Document km89yJD20e06rYrnLp9jxLGGO

) -- ' TESTIMONY REGARDING 16 CFR Parts 1304 and 1305 RESPIRABLE FREE-FORM ASBESTOS Proposal to Ban Certain Patching Compounds and Artificial-Emberizing.:; Materials (Embers and Ash} . - * As Published in the FEDERAL REGISTER, Vol. 42, No. 146 - Friday, July 29, 1977 , * ; Presented by Harrison B. Rhodes Union Carbide Corporation Metals Division Niagara Falls, New Yorte 14302 August 15, 1977 * o 1-02063WQ - - ASBESTOS INFORMATION ASSOCIATION/ North America 183S K Sheet N.-W. Suite 402 ffasbi D. (L 20005 " -  Harrison B. Rhodes and I speaking on behalf of the Union Carrflji^woratlon where 1 hold the position of Technology ttanager the "Cali4^|p^tos Department. Hy education is lo the field, of Chemical-; Engineer1**^miWX hold the degree of Dr. of Science from Columbia University. 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 Associ-ation/North America as Chairman of the Standards and Technical Committee. . 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^^W this country has been in tape-joint compounds. We do not ourselves manufacture 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; Hook at all of the commercial and consumer exposure data geilable 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. "K?"' ` -2- 3* A discussion of-thu elimination or reductft* of unreasonabl . ^.,\jn .* V. injury as required by the statute-and the absolute : regulatory approach that is advocated by the 'loners. .. - 4. The direction of your attention-ta- 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 zero. 5. The presentation of a suggested alternative approach to __ protect the consumer from unreasonable risk of injury which is more realistic, sure workable and more enforceable than ^ the proposed total ban. - It should 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 ftstd of our expertise and will not be considered. '4 " board.was developed around 1880-1900. It did not come into widMl^^EptlT World War II when the need for houses and other buildings .made this qilcfer,"less complex construction method very popular. Usage has., " grewn substantially since that time and drywall construction is now used in a. ^ majority of residential construction and in a wide variety of commercial and public buildings. Initially, ordinary plaster was used to embed and cover the .?:tap* to make the joint between the boards, but in. the mid 40's specially formulated *&k- ^-3-' ' . . -` .- ' _ . wr drym&ttfTes Caseinis tttfr blnder wife^fntroduc^- Tfibs# mixtures <15% asbestos. ttetfrve been told that the plaster of etf asbestos. - * f i.e. wet compounds or mud were introduced in the raid 50*s juui were in broad general-:use-by 1960i * The^isbcstos content of nuds in general droppf during -the 70*s to approximately the.range of 2-7%. Tape-joint compounds containing ashestos have thus been in widespread use for 30-75 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., 10-15%. The Commission's consultant, A.` T. Kearney, Inc.* 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 te-about 18 mill fen . m#r^ '* - cans. The formulations we have seen cost about 20-30^ 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 would carry the normal financing charges over the life of the indebtedness. ?tr should* 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 frqpi actions of a variety of governmental agencies. We betfevi^tifl tal of 5.5 million dollars annually presents a reasonably reliabWfl^^HBStfmate of the direct economic effects of the replacement of asbes6osy fn?lS|ie-fe1 nt compounds. The-added- effect of the poor performance % of many of the asbestos-free muds has not been considered. assessment of the risb that needs to be related to this cost burdfcn^ft'is important to have a reliable estimate of the level of consumer exposure* AIT of the available information on exposure has been assembled and 'Hr* ^ *> ^ ^xtr<tecwntK* amd discuss (tall- id^u^A^mHx t this H^sentatfoil which ta th^August 29*^1577, deadline for written caaoents. , v. ^-fWSF^fcl oi botsuomarized her*. Tho datm presented are contained,Iff'-five reports: ` 1 ,, The tests. conducted by Rohl et alUv )* at one location in New York, NY. Thtsvis the data cited by the petitioners. 2. A survey of a variety of sanding conditions made by Rhodes and Ingalls^ and cited extensively by the Asbestos Information Association/North America in their response to the petition. * ; * ^ ** ' :.v 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 industi 4. A report submitted to the CPSC by Union Carbide&jC&rporation 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 orranother consumer installation of drywall c^a large roo* including the ceiling. The results odtfefs survey-are summarized in the two figures you are now recelvliigV."~gtgpre bashaws along the vertical axis, the airborne adBestos^f^^HH^iiW* tn ftbers per cubic centimeter longer than 5 micrometers thatoeetri|HK|St breathing zone of the-operator during the sanding opera tion. Usually a-wmber of samples were collected at each location. The dark, bar shows the range of concentrations found" with, the arithmetic average of -t-. all samples indicated by the arrow. t?x: ? j ` ` ' *' *' . - .. .... -<*; Rohl efrely ScienceVolume 189, August 15* 1975* p.. 552^.. ^ tft* left are those of Rohl efc al that were cited ins, jtfliE These were obtained In one test in New York City. of 2B fibers/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 "blind" 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 spackllng and the installation of three panels of drywalK Jr The second is' for three walls and the ceiling of a large basement recreation latlcr room. Thls^mud contained 2.6% asbestos by weight on a dry basis. Exposures in these tests were only 0.2 to 1.0 flbers/cc >5y, 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- ^- commercial use. It is very important to understand that all of the concentrations shown occurred during the active pursuit of the particular operation, 1.e. sanding, wet^out, or cleanup. These operations generally take place for a moderate portion oftfced&y with concentrations at much lower values for the rest of the 8 hour i = period. Eight-h o tar ti*e-wefgfitf average exposures were OftS anrf~ tfte highest exposure found was O.Z^i i* * .; two daj$tjg|^^^^^tttos-containlng dust was being generated* ~ _. .* staff members, Dr. Stephen Bayard, has developed a modeT^ i ... . to estimate the risk of respiratory cancer from low level exposure to asbestos from 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., &2'f1ber/cc THh for ' % fan* ir * . two days of operation. ' 7 S. ` 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 mtort per day for one year, aAlatent period to tumor of 621 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 <fcaSfeassumptions used In the model but since an exposure of 0.004 fi tierstlnguishable from background, the values found not unreasonable Iso instructive to point out that if we assume an exposure w*t{ . of 5 fibers/ccfor two full 8-hour days, which isAabove 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. Memorandum. to Dan Clay dated June 3, 1977. 2. Pre^snedT>t Pinehurst, NC, March 12, 1976. Ol-G 206-3 46 , .v' V.'WM <$' '- : _.v 7** *<5; .^V ry ' compoan Let -7t^ now relate this risk to the proposed ban of cohsuaer patching respirable, free-fonn asbestos under Sections 8 and 9 of - the Cm 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.) r *& * Vs-' 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; 0>) that the promulgation of the rule is in the public kferest; 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.) . * ' . X *T,. / ;V . ai-G2G0:. .yrt Hots particularly the repeated use rtshf risk 3ffl1natev#*reduce izSSU^ TOt to sake this """makes clear tb*t"tSe intent fs not the total elfalta 'Hb bet' ef^unreesonable-rfUF'.ah#ft delegates to the Coraatsslon the complex and soul-searching problem t- '*t reasonable*. deciding what Is The comnents of your ovm staff on the strength of the evidence used to support the ban is well summarized by three sltiatet quotations from the record:. 'The petitioners believe that higbi-qpaittlties of asbestos- fibers remain in the air after theses products-are sanded and the fibers substantially Increase therislr.of mesothelioma and lima cancer." ^ 'r , "The petitioners have addressed problems:which' arise4from 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 th* fact that- these products do contain asbestos fibers and they-itave cited the fact that asbestos fibers in otbe* situations have been linked to lung disease. We? question Whether the evidence presented in the is sd^Wctefe^tcr show that ttidSe substances may cause Eel personal Injury or substantial illness during or as [gate result of any customary or reasonably foreseeable handling or use." (Emphasis added; 0) CFRi JTol. 42, bo. 146 - Friday, duly 29, 1577 p. 38790. ' *. ' -* UX Letter of July 11, 1976, from Gharles .J^to)bsonfc<,BCHT taFraoctne Sftacter, r?>,,>S?r. *V. T5dS** m- -"V ' v - - .0-2 006^-.us **r.` 2 3&a Instances of. s V- 1 ?*>&:* ^or^short-tmc.txpcsure te asbestos? pttWonj^^k. taken as evidence of> possible !vr ' ' ` sarltv.--awolMge-Lcause-effect relationship. How- themselves, they-would not stand op 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 cocmarcial use data upon which the petitioner** based their allegations Is substantially <* higher than that of all other investigators (including OSHA^pmeliance inspec- - .i5SS5r':. . tions). It has also been shown that consumer exposures. , areV*lfo; w , of short duration, and when averaged over a year or more are notdfatiijgdshable aribient background. We know of no evidence that suck casuaY^lbw exposure^ represents any hazard so that the question becomes one of a banning action based on the existence of a possible, but not provenrisk, which if it exists at all differs only slightly from zero. ., You are probably aware^that this question of the regulation of carcinogens is a major issue t^^before virtually all of the governmental regulatory agencies. The FWsai^dftrln ban has received wide publicity and OSHA is deeply involved witir eprgpcrsal for a generic regulation approach to carcinogH^HjuearingSvOn benzene are now in progress. All of this activity does nen^^^p^ffnd answerste our immediate problem, but we.are at least" Tfe problem we face originates in the so-called "one-hit" theory of cardnogenisis. In simplest outline, this theory holds that: (5) Briefing Package, February 2, 1977, presented to the Commission by - Fraclna Shatter. - `-Tt.T"- ; 01-0206-4 9 ' r.r- 3k; . ".____ ii-'.-v - a-~- _;n. ' 'ft.' ;::*,if!-k^v -,T^ -f .-"vkfc-.- " *r**.- -r^v'.' nr>Wr *# m . . - ->vv-;-f - -- * .*.* ^-.rf****1* pirttft (or a^? ` .' -T-'- - ' mtraet cancer* _ 3. Tt follows;1therefore, that there~iTno absototfitg^safe or zero -p****$&&**'' ` % . fcrtS*teveT for & carcinogen and sucfc* material should, depend- IV fn$ ott'tb* statutory authority of^agency Involved, be banned* V- ".Ste _. Severely restricted, replaced; controlled to tbe^iferfts of^ ... - detection, etc. bs=* * Vl--lr-*"*' It is useful to examine thlr theoi^tttlo light;dl^Kfafethere is : vj**z . . general agreement and where responsible op1nts^d1rergo^ Jia^lleee that . .,**' '* virtually alT medical authorities woaftTagree: --'*\?s o 5-. T. That there Is a wide range of itiu iji i Hn n i iirneifmi m dose-response relationship exists* - The largef^ni^dose, the greater percentage of these exposed contract caneer^wdy^Bm* versa. . ; . -s ti In exposed, pipe)ationsy^even at-sdfcftantial exposure levels*^ large proportlonsde# those exposed-to not contract cancer* 3. As tftfedosage- gbesfidowt the average* time to the appearance of : Is principlewes illustrated.by the ' fdrauU^ofi^nterTIne i the Bayard modiffcation *v .r.aifcf. - ' : ii 1 * . previously. 1.15 . a*. - "' *> r-.Z-"'r- - - '.U.&r ~ ...^ *. < -2yv<r*. . .- Thermedfcal disagreement occurs* over* whj& happens .as:;the dosage-lit =*. decreased-te.^wryTow levels. Thera=;ts one school1 of though; and this. H embraced bfmffcsC the regulatory agencies* th^ao completely safe-level. tfsts* Tla^are otNairesponsible authorities who. eonjte^d that.a dosa level faM- ' .** , i?**4*.. 01-0206350 <* rmcAud wftec* the body's defense mechanisms can effectively combat the altered ^"growth does not occur. Supporters of this position cite* ce of certain netals 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 agefit 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 risfci 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. Tfio American: people have always indicated a willingness to tab* rtsfcflHmjNfericed by such things as the widespread use of the automobile* srokingrJj|HKrimproper diet* and even the home as it is today. We believe . that the zero'rlsk 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 modified to balance risks against benefits in a realistic fashion. This**; sortrof balance rather than regulation by cliche, "its a carcinogen so ban it", shotfW'he applied here. The benefits from the continued use of asbestos in-- * ^J^ticoiBpQuwteiJs. sobsf^^and cannot ^->^c<^ft--*v' --^,.v j^-r. etude ,t-` iii'iiiV`',WSA-:^^arj,- . .*^;r H6tfc5r-- thertsb^benefit discussion ani'^eould Iilce to con- ..\ST by pointing^aut certain prattfca/Msspects of enforce^ sent of the ban as presently proposed In the. Federal Register. These questions * - ` '^e'v/ ' ^eert discussed at great length* and generally were not-so^radi at the recent - meting In-Gaithersburg, NO, conducted by the National Bureau of Standards. -w . #* -- Since, several members of your staff were present at tfel&iHeeting, they will only be Indicated briefly. .Jit** ~ i .. Since the promulgation of the-GSHA asbestos. * there has been a continuing debate on what is asbestos and wb*t is an asbestos 3^j^fiber Asbestos, when narrowly defined. In a way that wf11satisfy the iS*3X. precise minerologists is ubiquitous in the atmosphere *aI<Soughv3*nrany occurs at very low, but not zero, concentrations. When-the.definition is 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 * described by Or. Mai com Ross of the U.S. Geological Survey at the NBS meeting * . f: just mentioned, of "shutting, dflgfcthe face of the earth". Particles of tfc&T type are everywhere and would, contaminate any product containing a mineral.v , The EPA faced this prolgpt in 197& in writing emission standards for the spray^fea^^besflDmi containing product* and decided to treat it by setttn; a ll limit- Their reasoning war as follows: ` of the? l-percent limit ir to ban the use . ft of materials which contain significant quantities of asbestos, *' ^ to allow the use of materials which, would: (1) Contain , .... - -f tfrace amounts of asbestos which occur in numerous natural ~ ,. ' * substances, and (2) Include very small-quantities of asbestos .. ......... ... . (1). -.-vfless than 1 percent) added to enhance the material's effectiveness. 3Bte.No. 66 - Friday, '' * L. . P. JSBT.; 01-0206352 ^ ^ * Imorder fbr any 4K&fan-ftir;ttftrifMifcfiaiot^ to be wort^wairf-^ ^ Nafihsaia^g^fl^^3l|^,olMte ossevrtia'F tflifeywrprevide a definition of<r y- exactT&what mineral species and what fora of these ar^PH3rand specify whet pertfcledlmensions constitute an asbestos "fiber". The. present deflnition-ifr the proposal could be applied t#?Wr foct that covers much of'the surface of the earth. In addition, an analytical procedure and the levels of Impurities11 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 stmmrtee the Union Carbide position and expand on the approach presented in nor lilter of July 14, >577, which we believe is a reasonable alternative to the bw%reposed by Commission. ^>. 1. The products under consideration have been Iri widespread use for about 35 years and we know of no evidence that any consumer has ever been harmed by them. Ho "unreasonablfrTfblt* to the consumer has been demonstrated by the petitioners or by the staff. 2* Consumer exposure data have been presented which show that the exposures are both.'towrintf brief and-when averaged1 over a year are not distinguishable from the general background. The suchr eeposure, if indeed,any risk does exist. Is ly small and is basedron the? extrapolation of an &ven and unproveabla theory- 3v We question whether it is appropriate and whether the Act gives t* . . the Commission the authority to bam a product on the basis of a if ar - " hypothetical or theoretical risfcAon the basis of an absolute zero risk requirement. -- 't.'. 'V- -- ' 1?;*" r;r-:v#i*;.a "" j*'-' - <1&'l o? w c o o i n i cohtouwb mriqws Aianomc mu sips- ouathG i m m ft. ft: ftS2ft.2ftft::2~.~---< | m 4lM| 53/tJHU) 9NI0NVS SNIVAO KOUVtflN33M SUM S0U3$V 3W0tV 01-0206:53 sw**- : "**"i*-r ... - vV.'F%.--v*" <*U*W*. V - - .- ' 'W E.v ' S'*"*-: -r. " v * ` benefits of~the vv-r s'J . -'fiKtSitpSPCeftt b* >-r- - ` y-sitfflclent asbestos and serves to limit tftS* potential' for ekw&ire. ^Tt differs fro* li-V . - -s t.V'-V... ..,' r -,'1'JWtn^. . . ".' V.' t>' -tJUir "*" "' the It of total fomdatlan imtudTngL watei^suggested previous!* ifr thatdt ooreddHlfd*tfbefcttfe content fit the final product, in the ? 1 *' Is als*r*t a level"where ana* 1' ' \ b. Requiat a warninf label inclbdfhg ` '* . > ' . . r> on alt-conpounds under the Juris ded, It whethevtpackaged for direct consumer e* Irr consumer contact. This turns to good wfdeafEia#5 public awareness of:the . . __ * , >= ... .:. stos to eoGourage that; thepreduct to**; , "... . * r^rdfnfrto. directions and not abused*:. It ^ ,,V. ttWMJsera choice. 0#. _ is opportunity to speak to the Comission. .'/ `S liens jomray have or to proyi^ai^addttfonal ' - "'T' ' '- .,V ' *'*.?* ,=*. n-'i * -sSStf- -t... ,*s- v#7. ''>.. .->%;. |jjf ""' ' - 'v - ?-**- " ' ' -At#- . .* -- Vi, .... .. . - ... . ' .. '- &*'*- C-i -:L'/JX... -V.rr >B..* ' ' ' --