Document ykZL23yJL40aLovjwMnzrgN6V

JOSEPH E. KELLER JEROME H HECKMAN CHARLES M. MEEHAN WILLIAM HBOHOHESANI,JH ROBERT R TIE RifAN WAYNE V BLACK DAVID L HILL MARTIN W, beecovici PETER M. NEMEOV JOSEPH E. HADLEY CAROLE C. HARRIS PETER THOMAS SMITH MICHAEL F. MORROKE LARRY S. SOLOMON LAW OFFICES Kelieh and Heckman USO 17TB STREET, N. W. SUITE lOOO WASHINGTON, D. C. 20030 April 21, 1976 TELEPHONE SOS SSO'STOO CABLE ADDBESS "EELMAN" No. 20 TO: All Members of PVC/VCM Mailing Lists Ladies and Gentlemen: The purpose of this letter is to bring you up to date once again on Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) developments relative to vinyl chloride and polyvinyl chloride. Although nothing substantive has occurred in either of these major regulatory areas, we have received some information from "reliable sources," or have heard rumors which we considered to be well enough founded to share with you, FDA We have been reporting regularly that the technical review of the Comments filed with the Food and Drug Adminis tration has not yet been completed. The latest information in this regard is that, while a formal report has not been completed, the scientists in the Bureau of Foods have made an evaluation of the data. Furthermore, we believe that the evaluation, as far as it has gone, has satisfied the Bureau's technical people that the data provided by the industry regarding rigid and semi-rigid packaging materials demonstrates that no vinyl chloride could be detected in food or food-simulating solvents at the claimed limits of detection sensitivity. Hopefully, this will ultimately lead to a consensus that this assures there is no reasonable basis for an expectation that vinyl chloride will become a component of food when rigid and semi-rigid PVC packaging materials have an adequately low level of residual monomer, i.e. in the range of 0.35 ppm. CMA 101968 April 21, 1976 Page Two As many of you know, we have been cautioning that "political toxicology" may play a significant role in the ultimate regulatory decision. We understand, how ever, that the report or draft regulation that the Bureau of Foods has been directed to prepare for consideration by the Commissioner's office (which is where image or political considerations can come into play) will be based solely on an objective scientific evaluation. Based on our hope that this will indeed be the case, our general outlook is now cautiously optimistic. Many of you will recall that the FDA Consumer, the official magazine of the Food and Drug Administration, con tained an article on polyvinyl chloride in its DecemberJanuary issue to which we took immediate and strong objection. The March, 1976 issue reproduces, in its Consumer Forum section, a letter which we wrote voicing some of our ob jections. We are enclosing a copy of page 3 of the March, 1976 issue since it contains our letter, an FDA response and another letter which objected to other errors in the article. EPA Those of you who are directly concerned know that we have been expecting EPA to promulgate its final Vinyl Chloride Emissions Regulation by June 24, 1976. It now appears that because of the volume of technical commentary supplied to EPA staff and the Agency's general work load, it may be unable to complete work on the standard by this date. Excerpting from a lengthy internal report given us by Bill Ruckelshaus, the following additional information will be of interest to many of you: "We have advised you before that the vinyl chloride standard does not apply to the industry until 90 days after its promulgation date. During this 90-day period a waiver may be sought which will permit a source up to two years to comply. CMA 101969 April 21, 1976 Page Three Even though the Agency will not meet its own statutory deadline, in our opinion this will not affect the amount of time the companies will have for compliance; therefore the two year and 90-day periods will not start running until the date the final standard is promulgated. 'Legislation Both the Senate Public Works and House Interstate and Foreign Commerce Committees have reported out bills for consideration by their respective bodies. The House bill is not expected to be printed until the end of April. Forecasts are that the Senate may begin debate as early as next week; it is still uncleaf when the House will do so. The latest versions of these bills do not change earlier drafts we have reported on as they affect Section 112. We will furnish you with more details as soon as we have had an opportunity to review all final amendments. 'Other Copies of all comments on the proposed Vinyl Chloride Standard, including those filed after the February EPA hearing, will be available for our review next week. We will advise you of any significant comments after we have had a chance to review them. EPA advises that to date a total of 46 comments have been received." In addition to Federal standards promulgated by EPA, we understand that the Air Quality Boards of Maryland and Texas are becoming interested in the matter of vinyl chloride emissions. We are enclosing a letter from Gary H. Baise of the Ruckelshaus firm dated April 7, 1976 which discusses CMM01970 April 21, 1976 Page Pour this development. Generally speaking, if state regulations are promulgated which are more strict than the Federal standard, problems could develop in that it might encourage the press to heighten attacks, both on vinyl chloride and on EPA. Several times in the past states have promulgated unattainable standards stricter than EPA's which made EPA appear to be derelict. Subsequently, industry was unable to meet the state standards and the states' evaluations were exposed as being unrealistic. In the meantime, however, affected industries were caught in an uncomfortable tug-of-war. In any event, we are "scoping" the developing situations in Texas and Maryland so we will try to keep you posted on whatever we learn, or on any action taken by SPI, if such action becomes necessary. General For your general interest we are enclosing a copy of a letter from Ralph L. Harding, Jr. which appeared in the April 12, 1976 issue of Chemical and Engineering News, published by the American Chemical Society. We believe the letter answers very lucidly a charge which has been repeated in many quarters. In connection with the general discussions going on concerning environmental carcinogens, we are enclosing two articles from the New York Times, one from the April 10 issue, the other from the April 13 issue. We also want to direct your attention to the W. 0. Atwater Memorial Lecture delivered by Dr. Emil M. Mrak at the American Chemical Society's Centennial Meeting in New York. The entire talk was, we felt, quite cogent; the report of the lecture in Food Chemical News for April 19, 1976 provides an excellent summary. For this reason, with the permission of the publisher we are enclosing a copy of page 3 of Food Chemical News which includes some of the important points Dr. Mrak made. We want to call to your attention the fact that the Bureau of Explosives at the Association of American Railroads has requested assistance from SPI in setting up CMA 101971 April 21, 1976 Page Five a mutual aid response system for incidents in transportation involving vinyl chloride. This has been turned over to the VC/PVC Producers Group for prompt attention. it * We shall continue to monitor the various aspects of the vinyl chloride/polyvinyl chloride matter and report to you as fully and promptly as we can. ,ially yours Enclosures CMA 101972 Consumer Forum A Question of Timing While we certainly have no quarrel with your printing an article which recites the chronology and rationale for FDA action on polyvinyl chloride, we strongly question the timing and content of Polyvinyl Chloride; Why FDA Acted which appeared in the December/January issue of FDA Consumer. Should the official magazine of FDA publish an article on the vinyl chloride regulations prior to the completion of that process? We think not. In fact, we believe that the published article could suggest that FDA has prejudged the case and decided to ban several important types of polyvinyl chloride packaging prior to reviewing new industry data which shows that these products present no hazard to public health. We also find it difficult to understand why author Wayne Pines' otherwise excellent chronology fails to mention: Commissioner Schmidt's finding that polyvinyl chloride packaging presents no immediate hazard. The December 19 filing of 900 pages of comment by The Society of the Plastics Industry documenting industry's contention that there is no reasonable expectation of vinyl chloride monomer migration from any polyvinyl chloride product. The December 19 recommendation of the Office of. Wage and Price Stabilization urging FDA to delay its polyvinyl chloride regulations until it has evaluated more current data on the presence of polyvinyl chloride in food. Since the article states that "December 12" was the final date for filing comments on the FDA proposal, we believe it was written substantially ahead of important new factual developments in the chronology of this regulation. Therefore, we believe that FDA Consumer will want to set the record straight with an article that presents all the facts in the vinyl chloride regulation, including industry's arguments as well as the final action by the Agency. Jerome H. Heckman General Counsel The Society of the Plastics Industry Washington, D.C. FDA Consumer often carries articles on pro posed regulations because consumers should know what regulatory actions FDA is considering, and why. Publication of the article on polyvinyl chloride in no way indicates FDA has prejudged the case. FDA will carefully / 'view all the comments sub mitted on the proposal and make its judgment on the basis of the evidence. When final action is taken, it will be reported in FDA Consumer. The FDA Consumer article did point out that the public health hazard from polyvinyl chloride food packaging material was not of a nature that warranted either an immediate ban on use of the material or recall of food products packaged in it. The comments on FDA's proposal filed by the Society of the Plastics Industry and the recommen dation of the Office of Wage and. Price Stabilization occurred substantially after the FDA Consumer article was written and prepared for publication. Not Polyvinyl Chloride The December 75-January 76 issue of the FDA Consumer contained an article on polyvinyl chlo ride, accompanied by a picture of several containers which the article stated "may be" made from poly vinyl chloride. While no labels were visible in the picture, one of the containers was, nevertheless, readily identifiable as our RJR Foods Vermont Maid Syrup, because the distinctive container, made from private molds, is only available to us. RJR Foods adopted the plastic container for syrup several years ago as a convenience to the consumer because of its light weight and freedom from hazard of glass breakage. Since "may be" was included in the caption along side the picture and since we do not want consumers to be misled, we wish to state for the record that this package does not contain polyvinyl chloride nor has it ever. David L. Meggison Vice President, Technical Services RJR Foods Winston-Salem, North Carolina Consumer Forum is an opportunity for the readers of FDA Consumer to express their views. Short, tothe-point letters are most acceptable for publication. Please address letters to Consumer Forum, FDA Consumer, HFl-20, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20852. FDA Consumer / March 1976 / i CMA 101973 LAworriec* Ruckelshaus, Beveridge, Fairbanks & Diamond WILLIAM D. RUCftCLftMAUft j. nralrert bevcridoc. RICHARD M. FAIRBANKS, St HENRY L. DIAMOND 0ARY H. RAISE KEVIN M. FOLEY A. JAMES iARNCS HAROLD MIMMCwMAN JONATHAN 1. CANNON ANDREW C. MISHKIN CHRISTOPHER H. BUCKLEY, JR, One Farragut Square South Washington, D. C. 0006 TELEPHONE (201) S1S-7BOQ April 7, 1976 CAPL EAPOLET leonapo OAMmENT or counpel CABLE A0DPE9* "INDLAW" Mr. Jerome Heckman Keller & Heckman 1150 17th Street, N.W. Washington,D.C. 20036 Dear Jerry: Just a short note to advise you on some recent developments regarding Vinyl Chloride. We have been advised that the Air Quality Boards of two States, Maryland and Texas, have been requesting technical information from some of our members. The line of questioning indicates these States may be considering proposing Vinyl Chloride Emmission Standards which could be tougher than the one proposed by EPA. Also, the questions would lead one to be lieve the States are planning on proposing and promulgating regulations notwithstanding the fact that EPA has a proposed regulation under consideration. If you have any questions, please advise. Sincerely yours. CMA 101974 Letters CHEMICAL SAFETY Explosive reaction warning SIR: The following reaction has bean described In U S Patent 2,917,548* and In several book* on organic fluorine chemistry: RO* + CFi"CFj glym* or dloiene ROO=CFj + F~ We would like to Inform anyone wishing to repeat this work or to use the products that the compound CHjOCF--CFj has considerable explosive potential. Igniting it either by a hot wire or an electric spark causes it to decompose vi olently with a substantial and rapid temperature and pressure rise. Under equivalent initial con ditions of loading, this gas appears to have a far greater explosive potential than does acetylene. It should therefore be treated wth extreme caution. Although the products made from high alkoxides have not been tested for similar Insta bility. we recommend that they be considered to be potentially hazardous until proved other wise. Arthur W. Anderson Manager, PAD Division, Du Pont Co., Wilming ton, Dal. * Porfluorovinyt ethers. Stanley Dixon (to E. I. du Pont tie tiemours t Co.). U.S. 2,917,548, Dec. 15, 1959. Perfluorovlnyl ethers are prepd. from the re action of tetratluoroethyiene and a metal alkoxlde In an inert solvent. NaOPr (27 g.) in 53,1 g. ether is heated with SO g. C3F4 and 0.5 g. terpens inhibitor in a 400 ml. stainless steel bomb al 90*. After a pressure drop the bomb is heated to 110s until the pressure remains const Alter cooling, the contents art added to HjO and neutralized with HCI. Extn. with ether followed by drying and distn. of the ether soln. yields 4.5 g. propyl thtloorovinyl ether, b. 63*. Other trllluorcvlny! ethers similarly prepd. are (alkyl radical, g. Na alcoholate, g. yield, b p.l: Bu, 25. 16, 90-5*: 4-pentanyl, 29.S, 5.4, 54-7"/96 min ; CFjCH*. 25,18.5.40-1.5*: Me, 33.3, 19, 10.5-12.5*. Butyl trltluorovinyl ether adds Br in CSj to produce butyl 1,2-dlbrOmo-1,2,2-triftuOro. ethyl ether, b. 152*. The methyl ether also adds 8r readily and decolorizes KMnO* SOln. Trifhiorovinyt ethers ere monomers. PVC industry SIR- Your issue of March 8 (page 5) reports on a "stern warning" served on the chemical In dustry by Dr. Morton Com, new head of the Oc cupational Safety A Health Administration. Com joins others in making the accusation that the polyvinyl chloride industry "cried wolf" on the occasion of the original vinyl chloride hearing In 1974. As he put It,".. .the tone has been set for your industry by the vinyl chloride hearing. It was stated by several corporations that the proposed standard would put the Industry out of business. The industry still believes that the proposed standard would have. In effect, put It out of business. The industry survives today because the proposed standard, which had called for a "no-detectabl#" level of vinyl chloride In work areas, was changed under the permanent standard of Oct. 5, 1974, to permit levels In specified areas of 1 ppm for 8 hours and 5 ppm for 15 minutes on the basis ol time-weighted averages. This change and other significant changes In the proposed standard incorporated in m per manent standard in effect today were far reaching and essential to the continued health of our industry. Com went on. according to your report, to talk of "strident promotional cries." We commend to his attention recant comments by Dr. Irving Selikoff of Mount Sinai School of Medicine in New York who sees "... the case of vinyl chloride as a `success story.' He says it was a `success for science in having defined the problem: success for labor in the rapid mobili zation of concern; success for government in urgently collecting data, avaluating it. and translating it Into necessary regulations; and success for industry in preparing the necessary engineering controls to minimize or eliminate the hazard.' " Ralph L. Harding Jr. President, Society of the Plastics Industry, New York City More credence to many SIR: Dr. Selbin in a recant letter to C&EN sug gested that. "... whan people with families to support resign secure positions for uncertain futures... we must pay very careful attention." My scientific training, however, also suggests that the 10,000 or so scientists and engineers who continue to do a very fine job deserve more credence than the few who, for whatever rea sons, have renounced or will renounce their former employment. W. Carl Qottschal! University Of Denver, Colo. Recommendation letters SIR: I would appreciate it very much, if you kindly publish this letter In C&EN because I feel that many people might be facing the same problem that l am in connection with satisfying tha de mand of employers to make the applicant ar range for recommendations. First of all. I think it Is highly unnecessary and Inappropriate to seek recommendations from every applicant. No matter how many people are epplying for the position, I feel that recommen dations should be sought from only the small number of applicants who are under serious consideration. Even in that case, the recom mendations should be requested by the em ployer from the references. No matter how much you want somebody to get a good job and how much you know that somebody deserves a good job. the referee starts to lose Interest after sending a few letters for his subject, and that can be very harmful to the subject. It is possible to print resumes and send it with the applications, but sanding rec ommendations will not serve eny constructive purpose in this respect. I am one of the unfortunates who has to struggle hard to find a suitable position. This means writing to hundreds of places to find a job. I have requested my references so many times during the past that it is becoming more and more embarrassing to request them to send more. I therefore feel that this practice of asking for -recommendations from each end every candidate should be discontinued and should be only exercised for a small number of people that are under sincere considerstion. This will save a lot of trouble for a lot of people, including the poor secretaries. H. V. Navangul, Ph.D. Northeast Missouri State University, Klrksville Safety of cyctamates SIR: The March 15 article on the health hazard of cyclamates (page 6) st .uld outrage anyone concerned about the scientific effort of the federal government. We like to believe that In technical matters the government maintains proper scientific objectivity end impartiality. Yet, In the case of cyclamates, the National Cancer Institute has been unable to demonstrate car cinogenicity and still refuses to accept this re sult. Safety studies in animals are designed to provide extreme exposure to the test material in order to demonstrate safety at normal expo sure levels. One might still question the validity Of a statistically significant incidence of ill effects at such extreme exposure levels. However, when the incidence of III effects does not reach a statistically significant 1 /el, the meaning of the study must be very clear. Within the Intent of the experiments, no health hazard has been found. When a government agency hedges on the results of an experiment because the results do not fit those desired, this Is a travesty of scien tific objectivity, and I for one believe our gov ernment la capable of much better scientific effort. Bernard R. Neustadt, Ph.D. Bloomfiald, N.J. Mutual needs SIR: I was disturbed by the sharp separation between pollution facilities on the one hand, and goods and services on the other, which ap peared In Texaco vice president Coppac's statement in the March 8 issue (page 3) of C&EN: "There is no reason to believe that more jobs would be provided in constructing pollution fa cilities than would be created if the capital were spent on alternative investments in facilities producing goods and services." I take no side In the job issue. But the state ment, 1 submit, raises two fundamental ques tions; 1. Does Industry produce a service if it dimin ishes. to a reasonable or measurable degree, the extent to which the land, water, and air are polluted through its activities? 2. If the purpose of goods and services is to provide a fuller life for the targeted con sumer, doesn't success need to weigh in the adverse effects of pollution--especially on a tong-range basis--on his life too? I don't believe that the critical need for both a healthy economy and a healthy environment should be handled on a confrontation basis. The needs are mutually imperative, and in my view, fuM cooperation represents the only constructive approach for dealing with them. A. M. Gassier Cranford, N.J. Apr! 12, 1976 C&EN 5 CMA 101G7K THE NEW YORK TIMES, SATURDAY, APRIL 10, 1976 Flame-Retardan t Sleepwear: , f: ; r. i i Is There a Risk of Cancer?- mn By NADINE BROZAN With manmade factors increasingly b ewed as canccr-causing agents, controversy has come to rest lately on a seemingly harmless consumer product: children's sleepwear. Pajamas and cancer? The suspect ed link between them is a chemical compound called tris(2 3-dlbromopropyl) phosphate, popularly known as Tris. It is the substance most com monly used to make children's sleepwear flame retardant. The scientific evidence available so far indicates that Tris is mutage nic: that means it has the capability of altering the genetic material in living cells. Although not every muta gen is carcinogenic, it strongly raises the possibility, for the majority of carcinogens tested have been shown also to me mutagens. Several years ago, the Consumer Product Safety Commission issued regulations mandating that all child ren's sleepwear in sizes 0 to 14 be flame retardant. Since then, the agency has received reports from bum treatment units showing a sub stantial reduction in burn incidents among chiliren who had worn the treated sleepwear. The commission is now studying the feasibility of requiring that all clothing in nil sizes be flame retardant. Although it can issue such regAulations, it s authority does not extend to controll ing the technology of flame retardancy. "The standards set a limit on how much flame can spread in sleepwear, but in no way do we tell the manu facturers how to meet that limit," said Charles Flinner, a commission spokesman. Although any direct connection between Tris and cancer has yqt to be established, experiments on microorganisms have generated con siderable concern in Government and scientific circles. And consumer ad vocates believe that it is not too early to bring the issue to the public. Dr. Robert Harris, associate direc tor of the. Environmental Defense Fund's toxic chemicals program, said, "The suggestion of potential harm to some 45 million children is so great that we.believe the consumer must have this information. Who are we to' keep it to ourselves?" Last month, the fund and Dr. Har ris, in the name of his infant son, Alexander Samuel, filed a petition with the Consumer Product Safety Commission asking for action on Tris. s The i petition asked the agency to require the labeling of every gar ment containing more than 100 parts per million - of Tris on its surface with a tag reading, "Contains the flame retardant Tris. Should be washed at least three time prior to wearing." 'Test so far indicated that Tristreated fabrics contain far more than 100 parts per million surface concen trations, although not all fabrics have been tested," Dr. Harris said. The petition stated, "Two samples of different polyester fabric had 70.000 parts , per million and 37,500 parts per million of surface Tris before, and 35 parts per million and 100 parts per million of surface Tris after washing, respectively." The effect of triple laundering is still fn question because it would not remove the chemical contained inside the fabric. It will not reduce the flame retardancy because the regulation specifies that flame retardnney must be able to withstand 50 washings. The petition also asked the com mission to request manufacturers to test the extent to which Tris can he absorbed into the body, to conduct tests on potential cancer-causing ca pabilities by painting the chemical on the skin of animals and to investi gate possible substitutes and their safety. It also urged t'.e speeding up of experiments now being con ducted by the National Cancer Insti tute. Richard O. Simpson, chairman of the Consumer Product Safety Com mission, who discussed the con troversy at a forum of the American Apparel Manufacturers Association in Arlington, Va., this week, said, "I have instructed our staff to review all the technical references in the petition and to treat it as a high priority. Based on what I've exa mined and on discussion with our biomedical science experts, I would doubt that there is a problem. There is a great leap from the tests [cited in the petition] to a conclusion that the chemical is a carcinogen. "And I am skeptical when a peti tion which raises the speller jf can cer suggests the remedy of a label asking people to wash the clothes three times before wearing. If there is a real problem, there should be a b, n, not a label." The petition did not ask for an outright ban on Tris because, Dr. Harris explained, "We can't be sure that the alternatives to Tris are safer, so by banning it we might be going from the fire to the frying pan." Much of the evidence causing wor ry was generated by the research on salmonella bacteria conducted hv Dr. Bruce N. Ames, professor of biochemistry at the University of California at Berkeley. Dr, Ames is the inventor of a mutagencily test that bears his name. The test is considered by many to h- \ery reliab le. inexpenxive and eftu ent 1: vines not determine that a chc"ij| is ty suggestive. "I had Jong been suspicious of Tris because its structure is related to known cancer-causing chemicals," Dr. Ames said the other day. "That alone is not proof, but when it came up positive on the Environmen tal Protection Agency tests and sub sequent! on our own, 1 became even more suspicious. "There is a high probability that if something shows up as a mutagen in our system, it will be carcinogenic, too. We have tested 175 chemicals that have been found to cause cancer i in animals and 90 percent have shown up to be mutagens." Asked whether the findings in mi croscopic salmonella bacteria used in his test could be applied to people', Dr. Ames answered. "The genetic material is the same in all living things. About a dozen chemicals can cause cancer in people, and we get positive results with almost all of them in. our salmonella bacteria sys tem." In addit'on, Dr. Ames's test com bines the bacteria for measuring ge netic damage with liver samples ta^' ken from rat or human autopsies. That recreates the way that chemi cals, not in themselves cancer caus ing, can be convene dinto carcino gens by the human metabolic system. Dr. Herbert Rosenkranz, who be gan tests for the Environmental Protection Agency last fall when he was a irufessor of microbiology at Columbia University's College of Physicians and Surgeons and is con- CMA 101976 Some scientists said that for their own children they 'were borrowing old sleepwear manufactured before the flame retardant regulations were promulgated. tinuing them at New York Medical College, came up with the same results in three different tests, in cluding the Ames method. Now he has moved on from study of the , pure chemical to the textiles contain ing Tris. "We want to learn if it can be absorbed through the skin and if we can detect mutagenic effects in the body by studying the urine of Infants who wear the garments." he said. Although the textile researchis still in its initial phase, "The fabrics have already been shown to contain mutagenic activity," Dr. Rosenkranz said. Echoing the state ments of all the scientists inter viewed, he added, "We haven't tested for cancer, so we don't know, if it is cancerous." The National Cancer Institute is confronting that question head on by putting Tris into the feed of rats and mice, but conclusions are not expected until the summer of * 1977. A study on animals conducted at the New York University Medical Center will be discussed at a scienti fic meeting later this month. The research showed that when Tris was painted on the - skin of mice, it showed the ability to promote growth of tumors. According to this report, Tris is not a potent carcinogen, but may have a weak cancer-provoking effect. Inconclusive though the findings may be for the moment, the current use of Tris raises all sorts of chemi cal, philosophical and practical issues. As Dr, Ames put it, "Here we are Crying to keep children from being burned up, and we're doing it by using a mutagenic compound that has not been tested for carcin ogenicity." Dr. Sidney Wolfe, dir<vtor of the Public Citizens Health Research Group, the health wing of Ralph Nader's consumer advocate network. said, "The burden of proof for safety should be with industry, not with the American public after the fact of massive marketing of a chemical. . Why doesn't the chemicals industry screen its products before they go into massive use?" . That question may be resolved if the Toxic Substances Control Act, recently passed, by the Senate, is also passed by the House and signed into law. The legislation would give the Environmental Protection Agency the authority to require testing on the authority to require testing on both chemicals already in use and on ones not yet marketed that are believed to be hazardous to human health or the environment. In the, meantime, the industry is awaiting more information. Dr. Fred Kerst, vice president of research and engineering for the Michigan Chemical Corporation in Chicago, a leading producer of Tris, said, "We believe the potential ha zards are extremely minimal, and we think further studies will bear us out. The company, which has conducted toxicological tests in the past--it has been making; Tris for 20 years-- has now begun its own experiments on mutagencity and carcinogenicity, he said. Without proof one way or the other, what is the parent, who can buy nothing but flame retardant sleepwear, to do? Som scientist- said that for them own 'hildrcn they were borrowing old sleepwear manufacured before the flame retardant regulations were promulgated, dressing them in ther mal under wear or stocking up on cotton pajamas when they traveled abroad. Dr. Harris had another suggestion, "Surely the ability to sew hasn't been lost to this gener.von." 'e said. "And we all have mothers and grandmothers who remember how to sew. . , THE NEW YORK TIMES, TUESDAY. APRIL 13, 197S Issue and Debate Deciding What Is a Carcinogen By BAYARD WEBSTER Eighteen months ago the Environmental Protection Agency banned the use of the pesticides aldrin and dieldrin, saying that they were cancer-causing substan ces, Last Christmas Eve most uses of the agricultural pesti cides heptachior and chlordane were suspened by the agency because of an "im minent cancer risk" to hu mans. A month later, an agricul tural-scientific group took exception to these decisions, charging that the Govern ment agency's procedures for determining cancer causing substances were based on faulty assumptions. These opposing views have highlighted a growing con troversy over the scientific approaches to determining whether a substance is or is not a carcinogen (cancercausing agent). Described as Hazardous On one side of the ar gument are Government and independent scientists and cancer researchers who feel that almost any substance that can cause change in cell structure (mutagenesis) or that can cause tumors, even though benign, are usually carcinogens, and therefore hazardous. In the late 1960's these scientists* views came to be accepted as "principles of carcinogenicity" by several Federal health and regulato ry agencies, including the Environmental Protection Agency, which considered them in banning the insecti cide DDT in 1970 and other chemicals in later years. These guidelines, or criter ia, for determining carcinoge nicity included the broadly stated main principle: Any chemical that is found to cause tumors in animals or living tissue should be char acterized as a carcinogen and a hazard toman. A corollary principle stated that the concept of a threshhold exposure level for any cancer-causing agent was im possible to determine and, therefore, there should be a zero exposure level for the chemical. On the other side of the argument are agricultural trade groups, farm and gar den chemical manufacturers and a number of independent scientists. They are generally of the opinion that the regu latory agency's criteria for determining whether a sub stance is a carcinogen are ambiguous and too strict and that they should be relaxed or disregarded. This difference of opinion has come at a time when* the growing weight of . evidence seems to demon strate that cancer caused by toxic substances in the envir onment is one of the most pervasive health problems in the world. According to the World Health Organization, from 60 to 90 percent of all cancers are caused by such substances. Background From the time man discov ered fire, whose smoke pro duced hydrocarbons and tar ry byproducts, he has intro duced a host of carcinogens into the human environment. Since the Industrial Revolu tion in the latter 18th centu ry, more than 30.000 chemi cals have come into commer- | cial production and each year l the list grows by some 1,000 new compounds. According to Russell Train, j head of the environmental agency, only a few thousand of the more than 2,000,000 known chemicals have been tested for carcinogenicity. Of these, 1.000 have been shown to cause cancer in animals and nearly 200 have been demonstrated to cause can cer in humans. As the number of toxic chemicals proliferated, the environmental cancer prob lem intensified and began to be studied more closely by concerned scientific groups who came up with the informal guidelines, or so-called "principles," for de fining carcinogens. For Less Control Most chemical and pesti cide makers and the agricul tural industry contend that the guidelines are not wholly proven and are too restric tive for the billion-dollar in dustries that greatly in fluence the nation's welfare and economy. _ The Council for Agricultur al Science and 'Technology, a consortium of United States farm research and trade organizations, argues in a recent report that the guidelines fail to make a distinction between types of tumors. The report states: "All cancers are tumors, but : most tumors are not cancers --some tumors become can cers, but most do not." The council also argues that substances that cause cancers in animals do not necessarily cause them in hu mans. The group also says that the concept of zero ex posure to any environmental substance is impractical and almost impossible to achieve. Last month an editorial in Lancet, the British medical journal, stated that the En vironmental Protection Agen cy's cancer principals "vary from the innocuous to the absurd" and added that few experts would accept the: proposition of the World: j Health Organization and oth- I ers that cancer was mainly caused by c, m - nal factors such as chemi cals. For More Control Dr. Russell W. Peterson, chairman of the President's Council on Environmental Quality, last month ad dressed the annual meeting of the Society of Toxicology in Atlanta and supported the environmental agency's use of its principles of carcinoge nicity. "It is a social value judg ment," Dr. Peterson said. "And because certain in duced tumors transform into malignancies, and because we can seldom predict which tumors will become malig nant and which will not. we should regard all tumorigens [tumor-causing agents] as possible carcinogens." He added that it was "ob viously unacceptable to wait from 15 to 40 years [the range of cancer latency per iods] to find out whether a suspect chemical will pro duce cancer in man." He said that "every chemical that induces cancer in ani mals" must be regarded "as a potential carcinogen in hu mans." In a recent letter to Chemi cal and Engineering News, a publication of the Ameri can Chemical Society, Dr. Sidney Weinhouse, director of the Pels Research Institute in Philadelphia, stated: "There are no strict, quanti tative criteria that differen tiate benign from malignant tumors. So-called 'benign' tu mors simply grow more slow ly than malignant tumors." Dr. Harold Stewart, retired chief of pathology at the National Cancer Institute and now a consultant for that agency, also points out the difficulty in distinguishing between tumors and cancers. "You can't really separate the two terms." he said. "We know that if tumors are un treated they will very often metastasize (spread)" Outlook In the argument over the proper definition of carcino genicity and in the tangled thicket of scientists, legislative bodies, Federal agencies, in dustrial groups and other or ganizations concerned with :the problem, there is little evidence that a solution ac ceptable to industry and en- vironmentalists, to doctors and lawmakers, to farmers and consumers, is around the corner. But the following ac tions have been initiated: <3The National Cancer In stitute is preparing new criteria as suggested guide lines for defining an dgent as cancer-causing. These arc expected to be made public sometime this summer. JThe Environmental Protection Agency is prepar ing its own guidelines for determining environmental carcinogens using a benefit/ risk approach based on the hea..h risk to humans of a substance in the environ ment matched against its overall benefit to mankind. 4A national clearinghouse CMA 101978 on env'ronmcntal f'r.-lnogens is being set up bv the National Cancer InsLitute. It would act as an information center and an early warning network for scientists, indus try, Federal agencies and other concerned groups. *3New, simple and inexpen sive ways of testing chemi cals for their cancer-causing properties, using bacteria in stead of animals, are being examined by the Govern ment's scientific and regula tory departments. Such tests, though not as definitive as the vastly more expensive and time-consuming animals tests, are regarded as promis ing for ultimately being able to screen substances and de termine where or not they have enough harmful poten tial to merit being examined more closely. But despite these develop ments. the road toward es tablishing accepted defini tions of carcinogenicity in the near 'future seems filled with obstacles, according to most observers. The National Cancer Insti tute's latest draft of its new guidelines, for example, is reported to be quite similar to the Environmental Protec tion Agency's present criter ia, which will make the en vironmentalists happy but which are unacceptable to much of the chemical and agriculture industry. The promise of simpler test procedures, even if they hold true, are not expected to bear fruit for the next four or five years because it will take that long to thoroughly assess the scope and accura cy of the new methods. A Possible Approach One possible approach to the problem of identifying cancerous substances has been proposed by William D. Ruekolshaus, the first Ad ministrator of the Environ mental Protection Agency. In an interview in the journal. Science, Mr. Ruckelshaus said that whenever a new "devilish" substance was dis covered it should be sur veyed by an independent re search program prepared by everyone involved--industry, labor. Government and con cerned citizens. A review group of scientists of ''ur. questioned integrity" wouIl. then design a research pro gram. In this way, Mr RuckC shaus believes, research data could be generated that e\ eryone could agree on and the matter of acceptable risks--the benefit/risk factor --could then be determined. But even if such a compre hensive program is begun, many scientists believe it will be years before inexpensive and accurate testing proce dures can be developed tha can quickly identify cancercausing substances in man's environment. And it may be equally as long before th> various groups concerned come to agree on the prope definition of a cancer-causing agent. Jt FOOD CHEMICAL NEWS Editor: Louis Rothschild, Jr. Managing Editor: Raymond Galant Assistant to the Editor: Natalie Pargas Assistant Editor: Eileen Kugler Circulation Director: Shirley Galant Production Manager: Dorothy Hill Associate Editors: Cathy Cooper, Gail Tapscott W MRAK CALLS ON FOOD SCIENTISTS TO TAKE STAND ON ISSUES Scientists should come from behind their fortresses of scientific certainty, and be willing to take leadership in giving advice based on their expert knowledge. Dr. Emil M. Mrak, Chancellor Emeritus of the University of California (Davis), told the Ameri can Chemical Society's centennial meeting in New York (See FOOD CHEMICAL NEWS, April 12, Page 2). In delivering the V/ O. Atwater Memorial Lecture, Mrak urged scientists to speak out, explaining: "It appears to me that responsible scientists are well aware that perfection in science, and especially in biological science, is a rarity, if at all existent. Real izing this limitation, they testify with uncertainty and always indicate the need for more research. On the other hand, those who may be advocates, biased, illinformed or even completely uninformed, testify with a positiveness that leaves no doubt in the mind of the politician or the average citizen. How then is the politician or news media to know who is correct and responsible, and who is irresponsible?" Encouraging positive1 responsiveness, he warned against "paranoic defensive behavior," and suggested: "It must be made clear that there are limits to perfection." Lawmakers, implemerters, and enforcers must be educated into an understanding that a scientist who says something is probable but who refuses to speak in terms of absolutes "is more to be trusted than the biased advocate who speaks with specious certainty," Mrak continued. "It is the duty of the food scientist in the future to assume the leadership of the country in answering problems of food safety as well as in solving the problems of food quantity and quality, " he said. In a separate speech on food safety, Mrak was critical of what he called "new and young regulators endowed with ideals, but deficient in scientific training." He opined; "These regulators seem inclined to respond to pressures more than to sound scientific facts and, understandably, this has caused in some instances adverse feelings on the part of scientists in the same agencies." CMA101980