GAO urges final decision on saccharin safety The Food & Drug Administration should either determine that saccharin is safe to be used in food or ban its use. This recommendation by the General Accounting Office is characteristic of the hard times that have fallen on artificial sweeteners: Cyclamates were banned in October 1969, approval of aspartame use was stayed in December 1975 pending the results of further studies, and others are still in the experimental or developmental stage. 50% of the saccharin consumed in the U.S. is produced by Sherwin-Williams, and the remainder is imported from Japan and Korea. About 75% of the sweetener goes into diet soft drinks. In February 1972, FDA issued an interim regulation allowing the continued use of saccharin in food for a "limited time." The agency did not specify the time limit but cited the two studies that triggered its ruling. Both studies, one completed in England in 1957 and another completed at the University of Wisconsin in 1970, found that mice developed a significant incidence of bladder tumors after saccharin pellets were implanted in their bladders. FDA then asked the National Academy of Sciences to look into the matter. NAS said in December 1974 that "existing studies had not established conclusively whether saccharin is or is not carcinogenic
when administered orally to test animals. . . . Tests for carcinogenic effects by implanting pellets into the bladder have no known relevance to the safety of saccharin consumed orally." It then recommended a series of studies to resolve the question of whether the sweetener is safe in the. human diet. GAO finds that the studies have been under way, and are conducted by the health protection branch of the Canadian government. The agency understands that the Canadians won't be finished with
their studies until mid-1978, six years from when FDA issued its interim regulation. GAO says that allowing an interim regulation to remain in effect for so long when safety has not been conclusively established could expose the public to unnecessary risk. The studies recommended by NAS were to include an epidemiologic survey relating the incidence of cancer with the long-term consumption of saccharin, investigation of the toxicologic significance of impurities in commercial saccharin preparations, and study of the changes in urine composition at high levels of saccharin intake and the relation of such
Biggest market by far for saccharin is diet soft drinks
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Identity H2S COS CH 3 SH CH 3 CH 2 SH CH 3 CH 2 CH 2 SH
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Peak 1 2
Identity H2S
2
S02
3 4 5
CH 3 SH DMS DMDS
Identity H2S S02
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Sept. 27, 1976 C&EN
13
changes to the induction of bladder stones. They also were to include inves tigation of the question of transplacental carcinogenesis of saccharin and its im purities, and comparative studies of the role of bladder stones and parasites in the induction of bladder tumors in lab ani mals. GAO further finds that the level of saccharin allowed in food under the in terim regulation is based on a safety factor of 30 to 1, rather than the 100 to 1 factor normally allowed by the agency. (A safety factor of 100 to 1 means that the additive in food will not exceed Viooth of the max imum amount demonstrated to be with out harm to test animals.) And GAO finds that o-toluenesulfonamide, an impurity with a chemical structure similar to known carcinogens, is permitted in saccharin at levels much higher than the lowest level practically achievable under present manufacturing technology. Originally, FDA had set the level at 100 ppm based on what industry was capable of. But, says GAO, technology advancements have since made it possible to reduce the level to less than 50 ppm and as low as 1 to 3 ppm. FDA should immediately re-evaluate the justification for saccharin's continued use, GAO concludes. If continued use is justified, FDA should consider the need to hike the safety factor and to reduce the permissible level of o-toluenesulfonamide to the lowest level achievable. D
NEW!
Federal Alert— new legislation This C&EN report covers new legis lation introduced between July 27 and Sept. 15. Senate and House bills are listed under areas of interest by bill number, primary sponsor, and the committee to which the bill has been referred. SENATE
ON TAPE ACS CENTENNIAL GALA Featuring Linus Pauling—
Energy. S. 3749—Nelson (D.-Wis.). Autho rizes study by USDA of anaerobic digestion technology; would pay farmers with holdings of less than 640 acres up to $5000 for con struction and operation of various types of convertors; referred to Agriculture & For estry. Environment. S. 3764—Moss (D.-Utah). Sets deadlines for preparation and issuance of environmental impact statements—one year for draft EIS, followed by 120 days for comments and issuance of a final EIS. Fed eral agency involved then has 30 days to approve or deny project for which EIS was prepared; referred to Government Opera tions. S. 3820—Pearson (R.-Kan.). Requires manufacturers to label aerosol products with warning stating that halocarbons used as propellants may be harmful to environment and to health; referred to Commerce.
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C&EN Sept. 27, 1976
Antitrust. H.R. 14980—Moakley (D.-Mass.). Prohibits petroleum companies engaged in production, transportation, refining, or mar keting of petroleum assets from controlling any interest in another aspect of petroleum industry; referred to Judiciary. Employment. H.R. 15040—Abzug (D.-N.Y.). Directs heads of EPA and the Nuclear Reg ulatory Commission to investigate com plaints alleging employment loss as result of imposition of federal environmental or nu clear regulatory standards, and authorizes payment of unemployment benefits in such cases; referred to Ways & Means. Energy. H.R. 15359—Fraser (D.-Minn.). Di rects ERDA to prepare series of projections on consequences of phaseout or reduction in nuclear power development; referred to Atomic Energy and to Science & Technolo gyEnvironment. H.R. 14946—Lehman (D.Fla.). Authorizes setting of increased penalties for discharges of oil and hazardous substances under Federal Water Pollution Control Act; referred to Public Works & Transportation.
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H.R. 14965—Brown (D.-Calif.). Amends Solid Waste Disposal Act to authorize addi tional R&D activities, coordinated by new EPA intra-agency committee, lists specific areas as subjects for detailed reports; re ferred to Science & Technology.
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Safety. H.R. 14907—Beard (R.-Tenn.). Provides that any employer who successfully contests a citation or penalty imposed under Occupational Safety & Health Act shall be awarded a reasonable attorney's fee, other reasonable litigation costs; referred to Edu cation & Labor.
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