Document Qgw1JD0GKp2Jz9E38R1mN4EVE

Receweo jMt 13 1977 UANN Dpt' ONmOYAL, Inc. Oxford Management & Research Center 7- ?:V January Docket Officer, Docket No. H090 Room S-6212 U.S. Department of Labor 3rd Street and Constitution Ave, N.W. Washington, DC 20210 Dear Sir; These comments are directed to the October 4, 1977 OSHA Publication (FR 42, 54148-54246) under the title "Identification, classification and Regulation of Toxic Substances Posing a Potential Occupational Carcinogenic Risk." Uniroyal through its Chemical Division is supporting the efforts of the American Industrial Health Council. I have seen their early drafts and am generally in agreement with their constructive approach and with the content of their statement. From my vantage point as a member of Uniroyal's Corporate Medical Department and as a member of a number of technical committees of various trade associations and scientific societies, I make the following comments; (1) OSHA is grossly overestimating the amount of sickness and death caused by exposure to industrial carcinogens. It is ray considered opinion that OSHA can accomplish the same benefits at a small fraction of the cost which this proposal would cause. (2) The concept that once the rule is promulgated it is "foreclosed from reconsideration in future regulating activity" is not sound. AP00048735 2- (3) The Secretary should not determine the Category of a "carcinogen/' This should be left to a committee of competent experts preferably divorced from the Labor Department. (4) OSHA should not be locked into a fixed approach, chemicals vary so widely in properties and nature of exposure that they must be given individual consideration. Some limited grouping may be possible. (5) OSHA should not regulate beyond knowledge. While it may quiet certain pressure groups for the moment, it can damage American industry with no real benefit in improved health. , OSHA has succumbed to pressure from those who take for granted that a large part of the cancer problem is the result of industrial exposure to carcinogens. While this belief may be sincere it is ill-informed. There is no question but that a few chemicals have caused human cancer. However, the number of such deaths are almost infinitesimal compared with other risks which we accept such as driving cars and smoking. As a member since 1971 of the MCA Vinyl Chloride Committee I have been intimately involved in events leading to the final vinyl chloride standard. The discussion which follows is presented to show the nature of an industrial carcinogen. Much of the thinking on carcinogens fails to recognize that industrial exposure to a given carcinogen often involves few people.. Careful control at the source of exposure can often eliminate the problem at little expense. A gas such as vinyl chloride is so different from a waxy solid such as MOCA that it is unwise to cover them by the some type of regulation. ^ i AP00048736 -3 Vinyl Chloride is the best example of a large volume industrial carcinogen I which was regulated by OSHA* Much of the effort which went into the regulation of this chemical should be considered a learning process, I am convinced that the problem would have been taken care of by industry once it was known that VC is a human carcinogen and the 50 ppm limit set in the original ETS would have adequately protected the worker. As it is about 2 people per year have developed angiosarcoma in the U.S, and other types of cancer have not been high in the industry as was originally feared, in fact the University of North Carolina study of Uniroyal's Painesville, Ohio plant showed all types of cancer to be about 40% of the national average. There have been no cases of angiosarcoma or of any other liver cancer among the workers in this plant. This was an ordinary well run plant, not a special showplace plant. A review of the vinyl chloride facts is, therefore, instructive. Commercial production of vinyl chloride started in the late 30'sj grew during the war years and late 40's and expanded almost exponentially thereafter to about six billion pounds by 1974. The early plants were really pilot plants .for the much larger plants built in the 50's and thereafter. As experience was gained and as economics forced more efficient operation exposure almost certainly was- reduced. Discovery of VC related acroosteolysis (flattening of the end bones of the fingers) resulted in a further drop in exposure in the late 60's. With the report.of angiosarcoma at Louisville by Goodrich in late January 1974, the industry made a concerted effort to reduce every source of exposure. By mid-summer of 1974 most companies had reduced exposure of vessel cleaners to below 50 ppm from probably about 1,000 in the early years. Excursions to tens of thousands of ppm must have been present AP00048737 -4- in these early years as evidenced by reports of men fainting. OSHA rapidly dropped the limit from 500 ppm to 50 ppm and later to 1 ppm. The cost, to reach 50 ppm was not groat but to go from 50 to 1 ppm cost the industry tens this expense of millions of dollars. It is my considered opinion that was unnecessary but is possibly excusable as a learning experience in view of the sheer size of the industry. America can ill afford many such learning experiences. It was assumed by many that because of the almost logarithmic growth in the period 1950-1970 so many people were exposed that the rate of discovery would rise astronomically. But this has not happened. In evaluating the data shown on the table which follows it is important to realize that angiosarcoma due to VC exposure has been found only among people who were very heavily exposed for a period of years. I have reorganized NIOSH's August 1977 report of confirmed VC related cases so that they are arranged according to date of death (or date of discovery of angiosarcoma in the two men still living). Several facts stand out: (1) Since 1967 the number-of cases of angiosarcoma per year has averaged 2.1. (2) The rate of discovery has increased only slightly if at all l' since 1967. (3) The interval from first exposure to death has increased from years 15 in 1961 to an average of 35^through the first 7 months of 1977. (4) Because of the stretched interval as exposure was reduced prior to 1974 we will probably continue to see occasional cases until AP00048738 -5v?cll after the year 2000. It is my opinion that the 50 ppm standard would have been adequate and that all OSHA needed to do was make the facts available to the industry with sensible guidelines. AP00048739 -6- NIOSH Case No.* 08 05 04 07 10 16 12 11 02 01 23 03 13 17 09 19 18 06 20 22 25 .24 21 Angiosarcoma Among Vinyl Chloride Exposed Workers in Che United Star.es Year of Heath**' No, per Year Year of First Exposure Interval 1961 l 1946 15 Average Age at Death 41 f 1964 1 1944 20 52 1968 1952 16 IEi,4 43 H?>2 1968 1968 1969 1969 3 2 1944 1951 1950 1949 24 N* 17 19 1\ 20 45 55 41 50 1970 1 1946 24 2(},8 61 1971 1973 ' 1 1955 1948 16 25 \ 37 49 1973 3 1958 15 \ 50 * ' 1973 1945 28 58 1974 1974* 2 1944 1955 ' 30 .22,6 19 52 43 1 1975 1975* . 1975 4 1954 1943 1954 21 ' / 32 21 43 60 'f' 46 1975 1971. 1976 1977*** 2 1962 1955 1949 1947 13y 22.8 21 27 V ' 30 sr 45 SX'X 1 58 52 * 67 /JN 1977 1977 3 1939 ' 1946 38 33 31 i- 60 wn 67 *Casc8 14 and 15 were dropped because pathologists determined they were probably not related to Vinyl Chloride. **Year of recognition; still alive 1978, ***To August 1, 1977: Y - This case appears out of line. The other 4 cases average 25,3 years. AP00048740 7 The opening paragraph of che October 4th publication entitled "Summary"sets forth the concept that once this proposed rule is promulgated it is "foreclosed from reconsideration in future regulatory activity..." It would be the height of,folly to cut off all possibility of reconsideration. New facts will require change. We are still at a very primitive stage in our knowledge of cancer and its causes. Turning now to the proposed regulation Part 1990, I offer the following brief comments: Section 1990.103 a. Provides that "Whenever the Secretary receives information submitted in writing by any interested person, concerning any toxic substance, ....he shall..within thirty (30) days publish notice of receipt in the Federal Register." While the reason - to solicit informed comment - is laudable, che overall effect may be harmful. When anyone with a special interest cells the Secretary's attention to any data, however limited or unreliable, (s)he is then bound to publish the allegation in the Federal Register. When a carcinogen is involved such an announcement will be widely cited by the news media. The public has enough real worries without being bombarded continuously by unfounded scare V stories about cancer. Such data should first be given to a committee ofTcompetent scientists to decide whether the "lead" should be followed up. b. Classification. This paragraph gives to the Secretary the responsibility of classifying the chemical. (S)lle is generally not technically competent to make such a decision nor is it wise for him/her to make it. A committee of competent scientists, knowlcdgable in various areas of cancer research and completely independent of the Labor Department should do the classifying. AP0004874I -8- Part 1990.112 requires that if the chemical is classified as a Category X carcinogen the Secretary shall issue an Emergency Temporary Standard, which then locks OSHA into a strict time table. The problem here is that OSHA will often be taking a panic approach on a non-existent or very minor problem. Under the Toxic Substances Act EPA will have a list of all manufacturers of a given chemical. If confronted with real evidence of carcinogenicity, the chemical and allied industries will take the necessary steps if for no better reason than self-interest. Industry will run too great a risk of expensive litigation and compensation costs for "exposed" workers who get cancer whether caused by the chemical or not. The Secretary should wait for the best scientific advice. Simple notification of industry with recommended workable handling procedures will result in virtual elmination of the problem with far less expense and disruption than the procedure outlined by OSHA, A low but measurable limit should be set to enable OSHA to prosecute recalcitrant manufacturers. OSHA should avoid trying to regulate beyond knowledge. There will never be enough inspectors to enforce unrealistic regulations. When the public does not really believe in a regulation it is virtually impossible to enforce it. It is far better to write realistic regulations only on real problems and then to enforce them even handedly. Section 1990.113. It should be possible in any public hearing to present any data which sheds light on the subject of the hearing. The hearing officer admittedly should be allowed some freedom to cut off irrelevant information or debate. AP00048742 -9- Categorles Without going into great detail I would recommend the following general approach: Category I. Proven human carcinogens. Regulations should.be developed with, the aid of those most knowledgable about processes of manufacture and use so as to achieve minimum exposure vith minimum expense. This has to be done on one chemical at a time because of widely different properties, toxicity, and processes. The number of proven carcinogens is small and it is imperative that OSHA take the necessary time to set meaningful, workable standards. ' Category II. Suspect carcinogens based on animal studies or suggestive but inadequate epidemiological evidence. The known facts should be put before those handling the chemical and proper research carried out to determine as soon as possible whether it is likely to be a serious human carcinogen. Category III. Possible carcinogens based on very limited suggestive animal data whether or not backed up by Ames or other in vitro tests. Research should be continued. Under any circumstances provision for updating should be made as new facts emerge. We must never close the book. Even the ancient Babylonian and Persian kings had to change the "immutable laws"of the Modes and the Persians as new facts came to light. Respectfully submitted, Walter D, Harris, Ph.D. Corporate Industrial Toxicologist AP00048743 AP00048744 II January 1973 RECEIVED JAN 11 1977 Vo : J. T. Barr C. E. Blades R. Fleming R. H. Schenck 'I. Binlt'n ?ro January VI, 1978 LAW DEPT. Plastics WpT~ Polyurethane Manufacturers Association Enlists in Move Comer To Influence OSHA Policy By WILLIAM,H. LANDBR Mr. Ellis, along with the Journal of Commerce Staff current PMA president -- The Polyurethane Manufac George Kilbride who is presi turers Association, based a dent of- Mandrels, Inc., in Chicago, has' enisled in tha Louisville, Ohio -- and Wil ' move to try to encourage the - liam Stahr, PMA vice presi Occupational Safety and dent, of- Dayton Coatings & Health Administration- to' Chemicals,. division of Whit adopt a rational, practical and taker Carp., will also be fol effective policy in its regula* lowing , activities of the tions for the workplace: ; associations committee of the Ellis Morphy, executive sec council.- retary, reports that the PMAi PMA's current treasurer, is fully supporting the work of Gene Huber, vice president of the newly created American engineering for Sweco Inc., is imiustrlai Health council, along with The society of the' Plastics industry ana other , companies' aftd gfOUpl . ' ^urgamxauon of the AICH was described la Tha Journal following the work of the council's public relations com-. mittee. rsWhen the hearings start, .PMA plans to t>i th* provide testimony and will of Commerce on Nov. 25, ,v also take- alongisom_exper 1977 and the plans of the SPI Witnesses. "Wc are very much"' and plastics manufacturers opposed to giving OSHA the and processors to taka a righLito select `substitute' strong position in the Washing 1 "chemicals for us. We still ton hearings starting April 4r object strenuously to signage 1973 were described on Dee:. that;includes the world 'can- 22.1977- ' '9. . . :: j^qer^.We also expect to dial- ' "We will be following the tenge*, some aspects of the activities of the American. workplace regulations," Mr. Industrial Health Council -Ellis added. . closely and are committed to As- readers of this column keeping our members in know, who) MOCA and other formed and urging. them to ' questions affecting the inter provide data when such re ests of its members arises, the quests come, and to contact' Polyurethane Manufacturers their senators and representa Association does not fool tives," Mr. Ellis told this' around, but moves in full newspaper. strength to tackle the prob The PMA's legal counsel, lem. Arvid Sather of Michael, Best St Friedrich is serving on the council's legal committee, and Jay E. Meili, a past president of PMA and president of Molded Dimensions Inc., of Port Washington, Wis., will serve on the council's alterna tives committee. y-w l - c_ While thousands of hazardous substances are being used in the workplace with more being introduced every year, OSHA has completed regulatory activity for only 17. In an effort to escape the slow "substance-by-substancc" approach to set ting standards, OSHA has proposed a system that would per mit standardized responses, in regulatory terms, for suspected carcinogens, Secretary of Labor Ray Marshall and Assis tant Secretary Eula Bingham, head of the Occupational Safety and Health Administration, have announced the first comprehensive pro posal for regulating cancer-causing substances. The proposed cancer policy will establish a pro cedure for identification, classification, and regu lation of potential carcinogens in American workplaces. At the outset, osha recognizes that 1,500 to 2,000 agents have been identified by niosh as being ''suspect carcinogens'- (hew Pub lication No. (kiosh) 77-149). Yet osha has completed regulatory action on only 17. osha recognizes that in regulating occupa tional carcinogens, many gaps remain in the knowledge of cancer, its causes, prevention, and cure. However, to wait for years to resolve these issues scientifically without some consistent and workable system for the regulation of toxic sub stances* for which there is evidence of carcino genic potential to humans, would be inconsistent with osha's statutory obligations and unaccepta ble to all concerned. The new osm proposal and broad rulemaking proceeding which will accompany it arc intended to establish: New procedures and regulatory framework for regulating worker exposures to potential oc cupational carcinogens. Scientifically-based policies to Identify and classify such substances. Three model standards for use in specific rulemaking involving such substances. Secretary Marshall noted that "this compre hensive cancer policy represents a major break through for osha. Trying to control carcinogenic substances on a case-by-case basis is like try ing to put out a forest fire one tree at a lime. Instead, wc are proposing a systematic way of determining which toxic substances require emergency attention by osha. "This new policy will allow osha to respond to threats to worker health with much greater speed and efficiency. This represents another step in our continuing efforts to make osha a model regulatory agency. Eula Bingham and her staff are to be commended for their efforts in developing such an important policy." Dr. Bing ham pointed to the proposed cancer policy as another indication of osha's renewed commit ment to protecting American workers from health hazards. "The sad fact is that more than 1,000 Ameri cans die every day from cancer--370,000 a year. Leading cancer researchers have attributed more than GO percent of these cancer cases to en vironmental factors. "I believe the time has come to implement a comprehensive program to prevent cancer in the workplace." Dr. Bingham noted that as a result of the proposed rule, osha will develop three model standards, incorporating osha's views on which protective provisions are generally the most ap propriate for different categories of substances. Thus, in a later rulemaking for a specific sub stance, the only major issues to be resolved would be selection of an appropriate exposure limit and determination of whether osha has appropriately classified the substances. Classifying substances In classifying each toxic substance encoun tered, osha will rely on evidence from human epidemiological studies, adequately designed and conducted animal studies, or both. The degree of conclusivuiess of such data would determine whether the toxic substance in question should be regulated as a Category 1 or Category 11 sub stance. Alternatively, a designation of Category III may be assigned (for a substance requiring further data development) or Category IV (for substances osha believes arc not found in Amer ican workplaces, but otherwise would be regu lated). The proposed rules and system would permit arty "interested person" or osha itself to present 14 DECEMBER 1977 AP00048746 information to the Secretary of Labor for the classification of any toxic substance. After re ceipt of such information, the Secretary would publish a notice for public comment giving the contents and source of such information. Gen erally a 30-day public comment period would be provided following which the secretary would, within 30 additional days, publish a notice classifying the substance as Category I, II, III or IV, and explaining his decision. osha proposes to classify as Category I those substances whose carcinogenicity has been estab lished in humans, or in two mammalian species of test animals, or in one species if those results have been replicated. Category II substances would be those whose carcinogenicity has been reported but the evidence is only suggestive, or is positive in only erne species and not yet repli cated. Classification of a substance in Category I would trigger the immediate issuance ot the mo del emergency temporary standard. This would be quickly followed by rulemaking--using the model for proposed permanent standards for Category 1 substances. At the conclusion of the rulemaking, if the Secretary of Labor determines the substance should more correctly have been classified as Category II, the model for that standard would be followed in issuing the per manent rule. Under these procedures, rulemaking would be significantly streamlined and speeded because the issues for rulemaking in dealing with Cate gory I substances would be limited to: whether the Secretary correctly classified the substance as Category I: whether he was correct in the de termination that the Category I classification should not be rebutted; whether the lowest fea sible exposure level was selected or whether there are suitable less hazardous substitutes; whether the substance has unique properties that make provisions of the model inappropriate; and the environmental impact arising from regulation of the substance. Similarly, an initial classification of a toxic substance in Category II would initiate rulemak ing following the mode! for permanent standards for such substances. The three model standards to be developed include an emergency temporary standard to be issued, in general, if the toxic substance meets the criteria for a Category.I substance; a pro posed permanent standard Tor such subslanccs; and a proposed permanent standard for those subslanccs that meet the. criteria only fur a Cate gory If designation. In discussing its proposed system for classi fying substances as Category L If, III, or TV, osriA notes in the proposal (which appeared October 4 in the Federal Rcf>ifier) that there is general agreement among scientific experts on: the practical and ethical difficulties in relying on epidemiological studies in man as the sole basis for establishing the carcinogenic potential of a substance; the validity of studies in experi mental animals to establish the carcinogenic potential of a substance; the minimal and opti mal experimental conditions for carcinogenic testing; and, the kinds of statistically significant changes in tumor incidence that can be observed in experimental animals and used to characterize carcinogenic potential. Areas of agreement In particular, there appears to be general agreement on several major issues on which osha is relying in proposing these regulations: osha relies, in general, only upon results found in testing of mammalian species, especially the rat and mouse, because they are directly relevant to man in carcinogenicity testing. Positive results in any mammalian species will, as a general rule, supersede negative find ings in another species, and positive animal data generally should supersede human data because of frequent defects in human studies. Testing of substances at constant high ex posure Ifevcls is required to overcome the sta tistical insensitivity of laboratory bioassavs conducted with tlie limited number of animals than can be practicably handled in laboratories. The size of groups of test animals must be sufficiently large to permit statistical evaluation for significance. osha notes that while there is substantial agreement on these five issues which arc key to osha's classification system, there are six other areas where scientific experts arc less fully in agreement, osha hopes the uilcmaking will lead to full and comprehensive debate on till eleven of the classification factors to permit develop ment of n sound classification system. In the re maining six issues, osha proposes: To place ns much weight on tin experiment in which, only benign tumors arc observed, us when both benign and malignant tumors arc induced. To interpret the results of experiments JOS SAFETY AND HEALTH 15 AP00048747 showing increased incidence of umiors in acute or chronic effects other than carcinogen treated animals as evidence of carcinogenicity, icity. Also, where the record indicates that regardless of spontaneous cancer incidence, pro suitable substitute substances exist.* osha can vided that die experiments arc suflicictuly wcll- propose to prohibit the use of a Category I sub conlrnllcd and an increase in incidence is stn- stance. tisliciilty significant, Only the model for proposed permanent To consider development of tumors from standards for Category I toxic substances re dermal, inhalation, injection (with tumors at quires establishment of n regulated area (access distant sites) and ora! exposures tis directly to which must be limited by the employer to relevant to occupational exposure; conversely, "authorized" personnel). tumors at the site of injection or implantation shall generally be regarded as irrelevant to occupational exposure. To place much greater weight on positive results dial have been replicated in another study than on a single unconfirmed result. That in regulating a Category I toxic sub stance, the level of exposure to be set will not be a "'healthful," "safe," or "no-cffect" level, but a feasibility level to be determined by osha. Tliat although the agency is of the view that "no-effect" levels cannot be set for a 'carcinogen, there arc some who believe it may be desirable to quantify the degree of risk for the purpose of evaluating the expense and level of control considered feasible. Titus, the agency seeks comments on whether such an estimation should be attempted, and if so, the methods to be employed. In discussing the three proposed model stand ards, OSHA notes its intention that, apart from the unique substance-specific aspects of these In prescribing methods of compliance, the most significant difference between the model emergency rule and the proposed permanent rule for Category I substances is that the emer gency rule would permit greater reliance on respirators to reduce exposures; the permanent rule would require substantial reliance on en gineering and work practice controls to reduce exposures--with respirators pet milled only as an interim means of protection. Requirements for protective clothing and equipment would be essentially the same except that the proposed emergency rule would not require cloihcs-changing rooms. Requirements for hygiene facilities and practices are essentially the same for all three model proposals except that the emergency rule for any substance not previously regulated by OSHA would not require compliance with the requirements for lunch rooms, shower rooms, and the like. standards ns future rulemakings arc undertaken, The three model standards require the use the provisions of the models, as determined in of signs and labels with the two models for this rulemaking, will not be an issue. Category I substances requiring the warning of "cancer hazard." Model comparison Recordkeeping requirements tire essentially In the notice of proposed rulemaking, osha provides a side-by-side comparison of the three models. Each follows a standard format; but, to distinguish between emergency rules and pro posed permanent rules for Category I and Cate gory II chemicals, there arc some significant differences. Among the differences arc; Permissible exposure limits in the emer gency temporary rule and in the proposed the same except that the model emergency rule would prescribe shorter time periods for reten tion and would not require a transfer to niosii of medical records if the employer ceases to do business. Other sections of the three models which will be essentially the same include those covering: scope, definitions, exposure monitoring and measuring, housekeeping, waste disposal, medi cal surveillance (with substance-specific proto permanent rule for Category I substances would be set at the lowest level feasible; for Category II substances, exposure levels would be those currently prescribed in osua's table of permissi ble exposure levels, or at lower levels if appro priate; or where no prescribed levels exist, they cols to be filled in for each new substance dealt with), employee information and training, ob servation of monitoring, effective dates, and appendices. All three models call for three appendices: a substance safely data sheet, sub stance technical guidelines, and medical surveil would be set at an appropriate level based on lance guidelines. 16 DECEMBER 1977 AP00048748 osha is seeking full discussion of all of ihc issues raised by the proposed classification sys tem, the agency's rationale for classifying, the model standards, procedures to be followed, anti any other relevant issues raised by the proposed regulation. Comments, data, 'ant! views of in terested persons arc being sought. Osha lias scheduled a public hearing to begin at 9:30 a.m., March 14, 1978, in the Department of Labor Auditorium. Those who wish lo present testi mony should submit requests to appear, post marked no later than Junuary30, 1978, to the osJfA Division of Consumer Affairs. Room N3633, U.S. Department of Labor. Third Si. and Constitution Avc., NW, Washington, D.C. 20210. Requests lo appear at the hearing must con tain the following: name, address and phone number of each person lo appear; the capacity in which the person will appear; approximate time required; specific issue(s) raised by the proposal that will be addressed; a detailed state ment of the position to be taken on each such issue; and whether documentary evidence will be submitted, and if so, a brief summary of that evidence. Copies of all written submissions and requests to appear will be available for inspection and copying in the offices noted above. In addition to the above requirements, any person intending to testify for more than 15 minutes at the public hearing must submit not later than January 30, 1978, four copies of the full text and all documents to Ihc osiu Division of Consumer Adairs. Such submissions also will be available for inspection and copying, but at the OSIU Docket Office. The Environmental Protection Agency Earlier this year, Douglas M. Castle. ci'A Ad ministrator, delineated his agency's approach lo dealing with cancer hazards. The essence of the Toxic Substances Control Act is expressed in three policy statements which appear at the beginning of the Act, Castle said. The first statement is that "adequate data should be developed with respect lo the clTcet of chem ical substances and mixtures on health and the environment and the development of such data should bo the responsibility of those who manu facture and those who process such chemical substances anil mixtures." In detining this policy. Congress placed the burden for developing toxic substance information squarely upon the pro ducers of chemical products. Congress intended that the manufacturers and producers Like cor rective action themselves. It was _ not written simply to provide a means for gpa to obtain data to support regulatory actions, epa, of course, will use information developed by manu facturers to back up regulatory actions when necessary. "But if hpa thought its job was to protect human health and the environment solely through the imposition oT a wholesale series of individual regulations applicable to individual chemicals and in individual situations, then the real thrust and meaning of this first policy state ment would be lost," Costlc said. The second policy statement says "adequate authority should exist lo regulate chemical sub stances and mixtures which present an unreason able risk of injury to health or the environment and to lake alcion with respect to chemical sub stances and mixtures which are imminent haz ards," The burden is upon epa to use its legal authority aggressively in the protection of health aqd the environment. However, epa should use that authority only after it has evaluated the facts and determined that an "unreasonable risk" exists. To make this decision, the agency has to understand the toxicity of the chemical substance tn question, the population exposed to che chem ical, the degree of exposure, and the costs and problems associated with eliminating or limiting that exposure. The third policy says that "authority over chemical substances and mixtures should be exercised in such a maimer as not to impede un duly or create unnecessary economic barriuts to technological innovation." Again, the burden is on epa. The Congress intends that epa exercise judgment in the regulation of chemical sub stances. It docs not intend for epa to ask for more information than it really needs. All of the actions which epa has taken, and will lake, are consistent with tire three basic policies set down by Congress. "We will sec to it that adequate data arc developed with respect to the cITcct of chemical substances and mix tures on health and the environment. We will regulate chemical substances and mixtures which present an unreasonable risk. And we will exer cise our authority in a manner so as not to im pede unduly or create unnecessary economic barriers," Costlc said. Jim I'osicr is OSli.l chi*/ of news media services. JOB SAFETY AND HEALTH 17 AP00048749 Ji i . AGENT Wood Leather Iron oxide Nickel Arsenic Chromium ORGAN AFFECTED OCCUPATION Nasal cavity Woodworkers and sinuses Nasal cavity and sinuses; urinary blad der Leather and shoe workers Lung; larynx Iron ore miners; metal grinders and polishers; silver finishers; iron foundry workers Nasal sinuses; Nickel smelters, lung mixers, and roasters; electro lysis workers Skirt; lung; liver Miners; smelters; insecticide makers and sprayers; tanners; chemical workers; oil re finers; vintners Nasal cavity and sinuses; lung; larynx Chromium pro ducers, proces sors, and users; acetylene and aniline workers; bleachers; glass, pottery, and lino leum workers; battery makers 18 DECEMBER 1977 -'l l * iil~-1J1---------ill- - * ill,| iiiK. Asbestos Lung (pleural Miners; millers; and pcriLoncal textile, insulation, mesothelioma) and shipyard workers Petroleum, petroleum coke, wax, creosote, an thracene, pa raffin, shale, and mineral oils Nasal cavity; larynx; lung; skin; scrotum Contact with lubricating, cooling, paraffin or wax fuel oils or coke; rubber fil lers; retort work ers; textile weavers; diesel jet testers Mustard gas Larynx; lung; Mustard gas trachea; workers bronchi Vinyl chloride Liver; brain Plastic workers Dis-chloromcthyl ether, chloromcthyl ether Lung Chemical workers Isopropyl oil Nasal cavity Isopropyl oil producers Coal soot, Lung; larynx; Gashouse work coal tar, other skin; scrotum; ers, stokers, and products of urinary blad producers; as coal combus der phalt, coal tar, tion and pitch work ers; coke oven workers; miners; still cleaners Benzene Bone marrow Explosives, ben zene, or rubber cement workers; distillers; dye users; painters; shoemakers Atiraininc, Urinary blad Dyestuffs manu benzidine, der facturers and alpiia-Naph- users; rubber thylamirtc, bcta-Nnpth- thylaininc, magenta, 4- workers (press men, filtcrmcn, laborers); textile dyers; paint man Aminodiphenyl, 4-Ni- ufacturers trodiphcnyl Source: National Cancer Institute AP00048750 r Labor Secretary Ray Marshall "It was not too long ago that Dr. Bingham and I announced a redirection of the resources of osha. With limited resources we felt that we had to focus on the most serious threats to the health and safely of workers. We announced that we were going after the whales instead of ,thc minnows. "We are today announcing a ne\u policy that I believe will provide the broad net we need to catch some of the biggest whales--cancer caus ing substances. For too long osha has had to approach each toxic chemical on a substance by substance basis. Trying to control carcinogenic substances on a case by case basis is like trying to put out a forest fire one tree at a lime. "Instead we arc proposing a systematic way of determining which toxic substances require emergency attention by osha. I believe this com prehensive cancer policy represents a major breakthrough for osha--it will allow us to re spond to threats to worker health with much greater speed and efficiency. "This represents another step in our continu ing efforts to make osha a model regulatory agency. Eula Bingham and her staff are to be commended for their efforts in developing such an important policy." Dr. Eula Bingham, head ol OSHA "H is particularly significant that osha is tak ing the lead among government agencies in at tempting to set comprehensive policies to deal with the problems of cancer. Ours has been the agency chosen by many as the example of bu reaucratic nit-picking. [Jut we have pledged our efforts to attack the more serious hazards. There can be no doubt that cancer is among those serious hazards. Moreover, many of tiro chem icals which we now regard ns cnnccr-causing have first been recognized from the tragic con sequences of cancer in the workplace. "The sad fact is that more than 1,000 Amer icans die every day from cancer--370,000 per year. Leading cancer researchers have attributed more than 60 percent of those cancer cases to environmental factors. "So the message is clear. I believe the time has come to implement a comprehensive program to prevent cancer in the workplace. "Under this new cancer policy, we would clas sify a substance in one of four categories and then take specific action depending on the clas sification. A major purpose of the rulemaking is to settle once and for all, the policy issues that f will guide osha in its future regulation of occu pational carcinogens. In the past a great deal of time and energy has been expended in debate over scientific and medical questions about the extent to which available data could be con sidered as evidence of cancer hazard in man. This prudent public health policy will end the need for such exhaustive debate as we deal with each new substance. "Also, in the past we have as an agency ex pended horrendous amounts of lime and energy in developing each separate section of the job health standards on a substancc-by-subslancc basis, Through this rulemaking we will develop standard formats and content for the regulations needed lo deal with Category 1 and II sub stances. So we arc pressing model emergency temporary standards for all substances later classified ns Category I. That model would be the vehicle for promptly issuing an emergency JOB SAFETY AND HEALTH 19 AP00048751 rule us soon as Ihe substance invoived is classi worker exposure lo the lowest level feasible, fied as Category I or a confirmed carcinogen. while the Category II exposure level set wduld '`Another model standard would be used in be sufficiently low to prevent acute or chronic developing a permanent standard for Category T toxic effects in exposed workers. substances and a third model would be used to "Our proposed system, then, will enable us to develop a permanent rule for the Category II quickly react to new evidence oT carcinogenicity, suspect carcinogens. to properly classify a substance and deal with it "While there are a number of differences in an appropriate regulatory fashion with most among the three models, the most significant arc of the issues involved settled beforehand. This in the extent to which worker exposure must be will, we arc confident..markedly speed up our limited. capability to deal with carcinogens and greatly "The emergency and permanent rules we would enhance our ability to protect workers. issue for Category I substances would reduce --MeaggMcw^----wiawtawow : Grover Wrenn, OSHA health standards chief currently being tested by the National Cancer j* Institute, Tests of Category II substances would | show some positive results that .were not conclu- }S sivc such'as evidence in one species but not in ;; another, or evidence in one sex but not the 1 other. Examples would be recently-tested chlori- -jj nated hydrocarbon solvents such as perchloroe- jj thylene and trichloroethylene. H "Because this proposal does not, in itself, rec- jj "In general, those substances for which there (exists an overwhelming consensus based on j human and animal data would be placed in Category I. This would include such substances [as arsenic, coke oven emissions, benzene, beryl lium, chromates, and pesticides such as Dib- j romochloropropane and kepone. Category II (would be for those substances for which there is (some "strongly suggestive evidence" like those ulate exposure to any specific substance, an eco- 1; nomic impact statement would be meaningless. ~j As standards are developed under the new svs- tem, impact statements will be prepared. This is ^ not quite a "fill-in-the-blank" proposal, but it $ will reduce discussion to those unique areas that 5j relate to each substance. This proposal would ? make a big difference in the time needed for g osha to. respond to newly-discovered healths hazards. It would remove all doubt about the ? method of OSHA's response. jj "A preliminary review of the niosh list of sus- $ peeled carcinogens indicates about 100 would belong to Category I. Another 3-400 would be- g long to Category II. and the remainder would fc be in Category III or IV. jj By Peter S. Barth fflBTKSl eakanccr will kill some 370,000 Americans this year. While cardiovascular diseases will kill perhaps 2.5 limes as many per sons as cancer, the latter appears to inspire far more fear in the minds of the public. Perhaps C^ps^sai>0(M this can be explained by the suddenness with 'which cancer may appear in persons of all ages 20 DECEMBER 1977 AP00048752 as compared to the very gradual deterioration ahead to see hnw the problem will develop in that so frequently precedes death from cardio occupations where workers arc, or have been, vascular illnesses. The fear may also be traced exposed to presently known carcinogens. First, to the very high death rates, particularly in ear data on the ntimber of workers exposed to such lier years, in persons diagnosed as having cancer. agents is extremely crude and sketchy. For ex Ultimately, however, the root of the attitude is ample, no distinction is typically made among probably the absolute ignorance of the causes of workers who face occasional or extremely lim the disease. Simply put, in the vast majority of ited exposures, and those routinely exposed, or cases the cause of cancer is unknown. Further, others who periodically must face substantial even in those instances where the disease may be doses. Secondly, data tire presented, generally, traced to a specific carcinogen, it is not known as a stock of workers exposed at a point in time, why the agent induces the disease in some per rather than taking into account labor turnover sons and not in others. Thus, for example, it re and, therefore, reporting the number of workers mains a mystery why some persons will develop who have been exposed over a time period. cancer subsequent to very limited exposure to Since inter-industry turnover rates vary substan asbestos, while others necessarily exposed for tially, the problem is especially tricky. Overall, sufficiently prolonged periods to large amounts the task is difficult but until such data are de of the substance may develop (the potentially veloped we will not be able to gauge accurately deadly) asbestosis but do not develop cancer. the potential scope of the occupational cancer Occupational or industrial cancer occurs problem. where the cause of the disease is largely to be Finally, it should be noted that our growing found at the workplace. This definition, regrett ability to treat medically individuals with cancer ably, yields little insight into the magnitude of will partly undermine efforts to identify the ex the problem. Many substances to which one is tent of the problems of the workplace. A large exposed at the workplace may routinely be share of the knowledge linking cancer to specific found in the environment. At the extreme, pro occupations, industries and/or hazards is the longed and substantial exposure to sunlight is product of epidemiological research, much of understood to be hazardous, thus imperiling which depends upon fatality data and death workers in outdoors activities (sailors, farmers, records. In summary, resolving the issue of the recreation persons) ns well as sun-worshipping extent to which the workplace contributes to non-workers. The carcinogens asbestos, nickel, cancer will not be simple, cheap or quick. arsenic, etc. arc often found as air pollutants, jeopardizing workers and others indiscriminately, Environmental causes though the extent of exposure will typically be There appears to be wide agreement that per far higher at workplaces. It is only the rarest of haps 60-90 percent of cancer is environmentally situations such ns occurred in the case of vinyl caused, Breaking this down into its components, chloride where a relatively unusual type of can e.g., air pollution, diet, cigarettes, drinking-water cer is found and can be unambiguously traced contaminants, the workplace, etc., yields little to the workplace. agreement, however. That estimates of the extent Since the causes of cancer in most cases have to which work is responsible vary so widely is not been established, the extent to which the due to the problems enumerated above. While workplace is responsible for causing the disease it will certainly olTcnd parties on all sides of the cannot be established currently. Compounding debate, it seems reasonable to the author to the problems of attributing causality is the long describe as conservative, an estimate of 1 or 2 latency period of the disease. Thus, persons percent of the eases as caused by the workplace. developing the disease today mnv have been in Using such an estimate, based on the predicted contact with the causal agcnt(s) perhaps 20 or total of 370,000 cancer fatalities for 1977, even 30 years ago. This phenomenon also con some 3,800-7,600 persons will have died from tributes to the enormity of the task of putting occupational cancer. The author docs not be the responsibility at the workplace in a legal lieve that these numbers represent the "true" proceeding. number of cases, but instead arc only a very safe, Not only arc there these problems in deter lower estimate on the extent of the problem as mining how many cases of cancer arc occupa measured by fatalities, tional in origin, wc cannot even cITcctively look There exists an cnnrmous disparity between JOB SAFETY AND HEALTH 21 AP00048753 the numbers filed above and the extent to which occupational cancer is seen by state workers' compensation systems. Data have been compiled by the author oil the extent to which occupa tional disease claims arc paid under stale work ers' compensation laws. U has been found that a very small number of claims involving occupa tional diseases generally arc seen and processed by state agencies. Data from the states in this area are incomplete and generally difficult to aggregate. Data sources examined included annual reports of state agencies, separate mail and telephone surveys of these agencies, a mail survey of insurers, and data from the National Council on Compensation Insurance, the body that assists insurance carriers in setting rates. Piecing these all together it appears safe to con clude that perhaps fewer than 100 fatality cases a year due to cancer are being compensated. Since the data on non-fatnl claims are even more difficult to sort through, e.g., some skin cancer claims may be identified only as "skin disorders," it is far more speculative to guess the extent to which such cases are compensated. Nevertheless, it is absolutely certain ihat as in the case of fatalities, there is a large gap between claims compensated and any "conservative" estimate of the number of new cases of occupationallyrelated cancer each year. The disparity between the incidence of occu pational cancer and of eases compensated is likely attributable to a variety of sources. Prob ably foremost among these is the problem of ignorance. The physician may not know Dial his patient has been exposed to carcinogens at the workplace, employees may not know even what substances they handle and. moreover, they may not be aware of their potential rights to woikers' compensation. The personal agony that indi viduals and their families suffer when confronted with such a disease can explain why many seek to avoid the extended controversy that is al most inevitable in compensation proceedings. A second set of problems is that a variety of piovisions in various slate laws effectively pre clude receiving compensation in many eases. For example, some statutes of limitation pro visions that may bar claims based on earlier exposures may be reasonable in cases of most occupational diseases, but arc not where the latency period is as long as in cancer. A third factor tending to reduce claims is the enormity of the task of proving that the disease is work-connected. In workers' compensation proceedings the burden of proof rests with the claimant who may have been exposed to the carcinogenic agent decades earlier, and possibly while engaged in a different occupation and/or industry. Simply because a cancer victim has at one time or another been occupationally exposed to such a hazard will hardly suffice in most instances to assure that workers' compensation will be paid. Rather, claimants or their survivors must persuade the authorities that the disease was caused by a hazardous exposure that may have occurred years ago. Such issues frequently lead to physicians testifying for either litigant about the possible source of a disease that is still not basically understood. Adversary procedures Another problem that tends to discourage the filing of claims is the very lengthy and conten tious procedure that typically precedes the reso lution of u case involving occupational disease. Where a worker incurs a serious occupational disease, it typically takes well over a year from the time a claim is first filed until a first payment is made--in cases where indemnity benefits are eventually paid. The lengthiness of workers' compensation proceedings together with the adversary process may well discourage some physicians from ever willingly becoming involved in such eases. Con sequently, ir is likely that they will not raise the matter of workers' compensation where patients are found to have cancer. The system of workers' compensation in the U.S. is basically adversarial, and the resolution of a controversy regarding the source of a person's illness or death can involve substantial sums of money. Nevertheless, it is clear that the fundamental problems are scientific and tech nological. If tire problem was primarily the way we adjudicate claims one should expect to find a far larger number of cases involving cancer in other countries that tire using very different approaches to workers' compensation. Instead, it appears that the volume of claims for occupa tional cancer in most western European nations is quite small and not far out of line with the U.S. experience. In those countries, however, information about occupational cancer increas ingly is being brought to the public's and work ers' attention and a surge in claims may well result. A similar type of development in the United States should also be anticipated. 22 DECEMBER 1977 rest'? rw