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, ActingComptroller General.

Issue Area: Food (1700); Consumer and orker Protection: Safetyof 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 beformed into more complex compounds known as polymers that areused to make various plastic articles. Beverage bottles made ofacrylonitrile copolymers are lightweight, do not cause injury ifbroker,, and are, therefore, desirable to consumers. Acharacteristic of such bottles, however, is that afte,pclymerization, a small amoant of "residual" acrylcnitrile thathas not combined with other monomers remains in the plastic andmay become part of the substance in te bottle. Someacrylonitrile copolymers also depolymerize to some ext4 ent,allowing additional acrylonitrile to migrate to the rood.Findings/Conclusions: In January 1977, Food ad DrugAdministration (FDA) officials decided that the use ofacrylonitrile in making plastic bottles for carbonated beveraesand beer should be banned and that all other acrylcnitrile usesshould be restricted to a maximum permissible migration level of0.05 ppm. n arch 7,. 1977, Monsanto Coapany filed a moticn inthe U.S. court of appeals requesting a review of FDA'ssuspension of its regulati-n authorizing the use ofacrylonitrile in bottles intended to hold soft drinks. In itsmotion, Monsanto Company maintained that PA had not followedthe procedures required by section 4C9 of the Federal Food,Druq, and Cosmetic Act in suspending the regulation. The primaryissue of this motion was whether FDA could remove a previouslylawful product from the market without notice and opportaniryfor affected parties to contest the action. The ccurt crderedthat 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 fabricatebeverage containers were judged to be food additives and werenot safe for use in food. FDA tereinated all regulations thatpermit acrylonitrile in beverage containers. (SW)

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..cJ' 'ai REPORT OF THEo ;X}~BP COMPTROLLER GENERAL

~N'~' OF THE UNITED STATES

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Food Additive, Acrylonitrile,Banned in Beverage Containers

Acrylonitrile has been used for about 30years to make various plastic food contain-ers. Recent studies show that, when used inbeverage containers, this substance migratesto the packaged beverage, contaminating it.

Bated oc these studies and on the results of apublic hearing concerning these issues, onSep.amt3r 23, 1977', the Food and Drug Ad-ministration published a final order erminat-ing all regulations that permit acr!;',litile inbeverage containers.

HRD-78-9 NOVEMBER 2, 1977

COMPTROLLFR GENERAL OF THE UNITED STATESWASHINGTON. D.C. 20!48

B-164031(2)

The Honorable Toby MoffetLHouse of Representatives

Dear Mr. Mor.cett:

In your letter of March 15, 1977, you requested ourobservations 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 makingbeverage 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 offood additives; examined FDA's records relating to tneregulatory status of acrylonitrile; and reviewed testimonypresented at a public hearing on acrylonitrile used to makebeverage containers.

As agreed with your office, we are sending copies ofthis report to the Secretary of Health, Education, end Welfareand the FDA Commissioner. Unless you publicly announce itscontents earlier, we will not distribute this report furtheruntil 7 days from the date of the report.

REGULATION OF FOOD ADDITIVES

The Federal Food, Drug, and Cosmetic Act, as amended bythe Food Additives Amendment of 1958, requires FDA to estab-lish regulations prescribing the conditions under which a foodadditive 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, eitherdirectl" or indirectly, or which may otherwise affect thecharacteristics 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.

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Substances used in accordance with approvals given by theDepartment of Agriculture and FDA before the enactment of the1958 Food Additives Amendment are not subject to such regula-tions. Tnese approvals, generally known as prior-sanctionedapprovals, were based on safety requirements less formal andrestrictive 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 packagesis considered a food additive if it may reasonably be expectedto become a component, or to directly or indirectly affectthe characteristics of food packed in the container. Packag-ing material that migrates to the food is an indirect foodadditive.

The Food Additives Amendment of 1958 and FDA regulationsrequire that a petitioner requesting the approval of an in-direct food additive demonstrate the safety of the additivewith appropriate data showing the amount of the substancethat is expected to migrate to food and the results oftoxicological studies. The amendment also requires FDA toconsider 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, thenumber and type of toxicological tests the agency requiresfor a safety evaluation of an indirect additive depend on theamount of the chemical that is expected to migrate to thefood. He said that FDA requires only acute toxicity data toinsure that a substance is not a highly toxic chemical whenanticipated migration is "virtually nil" (generally less than0.05 parts per millicn (ppm)), provided that the substanceis not a heavy metal or a pesticide and there is no reasonto suspect carcinogenicity or teratogenicity. More extensivetoxicological test data is required when migration of a sub-stance is anticipated to be "negligible" (more than 0.05 ppmbut less than about 1.0 ppm).

WHAT IS ACRYLONITRILE?

Acrylonitrile is a volatile, clear liquid. Because ofits relatively low molecular weight, it is classified as amonomer, which, when joined with certain other monomersthrough a process known as polymerization, can form morecomplex compounds known as polymers that are used to makevarious plastic articles.

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Acrylonitrile copolymers, a class of polymers, havebeen used for about 30 years in various food containers,such as margarine tubs, vegetable oil bottles, and pipes forhandling food products. Copolymers with high concentrationsof acrylonitrile have excellent barrier (pressure-holdina)characteristics. Since such copolymers have low permeabilityto gases, they are suitable for carbonated beverage bottlesthat must retain gas for extended periods.

Beverage bottles made of acrylonitrile copolymers arelightweight, do not cause injury if broken, and are thereforedesirable to consumers. A characteristic of such bottles,however, is that after polymerization, a small amount of"residual" acrylonitrile that has not combined with othermonomers remains in the plastic and may become prt of thesubstance in the bottle. Some acrylonitrile copolymers alsodepolymerize to some extent, allowing additional acrylonitrileto 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 analyticaldata indicating that there was no significant migration ofacrylonitrile to food under the conditions of its intendeduse. These approvals included uses for oleomargarine wrapsand equipment and containers used in fod processing.

Pursuant to the 1958 Food Additives Akendment the ap-proval process for food additives requires the submission ofa petition proposing the issuance of a regulation that wouldprescribe the conditions under which an additive may be safelyused. Since 1958 FDA has issued 20 food additive regulationsapproving various additional acrylonitrile uses in food-contact articles. These approvals were based on data sub-mitted with petitions which showed no significant. migrationof acrylonitrile to the packaged food. The first regulationallowing the use of acrylonitrile in plastic beverage bottleswas issued to Vistron Corporation on June 11, 1970.

SAFETY LATER QUESTIONED

Extraction studies submitted by the E. I. duPont deNemours Company with its June 14, 1973, petition to FDArequesting approval for use of its acrylonitrile bottle topackage soft drinks showed that acrylonitrile migrated frombottles to food when stored at elevated temperatures for

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extended periods. Extraction stu-.es can measure, throughlanalytical methods, the aunt of a substance that hasmigrated to a food. Based on the new evidence and the factthat improved procedures for detecting and measuring acrylo-nitrile had been developed, FDA began a complete review ofall safety data available on this substance.

FDA found that available toxicity data on acrylonitrileconsisted primarily of two series of long-term feedingstudies. One series, entitled "The Pharmacology and Toxic-ity of Acrylonitrile and Acrylon" (by P. E. Tullar, GeorgeWashington University, Nov. 1, 194 ), does not, accordingto FDA, meet current standards for the toxicological testingof substances such as food additives. An FDA Division ofToxicology official said that, at best, a tentative "no-adverse-effect" level for acrylonitrile could be establishedfrom this study at 38 ppm.

The other series of studies available at that time wasmade by Svirbely and Floyd of the U.S. Public Health ScLviceat the Taft Sanitary Engineering Center in Cincinnati in thelate 1950s. The series consisted of 2-year fding studiesin 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-effectlevel for acrylonitrile.

Based on the results of its review, FDA concluded thatthe safety of acryloni-ile was questionable, that the evelof acceptable migration should be limited, and that addi-tional information and studies were needed on (1) analyticalmethods concerning migration and (2) toxicity.

FDA regulations (21 C.F.R. 180.?) state that substanceswith a history of use in food fo£ human consumption or infood-contact surfaces may at any time have their safety orfunctionality bought into question by new information thatin itself is inconclusive. An interim food additive regula-tion for the use of any such substance may be issued

"* * * when new information raises a substantialquestion about the safety or functionality of thesubstance but there is a reasonable certainty thatthe substance is not harmful and that no harm tothe public health will result from the continueduse of the substance for a limited period of time

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while the question raised is being resolved byfurther study."

On November 4, 1974, FDA published in the FederalRegister a proposed interim ooC additive regulation foracrylonitrile intended for use in food-contact articles.This regulation proposed, for an interim period; a limitof 0.3 ppm as the maximum amount of acrylonitrile allowedto iarate to food and required that toxicological studiesbe conducted to determine the safety of lcw levels of acry-Ionitrile ingestion.

The 0.3-ppm migration limitation was established byapplying 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) providethat

"* * * a food additive for use by man will notbe granted a tolerance that will exceed 1/100thof the maximum amount demonstrated to be withoutharm to experimental animals."

On June 19, 1975, the Manufacturing Chemists Associationsubmitted, for FDA review, protocols for a series of studiesdesigned to provide the toxicity data called for by the pro-posed interim regulation.. On July 18, 1975, FDA informed theassociation that the protocols, with some technical modifica-tions, were acceptable. The association contracted with theDo Chemical Company to make the studies. The studies weresponsored by the following manufacturers or major users ofacrylonitrile: American Cyanamid Company, Borg-WarnerChemicals, Dow Chemical Company, E. I. duPont de Nemours andCompany, Monsanto Company, Standard Oil Company (Ohio),Tennessee Eastman Company, and Uniroyal, Incorporated.

After publishing its proposed interim regulation onacrylonitrile, FDA issued regulations permitting duPont,Borg-Warner, Monsanto, and Dow to use acrylonitrile to makeplastic bottles.

ISSUANCE OF FINAL INTERIM REGULATION

On June 14, 1976, FDA issued in final form the interimfood additive regulation on the use of acrylonitrile in food-contact articles. The regulation established the maximumpermissible level of acrylonitrile migration at 0.3 ppm

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pending the results of the ongoing toxicity studies.Thirty days were allowed for comments on and objectionsto the regulation.

Four manufacturers and one industry association sub-mitted comments to FDA on the interim regulation. Thesecomments included questions about

-- the appropriateness of a 120 degree FaLrenheit tem-perature requirement for migration studies,

--the technical inconsistency of the volume-to-surfaccratio requirements for migration measurement,

--the Fossitility of extending the 30-day comment periodto allow time to obtain FDA's migration test method-clogy and evaluate the regulation: iTm-ct on theproduct being manufactured, and

-- the lack of prior knowledge about the existence ofthe proposed regulation.

Only the Natural Resources Defense Council filed anobjection 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 thatacrylonitrile causes cancer.

-- The fact that acrylonitrile, also known as vinylcyanide, is chemically related to vinyl chloride,a known carcinogen.

--An epidemiology study of Japanese acrylonitrileworkers which found a correlation between exposureto the substance and impairment of liver function.

Based on the lack of sufficient data supporting the safetyof acrylonitrile, the council on July 13, 1976, requestedthat a stay be granted of any food additive regulationunder which acrylonitrile might reasonably be expectedto migrate co a food product. The council requested thatthe stay remain in effect pending a hearing and a decisionon its objection.

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STUDY RESULTS

Studies done in response to the need for additionalinformation on acrylonitrile include toxicity studies iden-tified in the interim food additive regulation and migrationstudies 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 DowChemical. In the first study, rats were fed acrylonltrileat levels of 0, 35, 85, 210, and 500 ppm in their drinkingwater for 90 days.

The study report stated that:

"Results of this study indicate that male andfemale rats may ingest water containing atleast 85 ppm of acrylonitrile for a period f90 days without a deleterious effect on any ofthe arameters evaluated."

The repozt noted that decreased body weight gains were ob-served in male rats in the top dose level and in female ratsin the two top dose levels. It further reported that smallbu. significant increases in liver to body weight ratios wereobserved ii male and female rats on water containing 500 and210 ppm acrylonitrile.

Dur'.na the second study, purebred beagle dogs were fedacrylonitrile at levels of 0, 100, 200, and 300 ppm (eightdogs per level) ii their drinking water for 6 months.

The study report concluded that:

"Ingestion of AN [acrylonitrile] in the drinkingwater by male and female dogs at 200 and 300 ppmfor a period of 6 months was associated withtoxicological manifestations primarily andsecondarily related to AN.

"Ingestion of AN in the drinking water at 100 ppmfor 6 months resulted in no toxicological mani-festations in male or female dogs."

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The FDA toxicologist who evaluated the study, however,stated in a February 1977 memorandum to the Director ofFDA's Division of Food and Color Additives that:

"With the normal criteria of toxicity dataevaluations, the no-effect level appears to belower than 100 ppm (8-10 mg/kgm [milligrams perkilogram]). The effect at this level was aslight lag in owth, and microscopic changesin the esophagus, with increased thickening ofthe epithelium of the tongue."

He said that at the two higher dose levels, effects suchas growth lags, increased mortality, and reduced liverfunction were noted.

On Aril 19, 1976 the Manufacturing Chemists Associa-tion submitted to FDA the results of a study conducted byYounger Laboratories .. te joint toxic action betweenacrylonitrile and potassium cyanide. This study in whichmale and female rats were orally given mixtures of acrylo-nitrile and potassium cyanide showed no evidence of syner-gistic effect on acute toxicity.

On October 13, 1976, the association submitted resultsfrom nutagenici`y studies made in three different labora-tories. Only one laboratory reported evidence of mutageniceffects from one of several tests that it conducted.

In November 1976 the association submitted to FDA areport entitled "Teratologic Evaluation of AcrylonitrileMonomer Given to Rats by Gavage." The study, conducted byDow Chemical, was designed to evaluate the effects of acry-ionitrile on embryonal and fetal development. In the studypregnant rats were given, oii days 6 through 15 of gestation,either 0, .0, 25, or 65 mg of acrylonitrile per kilogram ofbody weight by gavage (oral administration of a substancedirectly to the stomach through a feeding tube). At the65-mg feeding level, effects such as maternal toxicity, in-creased numbers of fetal malformations, decreased fetalwei,ht, and minor skeletal variants occurred. At the 25-mgfeeding level, maternal toxicity and malformations alsooccurred, but with less frequency. The report stated thatat the 10-mg (approximately 100-ppm) feeding level, there wasno evidence of toxicity to either the mother or her develop-ing embryo or fetus.

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On January 14, 1977, the sscciation submitted to FDAa 13-month interim report on a 2-year rat feeding studybeing 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- and300-ppm levels, the interim report stated that:

"It is concluded hat administration of ANunder the condition of this study has signifi-cantly lowered body weight, produced pathologicchanges in the gastric epithelium, increased theincidence of masses of the ear duct and producedproliferative lesions in the centLal nervoussystem of rats. The significance of the higherincidence of subcutaneous masses in the mammaryregion of the rats is less clear, and its resolu-tion will have to await further progress in thestudy."

On April 11, 1977, the Manufacturing Chemists Associa-tion provided FDA with updated information on the interimfindings of Dow's 2-year rat feeding study. According tothe association, the study investigator had found tumors ofthe central nervous system in two rats on the 35-ppm feedinglevel of the same type found earlier in rats on the 100.- and300-ppm feeding levels.

The association also notified FDA that another 2-yearstudy in which rats were being exposed to 0, 20, or 80 ppmacrvlonitrile by inhalation showed the following interimresults.

-- Three rats in the highest dose group (80 ppm) devel-oped tumors of the central nervous system comparableto those reported in the 2-year ingestion study.

--An increased incidence of ear canal tumors and mammaryregion masses was detected at the 80-ppm level.

--An apparent increase in the subcutaneous masses of themammary region was detected in the rats in the 20-ppmgroup.

--No ear canal or central nervous system tumorF werefound in the 20-ppm group.

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'ccording to an FDA Division of Toxicology official, althoughan inhalation study is not directly relevant to ingestion-oxicity, the findings of tumors similar to those in thefeeding 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 Companyprovidedd3DA with preliminary results of an ongoing epidemi-ology st'ldy of workers exposed to acrylonitrile in a textilefibers lant. The preliminary findings revealed a possiblerelationship between exposure of in-plant workers to acrylo-nitrile and cancer. A higher-than-expected incidence ofvarious types of cancer was found among the 470 males sur-veyed. These men began working in the polymerization areaof the plant between 1950 and 1955 and are either stillactively employed by or retired from the company. Medicaldata analyze3 through December-31, 1975, showed that 16 cancercases among his group were found, compared with an expectedcompany rate of 5.8 and a national rate f 6.9. The casesinclude six lung cancers (1.5 expected) and three coloncancers (0.5 expected). All cases of cancer occurred in thegroup naving initial exposure during startup of the plant in1950 through .1952.

Migration/extraction stidies

In 1975 FDA began o develop methodologies for measuringacrylonitrile migration. The team leader responsible forFDA's efforts stated in written testimony for a public hear-ing (see pp. 16 and 17) that FDA had developed and confirmeaan extraction test method capable of measuring acrylonitrileat levels of 0.04 pm. e said that FDA's method is based onone submitted by duPont which uses gas liquid chromatography.

The team leader s.d that two migration studies onacrylonitrile bottis have been made with FDA's method. OnAugust 6, 1976, FDA began a migration study using two testgroups of acrylonitrile bottles--four 32-ounce bottles fromMonsanto and four 16-ounce bottles fron Borg-Warne:--which,according to FDA's analysis, contained 9 to 10 ppm and 25 ppmresidual acrylonitrile, respectively.

Two of the bottles from each company were filled withthe food simulant 3 percent acetic aid and two with foodsimulant 8 percent ethanol, and each was heated to 120 degreesFahrenheit. Food simulants are often used in place of food

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products during migration te.ts ir order to simplify detectionand measurement by eliminating many of the unknown substancesthat might be present in food. Acetic acid is generally ac-cepted as a substitute for carbonated beverages and ethanolas a substitute for alcoholic beverages.

Test samples were withdrawn from the bottles over a periodof about 5 months. The following table presents the averageconcentrations of acrylonitrile found on January 12, 1977, insamples drawn from the bottles during the test period.

Acrylonitrile foundSolvent Monsanto bottles Borg-Warner bottles

3 percent acetic acid 0.062 ppm 0.112 ppm8 percent ethanol .078 ppm .126 ppm

An FDA project manager involved in regulating acrylonitriletold us that the Borg-Warner bottles used in this test wereearly prototype bottles, not those made from copolymers thatcomplied with the final Borg-Warner regulation.

According to the team leader, the second FDA study usedempty and filled Monsanto bottles obtained from the Coca ColaBottling Company of New York on August 9, 1976. In one por-tion of the study, two empty bottles, whose walls were foundto contain approximately 7 to 8 ppm of residual acrylonitrile,were filled on February 14, 1977, with 3 percent acetic acidand stored at 120 degrees Fahrenheit. After various periodsof time, samples of the acid were withdrawn and tested. Theaverage amount of acrylonitrile found in the acid samples isindicated below.

Average amount ofacrylonitrile(estimated)

Date Elapsed time (note a)

2/24/77 10 days 0.005 ppm3/ 1/77 14 days .005 ppm3/15/77 28 days .005 ppm4/12/77 56 days .018 ppm5/10/77 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.

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In another phase of the study, four of the bottlesfilled with Coca Cola were maintained at room temperaturefrom the time of collection until January 1977. FDA extrac-

tion studies showed corcentrations of acrylonitrile in theCoca Cola ranging from 0.013 to 0.029 ppm.

The FDA laboratory confirmed these findings with massspectromeLric and polarographic techniques. Both techniquesconfirmed the levels of acrylonitrile found in the Coca Colausing the gas liquid chromotography method. The laboratoryteam leader believed that FDA's studies unequivocally estab-lish that acrylonitrile beverage containers can reasonablybe expected to become, and in fact do become, a component ofthe 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 inNovember 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 draftrevision to the interim regulation dated November 1976 wasprepared.

After receiving the interim report on Dow's 2-yearchronic-feeding study in January 1977, FDA officials decided

that the use of acrylonitrile in making plastic bottles forcarbonated 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'sOffice 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 occursin 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 toacrylonitrile from caroonated beverage containers than fromother food-contact uses.

On February 15, 1977, FDA published its environmentalimpact statement in the Federal Register which included an

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announcement of the agency's intentions to (1) suspend theuse of acrylonitrile in making plastic bottles for carbonatedbeverages and beer and (2) reduce the allowable amount ofacrylonitrile migration from 0.3 ppm to 0.05 ppm for allother food-contact articles.

At that time the Coca Cola Company was test marketingits product packaged in acrylonitrile bottles manufactured byMonsanto 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 useof such bottles. Monsanto's primary points were that (1) themigration test procedures which require storing the bottlesat 120 degrees Fahrenheit until no further migration occurswere unreasonable since sealed soft drink bottles deform atthat temperature and the contents are ruined, (2) in lieu ofa ban, a standard should be set allowing no acry onitrilemigration to soft drinks when the bottles are stored for30 days at 120 degrees Fahrenheit (equivalent to 2 years ofstorage at room temps-ature) and tested with a proposed testmethod sensitive to 0.01 ppm, and (3) the safety data sub-mitted to date plus the metabolic studies in progress wouldenable FDA to limit acrylonitrile consumption by setting amigration staneard for acrylonitrile bottles.

After evaluating Monsanto's data, FDA officials stillbelieved that the safety of acrylonitrile was sufficientlyquestionable to warrant banning its use in plastic bottlesfor carbonated beverages and beer. FDA advised Monsantothat (1) migration testing at 120 degrees represents onlya slight exaggeration of possible storage and transportationtemperatures and would cover all eventualities in the storageand shipments of the final product, (2) it could not guaranteethat 120 degrees for 30 days represents the point at which allpotential migration of acrylonitrile has occurred, nor couldit. determine, with available data, that consuming large -volumes of a beverage containing up to 0.01 ppm acrylonitrilewas safe, and (3) it could not set a no-effect level foracrylonitrile from the available data and the metabolicstudies need to be completed before conclusions on sch alevel could be drawn.

On March 11, 1977, FDA published two notices in theFederal Register. One notice proposed several amendnentsto the interim food additive regulation for acrylonitrile,including (1) the reduction of the maximum permissibleStDunt of the substance allowed to migrate from packaging

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material other than beverage containers from 0.3 ppm to0.05 ppm, (2) the deletion of duplicative requirements forsubmission of migration data on repeated-use articles, (3) arequirement 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 regulationsthat permitted acrylonitrile to be used to make beverage con-tainers. The notice stated that the regulations were beingsuspended pending full review of the objections and requestfor hearing filed by the National Resources Defense Councilon July 13, 1976. (See p. 6.) The notice also said theCommissioner anticipated that, when the Dow Chemical chronic-feeding study was completed or possibly sooner, it would beappropriate to convene an evidentiary hearing to resolve thefactual issues raised in the Council's objections.

FDA'S ACTION STAYED

)n March 7, 1977, Monsanto Company filed a motion inthe .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 ofthe merits and ordered that oral arguments be presented onMarch 16. The court granted the Natural Resources DefenseCouncil permission to present oral arguments.

In its motion Monsanto maintained that DA had notfollowed 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 notbe suspended without prior notice and hearing. Accordingto Monsanto the primary issue was whether FDA could removea previously lawful product from the market without noticeand 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'ssuspension of the regulation, Monsanto's group vice-presidentstated that the most sensitive validated test methods avail-able showed that no migration occurred in Monsanto bottlesunder the intended conditions of use. He said that ifMonsanto's motion were not granted, the company would sufferirreparable harm in at leas'. the following ways.

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-- It would be unable to sell existing inventories ofabout 15 nmillion bottles valued at more than$2 million.

-- It would be unable to resume operations at some plantsand 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 millionin 1977 and projected sales of more than $100 millionannually by 180.

FDA argued that it had followed the administrative pro-cedures outlined in section 409 of the act, which was itsbasis for the suspension. FDA said that its authority tosuspend the regulation was derived from that regulation'sdependence on the results of ongoing efforts to establishsafe conditions for use of acrylonitrile, as outlined in itFinterim regulation. FDA also argued that (1) Monsanto wasgiven the opportunity, through FDA's advance notice of itsintentions in the environmental impact statement, to presentdata and arguments to the agency before the suspension wasissued and (2) more importantly, Monsanto would have furtheropportunity at an evidentiary hearing to challenge FDA's judg-ment about the lack of safety of acrylonitrile in beveragebottles. FDA said that Monsanto's argument that a hearingshould precede rather than follow the suspension is moreappropriately directed at the Congress because section 409(e)provides that food additive regulations are effective at thetime of publication in the Federal Register but may thereafterbe stayed if objections are filed and a hearing is sought.FDA noted that the Congress has not provided for delayingregulations or for an automatic suspension upon receipt ofobjections.

FDA said that, although it did not dispute Monsanto'sassertion that the administrative suspension would result inloss of sales for Monsanto and "economic dislocation" ofthose workers laid off, it did not believe these injuriesamounted to "irreparable injury." FDA said that Monsanto'sclaim was mitigated by the fact that it had been on noticesince February 975, when the regulation for its product wasissued, and in act since November 1974, when the proposed

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interim regulation for acrylonitrile notified all interestedparties that the safety of the substance was an open questionand that its use could be affected at any time by FDA action.According to FDA, the very real questions about the safetyof the bottle could not allow Monsanto to assert its economiclosses as a basis for continuing to expose the public to apotential health hazard.

The court determined that for FDA to order a suspensionof regulations based on objections filed 8 months earlier bythe National Resources Defense Council constituted "arbitraryand capricious administrative action" and that the requirementof section 409(f)(1) of the Federal Food, Drug, and CosmeticAct that a hearing be held "as promptly as possible," com-pelled FDA to process objections more expeditiously than ithad in this case.

On March 18, 1977, the court ordered that FDA's suspen-sion of the regulation issued for Monsanto's product belifted until May 18 and that FDA hold the required publichearing promptly and issue final findings and conclusions bythat date. On April 11, 1977, all parties involved in thecase requested a 120-day extension, which the court granted,thus setting a new date of September 19 for issuance of finalfindings 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 NaturalResources Defense Council. The major issues addressed duringthe hearing, which was conducted by an administrative lawjudge, were (1) whether or not acrylonitrile is a food addi-tive as defined by law and (2) whether or not the safety ofacrylonitrile used to fabricate beverage containers has beenshown.

Cross-examination of witnesses took place fromJune 20 through 27, 1977, and briefs were submitted tothe administrative law judge for a decision. On August 4the judge rendered an initial decision that acrylonitriledoes migrate to food, thus making it subject to regulationunder the act, and that it has not been shown to be safe foruse in food.

The FDA Commissioner reviewed the initial decision alongwith exceptions filed by the manufacturers. The Commis-sioner's final decision, effective September 19, 1977,

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affirmed the initial decision of the administrative lawjudge by finding "* * * that acrylonitrile copolymers usedto fabricate beverage containers are food additives andthat they have not been shown to be safe." The Commis-sioner s decision concluded the hearing process requiredby the court of appeals, and an official of FDA's Officeof General Counsel said that a copy of the decision wasfiled 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 saidthat interested parties can now file objections to the·decision with the court, which could re iew the basis forFDA's decision. He added that 6 months or more may berequired to complete a court of appeals review of thedecision. At that time the parties wor ld be required toaccept the court's decision or appeal the case to theU.S. Supreme Court.

As requested by your office, we have not obtained theDepartment 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 consideredtheir comments.

Sincerely yours,

ACTING Comptroller Generalof the United States

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