I I. ’,,"" g . }, V ' 1?-. . —-LJ I’? i’ g _kV L W) ..— ‘<32. , A LC 2+ 7*!‘ 1: "J :15"! ‘ .' )3 , ‘ _' \ ~»k_' A ‘\.-""11 5 M: x-4 ‘5U’-r I-«.1 QA“‘I4;K;¥ a mum souri - C “" ||l||,1i;|'iU|’|i 2 1 I111» % . . T Universit s llllllllllllllil I; [I SEARCH SERVICE’ ~ °‘°' ° 35 LIBRARY OF‘ CONGRESS . SRCCHARIN: THE PROPOSED BAN ISSUE BRIEF NUMBER IB77038 AUTHOR: Knisbacher, Sandra Science Policy Research Division Dodge, Christopher H. Science Policy Research Division THE LIBRARY or cousnrss CONGRESSIONAL RESEARCH SERVICE MAJOR ISSUES SYSTEM If DATE ORIGINATED ggggggzz DATE UPDATED Qsgggggg FOR ADDITIONAL INFOBHATION CALL 287-5700 0325 no’2":~ U 1‘ N n. '2 f .9. C I A Y . xv-ah»: .3 ». ,- I _ov a‘- 7.‘ I - ' . 3 ‘ ‘. _. J ?€tfiW fiflf ;r?a;w*n§a ‘ vs: ‘ ' ' "-__~ '1 ' ‘T " _ J 9.? ~ -'¥"*. «:7, -.\_- .1 - An :~.Z£f\r,;e . ., ~ 21'?‘ I ;"' :~T.‘>..».£»:5! 1-1. 3 ‘ ‘*4. -: ‘. ,_t‘oT« ';i;;f .: 7 . ".11.; £L;‘:.1 "'“‘E.I . 5 .3 '12} ‘S L".'} F‘ ffm3;TIQfifi 90% ' 30 L"; 7 'Q’'_';;_, L V <7? 39». f ‘r CRS- 1 IB77038 UPDATE-03/24/80 ‘§§Q§_2§§lEl-lQE There are approximately 1,100 food additives and no color additives regulated for direct addition to food under requirements of the 1958 Food Additive Anendnent to the Food, Drug, and Cosmetic Act. Because of the safety and anti-cancer clauses in the act, the Food and Drug Administration (FDA) is required to ban fro: commerce any food additives found to be carcinogenic in animals or humans or otherwise harmful to health.- Under the general regulations, a number of additives and colors, and more recently, cyclanates and the food color Red Dye No. 2, were banned. Host recently, the artificial sweetener, saccharin, has been found to cause cancer in certain animal experiments and is therefore being considered by FDA for removal from the narket under the anti-cancer clause of the act. Because saccharin is used by millions of diabetics and overweight persons, the issue of anti-cancer clauses in the Food, Drug, and Cosmetic Act is being re-examined to determine whether the total prohibition of saccharin or other food additives found to cause cancer in animals is in the best public interest. l About 1,800 chemicals are added routinely to manufactured food for ‘a variety of reasons. At the present time, there are approximately 1,100 food additives and.flO color additives regulated for direct addition to food under the Food, Drug, and Cosmetic ‘Act. A "food additive" is defined as :a substance or mixture of substances, other than food itself, which is present A food for purposes of production, processing, storage, or packaging. ‘A "color additive“ is a substance which is added to food to make it more attractive to»consumers. 1 El§£Q§X The history of food and food additive regulation is extensive. The Food and Drugs Act of 1906 contained one provision relating to food safety. Sections? of the act provided that food was deemed adulterated, "if it contains any added poisonous or other deleterious ingredient which may render such article injurious to health." r , i As enacted in 1938, the amended Federal Food, Drug, and Cosmetic Act contained food safety provisions sinilar to those in the 1906 Act. Section ,402(a)(1) stated that a food shall be deemed to be adulterated: “if it contains any poisonous or deleterious substance which may render it injurious to health, but in case the substance is not an added substance, such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to the health.“ A This provision has not been anended since 1938. The 1938 act also added a A new provision designed to permit the establishment of tolerances for added poisonous or deleterious substances in food which cannot be avoided as long as such tolerances protect the public health. Finally, the Act also contained a new provision requiring premarket reviews to establish the safety cns- 2 1377033 venue-03/24/so \of any new drug prior to its marketing. Although the provision did not apply to food generally, it did apply to‘new animal drugs for use in food-producing animals. ; In 1958, the Food Additives Amendment to the Food, Drug, and Cosmetic Act, which included the "Delaney" anti-cancer clause, was passed. The 1958 Food Additives Amendment recognized three basic classes of food additives: (1) Those generally recognized as safe (GRAS)--there are 600 or more substances in this class, including salt and sugar, many of which are now undergoing review; (2) food additives with prior sanction (those approved prior to 1958); and (3) new food and color additives. Overall, food additives are. classified into chemical or functional groupings. They may also be classified as intentional or unintentional additives. ; On only two occasions since 1958, when it became law, has the Delaney anti—cancer clause been invoked by the Food and Drug Administration. In both cases, the action was taken against a chemical used as a component of food packaging adhesives. Nonetheless, new and sophisticated technologies and methodologies for determining the carcinogenic properties ,of chemicals increase the likelihood that certain additives now on the market may be determined to be carcinogenic under certain laboratory conditions. Under present law, such a determination would require the ban of such a substance from the market. The Federal Food, Drug, and Cosmetic Act now contains three anti-cancer clauses. Section u09(c)(3)(A) of the Act, as added by the Food Additives Amendment of 1958 and amended by the Drug Amendments of 1962 states: A 1 "Provided," That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or 0 A animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal, except that this proviso shall apply with respect to the use of a substance as an ingredient of feed for animals which are raised for food production if the Secretary finds (i) that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and (ii) that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsections (f) and (g) in any edible portion of A such animal after slaughter or in any food yielded by or ; derived from the living_animal.)" A ’ \ Section 706(b)(5)(B) of the Act, as added by the Color Additives Amendment of 1960 and anended by the Drug Amendments of 1962, states that: 3 "A color additive (i) shall be deemed unsafe, and shall not be listed, for any use which will or may result in ingestion of all or part of such additive, if the additive is found by the Secretary to induce cancer when ingested by man or animal, or it is found by the Secretary, after tests which are appropriate for the evaluation of safety of additives for use in food, to induce cancer in man or animal, and (ii) shall be deemed unsafe, and shall not be listed for any use which will not result in ingestion of any part of such additive, if, after tests which are appropriate for I’ cns- 3 11377033 UPDATE-03/zu/so the evaluation of the safety of additives for—such use, or after other relevant exposure of man or animal to such additive, it is found by the Secretary to induce cancer in man or animal: "Provided, That clause (i) of this subparagraph (B) shall not apply with respect to the use of a color additive as an ingredient of feed for animals which are raised for food production, if the Secretary finds that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsection (d) in any edible portion of such animals after slaughter or in any food yielded by or derived fro: the living animal." Finally, section 512(d)(1)(H), as added by the Animal Drug Anendnents of 1968, states that a new animal drug application shall not be approved if: A “such drug induces cancer when ingested by man or animal, or, after tests which are appropriate for the evaluation of the safety of such drug, induces cancer in man or animal, except that the foregoing provisions of this subparagraph shall not apply with respect to such drug if the Secretary finds that, under the conditions of use specified in proposed labeling and reasonably certain to be followed in practice (i) such drug will not adversely affect the animals for which it is intended, and (ii) no residue of such drug will be found (by methods of exauination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsections (c), (d), and (h), in any edible portion of such aninals after slaughter or in any food yielded by or derived from the living aninals.)" These three provisions were enacted by the Congress with the intent of enhancing the safety of the Nation's food supply. F » F B.§E§Ei.'éZ-§A§.1!.32.A22Z.'L'I. V......E5 Although other additives have been banned under the provisions of the Act, two aajor events which have recently involved the banning of food additives are briefly reviewed. a F QI§;§!Qg§§; In October 1969, the Food and Drug Administration announced that, one the basis of a deternination of carcinogenicity‘ in aninal experinents, cyclaaic acid and its salts could no longer be used int food. Because the cyclanates had been used on the basis of a deteraination by the Food and Drug Administration that they were generally recognized as safe i(GRAS), and thus the anti-cancer clause was not applicable, this action was taken under the general safety provision of the law and not under the " laney" clause of the Act. Recently, the FDA has ibeen petitioned to reverse this decision on the basis of new data which do not support earlier claims of carcinogenicity. 9 CRS- n 1377033 UPDATE-O3/24/d0 ggg_p1g_§9;_g; In the 1960s, the Soviet Union banned the food color Red Dye No. 2. other countries, including West Germany, subsequently limited its use to certain foods. The World Health Organization in 1972 recommended limitations so strict that they would have eliminated normal use of the dye. In the late 1960s, three Russian studies, which are still regarded somewhat controversial, strongly implicated Red Dye No. 2 as a “carcinogen or medium strength" and as a substance toxic to the gonads, and possibly to embryo as well, in rat experiments. The Russian finding contradicted earlier iexperimental findings from FDA. Subsequently, attempts were made in FDA: laboratories to determine the credibility of the Russian findings. The new" findings did not entirely support theRussian ones, but indicated that Red Dye Ho. 2 might be selectively carcinogenic in female rats. Although’ the newest FDA findings had a low confidence level, FDA came under heavy public pressure to ban the dye. It was finally banned on Feb. 12, 1976. The edye Red No. 40, which has been used to replace Red Dye Ho. 2, is now under scrutiny as a possible carcinogen. At the time of its ban, Red, Dye No. ;2 sales annually amounted to more than $4 million dollars and it was used in about $10 million dollars worth of food products each year. 4 \ 2EQEQ§§2_AQllQE§ gagghagigp This non-caloric sweetener was first discovered in a Johns Hopkins University laboratory in 1879 and thus has been known for almost 100 years. Almost immediately after its discovery, saccharin (chemically, 2, £3 dihydro-3 oxobenzisulfonazole) was the subject of scientific scrutiny for safety. In 1912 (during the Taft presidency), saccharin was banned from, use in foods. During World war 1, reduced sugar supplies prompted the lifting of that saccharin ban. In 1925, after a lengthy lawsuit, saccharin was once again allowed in foodstuffs. Questions about saccharin safety have continued and numerous scientific "blue ribbon" panels in 1911, 1955, and 1974 recommended maximum daily limits. Thus, in a broad overview of saccharin evaluation up to 1977,y one finds its safety has been investigated frequently, "challenged" a few times, I n and banned once for several years. _ ; \ 2 on Mar. 9, 1977, the Food and Drug Administration made an announcement on its intention to ban saccharin, as follows (in part): I "The Food and Drug Administration today announced it intends to prohibit use of saccharin in foods and beverages because the artificial sweetener has caused malignant bladder tumors in test animals. "saccharin is the only artificial sweetener currently approved for use in the United States. At least five million pounds a year are used in food, about three-quarters in diet sodas and the remainder in dietetic foods and as a table top sweetener in place of sugar. "The decision to prohibit use of saccharin was taken after careful consultation with the Health Protection Branch of the Canadian government. The action is based on two factors: - A study sponsored by the Canadian government showed that saccharin, when fed in high doses to rats, caused CRS- 5 IB77038 UPDATE-03/2%/30 malignant bladder tunors. FDA obtained preliminary results of the study at a meeting March 7 in Ottowa with Canadian scientists. Canada is taking action similar to that being announced by FDA. - The so-called Delaney Clause of the Food, Drug and Cosmetic Act prohibits the use in food of any ingredient shown to cause cancer in animals or man. "The law is clear. It says that no ingredient that causes cancer in nan or animals nay be added to our food supply.” "Science and law dictate that saccharin be reaoved from our food supply. » - 9 1 ‘ A "saccharin has been in use for more than 80 years and has never been known to harm people, and since the Canadian , data do not indicate an inmediate hazard to public health, we do not consider the recall of existing products to be necessary. We, nevertheless, encourage manufacturers to discontinue use of saccharin as soon as possible, even while we are drafting the documents neede to accomplish this action.” On Apr. 1a, 1977, the FDA issued a detailed plan for ending the use of ysaccharin as a general purpose food additive. The proposal.included banning its use in foods and beverages, cosmetics likely to be ingested, and as fa nonvnedical ingredient in drugs- Also proposed was the cntinued marketing of saccharin as a single-ingredient drug for use by diabetics and others who . ad to restrict their sugar intake for medical reasons. These proposals were published in the Apr. 15, 1977, Federal Register. ‘ EEQIS AEIQE The Departnent of Agriculture and related agencies appropriations bill for 1978. on June 21, 1977, the House, in passing H.R. 7558, agreed to an amendment introduced by Rep. Volkner prohibiting the use of funds to inplement a ban on saccharin for the next 15 nonths. On June 23, 1977, the Senate Appropriationsi Committee rejected the Volkner anendnent before reporting the bill to the full Senate (S.Rept. 95-296). The measure passed the Senate, amended, on June 29, 1977. Both Houses agreed to the conference report on July 29, 1977, and the measure was signed by the President on Aug.’ 12, 1977. _P.L. 95-203 (5. 1750) ’ Anends the Public Health Service Act" and the Federal Food, Drug, and Cosmetic Act, as amended,’ to conduct studies concerning toxic and carcinogenic substances in foods, to conduct studies concerning saccharin, fits impurities and toxicity and the health benefits, if any resulting from the use of nonnutritive sweetners including saccharin; to prohibit the S :retary of Health, Education, and Welfare from taking action with regard to saccharin for eighteen nonths, and to add additional provisions to section 403 of the Federal Food, Drug,‘ and Cosmetic Act, Has anended, concerning aisbranded foods. Introduced June 23, 1977; referred to the Committee on cns- 6 I-B77038 UPDATE-03/2a/30 Hunan Resources. Reported to the Senate from the Committee on Human Resources (s.Rept. 95-353) on July~19, 1977. Reported to the Senate from the Committee on Commerce, Science and Transportation (S.Rept. 95-369) on July 27, 1977. Passed Senate on Sept. 15, 1977. Passed the House Oct. 17, 1977. in lieu of H.R. 8518. Signed into law (P.L. 95-203) Nov. 23, 1977. H.R. 11 (Foley) Amends the saccharin Study and Labeling Act to extend from 18 to 36 months the period during which the Secretary of Health, Education, and Welfare nay ‘not take specified actions to restrict the continued use of saccharin or of any food, drug, or cosmetic containing saccharin. Introduced Jan. 15, 1979; referred to Committee on Interstate and Foreign Commerce. ” = H.R . 12 (Foley) Amends the Federal Food, Drug, and Cosmetic Act to repeal the blanket prohibition against regulations deeming safe and cancer-inducing food additives or color additives in food, drugs, or cosxetics. Abolishes the advisory committee of experts established to review regulations disapproving pcolor additives as cancer-inducing. Introduced Jan. 15, 1979; referred to, Committee on Interstate and Foreign Commerce. H.R. 1509 (Glicknan et al.) Amends the saccharin Study and Labeling Act to extend the period during. which the Secretary of Health, Education, and welfare is prohibited from taking certain actions restricting the continued use of saccharin as a food, drug, or cosmetic. Introduced Jan. 25, 1979; referred to Comnittee on Interstate and Foreign Commerce. 1 H.R. 1819 (Satterfield) Amends the Federal Food, Drug, and Cosmetic Act to broaden the discretioni of the Secretary of Health, Education, and Welfare respecting certain food additives found to induce cancer in aninals. Introduced Feb. 1, 1979; referred to Committee on Interstate and Foreign Commerce. H.R. 3582 (Ottinger) Respecting the continued use of saccharin as a food additive, drug, and cosmetic. Introduced Apr. 10, 1979; referred to Committee on Interstate and Foreign Connerce. H.R. uu53 (waxnan et al.) i Amends the saccharin Study and Labeling Act to extend to June 30, 1981, the ban on actions by the Secretary of Health, Education, and Welfare respecting saccharin. Introduced June 13, 1979; referred to Conmittee on Interstate and Foreign Commerce. Ordered to be reported June 26. Reported July 17, 1979 (H.Rept. 96-3&8). Passed House July 2H, 1979. I H.R. 6833 (ihitehurst) Amends the Food, Drug, and Cosmetic Act to give the FDA greater discretion in the control of food additives. Introduced fiar. 17, 1980; referred Committee on Interstate and Foreign Commerce. 5. 587 iéchveiker) 1 cns- 7 1377033 upnarzs:-03/2 u/elo Anends the Federal Food, Drug, and Cbsnetic Act to authorize an evaluation of the risks and benefits of certain food additives. Introduced Mar. 8, 1979; referred to Committee on Human Resources. E§AB£!§§ U.S. Congress. House. Committee on Appropriations. Subcommittee on Agriculture -— Environmental and Consumer Protection. ‘ V Agriculture +- Environmental, and Consumer Protection Appropriations for 1975. Hearings, 93d Congress, 2d session, on Food and Drug Administration “Study of the Delaney Clause and other Anti-Cancer Clauses.“ Part 8.‘ [Hashington, U.S. Govt. Print. Off., 1974] 591 p. ’ U.S. Congress. House. Committee on Government Operations. Cyclamate sweeteners. Hearing, 91st Congress, 2d session. June 10, 1970. Washington, U.S. Govt. Print. Off., 1970. 103 p. 0.5. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment. inoratoriun on saccharin ban. Hearings, 95th Congress, 1st session, on H.R. 7753, directing the Institute of Medicine of the National Academy of Sciences to consuct a one-year review on the toxicity and carcinogenicity of food additives. June 27, 1977. [iashington, U.S. Govt. Print. Off.] 1977. 143 p. ----- Proposed saccharin ban. Oversight hearings, 95th Congress, 1st session. Hat. 21-22, 1977. fwashington, U.S. Govt. Print. Off.] 1977. 592 p. ---- Saccharin ban - Oversight. Hearing, 96th Congress, 1st session, Findings of the National Academy of Sciences in the use of saccharin. Apr. 11, 1979. Washington, U.S. Govt. Print. Off., 1979. 48 p. ‘ ---—- Saccharin moratorium. Hearings, 96th Congress, 1st sessio, on H.R. 4194, H.R. 1819, H.R. 4160, and H.R. 4172 (and all similar bills). Bills to amend the authority of the Food and Drug Adninistration respecting the availability of saccharin. may 23, 1979. [fiashington, U.S. Govt. Print. Off.] 1979. 176 p. U.S. Acongress. House. Committee on the Judiciary. Subcommittee No. 2. Cyclanates. Hearings, 92d Congress, 1st session, on H.R. 4264, ‘ H.R. 4180, H.B. 4265, H.R. 4870, H.R. 4912, H.R. 5848, H.R. 5862, 1 H.R. 6163, H.R. 6155. Sept. 29-30; Oct. 6, 1971. Washington, 0.5.; Govt. Print. Off., 1971. 384 p. . ‘ "serial No. 22" U.S. Congress. Senate. Committee on Hunan Resources. Subcommittee on Health and Scientific Research. The banning of saccharin. 1977. Hearings, 95th Congress, 1st session, on examination of the risks included in the use of saccharin and the decision by the Food and Drug Administration to ban the substance from ~ the narket. June 7, 1977. [Washington, U.S. Govt. CRS- 8 Print. Off.] 1977. 173 p. ---- Proposed ban on the artificial sweetner saccharin. U.S. §§29§l§- U.S. Hearings, 95th Congress, 1st session. Mar. 24, 1977. [Not yet printed] — Committee on the Judiciary. Ad Hoc Hearings, 92d Congress, 2d session, 1972. Washington, U.S. Govt. Print. Congress. Senate. Subcommittee. Cyclamates. on H.R. 13366. Sept. 7-8, off., 1972. 310 p. Congress. Senate. fselect Committee on Small Business. Food additives: Competitive, regulatory and safety problems: Parts I and II._ Hearings, 95th Congress, 1st session. Jan. 13-1n, 1977. [iashington, 0.5. Govt. Print. Off.] 1977. 979 p. 3L-Q-§Q!§!I§ AE2-§QE§B§§§lQE Committee on Governnent Operations. Regulations Thirty-sixth report. Washington, 1970. House. Report no. 91-1585) Congress. House. of cyclanate sweeteners. 17 p. (91st Congress, 2d session. Committee on Interstate and Foreign Washington, pHouse. Congress. House. Commerce. Saccharin extension (H.R. HQS3). 1979. 55 p. (96th Congress, 1st session. Report no. 96-3&8) Congress. House. Committee on the Judiciary. Compensation for losses resulting from the ban on cyclanates (H.R. 13366). Washington, 1971- 19 p- (92d Congress, 2d session. House. Report no. 92-1070) 1 Commerce, Science, and Labeling, and Advertising 7 p. (95th Congress, 95-369) Senate. Committee on Saccharin Study, Washington, 1977. Senate. Report no. Congress. Transportation. Act (5. 1750). 1st session. Congress. Senate. Committee on Human Resources. Amending the Public Health Service Act, Federal Food, Drug, and Cosmetic Act (5. 1750). Washington, 1977. 22 p.‘ (95th congress, 1st session. Senate. Report no. 95-353) EERON LQEZ Q§_E!§EI§ 03/14/80 - The American Health Foundation reported that "In a O3/06/80 - case-control study of 302 male and 65 fenale bladder icanceripatients...no association was found between use of artificial sweeteners or diet beverages and bladder cancer." (See REFERENCES section, Rynder, E. L. et al.) Study published by researchers at Harvard School of Public Health suggests that, as a group, users of artificial sweeteners have little or no excess risk IB77038 UPDATE’O3/2%/d0 02/00/80 12/20/79 09/00/79 07/24/79 06/06/79 05/23/79 03/02/79 -. 11/00/78 09/07/78 07/19/73 - CRS- 9 IB77038 UPDATE—03/2%/$0 of cancer of the lower urinary tract. references: uorrison, A.S. et al.) (See Aspartame has been approved as a table top sweetener in Belgium and Luxembourg. The Rational Cancer Institute released a progress report to the FDA on the National Bladder Cancer Study. Preliminary findings indicated no increased bladder cancer risk in the overall study population from the use of artificial sweeteners, but heavy use of artificial sweeteners may provide a 60% increased risk among certain groups. iThe'CanadianiHealthnProtectioniBranch‘proposed clearing the sweetener, aspartame for wide food use in Canada, including use in soft drinks. 4fl53 to extend the 1981. House passed (39u—22) H.R. saccharin moratorium until June 30, The House Subcommittee on Health and the Environment of the Committee on Interstate and Foreign Commerce approved for full Committee action a clean bill in lieu of H.R. 419a, to amend the Saccharin Study and Labeling Act. The legislation would extend the moratorium on FDA's proposed ban on saccharin until June 30, 1981, a cospromise between an 18 or 36 month extension. The moratorium on the saccharin ban expired. The National Academy of Sciences released the second part of its food safety study, which called for a complete overhauling of existing food safety laws. National Academy of sciences released "Saccharin:" Technical Assessment of Risks and Benefits," Report No. 1, Committee for a Study on Saccharin and Food Safety Policy, as mandated by P.L. 95-203. The 2nd open meeting of the Committee for a study on Saccharin and Food Safety Policy was held September 7, at the National Academy of Sciences. The purpose of the 2nd meeting was to provide an opportunity for participation from interested parties and to receive information and materials relevant to food safety policy in the United States. In particular, participants were invited to address issues related to the appropriateness and feasibility of assessing risks and benefits in the regulation of food safety and in the design of food safety policy. 1st public meeting held by the Committee for a Study on Saccaharin and Food Safety Policy of the National Academy of Sciences. The Committee performed a study in response to P.L. 95-203, The Saccharin Study and Labeling Act. The purpose of this study was to evaluate the adequacy of existing ‘O2/21/78 o1/25/73 311/23/77 11/on/77 11/03/77 10/17/77 09/15/77 07/27/77 07/13/77 07/11/77 07/01/77 CBS-10 IB77038 UPDATE-03/24/80 food safety statutes and policies in light of changing technical and scientific capabilities for detecting toxic and carcinogenic substances in foods. Emphasis was placed on identifying the elements of food safety policy and the methods to assess different technologies in relation to food safety. P.L. 95-203 went into effect. The FDA and the Hationa1.Cancer Institute announced they would conduct an 18-month study of 9,000 people to determine whether saccharin causes bladder cancer. P.L. 95-203 was enacted, requiring that by Feb. 21, 1978, all saccharin products must be labeled with the warning that saccharin is a possible cancer risk. Senate agreed to conference report on S. 1750. House agreed to conference report on S. 1750. Conference report on S. 1750 filed in the House (H.Rept. 95-810). The House passed 5. 1750, a modifed form of H.R. 8518, by a vote of 375-23, to block the saccharin ban for 18 months. The bill requires that warning signs be posted in retail establishments where saccharin products are sold. The Senate approved, 87 to 7, a modified 5. 1750, which blocks the implementation of the saccharin ban for 18 months. The Senate rejected the requirement of warnings of possible cancer risk in printed advertising or in radio or television commercials. The bill does require warning labels on saccharin-containing products. The Senate Committee on Commerce, Science, and Transportation reported on S. 1750, the saccharin Study, Labeling, and Advertising Act, amending the section on electronic media advertising. The Senate Human Resources Committee voted to allow the sale of saccharin and saccharin-containing products for 18 more months, but with a requirement for cancer warnings on the label and in advertising. The House Subcommittee on Health and the Environment of the Interstate and Foreign Commerce Committee approved for full committee action H.R. 7753, amended, directing the Institute of nedicine of the National Academy of Sciences to conduct a one-year review on the toxicity and carcinogenicity of food additives. The Food and Drug Administration extended the comment period on the proposal to restrict saccharin use until Aug. 31, 1977. 06/27/77 06/22/77 05/21/77 06/20/77 06/17/77 06/07/77 05/18/77 ‘O4/19/77 04/15/77 03/2“/77 03/21/77 03/09/77 CBS-11 IB77038 UPDATE-03/24/80 The House Subcommittee on Health and the Environnent of Interstate and Foreign Commerce held a hearing on H.R. 7753. Senate Appropriations Committee rejected the House amendment to delay the saccharin ban. ' The House approved measure to delay FDA's ban on saccharin for the next 15 months. FDA delayed the drafting of a new regulation banning saccharin in order to evaluate new studies. Canada's National Cancer Institute reported on a new study which links saccharin consumption to bladder cancer in males. At the sane time, Johns Hopkins researchers released infornation on their study which indicates no correlation on the incidence of bladder cancer and human saccharin consunption. Hearings were neld before the Senate Committee won Human Resources, Subconnittee on Health and Scientific Research, to evaluate information upon which the FDA based its decision to propose regulations banning the use of saccharin. -05/19/77 -“ FDA held public hearings on saccharin. -—-The Canadian Health Department announced they are postponing their restriction on the use of saccharin in foods and beverages to allow manufacturers time to find substitute sweetners. The FDA published its proposed rule for the banning of saccharin. Hearings were held before the Senate Committee on Human Resources, Subcommittee on Health and Scientific Research, to consider the proposed ban on the artificial sweetener, saccharin. I -.03/22/77 - Hearings were held before the House Committee on Interstate and Foreign Conmerce, Subcommittee on Health and Environnent, on the advisability of withdrawing saccharin fro the narket. % The Food and Drug ldninistration announced its intention to prohibit the use of saccharin in foods and beverages because the artificial sweetener has caused malignant bladder tumors in test animals. Canadian Health and Welfare Minister Harc Lalonde announced ‘that the results of over three years of study in Canadian Health Protection Branch laboratories indicated that saccharin is a carcinogen. cns—12 1377033 UPDATE-03/24/HO 01/13/77 -01/14/77 - Hearings were held before the Senate Select 01/07/77 02/12/76 12/00/74 05/05/7n O6/00/72 1Q/18/69 12/00/69 OH/O0/67 06/00/60 00/00/60 08/07/59 -—b Committee on Small Business to examine the safety, marketing, and regulations of food additives. FDA extended the effective date of the interim food additives regulation for saccharin and its salts by authorizing continued limited use of the food additives until ongoing studies are completed and evaluated. [21 CFR, Part 121] The FDA proposed to amend the interim food additive regulation for saccharin and its salts by establishing a tolerance for V toluenesnlfonamide of 25 parts per million, the lowest level; currently achievable. [21 CFR, Part 121] A Bed Dye no. 2 was banned by the Food and Drug Administration. The National Academy of Sciences/The National Research Council (NAS/NRC) released recommendation for further study into thew carcinogenicity of saccharin, since no conclusions could be {drawn on existing data. Hearings were held before the House subcommittee on Agriculture, Environment and Consumer Protection, on the Food and Drug Administration "Study of the Delaney Clause and other Anticancer Clauses.“ The FDA asked HAS/NRC to review the results of all experiments, either completed or on-going, on the possible carcinogenicity of saccharin. Cyclamates were banned by the FDA on the basis of a determination of carcinogenicity. The anti—cancer clause was invoked for the second time by banning the additive 2—choroanaline, previously used as a polyurethane curing agent and as a component of food packagin adhesive and polyurethane resins. : The antiecancer clause was invoked for the first time by banning Flectol H, previously used as a component of food packaging adhesives. Hearings were held on food additives by the House Committee on Interstate and Foreign Commerce, Subcommittee on Public Health and Environment. 1 Color Additives Amendments of 1960, of the Federal Food, Drug, and Cosmetic Act, required that the conditions for safe use of a color additive be established by regulation. The 1 legislation allowed for the use of any color additive if the, substance was proven safe for its intended use. It also put} the burden of proof on the manufacturer. Food colorings 1 would now come under the jurisdiction of the Delaney clause, which prohibited their use if known to produce cancer in man or animals. Insecticide Amendments to the 195a Pesticide Chemical Amendments were signed into law. cns-13 n377o3a UPDATE-O3/2 who 12/15/58 —- The Supreme Court in Fleeing v- §l9.ri.<1a-§i2ru.§..§2r.sheI.29e upheld the position of the FDA which forbade the use of coal—tar dyes found to be harmful in any amount. O9/06/58 - ’Food Additives Amendment signed into law by President Eisenhower. The amendment contained: a specific requirement for pre-market testing of food additives; and the anti-cancer (or Delaney) clause. OZ/09/56 - Orange Coloring Amendment was passed to allow the usage of A ‘ iRed—No. 32, which was found to be toxic, limited to coloring: orange peels.‘ A 07/22/Eu ->-The Pesticide Chemical Amendnent of 1954 gave manufacturers the responsibility for determining the residue levels on or in’ raw agricultural products; provided procedures for determining tolerance levels for pesticides previously registered; and A the FDA was given authority to exempt any pesticide chemical: from the tolerance requirement when the safety of the consumer was not affected. 1 06/00/50 ——-The House adopted a resolution creating a Select Committee to Investigate the Use of Chemicals in Foods (the “Delaney Committee“). ‘ 06/24/H8 - The Regulatory Amendments of 19fl8 made it clear that the 1938 provisions against adulterated or misbranded foods, drugs, 7 F devices, and cosmetics applied any time after shipment and prior to purchase by the ultimate consumer.’ ‘ 06/25/38 - The Federal Food, Drug, and Cosmetic Act was adopted by Congress. O6/30/06 - »The first Federal food and drug law, the Food and Drugs Act of C 1906, was signed by President Theodore Roosevelt. A 2DI$lQEAL-§EE§B§E§E-§ 23935 A Bitter reaction to»an FDA ban. Tine, Bar. 21, 1977: 60-61. Allera, Edward J. An Overview of how the FDA regulates carcinogens under the Federal Food, Drug, and Cosmetic Act. Food drug cosmetic law journal, v. 2, February 1978: 59- ;. A Cohen, Bernard L. Saccharin: the risks and benefits.« Nature, v. 271, Feb. 9, 1978: #92. Furia, T.E. ma.) Handbook of food additives. Cleveland, Ohio, the Chemical Rubber Co., 1968. 771 p. Kessler, Irving I. and J. Page Clark. Saccharin, cyclamate, and human bladder cancer. No evidence of an association. Journal of the American Hedical Association, v. zuo, no. 4. July 28, 1978: i3u9-355. ' cns-1n IB77038 UPDATE-03/2%/90 Langway, Lynn. The saccharin ban. Newsweek, Mar. 21, 1977: 65-66. Lyons, Richard D. The F.D.A. saccharin ban. New York times, Mar. 25, 1977: Ala. Morrison, Alan S. and Julie E. Buring. Artificial sweeteners and cancer of the lower urinary tract. New England journal of medicine, v. 302, no. 10, Bar. 6, 1980: 537-5u1. National Academy of Sciences.y Academy Forum. How safe is safe? The design of policy on drugs and foods additives. Washington, 197a. 23H p. A y ~y_y National Academy of Sciences. Committee on Food Protection, Subcommittee on Nonnutritive Sweeteners, Food and Nutrition Board. Safety of saccharin and sodium saccharin in the human diet. Washington, D.C., 197n. 74 p. National Academy of sciences/National Research Council. Assembly of Life Sciences/Institute of Medicine. Committee for a Study on saccharin and Food Safety Policy. Report no. 1, saccharin: technical assessment of risks and benefits. Washington, D.C. November 1978. ---- Report no. 2, food safety policy: scientific and societal considerations. Washington, D.C. Har. 1, 1979. National Cancer Institute. Division of Cancer Cause and Prevention. Report of the Temporary Committee for the Review of Data on Carcinogenicity of Cyclamate. February 1976. 50 p. National Cancer Institute. Progress report to the Food and Drug Administration from the National Cancer Institute concerning the national bladder cancer study. Dec. 20, 1979. 32 p., plus appendices. News Forum. Should the Delaney Clause be changed? A debate on food additive safety, animal tests, and cancer. Chemical and engineering news, June 27, 1977: 24-28, 33-36. Oser, B.L. Are food additives overregulated? Food, drug, cosmetic law journal, November 1976: 627-635. Pro and con: Should saccharin be banned?, U.S. news 8 world report, Apr. 4, 1977: 59-60. ~ I The saccharin question re-examined: An A.D.A. statement. Journal of the American dietetic association, v- 7n, no. 5, may 1979: 57a-581. \ saccharin: technical assessment of risks and benefits. Report no. 1. Panel I: Study of saccharin and its impurities, Committee for a Study on saccharin and Food Safety Policy; Assembly of Life Sciences, National Research Council; and Institute of Medicine, National Academy of Sciences (Committee for a Study on saccharin and Food Safety Policy, November 1978, 2H9 p. (Available from cns-15 113770 33 UPDATE-O3/2 4/80 Hearing Clerk, Food and Drug Administration). U.S. Congress. Office of Technology Assessment. Cancer testing technology and saccharin. [Washington] October 1977. 1&9 p. U.S. Dept. of Health, Education, and Welfare. National Cancer Institute National Cancer Advisory Board. General criteria for assessing the evidence for carcinogenicity of chemical substances. Bethesda, Hd., June 2, 1976. 9 p. U.S. Dept. of Health, Education, and Welfare. Public Health Service. 1 Food and Drug Administration. Federal Food, Drug, and.Cosaetic Act, as amended. October 1976. U.S. Govt. Print. 0ff., Washington, D.C. 1H9 Pu ‘ "- “7:“ -= - 4 ‘ A * * Saccharin and its salts: proposed rule and hearing. Federal register, Apr. 15, 1977: 19996-20010. U.S. General Accounting Office. Need to resolve safety questions on saccharin: Food and Drug Administration, Department of Health, Education, and Welfare. Aug. 16, 1976. 32 p. (HRD-76-156) U.S. Library of Congress. Congressional Research Service. A Legislative history of the Federal Food, Drug and Cosmetic Act [by] Jack B. Bresler and Mary Nell Lehnhard. Apr. 1, 1977. nultilith 77-98SP saccharin: A Review of current issues [by] Jack B. Bresler, Christopher H. Dodge, Sandra Knisbacher, and Stephanie L. Forbes. June 1, 1977. Hultilith 7 7-1 1% 95]? Wehr, Elizabeth. Saccharin ban at issue again: Congress plans major review of food laws. Congressional quarterly weekly report, Feb. 10, 1979: 230-236. wurster, Charles F. For the saccharin ban. Rev York tines, Har. 20, 1977: 17. A Wynder, Ernst L. and Steven D. Stellnan. Artificial sweetener use and bladder cancer: a case-control study. Science, v. 207, Mar. 14, 1980: 1214-1216. LIBRARY OF WASHINGTON UNIVERSITY ST. LOUi¥5 — MO.