Document 44QVLawwj1w0R1xkEVM9q7NOV

Page 26 October 22, 1973 FOOD CHEMICAL NEWS ~^PVC SANCTION FOR LIQUOR BOTTLES WITH EXTRACTION LIMIT URGED The Society for the Plastics Industry last week unveiled research showing no detectable migration from alcoholic beverage bottles, and said that this can be analytically checked. In a comment, SP1 endorsed the Food and Drug Administration's proposed prior sanction affirmation for PVC in food packaging, but opposed the proposed ban on use of PVC for packaging alcoholic beverages (See FOOD CHEMICAL NEWS, Oct. 15, Page 2). . It is now apparent that polyvinyl chloride compounds for rigid containers can be prepared on commercial equipment which will show no detectable migration of vinyl chloride monomer to distilled alcoholic spirits packaged therein," SPI said, enc'osing a report of the scientific studies. When the problem of possible migration arose, the Society said, "a concentrated effort was made by the major suppliers of such compounds to confirm and then take very possible and practical steps to eliminate the possibility of such unexpected migration." PVC compounds, the comments said, have been "prepared by new technology to assure a low residual vinyl chloride monomer content, " and have been processed into bottles ' and extracted with water, 3% acetic acid, 5 0% ethanol, and heptane. ".. It can be stated that for each manufacturer reporting the extraction studies at 120F. for periods of time up to one month, no vinyl chloride monomer was detected in any of the solvents with methods ranging in sensitivity from 0.5 p p.m. to at least 0 = 05 p - p. m. ," SPI wrote. One bottle manufacturer performed extraction tests on bottles made from compounds supplied by two manufacturers, and no vinyl chloride monomers were detected with a method sensitive to at least 0 05 p.p.m., the letter said. Two firms independently developed gas chromatographic methods for determining vinyl chloride content in the 50% ethanol solvent, SPI said, and it would appear "that either method can be used satisfactorily for the intended purpose." T( s' s were made both of bottles made from virgin material and from 40% regrind, kPi said, with no vinyl chloride monomer detected using methods sensitive to 10 p.p.m "C un this it can be concluded that there was no significant increase in residual .moimmei >ntent as a result of processing and reuse, " the letter said. SPI continued: "... The FDA can now be assured that manufacturers of PVC I:oit!e compounds can provide formulations whi h, when used for packaging distilled spirits, will not yield v-t< ciabb vinyl chloride monomer to the contents when tested with analytical AS I methods sensitive to 0 05 p.p.m In light of the calculated no-effect level of 250 p.p.m for VCM in the total diet. . . , a finding of 'none detected' using methods sensitive to 0 05 p.p.m. is eminently suitable by a large safety factor to assure safety of such compounds when used to package distilled alcoholic spirits. 0000 165 95 .)'x:r 12 1973 Page 27 POOD CHEMICAL NEWS "Accordingly, it js submitted that the industry has now clearly demonstrated thoi continuing to accord prior sanctioned status. . . to polyvinyl .chloride resins in such a way as to encompass the use of such resins, when properly formulated, to package distilled alcoholic spirits would be wholly appropriate and consonant with the public inteicst." In a separate letter, Dewey and Almy submitted to TDA the results of its extraction tests using PVO gaskets in 8% alcohol, 100% alcohol, and wine which was 12% alcohol. The turn said vinyl chloride monomer in each test was less than 50 p.p.b. SPI recommended that a limit be placed on "the level of vinyl chloride monomer detectable in an appropriate food-simulating solvent when exposed under suitable test conditions," suggesting that the proposed 121.2009 prior sanction regulation read, as follows: "Polyvinyl chloride resins .. . may be used as a component of food packaging material. As regards rigid containers made from polyvinyl chloride resins and intended for packaging of distilled alcoholic spirits, such containers shall show no detectable extraction (at the level of sensitivity of the method) of vinyl chloride monomer in a 50% solution by volume of ethyl alcohol in water when one pint containers containing such alcohol solutions are stored at 120F. for 28 days and are tested with a procedure capable of detecting vinyl chloride monomer down to a sensitivity of 0.05 p.p.m. A suitable procedure is available from the Commissioner on request." The Society said a ban on PVC for packaging alcoholic foods "is neither necessary nor appropriate, " and that such a ban "would cause unnecessary hardship and economic loss..SPI also said consumers "would be denied the choice of a safe and suitable packaging material." The letter said that "any controls required should be directed not at PVC resins per se but rot! or , should be aimed at assuring that the compounds. .. used for packaging distilled alcoholic spirits are suitable for their intended use." SIT also asked that FDA not use the phrase "alcoholic foods, " noting that since any mig'ation problem pertains only to distilled alcoholic spirits that any limitations should apply to "well identified problem areas." The term "alcoholic foods," the letter said "world be subject to wide variations in interpretation and could only lead to unnecessary and continuing confusion." IT jo American Conference of Governmental Industrial Hygienists have set a 200 p.p.m, limit for vinyl chloride monomer in air, SPI said, concluding from this that "250 p.p.min me total diet is without effect." The organization explained that theACGIH figure 'as "based upon chronic exposure in man, not experimental animals, and the assumptions ore quire 'conservative' on the side of safety..." AS I 000016596 > . V, Daqe 2 8 October 7 2 . 197 3 FOOD CHEMICAL NEWS SPI also refened to limits on rVC set under two Euod Additive orders, 121.25:9 `'or resinous and polymeric coatings and 121.2550 for scaling gaskets with elesurbs for food containers. Extraction studies were conducted with PVC can linei enamels which have been cleared under the Orders, BPI said and the test results showed "no detection of vinyl chloride monomer in alcoholic beverages such as malt beverages and wine or in 'he spectrum of food-simulat mg solvents used to O lear' other i or d pai. haqmg materials . " Regarding possible environmental effects, BPI recalled that tno Bureau of Alconol Tobacco and Firearms had filed a favorable Pinal Environmental Impact Stutenmnt which concluded that "PVC plastic is a suitable material for use in the mqnufaetur.- of liquor bottles." The Society endorsed FDA's proposal to affirm the PVC prior sanction, noting mat this win be the first one listing a basic polymer "indirect additive." SPI called the affirmation "picccdentaJ. " Tracing the history of PVC use for alcoholic beverages SPI noted chat BAT:' in 19h8 permitted experimental use, and said; "At a very late and critical time when BATF had completed and published a favorable Final Impact Statement on the use ot PVC iiquor bottles so that it appeared routine commercial '..so wemd soon be allowed, it was reported to the FDA, to the surprise of most of those in t re plastics and alcoholic beverages industries that vinyl chloride monomer in the range of 1U to 20 p.p.rr.. was found in some experimentally packaged distil fed alcoholic beverages " , SPI said it is "unaware of any contention that the presence of vir,/] monomer m ;oods ewm at the 10 tc 20 p-.p-. rm. range presen's a f roblem to public healt" cm surer,', " and said it understands that the problem would be one of adulte, alien under 402 of FDA's iaw, Tn<' Society also noted "thar the reports on detection ot tue presence oi monorne in drs'iEmd alcohc iic spirits came as a surprise to the scierniiic community because r. nad be- n gene, ally assumed that the monomer, Being a gas m ndtn-e, would most e;Tain;y volatilize off during the various manufacturing process is u cH-cd m compound and bottle pr t'diicnon, " SPI said rosou: :h was conducted into Iho "possible migration of vinvl cfoiid-. monomer to olccu'cujc bo-erages of 3 >wcu aicohoi content pachaned in japan," and tuat "nc sample surwed detuctaale vinyl chloride monomers " The hT n addon: "It is ecognizcd mat these results arc at variance vpi, 'hose ahuded to in the preamble of the subject pioposcd r. g Nation wherein it is stated that vinyl chloride monomer was found in wine packaged in PVC containers. It is 1" ivveri :Ou any o! i: f' - * ' m probably reflect differences in the vinyl chloiide compounds wire . were used tc prepare the bottles. In any ro.se, n is submitted it,at these Japanese data -- the only information known tc us directly relevant to lower alcohol content beverages -- adequateiv indicate that the distilled spirits situation is unique and should be treated in this light." 0000l6a^ s