Document 8VwdNwYzxrem24Qqwjopjzqak

PLAINTIFF'S EXHIBIT C PM* ] J P3U ASBESTOS INFORMATION ASSOCIATION 1635 K street, N.W.. VVashmoton. DC. 20006 (202) 223-4e&5 hr }: iu os'JH 7S ..'H: Y c. 1 September 1976 .Mr. S. John Byington ' . Chairman * Consumer Product Safety Commission 1750 K Street, N.W. . Washington, D. C. 20036 Re: Petition of Natural Resources Defense . Council, Inc.,and the Consumers Union of U.S.A., Inc., for the Promulgation of a Rule Declaring Certain Patching Compounds to be Banned Hazardous Substances >XV *' .* T>\ 'f . *>v "it.' i- Dear Chairman Byington: The Asbestos Information Association/North America, an in corporated, non-profit organization of firms, and corporations engaged in the manufacture or processing of asbestos-containing products and in the mining and milling of asbestos fiber, de sires to comment on the petition to the Commission submitted July 15, 1976 by the Natural Resources Defense Council, Inc. and the Consumers Union of U.S.A., Inc. The petitioners, seek an order by the Commission to bear patching compounds containing asbestos by declaring such compounds to be hazardous products. Comments contained in the attachment have been prepared fol lowing consultation with member companies of the Association and other expert sources of information. We are pleased to have this opportunity to present our comments and to advise that, if desired, we are prepared to further address this matter with you or members of your staff. We wish to inform you that Ms. Shacter of the Commission staff has been highly efficient and responsive to her public interest charge in the conduct of business with this Association. We commend to your attention her professionalism and pleasant demeanor. * .'1 JS C *7 < ASBESTOS INFORMATION ASSOCIATION AMtWCA rri iir"' - ...... 1835 K Street, N.WM Washington. D.C. 20006 (202) 223-4885 Response to Consumer Product Safety Commission on petition by Natural Resources Defense Council, Inc. and Consumers Union of U.S.A., Inc. for the Promulgation of Rule Declaring Certain Patching Compounds to be Banned Hazardous Substances, dated July 15, 1976. ( 30 August 1976 . ... SGP 0008841 . ''A- c I INTRODUCTION * v w '- "**** lix V; 7 -k. - * '*&$& 5+ "Y^ ' . .:...*L . . . On July 15, 1976, a petition was filed by the Natural * Resources Defense Council, Inc. (NRDC) and Consumers Union of U.S.A. , Inc. with the Consumer Product Safety Commission pur suant to paragraph 2 of the .Federal Hazardous Substances Act, 15 U.S.C. paragraph 1261 (1974) requesting that consumer patching ' compounds containing asbestos be banned as hazardous substances. ^ Patching compounds were indicated to include taping, epackling . and joint sealing and joint sealing compounds.' The petition alleged that continued use of these compounds "... will result in a significantly higher incidence of cancer (including lung cancer and mesothelioma)" and "that no cautionary label would adequately 7- protect the public from the risk of illness associated with patching compounds." The Asbestos Information Association/North America is an association of 32 producers of asbestos and asbestos containing . products. Members of the Association are directly affected by the petition and wish to enter this response into the record. II USE OF ASBESTOS IN PATCHING COMPOUNDS Composition of Drywall Compounds ' The petitioners note correctly that the principal use of patchinc compounds by consumers isj in home drywall construction and repair. This discussion therefore will focus on the material generally used for the application, tape-joint compound (TJC). There are two principal types of join compound. One uses a latex or water-soluble glue as a binder and "sets" by evaporation of the water. The other uses dehydrated gypsum as the binder(and the principal dry ingredient), or gypsum in combination with water soluble binders, and sets by chemical reaction as the gypsum com bines with water of hydration. The evaporative type, composed mainly of limestone, lesser amounts of mica and 3-5 percent as-' bestos plus the binder, controls about 80 percent of the market, and usually is. sold in the ready-mixed, wet form. The hydrating type (gypsum-based) , with roughly. 20 percent of the- market, also typically contains asbestos and must, of course, be sold dry and mixed just before use." Asbestos is added to these compounds for two principal reasons: . It imparts properties to the compound (mud) which make it flow easily and smoothly when trowelled on, while still remaining viscous enough to stay in place during the initial Stages of Vv7.'. -1L- * ' Jdifc.'' SGP 0008842 ( -2- } "-V I v.*- 15^'. A '*. / .2 The fibers help to make the mud aiShere to'`the joint and form a reinforcing networlj thab-w reduces shrinkage and cracking as the mud dries. The asbestos thus is not ai impurity or an incidental ingredient but makes an important contribution to product performance. A great deal of research effort has been devoted during the past- five years to the development of asbestos-free joint compounds for use by the construction industry. Several .manufacturers claim success in that effort but a majority still consider as-, bestos an essential^ element of a quality product. > .. Although there has been a moderate drop in asbestos .`use. in tape joint compounds, most manufacturers, particularly, the large regional companies today either do not have an asbestos-free compound or have it available to supply only if the user demands it. It is recognized that the commercial and comsumer markets may have different product performance requirements. The commercial installer must have a prod' rt which can be applied rapidly over extended time periods and ich will require a minimum of workover and refinishing'. Th lome repair craftsman is not under this production" pressure anc jould use a product which is more difficult o handle. On the other hand, the consumer-user generally does iiot have the tools or the skill of the professional and needs all the help he can get from product performance. There should be well documented .reasons if he is to be required by law to use less statisfactory materials. . The Size and Character of the Market The following very approximate! calculations' serve to illustrate the principal characteristics of the market. In 1975, about 10,000 tons of asbestos were used in the manufacture of tape joint and similar compounds. The amount of asbestos used in each product varies considerably but an average quantity of 3% by weight should be approximately correct. On, this basis*, total annual production would be on the order of 350,000 tons of compound. According to petitioners, $6.9 MM worth of patching compounds were sold in the consumer* market in 1975. The average unit was about one quart at a price of $2.00. Using .these figures and assuming that all of this compound contained 3%-asbestos, values of 5,390 tons of compound containing 160 tons of asbestos are ob tained. Consumer products thus appear to represent somewhat less than 5% of the total usage of patching compounds. ; a:. *>**. f X SGP 0008843 V J . . K/ ** <>* * * *' *V ( - 3- ' 'T+ . ` &*-' . ' > ' -v-ci} . It also is appropriate to examine the significance.^f^the ' quart of compound cited'Mlri the petition as the typical purchase ' size. A quart of ready-mix compound weighs a little over threes pounds and-will finish about 45 square feet of drywall. This is less than two of the standard size 4' X 8' gypsum board sheets and appears to be a reasonable quantity for the usual do-it-your- self craftsman. .. . Most of the packaging and distribution of products to Wie consumer market is done bygone or" two" of the large building -'"'' ' products companiesr severer larger companies that specialize in the consumer tape joint compound field, and a substantial proportion of the major paint manufacturers who market through their own distribution outlets. The medium to large regional manufacturing companies which have a substantial share of the commercial TJC business generally are not involved. Consumer TJC is distinguishable from ' commercial TJC in that the consumer product finally passes into and through mass distribution retail outlets. The question of container size is particularly relevant to the issue raised by the petition. .TJC for retail distribution typically is packaged either in a one gallon container of the wet type or in a one pound or five pound package- of the dry type. The largest clearly identified consumer product found in our brief survey was a kit containing 18 lbs. of wet compound plus tape which was intended for use in the installation of 250 sq. ft. area, i.e., a small room. Some large retail stores,however, stock limited quantities of commercial 5 gallon pails for the convenience of the smaller commerical contractor. While it is conceivable that a homecraftsman might purchase one of these 5 gallon pails,it would be a rare home repariman who would undertake a complete three room finishing job. Ready-mix compound intended for commercial use, by contrast, universally is packaged either in 5 gallon pails (62.5 lbs.) or in 25 lb. polyethylene bags in cardboard boxes. If these commercial containers are judged to be ". . . packaged in a form suitable for use in the household" the ban requested by the petitioners will apply, not just to the consumer market (5% of the total), but to the entire market, commercial as well as consumer. Ill ASBESTOS EXPOSURE DURING DRYWALL INSTALLATION The petitioners do not provide any data which show the level of exposure that occurs during use of the compounds at a scale and under conditions likely in consumer use. The only data presented is that of P.ohl et al (Reference 7) obtained during'a test performed at one location by commercial drywall workers. Materials were handled on a much larger scale than that which must be considered here. Exposures recorded were high, and it is alleged that exposures in consumer use would be similar.. SGP 0008844 ***.' w'v ( > ** . f **'*..-'I ''' ' i..,-.*^ ,'/ S**v. t> . ^ 4 `V' '. -:;V ^ :','! .V .,; < ` *'" - "*# - * V*H ^ '"' '-'(1L 1 . '`iifjj Subsequent to- the Rohl et al wor)c# Rhodes ana Ingalls |^cojviv ducted a study of asbestos dust levels during sanding at six locations throughout the United States. These tests were run at commercial jobsites selected to represent the range of sanding ^conditions typically encountered in the construction industry ;* and `samples were collected during routine operations. The results are compared with those cited by Rohl in Figure 1. ^ ~' - ' When very^arge differences in dust levels between the two ~ -^v studies became apparent/ samples from three locations.in the Rhodes. and Ingalls Study were counted "blind" by two other laboratories' to check the accuracy of the initial calculations. The results of this recount are tabulated below. ' ^ INTERLABORATORY COMPARISON ASBESTOS FIBER COUNTS 5 Sample Source Airborne Asbestos Fiber Concentratio (Fibers/cc longer than 5um) Base By Lab A By Lab B Location I (Filter #.l) 0.4 0. 3 0.2 Location I (Filter #2) Location II (Filter #1) Location II (Filter #2) Location III (Filter #1) Location III (Filter #2) 0.4 1.5 ' 1.3 0.6 0.4 0.0 1.0 1.0 0.0 0.2 0.2 1.6 0.6 0.9 0.2 The author's commentary regarding these differences is shown below: " "Although there is some variation,these are difficult samples to count and the agreement between laboratories is excellent. It is evi dent that the differences between this survey and that of Nicholson ( the Rohl study) are not due to sample analysis. The sanding procedures used- to generate dust seem to be the most likely cause. In any case, the Nicholson results do not appear to be typical of the concentrations encountered under most job-site working conditions." ^(1) GDIC Drjjwal >k SGP 0008845 r .**,*: ' . - y *;. ** ^ * ** * ' *K*-- - 5 -' *&. The concentrations described above all were'ceiling concentrations obtained during sanding operations. In most cases even commercial operators . do not sand for an entire shift so that'the 8-hour time weighted average exposytre will be'considerably less. TWA values for the study cited 11) are shown in the table below: ;SUMMARY OF AIRBORNE ASBESTOS Fiber Concentrations During Drywall Sanding :-y... Location Ceiling Exposure. (Fibers/cc> 5wm) Exposure Time During Sanding (Hours) Estimated 8-hour TWA Expos: (Fibers/cc New York City, N.Y. 0.4 8.0 0.3 Hialeah, FL 1.0 4.0 ' 0.4 Ft. Lauderdale, FL (Hand) 1.1 1.0 0.1 Detroit, MI 1.3 8.0 0.9 Dallas, TX 1.8 0.5 0.1 Ft. Lauderdale/(Pole) 3.4 3.3 0.6 Niagara Falls,N.Y. 3.6 0.6 0.2 It is our contention that these lower values are much more representative of exposure during commercial operations than' those` cited by the petitioners. It is also our contention that, because smaller quantities are handled, peak consumer exposures generally will be no greater than the commercial ceiling exposures recorded above. And. since consumers work with tape joint compound in frequently ,average or TWA exposures for consumers will be much lower than for commercial operators. IV THE MEDICAL EVIDENCE . Petitioners cite,in support of their position, a selection of pieces from the medical, scientific and popular literature, some of which items are.of questionable value in furthering the regulatory process. Because time does not permit a detailed analysis of each reference cited,*we can only offer a few cautionary considerations to'be borne in mihd when studying the petition: . J >:h*. SGP 0008846 'V c -6'" *iT : 1. Few epidemiological'studies of populations "^exposed to airborne asbestos fibers offer any definitive or credible evidence of the levels or 'concentrations of dust which the members of the population may have inhaled. 2. Based upon the recollections of persons familiar with the use of asbestos and asbestos products.over the years, it is not valid to assume that past indirect^ domestic or neighborhood exposures to airborne asbestos, necessarily were either light or intermittent. 3. It can be argued in good faith that the exposures of. most,.or perhaps all, populations studied to date included a substantial number of high average or massive intermittent exposure \ to airborne fibers and/or si- multaneous exposures to other carcinogens. Among the references cited by petitioners is the following state ment from the October 9, 1975 OSHA Proposed Rulemaking concerning certain occupational expousre to.airborne asbestos: "Because of the variability of individual responseto carcinogens and other factors, the concept of a 'no effect' or 'threshold level' may have little real significance on the basis of existing knowledge, while some level, below which exposure to a carcinogen does not cause cancer, may conceivably exist for any one individual, other individuals in the working population may have' cancer induced by doses so low as to be effectively zero. (Emphasis added) 72/n~ As part of their response to the above noted Rulemaking, the AIA/NA, together with its cooperating companies and trade associations commissioned an outside consultant, Hans Weill, M. D. of Tulane University, to review the literature cited and advise on the sig nificance of any pertinent medical evidence. Dr. Weill's statement is attached for reference. The AIA/NA position statement, taken from its*April 9, 1976 response to OSHA. is given below. We stand on this position for the present petition. " SUMMARY OF FINDINGS #* The Task Force has reviewed the work of Dr. Weill . . . and . . . has drawn certain conclusions. Medical Statement SGP 0008847 Although the volume of epidemiological data available for statistical analysis in 1976 is greater than that available in 1972, the conlusions which reasonable may be drawn from those data are not significantly different from conclusions which were,. or could have been,drawn in 1972. Then, as now, - \  . mfh* - .7 - .v . ^ '* qualified experts would '. 1' conclude * thats v" . .-.* -' ' ;K-i4*\.r i! , .1. Asbestos, when inhaled, causes fibrosis (asbestosis). 2. Asbestos, when inhaled, is associated with the develop ment of malignant tumors of the bronchial system and lung and with mesothelioma, (in other words, asbestos is a carcinogen)-. Few,' if any students of the, subject would;disagree with the conclusion that there is a dose-response relation ship between exposure to airborne asbestos and the devel opment of asbestosis. There is also a substantial body of expert opinion! which supports the premise that there is a dose-response relationship between exposure to most, if not all, carcinogens and the development of cancer. There is no reason to believe, from the data available to us /. that asbestos is an exception to this generality; although, at this time, no one definitely can say at what exposure level asbestos becomes a cancer hazard to man. Our view of the literature indicates that no credible epidemiological studies have been published which would suggest an excess of malignant tumors among persons ex posed to no more than 2 asbestos fibers per cc of air (TWA), using the presecribed membrane filter test method. This is a fact simply because there have yet been identified for study no .populations the exposure experience of which consistently'has been as low as 2 fiber's. Since all populations studied to date have been exposed to substantially higher concentrations of airborne asbestos, we can conclude only that an excess of all types of as bestos disease is associated with levels of exposure significantly higher than the level currently mandated to become effective on July 1, 1976." Johns-Manville Corporation,the largest producer of fiber in the western world and the largest manufacturer of asbestos-containing products in the United States, also conducted a detailed medical review and the following conclusions were included in their state ment to OSHA. Exhibits B ' and C from the Johns-Manville response are attached hereto for reference. From page 4: SGP 0008848 "2. J-M's Review of the Medical References Cited By OSHA We have reviewed in considerable detail all of the references cited by OSHA, and conclude from this study that,these references totally .fail to provide. . .. '( :C-. r' 8--' -- 4 " * any sound "new information", as OSHA contends/ ' '1* ^ as a basis or rationale for the Proposal. Specifically, no "new information has been forthcoming on the toxic effects of asbestos," since June, 1972, that justify the substantial modifications being proposed by 6SHA. In fact, new information not referred to by OSHA strongly suggest that 2 or perhaps more' fibers/cc is not*** associated with an excess incidence of pulmonary cancer. In addition, we have reviewed all available non-cited relevant scientific publications and data sources, and find that these reinforce our conclusions as to the absence of any scientific basis for the Proposal to to reduce the 8-hour time-weighted average airborne exposure to asbestos from 2 fibers/cc to 0.5 fibers"/ cc. The results of our detailed review are set forth in Exhibit B attached hereto.". From page 19: "Our critical review of the carcinogenesis literature through 1975 is attached hereto as Exhibit C. Our review leads us to.the following conclusions: 1. A dose must exist below which a carcinogen is ineffective. Chemical carcinogens of every known category, chemical composition, and steric con figuration produce more cancers when administered in large doses than smaller ones, and a doseresponse curve can be demonstrated for graduated doses. 2. A threshold level exists below which a biological system will not exhibit any adverse effects from exposure to a carcinogenic agent. Chemical carcino gens can be administered at dose levels which yield no cancers in laboratory animal models and, which neither shorten the animal's life span nor result ih demonstrable abnormalities in metabolic and physio logical capabilities. This is clearly a no-effect (threshold) level. 3. There exists an array of environmental situations in which exposure to chemical carcinogens has failed to result in an increased incidence of cancer. The clear implication is that indeed a sub-threshold level for exposure exists in actuality." (2) The following statements made by the-National Cancer Institute are also directly relevant to the question: ^2 (2) General Criteria foj-rAssessing the Evidence of Carcinogency of Chemical Substances, P. 4. SGP 0008849 * -9- v,W >/ "B. Criteria 'in Human Studies fe*vry< i'>'ir'>.t,vk- * tvv VjAjl\u.ii V*>J*>/ `.*5; '' Types of evidence suggesting that an^ag^nt is ;. '7 carcinogenic in humans include: neoplastic rresponse^ '-.- directly related to exposure (both duration and dose), incidence and mortality differences related to occu- ' pational exposure; incidence and mortality, ^differences between geographic regions*related to differencejex^ posures rather than, genetic differences* and/dr ' .- altered incidence in migrant populations; time trendsTW , in incidence or mortality ^elated^ to either^the'intfor^^2 * duction or removal of a specific'agent from'the erjvirorir,. ment; case control studies; and the results'^of re^jgpgpective- prospective and prospective studies of the consequences of human exposure. . Clinical case reports may alsb^rovide early warning of a potential carcinogen. Negative.*''*' epidemiologic data may not establish the safety of^sus pected materials. Negative data on a given agent ob tained from extensive epidemiologic studies of suf ficient duration are useful for .Indicating upper limits for the rate at which a specific type of exposure to that agent could affect the incidence and/or mortiality of spe cific human cancers (Emphasis added.) " ~' "E. Extrapolation from Experimental Data and Evaluation of Human Risks The criteria listed above provide a guide to determining whether a compound is carcinogenic under a specific set of exposure conditions in a given species or subpopulation. Quantitative extrapolation from animal studies for the purposes of evaluating human risks entails large uncertainties at the present time. Each case must be individually e- valuated, taking into consideration such factors as adequacy of experimental design, statistical significance of the data, dose-response relations, duration of exposure , route of administration, metabolism (including species variations): host susceptibility, co-factors and other modifying factors, and the amount of the material to which humans will be exposed. The criteria for extrapolation may vary depending on the agent in question. (Emphasis added.)". The National Cancer Institute report does not appear to support the OSHA position that the concept of a "no effect" or "threshold level" may have little real* significance. V STATEMENT OF POSITION For the reasons cited above, it is the position of the AIA/NA that: 1. Because consumers use tape joint compounds in smalt; quantities and at infrequent ^intervals,f-the levels4 of airborne asbestos to which consumers:will-be ' v-' . ` Vv . v, SGP 0008850 ( 10 2. Even if consumer exposure leyiels were similar those in commercial operations, the medical ev idence^f; taken in overall does not support the allegation of the petitioners that continued use of asbestos- containing tape joint compounds "... will result 5 in a significantly'higher incidence of cancer (in- .' eluding lung cancer and-mesothelioma)." - ^i ,- * / ,v . sj. 3. Because there is no evidence-that asbestos-containing^ consumer tape joint compounds "cause substantial persp/ial injury during or as a proximate result of any customary ; or reasonably forseeabie handling or use" , they are riot "hazardous substances" within the meaning of 15 USC ^v- Sec. 1261 (f) (1) (A). V 4. Unless packages of 5 crallons or 25 lbs. or more are specifically exempted, a ban on the use of asbestos fibers in consumer tape joint compounds may require the elimination of asbestos from all tape joint compounds,. whether destined for consumer or commercial use, with a severe and unnecessary adverse impact upon the market for commercial compounds. 5. In general, the petition of NRDC and Consumers Union>U.S.A., Inc., has no merit and should be denied. i "*00 ' SGP 0008851 f . / ** .. . 9 * *< V`>: M-/ ; - AIRDCRKE asbestos FIBER concentration {i ic c rs /c c longer than 5 tn;cror.ctGrs) SGP 0008852