DLCUNEIIT RESUME 1/- 9-'77 04045 - B3074327] Food Additive, Acrylonitrile, Banned in Beveraae Containers. 4RD-78-9; B-164031(2). ovember 2, 1977. Released ovember 9, 1977. 17 pp. Report to Rep. Toby offett; by Paul G. Dembling, Acting Comptroller General. Issue Area: Food (1700); Consumer and orker Protection: Safety of Food Additives (905). Contact: Human Resources Div. Budget Function: Health: PreventJ.oa and Control of Health Problems (553). Organization Concerned: Food and Drug Administration. Congressional Relevance: Rep. Toby olof'ett. Authority: Food, Drug, and Cosmetic Act, as amended; Food Additives Amendment of 1958 (21 O.S.C. 348). 21 C.F.R. 170.3(e). 21 C.F.R. 170.22. Acrylonitrile is a volatile, clear liquid, which cn 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, pclymerization, a small amoant of "residual" acrylcnitrile that has not combined with other monomers remains in the plastic and may become part of the substance in te bottle. Some acrylonitrile copolymers also depolymerize to some ext 4 ent, allowing additional acrylonitrile to migrate to the rood. Findings/Conclusions: In January 1977, Food ad Drug Administration (FDA) officials decided that the use of acrylonitrile in making plastic bottles for carbonated beveraes and beer should be banned and that all other acrylcnitrile uses should be restricted to a maximum permissible migration level of 0.05 ppm. n arch 7,. 1977, Monsanto Coapany filed a moticn in the U.S. court of appeals requesting a review of FDA's suspension of its regulati-n authorizing the use of acrylonitrile in bottles intended to hold soft drinks. In its motion, Monsanto Company maintained that PA had not followed the procedures required by section 4C9 of the Federal Food, Druq, 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 opportaniry for affected parties to contest the action. The ccurt crdered that FDA's suspension of the regulation be lifted until ay 18, 1977, and that FDA hold the required public hearing roaptly,. The outcome was that acrylonitrile copolymers used to fabricate beverage containers were judged to be food additives and were not safe for use in food. FDA tereinated all regulations that permit acrylonitrile in beverage containers. (SW) -4 ..cJ' 'ai REPORT OF THE o ;X}~BP COMPTROLLER GENERAL ~N'~' OF THE UNITED STATES R£2T CT4b - e. R E DE '9 H rE'cta w.F-*ide ied e noral Accauwt *. .- ' :i: e· '-; :. _ .r - ' ~ plctic appoval b te A..d In Aid ,.J.)iV ;^^:>n Food Additive, Acrylonitrile, Banned in Beverage Containers Acrylonitrile has been used for about 30 years to make various plastic food contain- ers. Recent studies show that, when used in beverage containers, this substance migrates to the packaged beverage, contaminating it. Bated oc these studies and on the results of a public hearing concerning these issues, on Sep.amt3r 23, 1977', the Food and Drug Ad- ministration published a final order erminat- ing all regulations that permit acr!;',litile in beverage containers. HRD-78-9 NOVEMBER 2, 1977 COMPTROLLFR GENERAL OF THE UNITED STATES WASHINGTON. D.C. 20!48 B-164031(2) The Honorable Toby MoffetL House of Representatives Dear Mr. Mor.cett: In your letter of March 15, 1977, you requested our observations on the Food and Drug Administration's (FDA's) March 11, 1977, decision to stay its food additive regula- tions that had permitted acrylonitrile to be used in making beverage containers. You indicated that FDA's only scien- tific data on which to base such decision was the prelimi- nary report of a 2-year study which was only half completed. We interviewed FDA officials; reviewed legislation, regulations, and practices relating to FDA's regulation of food additives; examined FDA's records relating to tne regulatory status of acrylonitrile; and reviewed testimony presented at a public hearing on acrylonitrile used to make beverage containers. As agreed with your office, we are sending copies of this report to the Secretary of Health, Education, end Welfare and the FDA Commissioner. Unless you publicly announce its contents earlier, we will not distribute this report further until 7 days from the date of the report. REGULATION OF FOOD ADDITIVES The Federal Food, Drug, and Cosmetic Act, as amended by the Food Additives Amendment of 1958, requires FDA to estab- lish regulations prescribing the conditions under which a food additive may be safely used (21 U.S.C. 348). The act defines "food additive" as any substance that becomes or may reason- ably be expected to become a component of food, either directl" or indirectly, or which may otherwise affect the characteristics of the food. The effective date of a regula- tion may be stayed if a hearing is sought by any person ad- versely affected by such a regulation. B-164031(2) Substances used in accordance with approvals given by the Department of Agriculture and FDA before the enactment of the 1958 Food Additives Amendment are not subject to such regula- tions. Tnese approvals, generally known as prior-sanctioned approvals, were based on safety requirements less formal and restrictive than those provided by the 1958 amendment. FDA's food additive regulations (21 C.F.R. 170.3(e)) state that a material used to produce containers and packages is considered a food additive if it may reasonably be expected to become a component, or to directly or indirectly affect the characteristics of food packed in the container. Packag- ing material that migrates to the food is an indirect food additive. The Food Additives Amendment of 1958 and FDA regulations require that a petitioner requesting the approval of an in- direct food additive demonstrate the safety of the additive with appropriate data showing the amount of the substance that is expected to migrate to food and the results of toxicological studies. The amendment also requires FDA to consider the probable consumption of the additive when deter- mining the safety of the proposed use of a food additive. According to an FDA Division of Toxicology official, the number and type of toxicological tests the agency requires for a safety evaluation of an indirect additive depend on the amount of the chemical that is expected to migrate to the food. He said that FDA requires only acute toxicity data to insure that a substance is not a highly toxic chemical when anticipated migration is "virtually nil" (generally less than 0.05 parts per millicn (ppm)), provided that the substance is not a heavy metal or a pesticide and there is no reason to suspect carcinogenicity or teratogenicity. More extensive toxicological test data is required when migration of a sub- stance is anticipated to be "negligible" (more than 0.05 ppm but less than about 1.0 ppm). WHAT IS ACRYLONITRILE? Acrylonitrile is a volatile, clear liquid. Because of its relatively low molecular weight, it is classified as a monomer, which, when joined with certain other monomers through a process known as polymerization, can form more complex compounds known as polymers that are used to make various plastic articles. 2 B-164031(2) Acrylonitrile copolymers, a class of polymers, have been used for about 30 years in various food containers, such as margarine tubs, vegetable oil bottles, and pipes for handling food products. Copolymers with high concentrations of acrylonitrile have excellent barrier (pressure-holdina) characteristics. Since such copolymers have low permeability to gases, they are suitable for carbonated beverage bottles that must retain gas for extended periods. Beverage bottles made of acrylonitrile copolymers are lightweight, do not cause injury if broken, and are therefore desirable to consumers. A characteristic of such bottles, however, is that after polymerization, a small amount of "residual" acrylonitrile that has not combined with other monomers remains in the plastic and may become prt of the substance in the bottle. Some acrylonitrile copolymers also depolymerize to some extent, allowing additional acrylonitrile to migrat'e to the food. BASIS FOR INITIAL SAFETY DETERMINATION FDA's initial prior-sanctioned approvals of acryloni- trile's use in food-contact articles were based on analytical data indicating that there was no significant migration of acrylonitrile to food under the conditions of its intended use. These approvals included uses for oleomargarine wraps and equipment and containers used in fod processing. Pursuant to the 1958 Food Additives Akendment the ap- proval process for food additives requires the submission of a petition proposing the issuance of a regulation that would prescribe the conditions under which an additive may be safely used. Since 1958 FDA has issued 20 food additive regulations approving various additional acrylonitrile uses in food- contact articles. These approvals were based on data sub- mitted with petitions which showed no significant. migration of acrylonitrile to the packaged food. The first regulation allowing the use of acrylonitrile in plastic beverage bottles was issued to Vistron Corporation on June 11, 1970. SAFETY LATER QUESTIONED Extraction studies submitted by the E. I. duPont de Nemours Company with its June 14, 1973, petition to FDA requesting approval for use of its acrylonitrile bottle to package soft drinks showed that acrylonitrile migrated from bottles to food when stored at elevated temperatures for 3 B-164031(2) extended periods. Extraction stu-.es can measure, throughl analytical methods, the aunt of a substance that has migrated to a food. Based on the new evidence and the fact that improved procedures for detecting and measuring acrylo- nitrile had been developed, FDA began a complete review of all safety data available on this substance. FDA found that available toxicity data on acrylonitrile consisted primarily of two series of long-term feeding studies. One series, entitled "The Pharmacology and Toxic- ity of Acrylonitrile and Acrylon" (by P. E. Tullar, George Washington University, Nov. 1, 194 ), does not, according to FDA, meet current standards for the toxicological testing of substances such as food additives. An FDA Division of Toxicology official said that, at best, a tentative "no- adverse-effect" level for acrylonitrile could be established from this study at 38 ppm. The other series of studies available at that time was made by Svirbely and Floyd of the U.S. Public Health ScLvice at the Taft Sanitary Engineering Center in Cincinnati in the late 1950s. The series consisted of 2-year fding studies in rats and dogs and a 3-generation rat r:production study. A final report on this series was nZver pepared, and accord- ing t FDA the available aLa provided only limited informa- tion that was inadequate to establish a no-adverse-effect level for acrylonitrile. Based on the results of its review, FDA concluded that the safety of acryloni-ile was questionable, that the evel of acceptable migration should be limited, and that addi- tional information and studies were needed on (1) analytical methods concerning migration and (2) toxicity. FDA regulations (21 C.F.R. 180.?) state that substances with a history of use in food fo£ human consumption or in food-contact surfaces may at any time have their safety or functionality bought into question by new information that in itself is inconclusive. An interim food additive regula- tion for the use of any such substance may be issued "* * * when new information raises a substantial question about the safety or functionality of the substance but there is a reasonable certainty that the substance is not harmful and that no harm to the public health will result from the continued use of the substance for a limited period of time 4 B-164031(2) while the question raised is being resolved by further study." On November 4, 1974, FDA published in the Federal Register a proposed interim ooC additive regulation for acrylonitrile intended for use in food-contact articles. This regulation proposed, for an interim period; a limit of 0.3 ppm as the maximum amount of acrylonitrile allowed to iarate to food and required that toxicological studies be conducted to determine the safety of lcw levels of acry- Ionitrile ingestion. The 0.3-ppm migration limitation was established by applying a 100 to 1 safety factor to a tentative no-adverse- effect evel of 38 ppm, which was based on the 1947 P. E. Tullar study. FDA regulations (21 C.F.R. 170.22) provide that "* * * a food additive for use by man will not be granted a tolerance that will exceed 1/100th of the maximum amount demonstrated to be without harm to experimental animals." On June 19, 1975, the Manufacturing Chemists Association submitted, for FDA review, protocols for a series of studies designed to provide the toxicity data called for by the pro- posed interim regulation.. On July 18, 1975, FDA informed the association that the protocols, with some technical modifica- tions, were acceptable. The association contracted with the Do Chemical Company to make the studies. The studies were sponsored by the following manufacturers or major users of acrylonitrile: American Cyanamid Company, Borg-Warner Chemicals, Dow Chemical Company, E. I. duPont de Nemours and Company, Monsanto Company, Standard Oil Company (Ohio), Tennessee Eastman Company, and Uniroyal, Incorporated. After publishing its proposed interim regulation on acrylonitrile, FDA issued regulations permitting duPont, Borg-Warner, Monsanto, and Dow to use acrylonitrile to make plastic bottles. ISSUANCE OF FINAL INTERIM REGULATION On June 14, 1976, FDA issued in final form the interim food additive regulation on the use of acrylonitrile in food- contact articles. The regulation established the maximum permissible level of acrylonitrile migration at 0.3 ppm 5 B-164031(2) pending the results of the ongoing toxicity studies. Thirty days were allowed for comments on and objections to the regulation. Four manufacturers and one industry association sub- mitted comments to FDA on the interim regulation. These comments included questions about -- the appropriateness of a 120 degree FaLrenheit tem- perature requirement for migration studies, -- the technical inconsistency of the volume-to-surfacc ratio requirements for migration measurement, -- the Fossitility of extending the 30-day comment period to allow time to obtain FDA's migration test method- clogy and evaluate the regulation: iTm-ct on the product being manufactured, and -- the lack of prior knowledge about the existence of the proposed regulation. Only the Natural Resources Defense Council filed an objection questicning the safety of acrylonitrile in food- contact applications. It cited several reasons for ques- tioning the safety of acrylonitrile. -- The 1947 P. E. Tullar study, which concluded that acrylonitrile causes cancer. -- The fact that acrylonitrile, also known as vinyl cyanide, is chemically related to vinyl chloride, a known carcinogen. -- An epidemiology study of Japanese acrylonitrile workers which found a correlation between exposure to the substance and impairment of liver function. Based on the lack of sufficient data supporting the safety of acrylonitrile, the council on July 13, 1976, requested that a stay be granted of any food additive regulation under which acrylonitrile might reasonably be expected to migrate co a food product. The council requested that the stay remain in effect pending a hearing and a decision on its objection. 6 [-164031(2) STUDY RESULTS Studies done in response to the need for additional information on acrylonitrile include toxicity studies iden- tified in the interim food additive regulation and migration studies designed to measure very small amounts of the sub- stance in fcod. Toxicity studies On Decembe:: 9, 1975, the Manufacturing Chemists Associa- tion submitted to FDA results of two toxicity studies by Dow Chemical. In the first study, rats were fed acrylonltrile at levels of 0, 35, 85, 210, and 500 ppm in their drinking water for 90 days. The study report stated that: "Results of this study indicate that male and female rats may ingest water containing at least 85 ppm of acrylonitrile for a period f 90 days without a deleterious effect on any of the arameters evaluated." The repozt noted that decreased body weight gains were ob- served in male rats in the top dose level and in female rats in the two top dose levels. It further reported that small bu. significant increases in liver to body weight ratios were observed ii male and female rats on water containing 500 and 210 ppm acrylonitrile. Dur'.na the second study, purebred beagle dogs were fed acrylonitrile at levels of 0, 100, 200, and 300 ppm (eight dogs per level) ii their drinking water for 6 months. The study report concluded that: "Ingestion of AN [acrylonitrile] in the drinking water by male and female dogs at 200 and 300 ppm for a period of 6 months was associated with toxicological manifestations primarily and secondarily related to AN. "Ingestion of AN in the drinking water at 100 ppm for 6 months resulted in no toxicological mani- festations in male or female dogs." 7 B-164031(2) The FDA toxicologist who evaluated the study, however, stated in a February 1977 memorandum to the Director of FDA's Division of Food and Color Additives that: "With the normal criteria of toxicity data evaluations, the no-effect level appears to be lower than 100 ppm (8-10 mg/kgm [milligrams per kilogram]). The effect at this level was a slight lag in owth, and microscopic changes in the esophagus, with increased thickening of the epithelium of the tongue." He said that at the two higher dose levels, effects such as growth lags, increased mortality, and reduced liver function were noted. On Aril 19, 1976 the Manufacturing Chemists Associa- tion submitted to FDA the results of a study conducted Younger Laboratories .. te joint toxic action between by acrylonitrile and potassium cyanide. This study male and female rats were orally given mixtures ofin acrylo- which nitrile and potassium cyanide showed no evidence of syner- gistic effect on acute toxicity. On October 13, 1976, the association submitted results from nutagenici`y studies made in three different labora- tories. Only one laboratory reported evidence of mutagenic effects from one of several tests that it conducted. In November 1976 the association submitted to FDA a report entitled "Teratologic Evaluation of Acrylonitrile Monomer Given to Rats by Gavage." The study, conducted by Dow Chemical, was designed to evaluate the effects of acry- ionitrile on embryonal and fetal development. In the study pregnant rats were given, oii days 6 through 15 of gestation, either 0, .0, 25, or 65 mg of acrylonitrile per kilogram body weight by gavage (oral administration of a substance of directly to the stomach through a feeding tube). At the 65-mg feeding level, effects such as maternal toxicity, in- creased numbers of fetal malformations, decreased fetal wei,ht, and minor skeletal variants occurred. At the 25-mg feeding level, maternal toxicity and malformations also occurred, but with less frequency. The report stated that at the 10-mg (approximately 100-ppm) feeding level, there was no evidence of toxicity to either the mother or her develop- ing embryo or fetus. 8 B-164031 2) On January 14, 1977, the sscciation submitted to FDA a 13-month interim report on a 2-year rat feeding study being made by Dow Chemical. The study, scheduled for com- pletion about November 1977, involves feeding rats acryloni- trile in their drinking water at concentrations of 0, 35, 100, and 300 ppm. With respect to eedings at the 100- and 300-ppm levels, the interim report stated that: "It is concluded hat administration of AN under the condition of this study has signifi- cantly lowered body weight, produced pathologic changes in the gastric epithelium, increased the incidence of masses of the ear duct and produced proliferative lesions in the centLal nervous system of rats. The significance of the higher incidence of subcutaneous masses in the mammary region of the rats is less clear, and its resolu- tion will have to await further progress in the study." On April 11, 1977, the Manufacturing Chemists Associa- tion provided FDA with updated information on the interim findings of Dow's 2-year rat feeding study. According to the association, the study investigator had found tumors of the central nervous system in two rats on the 35-ppm feeding level of the same type found earlier in rats on the 100.- and 300-ppm feeding levels. The association also notified FDA that another 2-year study in which rats were being exposed to 0, 20, or 80 ppm acrvlonitrile by inhalation showed the following interim results. -- Three rats in the highest dose group (80 ppm) devel- oped tumors of the central nervous system comparable to those reported in the 2-year ingestion study. -- An increased incidence of ear canal tumors and mammary region masses was detected at the 80-ppm level. -- An apparent increase in the subcutaneous masses of the mammary region was detected in the rats in the 20-ppm group. -- No ear canal or central nervous system tumorF were found in the 20-ppm group. 9 B-164031(2) 'ccording to an FDA Division of Toxicology official, although an inhalation study is not directly relevant to ingestion -oxicity, the findings of tumors similar to those in the feeding study and tumors other than of the lung or respira- tory tract indicate the systemic nature of the apparent car- cinogenic effect of acrylonitrile after absorption. By letter dated May 23, 1977, the E. I. duPont Company providedd3DA with preliminary results of an ongoing epidemi- ology st'ldy of workers exposed to acrylonitrile in a textile fibers lant. The preliminary findings revealed a possible relationship between exposure of in-plant workers to acrylo- nitrile and cancer. A higher-than-expected incidence of various types of cancer was found among the 470 males sur- veyed. These men began working in the polymerization area of the plant between 1950 and 1955 and are either still actively employed by or retired from the company. Medical data analyze3 through December-31, 1975, showed that 16 cancer cases among his group were found, compared with an expected company rate of 5.8 and a national rate f 6.9. The cases include six lung cancers (1.5 expected) and three colon cancers (0.5 expected). All cases of cancer occurred in the group naving initial exposure during startup of the plant in 1950 through .1952. Migration/extraction stidies In 1975 FDA began o develop methodologies for measuring acrylonitrile migration. The team leader responsible for FDA's efforts stated in written testimony for a public hear- ing (see pp. 16 and 17) that FDA had developed and confirmea an extraction test method capable of measuring acrylonitrile at levels of 0.04 pm. e said that FDA's method is based on one submitted by duPont which uses gas liquid chromatography. The team leader s.d that two migration studies on acrylonitrile bottis have been made with FDA's method. On August 6, 1976, FDA began a migration study using two test groups of acrylonitrile bottles--four 32-ounce bottles from Monsanto and four 16-ounce bottles fron Borg-Warne:--which, according to FDA's analysis, contained 9 to 10 ppm and 25 ppm residual acrylonitrile, respectively. Two of the bottles from each company were filled with the food simulant 3 percent acetic aid and two with food simulant 8 percent ethanol, and each was heated to 120 degrees Fahrenheit. Food simulants are often used in place of food 10 B-164031(2) products during migration te.ts ir order to simplify detection and measurement by eliminating many of the unknown substances that might be present in food. Acetic acid is generally ac- cepted as a substitute for carbonated beverages and ethanol as a substitute for alcoholic beverages. Test samples were withdrawn from the bottles over a period of about 5 months. The following table presents the average concentrations of acrylonitrile found on January 12, 1977, in samples drawn from the bottles during the test period. Acrylonitrile found Solvent Monsanto bottles Borg-Warner bottles 3 percent acetic acid 0.062 ppm 0.112 ppm 8 percent ethanol .078 ppm .126 ppm An FDA project manager involved in regulating acrylonitrile told us that the Borg-Warner bottles used in this test were early prototype bottles, not those made from copolymers that complied with the final Borg-Warner regulation. According to the team leader, the second FDA study used empty and filled Monsanto bottles obtained from the Coca Cola Bottling Company of New York on August 9, 1976. In one por- tion of the study, two empty bottles, whose walls were found to contain approximately 7 to 8 ppm of residual acrylonitrile, were filled on February 14, 1977, with 3 percent acetic acid and stored at 120 degrees Fahrenheit. After various periods of time, samples of the acid were withdrawn and tested. The average amount of acrylonitrile found in the acid samples is indicated below. Average amount of acrylonitrile (estimated) Date Elapsed time (note a) 2/24/77 10 days 0.005 ppm 3/ 1/77 14 days .005 ppm 3/15/77 28 days .005 ppm 4/12/77 56 days .018 ppm 5/10/77 84 days .022 ppm a/These values are estimated because the gas liquid chromoto- graphy method is not capable of accurately quantifying con- centrations of acrylonitrile less than 0.04 ppm. 11 B-164031(2) In another phase of the study, four of the bottles filled with Coca Cola were maintained at room temperature from the time of collection until January 1977. FDA extrac- tion studies showed corcentrations of acrylonitrile in the Coca Cola ranging from 0.013 to 0.029 ppm. The FDA laboratory confirmed these findings with mass spectromeLric and polarographic techniques. Both techniques confirmed the levels of acrylonitrile found in the Coca Cola using the gas liquid chromotography method. The laboratory team leader believed that FDA's studies unequivocally estab- lish that acrylonitrile beverage containers can reasonably be expected to become, and in fact do become, a component of the beverage packaged in them. DECISION TO BAN USE OF ACRYLONITRILE An FDA project manager involved in regulating acryloni- trile told us that, on the basis of the positive findings of the teratogenic study (see p. 8), FDA officials decided in November 1976 to revise the interim regulation for acryloni- trile regarding its use in making plastic bottles for car- bonated beverages and beer by reducing its permissible migra- tion level from 0.3 ppm to 0.05 ppm. This evel approximated the lowest attainable level of measurable detection. A draft revision to the interim regulation dated November 1976 was prepared. After receiving the interim report on Dow's 2-year chronic-feeding study in January 1977, FDA officials decided that the use of acrylonitrile in making plastic bottles for carbonated beverages and beer should be banned and that all other crylonitrile uses should be restricted to a maximum permissible migration level of 0.05 ppm. According to FDA's Office of General Counsel, this decision was based not only on the findings of the teratology and chronic-feeding studies but also in combination with (1) data developed by FDA extrac- tion studies indicating that migration of acrylonitrile occurs in beverage containers containing the substance, (2) indica- tions that the containers being manufactured might not meet the proposed 0.05-ppm limit on acrylonitrile migration, and (3) the possibility of much greater consumer exposure to acrylonitrile from caroonated beverage containers than from other food-contact uses. On February 15, 1977, FDA published its environmental impact statement in the Federal Register which included an 12 B-164031(2) announcement of the agency's intentions to (1) suspend the use of acrylonitrile in making plastic bottles for carbonated beverages and beer and (2) reduce the allowable amount of acrylonitrile migration from 0.3 ppm to 0.05 ppm for all other food-contact articles. At that time the Coca Cola Company was test marketing its product packaged in acrylonitrile bottles manufactured by Monsanto Company. On February 14 ad 16 and March 3, 1977, Monsanto met with FDA officials and presented data in an at- tempt to convince FDA to withdraw its intended ban on the use of such bottles. Monsanto's primary points were that (1) the migration test procedures which require storing the bottles at 120 degrees Fahrenheit until no further migration occurs were unreasonable since sealed soft drink bottles deform at that temperature and the contents are ruined, (2) in lieu of a ban, a standard should be set allowing no acry onitrile migration to soft drinks when the bottles are stored for 30 days at 120 degrees Fahrenheit (equivalent to 2 years of storage at room temps-ature) and tested with a proposed test method sensitive to 0.01 ppm, and (3) the safety data sub- mitted to date plus the metabolic studies in progress would enable FDA to limit acrylonitrile consumption by setting a migration staneard for acrylonitrile bottles. After evaluating Monsanto's data, FDA officials still believed that the safety of acrylonitrile was sufficiently questionable to warrant banning its use in plastic bottles for carbonated beverages and beer. FDA advised Monsanto that (1) migration testing at 120 degrees represents only a slight exaggeration of possible storage and transportation temperatures and would cover all eventualities in the storage and shipments of the final product, (2) it could not guarantee that 120 degrees for 30 days represents the point at which all potential migration of acrylonitrile has occurred, nor could it. determine, with available data, that consuming large - volumes of a beverage containing up to 0.01 ppm acrylonitrile was safe, and (3) it could not set a no-effect level for acrylonitrile from the available data and the metabolic studies need to be completed before conclusions on sch a level could be drawn. On March 11, 1977, FDA published two notices in the Federal Register. One notice proposed several amendnents to the interim food additive regulation for acrylonitrile, including (1) the reduction of the maximum permissible StDunt of the substance allowed to migrate from packaging 13 B-164031(2) material other than beverage containers from 0.3 ppm to 0.05 ppm, (2) the deletion of duplicative requirements for submission of migration data on repeated-use articles, (3) a requirement for higher test temperatures, if needed, to simu- late actual use conditions, and (4) a requirement for addi- tional teratogenic tests in a species other than rats. The other notice suspended the food additive regulations that permitted acrylonitrile to be used to make beverage con- tainers. The notice stated that the regulations were being suspended pending full review of the objections and request for hearing filed by the National Resources Defense Council on July 13, 1976. (See p. 6.) The notice also said the Commissioner anticipated that, when the Dow Chemical chronic- feeding study was completed or possibly sooner, it would be appropriate to convene an evidentiary hearing to resolve the factual issues raised in the Council's objections. FDA'S ACTION STAYED )n March 7, 1977, Monsanto Company filed a motion in the .S. court of appeals requesting a review of FDA's sus- pens on of its regulation authorizing the use of acryloni- trile in bottles intended to hold soft drinks. On March 1, the court sustained Monsanto's motion pending its review of the merits and ordered that oral arguments be presented on March 16. The court granted the Natural Resources Defense Council permission to present oral arguments. In its motion Monsanto maintained that DA had not followed the procedures required by section 409 of the Fed- eral Food, Drug, and Cosmetic Act in suspending the regula- tion. Monsanto said that the regulation issued to it permit- ting the use of acry.onitrile in beverage bottles could not be suspended without prior notice and hearing. According to Monsanto the primary issue was whether FDA could remove a previously lawful product from the market without notice and opportunity for affected parties to contest the reason- ableness, necessity, or legality o the action. In an affidavit submitted with its motion to review FDA's suspension of the regulation, Monsanto's group vice-president stated that the most sensitive validated test methods avail- able showed that no migration occurred in Monsanto bottles under the intended conditions of use. He said that if Monsanto's motion were not granted, the company would suffer irreparable harm in at leas'. the following ways. 14 B-164031(2) -- It would be unable to sell existing inventories of about 15 nmillion bottles valued at more than $2 million. -- It would be unable to resume operations at some plants and facilities, and hundreds of jobs would be perma- nently lost. -- A arge part of its capital investment in the facili- ties producing the bottles, exceeding $60 million, would be lost. -- It would lose potential sales of more than $30 million in 1977 and projected sales of more than $100 million annually by 180. FDA argued that it had followed the administrative pro- cedures outlined in section 409 of the act, which was its basis for the suspension. FDA said that its authority to suspend the regulation was derived from that regulation's dependence on the results of ongoing efforts to establish safe conditions for use of acrylonitrile, as outlined in itF interim regulation. FDA also argued that (1) Monsanto was given the opportunity, through FDA's advance notice of its intentions in the environmental impact statement, to present data and arguments to the agency before the suspension was issued and (2) more importantly, Monsanto would have further opportunity at an evidentiary hearing to challenge FDA's judg- ment about the lack of safety of acrylonitrile in beverage bottles. FDA said that Monsanto's argument that a hearing should precede rather than follow the suspension is more appropriately directed at the Congress because section 409(e) provides that food additive regulations are effective at the time of publication in the Federal Register but may thereafter be stayed if objections are filed and a hearing is sought. FDA noted that the Congress has not provided for delaying regulations or for an automatic suspension upon receipt of objections. FDA said that, although it did not dispute Monsanto's assertion that the administrative suspension would result in loss of sales for Monsanto and "economic dislocation" of those workers laid off, it did not believe these injuries amounted to "irreparable injury." FDA said that Monsanto's claim was mitigated by the fact that it had been on notice since February 975, when the regulation for its product was issued, and in act since November 1974, when the proposed 15 B-164031(2) interim regulation for acrylonitrile notified all interested parties that the safety of the substance was an open question and that its use could be affected at any time by FDA action. According to FDA, the very real questions about the safety of the bottle could not allow Monsanto to assert its economic losses as a basis for continuing to expose the public to a potential health hazard. The court determined that for FDA to order a suspension of regulations based on objections filed 8 months earlier by the National Resources Defense Council constituted "arbitrary and capricious administrative action" and that the requirement of section 409(f)(1) of the Federal Food, Drug, and Cosmetic Act that a hearing be held "as promptly as possible," com- pelled FDA to process objections more expeditiously than it had in this case. On March 18, 1977, the court ordered that FDA's suspen- sion of the regulation issued for Monsanto's product be lifted until May 18 and that FDA hold the required public hearing promptly and issue final findings and conclusions by that date. On April 11, 1977, all parties involved in the case requested a 120-day extension, which the court granted, thus setting a new date of September 19 for issuance of final findings and conclusions. The hearing process required by the court has been com- pleted. Five parties participated: FDA, Monsanto Company, Borg-Warner Corporation, Vistron Corporation, and the Natural Resources Defense Council. The major issues addressed during the hearing, which was conducted by an administrative law judge, were (1) whether or not acrylonitrile is a food addi- tive as defined by law and (2) whether or not the safety of acrylonitrile used to fabricate beverage containers has been shown. Cross-examination of witnesses took place from June 20 through 27, 1977, and briefs were submitted to the administrative law judge for a decision. On August 4 the judge rendered an initial decision that acrylonitrile does migrate to food, thus making it subject to regulation under the act, and that it has not been shown to be safe for use in food. The FDA Commissioner reviewed the initial decision along with exceptions filed by the manufacturers. The Commis- sioner's final decision, effective September 19, 1977, 16 B-164031(2) affirmed the initial decision of the administrative law judge by finding "* * * that acrylonitrile copolymers used to fabricate beverage containers are food additives and that they have not been shown to be safe." The Commis- sioner s decision concluded the hearing process required by the court of appeals, and an official of FDA's Office of General Counsel said that a copy of the decision was filed with the court on September 20. On September 23 FDA published in the Federal Register, to be effective 90 days from that date, a final order ter- minating all regulations which permit the use of acryloni- trile in making beverage containers. An official of FDA's Office of General Counsel said that interested parties can now file objections to the ·decision with the court, which could re iew the basis for FDA's decision. He added that 6 months or more may be required to complete a court of appeals review of the decision. At that time the parties wor ld be required to accept the court's decision or appeal the case to the U.S. Supreme Court. As requested by your office, we have not obtained the Department of Health, Education, and Welfare's written com- ments on the matters in this report. However, we have dis- cussed these matters with FDA officials and have considered their comments. Sincerely yours, ACTING Comptroller General of the United States (10878) 17
Food Additive, Acrylonitrile, Banned in Beverage Containers
Published by the Government Accountability Office on 1977-11-02.
Below is a raw (and likely hideous) rendition of the original report. (PDF)