lost $17.2 million after taxes on sales of $317 million (15% of the company's total sales of $2.07 billion). This year, fiber sales are down about one third to $152 mil­ lion through three quarters, yield­ ing an after-tax loss of $4.8 million. The major headache in FMC's fibers operation is rayon. FMC dominates rayon staple, the princi­ pal remaining product form with over half the industry's capacity. Al­ though rayon staple shipments have risen steadily in recent months, this fiber is still far worse off than most other fibers. Rayon staple ship­ ments now are only half their vol­ ume of early 1974. Besides rayon staple, FMC pro­ duces small amounts of rayon tire cord, polyester filament and staple, cellulose acetate filament, and vinyon staple. Book value of FMC's total fibers operations was about $120 million as of September. α

Joint environment project going well Cooperation between the U.S. and the U.S.S.R. in environmental pro­ tection has "produced dramatic re­ sults and promises to produce even more" since the cooperation began in May 1972. So said Environmen­ tal Protection Agency Administra­ tor Russell E. Train at the opening of the fourth annual meeting of the U.S.-U.S.S.R. Joint Committee on Cooperation in the Field of Envi­ ronmental Protection last week in Washington, D.C. Train and academician Yuri A. Izrael, head of the HydrometeoroloNov. 3, 1975C&EN

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