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' TESTIMONY REGARDING 16 CFR Parts 1304 and 1305 RESPIRABLE FREE-FORM ASBESTOS Proposal to Ban Certain Patching Compounds and Arti fi c ial - Emberiziflf> r . >. Materials (Embers and Ash} - . ... . ' rf.dtj -- As Published in the FEDERAL REGISTER, Vol. 42, No. 146 - Friday, July 29, 1977 - T'V Presented by Harrison B. Rhodes Union Carbide Corporation Metals Division Niagara Falls, New Yorlr, 14302 August T5, 1977 T 01-0206 MOtaiUi WJrUWWWIQR ASSOCIATION/ North America 1835 K Street. N.W. Suite 402 Washington, 0. IL 20006 srSsjs- AIA-73 Hy nam Is Harrison B. Rhodes and I an speaking on beh&W of the Union C the "Ca a, tton where I, hold the position of Technology tomager fa^ itos Department. My education is 1o the field of Chemical Engineerlngnn&rtF X hold the degree of Dr. of Science from Columbia Universttjr- For the past four years my assignment has been In the area of asbestos health and regulatory matters and has also Included research on monitoring techniques. I am currently serving the Asbestos Information Association/North America as Chairman of the Standards and Technical CoMrtttee. . Union Carbide Corporation has been actively engaged* since 1963, in the mining and milling of asbestos ore at facilities in central California. The asbestos fiber produced is marketed throughout the United States and in many foreign countries. One of the principal applications for this asbes^r thf this country has been in tape-joint compounds. We do not ourselves manuf&tiire such compounds, however, nor do we manufacture any other asbestos-containing finished products. . As the Commissioners are well aware, there has been a tremendous flood of "paper" generated in relation to the asbestos regulatory matters under consideration here. We believe that several crucial Issues have been lost in the flood and would like to take the.opportunity today to address these issues* as follows: ook at all of the commercial and consumer exposure data Kliable today including some recent consumer tests and also ' . some OSHA compliance inspection results. 2. An examination of the risk estimation model proposed by Dr. Bayard of the CPSC staff in terms of actual consumer exposure. i!&" -2 3. A dfscussion of-the- elimination or reduction of uaroasonable^.>j^ . ^ - . .*, Jm ' V. -Injury as required fay the statute-and the absolute > F^rtsfc regulatory approach that Is advocated fay the honors. . - 4. The direction of your attention to-the fact that "asbestos" of one type or another Is present throughout the air, water and earth of this planet and the overwhelming consequences of a ban of ubiquitous material such as this without a precise definition of what is banned, a well specified analytical procedure, and some allowable levels other than zercr. 5. The presentation of a suggested alternative approach to __ protect the consumer from unreasonable risk of injury which is more realistic, more workable and more enforceable than the proposed total ban. Itshould be emphasized that this discussion will deal directly with, and be presented, in terms of tape-joint compounds. Spackling compounds are. similar in composition and use, but are applied in so much smaller amounts that the potential for significant exposure is virtually non-existent. Emberizing kits are outside the ffsTd of our expertise and will not be considered. 'it " 1 board.was developed around 1880-1900. It did not come *7 World War II when the need for houses and other buildings ess complex construction method very popular. Usage has.. grown substantially since that time and drywall construction is now used in a __ majority of residential construction and in a wide variety of coamtercial and public buildings. Initially, ordinary plaster was used to embed and cover the vtape. to make the joint between the boards, but in. the mid 40`s specially formulated ALA-73 ,,4r -f' ,% . Caseinas tte binder iirer Introduced; TRts# *titures fclSt asbestos. Wdftave been told that the plaster of led asbestos. ` * l.e., wet compounds or mud were Introduced in the raid 50's and were in broad ijeneral : use by 1960i The asbestos content of muds in general dropped"during-the 70`s to approximately the.range of 2-7%. Tape-joint compounds containing asbestos have thus been in widespread use for 30-35 years. Over the first 15 years of this period the main material used.was provided dry and con tained relatively high levels of asbestos, l.e., lG-15%. The Commission's consultant. A.1 T. Kearney, Tnc. estimates that today's annual value of shipments of patching compounds is 80 million dollars. At an average price of $4.50 per can. This is equivalent to about 18 mi 11 fen , ' mre '* .. cans. The formulations we have seen cost about 2Q-30tt per can in raw material costs to replace asbestos so that the added burden, just to cover raw materials cost Is about 4.5 million dollars annually. This cost, plus arty percentage markups used, would be added to the cost of the structure and wouTd carry the normal financing charges over the life of the indebtedness. T should1 also ' be noted that about 10,009 tons per year of asbestos with a produet value of ' about one million dollars were used in this application prior to the decline that has resulted fro* actions of a variety of governmental agencies. We betfevip:tfl|^^HB$gaT of'5.5 million dollars annually presents a reasonably reliab'fi^^^H|^wtfinate of the direct7 economic effects of the. replacement of asbestos7fh^lS^e-jPoInt compounds. The-added effect of the poor performance of many* of the asbestos-free muds has not been considered. " Ifrttfte assessment of the risb that needs to be related to this cost burd&fr,?Tt is important to have a reliable estimate of the 1 evel of consumer exposure* All of Ithe available information on exposure has been assembled and V-i. ^r.s- , * /-I r* ~`,J* $4?rir'V.v,-'*r*'*? r- A ' r 20 - - /i: . -V . V. ~' ... rtK dlcimnUdt^^^^usse^t^dattil in^aj^Af^endix t tftls presentation whfcfe +- . ^. . ' ^ .- li' ^ ' :fcV/ IdlMaefi tathe^August 29VJ577, deadline for written consents. . -i ,*.. bfesumparized here,. 7--'~ T1i data? presented'*** contained in five reports: u" - r - - /I \ ' ` ' ^b^-vs?* ** 1.. The tests; conducted by Rioftl t alv 1 at one location in New York, NY. ' Thlsvts the data cited by the petitioners. ----- ... * z. A survey of a variety of sanding conditions made by Rhodes and Ingalls^ and, cited extensively by the Asbestos Information -i Association/North America in their response to the petition. : ' ; ** " 3. Data from State and Federal OSHA compliance inspections com . piled by Equitable Environmental Health Incorporated as part -: of a study of asbestos exposure in the construction industr " * - 4. A report submitted to the CPSC by Union Carbidea.Cdrporation July 14, 1977, covering consumer exposure during-a typical spackling and a moderate size drywall installation operation. 5. A study by Union Carbide Corporation which has just been finished oiranother consumer Installation of drywall f,a large roon including the ceil ing. The results of^tfcfs survey-are summarized in the two figures you are now receiviwgV"iStgp,,e i^sbows along the vertical axis, the airborne a^fiestos'j^^BMpion, fn ftbers per cubic centimeter longer than 5 micrometers, that oectM^H^^^breathing zone of the; operator during the sanding opera tion. Usually diiwmber of samples were collected at each location, *Ehe dark, .' ' . . . bar shows the range of concentrations found with, the arithmetic average of all samples Indicated by the arrow. * ' `* ` , . ,, , tehl etaly Science,.Voluroe 189, August T5 197S, p.- 552*. Ol JL\. '2o6~ V L . vfr . -> .. ` dAIA-73 ;^- pit th* left are those of Rohl et al that were cited fte,^ support ofH Note that :jj& These were obtained in one test In New York City. *V 20 flbers/cc for four days, was used by Dr. Bayard In his projection of risk to be discussed later. ' The next group of results were obtained by the Union Carbide Corpora tion in a survey of commercial operations in eight different cities. Results range from about 0.2 to 3 flbers/cc. These fiber counts have been spot checked "bHnd" by two other laboratories. The EEH and OSHA compliance data shown next fall In the same range as those of Union Carbide. The consumer-use data are shown on the far right. The first case is for extensive spackling and the installation of three panels of drywatl^ f" The second is' for three walls and the ceiling of a large basement recreation latfirr room. This*mud contained 2.6X asbestos by weight on a dry basis. Exposures in these tests were only 0.2 to 1.0 flbers/cc >5u, which correspond roughly to the lower end of the range found for commercial use. Two other operations in tape-joint installation present the possibility of exposure to free-forn asbestos fiber? the addition of dry powder product to water and the cleanup after sanding. Data for these operations are shown In Figure 2. Here, in order to get the Rohl et al data on the graph it was nec essary to ruftythe scald from zero to sixty instead of zero to twenty as in the previ<nis-j||^H|t.Otherwise the graph follows the same format and shows a very slnflao pafljHpTThe Rohl et al data are far higher than the OSHA results and the consumer values are below or in the lower end of the range found for \ commercial use. It is very important to understand that all of the concentrations shown occurred during the active pursuit of the particular operation, i.e. sanding, wet^out, or cleanup. These operations generally take place for a moderate portion of;thm day with concentrations at much lower values for the rest of the 8 hour . . u l-02Da tut ^ .;.. perlW- Eigfct-hofflr tliae-wofgfitotf'avoragt exposures were ' r&t two ds^jt Otts and~ the highest exposure found was O.J ^ t* - ;i conta. ining dust was being generated. ' * - * staff members Dr. Stephen Bayard, has developed a model^ ^ to estimate the risk of respiratory cancer front low level exposure to asbestos frost taping compounds. This model is patterned on that described in a paper by Enterline and Henderson^ except that Dr. Bayard has made an assumption that the effect of dose is cumulative. This builds a geometric increase in risk into the model. We question whether there is any basis for this assumption, but do not feel that this is an appropriate place to debate the issue. It Is of more interest to use this model, which is heavily biased toward predicting a high risk with the highest exposure just noted for consumer use, i.e.:, CK2`fiber/cc THA for ir two days of operation. ' f- ?- ' Following Dr. Bayard's directions dn page 3, Part C Of the reference cited for the highest time-weighted average of 0.2 fibers/cc for two days found for the consumer applications we obtain an annual exposure of 0.004 fibers/cc mean per day for one year, latent period to tumor of 21 years, and zero deaths of asbestos Induced cancer In the 40-year period considered. If the period examined is extended to 100 years, the number of deaths predicted would be 0.000003 which is still far less than a single death. These estimates are probably on the high side assuctions used in the model but since an exposure of 0.004 fitierstlnguishable from background, the values found not unreasonable .Iso instructive to point out that if we assume an exposure w*tf of 5 fibers/cc-for two full 8-hour days, which isA above that found in commercial use, the yearly rate becomes 0.1 fiber/cc. This yields a median time to tumor of 212.5 years and an asbestos induced cancer estimate of 0.02 deaths. We question whether these are the unreasonable risks referred to in the statute. T. Raottrandum.to Dan Clay dated June 3, 1977. Pinehurst, NC, March 12, 1976. -- v. D1-020a346 ^ -7- . -73 .. , row relate this risk to the proposed ban of conswer patching ; **t*h.-e,. Con* respirable, free-form asbestos under Sections 8 and 9 of *> . . Safety Act. To quote Section 8: ' Whenever the Commission finds that-- 0) a consumer product Is being, or will be, distributed in commerce and such consumer product presents an unreasonable risk of Injury; and * (2) no feasible consumer product safety standard under this Act would adequately protect the public from the unreasonable risk of injury associated with such product, the Commission may propose and, in accordance with section 9, promulgate a rule declaring such product a banned hazardous product." (Emphasis added.) & v^' * And from Section 9, Paragraph 2 (c): (2) The Commission shall not promulgate a consumer product safety rule unless it finds (and includes such finding In the rule)- . (A) that the rule (including its effective date) Is reasonably necessary to eliminate or reduce an unreasonable risk of Injury associated with such product; (B) that the promulgation, of the rule is in the public rferest; and (C) in the case of a rule declaring the product a. banned . hazardous product, that no feasible consumer product safety standard under this Act would acequately protect the public from the unreasonable risk of injury associated with such product." (Emphasis added.) . 01-0 2063- 'S': it* **>& v-i' . The consents of your own staff on the strength of the evidence used to support the ban Is well summarized by three'sftdrfc quotations from the record:. "The petitioners believe that htg^^uantlties of asbestos fibers remain in the air after theses products-are sanded and the fibers substantially increase theorist:of mesothelioma and lung cancer. . 0) "The petitioners have addressed prebla^whlehVerl^^rom being exposed to asbestos fibers occupationally and environ mentally. However, they have not cited any concrete evidence., of the hazard which is tied directly to the products for which they seek a ban. It merely cited the fict that- these products do contain asbestos fibers and they-iave cited the fact that asbestos fibers in athe* situations have been linked to lung disease. We questtotf Wfrether the evidence presented in the 'sufficientstcf show that tbdfe substances may cause ^MPal personal injury or substantial illness during or as irawncimatc result of any customary or reasonably foreseeable v handling or use." (Emphasis added; (1) CFR;yol. 42, ho. 146 - Friday, July 29, 1377 p. 38790. !r***\*; be?-.-* ' IA-73 ife -*' ^Xte instances of. sir ' 3r |^^short-tank*xpure tenbestoP taken as evidence ofa possible ~T *' - ;sartlv probahTel. cause-effact relationship. How- themselves. they*would not stand up to statistical scrutiny In. predicting a correlation between brief exposure to asbestos and the later development of cancer caused by such exposure." ^ (Emphasis added.) * Substantial evidence has been presented here that the comnerclal use data upon which the petitioner** based their allegations' Is substantially higher than that of all other Investigators (Including OSHA^epaplIance ins pec- tlons). It has also been shown that consumer exposures. are.low, of short duration, and when averaged over a year or more are not dfstti^ilshabl e ;vr*v ambient background. He know of no evidence that such- casuaj^JEbw exposur^ represents any hazard so that the question becomes one of * banning action based on the existence of a possible, but not provenHsk, which If It exists at all differs only slightly from zero. Too are probably aware^that this question of the regulation of carcinogens is a major Issue, t^dt^tefore virtually all of the governmental ` ' s`-`-r'Z?. . regulatory agencies. The FD&"smqqffiirlR ban has received wide publicity and _>'" OSHA Is de^ly trtvolved with aprogosal for a generic regulation approach to carcinogaflHpiearings oiv benzene are now in progress. All of this activity does netsjl^^Krffhd answers^to our immediate problem, but we.are at leastr The. problem we face originates In the so-called "one-hit" theory of cardnogenisis. In simplest outline*.this theory holds that: (3) Briefing Package, February 2, 1977, presented to the Commission by -= Fraclne Shatter. o y?^.&.*.*.`*..?. if'-" ' f. ate *_ 01 0 2 0 6 lj 9 -T*a ^ -*r**..................... ' ^ __ ......... " ;r 3:. Tt felloes; "therefore, that there-tana abso$atQ*3afe or zero - ^till^TCTe^ far & carcinogen .and sucfca Baterialshould, dependA<? ibg.oa'the statutory authority of*agency Involved, be banned, *v-**' . -W.jT.' ^^ Severely'restricted, replaced; controlled to thowiferits _ .** detection, etc. : . It Is useful to examine thlr theory* tee the light general agreement and where responsible opInioAf'diyei^^- Jfdflii^eott that ''1V^S>*1/ virtually alT redlcal authorities woaW"agree:r-^.ffrS; -* . T. That there is a wide range of dosages for^a 'caedwxwam w , dose-response relationship exists. - The larger^||||kdbset the greater percentage of these exposed contract cene*^and:`'yteS versa. ' ***.. 2; In exposed- p#u)attons^even at-sefcstantial exposure levels large preportionsthose exposed-da not contract cancwr. .. r> 3. te thMosage goesfcdfwe the average time to the appearance of Ixprtnciplewes illustrated.by the - vf farnuta^a&nter?ine the Bayard imxtfficatioou previously. i.xr . V t-'-HA -V?' ' : v - ' \* -:-'?33pr t* ; ;*>- ' . *' ' .- ' ' . %~** '- *st TBerjKtHeeV disagreement accurs^overwhdfehappensasthe dosag&rfcfc "th.-.. decreased-ta^very low levels. .. * , . Thert.ts one school .*< ***,* of thou^it, and this. Is .L>--vr. r>, 3te- cnbraced hijan|ft.p; the regulatory agencies, .tb*# completely safe level exists, Thaeas-are ,.. . . bPhiBel eerponsible authorities who. eonjot?nETd that a dosagwlevet -* - *yi`; 1's>*- h * /*t!e*e*! . 01-0206350 & -H Mtobed where .the bong's defense mechanisms can effectively combat the altered is growth does not occur. Supporters of this position cite; ice of certain metals and hormones that are essential to the human body In trace amounts but at higher levels are carcinogens. - ------ Unfortunately* there Is no way to demonstrate the correctness of either view since there is a background level of cancer In both man and experimental animal. As the dosage and the corresponding number of cancers decreases one point of view Is that the occasional-cancer from the specific agent still occurs but cannot be distinguished from the'background while ' the ether Is that the added cases do not occur. These views can be partially resolved with the model of Enterline discussed previously* 1.e. a-very low exposure may cause a cancer but the time to t With an expected life span of 70 years this. a safe threshold exposure, at least until life expectancy approaches 150 years. Since there is no provable scientific answer to this risk question* we are really left with a socio-political rather than a scientific decision to consider. The fundamental question* then* Is whether a total absence of rlsfcx-. approach to regulation is appropriate or more particularly will be acceptable, to society. In our lives we undergo a succession of risks, some knowingly and some unknowingly. The American;people have always indicated a willingness to take rfsMgH^^denced by such things as the widespread use of the automobile, smakingvJfl|flfi& Improper diet, and even the home as it is today. We believe . that the zero'risk concept, when it begins to impact on jobs and the way of*life of a substantial number of people will not be acceptable and will have to be modfffed to balance risks against benefits in a realistic fashion. This'*; sort of balance rather than regulation by cliche, "its a carcinogen so ban It", showlx^'he applied here. The benefits from the continued use of asbestos into -*.. -JSfnfccompounds^*. sobstanttaland tfierfsfcjs* k- --- - y;' .-^-iV.-- -*-. ' . -;tS^ '*'&& cannot ----------------------------------------- -- ` (fa^Z^CI; - -^*^^** '*"*>' *' -.^'Tr:-'<?){{*' -, the risl&fcaitefit discussion amd^fcgwuld Tike to con* .^jy" hypointlag~-oot certain prattfcal^spects of enforce- meat of the baa as presently proposed In the. Federal Register. These questions .- -- ` ' -*'.-' ` smart discussed a great lengthy and generally were not-salyedt at the recent ' meting in Gaithersburg, MO, conducted by the National Bureau of Standards. * fc , -- Since-several members of your staff were present at tbit-joeeting, they will, only be indicated briefly. jhfr Since the promulgation of the-QSHA asbestos. 1972 there has been a continuing debate on what is asbestos and whet is an asbestos 3*^5;fiber. Asbestos, when narrowly defined. In a way that:^l-satisfy the 7*; -S*C , 1:?^, - precise minerologists is ubiquitous in the atmosphere`atflough^generally !?> occurs at very low, but not zero, concentrations. Mien-the.definition if broadened to include all amphibole chips which are longer than* 5-microns and have a length to diameter ratio greater than 3, you approach a condition aptly * . i- . * described by Or. Maicom Ross of the U.S. Geological Survey at the NBS meeting just mentioned, of "shutting.dwgfcthe face of the earth". Particles of thfif . ` * ,' 'T-< type are everywhere and would contaminate.any product containing a mineral." The EPA faced this prompt in 197& in writing emission standards for the sprayjaa^a&asbestoncontainfmr productrand decided to treat it by setting ' ` to ' j . "'V a It bj^M^^HKhemi limits Their reasoning war as follows: * ntent of the l-percent limit is to ban the use _ ei materials which contain significant quantities of asbestos, *' to allow the use of materials which.would: (1) Contain 'St*- . -*f trace amounts of asbestos which occur in numerous natural . substances, and {2) Include very snail.quantities of asbestos , _ - ::tless than 1 percent) added to enhance the material's effectiveness. (1) ` *. .. '* .* ' . ....**- ** - : - '.. . ; ' \ ' -V' ' 1 3"afe*!to. <6 - Friday. * 'ri'xL'SSli . ' -2. , p^"T. 0 1-0206 35 2 AA-73 i-icw Imepderjfor any atftiooilisr tftoRfcimfsslon to be wotliKi^aad;- "asbestos olutely essentia? tfwt yw prevtde a. definition of<J y ff? . " bar exactly, what afneral species and what fora of these .' 'species ' and specify what p*rticTed1mens1ons constitute an " asbestos "fiber*1. The. present deflnttloo-itt the proposal could be applied taftffke fet"that covers much of'the sortie* of the earth. In addition, an analytical procedure and the levels of "impurities" that are acceptable,.as measured by this procedure, must be specified. Without the practical defini tions the ban is virtually universal and completely unworkable. To conclude this discussion, I would like to stmmarfte the Union Carbide position and expand on the approach presented in my letter of July 14, 1577, which we believe is a reasonable alternative to the ban*propcsed by Commission. 1. The products under consideration have been in widespread use for about 35 years and we know of no evidence that any consumer has ever been harmed by them. Ho "unreasonable^ rfSsk* to the consumer has been demonstrated by the petitioners or by the staff. 2. Consumer exposure dot* have been presented which show that the exposures are botfi low and brief and-when averaged over a year are not. distinguishable from the general background. The ;fboim Jtidexposure, if indeed.any risk does exist. Is sly small and is basedron the* extrapolation of an 'and unpraveable'theory. 1 ' ' ' * & We question whether it is appropriate and whether the Act gives t- - .. the Comnission the authority to ban a product on the basis of a or - " hypothetical or theoretical risfcAon the basis of an absolute zero risk requirement. > - v*- 5SR&- ^*3? J*?*' MWIH6 SAMDINC Of TAM-JOINT COHfOUHB w s. S': 2S--.2S2S2.. - - - - . (tMtMjat* j an m*m| miohvs skims Kouvauuawn msu siusiasv niwsm01 01 -G206 :55- *ir/** ,3'. ' ji V* f ^^1^41,-i- / serves to Vfinttthd potentfaT' for eiqp65ure.lt differs fro* / -' J *&*'+ - "w- j - %. .tatsTJ'-..'' -;? ,'r the IS of total fomriatloo rfifclddTn$Lyrte^suggested > - ' * .1 v * * -- f . c previously in thatdt nore GRSpiydtftluMK tfjpicontent fit the final product.irt the ded. It :.. Is alst^at a level -where ana] ` -7^: v, ; ............. b. Require^ a warning label incfadfr^jgib on alt-conpounds under the Juris * ` 'v '.T whethectpackaged foe direct corauner eeca ercfal use contact. This turns to good StN; public awareness of:the stos tbenoourage that theprisk&ct b#'- rdingto directions and not abused. IJ the user a choice. ' ' - ': a#-' its opportunity to speak to the Camisalon. lions yofeqny hee or to proiri^M&fddftfonal :- ^V,^- "> . . ; OT?'Jf- .;: ` ' : * ^ -r-/' >. Viyjfc- v?. -i. v;. -- `h*--* ' . . . . - > W*- >. . rj-4, ; .-..-siT- ^ - . iv , - affiT. twr~ ~ irtff .iT^ ^ -ii^T 3?TM 7'j. 4* -LviO-"ln*' -* t^Stt**t?**.'*-* - 01-020635^