Document 1QQZD5db12jokpbXxbQ11aZkZ

Arsenic, Cancer By Bill Rickards and Rachel Scott Richards is a Washington Post metropolitan staff writer. Seott, whose book, **Masciff and Blood," was published last year, b director of health and safety for the Illinois Industrial Commission. All processing of arsenic in thn United States is done aC the Tacoma plant of the American Smelting and Refining Company. ARSENIC hit' Mrwd a certain no toriety ovei - years as a parlor room poison--death by the teacup, ad TnE WASTTT TON POST ministered by -smiling spinsters seek ing to polish Cf their victims in as eracLous a manner as possible. But there nothing gracious in the deadly evi dence beginning to emerge, far from the lace and the china teacups, that ar senic causes cancer and that a million or more American workers may be un wittingly putting their lives on the line through daily exposure to the chemical on the Job. Missed Signals IT IS HARDLY any secret that ar senic can cause cancer. The first sug gestion that it might be a carcinogen was raised in 1820. But the Allied and Dow disclosures pose the cardinal question--why were workers exposed to hazardous amounts of arsenic in the first place? Concern began growing last summer when two of the chemical Industry's giants--the Dow Chemical Company and the Allied Chemical Corporationadmitted in an unusual display of cor porate candor that workers who once handled inorganic arsenic at their Mid land, Mich., and Baltimore pesticide plants were dying of lung and lymph cancer at an alarming rate. Allied reported that among workers retired from Ha Race Street plant in Baltimore lung cancer was seven times that of other males in the city and lymph cancer rates were six times higher than expected. Dow's separate study at its now-closed Midland plant revealed a 32.9 per cent cancer rate among workers exposed to inorganic arsenic in the 1959s. While the numbers covered by the studies are relatively small the impli cations for industry are enormous. Some federal health experts now con cede that the inorganic arsenic menace may be as substantial in the workplace as that posed by the more widely pub licized vinyl chloride cancer connec tion discovered a year ago. Inorganic arsenic is a byproduct of the smelting process. Some 15 copper, lead and zinc smelters ship it to the lone processor in the United States, the Tacoma, Wash., plant owned by the American Smelting and Refining Com pany (ASARCO). Arsenic trioxide, an inorganic arsenic compound that is the most widely used form of the chemi cal, shows up in at least 44 different major industries by a federal count, from tinting windshields in Toledo to spraying roses in Texas. The United Steelworker* Union alone estimates that 40,000 or more of its workers may be exposed. Federal estimates of ex posed workers run to 1.5 million. While there arc substitutes for ar senic in some secondary industries the most seriously exposed workers--in copper and lead smelters where inor ganic arsenic is a maior byproduct of the smelting process--are virtually condemned to further exposure, if in dustry spokesmen are to be believed. In pleas to federal regulatory offi cials to keep the present exposure standards--which were in effect for Allied workers--the melal smelting in dustry claimed any change at this point would be economically disas trous. Norman Herington, a spokesman for Allied Chemical, recently supplied one answer. "I'm sorry o tell you," he said, "that until 1973 we didn't have any sus picions that the conditions existing at (Allied's Baltimore plant) were causing cancer." According to Herington., "none of the manufacturers who were making arsenical compounds had any indications" there wore cancer prob lems associated with inorganic arsenic. Curiously, Allied, Dow, ASARCO and the other manufacturers, with bil lions of dollars in resources and sta bles of researchers, apparently man aged to miss, or ignored, some disturb ing warning signs--reports stretching back to the 1930s linking arsenic with several types of cancers. "This isn't something new that Is Just bursting out," Dr. J. William Lloyd, a biostatistician for the Na tional Institute for Occupational Safety and Health, said recently. The reason the companies missed the warn ing signs, said Lloyd, was because "nobody was looking. Sometimes be cause they didn't want to look, and sometimes because they didn't think to look." . A few of the missed signals Included: Reports dating back to the 1930s of auspiciously high skin cancer rates among persons who had inorganic ar senic compounds prescribed for skin ailments. One study in 1966 noted that 21 skin cancers were observed among 180 patients who used inorganic ar senic preparations. Findings by British researchers in 1948 that high lung and akin cancer rates were turning up among factory workers involved in the manufacture of sheep dip, containing inorganic ar senic. A 1959 study of workers at an Eng lish nickel refinery, where ores con tained a high arsenic content, showing 45 cases of lung cancer and two of skin ' cancer over a decade. A study in 1969 by Dra. Frederick P. Lee and Joseph F. Fraumeni, of the National Cancer Institute, of 8,047 American metal smelter workers. The workers showed a threefold excess of respiratory cancer mortality and, when they were heavily exposed for long pe riods to Inorganic arsenic, as much as eight times the expected mortality rate. Basis for Standards The cornerstone study, however, accepted until recently as in disputable evidence on the potency' of arsenic and used as the basis for the present arsenic, exposure standards, was done by Dr. Sherman Pinto in 1963. Pinto's research team studied 229 deaths among copper smelter workers exposed to .5 milligrams of inorganic arsenic per cubic meter of air at AS. ARCO'a Tacoma plant--the current federal exposure standard--and com pared them to other worker* at tbe smelter Mho he claimed were not ex posed. lie discovered almost no differ ence between the two groups and con cluded that chronic exposure to arsenic did not cause excess amounts of respiratory cancer. Industry quickly pounced on the study done by Pinto--who was then medical director of the same ASARCO plant in Tacoma--disregarding the contrary evidence. Worse still, Pinto's findings became the basis for the present federal stand ards for inorganic arsenic exposure af ter they were accepted by the Ameri can Conference of Governmental In dustrial Hygienists (ACGIH). a quasiofficial body which, until 1970, was the only organization setting standards for toxic dusts and fumes in the work place. The ACGIH standards Merc incorpo rated into the old federal Walsh-Hcaley Act, which regulated working con ditions for plants operating under fed eral contracts, and were adopted by the states in their regulations as well. With the passage of the Occupational Safety and Health Act of 1970, the Pinto-based standards were again called upon. Despite the reliance on Pinto's data by the ACGIH and later the Occupa tional Safety and Health Administra tion (OSHA). which adopted the cur rent federal arsenic standards, a num ber of federal investigators are now convinced that the Pinto findings are seriously flawed. As early as 1969, Lee and Fraumeni pointed out in their study that Pinto's conclusions compared exposed and non-exposed smelter workers but ne glected one critically additional step-- Pinto failed to compare his two work er groups with others outside the plant The two researchers noted that while Pinto seemed correct in saying there was little difference between cancer levels inside the smelter, the plant population as a whole showed lung cancer rales as much as three times the general population. Pinto, contacted last week by Th* Washington Post, acknowledged that no comparison had been made in his study with people outside the plant. "The criticism has been raised about non-exposed people," he said. "I don't believe it too much. I don't pay much attention to it." ASARCO Assurances AT THE LATEST round of federal hearings last September to ex plore new exposure standards for in organic arsenic, ASARCO showed up os the major arsenic industry witness, with a panel or experts Including Pinto, now a semi-retired consultant to the giant smelting company. Pru dently, Pinto kept in the background and let ASARCO's other spokesmen assure the federal' representatives that there was little cause for alarm and. certainty no reason to lighten up the prevailing standards. ASARCO once again hauled out the original Pinto study, sayinf that the findings, and an update also done by Pinto, indicated there did not seem to be any increased mortality from ar senic exposure among the Tacoma smelter workers. With this, ASARCO called for retaining the current expo sure standard and suggested an inde pendent study of the findings of their colleagues at Dow and Allied. What they neglected to mention was that in addition to the heavy criticism of the original Pinto study the update was attacked last year by Dr: Samuel Militant Jr., a chronic disease epide miologist for the Washington State Health Department, for its lax han dling of statistics. Milham pointed out that Pinto neg lected to include in his study of smel ter workers the secondary cause of death listed on death certificates. If ;t worker had pneumonia on his death certificate as the primary cause of death Pinto listed that---and skipped the notation that the man also had lung cancer. **We found that he missed 25 per cent of the lung cancers at a conservative estimate," Milham said. In fact, instead of the 18 lung cancers 'an predicted by standard mortality table# for Pierce County, Wash., smelter workers, Milham discovered 40. Asked about Milham'a findings, Pinto said, "In my own mind I'm quite sure that my material is accurate." Nevertheless, he said he had turned over all the material he had on deaths to Dr. Philip Enterline, professor of epidemiology at the University of Pittsburgh, for an "outside" analysis. "The criticism has been raised that I'm not a professional codifier so now the information is in the hands of a professional. He's a highly regarded expert in his field and I think industry is doing the right thing when they get an unbiased opinion like his." Enterline, Pinto noted, received a contract seven years ago from ASARCO to do consulting research for the company. The choice of the Pittaburgh researcher this time was sug gested, according to Pinto, by ARARCO's vice president, Kenneth Nelson. H was Nelson who testified at the OSHA hearing last fall for ASARCO in defense of Pinto's earlier findings, Nelson told the OSHA investigator* at the hearing that a decision to cut back on exposure levels among Its workers could be financially ruinous for the company and later said it could force the shutdown, of lead eud copper smelters throughout the West. "There is absolutely no conflict of interest On the choice of Enterline)," Pinto said last week. "He would be tha first to tell me if I were wrong." The "22 Milestones" WHAT HAPPENS row concerning arsenic is up to OSHA, but the preliminary indications are not encour aging. In an interim report following the hearing the National Institute for Occupational Safety and Health, OSHA's own research arm, flatly de clared that inorganic arsenic is a car cinogen and "any exposure to inor ganic arsenic in excess of background levels should be considered an unac ceptable risk" until new data are avail able. OSHA dutifully accepted their com ments, filed them away, and embarked on what is known in the agency as the "22 milestones"--the steps it must take before setting out a permanent stand ard for arsenic exposure. Among those steps is the consideration of relevant research data on arsenic. OSHA staf fers handling the project acknowl edged recently that ht^li up on the list of research - still considered "significant" ore the two Pinto studies. e:" 03 <53 Moreoever, there appear to' S strong indications that OSHA may end up compromising the safety of workers exposed to inorganic arsenic for economics of the chemical and smelt ing industry'. **5 "Whatever we do must be feasible, regardless of what NlOSH recoin- me'nds," James Foster, a spokesman for OSHA, explained recently. "NIOSII specifically deals with the sci entific, medical and technical aspects of this. On the other hand it's our job to look at what this is going to cost in dustry' as well as those other things." No matter what OSIIA decides to dc, traveling the 22 milestones is certain to take the agency far into 1975 before any tougher standard is set to protect workers from a known carcinogen. And almost certainly the process will involve another public hearing and yet another appearance of Dr. Sherman Pinto and his arsenic study. THE WASHINGTON POST Wednesday, Jan. 29, 1975 Court Raps EPA' On Gas Lead Rule By Timothy Robinson Wuhluglon Pol Stiff Writer iTte Environmental Protec U.S. Circuit Court Judge tion Agency has failed .to Malcolm WilUey agreed with prove that lead spewed into the refiners' arguments in a the air from automobile ex 73-page majority opinion, in hausts causes a significant which he was joined by Judge health hazard, and therefore Edward Tamm. its regulations phasing out the The EPA administrator had lead content in gasoline must based his authority'to issue he set aside, the U.S. Court of the regulations on statutory Appeals explained hero yester grounds th.it enable him to day. prohibit the use of fuel addi The enurt. aligned 2-to-l tives that "will endanger the .against the EPA guidelines, is public health or welfare." sued a brief ruling selling Judge Wilkoy said any deci aside those regulations tec. 23. Yesterday's opinion ex plained in detail the reasoning behind that earlier ruling. sion under that authority to prohibit the sale of additives must be based specifically on facts, and not conjecture. `We think that the statute The regulations had been does require that, before the described ns among the most administrator can prescribe important passed by the envi the regulations involved here, ronmental agency. They would he must find that the lead have required the overall con from auto emissions by itself tent of lead in gasoline to be reduced bv approximately two- or alone contributes a measur able increment of lead to the ing that the function of a re thirds by 1979. human body, and that tins viewing court is to "detect and Gasoline refiners had op measurable increment causes set aside agency action based posed the regulations, claim a significant health hazard," cm such shoddy foundations, ing that lead additives provide Judge Wilkcv said. them with the flexibility to Studies ha\e shown produce gasoline with differ- .lead from automobile that cmis- not to engage in rival scienliiic calculations or substitute ing octane ratings with a mini-jsions contributes to the prob- judgment." mum of refining and processing! Jems of lead in the blood of Judge Wilkey commented equipment. The refiners also! adults and children, but the that the EPA decision wasj , claimed that higher octane production of gasoline with* majority opin nn said the jes did not prove that studlead `Hamlet-Like, a blind stabj out the use of lead would re- from gasoline was a signifi- through a curtain of igno- j quire greater amounts of cant health i actor, ranee, inflicting anguish, but I scarce crude oil. "Several vital links in the in our judgment not rationally The refiners the court suit had argued in that the EPA chain arc unsupported; for the administrator to leap to the solving any problem." had used an improper legal conclusion ho rild can only be U.S. Circuit Court Judge J. basis for drawing up the regu-: termed arbitrary and enpri- Skrlly Wright disagreed, lations, that the evidence did icious," Judge Wilkcy said, sometimes bitterly, with the not support T.PA's concern for j ``Wc think this brand of ad- majority court's opinion, i thc public health, and that Hu-iministrative agency action tn his SG-pagc dissent, lie ac-| casc.against auto load cmis- should be readily apparent-- cuscd the majority judges of sions "is a speculative and in-!and equally abhorrent--to any "confusing a very important conclusive one at best." lappeilate judge," he said, add isiue." .* <S> 1-0 <35 <55 <-n e^i oo January 20, 197 5 Page 33 FOOD CHEMICAL NEWS _i '1'*3 S3 S3 Each sample, according to FDA, should consist of 24 containers of the same code, if possible. FDA ordered detention of products above the 10 p.p.m. temporary tolerance after check and confirmatory analyses. <33 33 O' OJ P7C IUTEFIM REGULATION BASED ONVCM EXTRACTION PREVIEWED Secretary of Health, Education and Welfare Caspar. Weinberger has indicated that the interim Food Additive Order proposed for polyvinyl chloride wiLl be based on a 50 p.p.b. limit on extraction of vinyl chloride monomer, apparently confirming that there will be no Limits at the manufacturing level (See FOOD CHEMICAL NEWS, Dec. 16, Page 2). At various times, the Food and Drug Administration has tended towards limits on vinyl chloride content of the packaging material itself and limits on film thickness. Use instead of a limit on migration using food-simulating solvents has been urged by .he Society of the Plastics Industry, and the Weinberger letter -- dated Dec. 13 -- indi cates that FDA may use this approach. FDA enclosed a copy of the HEW letter Jan. 9 in responding to an inquiry from Hooker's RUCO Division. Although the letter indicated that only the extraction limit will beproposed,, there is not believed to be unanimity on the subject within FDA's Bureau of Foods. Weinberger said the draft Federal Register documents would include an interim Foot*. Additive Order proposal to "limit the use of vinyl chloride polymers to only those foodcontact applications where the possibility for vinyl chloride extractives in food is essentially zero." The HEW Secretary said FDA "is currently considering, as one alternative, a proposed Interim food additive regulation which would require that there be no detectable migra tion of vinyl chloride monomerto food-simulating solvents using the most sensitive confirmed analytical procedure available, which FDA believes is presently SO p.p.b." If improved analytical procedures are developed later, he said, lower levels "would then be proposed by FDA for a new standard approaching zero." Data to be Required on PVC Weinberger revealed that FDA's draft documents "would also require prompt initiation of appropriate animal feeding studies with periodic submission of progress reports, and require the submission of other scientific data including validated analytic methodology, levels of residual vinyl chloride monomer in PVC food-contact articles and levels of vinyl chloride extractives." The Secretary continued: "The major problem confronting FDA in the preparation of the new draft proposals has been the lack of a sound scientific basis fora definitive decision. Although vinyl chloride has been shown to be carcinogenic by inhalation, there is very little information concerning its effect upon Page 34 January 20, 1975 FOOD CHEMICAL NEWS ingestion. The FDA knows of no studies which establish a safe level of consumption when this monomer is leached from containers into packaged foods. "Therefore, until such time as there is a sound scientific basis for a definitive decision, FDA believes it is neces sary that they propose, on an interim basis, to limit further food-contact use of polyvinyl chloride to only those uses where the possibility for migration of vinyl chloride monomer to food approaches zero and represents negligible levels in the diets of consumers." S3 S3 S3 S3 S3 o*- -C. S3 Weinberger wrote that FDA has been investigating analytical methods to "establish the lowest level that can be determined using various food-simulating solvents," and that there have been "a few reports of quantities of 20-30 p.p.b. vinyl chloride extractives detectable by existing methodology." However, he added that FDA studies "have indi cated that in the hands of qualified analysts a reading of 50 p.p.b. ... is the lowest that can be reported with confidence." The Secretary's letter was in response to Sen. Tunney (D-Caiif.), who asked clarifica tion of testimony given before the Senate Commerce environment subcommittee (See FOOD CHEMICAL NEWS, Aug. 26, Page 2). He asked Weinberger to "explain what FDA proposes to do in regard to polyvinyl chloride food packaging, and the scientific and legal justifications for setting a non-zero tolerance for vinyL chloride in polyvinyl ch loride food packaging, foods, drugs and cosmetics, if that is in fact your intention." The Senator also asked for information on FDA's decision to ban packaging of alcoholic beverages in PVC containers, plus "any recommendations which may have been made to FDA by SIT concerning particular non-zero levels of vinyl chloride which might be acceptable in beverages, and the scientific and legal justification for any such recommendations. " VCM Found in Vegetable Oil Ranges From 0.1 p.p.m. to 9 p.p.m. Tunney asked for levels of VCM found to leach in consumer products. FDA analyses have shown VCM in vegetable oil packaged in PVC ranged from 5 p.p.m. to 9 p.p.m. for a 3-year-old sample , ana from 0.1 p.p.m, to 0.2 p.p.m. in a 6-month-old sample. No VCM was detected in samples of blood bags and anticoagulant solutions, but some brands of mouthwash showed the monomer in amounts ranging up to 7.9 p.p.m. Hooker's RLJCO urged that FDA "avoid any precipitous action which might unnecessarily disrupt the safe and successful use of PVC in food packaging applications," saying: "Should regulation be deemed advisable with the advent of feeding test data, then the extent to which vinyl chloride becomes a food additive should be the controlling factor and not product specifications such as wall thickness, trace composition con centrations, etc." The firm said vinyl chloride content of the packaging material need not be regulated, since "the prime function of the FDA is to obviously deal with food additives." Hooker January 2u, 1975 Page 35 FOOD CHEMICAL NEWS a said that "a PVC compound is not a single formulation and therefore the primary concern should properly be limited to the food additive behavior and not include product specifications which have complex relationships to potential migration." Opposing any limit on wall thickness, the firm said this "could arbitrarily legislate out of existence many useful and safe PVC packages," adding that "the only equitable test of suitability . . . must be the extent to which a suspect ingredient becomes a food additive in a real-life situation." Noting the lack of ingestion data on the effects of VCM in foods and the absence of any instance "where harmful effects have been attributed to the consumption of food packaged in PVC containers," Hooker asked, "What would be the rationale, there fore, of setting extremely low allowable limits, in parts per billion, on vinyl chloride monomer in food products?" The company urged that FDA "await evidence on the re sults of feeding tests before promulgating restrictive and disruptive regulations." FDA Deputy Associate Commissioner for Compliance William F. Randolph replied on Jan. 9 that the "draft proposed regulations are still under review at the FDA Bureau level," suggesting that Hooker might want to arrange a meeting with representatives of the Bureau of Foods. FDA EXPECTED TO STICK WITH PROPOSED BAN ON ANTIBIOTIC COMBINATIONS The Food and Drug Administration is expected to stick with its revised proposal to ban combinations of low-level antibiotics on which required data has not been sub mitted, despite industry comments urging that the proposal be replaced by another revision (See FOOD CHEMICAL NEWS, Dec. 23, Page 33). Agency officials conceded that comments pose a serious question regarding the legality of banning the combinations without first offering an opportunity for a public hearing. In comments it has been contended that the products are covered by New Animal Drug regulations or their equivalents which cannot be revoked without formal procedures. This question will be put to FDA attorneys in its General Counsel's office for a determination. Many comments contended that 135.109 of the regulations, which is being invoked in the proposal, pertains only to animal drugs used for non-therapeutic purposes, whereas some of the combinations proposed for banning are therapeutic. In attempting to resolve the question of when a product becomes "therapeutic," FDA-ers have stated that a product is non-therapeutic and is covered by 135.109 if it is used continuously for more than 14 days. Agency spokesmen say that firms cannot avoid the review of low-level antibiotic products simply by increasing dosages and including the "for the treatment of" phrase in labeling. Regarding the errors of omission and commission alleged in many comments, FDA-ers say the proposal and the comments are being carefully reviewed to pinpoint any such errors and to eliminate them.