Document o9OgGLgkYyxEbM41jn3VZMRBr

A REPORT SCIENTIFIC EVALUATION OF THE REVIEW OF TIE ENVIRONMENTAL EFFECTS OF ASBESTOS BY AN AD HOC STUDY GROUP TO THE HAZARDOUS MATERIALS ADVISORY COMITTEE SCIENCE ADVISORY BOARD U. S. EWIRO^IENTAL PROTECTION AGENCY February 4, 1976 Asbestos Information Association North America 1660 L Street, N. W. Washington, 0. C. 2Q036 1 EPA NOTICE This report has been written as a part of the activities of the Agency Science Advisory Board, a public advisory group providing extra mural scientific information to the Administrator and other officials of the Environmental Protection Agency. The Board is structured to provide a balanced expert assessment of scientific matters related to problems facing the Agency. This report has not been reviewed for approval by the Agency and hence its contents do not represent the views and policies of the Environmental Protection Agency, nor does mention of trade names or commercial products constitute endorsement or recomaendation for use. 1 )(-05Li5'55Sa UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20460 February 4, 1976 Hr. ,'lartin Alexander, Chairman Hazardous Materials Advisory Committee Science Advisory Board, EPA Department of Agronomy Cornell University Ithaca, New York 148S3 OFFICE OF THE ADMINISTRATOR Dear Dr. Alexander: I transmit, herewith, report of the Ad Hoc Study Group to critique the document entitled REVIEW OF THE EhVlROfMENTAL EFFECTS OF ASBESTOS designated 0RNL-EPA-17, November 30, 1974. A memorandum dated May 20, 1975 fron Dr. Bnil Mrak, then Chairman of the Hazardous Materials Advisory Conmittee, charged the Ad Hoc Study Group to 1) give its best assessment of the appropriateness and completeness of the information presented; and 2) give its best assessment of the adequacy of the inform.* tion to serve as a basis for standards under an anticipated legislative mandate. The Ad Hoc Group understood that it was not supposed to rewrite the document, only to critique it. This, it has done, but in so doing it felt obliged to make its comments more or less pointed and it attempted to be helpful and constructive by suggesting ways to correct and improve. The Group also went to considerable effort to provide additional references it thought would be helpful in any rewriting and revision of the document. The Ad Hoc Group was composed of very knowledgeable persons, truly expert in~their fields with respect to asbestos. They put many of their personal hours into the substance of the report and I wish to thank them for their dedicated effort. I should also like to ackiowledge the assistance of Dr. J Frances Allen, and the Science Advisory Board Staff. The Ad Hoc Study Group hopes that the attached report is a satisfactory response to the charges it was created to answer. Respectfully submitted on behalf of the entire Ad Hoc Study Group. cc Members Ad Hoc Study Group V. K. Rowe, Sc.D. Chairman, Ad Hoc Study Group in w m TABLE OF CONTENTS I. LViHODUCnON II. CENTRAL CO'DENTS III. DETAILED COMENTS ON INDIVIDUAL SECTIONS ....................................... 9 A. Section 1.0 General Summary ..................................................... 9 B. Section 2.0 Physical and Chemical Properties ..................... 15 C. Section 3.0 Biological Aspects of Asbestos in Plants and Microorganisms ................................. 21 D. Section 4.0 Biological Aspects of Animals ........................... 21 E. Section 5.0 Physiological and Pathological ; Aspects of Asbestos in Humans .......................... 29 F. Section 6.0 Environmental Distribution and Processes ................................................................ 43 G. Section 7.0 Environmental Interactions and Their Consequences .............................. 45 IV. APPENDICES A. Letter of May 13, 1975, from Dr. Wilson D. Talley to Dr. Emil M. Mrak and "perspectives" document ..................47 B. Charge to the Ad Hoc Study Group .............................................. 51 C. Memorandum, November 13, 1975, Dr. John A. Moore on NIEHS Asbestos Projects .......................................................... S3 D. List-Documents Distributed to the Ad Hoc Study Group ........ 57 VI1 01 -020-' A REPORT SCIENTIFIC EVALUATION OF THE REVIEW OF THE ENVIRONMENTAL EFFECTS OF ASBESTOS BY AN AD HOC STUDY GROUP TO THE SCIENCE ADVISORY BOARD - HAZARDOUS MATERIALS ADVISORY COMITTEE MEMBERS Dr. V. K. Rowe, Chairman Toxicological Affairs Health and Environmental Research The Dow Chemical Company Dr. Henry A. Anderson Department of Medicine Mt. Sinai School of Medicine Dr. H. Buchwald Director of Industrial Health Services Government of Alberta Dr. Paul Gross Professor Bneritus of Pathology Medical University of South Carolina Dr. James R. Kramer Department of Geology McMaster University Miss Anne M. Wolven Senior Toxicologist Shell Chemical Company February 4, 1D76 v I. INTRODUCTION A letter of May 13, 1975, (APPENDIX A) from Dr. Wilson Talley, Assist,-mt Administrator for Research and Development, to Dr. Emil M. Mrak, Chairman of the Executive Committee of the Science Advisory Board, points out that the Congress has been considering the passage of legislation to address the problem of protection of the public health and welfare against any dangers that might be associated with the disposal of hazardous materials to the soil. In anticipation of the passage of such legislation, the Office of Research and Development is in the process of gathering and organizing information for a series of reports on the transport and effects of critical pollutants, including asbestos and mercury, which are components of materials commonly disposed to the soil. Dr. Tailey is seeking through the Science Advisory Board views of the scientific coimunity as to the appropriateness and completeness of the information presented in the reports as well as their adequacy to serve as a basis for setting of standards under the anticipated legislation before the reports are finalized. At the meeting of the Board's Executive Conmittee on May 16, 1975, the responsibility for critiquing the draft reports on asbestos and mercury was assigned to the Hazardous Materials Advisory Conmittee. In response to this request the Chairman of .the Hazardous Materials Advisory Committee established an Ad Hoc Study Group to evaluate the draft report, Review of the Envlromiental Effects of Asbestos. In a memorandum dated May 2Q, 197S, (APFENDDt B) Dr."TIrak, at that "time also Chairman of the Hazardous Materials Advisory Coranittee, charged the Ad Hoc Study Group to consider in detail the information contained in~"the asbestos draft document and to provide a report of its findings to the Conmittee. This report is to include the following: 1. The Study Group's best assessment of the appropriateness and completeness of the information presented. 2. The Study Group's best assessment of the adequacy of this information to serve as a basis for standards under an anticipated legislative mandate. The background and purpose of these documents (asbestos and mercury) is stated in the Guidelines and Background for the External Panel Review as follows: 1 "Hie Solid and Hazardous Waste Research Laboratory, at the request of the Office of Solid Waste Management Programs (OSWMP), is developing comprehensive multimedia State of the Knowledge Reports on the Hnvironmental and Health Effects of Substances deemed hazardous and present as components of waste streams destined for land disposal. These reports to oe developed from existing literature, are to serve as part (i.e. bioenvironmental aspects) of the total scientific base which must be considered if promulgated guidelines/standards for the disposal of hazardous materials are to be scientifically sound and economically feasible. These reports are being developed under the authority of Section 212 of the Solid Waste Disposal Act, as amended in 1970 and in anticipation of the passage of the proposed Hazardous Waste Management Act or similar legislation." It is anticipated, as stated in the charge to the Ad Hoc Study Group, that this document on asbestos will: . Provide an up-to-date compendium of information on toxicities/effects associated with exposures to specific substances contained in the air, water, and land media. . Provide insight into the effective soil and plant indicators for detecting the presence of substances. . Provide general data on the complexity, cost, and reliability of state-of-the-art analytical procedures for determining the presence of substances. . Provide information on predictable reaction products of the substances to aid in the design of criteria relating to nixing of wastes. . Permit assessment of the need for additional air emission standards because of the operational characteristics of hazardous waste treatment sites. This report will first discuss briefly the overall Review and then deal in considerable detail with the deficiences of the individual sections. The Ad Hoc Group agreed that pointing out deficiencies in this draft document without offering suggestions as to how they could be remedied would be inappropriate. This report is a collection of comments and suggested changes that will be meaningless by themselves without coordination with the substance of the original document. 2 01-0^055^3 4 In general, the Review of the Environmental Effects of Asbestos includes a very large part or the knowledge about asBFstos tnat existed before the past two or three years. Since then, a great amount of information on asbestos has become available. When one considers that this document was completed in November 1974, it is obvious that it must have been in preparation for some time before that. The lack of more recent information should not be considered as a deficiency, but the Ad Hoc Group is of the opinion that unless steps are taken to update tHe document, its usefulness for the stated purpose will be minimal. Furthermore, its adequacy to withstand criticism of validity would be open to serious question. There are areas in the Review where the data liave been inaccurately presented and misinterpreted, and pertinent references overlooked. The commentary will deal specifically with the individual sections. 3 II. GENERAL OTMEN7S SECTION 1.0 -- General Summary 1.1 FINDINGS If the Study Group could assume that the draft Review of the Environmental Effects of .Asbestos will be rewritten, tKTs Section would then be expected to reflect essential changes needed in subsequent Sections and Subsections, and little else would need to be said. However, changes in definition of certain disease states are suggested. Other modifications, as well, such as the elimination of irrelevant material, should be given attention. 1.2 CONCLUSIONS Changes in this Subsection should reflect modifications in subsequent sections. This Subsection includes a considerable amount of irrelevant material that is and would be inappropriate, irrespective of other changes. SECTION 2.0 -- Physical and Chemical Properties This Section is badly in need of rewriting chiefly because it is far out of date. New information is available, beginning in 1973, particularly with respect to analytical methodology. Reorganization of the material in 2.0 is required in order to reflect recently developed information. Inclusion of new analytical methods and data is critical to the effectiveness of the Review. SECTION 3.0 -- Biological Aspects of Asbestos in Plants and Microorganisms .Apparently there is little information available on the biological aspects of asbestos in plants and microorganisms. 5 4 SECTION 4.0 -- Biological Aspects of Asbestos in Animals As one ..views this whole Section it becomes apparent that there is a huge void in the data base needed to assess the hazard of environmentally encountered asbestos. The experimental data available deal largely with the type of material and the type of exposure encountered in the occupational or occupationally related setting. Toxicological data pertaining to the type of material and the type of exposure encountered in the general environment are lacking for the most part. Tlie greatest need is for information which will permit an assessment of the noncccupational hazard(s) attending various exposures falling within the jurisdiction of EPA (i.c. drinking water and cozitunity air) and also of concern to FL)A (i.e. foods and drugs). Recent developments in analytical procedures as noted in the suggested revisions of Section 2.0 have demonstrated that the asbestos to which the general population is most likely to be exposed on a continuing basis is quite different from that nonrally encountered in the occupational area. Studies of water and foods have shown that asbestos is ubiquitous in them and tiiat it t>pically is in the form of very fine fibrils averaging in length about 1 to 2 urn and with an aspect ratio of 30 or more. Even though the numbers of these fibrils is huge, millions, even hundreds of millions/liter of water, one million such fibers is equivalent to only about 0.01 to 0.02 ug in total russ. If Subsection 4.4.1.3.3 of the Review is revised to include infor mation as suggested by the Ad Hoc "Group there will be a body of information showing that asEestos fibers less than 5 m in length have a minimal, if any, activity when inhaled by, or administered intratracheally to animals. Since this is the type of asbestos widely encountered in nonoccupational settings it would seem that it is the type of material that should be included as a part of any comprehensive study of prime interest to EPA or FDA. Consideration also should be given to the types of asbestos that may be found in homes, offices, public buildings, public water or elsewhere as a result of tlie use of asbestos. Consideration should be given to that which could be expected from solid waste disposal if different from that occurring in occupationally related areas. The Ad Hoc Croup feels that development of both qualitative and quantitative data through appropriate animal studies on the types of asbestos most commonly encountered in the nonoccupational environment would be most useful. 6 O 1 -n The Ad Hoc Group is aware that some ingestion studies on asbestos are already underway. Hie studies are as follows: 1) A study under the direction oi Dr. A. Pelfrene of Eppley Institute in Omaha, funded by \'CI 2) A study under the direction of Dr. Will at the University of Iowa, funded by \'CI 3) A study by dr. J. C. Wagner of Wales 4) A study by Dr. W. E. Snith at Fairleigh Dickinson University 5) A study being Tnanaged by NIEHS resulting from a specific appropriation from the Congress to assess the effects of oral ingestion of asbestos (APPENDIX C). Judging from the protocol available it appears that the NIEHS study is designed to more closely simulate occupationally related exposure than general environmental exposure, particularly with respect to particle size of test material and dosage which seems grossly excessive. Examination by EPA of the protocols for these wid other animal studies in progress to determine whether the results will, or will not, provide information useful in assessing the hazard associated with nonoccupational exposure to asbestos is most desirable. Such in-deptK consideration before embarking upon any additional animal studies is critical. SECTION S.O -- Physiological and Pathological Aspects of Asbestos in Humans .Vs with Section 4.0, the conmentary on this Section is extensive probably because the Ad Hoc Group is privileged to have as members persons with first hantT knowledge on the subject. Generally, the comments reflect the need for precise language and the clinical interpretation of the data presented. Also provided are current data and numerous current references to support this Section. 7 oi 0 2u Continuation of EPA epidemiologic stud .es in progress and search for other sites wlierc exposure to naturally occurring asbestos can be documented and a meaningful study conducted would be of great value in producing much needed information. It may well be that the results of epidemiologic studies of local populations will provide reasonable answers to the EPA problem of assessing the risk from exposure related to nature, current uses, and waste. SECTION 6.0 -- Environmental Distribution and Processes There appears to be some confusion in this Section with respect to units of measurement. The apparent contradictions are pointed out in the detailed conrcientary. The Section needs to emphasize the ubiquitousness of asbestos and the fact that it has been with us for a long time. SECTION 7-0 -- Environmental Interactions and Their Consequences This Section can be expanded to make it more useful. Further research and data collection are needed in this area and. could be of great value in producing much needed information. Actually this Section could easily be combined with Section 6.0. III. DETAILED COMENT5 ON INDIVIDUAL .SECTIONS SECTION 1.0 -- General Suirmry 1.1 Para. 1, line 2: asbestosis, pleural plaques, lung and laryngeal cancer, pleural and peritoneal mesotheliomas, and gastrointestinal cancers. Pleural plaques is not a lung abnormality. Para. 3, line 7: Concerning the relative fibrogenic potential of various asbestos types (Subsection 4.4.1.3.2) Fibers less than 5 um in length have not caused fibrosis when inhaled or injected intratracheally. (*.4.1.3,3) Firm conclusions regarding the fibrogenic mechanism are not possible at this time. Delete rest of the sentence. Para 4, line 1: Conclusions about the carcinogenic mechanism of asbestos are also problematic. Line 10: After chrysotile, insert and has not been demonstrated with anthophyilite. (Subsection 5.3.473). Line 11: ". . . amosite, crocidolite, and anthophyilite produce . . . ." Page 2, Para. 1, last line: Change proportionate to related Section 6.0 reference is not pertinent to the statement, use (4.4.2.1). Para 2, line 3: The signs and symptoms. Delete emphysema. Line 15: Signs and symptoms include. Page 3, Table 1.1: Definitions as given do not seem appropriate--suggest the following changes and additions: 9 ci Pleural calcification: Deposition of calciicn salts in fibrotically thickened pleura. Pleural fibrosis: Diffuse, shaggy, fibrotically thickened pleura. Pleural plaque: A localized, milky-white, glistening patch of fibrotically thickened pleura, usually on the parietal aspect. PleuTal and peritoneal mesothelioma: A rare malignant neoplasm, etc. Lung cancer: An epithelial malignant neoplasm, most coiunonly of a bronchus that often invades surrounding tissues and metastasizes to other organs. Page 4, para 1: Delete last sentence because the conclusion does not relate to the findings. Para 3, line 9: . . . and the condition results in death. Para 4, line 1: There is preliminary evidence that asbestos inhalation may e:nnance. . . . Line 10: Duluth, Minnesota, over the past 20 years has. . . . Line 12: The findings are considered inconclusive because cancer induction nay require more than 20 years. There is a lack of epidemiological information. . . Page S, line 1: Nianerical dose-response. . . Lines 5 to 7 beginning with "An exception . . . delete because inappropriate. Para 3, line 1: Cigarette smoking is a co-factor in lung cancer. 10 0i Line 5:- Add, No such relationship has been demonstrated for mesothelioma. Para 4, line 4: . , . population to occupationally related asbestos. . . . Line 3: Add after "United States" but have no significance with regard to health effects. Delete rest of para 4 unless documentation can be produced. It is not in 5.3.6.2.2 . Para 5, line 5: Delete sentence beginning with "Because of." Last line.. Delete sentence beginning here and ending on page 6. Page 6, para 1, lines 3-5: Delete all cities. Line 6: In addition, asbestos fibers are detectable in beverages. ... Para 2, line 2: "... and ingestion, but no adverse health effect has been demonstrated. Delete the rest. 1.2 CONCLUSIONS a. All types of asbestos are pathogenic to humans, causing asbestosis, pleural plaques, and lung cancer. Crocidolite, amosite, and chrysotile also cause mesothelioma. There is also preliminary evidence that they may increase the risk of GI cancers. However, anthophyllite has not been demon strated to produce mesothelioma in man. In animals all types of industrially used asbestos have produced asbestosis, lung cancer, and mesothelioma. Page 7 (b) line 2. After "asbestos" insert on humans. 11 01-O 2 0 5* 4 Line 4, after "significance" insert for humans. Line S, put period (.) after "controversial." Delete rest of paragraph. d. to predict accurately g. Page S, line 6, delete, everything beginning with "The recent." h. Delete "asbescosis and" i. Available data indicate that the presence of asbestos is widespread in air, water, soil, and food. Methods for quantitatively identifying the concentrations, size distributions, and types of asbestos fibers in the environment are being developed. j. .Vo human health hazards. . .have been demonstrated. There is paucity of information concerning numerical human. . . k. A nonoccupational asbestos exposure standard. . . and related hazards. Available environmental and . . . insufficient to enable a scientifically. . . . . . . standards. Delete the rest of the paragraph. This material is not relevant to text and should be deleted. l. This material is not relevant because it deals with occupational exposure and it should be deleted. m. Page 9, add: Because of the many new publications and reports that are now being generated the data base is being updated continuously. 12 o l -0205-: ;'? sr.cnON 2.0 -- Physical and Chemical Properties This section is not up-to-date, particularly with respect to analytical methodology. It is critical that the Section be up-to-date and that the more recent literature, especially since -1975 be included. A number of new and pertinent references are given at the end of this ccircnentary. 2.1 ' Page 10. .Asbestos is defined here as a group of hydrated silicate minerals possessing a fibrous morphology and having comnercial worth. The definition generally limits the mineral group to chrysotile, cummingtonite ("amosite"), tremolite-actinolite, anthophyllite, and crocidolite although there are other asbestos minerals such as eckermannite. Would it not be desirable to point out that there are other minerals of the class and also physical forms -enerally referred to as asbestos . bodies? For example, if one uses the common criteria of viewing length/width of ^ 3 for an asbestiform ( fibrous,3- acicular) mineral, the definition can be extended to many tens of commonly occurring minerals, such as plagioclase, other amphiboles (hornblende), wollastonite, pyLXte, pectolite, etc. The length/ width ratio (aspect ratio) has considerable significance in health considerations, especially for the general environment. In this context, the difficulties of analysis due to the large number of mineral candidates must be considered as highly important. Page 11. Table 2.1 could well be expanded to include a listing of common impurities, surface properties such as surface area and zero point of charge, solubilities in water, effect of pH, etc. Perhaps new references 3a, Sa, 9a (Tables 2 3 especially), and 13a will be helpful here as well in the expansion of the discussion as suggested below. 2.2 2.3 Pages 10, 11, 12 and 13. General. Suggest re organizing the presentation of this information so as to deal more comprehensively with each major item. For example, 2.2 - Uses. This is believed to be of sufficient importance as to merit more attention. 13 0 i-- 2.2.1 - Building materials 2.2.2 - Cement pipe 2.2.3 - Floor tile 2.2.4 - Insulation 2.2.5 - Pipe covering 2.2.6 - Brake lining 2.2.7 - Chlorine cell diaphragms 2.2.S - Paint etc. It would be most effective to consider for each use the amount, type, ultimate fate or, what does that use contribute to the various environments, and what are the future prospects and possible substitutes. Such information would be useful to the decision makers dealing with waste disposal of asbestos. Perhaps new reference Xo. 3a will be helpful in several ways. To continue, 2.3 Properties. It would seem desirable to reorganize this section to deal with the various asbestos types separately and organize the discussion of each separately. For example: 2.3.1 2.3.1.1 2.3.1.2 2.3.1.3 Serpentine: Chrysotile Composition Physical properties Chemical properties etc. 2.3.2 - Amphiboles -- general description and discussion 2.3.2.1 - Ortho-amphlboles:anthophyllite 2.3.2.1.1 - Composition 2.3.2.1.2 - Physical properties 2.3.2.1.3 - Chemical properties etc. 2.3.2.2 - Cl ino- amphiboles *tTemolite- actinolite, cummingtonite-grunerite(amesite),crocidolite. 2.3.2.2.1 - Tremolite-actinolite 2.3.2.2.1.1 - etc. 2.3.2.2.2 - Cunjningtonite-grunerite (amosite). Amosite is a conmonly used acronym (nonmineral) for Asbestos Mines of South Africa). A statement of the sort. . "Because of Its common use in the literature it is retained, even though it is not a proper mineral term." 14 Its mineral equivalence to cummingtonite-gruneritc series should be noted. Until approximately 10 years ago amosite was mis-identified as anthophyllite due to small extinction angle. 2.3.2.2.2.1 - etc. Perhaps the following points will be useful for expanding the above section: Chrysotile has a fairly constant stoichiometry. Arches sheets (misfit at the atomic level) give a TOt tubular appearance and high porosity, low apparent density, etc. Sometimes the tubular vacancy is filled with other material. Many articles on this appear in the American Mineralogist.. Also see Rickards, 1973. . Ortho-amphiboles: .Anthophyllite: Polymorph of cummingtonite. Variable Fe, Mg, and Al substitutes for Si. Often Mg is greater in -anthophyllite. than in cumningtonite, although . . there is overlap. Clino-amphiboles: Tremolite-actir.olite: Continuous series between tremolite and ferroactinolite; e.g. continuity of optical properties, cell parameters, stoichiometry. Cunmingtonite-grunerite: Variable Fe, Mg, with minor Al, Ca substitution. Due to lack of big cations (Ca, Na), a and b cell dimensions are smaller than other clino-amphiboles. Crocidolite: Variable substitution Mg for Fe, Ca for N'a (Al for Si). Cleavage is strongly developed parallel to the c axis, and along with crystal growth determines the acicular (fibrous nature) of the anqphibole asbestos. Contrasts with serpentine asbestos. 15 01-0205605 Occurrences are generally in retrograde netamorphic deposits. Because of the multiple defects and substitutions in the amphiboles, it is often difficult to specifically identify eacS\ fibre at the specific mineral level. (See Fear.an and File for example on well documented occurrences). All of the above named minerals occur as fibrous and nor.fibrous varieties. A table summarizing their properties, typical occurrences, variable composition, and optical properties vouid be useful, also a comment an kinds of occurrences in nat'ire. This section needs to be expanded and brought up-to-date so as to deal with many of the intricacies of technique required to obtain reliable results. Much progress has been made in this area recently and the new techniques need to be brought into focus. In order to be helpful a nianber of new references are listed at the end of this commentary. For example, 3a treats new analytical methodology and analyzes the procedural problems; 3b gives new data with respect to X-ray diffraction methods; 9a covers a wide variety of topics in an up-to-date manner. Since this is an HPA report it should have access to work done for Dr. C. Anderson of EPA in Athens, GA, by Battelle (Contract No. 68-03-2199), which tells how to separate chrysotile from diatomaceous earth using a tv*> phase, aqueous-benzene system. It also appears that the authors may be confused about energy dispersive spectrometry (EOS)* It can be used effectively on both TEM and SE4 type instruments. The listing of equipment on pages IS and 16 seems useless in view of the above. As a suggestion, perhaps the following outline may be useful to expand and update this section. ANALYTICAL METHODS A. Measurements that are commonly desired -Concentrations-mass fibre count sizing + L/W 'Mineral ID Elemental composition Surface--charge, morphology, degradation, trace substances B. Methods Match methods to A and differentiate in a classification bulk analysis from fibre analysis: BULK (mass) SRD, AA, IR etc FIBRE ANALYSIS (count) High Magnification Microscopy <2-3 ym (SEM), TEM, elemental analysis etc. Optical >2-3 urn Phase contrast petrographic microscope etc. C. Techniques Follow the classification in B. MB on fibre counts of large particles where optical mike can be used, optical properties are quite definitive (Deer, et al, 1963 and a paper by McCrone). On small particles TBf + energy dispersive elemental analysis + SAEDA are more definitive (Beaman and File, and others) 17 01-020? 0. Sample handling air/water a. Concentration (if required) filtration, ultracentrifuge b. Grid transfer: solvent refluxing, ultrasonification, etc. c. Counting reporting fibre ID procedures d. Errors: large in TEM: contamination "everywhere" filter paper, separator paper, water solvents. ` Asbestos fibres are ubiquitous even in a modem laboratory. Also all methods using TEM require a large concentration step of 105 to 106 typically in the analysis. The extreme difficulty of resolving very small particles (< .x urn) into mineralogy and the problem of resolving amphiboles from other fibrous minerals and amongst amphiboles in the general environment should be emphasized. 2.4.2 Because of the many problems intrinsic in the analytical procedures, it is suggested that whatever methods are selected foT recognition be tested in various laboratories in a "roundrobin" type of exercise in order to determine the confidence limits within laboratories and between laboratories. Such data seem essential to a realistic approach to solving real-life problems. Perhaps a scheme can be developed. 2.4.3 Contaminants: Methodology for this needs to be developed and tested; i.e. 2.S.2 above. 2.S References (old 2.5) Additional references need to be added if the)' are cited in the text as recomnended. 18 Ol .07. 0- o'- 3 3a Beaman, 0, R., F. P. Boer, C. T. Lichy, R. J. Moolenaa.r, F. iv. Spillers, 0. C. Taylor, and 0.-M. Young. Asbestos in Water in the Chlor-Alkali Industr>*. (Presented at Eighteenth Chlorine Plant Managers Seninar, New Orleans, Feb. 5, 1973) Proc. Plant Managers Seminar - Available from Chlorine Institute, Inc. 342 Madison Ave. New York, NY 10017 (Presented to EPA and other Government Agencies on Feb. 3, 1975). 5b Beaman, D. R. and D. M. File. The Quantitative Determination of Asbestos Fiber Concentrations Anal. Chem. 48: Xo. 1, 101-110, 1976. 3c Birks, L. S., M. Fatami, J. V. Gilfrich, and E. T. Johnson. Xaval Research Laboratory, , Report Xo. 7874, Feb. 2S, 1975. ' 3d Choi,.-.I. and R. IV. Smith. Kinetic Study of .Dissolution of Asbestos Fibers in Water. . J. Colloid Interface Science 40, 253-62, 1972. 5a Deer, IV. A., R. A. Howie and J. Tussman. Rock . Forming. Minerals, Vol. 2 and Vol 3. John Wiley and Sons, Publ. 1963. 9a Kiamer, J. A., 0. Mudroch, and S. Tihor. Asbestos in the Environment. McMaster University (LSS-4KL) for the International Joint Commission Great Lakes Research Advisory Board, May 1, 1974. Cited in February 197S Report to the I.J.C. from the Great Lakes Res. Adv. Bd. entitled "Asbestos in the Great Lakes Basin with emphasis on Lake Superior." 19 13a Parks, G. Aqueous Surface Chemistry of Oxides and Complex Oxide Minerals. Am. Chen. Soc. Advances in Chemistry Series, N'o. 67:121-160, 1967. ira Rickards, A. f,. Estimation of Subnicrogram Quantities of Chrysotile Asbestos by Electron, Microscopy. Anal. Chem. 45:309-811, 1973. 17b Speil, S. and J. P. Leineweber. Asbestos Minerals In Modem Technology. Environ. Res. 2:166-203, 1969. 25 0 2 -n r>, - -J 6 SUCTION 5.0 -- Biologic il Aspects of Asbestos in Plants and .Microorganisms It is -recognized that there is little information available relative to the effects of asbestos upon plants and micro organisms. There is need for data on the uptake of asbestos in plants, particularly edible plants, and animals grown on or in asbestos containing substrates. Page 20, para 2, line 2. The conversion of inorganics to sugars needs more explanation. SECTION 4.-0 -- Biological Aspects of Asbestos in Animals Page 22. .Any indication of the intensity of the exposure (concentration and time) of the animals would be helpful. Page 22,-Para. 2. It is doubtful that intra tracheal injection permits greater control over dose than inhalation. Statement is correct for other types of injection. Para 3, line 1. What is the antecedent of "this?" Suggest reconstructing sentence. Line 2. Extrapolation from animals to humans is difficult for many reasons. Line 3. The amount of asbestos dust (mass/mass) usually. . . . Another important reason is encountered when the route of administration employed in animals is an abnormal one, that is, not seen in man. Page 23, line 10-11. Trace metal content and polycyclic hydrocarbons are no longer considered involved. Page 23, line 4-6. Suggest deletion of clause beginning with ". . but. . ., or document." Do not believe statement as made is true. Page 23, line 9-10. 400 hours is wrong. Suggest . . . or as great as a lifetime. Line 10-12. Restate to clarify. Interpretation of results is difficult. . . . Page 24, line 2. Studies presented here are examples of attempts. Page 26. Para. 2, line 2-3. Delete "and gastrointestinal cancers" or give reference. Page 26, para. 2, line 2. . . .have been reported to penetrate. . . . Line 7. after (1974). Suggest inserting: "In a Letter to the Editor, Gross (1974) pointed to anatomic barriers and the extensive experience of pathologists everywhere that would appear to contradict the results of the experiences of Volksheiater and Schreiber." Page 26, line 10. "... stomach of rats have been reported in the blood. . Page 27, line 4. After "contamination" add, because asbestos fibers were found in control animals. Line 4-6. Begininning with, "Some cancers. . suggest deletion or rephrasing so as not to suggest a difference from controls. :.3.1.3 Page 28, line 12-14. U'rong. Suggest, 'The - distribution of radio nucleotides, consistent with that which would be expected from chrysotilo, was found in the heart. ..." 1.3.1.3.4, Page 29, line 13. "absorbed" is wrong word. Suggest "distributed." ; Para.- 2-.. Add .the-following: The artifacts consist of a needle tract in the stomach wall which remained open and could have allowed the escape of asbestos fibers into the abdominal cavity and caused the contamination of the laparotomy incision. The fibers could have entered the open cut or tom vessels in the needle tract of the gastric wall and in the laparotomy incision. 4.4 Page 30, para 2, line 3-5. "... fibrosis is a - relatively fast response to asbestos exposure; and tumor production may take a lifetime." 4.4.1.1 - Page 30, para. 2,. line 2. Types I and II are the - preferred designation of alveolar epithelial cells. 4.4.1.2 Page 31, para. 5, line 1-3. ". . .proposed the generic term, ferrunginous body, since structures similar to asbestos bodies were formed after exposure. . Line 4. . . iniection of fibers of . . ." Line 6-8. Delete last sentence because it is inappropriate. 4.4.1.3 Page 31, line 2. More recent references are available, so suggest updating. Page 32, line 12-13. Miller reference is inappropriate. How small is small? Dimensions should be given. 23 4.4.1.3.1 4.4.1.3.2 4.4.1.3.3 Page 32, para. 3, line 3. However, the Just produced by Holt also contained long fibers, ^he effect of which cannot be ignored. hint' 9. How fine is very fine? Dimensions should be given. Page 33, line 4-7. Incorrect and incor^)lete. Suggest, ", . . and hamsters by inhalation for 50 hours/week for 17 months at an average concentra tion of $6 ng/m3. It was also injected intra tracheal ly in one to six doses of 3.S mg each into rats. Last line, ", . . and a progressive cellular consolidation of the lung tissue was noted.71 Page 34, para 4, line 3. Should not Ferringer be Firminger? Page 34, line 1. Change most to all asbestos fiber. . . . Page 35, line 12. Incomplete. Suggest insertion after ". . . air passages. . of tr:e following; This type of reaction has been reported to be an artifact attributable to the intratracheal injection (Gross, et al, 1970.) Line IS. Suggest changing crystalline structure to morphology Line 16. Add the following to the end of the paragraph: Klosterkotter injected chrysotile and cracidolite fibers less than 5um long intratracheally and intraabdominally into rats and noted no fihrcgenic response whereas longer fibers were fibrogenic. 24 0/ *"0 70 * Timbrcll and Skidnore also observed that short, fibers (90% were Less than. 4um long) injected intratracheally were less fibrogenic than longer fibers (45% were longer than 4um). . Webster found that exposure of monkeys to crocidolite fibers less than Sun long resulted only in a pulmonary .macrophage response. There was no fibrosis. Maroudas, et al concluded that fibers shorter than ZOum "induce neither growth in vitro nor mesotheliomas in vivo/* Smith, et al noted that chrysotile fibers less than lun long injected intrapleurally into hamsters caused no cancer, whereas similar injections with longer fibers did cause cancers. Wagner et al stated that only fibers less than . 0.5uni thick and more than 10um long were significant. By "significant" he considered the ability of the fibers to induce cancer production. ; Para. 3. Miller reference is inappropriate. * This paragraph is best deleted in view of the added citations. 4.4.1.3.4 . Page 35, line 5. Change fibrous-glass to fiberglass. 4.4.2.1 Page 36, line 2. Change silica to quartz. Line 3. Change reference to (Wagner et al 1975) Para . 5, line 4. Change fibrous glass to fiberglass. Page 38, para. 4 5. It is important that the doses administered be indicated in the citations. 01-0205613 4.4.2;2 4.4.3 4.5 Page 39, para. 3. .After end add reference. . . and (Gross and Harley, 1973). Para 5. At the end of the paragraph add the following statement: On the other hand, no increased tumor production was observed by Pott, et al (1972) following the intra-abdominal injection of chrysotile and added BP into rats above that noted following the injection of chrysotile alone. Page 43, para 3, line 5. Would it not be better to say vinylpyridine-V-oxide? Page 44, No, 1. Kriedrichs should be Friedrichs. Xo. 7 Brian should be Brain. Page 46, No. 23. Sriedrichs should be. Friedrichs. Ref. 26a. Gross, P., et al. The pulmonary response to fibrous dusts of diverse compositions. Am. Indust. Hyg. J. 31:125-132, 1970. Ref. 26b. Gross, P. and R. A. Harley. Asbestos induced intrathoracic tissue reaction. Arch. Path, 96:245-250, 1973. Ref. 26c. Gross, P. Letter to the Editor. Arch. Environ. Health 29:298, 1974. Ref. 40a. Klosterkotter, W. Experiroentelle Ontersuchungen uber die Bedeutung der Faserlange fur die Asbestfibrose soviet uber die Beeinflussung der Fibrose durch Polyvinylpyridin-N-Gxid* in Biologische Wirkungen des Asbestes: Internationale Konferenz, 1968, Dresden, Berlin, Deutsches Zentralinstitut fur Arbeitsmedizin, pp. 47-52. ; .* I ' : . 26 oi Ref. 44a. Maroudas, C., et al. Fibroblast anchorage in carcinogenesis by fibres. Lancet 1:307-809, 1975. Ref. 65a. Smith, W. ., et al. Biologic differences in response to long and sHort asbestos fibers. ;\n. Indust. iiyg. Assoc. J. 33:A162, 1972. Ref. 72a. Timbrel!, V. and Skidmore, J.W. Significance of-fibre length in experimental asbestosis. Internationale Konferenz, 1968, Dresden, Berlin, Deutsches Zentralinstitut fur Arbeitsmedizin. pp. 52-56. Ref. 7Sa. Wagner, J.C0 et al. Mesotheliomata in rats after inoculation with aiFestos and other materials. Brit. J. Cancer 23:173-185, 1973. ' Ref. 79a. Webster I. The pathogenesis of asbestosis Ini Pneumoconiosis: Proceedings of the International , Conference, (Johannesburg, 1969) Shapiro, H. A. (Ed.) Cape Town, Oxford University Press, 1970, pp 117-119* 27 11 -C23S SECTION' 3.J -- Physiological and Pathological Aspects of Asbestos in Humans Throughout, this section, care must be given to avoid the use of nonspecific terms. For example, the term cancer is used quite often and refers to different types at cifferent times. The spcific type should be used instead of the word cancer. Such words as ' "large," "small," "frequent," "rare" should be avoided and replaced by the appropriate numerical data. Instead of "asbestos" the specific type should be listed, or if unknown,,it should be listed as such. It must be remembered that most individuals reading the document will not. read the references quoted, thus'the actual numerical data as to size,, type of exposure, amount, duration, etc., should appear in the document. Whenever possible, original articles should be quoted rather than "Anonymous," or other governmental documents. Somewhere in this section, perhaps in 5.1, a table showing the number of individuals potentially exposed and at risk should be included. This is important to understand the extent of the various occupational exposures to asbestos as well as their potential for environmental contamination. * More tables or figures sunnarizing concepts should be included.(General Comment *4) .1 This section needs to be reorganized and generaliza tions and inaccuracies removed. Difficulty arises from the treating of asbestosis and asbestos associated malignancies in the same sentences and paragraph. Their mechanisms are different and should be separated in the sumnary. 29 0 1 0 2Of - The definition of asbesosis should be separated into "tissue pathology" and other diagnostic criteria. A tissue diagnosis of a^bestosis does not include "unpaired lung function." Current diagnostic (clinical) criteria should be mentioned, i.e. 1. known asbestos exposure (occupational); 2. radiologic evidence of parenchymal and/or pleural fibrosis; 3. absence of other diseases known to cause pulmonary fibrosis. The pathologist's problems are different from those of the clinician. Page 52, para 1, line 7: Delete impaired lung function. Lines 8 to 10: The "50$ of persons who develop asbestosis also develop lung cancer" is no longer an accurate statement. Suggest deletion of sentence, "It is estimated . . .lung cancer." Lines 15 to-15: 30$ is too definite. Suggest, "Epidemiological studies suggest that a high percent of the ..." Line 16: Care must be taken in interpreting epidemiologic data. Such studies make associations, but cannot produce cause-effect information, i.e. "attributed to" should read "associated with." Lines 18 to 23: Suggest rephrasing. It is not clear what the term "dose-response" means in the context of the statements made. More specificity is needed. All epidemiologic and other studies show a definite dose-response relationship, especially for asbestos related lung fibrosis. What is non existent is numerical (in terms of today's current fibers/mm3 definition) data showing a "highest level of exposure" at which no pathologic response is seen, the issue of "TLV" must be treated separately from the demonstration of crude doseresponse relationships. 30 f- teost,{<f 1 oi .1.1 5.2.2 5.2.2.2 Para 2, lines 4 and 5: An example of a general consent type error is in the l3St sentence of this section. The term ''cancer1' is used to mean lung cancer. Suggest rewording as: Cigarette smoking acts synergistically with asbestos in causing lung cancer. Delete ''and fibrosis." Page 53, para 1, line IS: Delete "efficiently." S.2.2.1 might be better called "Cellular Transport" and be placed in section 5.2.3. The rest of the subsection should be expanded to include descriptions of the process of fibrosis which is more important than the development of asbestos bodies and should be given equal space. It would also be useful to include a discussion of the actual amounts (weight) of asbestos found in the lungs of urban dwellers as compared to occupationally exposed individuals. The location of the fibers in the lungs should be mentioned (lower lobes). Mention should be made on the natural history of how fibers are handled by the lung. Page 53: Suggest heading be relabeled "Cellular Response-Asbestos Body Formation." It would be useful to state in 5.2.2.3 the relative number of uncoated fibers found for every coated fiber seen. For all the studies quoted, fiber type, actual fiber size, and identification Methods used should be stated. See 5.0, p. 29, par. 1. 31 o i- Q2a Page 54, para 2: This paragraph seems inordinately detailed in view of the lack of consideration of mechanisms of fibrosis formation. Perhaps this subject can be dealt with. Para 5, line 2:.' Suggest replacing "in" with together with. Page 55, para 2, lines 4 and 5: Suggest deletion of "probably . . .interactions." Avoid speculation. The implied generalization to all asbestos-exposed individuals from data on mesothelioma cases is not properly supported. Para 1, line 13: Once again the term "fiber" is used when a less ambiguous term is required. Page 55, para 1, line 17: After 1973) add the remainder being of unknown composition. " Line 19: What abnormalities? Para 2, line 4: Specify type of fiber. Page 55, para 1, line 8: change "physiological" to pathological. The last sentence in this section on page 59 concerning a possible link between pleural plaques and mesotheliom (mesothelioma should read pleural mesothelioma) is really too speculative to include in a document such as this. Suggest deletion. The occupation and type of exposure should be mentioned as complicating factors may obscure the results of this paper. The limited scope of this study as well as its singular findings should be stressed. 32 0i~03OS6Lj 1 3.3.1 ' * 5.3.1.1 The use of the Otte reference is confusing. Once again the difference between a tissue pathology diagnosis and its difficulties are greatly different from a clinical diagnosis perspective. Otte is speaking from a tissue pathologist's view point. Clinical criteria should be mentioned. The same comments hold for the outdated Gough reference. ihe Gough statements are outdated because of the electron microscope. Fibers (asbestos-chrysotile) can be found in all lungs. Page 57, line 1: Insert after . . .''fibrosis" identifiable by X-ray, .... tine 3: Should reference be 1970b instead of 1970a? Once again care must be taken to separate "tissue pathology" from clinical diagnostic methods (noninvasive). The term interstitial lung disease is wrong as Solomon was speaking of radiologic evidence of interstitial lung disease. The Mackenzie reference is back to tissue microscopic pathology. It would be helpful to include in this section the inter-relationship of intensity of exposure, duration of exposure, and time elapsed since first exposure. It should be made clear that the 3 to 6 year figure for development of radiologic inter stitial fibrosis is rare and occurs under extreme conditions of the previously mentioned factors. 33 5.5.1.1 A discussion of the ILO U/C Pneumoconiosis Classifi cation system which is now in wide use would'be appropriate. There should be a separate discussion of pleural plaques and diffuse pleural fibrosis. There is no mention of pleural fibrosis as a separate entity. Line 1: Commonly? How frequently do these changes occur? Page S8, para 1, lines 16 to 20: Too positive a statement. Page 1, lines 9 to 11, para 2: Is there a contradiction here? Para 4: Again type of asbestos needs to be specified. Page 66, line 3: What mine workers exposed to what? Line 13: What type of asbestos? Page 66, paragraph misquotes the Gross et al. paper. Para 3, line 4: Delete "low". Lines 18 to 20: Did Murphy say this? If so, quote him. If not, indicate opinion of whom? Lines 22 to 24: References inadequate. 34 01-020 56 2 5*3.1.3 Page 66-67, para. 2: includes editorialising which is inappropriate in this document. This section needs to include a brief discussion on the changing methods of quantifying asbestos e:cposures and the impossibility of accurately interpreting past "particle counts" in terms of today's use of fibers/cc with individual fiber type identified. Perhaps an historical development of changing methodologies would provide the perspective heeded to understand the papers mentioned at the end of the section. A table showing the fiber count range in each of the old methods might also be helpful. With the above in mind, special care must be taken to be specific as to methods each paper used. The most confusing is on page 67, paragraph *3, the fil-Sewefy work. IXist determination (weight) is construed to mean "asbestos dust" and then weight is changed to "counts." This paper needs to be carefully reviewed to see whether asbestos was actually measure or just a mixed dust. Terminology must be tightened up in this whole section. Page 67, para 3: The use of one case report should be replaced with studies of larger numbers. Page 68, para 1: In reality, the latency period is not between first exposure and the development of the lesion but between the exposure and the detection by X-ray. Para 3: Counting is of asbestos bodies, not asbestos or fibers. Page 68, para 4: Probably belongs in another subsection such as 5.3.2 This section could more accurately be titled ' 'Pulmonary Pathophysiology.1' 35 01-0205A2U Page 60, para. 2. The Hunt statement is misleading. .Ysbestos-is and related pulmonary defects are progressive even after ceasing exposure. The length of time the group was followed should be stated if the point is to be used at all. It should be stated that cases of asbestosis having "rheumatoid-asbestosis lung" are few, but that individuals having both diseases require special observation because of their potentially rapidly' progressive disease. Suggest inclusion of last paragraph on page 68 (Badr and Hl-Sewefy study) in this section. Mention should be made of asbestos warts. Qualifying statements should be placed on this section. The interrelationship between heart . disease as a secondary effect of chronic lung' disease should be mentioned. It should not be construed that asbestos has a direct effect onvthe heart unless more evidence is mentioned. T* ' This section needs to be updated. Suggest more recent papers by Morgan and also by Schnitzer. ' Page 62: The introductory paragraph is inadequate. The comments made under subsection 5.1 are also relevant to this subsection. Reference is not sufficiently specific. Care must also be taken to state the specific environment being discussed; i.e. occupational or general? Once again all studies mentioned should have fiber type and characteristic mentioned. Page 63, line 6: What is meant by "environmental," occupational ot general? 5.5.-t.1.2.1 This section nee-J> norc depth to include the relationship to various asbestos types. Frequency of occurrence should be mentioned as well as what is meant by "increasing frequency." 5.5.4.1.2.1 Fara 2: Inadequate and inaccurate discussion. Invasion of lung parenchyma is rare. If pathology is to be discussed, it should be dealt with in more depth. 5.5.4.1.2.2 This section should include the relative frequency of peritoneal mesothelioma in relation to pleural mesothelioma. a. and b. are not "common signs and symptoms" of peritoneal mesothelioma. This is an incorrect interpretation of the reference. They are signs of asbestosis, but are not a prerequisite for mesothelioma. This section as well as the two previous ones should include location of tumors (for lung cancer section) and metastatic potential. 5.5.4.1.3 Line 13: Suggest inserting has been interpreted as before "indicating." The appropriateness of paragraph 2, page 72 is questioned. It is suggested that it be rewritten to reflect views in contradiction to those of Merliss, 1971. Suggest reviewing papers by Haemtel et al (new ref. no. 45a) which expresses contrary views; a paper by Smith (new ref. no. 106a) which points out that Chile, not Japan, has the highest GI cancer rate and offers some possible reasons; and a paper by McDonald and Urolf (new ref. no. 72a) cited in the Smith paper referred to above. 58 0 1 -- 0 f7cU,nve-O It nust.be stated more clearly in paragraphs 1 and 3 that information on penetration of asbestos fibers into human bov/el is still speculative and such speculation should be separated from the more substantial epidemiologic incidence data. It must be stressed that the effects of asbestos ingestion are as yet unknown. The step from incidence to mechanism is not warranted. Para 3, line 9: Suggest inserting after about 20 years after "So far," The last sentence in paragraph 1 is false. There are several exceptions. Suggest use of recent Selikoff paper to support this point. Para 2, lines l and 2: There are better references; for example, Nbs. 97, 100, 104a,.104b. Lines 7 to 9: Suggest deletion or refer to references 104a and 104b. Para 3: Use of.NIOSH reports is inappropriate.. Use references of original papers cited therein. The list of mechanisms is outdated and point a and b have been proven false and are of historical interest only, and should be treated as such. Page 74: c. not a mechanism. The use of Anonymous sources should be avoided. Paragraphs 1, 2, and 3 on Page 74 do not deal with mechanisms and should be placed in the appropriate subsections, perhaps 5.3.4.1.2. Para 4 and 5: Are no longer at issue. They are of historical interest only. The Harries, et al reference (NoI 46) is thought to refe to nonmalignant asbestotic disease and therefore should not be included in this section on. carcinogenesis. If this is the case it should be positioned elsewhere. Pages 75 and 76, para. 1: needs a comment on the significance of-the excess mortality found. Once again, original articles should be used as references rather than governmental documents. Page 76 and 30: McDonald references Xo. 71 and .'Co. 72 should be discussed here. Radiologic findings or neighborhood and household asbestos exposure should be in a separate paragraph from identification of fibers in lungs. There are several other references which should be included here. They are such papers as Anderson (3a), Hroraek (Sla) Zolov (137) and Udidjian (128). The Newhouse reference is wrong and should be Kiviluoto (55) instead. Newhouse only studied London populations. Page 81, Para. 1: should broaden the term "occupatiu; exposed" to having had occupationally-related exposure. This will cover the disease found among family members and neighborhood people. Page 86, ref. 34, line 5: Change Long to Lung. References: The following should be added and discussed. Page 82, ref. 3a Anderson, H.A., etal., .Household-Contact Asbestos Neoplastic Risk, N.Y. Acad. Sci., No. 502. In Press. * Page 86, new ref. 51a, Hromek, J., The mass incidence of characteristic pleural changes in citizens of the western part of the former Jihlava region. Rozhledy Tuberk, 22R4GS, 1962. Page 89, ref. 83: Such a general reference is inappropriate In a document such as this. New ref. 84a: Newhouse, M.L. and Thompson !!., Mesothelioma of pleura and peritoneum following exposure to asbestos in the London area, Brit. J. Ind. Nfed., 22:261-269, 1965. Ref. 85: Title of paper needs to be added. Page 91, new ref. 104a: Selikoff, I.J., Epidemiology of Gastrointestinal Cancer, Envir. Health Perspeccives, 9} 299- 305, 1974.. New ref. 104b* Selikoff, I.J., Asbestos Disease in the U.S. 1918-1975, Proc. Conf. on Asbestos Disease, Rouen, France. Oct. 27, 1975 i SiiCiTON 6.0 -- l.nviroumcncal Distribution and Processes A fair amount of perspective is evident in the treatment of this Section. However, there are some contradictions and areas where additional information would be helpful. In several of the following paragraphs there is a fixing of units to designate concentrations. It is suggested that in each case units, preferably metric units be used, but do not confuse mass with counts of fibers. Some nay be off by a thousandfold. 6.1 Asbestos in various forms has been with us since the beginning; this point needs to be empahsized. It would seem most useful to include in this document a nap of the United States and Canada showing where major deposits of the various forms of asbestos occur naturally and the location of mines, processing plants^and users. - This, together with discussion of known movement would seem to be very useful in evaluating sources of community or general exposure. Page 95, para 4; It seems a bit unfair to imply that a safe or a hazardous level of asbestos has not been been established because of the inadequacies of analytical methodology. This is only one of the limiting factors. Much progress has been made in analytical technology, perhaps more than in the biological areas. See Section 2.0. 6.2.1.2 Sane very useful information has been published relative to the presence of asbestos in the drinking water in The Netherlands (Elzenga et al, 1974). The information is very pertinent to this report and should be included. (New Ref. No. 10a) 43 al-o*sfc30 * 0.2.i.5 6.2.2 6.2.2.2 6:2.3 6.3 Perhaps information presented by Zclov, et ai, 1970 would be useful at end of this section. ]Tew Ref. Mo. 23). Mobility - in general other data (high concentration around cities, distance of transport from mining and manufacturing sites) could be added. Settling data in Lake Superior is one person's speculation. Delete. Setter use Baumgartner and Cook's sediment trap data of distance from source to show how far away cummingtonite was found. The statements, as made, are speculation and have been challenged in court. Perhaps some data could be given relating the number of fibers and masses found in the environment normally and in areas surrounding occupational settings. Is it possible to develop a table showing relative concentrations in air, water, and soil? It is highly undesirable to use anonymous references. They are not appropriate for this document. Suggest including following references with appropriate discussion* New Ref. 10a. Elzenga, P.B. Meyer, and . J. Stunphius. A Preliminary Investigation into the Appearance of Asbestos in Dutch Drinking Water (Orienterend onderzoek naar het voorkumen van asbest in het Nederlandse drinkwater) (English translation by Leo Kanner Associates, Redwood City, CA. for NERC- Library, EPA. Overdruk uit H?0 Zevenda Jaargang 19: 406-410, September 12, 1974, New Ref. 25. Zolov, C., T. Bourilkov, and L. Babadjov. Pleural asbestosis in agricultural workers. Environ. Res. 3:443-451, 1970. 44 SLCTIOX 7.0 Environmental Interactions and Their Consequences The relative significance of the sources indicated should be discussed. Interpretation of the last 2 lines on fage 102 may be questioned. More explicitnc.^ is required, 'fet is its significance as far as land use is concerned? '\hat is the significance of recycling? Suggest inclusion of a statement emphasizing need for consideration of research in this area. Page 104, para. 2: There are several research projects underway which are supposed to shed light on the possible effects of ingesting asbestos and another is planned. Refer to section 4.3.1.2.1. Para. 5: This is an overstatement. There are no data from which one can deduct that ingestion is a signifi cant health hazard. It may be, but the data available do not so .indicate. See page 31, Section S.3.6.2.2, para. 2. Suggest deletion of paragraph. 45 APPENDIX A UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. O.C 20460 MAY 13 1975 OFFICE OF RESEARCH ANO DEVELOPMENT Or. Emil M* Mrak, Chairman Executive Committee Science Advisory Board University House University of California Davis, California 95616 Dear Emil: .. .For the past several years, the Congress has been considering.the passage of legislation to address the problem of protection of the public ,, health and welfare against any.dangers, which might be associated with-the disposal, of hazardous substances, to the soil. In-anticipation^of-the passage of such legislation in the fairly near*-term future, EPA*s Office of;Research and.Development is tnthe process erf-gathering-information * c.ij whicJtcould serve-as a basis font-standard setting, in- these situations.- information is being organized into a set of reports om the effects - and transport of* critical pollutants (asbestos,-mercury, etev)-which are and components of materials comnonly disposed to the soil. ss Before we finalize these reports, I feel that it would be useful to seek, through the Science Advisatyr Board, the-views of the scientific ^community as to their content. Specifically,-1 would like yoar-conments -";r^ as to the appropriateness and-.completeness of the information presented ^ in the reports as well as their-adequacy to serve as a basis for standards :f1 , f under the forthcoming legislation. The attached "perspectives'- document, ~ prepared by the;Officft-of Saltd.-Waste Management Programs, should-be * helpful to you in establishing the context in which this information would be used by the Agency. The documents will be furnished to the Science Advisory Board Staff after internal review by the Office of Research and Development. I would hope that you would find a two month time period adequate for the review of these documents. Attachment Z\ Wilson K. Talley Assistant Administrator for Research and Development 47 UNtTED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF SOLID WASTE MANAGEMENT PROGRAMS . subject: sKWRL Criteria Documents FROM: John P. Lehman, Director Hazardous.Waste Management Division (AW-565) Dr. Thomas Bath, Executive Director TO: Science Advisory Board In response to your request for some insight into the user's perspective on these criteria documents, may T first comment that we appreciate the SAB taking the occasion to review them prior to our receipt. In this way, the Agency benefits both from the fresh viewpoint provided by an extramural review as well as a level of scientific quality control beyond that already planned. Based on our legislative mandate, these documents will be used by the Office of Solid Waste Management Programs in.developing recommended procedures, guidelines, and, ultimately, standards governing the transport, storage, treatment, and disposal of hazardous industrial wastes. - As you know, the focus -of this program is on the non * radioactive portion of the approximately 260 million dry tons of industrial residuals which contain toxic chemicals, * acids, caustics, explosives, carcinogens, etc. The possible direct effects of these wastes as well-as .of the processes applied to them on air, water (both surface and sub-surface), land, as well as the public health are of concern. Specifically, we anticipate that the documents will; (1) Provide an up-to-date compendium of information on toxicitxes/effects associated with exposures to specific substances contained in the air, water, and land media (2) Provide insight into the effective soil and plant indicators for detecting the presence of substances $ EPA Form 1330.4 (R*v. 4.73) 48 0 ^003543^ 2 ($} -Provide general data on the complexity, cost, and reliability of state-of-the-- - art analytical procedures for determining . . . the presence of substances (4) Provide information on predictable reaction products of .the substances to aid in the . ...design of criteria relating to mixing of wastes - (5) . . - Permit assessment of the need for additional air emission standards due -to the operational characteristics of hazardous waste treatment sites cc:; Mr. H. Lanier Hickman, Jr Mr. William Sanjour Dr. Robert Stenburg (AW-562) (AW-565) 49 .APPENDIX B UNITED STATES ENVIRONMENTAL PROTECTION AGENCY . . WASHINGTON. D C. 20460 May 20, 197S SUBJECT: Charge to the Ad Hoc Study Croup to Review the Asbestos Document ^ Or">C Of fw? AOM.MSTSATOft FROM: Chairman Hazardous Materials Advisory Committee (A-101) TO: Members of the Ad Hoc Study Group to Review the Asbestos Document For the past several years, the Congress has been considering the passage of legislation to address the problem of protection of the ' public health and welfare against any dangers which might be associated with the disposal of hazardous substances to the soil. In anticipation of the passage of such legislation, EPA's Office of Research and Develop ment is in the process of gathering information which could serve as a basis for standard setting in these situations. This information is being organized into a set of reports on the effects and transport of critical pollutants including (asbestos and mercury), that are components of materials commonly disposed to the soil. ' ; Before these reports are finalized the Agency is seeking, through the Science Advisory Board, the views of the scientific community as to the content of these reports. They will have had internal review by the Office of Research and Development, prior to their coming to the Science Advisory Board. The Executive Committee of the Board has decided to refer these requests to the Hazardous Materials Advisory Coninittee. It is anticipated that the documents will: . o Provide an up-to-date compendium of information, on toxicities/effects associated with exposures to specific substances contained in the air, water, and land media. o Provide insight into the effective soil and plant indicators for detecting the presence of substances. o Provide general data on the complexity, cost, and reliability of state-of-the-art analytical procedures for determining the presence of substances. o Provide information on predictable reaction products of the substances to aid in the design of criteria rzlating to mixing of wastes. 51 o Permit assessment of the need for additional air emission standards because of the operational characteristics of hazardous waste treatment sites. - The Hazardous Materials-Advisory Cornnittee acted at its last meeting to set up an ad hoc panel to report on the content of this document. . In order to provide the best possible criteria to the Agency I an asking the Ad Hoc Study Croup.to review the Asbestos Document, consider in detail tne information contained therein, and to provide the Committee with a report. This report should include the following: 1. The Study Group's best assessment of the appropriateness and completeness of the information presented. . 2. The study group's best assessment of the adequacy of this information to serve as a'basis for standards under an anticipated legislative mandate. The Study Group wi-11 be provided with the draft of "Review' of the Environmental Aspects of Asbestos," and a copy of "Guidelines and Background for the* External Review Panel." Representatives of"-the Office' of -Solid- Waste: Management Program and the Solid and Hazardous Waste Research Laboratory, Office; of Research and'f^evelopment will be available rfor * ' consultation. The Study Group report to the Hazardous Materials Advisory Committee is due December 15-, 1975. It is important that this date not he exceeded in-order for the asbestos document to be finalized and made available for its intended use. ' . . / . l' 1 ...' :-.j| .. id;: iii!. ntconn APPE'OIX C [V ` 'l A. { A- A . > i '1 .r > i,i. * ..i. i t; > ; .^v.- ,: I, jVCh jC>' 13; 19 I i'O.M Da. John A. Moore, CliHEnvi ro:i fitr.l Biology SV. Ji NJn:s Asbestos Projects Branch Bacberoend: The i.'JEHS asbestos project is the result of a specific appropriation from Congress to assess the of;acts o' oral ingestion of asbestos. The project reflects in o general way the protocol which was dcvs'lope:! by the'Subccr-iiittee on Asbestos, DI-JEW Conftittce to Coordinate Toxicology and Delated Programs. Ashes^to^j i .. ( . Several specific..types of asbestos are to be used. The-current thinking is to employ two forms of chrysotile, one which has a broad rang.** of fiber length and another one which represents a range of fibers less th?r. 20 microns in length. In addition to the two chrysotile sample:, two forms of axosite (again reflecting the broad rango of fiber length as well as a second settle which is restricted to the shorter fiber length). Tromotite and crocidolite will be evaluated. Great care is being given in the preparation and chsrectenraticn of the asbestos material to insure that the Scirpiea are truly representative of asbestos par $e. Animal Studies: The studios are to be done in either F-344 rats or hamsters. All materials will be tested in rats, whereas the two chrysotile samples and broad range amo si to v.'ill be tested in hamsters. The hamster represents the "second species;1' as such, it is being fed a material that represents a serpentine and an ampniboie type of asbestos. Each material is to be fed continuously in the diet at a Vf> level. The two short-range fiber sices vnll Us fed at something less than VL to tal'.e into consideration the correlation of mass/fiber relationships. ,/ S3 01-02C563P Lf^ 1 i, i /.:! ,:if. to f n'f , "-S !.!: ! 'i fr '.(if..! of U.- c'ni;.'1, \:U id) i <' i i o'- - !. 'i-ins fuii.'l,.'; so! id i -V.vi iniil doeUu 1 '/ v.inr \i;L fi M'.\' i i .0-:n*| Oi*I V . C 'V ' : U J'<.- by C'lYUO' - [ ; i t ! . v. ( i V. - 111] ( ' ` l < - i . i '; v. - '.if COH . oil or j.i ill Ll;C* li.r :.\)f. nr:-] cvrc i i 0 bo o'-.i 1 ie r! is to bo oit.bcr o`i:-,r.i:!;yl- r,r :.;!;! vr. -cme!. 1*0LI* or.: to Cc-S'SC U:;jjr" o T l be vw:\ rv '> n'."t c i n/: \ ri.c.i.. Mir.-r-H *re to receive <i complete gross av.l microscopic pathology Gvelu-i, ior:. The re.i studicr, aro to be pericr.-'d un^er contract by H<.rcltcn Pester eh l-boroi.orics, Vienne, Virginia; Dr. j|. 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CM III tu /.it --i; : NX M' ,t**> r-: iTi t-- r* tr' < * ~r* O 00 to Ul f.' ,,J t * r/ i* ; o v'' fc,` t i' l 5 .1 . ` cj iv: O OO u> ' O ~- 1.') i . r O oo UJ 7.1 o to f ^- O Oo U> 3: a .z Oo O ul to O') >' o o OJ ' lO ps. ri r-. i" O Oo U) SC a k to <>. O l> uol U) O') o o 04 to f-* CJ r V oi oi -j 'i 4O4 -- <; 0 o r **J 1. -1t O. J 4* . : <> r- tj U n> p* m ;U ..1 t-> t 4t 'IJ t v -`-rJ- Cn < : t. i/: < i Jl 4> > r.i ; o t O to </> 1-- X. OS .J < ho t-- a v: o o 04 O * O to 04 w * t r,j (* / o a c; r* 1 > r: Ti f-- !# 4/1 r o c. ,,1 >1 c: -* ''i 0 r". TJ r. O' :j O T* V) u 'U (M 4. 4J O t: rj ' i 41 -j CJ n '/> o > - r c p hj r.Nz fj S- j.i o c: r-- p14 r-- <.J 4J W i: <*; 4St to M i2 v cj tU O IO o. c Ol T- CJ <0 S- v c 0) p r- U C: rj tZ C. 4J A) fli iZ v 4>J O OJ tu r.i *o >. !-- o o "O 4-> c. X -- Ol 0) to <U s. r* 4J O <4 O. +j i * CJ V) 44 T3 O 0J 4-* c 44 CJ f-- O CJ o> " U f-- O.'K nci X 4> O L* o VI /-- VI r* fx o TO 44 20 *- > <4- ft) O > -oco1 V) r-- 4J tO 4> c; cm r* o o 3 i/> fl) OMo- Cf_) * *t# (. t- o w 4 rt 4.* 44 n. </i o c p* 4J Ot p* i. <u <0 *o U ") c s: M (. 17) oi fj Ci *.11 Cl vJ Vi i\J o 01 CJ c* V. . J) 4 4.) in c> o .3 1/1 44 n *.* *-> *c < T) to 4j) 4> 4> i*l 0 4/10 .1.) ' ) P * OJ tJ <1 1 . "J 't :. x c: , .> OJ 41 ; _ ; * * U <. */i o -- u 4> '/ /) 1) C r - r * ^A ^ ~EB L; hii APPENDIX D Documents Provided to the Ad Hoc Study Group .Anderson, Henry A., Rush Lilis, Susan M. Daum, Alf S. Fischbein, and Trying J. Selikoff. 1975. Household Contact Asbestos Neoplastic - Risk. New York Academy of Sciences Monograph 502. In Press. itanman, D. R. and D. M. File. 1976. The Quantitative Determination of Asbestos Fiber Concentration. .Anal. Chem. 48(1):101-110. Beaman, D. R., F. P. Boer, C. T. Lichv, R. J. Moolenaar, ?. TV. Spillers, 0. C. Taylor, and D. M. Young. 197$. Asbestos. in. Water in the Chlor*Aikali Industry'. Proc. Plant Managers Seminar. Chlorine Institute, Inc. New York. Flowers, Earl S. 1974. Relationship between Exposure to Asbestos, Collagen Formation, Ferruginous Bodies, and Carcinoma. Amer. Ind. - Hyg. Assoc. 35(11):724-729. Kramer, J. A., 0. Mudroch, and S. Tihor. Asbestos in the Environment. MeMaster University (LSS-4M1) for the International Joint Conmission Great Lakes Research Advisory Board. May 1, 1974. (56 pages plus references). Memorandum. November 13, 1975. Department of Health, Education, and Welfare, Public Health Service. Protocol NIEKS Asbestos Projects. Selikoff, Irving J. 1974. Epidemiology of Gastrointestinal Cancer. Environmental Health Perspectives. 9:299-305. Selikoff, Irving J. 1975. Asbestos Disease in the United States 1918-1975. Presentation at the Conference on Asbestos Disease, Rouen, France, October 27, 1975. Selikoff, Irving J. 1975. Environmental Cancer with Inorganic Micro particulate Air Pollution in Monograph Persons at High Risk of Cancer. Academic Press, U. S. Department of Labor, Occupational Safety and Health Administration. Occupational Exposure to Asbestos -- Notice of Proposed Rule Making. October 9, 1975. Federal Register. 40(197), Part 11:17652-17665. II. S. Environmental Protection Agency. National Emission Standards for Hazardous Pollutants -- Asbestos and Mercury. October 14, 1975. Federal Register. 40(199), Part V:48292-48311. U. S, Environmental Protection Agency, Solid and Hazardous Waste Research laboratory, Cincinnati. 1975. Guidelines and Background for the External Review Panel.