Document Z4M9Vm4e1Or8pNZZMv8ZN4DwO

a) (2) :onsider ,`.e t of ,tyltin es of yi of the ;>f the fuite --rate with the ts of : Terences. melting ,_s readily ased on i-mefitoered --Errbered ormer to ..n 121, -.376). . (1964). Vi (1979). Pure <1 Appl. Cher,,, Vol,53, pp,563-592. Pergamon Press Ltd. 1981. Printed in Great Britain'. TUPAC 0033-4545/81/0201-0583S02.00/0 : i i REGULATORY STATUS OF POLYVINYL CHLORIDE, 1980 i f Jerome H. Heckman * \ Keller and Heckman, Washington, D.C. 20036, USA i Abstract - The regulatory history of Vinyl Chloride and i Polyvinyl Chloride, particularly at the Occupational Safety and Health Administration, the Food and Drug Administra tion, and the Environmental Protection Agency, is reviewed in detail. It is evaluated in terms of perceptions of the soundness of governmental actions and also as an ex ample of responsible industry achievement. Despite con stant reevaluation by the involved agencies, the urgency j that initially characterized their actions regarding vinyl chloride has been tempered by continuing improvements in monomer management and recently maturing concepts of risk assessment. The most valuable benefit to flow from the vinyl chloride experience may well be its influence in focusing attention on the need for more objective risk assessment as an accepted basis for all regulatory deci sion-making. * ** Many have waxed eloquently on the vinyl chloride (VCM) and polyvinyl chlor ide (PVC) sagas. Depending on their disciplines, motivation and timing, some have given the problem the kind of treatment designed to conjure up the image of the industrial holocaust of this century; others have used the handling of it as a model for diagnosis and corrective achieve ment in the "era of environmentalism." In short, you can find Support for theorizing that the vinyl chloride regulatory story is the Last Sup per, or "Chock Full of Nuts." As usual, the truth lies somewhere in between, and the telling of it might well test the powers of a Tacitus or Toynbee. 1 have no such powers. My qualifications to retell the story are the same as those given by Tal leyrand who replied when asked what he contributed to the French Revolu tion: "I lived through it." To this famous Frenchman's succinct response I must add "so far." It is never accurate to break history into parts since events overlap, i chronologically and dynamically. Nevertheless, the practice is time honored; it is also the approach least likely to add confusion to this discussion. Hence, please bear with me while I divide my tale into three chapters of regulatory history--the Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), and Environmental Protection j Agency (EPA) PVC and VCM stories (Note a). All three areas have a begin- ' Note a: Since we have no shortage of regulatory coverage at this time j in our history, I note in passing that other agencies have also played some role in the vinyl chloride exercise. For example, in early 1974, the Consumer Product Safety Commission, as well as FDA and EPA, banned l the already-outmoded use of vinyl chloride as an aerosol propellant, i As with CPSC, I will only footnote the fact that the Departments of Trans it portation (DOT) and Housing and Urban Development, as well as many state < legislative and other bodies, have at one time or another played roles j on the vcm regulatory scene. The actions were necessary on occasion (e.^., DOT warning requirements). On others, this is questionable. For the ~ ipurposes of this paper, little or no further mention will be made of these related activities since I think it fair to say that all amounted to "fall out" from the more essential situations covered here. 583 VC5662 4 584 JERO ; II. HECKMAN ning, more or less well-defined. None of them has an end as yet, but then this is America in the last half of the Twentieth Century. It is a time when agencies issue documents with self-contradicting designations like interim final regulations, or temporary permanent standard. Keeping doors open in this peculiar way means few regulatory issues ever appear to be laid to rest. The first regulatory crisis directly impacting the PVC marketplace came as a result of an FDA proposal after the surprising finding by Schenley Distillers that VCM was leaching into alcoholic beverages from polyvinyl chloride liquor bottles. This 1973 revelation, however, concerned a li mited market. It gained nowhere near the media and consumerist attention that came in 1974 when OSttA focused its attention on vinyl chloride after an alert industry physician called attention to his uncovering of an unsus pected occupational health problem. Somewhat arbitrarily, then, let's reexamine the OSHA experience following the principle that what the media finds most worthy of its attention gets the public's attention and thus must always be dealt with first. Next, I will review the current status of things at FDA, where the impact of regulatory reaction and inaction is still being felt strongly. Finally, I will do my best to tell you about the prologue for the present state of affairs at the Environmental Protection Agency (EPA). As with many raw materials used in the production of safe and useful fin ished products, VCM, the essential building block for PVC, had long been known to cause side effects experienced by workers exposed to high concen trations. At extremely high levels, it exhibits a narcotic effect. Know ing what we do today, it is ironic that the medical profession used VCM as an anesthetic, halting this practice when the gas was found to cause heart arrhythmia (Ref. 1). At the high levels, vinyl chloride also pre sents a flammability and explosion risk, readily handled through careful monitoring and use of control technology. Through the 1960s, although exposure to moderate concentrations of vinyl chloride was thought to be innocuous, it was discovered that exposure occasionally led to accroosteolysis, a reversible disease characterized by a softening or flattening of the bones in the fingertips (Ref. 2). The disease occurred among heavily-exposed PVC reactor cleaners and could be eliminated by appropriate industrial hygiene measures. Although a relationship between vinyl chloride and cancer was first docu mented in studies by Viola in 1970, his findings went virtually unnoticed. Neither government, industry nor labor saw a need to take action because the Viola tests with laboratory rats had been conducted at unrealistically high atmospheric dose levels. They actually bordered on the lower explo sion limit of VCM (Ref. 3). Heads did start turning, however, when in January, 1974, Dr. Maury John son of the B.F. Goodrich Company identified three cases of angiosarcoma, a rare type of liver cancer, among PVC employees who had worked as reac tor cleaners (Ref. 4). Suspecting VCM as the responsible agent in these three deaths, the company made a public announcement to this effect which attracted wide attention in the press and immediately brought OSHA into the picture. An extensive search by industry through old medical records ultimately confirmed thirteen angiosarcoma deaths of workers exposed to VCM in four U.S. plants (Ref. 5). These findings prompted those like Dr. Irving Selikoff of Mt. Sinai Hospi tal in New York; and later Health, Education and Welfare (HEW) Secretary Joseph Califano, as well as many OSHA and organized labor leaders to pre dict an epidemic of environmentally-caused cancer as a result of worker exposure to vinyl chloride. Their ominous predictions that PVC was a virtual time bomb, certain to leave a trail of fatalities in its wake, have since proven as hyperbolic as industry immediately protested when the rhetoric was flowing with great impact. Now, some six years after the first of these predictions, and almost three years after Secretary t A e w 5 fI f- 0: t lc fc Me de ev ca at da an as in re. t l ti. l By wit tht anc ful vol was i i i 1 The r of th Iby th chanc 4 envir with incer. VC5663 ;n$ .ng 1 .or. ;er iSUS_ng >ts .n:eniow- i i -Id red. ;e -Ily -ch :'ds :?l-/ : e- Regulatory status < polyvinyl chloride, 1980 585 Califano's apocalyptic 1978 pronunciations (Ref. 6), there is no evidence 1 of any excessive number of cases of angiosarcoma among workers in the vinyl chloride industry. Part of the explanation may lie in changes in ' industry practices and standards but we feel strongly that the predic tions were ungrounded, if not irresponsible, when they were made. ^ At the time of Goodrich's announcement, the stan- dard for occupational exposure to vinyl chloride was already down to 500 parts per million (ppm) whereas in earlier years levels may have been as high as 4,000 ppm. The 500 ppm exposure ceiling had been adopted on the basis of recommendations from the American conference of Governmental Industrial Hygienists (ACGIH). In 1962, it had chosen that level as an appropriate standard after care ful review of all then-existing data (Ref. 7). OSHA's Emergency Temporary Standard, promulgated in response to informa tion presented during the fact-finding hearings held in February of 1974, lowered the maximum VCM exposure limits to 50 ppm (Ref. 8). This ten fold reduction was based primarily on studies conducted by Dr. Caesare Maltoni of Bologna, Italy, showing that rats exposed to vinyl chloride developed liver cancer at levels above 50 ppm. Shortly thereafter, how ever, additional animal data from Industrial Biotest Laboratories indi cated that angiosarcomas could in fact be induced in laboratory animals at 50 ppm. As a result, OSHA proposed a permanent "non-detectable" stan dard for occupational exposure to vinyl chloride prescribing use of an analytical method capable of measuring concentrations at least as low as 1 ppm. The standard further provided that, until such time as engineer ing controls capable of meeting the standard became available, air line respirator equipment would have to be worn when vinyl chloride concentra tions exceeded the "non-detectable" level (Ref. 9). By approaching the vinyl chloride problem in this manner, OSHA was charged with threatening to close down the entire VCM and PVC industry. Since the "zero" exposure limitations were technologically beyond known compli ance capabilities, this limitation could only have been achieved by the full-time use of air line respirators which, were it possible, would in volve a different but perhaps equivalent risk of injury to workers. As was stated in one of the briefs filed in the case: That the use of respiratory equipment can lead directly to severe injury is k almost self-evident. This is particu larly true where such equipment must be employed in complex industrial manu facturing establishments. As a repre sentative of Tenneco pointed out during the course of the OSHA Hearing, workers burdened with bulky breathing equipment or trailing long hoses can find them selves in serious jeopardy in a vinyl chloride facility which, typically, is a "multi-story operation /with? many catwalks_or narrow passageways, stair wells, /and? moving machinery." Tenneco's representative had reason for being par ticularly impressed with the hazards involved for he was aware that his com pany had had at least one employee fatal ity which occurred when a worker wearing breathing apparatus connected to a lengthy air hose fell from a ladder due to the cumbersome nature of the sespiratory equipment. (Ref. 10). The atmosphere during the required proceedings to bring about adoption of the permanent VCM standard was highly charged. It was made moreso by the media coverage which tended to heighten extravagantly hostile ex changes between labor and industry leaders. Labor and self-appointed environmentalist representatives were convinced that industry had an "in" with the Agency. Industry was sure that the case was prejudged and was incensed when the TV cameras and lay press reporters stayed around at VC5664 SHb JEROME H. HECKMAN the hearings only while labor leaders spoke their pieces. Accusations of collusion and cover-ups flew like feathers before a fan. Any suspicions about possible collusion between industry and OSHA were no doubt dispelled on October 1, 1974, when the permanent regulation set ting a standard for maximum permissible exposure of 1 ppm (time weighted average, TWA) was signed by then Assistant Secretary of Labor for Occupa tional Safety and Health, John Stender (Ref. 11). Just the night before, the Washington rumor mill had the magic level pegged at a likely 10 ppm, the lowest industry said it could live with. The regulations finally promulgated by OSHA were, nevertheless, substan tially different from those originally proposed. Firstly, OSHA changed from a "non-detectable" to a 1 ppm exposure level for vinyl chloride. This brought the standard into the realm of technological feasibility, albeit the technology would have to be forced; some plants would ultimately be closed; and industry would have to surprise itself on how low it could go. Secondly, a major immediate compliance difficulty was eliminated when OSHA agreed to allow the use of cartridge gas masks rather than the cumbersome air line respirators initially proposed. But for these seem ingly minor yet critically significant changes, the industry might have had to shut down as its spokesmen had predicted. As it turned out, the VCM and PVC producers turned a potential nightmare into what Dr. Irving J. Selikoff, then a thorn in industry's side, now refers to as one of industry's greatest success stories. Although our unsuccessful challenge of the final standard in the courts was anything but amusing at the time, in retrospect it had its ironic aspects so I thought I would tell you part of the story. In the period leading up to the formal announcement of the VCM standard by OSHA, industry had no prior knowledge as to what permissible exposure level would be selected. In fact, as I mentioned earlier, the night be fore OSHA's press conference to announce its decision, the Agency was rumored to be planning to adopt the 10 ppm time weighted average level, apparently unsure about the need for the much more stringent 1 ppm stan dard that was ultimately set. There simply was no way to know or foresee how the Agency would make up its mind, except that it seemed clear it was probably going to have to make its decision on political grounds, not on need or feasibility. Thus, our only sensible course was to prepare a Petition for Review and stand ready to engage in a "race to the courthouse steps." We knew we would have to go "forum shopping" and pick a court because, under the Occupa tional Safety and Health Act appeal procedures, the party who files the first notice of appeal gets the United States Circuit Court of its choice. (Where suits challenging the same regulation are filed in more than one United States Circuit Court, all suits must be transferred to the circuit in which the appeal "was first instituted.") Our aim, of course, was to try to get our case before one of the Courts of Appeals that might be expected to interest itself in the complexities of such a matter. Applying these concepts and objectives to the VCM rule making, the strat egy we decided upon was to file our appeal--actually a Petition for Re view of the final standard--in New York City in the United States Court of Appeals for the Second Circuit, why this court? Simply because, in a previous decision, its Chief Judge had indicated at least some willing ness to scrutinize OSHA decisions with enough care to reverse sr. ur.reascr.able one, _i.e., one which called fcr the use rf -.ere crecaJcicnari mea sures than-seemed necessa: / or feasible. every one of the thirteen judges of the Second Circuit disqualified him self from hearing the case, presumably because all of them had some re mote financial interest (stock or bond ownership, probably) in one of the multitude of companies in the proceeding. After every judge of the court declared himself unable to hear the case, in accordance with the federal and court rules, retired Supreme Court Justice Tom Clark was ap pointed to preside with two Distict Court Judges completing the usual three-man panel. VC5665 tely id m- Regulatory status 01 polyvinyl chloride, 1980 587 In my opinion. Justice Clark did not even consider some of the statutory or other important legal issues ruled on later in cases like this year's Supreme Court decision on benzene. He was emotionally unable to get past the conceded fact that thirteen workers had by then died from liver can cer caused by occupational exposure to vinyl chloride. The late Justice turned a deaf ear to industry's point that these fatalities were the re sult of long-ago high exposure levels, since significantly reduced; gave short shrift to the other positions so arduously advanced; and, in his opinion for the court, denied our Petition for Review of the standard. In so doing, the Second Circuit declared that OSHA was not to be fettered by the limitations of existing technology but was well within its author ity to adopt technology-forcing standards (Ref. 12). This ruling shook and continues to haunt the industrial community. Even so, it was not enough to induce the Supreme Court to take the case (Ref. 13). Basically, this is where we stand today except that the PVC industry is again under investigation by some in OSHA. On December 18, 1979, the Agency published a notice requesting the latest information on the health effects of vinyl chloride and adding a new inquiry into alleged possible effects of polyvinyl chloride dust (Ref. 14). A conference was held in connection with OSHA's request for information in March of this year. We consider it fair to say that no data not previously known to govern ment and industry were presented at the sessions. We are, therefore, hopeful that the Agency's latest expressions of concern will be resolved without further regulatory action. This remains to be seen and no one in the industry is taking anything for granted. ^ *** Turning to the FDA front, our story goes back to 1968 when the Department of Treasury's Bureau of Alcohol, Tobacco and Firearms (BATF) began an industry urged program to test the suitability of using PVC containers for alcoholic beverages by allowing selected sizes to be marketed on an experimental basis (Ref. 15). This temporary authority to package dis tilled spirits in polyvinyl chloride was extended annually through a series of BATF circulars. During this time industry worked closely with the Bureau looking towards obtaining permanent regulatory authority to allow appropriate use of PVC packaging. The effort to remove the "experimental" tag met its most unexpected first^ challenge when, in 1971, the Treasury Department decided that allowing full-scale marketing of PVC liquor bottles would be a "major federal ac tion significantly affecting the quality of the human environment," thus requiring preparation of an Environmental Impact Statement (EIS) in ac cordance with the National Environmental Policy Act of 1969, commonly referred to as "NEPA." without belaboring the details, the final Environ mental Impact Statement issued by BATF in 1973 was very favorable to PVC manufacturers. Based in large part on a study conducted by an indepen dent consulting group (Bailie Associates), the Impact Statement concluded that PVC bottles are less energy intensive to produce than their glass counterparts. The EIS endorsed approval of PVC as a suitable container for use with distilled spirits (Ref. 16). With this hurdle out of the way, the road seemed clear for PVC liquor bottles. A stamp of approval here would also result in an increase in PVC's share of many processed food packaging markets where clear contain ers with good water vapor barrier properties were needed. Any authoriza tion from BATF was always contingent upon satisfying FDA criteria for food safety, however, and suddenly another much more significant, and wholly unexpected problem arose. 3f About the same time BATF was finalizing its environmental asssessment of PVC liquor bottles, representatives, of Schenley Distillers, Inc. were discovering that trace amounts of vinyl chloride were migrating from PVC bottles into distilled alcoholic beverages, such as vodka and gin. Most scientists were taken completely by surprise by this discovery because VCM is a gas at ten to fifteen degress below zero degrees centigrade. Hence, it was reasonably assumed that finding monomer in any foodstuff, much less a liquid, was not very likely. >*'/fet? VCS666 58b .'10ME H, HECKMAN Nonetheless, FDA and others subsequently confirmed the Schenley findings. It then advised BATF that it would be issuing a proposed regulation which, if finalized, would prohibit the packaging of alcoholic beverages in PVC bottles (Ref. 17). BATF's reaction was immediate--some have said precipitous. In deference to FDA, the Bureau terminated experimental use of PVC packaging for dis tilled spirits on May 11, 1973 (Ref. 18). FDA's 1973 proposal would have precluded the use of PVC resin for packag ing alcoholic beverages while permitting the continued use of other rigid and semirigid PVC articles. On the basis of data generated from the OSHA proceedings concerning the toxic effects of exposure to vinyl chloride, FDA broadened its proposal in 1975 and thereby indicated an intent to ban all rigid and semirigid PVC products, while allowing continued use of thin film and coatings or closure liners (Ref. 19). * The Agency has never finalized its 1975 proposal. I think it fair to say that the reason its proposal remains just that, and is unlikely to become law, is because the problem of migration of residual VCM which resulted in the BATF liquor bottle ban in 1973 Ij^^beenresojjxd. Con tinuous refinements in production techniques have reduced tne level of monomer in bottle walls by a factor of nearly one million. ,1 As recently as October 15, 1979, an official FDA opinion sent to an in quirer noted that "PVC continues to be prior sanctioned for food-contact purposes providing that no vinyl chloride monomer migrates to the food" and indicates that, since the 1975 proposal was published, "manufacturers have improved their manufacturing techniques so that little or no vinyl chloride monomer remains in the polymer" (Ref. 20). Moreover, FDA's scientists have recognized the reality and importance of the progress made by industry by noting in a much-discussed, though not yet completely revealed, memorandum dated July 27, 1979, that "the distinctions between plasticized and rigid PVC have become irrelevant based on new manufacturing techniques, and the uses should be treated 'Similarly," This statement was printed in Food Chemical News which quoted it and attributed the statement to FDA's Division of Chemistry and Phy sics, a part of the Bureau of Foods (Ref. 21). Despite all of these favorable signs for PVC, it seems to be most diffi cult to blow away the "little black cloud" hanging over it. This has to be more because of history than today's reality, and much more because of FDA's inaction than any adverse action it has taken. Thus, for example, notwithstanding a recent unique Petition filed by The Society of the Plastics Industry, Inc. (SPI) urging "reapproval" by BATF of PVC liquor bottles, the Bureau is not expected to move until FDA pro vides it with a statement clearly indicating that PVC is now considered legally acceptable for this use. Anomalously, there really is no valid question of legality here since PVC remains "prior sanctioned" for all uses under the Food Additives Amendment and FDA has so indicated in re cent correspondence. This, however, is not enough to satisfy BATF--it feels it needs something more specific to avoid "being burned by FDA's vagaries again" (Note b) . There is a relevant collateral point worthy of mention here since it could have a bearing on when and how PVC's currently satisfactory legal status at FDA might ultimately be emphasized or at least become more clearly understood. In the wake of the United States Court of Appeals for the Note b: The fact that this is so ,i!s demonstrated by a BATF letter directed to the Bureau of Foods of the FDA by Mr. William T. Drake, Assistant Di rector of BATF on February 27, 1980. In this letter FDA has been requested to inform BATF about its position and undoubtedly will do so at some time in the future. Thus, it should be recognized that the language in quota tion marks in this sentence constitutes a paraphrasing of informal remarks made by BATF officials to inquirers; there is no official document where this language is used. VC5667 ;S. -Ch, ag:!ia jHA .ct H ers 1 ;oted .use 'he iTF -o,-d id 1 could tus rected Di gested time ota- Regulatory status o polyvinyl chloride, 1y0 3&y District of Columbia Circuit's decision in Monsanto Co. v. Kennedy, more commonly referred to as the acrylonitrile (OT1 beverage container case (Ref. 22), FDA is known to be working on changes in its policies on indi rect additives. Hopefully, whatever new "game plan" is adopted will make it_DO.<j;sibl_B_fnr ^ipod anrt Drug to dec 1 are nnn-aridjjjup for compo- nents of food-contact materials in so-called de minimis situations where the potential level of migration into food of a particular is 5B_negJ^^^^yT^P^^enT no pu5i_lg_. health or safety _conceJlSj- If and when this is satisfactorily accomplished, we would certainly hope that FDA could publish a notice unequivocably withdrawing its 1975 PVC proposal. Such action, along with the type of letter we hope FDA will soon send BATF to allow it to permit renewed use of PVC liquor bottles, should certainly push the "little black cloud" off the horizon. Mean while, PVC's food-contact regulatory status remains satisfactory; it's only the public relations sky that's cloudy. *** Moving to our third and final chapter, regulatory action by EPA to con trol plant emissions of vinyl chloride monomer got under way in December of 1975. This is when the Agency published a proposal calling for dras tic reductions in emissions from VCM and PVC manufacturing operations. Precisely why EPA felt the necessity to act remains unclear to me since ambient air monitoring had revealed no indication of any hazard. Neverthe less, probably because of the impetus provided by the widely publicized OSHA proceedings, and perhaps public concern about all air quality mat ters, in 1976 EPA promulgated what amounted to a 10 ppm national emis sions standard for vinyl chloride. This standard, adopted under Section 112 of the Clean Air Act, is still in effect today (Ref. 23). cortroWiiwi^ it industrvwill^av^ For some f^asorTIthoug h nuT'staWarcPSeemsto be a favorite target for enviromentalist and Agency reevaluation even though (1) there is still no evidence whatsoever that VCM ambient air emissions have given rise to any public health problem, and (2) it would appear that the Supreme Court's recent decision in the benzene case (Ref. 24) would make some evidence of health relevance a prerequisite to lowering a standard at great cost to indus try. /" This observer is of the view that the benzene case is as appli cable to EPA's Clean Air Act regulatory authority as it is to OSHA's stan- _7dards-making although it is recognized that EPA counsel may not agree. Arguing that the standard merely reflected industry's best available con trol technology, rather than the degree of control necessary to protect public health, the Environmental Defense Fund (EDF) brought suit in 1976 challenging the final rule (Ref. 25). After lengthy negotiations between EDF and EPA, from which industry was flatly excluded over its vigorous protests, EDF and EPA reached a "settlement agreement." In accordance with this compromise, EPA proposed amendments to cut the 10 ppm level by one-half, prohibit emission increases within the vicinity of existing plants due to expansion, and set an ultimate goal of "zero" for vinyl chloride emissions. However, these emission reductions, proposed by EPA in June of 1977, have, for all practical purposes, been abandoned by the Agency. EDF relatively recently sought to reopen the original proceedings on the grounds that EPA had reneged on its promise to take final action on the proposed amend ments by January 1, 1978. Strong oppositions were filed by EPA and SPI, both of which protested that the Agency should not decide on whether to amend the vinyl chloride standard until after reconsideration of EPA's overall policy for dealing with carcinog'ens. Heeding these arguments, the court denied EDF1s motion and refused to issue an order requiring compliance with the so-called settlement agreement. Vinyl chloride is still a "flagship" issue and appears to be one of the major stimuli behind the Agency's general review of its carcinogen regula tions. This being the case, VCM may well be one of the first substances to which EPA's cancer policy, once finalized, will be applied. Meanwhile, industry is still having some difficulty coming into full compliance with VC5668 590 JEROM H. HECKMAN the 1976 standard, the major problems being emergency relief valve and reactor opening discharges. In addition to the limitation on VCM emissions, the discharge of PVC waste into navigable waters is controlled through EPA's permit procedures estab lished pursuant to the Clean Water Act (Ref. 26). In the recently-issued Solid Waste Regulations--perhaps the most all-en compassing environmental regulations issued to date--EPA has been reason ably responsive to industry comments. For example, it adopted SPl's recom mendation that PVC sludge be excluded from the rule making (Ref. 27). This could be a temporary "plus,* however, because the Agency has indi cated that it intends to issue final regulations this fall which will classify and regulate, on a generic basis, the batch and solution resi dues from the production of all chlorinated polymers. ** The PVC story clearly illustrates the increasingly interdisciplinary na ture of regulatory issues. The problems t,hat arose triggered a chain reaction among a variety of federal agencies including the three 1 have discussed in depth and the Consumer Product Safety Commission. These four agencies and the Department of Agriculture have since acknowledged that they share common regulatory concerns by joining together in the Inter-Agency Regulatory Liaison Group (IRLG), instituted to achieve a uniform approach to identifying protential carcinogens and estimating their risks. Complicating all attempts to develop appropriate regulatory responses to carcinogenic hazards are the phenomenal, daily breakthroughs in scien tific testing. Technological advancements are now enabling us to detect substances at levels where the impact may remain unknown forever. There is no question in my mind but that requlg2ttJ2Iii&JiiAJtaili? tointej^at^somesoj^j^jj^J^j^gesgmgjjt^mgThoi^^^^JJ^^^^^^^^Tkioniffirni^process^^T^D^ver^^BmoDiTiz'^^Sr^o^^CT^^r^^^^^has become tTJSTTTTTOTTT"To""WST^ome"TT!e""EuTeaucratic fear tnat a decision made today might look like a grievous error tomorrow because a more sensitive test method turns up a trace of a substance shown to be a carcinogen, mutagen or teratogen at high levels. FDA has already taken steps in this direc tion by moving forward on its policy for dealing with low levels of puta tively carcinogenic constitutents in animal drug residues. The other agencies will have to play variations on this theme or b>-ing an already seriously treatened chemical industry economy to its knees. Notwithstanding the general quagmire in which current Agency attempts to regulate deleterious substances rest, the combined efforts of a respon sible industry and concerned federal agencies appear to have eliminated the hazards associated with the manufacture and use of PVC. Industry deserves much credit for having identified and controlled the vinyl chlor ide monomer problem. Assuming the government also acts appropriately, using the common sense that sound risk assessment and related action dic tate, it will some day have played its role in bringing this episode to an exemplary conclusion. If these principles are kept in the forefront as debate continues, they should pay off in the form of a stable market place for industry and a safer environment for everyone. If the VCM/PVC experience proves to have helped bring about this result, j the "success story" label will be as worthwhile as it has been hard won. REFERENCES 1. Weaver, Paul H., "On the Horns of the Vinyl Chloride Dilemma," For tune, p. 153 (Oct. 1974). 2. DHEW Publication Number (NIH) 79-1599, vinyl Chloride; An Informa tion Resource, p. 35 (T. H. Milby, M.D. ed. Marcn, 1978). VC5669 and JC waste s estab- il-enreason's recom7) . mdi-11 resi- ry naain have ?se sdged T:he ?a ing ses scien~ ^etect 1 nave scision7ome de today test jtagen direct puta-,er ready pts respon- nated tty 1 ehlor- - iy i jn die ne to front utket 2Sult, 3 won. For- forma- Regulatory st'Lus of polyvinyl chloride, 1980 591 3. Publication by German Plastics Association (VKE), 8 Frankfurt/Main. t Karlstrasse 21, Frankfurt, West Germany, vinyl Chloride/Polvvinyl Chloride: Measures for Health Protection, p. 5 (Nov. 12, 19741. 4. The Society of the Plastics Industry, Inc. v. OSHA, 509 F.2d 1301 (2d Cir. 1975), cert, denied, 421 U.S. 992 (1975). Dr. Creech brought the matter to the attention of NIOSH on January 22, 1974. i j 5. The Society of the Plastics Industry, Inc. v. OSHA, 509 F.2d 1301 (2d Cir. 1975). Brief for Respondents at 46 (No. 74-2284, et al.) \ 6. Cf. remarks (and particularly p. 3 of his appendix) of Secretary 1 Jospeh A. Califano, Jr., to the AFL-CIO National Conference on Occupa tional Safety and Health, September 11, 1978 (Washington, D.C.). 4 7. The Society of the Plastics Industry, Inc., PVC and Health--A Back ground Statement, p. 5 (April, 1976). ~ \ 8. 39 Fed. Reg. 12342 (April 5, 1974). 1 9. 39 Fed. Reg. 16896 (May 10, 1974). 1 t 10. The Society of the Plastics Industry, Inc. v. OSHA, 509 F.2d 1301 (2d Cir. 1975), cert, denied, 421 U.S. 992 (1975). .Brief for Peti j tioner at 23 (No~'74-'^64,~et al.). j it 11. U.S. Department of Labor News Release (USDL-74-545) (Oct. 1, 1974). :i 3 12. The Society of the Plastics Industry, Inc. v. OSHA, 509 F.2d 1301 (2d Cir. 1975), cert, denied, 421 U.S. 992 (1975). . lJ 13. 44 Fed. Reg. 74928 (Dec. 18, 1979). 4 i 14. Note Ref. 12, supra. 4 15. Bureau of Alcohol, Tobacco and Firearms, Industry Circular 68-32 t (Nov. 21, 1968). , *- 16. Polyvinyl Chloride Liquor Bottles Final Environmental Impact State ment, prepared by the Bureau of Alcohol, Tobacco and Firearms (Rex i D. Davis, Dir.) for U.S. Department of Treasury (March 9, 1973). i 17. 38 Fed. Reg. 12931 (May 17, 1973). 18. Undocumented. For collateral reference, see: Petition for Generic Approval of Polyvinyl Chloride as a Suitable Material to Package Kt5 Distilled Spirits at 20, submitted by The Society of the Plastics Industry, Inc. to the Bureau of Alcohol, Tobacco and Firearms (Jan. 23, 1980). 19. 40 Fed. Reg. 40529 (Sept. 5, 1975). .20 Letter from Martin J. Stutsman, Assistant to the Director, Division of Regulatory Guidance, Bureau of Foods, to Mr. J. M. Gyenge of GTR Chemical Company, October 15, 1979. .21 See "FDA May Not Ban Rigid, Semirigid Uses of PVC," Food Chemical News, pp. 7-8 (Oct. 9, 1978); and "Internal Memo Calls on FDA to Regulate PVC on 'Realistic' Basis," Food Chemical News (Oct. 15. 1979). ------------------------------------- .22 Monsanto Co. v. Kennedy, 613'F.2d 447 (D.C. Cir. 1979). 23. 41 Fed. Reg. 46564 (Oct. 21, 1976), codified at 40 C.F.R. Part 60. 24. Industrial Union Department, AFL-CIO v. American Petroleum Institute, 48 U.S.L.W. 5022 (1980). 25. EDF Petition for the Institution of Rule Making Proceedings to Estab lish a Policy Governing the Classification and Regulation of Carcino- VC5670 92 ,'::R0ME H. HECKMAN genic Air Pollutants unde, the Clean Air Act, filed in the United States Court of Appeals for the District of Columbia Circuit on Novem ber 19, 1976. 26. 33 U.S.C. 1342; 40 C.F.R. 124. 27. 40 Fed. Reg. 33063 (May 19, 1980). VC5671