Document JrnxpV3JyJY8abm1OBdb4e6k2

msisutei.bm. vmtimgton. OC 2000b 202-872-1060 PLAINTIFF'S EXHIBIT H8K5K?"""5 February 21, 19.84 c TO: ORC Asbestos Task Force . From: Darrell K.* . Mattheis Subject: Report of February 9, 1984 Task Force Meeting and Announcment of the next Task Force Meeting Next Task Force Meet in g- The next meeting of the Asbestos Task Force wdJSK hfeCeir ttatrcbt 26, 1984 at ORC Offices in Washington D.C. The meeting will begin at 1:00 pra and last to approximately 5:00 p..m.~ Purpose of the February 9> 1984 Meeting The Task Force met to decide what Mind of a response should be made to the OSHA Notice of Proposed Rulemaking (Draft-) that., had previously been distributed. Defining ObHA-s latent The draft NPR is so vaguely worded that it is difficult to determine just what OSHA has in mind. The NPR rather than outlining what OSHA intends to do, asks for comments at every critical juncture, and says that final action will depend on the comments that it receives! This format.gives the agency almost complete freedom of action to do what ever it wishes, since in addition to the comments that they already have, they will receive additional arguments on both sides of every question asked. This will enable OSHA to shape its response to meet the demands of the moment, rather than be locked into a clearly outlined position. [ CONFIDENTIAL 005490 Page 2 Given the fact that OSHA's risk assessment was developed with the assistanceof Dr. Selikoff's group at Mount Sinair and that Labac^ SI OSH &tMi j&bma lMt&TOame n ta 1 groups have pu?8feed*`v4ry' Hkvd PEL of 0.1 fibers/cc, it seems possible that with appftOgHPifttrft.) lfcr.il pressure, OSHA could be persuaded to lower the PEL to 0.1 fibers/cc. NPR At 0MB (EARLY MARCH .PUBLICATION POSSIBLE) At the moment, OSHA seems to be committed to a PEL of 0.5? Jfibdrb/cc with reasonable flexibility allowed for the us# of respirators. OSHA sent an asbestos NPR to 0MB on February 10, 1984, and it is said to be very similar to the early draft released to the Construc tion Advisory Committee. The draft' -sehf to 01 tft&ettMfed 0.5, 0.2 and . 0.1 fibers per/cc as a possible PEL. It is possible that the NPR will be published by the begirfihf of fkarrcb ISS^, as 0MB has seen it already, and it is being handled on an "expedited" basis. What Should Our Strategy Be? To be most effective, we must be positive in our comments. If we wish OSHA to continue to support a PEL of 0.5L .-.fibers /be, it is important that we give the agency positive comments designed to strengthen the 0.5* PEL. This does not mean that we cannot be critical of the risk assessment or other assumptions made in the document. Indeed, it is imperative that we take care to point out (in a positive way) that because of the very conservative assumptions*made in the- risk estimate, the number of actual cases of disease that may result from exposure to asbestos fibers in the-modern working environment is likely to be significantly smaller than- those in OSHA1s risk estimate. The Task Force should concentrate on those elements of the NPR where we have good data, or where we know that OSHA is weak. This means that we need to respond to individual elements of the. risk estimate as well as many of the specific questions that OSHA is asking. Responding To The Risk Estimate The first thing we need to do here is to carefully read the OSHA ETS, because it contains a much more detailed discussion of their risk estimate than the NPR. Additionally, I will obtain a copy of the risk estimate that OSHA entered into the record and make this available to those who request it. CONFIDENTIAL 005491 Page 3 Several analysis assumed _____________r_ _____ day, 5 days a wsek'Jr",Tfti3"4 4i.t1 ale&iipt attacked on a.number of basis,, including in a number "df "raa.jdf 'industries* declining, t_o___a__s_b_e__s_t_o_s_ number of indusi'tfiai 'pfaHtl #ltAJilg^i asbestos ts"'seadfiy*cli^finfii-iififi *.**<? s.^Phatirs^ '* " fItr*il"lve7- **d'.t 11 *; as the basis for 'rislt^esfi plants remainingfgg&f as well as thei'rx Dr-';t air.^r-irrTe. : "t r . . j. *.:* A useful tool for our ddmnetffs dn''tfi4 dsM'iT,'rilsk"#stini'Ee",s' aq r` affidavit of Dr. Kenny Sherman Crump concerning the OSHA " ' ' ' :c0 ETS. I am including that .document with ,this report.. Another area of concern ' is* that of '`frlctibn 'pro&ct,s',/'s'ince',.Jo:ffe Of "t* the major remaining uses **; i^bestOS "is'l'Ek ta^pro^kctl&hV 'Instil- : r lation, repair and replacement of brake linings and clutch facings. We need to collect as much as possible of the pert.inept, data published in this area, and where it i-s available, unpublished dtf-tfa 'that would assist us in making..our`case. Preparing Our Response _ We should re-submit" t'6 ,Q'8HA\ and Wfteereverf ppssibfd i'ni bur ''comments*^ answer by reference- rto,' 'the- i)RC Eecomimfended'' Revision :o^rX01(j.i0{n "" In our comments to OSHA we need to present data show'i:ng...that..the actual, as opposed to calculated, hazard at 0.5 fibWfS/bC ''is'-eirifcflV-- and that with appropriate measures, personal exposure levels should . be much lower than 0.S. ` t\ The comments should emphasize that* in general .imittstry^ where most'.. . of the potential exposure' to asbestos fibers exists, exposures, are"' : low, intermittent, often not feasible to engineer out, and rthat, in' any case the individual is protected through the use of personal protective equipment. Cw tittuENTIA) 005492 Pag* 4 We need to make the point that in & practical.sense, the quail# 6,t;h6 ffote&iioij tftceiyed by the'employee depends more :n"thfc ,'qjjaiity df tliq .safety and heal$fi,program'and its enforeei^ot^ .tl*ah .ii 4$#^*on setting a.lot-PEL. We,need to make,.it .clqar .thgt whilf.we would like to.keep the' ambient' levels of' asbesiod^fibefcs, as.4d>w . ^possible, it. is often difficult to"ke^p>them ;beiow!!0*5, .'while 'job is'"being ^done, ufhfii: th^tuf,,qf 'f f|^tes|ed% . respt*t'd?s can .;and' does reduce, employee %e^pofure ;^ar,,; . beiow'O.S 'fibers/cc.'' fe nedd' to emphasize!,that ,lt!.ddes not make sense to equate ambient air concentrations with employee exposure, and present data to back up that contention. We need to comment on fiber type and industrial process as important deterrainent.s in the kind and amount of disease found among those exposed. Our Time Is Limited! We need to carefully read OSHA's ETS and MPR; Dr. Kenny Crump's affidavit, and we should look over the OTA paper. Then, as individuals, determine which of OSHA's. questions we can best answer. We should begin this reading and selection process as early as possible, since once the NPR Is- published, we are only, going, to have 45 days to. prepare'and submit our written'response. What I Am Requesting I would like to request that as you read over the questions that OSHA has asked, or as you contemplate the larger questions involved, you select a question or questions that you would feel comfortable answering, and write up your thoughts and bring them to the March 26 meeting of the task force. Once you have chosen a topic or question if you would give me a call to let me know what you have selected 1 would appreciate It. That way I can coordinate things so we have the most complete coverage of the questions. CONFIDENTIAL 0054^3 Page 5 OSHA1s Questions ' '* i r Beglnlttgr on paigtf 7'In tWe 'dtitt 6o$#y -of tfteii* IfFR 8HA'*1 ists : 19 quesftiows ;fbkt tianm'r, `th * geAtefcar way5, tU& mmtPs -where they want some answers. these questfoftrf `do hot match ' those thfct OSHA asks In the edurstf of^the disdustfion. - Thus-it- is important to- carefully etfcttine -ttbth-sets*of qneStf-Ons 'to determine what .the afteney really want's*' * " ' '' 1 have reproduced the initial 19 questions, (attached) and in the following, 1 list the questions OSHA asks in the course of the NPR discussion and the page thgy `Are on. I urge all to read the whole discussion however, because the intent of 'the questions becomes' clearer in context. * Definitions *' ' page 28: "OSHA requests comments on how the nonasbestiforms or varieties of the mineral should e"regulated. A change in defini tion would mean that the mineral fibers that are now regulated as asbestos under the OSHA 'Standard would ho longer* ie-'Specif-tealiy regulated, "but would rther fall into the nuisance dtfst category OSHA requests and encourages public * coments os whether* the raineralogic definition of asbestos"fibers should be Used 1ft OSHA-s definition for protecting worker health. OSHA requests comments on how mineral fibers that are not asbestos in the mineralogic sense should be regulated. page 28: "Another issue concerning the definition of asbestos is whether asbestos which has been chemically treated*or altered should be regulated the same as untreated or unaltered asbestos." Page 29: "Public comment is requested regarding whether asbestos that has been chemically treated'and/or altered***should be' regu-* lated to the same extent as other forms of asbestos." PERMISSIBLE EXPOSURE LEVELS Page 32: "OSHA belives however, that a PEL lower than 0.5 fibers/cc maybe desirable to reduce risk for any fiber type if measurable, and OSHA is encouraged that the British appear to have had success with the 0.2 f/cc limits for certain fiber types. OSHA requests comments on whether the scientific evidence is sufficient to support differences in the asbestos standard for some fiber types and whether such differences are feasible." CONFIDENTS! 005494 Page 6 ACTION LEVEL Page 37: "Also, although OSHA recognizes the potenl of asbestos %^r '#&qcqni5%t%Mie Jplfm,ntjm PEL, OSHAKh^eK.pr unreliability ; . j; and in *0*daemon(QS9&^am&W*&ttIW #8 %taP5P&Afc , -, action im)iMKtl| a3tm|e|te|roii,,th!i;s .issue.,r.; "OSHA requests eomtfrt or. wqgMft *W adopted, and if so, trltift requirements it should* triggggeerri " .v.y -;` Hi> ' " -' r-<r>...* 1 " m } , anoi JSfSiJp Hi ! s ' ,.; 4 7 ;*? ": ' =ni' r.I aH9 * H20 an,: ;:; : ? l I . yr .- w ' .:a *r~r JgPQgMB MONITORING, ,,. , - : ;: , ,,: > adj Ic .;ftsJni `.*H3 sfcussed .'?'' ro ; a >:?; ;r -: r * - ~ t Page 38 "OSHA requests data, informatiqn^%.Bbr.coiM|eutiS.^cpncerniiig5r^ny changes that should be -"-made in the monitoring`provisions of the" current asbestos st*od*d> " .-a 'iCS won R-ESS^m^REAS, ,, . : ; v--a ?", tam ; , -fr ';r Lp&t -s: ,1 `f "an; . . ?s . v ,, . < Page 39: -, -?QSlMf Antftotpagfeec ftl*t i-bha .Eejplated.areas,..(nay be.esxta,- * A blished-.at r,thea#iL,B%#p}.^fEfl4!l;:'0SI{^treq-'qests,.cqmmeat8 on -.wbe.thq ' this is appqos^lftfi* e^^fl^oidlitlqnalActivities-should,^e*.' '.14' required..prr.pirqh4Mtd -ip r$*ft8rf$Ate*<f area..5 ,,... . . ,- - r "cjps i A . , ` .dll*ert - y , '-i - -f r n t t*.-;aedas fon :- * , - . METHODS Of COMPLIANCE ,' Page 41: "QSHA;solicits*q(gmep ts^concerning...the .methods .of .com pliance. Thq agem-cssis^pasrtteulabiy'Iinterested'-in receiving-,;" comments, .iqformatiqUr dtam.g4*TOtfte^evidence ..concerning "the. '; extent to which respirators Aay provide effective protection agalnst . asbesff.s|||^|||tt^Bfgj| Stable?:Had ^Ron,n ,a substitute.,. . for engineegingi^-ff^^fftd^ih^S^^s?" , - . :r" *f '* .seiaedea lo eunci z-dl i r'-- ^ i Page 42: As an aTtemative to proposing a flexible compliance requirement for all asbestos workplaces, OSHA is considering a limited exemption from sugS|jgineeriqgccontro 1 rnequir.ement for intermittent esposurs sitSc^itnfst*0$HA -requests-comroents regarding,jthefrgfliq|.|rton-3qfs&n .exemption,, from engineering controls; for intermittetj* .e-jq^sur^s t;q,asbestqs and hoy 'll: 'can.,be' applied---! to the types<j^|"efpqsureis,'',in^the affected .industries,", ' " in Any case OSHA.-int'endf+tQ."maintain "the' existing; requirement for engineeringlcoqtnols .to..reduce'.exposures'to 2 f/.cc. This will prevent massive .release qf .asbestos fiber in the working environment." PERSONAL PROTECTIVE EQUIPMENT Page 44-45: "OSHA believes that advances in work practices Since 1972 have reduced exposure levels in these operations * 005^95 Page 7 AH 20 3t C abrll ,,___ betoorftW%l*deiy' `inf condCtfenM' _. ducti-on ia the PEL will' wsi types-At lower amMieat air levels, OSHA and i prsd^bkY "Ifor reqWKf Vs# 4rf` suttp . .. --< -, <4f'7 r<-iir , % '. 1 q --: . ei: ' .T * Z .. "* "3 :,t-V-'.1 '" ' -'t";. 1a';-* US MEDICAL SORVEILLANCE PEOGEAM act ,; ^>1 s i < ii > `OHiS Page *f7-V f,. by; 9S'J is-t-r*tivP 4nt&p&fck&Vb ft#tesl * rc'l"T". survellllfnfeev`;irrb%e'4^1ir 'itfe 'ffift trtfe4 level? Included< ^ibr ; ,, - af-.. . '' ! * r;: ! i:-,; '. -'*4.'- ' 2i ""; '-" : * 's>,?. -r- a .- .-*in0j (ft) ^Ta^fectflbn*iveFConeepF is^m^didaF lance aad what action level should apply^'-r-'1" *,1 ....... ' " ' "'.......1...-t'fi q` (b) ThfeP fre<" ueficy' of1* chest-'Hwa^&^%atlbb^jsIibul& fee'' ii'eC'r&ssecf; _ for yom- f- g- empl.o, yees- or- emplt>yf\e`et s* -:!%; -xqr.t-irf, r:iyhncinrfcr cf/t*i^;.i:ib~ ir expo: sures*." " ': (c) There- siro'uM; be k- claritlba-iioif of- Yir#tim%"within-whichv the employer-raust*? conduct prep!Ab&raent'examination#'if ter "hi r trig' employees; .. *' (d} There should be any additional tests or procedures (such' as use of questionnaires) for the purposes of early diagnosis of any disease, including asbestosis; and (e) There should be screening tests for colo-rectal cancer such as tests- for occdlt!'Bld6d^ih'the^ feces1;- and1 (fL' `Onlf;::"Br'read4'rs^;~'l!,7 should'-interpret--rays.- ' 7 '' '* ' ~ ''^G METHODS OPMEASDREMENT Page 49-50: "One issue raised in the record to date is whether phase contrast microscopy analysis.is capable of reliable measuring airborne concentrations of 0.5 fibers/cc and lesW" It may. oe => possible that phase contrast microscopy errors''can be reduced.''if improved and standardized procedures are followed, perhaps by adding requirements to the standard." CONFIDENTIAL 005495 Page "In revisions to the permanent asbestos standard, OSHA nay, teShnixal *\ 'n g& fftlibnn: 1 [ x * ,,`35 Hi noliDiib ii/py\ BSC .UI t;* jr.ei-dft* cssol J ?*sqy.d ... hr?a coroments' th'''wareh Vnaiytfc*aT proacedur.e.....p...r..o..v...i.d...e...s.. the beet results and whether OSHA should specify the procedure in the revised asbestos standard." A3sea*l iO'/A.iJI3Vr:: Page., Sir53:... "0 ,aa*lytlC*l ^ - &H - tn;. nij^--- reFlce..p|iise, 3bat*dg ]&^Jp*8- v r fa 11 i 7 1 /ev-i.a measuring airborne coacentri^M^^*&>*$ **&*>*t>u* un I OSHA believes that it is not practical' or necessary to modify its - standard, %o;.electroii. ffli^rohe^py;-. analysis.Instead;.pf a , phase" contrast' light ' kfeVroscogy^*'": :7 - - , -,,. .,*{ "OSHA requests information. relu^pg^ou^hesrelative- merits^ o-fhT the electron microscppy.' and..^|*pa^&e,.ponj^-asst;jaiotoscope roethode< ' and to the feasibility'and appropriateness of other methods of measurement,, for airbpfse asbe*o&, flbers?~ ,3OSHA also' requestsTM r data on , thef statistical.. lind.ts. pf^jmeaeurementSKat- the-G.-S^f/ecy-.. 0.2 f/cc and" 0.1 f/cc levels and comments on whether OSHA should:.; - choose an action level which is more uncertain in terms of measure ment than the PEL." '~ CLOSING COMMEN'i. ; These..ire >he-raaiarc|uestin OSHAc. i 8o asking*-inr the; body ofits*-?.' DRAFT NPR. " These questions, plus those listed ^initially- represent:'?^ a lot of work if we try to answer all of them, but I do not think we can answer them all in the time available. Again I want to remind you that we may see theNPR published by the beginning of March 1984. DKM/dm CONFIDENTIAL 005497 BEFORE TEE UNITED STATES DEPARTMENT OF LABOR . OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION _ In re _____ -j ) ,, .. EMERGENCY TEMPORARY-STANDARD FOR OCCUPATIONAL EXPOSURE TO ASBESTOS - - ' _____________________________ ) ' 'OSHA;fioekt1 " ) No. B-033C ) ' ). , AFFIDAVIT OF DR. KENNY SHERMAN CRUMP { Kenny Sherman Crump, being first duly sworn deposes and says: 1. I am an expert in biostatistics and quantitative risk assessment. As further detailed in my attached curric ulum vitae (Attachment 1), I have extensive education and experience in critiquing and performing quantitative risk assessments. I earned a Ph.D. .in mathematics from Montana State University in 1968, and was a Professor of Mathematics from 1966 to 1980 at Louisiana Tech University. In 1974 and 1975 I was a visting scientist at the National Institute of Environmental Health Sciences (NIEBS). Since 1978, 1 have been the President of Science Research systems, Inc., in Ruston, Louisiana. 2. Since 1968 I have authored numerous articles in refereed scientific publications, as listed in my curriculum CONFIDENTIAL 005498 -2- vitae, particularly on issues relating to quantitative risk assessment. 1 have consulted for and prepared reports for many Government agencies, including NIEHS , the Environmental Protection Agency, the Council on Environmental Quality, and the Congressional Office of Technology Assessment, as well as for a number of private industry groups. 1 have been a member of .National .Academy of Science-panrlf-, including the panel that earlier this year issued the report, Assess ment in the Federal Government:....Managing"the Process!1 (OSHA Ex. 84-322). , 3. Most recently, 1 have developed several quantita tive risk assessments for' the Occupational Safety and Health Administration (OSHA). I conducted a risk assessment for OSHA on workplace arsenic exposure in 1982 and testified for OSHA at its hearings conducted as part of its rulemaking to establish an arsenic standard. 1 performed a comparable role for OSHA in its 1983 proceedings to regulate ethylene oxide. 4. I have become thoroughly acquainted with the evidence on health risks associated with asbestos exposures over the past four years. As a result of my review of the animal and human studies of asbestos exposures, 1 was asked by the Asbestos Information Association/North America (AIA/NA) to testify on quantitative risk assessment of asbestos in August 1981 before the Royal Commission on Asbestos of the province of Ontario, Canada (OSHA Ex. 85-22). CONFIDENTIAL 005499 -3 5. X have reviewed OSHA's asbestos ETS Federal Regis ter notice and its underlying quantitative risk -assessments (OSHA pis. &4-1, 84-349, 84-392), as well as other .asbestos risk assessments made for the government .pi .the United Kingdom (OSHA Exs. 04-216 and 8,4-243) .apd .thp Consumer Product Safety Commission (Ex. 84-256), X. The Mature of Quantitative "Risk "Assessment 6. Quantitative, risk., assessment.is..inherently .uncer tain. As the MAS .Committee, .on.Risk.. Assessment on nfh&ch. I . served wrote: "The dominant analytic ..difficulty, of ..[risk assessment] is pervasive uncertainty." (OSHA,.Ex. 84-322, at 11). 7. In describing the.many-uncertainties of quantita tive risk assessment, the .MAS Committee listed a number of assumptions that are .particularly relevant to risk assesments of asbestos. For example, in dose-response assessment, the MAS Committee lists the need to .determine,, inter alia, (a) "what dose-response models should be used to extrapolate from observed doses to relevant doses," (b) "how should exposures to other carcinogens, such as cigarette smoke, be taken into consideration," and (e) "how should one deal with different temporal exposure patterns in the study population and in the population for which risk estimates are required." (OSHA Ex. 84-322, at 31). An additional crucial determination i CONFIDENTIAL 005500 -4 is what were the levels of exposure in the study populations. In assessing-'current exposures, the sane crucial determination must he made, namely, as phrased in the NAS report, "how should one estimate the size and nature of the populations likely to be exposed." (OSHA EX. 64-322, at 32). 8. The'uncertainties' inherent in quantitative risk assessment are particularly severe %#heh one attempts "to assess the risk of a .small segment of total .human expasure. For example, quantitative estimates of the risk to indivi duals from'a lifetime of'' wi&kihg cigarettes involve, uncer tainties, hut even" greater'uncertainty exists if one attempts to assess the risk "of' smoking one Cigarette, of the change in overall lifetime smoking- risks- for abstaining from smoking for a short period. Similarly,' numerous uncertainties exist in assessing risks from lifetime exposure to asbestos; even greater uncertainty exists in estimating the risk of the contribution of one six month's'asbestos 'exposure during a working lifetime, or the change in overall lifetime risks from reducing asbestos exposures during any given six month period. 9. Because of the many uncertainties in quantitative risk assessment, the NAS Panel on which 1 served recommended any "agency's risk assessment should be reviewed by an independent science advisory panel before any major regula tory action or decision not to regulate." (OSHA Ex. 4-322, at 156). CONFIDENTIAL -&> . 10. The HAS Committee envisioned that the public would be given an opportunity to nominate persons to serve on such a panel and that the panel would then subject the assessment to "such scrutiny as the members find necessary-to satisfy themselves that it i . . as complete , and.objective as available data permit." The-panel then ''should provide a written evaluation of .the agency`e risk- assessment.H (OSHA Ex. 84-322, at 157-58). The, HAS report further recommends that the agency" "should discuss any important criticisms f its [risk] assessment in its-, proposed --regulatory action . . . {OSHA-EX 84-322, at 1-59-)-. 11. In -the .-absence of-- -an = independent peer review panel's scrutiny of agency risk -assessments, as called for by the NAS -.Committee, some aspects of -Quantitative risk assessment can be explored effectively through .rulemaking and hearing procedures conducted after -an agency proposal is made. For example, determination of exposures ..of workers both in the studied populations, and among current workers, can often be effectively-assessed through reports from and testimony of the scientists who conducted the studies of past exposures and of industrial hygiene personnel who are familiar with current exposure levels in the workplace. Absent a peer review panel as envisioned by the MAS Com mittee, these review procedures can be effected through agency hearings. ONFIDENTIAL 005502 - -6 * - 134- -The Assumptions in OSHA-1 s - 'Asbestos Quantitative Risk Assessment. 12- In estimating health risks from exposure to asbestos fibers, OSHA makes -a hUiriber of assumptions 'Which -are -open to question. These include: (a) -OSHA-assumes that "there- -M' & linear relationships between -asbestos ^xpoi^r^S5 (in-terms of both intensity and'"duration')''-tod ^heel'tijieffebts at exposure levels as low as:-2" fiberi^ec -for-as short -a time -ms mbhths. (b) OSHA assumes -that estimates -of exposures in. two- Of -the - studies on-`Which 30SHA relies- are valid'even thbugh no- exposure - information was col- ' lected- ion: the - Workers -whose health -effects were examined in those: studies - (ive. ,- the- saiikoff:-end . Seidman - studies, 'OSHA 4Sxs. 84-90 end 84-87). OSHA estimates exposures for the workers-' studied by Seidman, who were in a plant in ?atecsonT New -Jersey, -during-World-ar II, based---on measurements in two other plants, -which-OSHA--states ^manufac tured the same products with similar fiber and machinery," which measurements were made 21 to 31 years later at these other plants in Texas and Pennsylvania (Ex. 84-392, at 28-27). I know of no other instance in which regulators have relied on quantitative risk assessment based on studies for CONFIDENTLY V 005503 - 7--- which exposures among the studied workers are equated to exposures in other plants 25 or {more years later. (c) OSHA assumes that estimated exposures in the remaining studies on which OSHA relied are accurate -despite being based upon-very'limited data, and despite .numerous- changes in the exposure measure ment techniques -which have- occurred over the years. As- OSHA - itself states-: ' "Exposure t data frequently, are not -available for workers exposed 9 before 1970. . Where, historical! -exposure data are available, the^ata-often have 'sudh limitations as having been collected and analyzed using industrial hygiene techniques - no' longer in use or having been collected in - only some areas of the worksite or having been collected on-only a few occasions. Therefore, of necessity, estimates of dose-response based on epidemiologic studies will have a fairly broad range of uncertainty." <48 Fed. Beg.' at 51100). Prior to the 19S0*s most asbestos measure ments were in terms of particles (of any substance) rather than in terms of fibers. The graticule grid method of counting fibers vsed today gives different fiber counts than the previously used whole field counting method. Also, many of the older fiber counts were made using samplers fixed CONFIDENTIAL 005504 - 8--" - in place and those measurements can be quite differ ent from those obtained from personal samplers, which OSHA will use to enforce the STS {Ex. 84-216). Consequently, .both the very limited amount of exposure data available from early*periods (when exposures .1were - highest) plus thesChanges in measure ment techniques imply '-that there; ,d Considerable uncertainty associatedvwith ithe^exposure estimates used by OSHAderive, quantitative srssk estimated. (.d) '5OSBA..-assumes .-that* no. Jimtinctions in risk should, be.-.aade-, fbr-di fferent bypef asbestos or different-.types of asbestos derations. (e) OSHA assume*- that each of:'the eleven studies. relied upon -1 in,^SHAVs-.-risk.. assessment should ;be accorded-equal. reliability -and weight in determining a. best estimate of- quantitative risk. (f) .-OSHA assumes -that ".the eleven studies upon which -OSHA - relies to ..predict lung cancer risks, are the appropriate, studies upon rwhich to rely in - estimating asbestos lung cancer risks. (g) `OSHA assumes that the.four studies upon which OSHA relies to predict mesothelioma risks are the appropriate studies upon which to rely in estimating mesothelioma asbestos risks. (h) OSHA assumes that risks estimated from historical populations are extrapolatable to modem CONFIDENTIAL 005505 -9- workers despite differences in lifestyle, smoking habits, etc. Each of these assumptions is subject to considerable dispute in the scientific community. Were any of these assumptions altered, they could significantly affect OSHA's quantitative risk assessment and thus its prediction of the benefits of the emergency standard. The following two paragraphs contain examples of two of many assumptions made by OSHA which have been called into question, and which could have a significant impact upon their risk estimate. 13. OSHA's predictions of mesothelioma risk are derived from only 4 of the 11 studies used to develop lung cancer risks. In the remaining 7 studies very few mesotheliomas were observed. Consequently, OSHA's estimates for mesothelioma come only from studies that show relatively high risks. Although OSHA made an adjustment to account for this bias, it is by no means clear that this adjustment was adequate. In the Dement study (Ex. 84-35) which OSHA did not use to estimate mesothelioma risk, 18.5 excess lung cancers were discovered and only 1 mesothelioma. By way of contrast, in the Selikoff et al. study, (Ex. 84-90) which OSHA did use, there were 323 excess lung cancers and 104 mesotheliomas, based upon death certificate data. This suggests that the fibers in the Dement study were only (1/19.5)/(104/323) 0.16 as potent in producing mesotheliomas as in producing lung CONFIDENTIAL - 10 - cancers, relative to the fibers in the Selikoff study. Since the carcinogenic potencies for lung cancer estimated by OSEA were * 0.020 for the Selikoff study and * 0.042 for the Dement study and the potency for mesothelioma from the Selikoff study was = 1.5 x 10 , this suggests a potency for mesothelioma in the Dement study of ILj * (0*16) (0.042)7(0.020)(1.5 x 10 ) 5.0 x 10 . This value is ,, .t 1 " ; *; * smaller than any of the four potencies for mesothelioma estimated by OSHA and is one-half the 3^ value used in OSHA's risk assessment to predict mesothelioma deaths; *; , , -9 14. There are also many assumptions used in analyzing the individual studies which could be questioned. For example, for the Peto study (Ex. 84-169), OSHA calculated values of of 0.0076 and 0.00091 for pre-1950 and post- 1950 groups, respectively (Ex. 84-392). However, rather than combining these estimates, OSHA took the larger value of 0.0076 as their estimate of (48 Fed. Reg. at 51127), which is about eight times larger than the post-1951 group value. 15. OSHA makes a significant omission in its risk assessment by failing to distinguish lung cancer risks for workers who do and do not smoke. OSHA acknowledges the association between smoking and lung cancer among asbestos workers and notes that risks from asbestos exposure are approximately ten times higher for smokers than for non- smokers , 48 Fed. Reg. at 51108. However, OSHA1 quantita tive risk assessment does not calculate the resultant ONFiDENTIAL 11* - * ten*fold difference in lung - cancer risks for -smokers and non-smokers. * 111. Comparisons with Risks Predicted by OSHA in -Other -.Proceedings- -here:- Emergency Standards Have Wot Issued x` * ~ %.--v ' * . ; . 16. 1 am familiar with, indeed 1 myself developed in Hi. te; ' some cases, quantitative risk assessments upon which OSHA . r . - . i+tcoooo s,t has relied in regulatory proceedings on other substances. In several of those proceedings, OSHA's estimates of the . . - : . ijj:, i. i'.r'C- V'--' -5 :: :v.. risks at the then-existing 'permissible exposure levels for each substance have been ` significantly higher than its estimates of risk for asbestos at the existing 2 "fiber/cc standard. Yet, in none of these cases has OSHA issued 'an emergency temporary standard. 17. OSHA's best estimate of lifetime cancer risks for asbestos workers -exposed to >2 fi-hers/cc is 6.4/1000, 48 Fed. Reg. at 51089. By contrast, OSHA followed its normal rule- making procedures with, respect-to-arsenic ..despite a beit estimate of lifetime, lung cancer risk -at the .existing 5.00 pg/m3 standard of 375 to 455/1000. See:the ^arsenic preamble, 44 Fed. Reg. at 15360 (April 9, 1982). 18. Likewise, in its advanced notice of proposed rulemaking on ethylene dibromide, a substance for which OSHA denied an ETS request (OSHA Ex. 84-282), OSHA noted -that an excess cancer risk of 400/1000 had been predicted at the existing permissible exposure level. 46 Fed. Reg. at 61674 CONFIDENTIAL 005508 - 12:; (Dec. 18, 1981). Thia risk is nearly s'Sven times higher than the risks OSHA estimates for asbestos exposure'at-the current standard. 19. Similarly, OSHA denied -a petition to issue an ETS for ethylene oxide (OSHA Ex. 04-283), even though it esti mated an excess cancer risk of from 63/1000 to 152/1000 from ........ : * . - . J& 3 1 Jii&Vf sSifiO ' -r-..- lifetime occupational exposure at the then-existing OSHA " ~v:-. T ... ; 'v.;; zvlL'i'z standard of 50 ppm. 48 Fed. leg. at 17293. The population exposed to ethylene oxide is comparable in size to that OSHA estimates to be exposed to.asbestos. OSHA estimated 80,000 workers directly exposed, and 144,000 indirectly exposed to ethylene oxide, 48 Fed. 17297, as.compared to 375,399 exposed to asbestos with only 48,644 exposed above the ETS of 0.5 fibers/cc, 48 Fed. Reg. at.51094. IV. -The- -'Absence of 4few- Evidence * in OSHA's Asbestos Risk Agreement 20. Besides estimating risks' lower than -on other substances where an ETS was xefected, OSHA'* asbestos risk assessment-does-not rely on any hew data. 21. As is typical of most assessments of asbestos that seek to determine the quantitative risks of various expo sures (in terras of both intensity and duration), OSHA's -risk assessment is based on the findings of a number of worker mortality epidemiology studies (i.e., studies that compare roNFinnwTiM 005509 - 13 - the mortality-experience among groups of workers exposed to asbestos to the mortality experience among some segment of the geperal population). 22. All eleven of the epidemiology studies on which OSHA relies in its - quantitative 'risk assessment, as listed at 48 Fed. Reg. 51124, have been available* lor revilaw for more than two years. Several, although korr recently updated, were first published in thfe I960' s and early 1970's (e.g., the Selikoff, Ex. 84-90; WCDonald-Liddell, Ex. 84-65; and Enterline, Ex. 84-48 studies).', lost of the 'eleven Studies ,P were published between 1975"mud 1980. The results Of only three of the eleven studies relied on by OSHA fi.e., the Finkelstein, x. 84-240, Dement, 'Ex. 84-35, and Berry and Newhouse, Ex. 84-21, studies') 'were published since 1980, but each of those study's results were widely circulated in scientific and regulatory circles by the summer of 1981. 23. In sum, the risks predicted by OSHA'are not pre mised on new evidence; rather, the results of all the studies have been available for review and quantitative risk assess ment for more than two years. V. The Absence of Direct Evidence that OSHA's ETS Will Provide Health Benefits 24. In its Federal Register notice, OSHA asserts that health benefits will be achieved if exposures to asbestos are lowered over the next six months, because of its emergency CONFIDENTIAL 005510 - 14 - standard, from 2.0 to 0.5 fibers/cubic -centimeter -4.ee), 48 Fed. Reg. at 51089-90. QSBA's assertion is -premised on a number, of assumptions, as enumerated in f 12. Hone of the studies on which it relies .found increased .-risks of asbestos- - - ! related deaths among workers .exposed .at such low levels, for such a short period of. ft.ime. 25. As OSHA .itself notes (48 Fed. leg-,-at SHOO-), in each of the ...eleven ..studies 4on what it- relies workers were exposed to asbestos at. levels considerably above .the current standard f 2 fibers/cc. For example, OSHA estimates that exposures in the Seliko-ff .study- of asbestos insulators ranged from 10 to 0. fibers/cc (Ex. .84-392, at 25), and exposure of .amosite insulation, .manufacturers in the Seidman study averaged 35 fibers/cc (Ex. 64-192, at 28). Although lower average exposures were estimated for some workers in other studies, none of the,studies provide OSHA with risk estimates based on workers exposed at levels of 2 fibers/cc or less. 26. OSHA, assumes, in its prediction that benefits will be achieved by lowering the permissible exposure level, that cumulative exposures achieved at the low exposure levels prevalent in the workplace today are equal to cumulative exposures of workers obtained at much higher fiber concen trations in the past. It appears that it is not possible to verify directly this assumption. As 08HA states, 48 Fed. CONFIDENTIAL 005511 Reg. at 51101: "At this time, it does not appear possible to determine whether intensity of exposure has an effect on disease separate from that of cumulative exposure." 27. In other words, GSHA has found no, evidence on which to rely in supporting, its assumption.that .cumulative exposures, from exposure, at 1 fiber/cc for. twenty..yeers pose as much risk as exposures in the ..past, 5ffberf/cc for, one year. Hone of. the studies., on which..SHA fays it relies demonstrate directly that there is increased risk for.workers who would be, exposed to. 1- fiber/cc-year,.: &hf. cumulative exposure that would be achieved over,, the next .six -months ,-at average exposures of 2.0 fibers/cc. vi. An Apparent'Miscalculation in OSHA's Risk Assessment . 28. I have reviewed Tables 1, 3, 4 and 11, in OSHA's ETS notice, 48 Fed. Reg. at "51093-94, 51096, 51097, 51129. Table 4 is labeled "Cancer Deaths Avoided with a 0.5 ETS Asstuning Compliance with the 2 f/cc Standard." This table assumes that all' workers are currently exposed at no more than the 2.0 fxbers/cc standard. It thus determines what additional benefits OSHA calculates would be gained by reducing all worker exposures to the 0.5 fibers/cc ETS level. 29. Table 4 is based on OSHA's estimates of current exposure levels in Table 1 and its estimates of cancer risks CONFIDENTIAL 005512 - is - for various exposure levels and durations of exposures in Table ll. 30- Eased on fables 1 and 11, 1 am able to" calculate the same numbers in Table 4 as does OSHA, except' for the category -construction -workers. That is," T)SHA calculates, ' in the -first column' of*Table"4, 'that"57 fcbftstruic'ti6n`'%bi?^er lives will-'he`-saved %y '''feducing' expbiub^'^fdl:'iW kd^ihs from 2:0: fibers/cc"to*t> A*' fibefs/Cc. llfinif tKe"iiame"nlihofl " of-Calculation-1 u.se;d' to -reconstruct the fable' ' numbers for' other-worker categories,'"1 calculated ttHt'Uie 'ntuuTSr"of .a construction''worker lives'" iiveW' bvesf 6-:aoht3ii is "17, rather'" than 57 as reported by OSHA'- `I performed the following' calculations for,the three .categories pf construction workers currently maid-by'^OSSA--to-be exposed-^ibOve 0.5 fibers/cc: A/C pipe workers: '57458' Workers]' x '[.5 years] x [the one ,year, risk at T f/cc. minus- - the one `year risk at 0.5 f/cc, . namely. {111-14)/100,000]. 1.0 life. ' A/C sheet workers: [1 ,765 workers']~xJ [.S'years] x [the_ne_year.risk at.*2 .f/cc.. Einut the 'Me year risk at ..0,5 ..f/cc,. nainely. ,<296-74)/ f00,t>00] = X.9 fives................ Drywall removal, demolition, and renovation workers: [12,955 worker's]' x [.5 years] x [the one, year risk at 2.0 f/cc minus the one year risk'at 0.5 f/cc, namely (297-74)/ 100,000] =14.3 lives. Thus, 1.0 + 1.9 + 14.3 = 17.2, or rounded off, 17. CONFIDENTIAL 005513 - 17 31. Similar errors appear to exist in OSHA's calculation in Table 4 of construction workers lives saved for 1 year, 20 year, and 45 year exposure reductions from 2.C to 0.5 fibers/cc. 32. After correcting OSHA's apparent error in the number of lives saved among construction worfcersJby reducing exposures from 2.0 fibers/cc to 0.5 fibers/cc li.e., 17 lives rather than-OSHAV 57) , 'the assumptions used by 05HA imply that the total number of lives saved in Table 4 over a six-month period is 40, rather,than the 80 reported, at the bottom of the first column of that Table by OSHA. 33. Although even the figure of 40 lives is subject to doubt because of the doubtful assumptions used in deriving it, finding of this apparent error reinforces the premise that the OSHA risk assessment could benefit from careful review such as might be obtained in a formal OSHA hearing. 34. In Table 3, OSHA calculates that 210 lives would be saved over a six-month period if all worker exposures were lowered from their current levels to the 0.5 ETS level. As determined in paragraph 32 above, 40 of those 210 lives are the lives saved by reducing exposures from 2.0 fibers/cc to 0.5 fibers/cc. Therefore, 170 of the 210 predicted saved lives (210-40), or @1% of OSHA's claimed benefits of reducing the standard to 0.5 fibers/cc, would be achieved if all workers' exposures were in compliance with the pre-existing 2.0 fiber standard. CONFIDENTIAL 005514 Louisiana Dr. Kenny S. Crump, being first duly sworn, deposes end says that all facts contained in the foregoing affidavit are- true'-atid borreot' to- tharbVtf' of1 m*: fchowledge,^nformation and belief. Subscribed and sworn before me this /M- -day-of-leveiftNet *'' 193' ;o CONFIDENT;/.'. 005515 ^ | gn, v>r;IWF". ...jmn. CURRICULUM VITAE Kenny Sherman Crump Address ---------- Office Science Research Systems, Inc. 1201 Gaines Street Ruston, Louisiana 71270 Telephone: (318) 255-4800 Home 1628 Hodges Road Ruston, Louisiana 71270 Telephone: (318) 255-7056 Date of Birth "Place of Birth Marital Status Children October 43, 1939 Haynesville, Louisiana Married Three Education 1961 B.S. Electrical Engineering 1963 M.A. Mathematics 1968 Ph.D. Mathematics Louisiana Tech University University Of Denver Montana State University Honors B.S. cum laude, Omicron Delta Kappa, Phi-Kappa Phi, Tau Seta Pi, Eta Kappa Nu, Who's Who in American Colleges and Universities, Engineering Honor Freshman, Louisiana Tech Sigma XI -Research Award-1977, Sigma Pi Sigma. Research Interests Application of statistics and stochastic processes to problems in biology and health. Methodology for assessment of effects upon human health from environmental exposures. Professional Society Memberships American Association for the Advancement of Science American Statistical Association Biometric Society Institute of Mathematical Statistics Sigma Xi, The Scientific Research Society of North America Society for Epidemiologic Research Society for Risk Analysis Society for Mathematical Biology Professional Experience 1961-1963 1963-1966 1966-1980 1967-1968 Research Associate, Denver Research Institute Instructor of Mathematics, Montana State University Professor of Mathematics and Statistics, Louisiana Tech University Research Associate, Department of Statistics, State University of New York at Buffalo (on leave) -1- K. S. Crump | CONFIDENTIAL 005516 e'jritiS'. ~P1BJ. HI" Professional Experience (continued) 1969 {summer) 1974-1976 1978-present Research participant. Statistics group, Mathematics Section, "Oak-Ridge''National' Laboratory, Tennessee Visiting Scientist, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina {on leave) President, Science Research -Systems ,'ilric. - Ruston, Louisiana " - - Committees and Offices , 1976-1979 Officer, Louisiana Chapter -American ^ttf&flstl cal -|||gMg|#t1on Secretary-Treasurer : 4976*1977- s-vsh -ZLU Vice-President 1977-1978 ' .*/ President 1978-1979 = 4 1978- 1979 United States Congress Office of Technology Assessment--.; member of Tolerance Advisory - Panel^Environmental TSniaminants itf'food. ' = l&s.'.it,-j ,.* 1979- 1986'National Academy of Sciences; member df^fiifil 4mp$ets Study* Conroittee and Panel on the Health Effects of Diesel Emissions. 1980- 1983 American Statistical Association; member of Connittee on - Statistics *and the Environment '- " 1981- 1982 National - Academy of Sciences ; member "of Midwfttee -on Institutional Means for the Assessment of Risks to Public Health ' Selected Testimony Royal t-omrni ssion on--Matters of -Health--and Safety Arising -from -the Use -of Asbestos In Ontario August 13. 1981 (presented findings resulting from-review of asbestos healthaffect literature, critiques of risk assessments carried out by other investigators, and independent riskIjBAlcUidttons^X Congress of the United States.House'of`Representatives, -Committee on Science and Technology May 20, 1982 (reviewed^PA's-carcinogenic-risk assessment on formaldehyde.) Occupational Safety and Health Administration Hearing on Exposure to Inorganic Arsenic, June 18, 1982 (critiqued quantitative risk assessments and presented independent findings.) Areas of Consulting Experience Environmental Statistics lioassay Statistical Design and Analysis Environmental Epidemiology Cancer Epidemiology Health Risk Assessment (especially cancer) -2- &. S. Crump CONFIDENTIAL 005517 Publications In Refereed Journals 1. Crump, K. S. and Mode, C. J. (1968). A general age-dependent branching process I. Journal of Mathematical Analysis and Applications 24, . 494-508. 2. Crump, K. S. and Mode, C. J. 11969). A general. age-dependent branching process II. Journal of Mathematical Analysis and Application 25, No. 1, 8-17. : ".* 3. Crump, K. S. and Mode, C. J. (1969). A-tancMNgrdnoMitftli correla tions among siblings. Journal of Applied Probability 6, 205-210. 4. Crump, 1C. S. (1970). On systems of renewal- equations. Journal; of Mathematical Analysis and Appl4ct-iflns.J0, No.;.*: 426-434. 5. Crump, K. S. (1970). On systems at renewal equations: The reducible case. Journal of Mathematical Analysis and floplieatioris-- 30. No. 3, 617-528. .* . 6. Crump, K. 5. (1970). Migratory populations in branching processes. Journal of Applied Probability 7, 565-572. 7. Crump, K. S. and Hoel, 0. G. (1970). Some applications for renewal theory on the whole line. Journal of Applied Probability 7. 734-746. 9 8. Crump, K. S. and Howe, R. fi. (1972). Nonparanetric estimation of the age of a Galton-Watson branching process. 81wetrfka 59, 533-538. 9. Hoel, 0. 6. end Crump, K. 5. (1974). Estimating the generation-time of an age-dependent branching process. Biometrics 30. 125-235. 10. Crump, 1C. S. and Hoel, D. G. (1974). Mathematical models for estimating mutation rates in cell populations. Blometrlka 61, 237-252. 11. Crump, K. S. and Howe, R. B. (1974). Estimation of the age of a Bellman Harris branching process. Mathematical - Bloscfences 19, 175-184. 12. Crump, K. S. (1975). On point processes having an order statistic structure. Sankhva 37, Series A, 395-404. 13. Crump, k. 5. (1976). Numerical inversion of Laplace transforms usiijg a Fourier series approximation. Journal of the Association for Computing Machinery 23, 89-96. 14. Crump, K. $., Hoel, 0. 6., Langley, t. H. and Peto, R. (1976). Fundamental carcinogenic processes and their implications to low dose risk assessment. Cancer Research 36, 2973-2979. 15. Crump, K. S. and Gillespie, J. H. (1976). The dispersion of a neutral allele considered as a branching process. Journal of Applied Probability 13 , 208-218. -- 1TV r* -3- K. S. Crump 005518 Publications in Refereed Journals (continued) 16. Crump, K. S. (1976). A birth-death-migration solution to the geographical distribution of a neutral allele In a continuous finite habitat. Mathematical Biosciences 30, 159-167. 17. Guess, H. A. and Crump, K. S. (1976). low-dose extrapolation of data from animal- carcinogenesis experiments--analysis of a new statistical technique. Mathematical Biosciences 32, 15-36. 18. Crump, K. S. (1977). Mathematical models for mutations In cultures of diploid cells. Mathematical Blosclences 33, 177-188. - 19. Crump, K. S., Guessy H. A.-and Deal, K. 1. (1977). Confidence Intervals and tests of hypotheses inferred from animal carcinogenicity data. Biometrics 33, No." 2, 437-451. ......... ............ ............... uiuuuuu. _ 20. Crump, K. S. and Gillespie, 3. M. (1977). The geographical distribution of a neutral allele. Theoretical Population Biology If, 10-20. 21. Guess, H. A., Crump, K. S. end.Peto, R. (1977). Uncertainty estimates for low-dose extrapolations of animal carcinogenicity data. Cancer Research 37 3475-3483. 22. Guess, H. A. and Crump, K. S. (1978). Maximum likelihood estimation of dose-response functions subject to absolutely monotonic constraints. Annals of Statistics 6. No. 1, 101-111. 23. Garner, J. B., Crump, K. S. and Stephenson, J. L. (1978). Transient behavior to the single loop solute cycling model of the renal medulla. Bulletin of Mathematical Biology 40, 273-300. 24. Crump, K. S. (1977). Open Query: Theoretical Problems in the modified Mantel-Bryan procedure. Biometrics 33 , 752-755. 25. Crump, K. S. and 0*Young, N. C. (1979). Some stochastic features of bacterial constant growth apparatus. Bulletin of Mathematical Biology 41, 56-66. 26. Crump, K. S. (1978). low-dose extrapolations of animal carcinogenicity data (reply to the letter of Nathan Mantel). Cancer Research 38, (June issue). 27. Crump, K. S. (1978). Models for carcinogenic risk assessment (Technical Comment), Science 202, 1106. 26. Crump, K. S. (1979). Dose response problems in carcinogenesis. Biometrics 35, 157-168. 29. Differ, P. Z., Crump, K. S. and Masterman. M. D. (1980). Asymptotic theory for analyzing dose response survival data with application to the low-dose extrapolation problem. Mathematical Biosciences SO, 207-230. ------- ------------ _____ K. S. Crump CONFIDENTIAL 005519 Publications in Refereed Journals (continued) 30. Crump, K. S. {3981); 4n;inq>roed jprdcedurerfor lof-de.`*rciigenic risk .-.assessment from;*nime1 ^dat*;- journal ef:nvf ranaantal Pathology and Toxocology. Vote ,f* 316.' i.' <676-684; -m ' : 31. Crump, K. S; (1982); -designs.for-discriminatingbetween binary dose response -models *?i th rappl icatfops itoanimalxarcinqgenicity experiments.'' "Communications in 'Statistic!.; $H4)i. 32. Crump, K. S. and Sims, S. E. (1982). The quantitative effect ef migration upon geographic studies, '{-submitted)., "r.s . * .4 uvj-i S*ss ft!*#. (SI* 33. KreWskl ^.i'Cnimp^lc; 2S* -fktutrysd^nS^ Portier, C., Salsburg, B. 51elken, (1982). A comparison.of statistical thods for'-low-dose extrapolation utilizing:tii*totiiiowt^tay^aFuridafetnta 1 sand Applied ToxicolooyefBudcOdfatezof thealTockshOD?onviB?iPolca i and 'Statistical4mp)ieatfoKs-fof TSftd/iandSielatedaftata 'Bases) '(tooappearj; riezsc v."^ " V, \:*;: 34. Rodricks, J, V., and Crump, K. S. (1982). Assessing the risks of food constituents, -{submitted). -- , 35. Crump, K. S. (1983). Ranking carcinogens for*regulationa(1etter to the editor). Science. 219:4582, ,236-238. 36. .Crump* -K. &. -and-Howe,^. B.:-{1983).. The u"itistfge sffidel wtth a time-dependent dose pattern:(Applications to:carcinogenic risk assessment, (submitted) CONFiDENT'M, -5- K S. Crump nnR520 Other Publications. Reports. Etc. 1. Johnson, A. H. and Crump; 1. S. (1976). Transient solution of -solute cycling-model of the renal medul-1a-using Laplace transforms. . proceedings of'the 1976 Sunnier Simulation Conference, 460-463. 2. Guess, H. A. *nd Crump, K. S. (1977). Best-estimate low-dose extrapolation of carcinogenicity data, -environmental -Health Perspectives 22, 149-152. ' 3. Guess, H. A. and Crump, It. $. (T977). Can we use-enlaal experiments to estimate 'safe* doses for chemical carcinogens? Environmental Health: Quantitative^Methods: 43-30. cSIAM,-Philadelphia r(ed.' by Alice Whlttmore}. . .-? 4. Langley, X. H. andXrump,-K. .*5.:(1977). Possible advantages*and dl sadvantages *ofwnontransmitted-single-cell 4MmdnjmRttagines1 s assays. -:2entrallaboratirium fur;Motagei>1tatsprufuno-Tfldnfcrence on population monitoring "methods for detecting increasedatitatlon rates, 1976), 83-85. 5. Crump, K. S. (1978). Estimates of Risks to Humans from Chemical Residues in Heat. Prepared for the United States Congress Office of Technology ^Assessment. 6. Crump, K. S. (1978). Estimation 6f Mean Pesticide Concentrations When Observations are Detected Below the Quantification Limit. Prepared for Food and Drug Administration. 7. Crump, K. S. (1977). Experimental Design. Proceedings of the Conference on TSCA Carcinogenicity Testing Methods, 140-^41 (sponsored hyUtlohal Center for Toxicological Research) Little Rock, Ark., Aug. 22-23. 8. Cohen, A. C. and Crump, K. S. (1978). Statistical Analysis of Radionuclide Levels in Food Commodities. Prepared for the Food and Drug Administration. 9. Crump, K. S. and Masterman, M. D. (1979). Assessment of Carcinogenic Risks from PCBs in Food. Prepared for the United States Congress Office of Technology Assessment. In: Environmental Contaminants in Food. Vol. II - Working Papers (available from NHS). 10. Hoel, D. 6. and Crump, K. S. (1981). Waterborne carcinogens: a scientists view. In: (R. W. Crandall and L. B. Lave, eds.) The Scientific Basis of Health and Safety Regulation. The Brookings Institution, pp. 173-195. 11. Crump, K. S. and Masterman, H. D. (1979). Review and evaluation of Methods of Determining Risks from Chronic Low Level Carcinogenic Insult. Environmental Contaminants In Food: 154:165. Congress of the United States Office of Technology Assessment. Library of Congress Catalog Card Mo. 79-600207. K. S. Crump CONFIDENTIAL 005521 Other Publications. Reports. Etc, (continued) 12. Crump, DC. S. and Matson, W. W. (1979). 6L0BAL79: A FORTRAN Program to Extrapolate Dichotomous Animal Carcinogenicity to Low Dose. 13. Crump, SC. S., Howe, R. 8., Masterman, M. D. and Watson, W. W. (1980). RANK: A FORTRAN Program for Risk Assessment Using Tlme-tooccurrence Data. 14. Crump, K. S. and Howe, R. B. (1980). A Small Sample Study'$f Permutation Tests for Detecting:Teratogen1c Effects.. Prepared for..the Food and Drug Administration under Contract 223-79-2274. 15. Crump, K. S. and Mawon, W. W. (1980). Water Quil 1ty Criteria ~Calculatcd from''Multi stage 'and.. One-Hit-Models. Preplred'for^the'Environmental Protection Agency, Cincinnati, Ohio. a 16. Crump, K. S. (1980). Evaluation of Uncertainties in the Estimation of Carcinogenic Risks. Prepared for the American Petroleum Institute, 46 pages. 17. Crump, K. S. and Howe, R."B.-41980}. Carcinogenic, Mutagenic and Teratogenic Risk Assessment: An Annotated Bibliography. Prepared for the Environmental Protection Agency under Contract 68-01-5975, 30 pages. 18. Crump, K. S. and Howe, R. B. (1980'). Approaches to Carcinogenic, Mutagenic and Teratogenic Risk Assessment. U. S. Environmental Protection Agency, Contract Ho. 68-01-5975, Task A, Subtask HO. 5 Summary Report, 169 pages. 19. Crump, K. S. (1980). Carcinogen-based Criteria: Assessment of Uncertainties. Proceedinos-ofSymposium m the Development. Use and Value-of "Water-Quality `Criteria- and -"Standards, -Oeoroe Washington University, June Z3-25, l9Bo, l& pages. 20. Crump, K. S. and Guess, H. A. (1980). Drinking "Water und Cancer: Review of Recent Findings end Assessment of Risks. Executive Office of the President, Council on environmental Quality, Washington, 0. C. Contract Wo. EQ10AC018, 109 -pages. ' 21. Nisbet, I. C. T. Crump, K. S., Paxton, H. B. and Turin, J. (1980). Carcinogenic Risk Assessment for Hexachlorobenaene. Prepared for the U. S. Environmental Protection Agency, Contract No. 68-01-5824, 7 pages. 22. Crump, K. S. and Guess, H. A. (1982). Drinking water and cancer. In: (L. Breslow, J. E. Fielding and L. 8. Lave, eds.) Annual Review of Public Health Vol. 3, pp. 339-357. -- 23. Ricci, P. F., Crouch, E. A. C., end Croup, K. S. (1982). Sourcebook on Technological Risk Assessment (in preparation). CONFIDENTIAL -7- K. S. Crump 005522 Other Publications, Reports. Etc, (continued) 24. Crump, K. S. and Howe, R. B. 11960). A Small Sample Study of-Some Multivariate and Dose Response Permutation Tests for Use with Teratogenesis or Carcinogenesis Data. Prepared for the Food and Drug Administration under contract to Ebon Research Systems, 34 pages, 25. Crump, K. S. (1981). Statistical aspects of linear extrapolation. In: (ed. C. R. Richmond, P. J. Walsh, and D. JCepenhavtr)i .Proceedings of the Third Life Sciences Sypesium, StealthvIlsk^analysisT StilriburoT" 'Tennessee,' October, 1980, pp.35T35?I ."Trrr... rt. 26. Crump, K. S. (1981). Issues related to carcinogenic rJskxassessment from-animal,data. Presented at the International `-School of Technological Risk Assessment, a NATO Advanced: Study Institute, Erice, Italy, (in press) 27. Crump, K. S. (1981),. Chlorinated-drinking water,and.cancei;: The strength of the epidemiologic evidence. In: (ed. R. L. Jolley,set al.) Water Chiorination: Environmental Impact and Health Effects, 51time 4, Book l.TEnvf'io5saimii jhg^RlskT.-Ann Arbor Science BabHshers. pc. llSl-1491. 28. Crump, SC. S. and Howe R. B. (1982). Examination of-Options for Calculating Daily Intake Levels (OILS). Prepared for the Environmental Protection Agency, Order fto^ C2171NAST, 56 pages. 29. Crump, K. S. (1982). Implications of the Multistage Model to Risks from Partial lifetime Exposure. Prepared-for the Environmental Protec tion Agency, Order No. C2171NASR, 26 pages. 30. Crump, K. S. (1982). The Scientific Basis for Health Risk Assessment. Presented at .the seminar sponsored by George -Washington University Graduate Program in Science, Technology, end Public Policy and by the U. S. Environmental Protection Agency, Washington, 0. C. March 2, 29 .pages. 31. Howe, R. B., ond-Crump, K. S. (1982). GLOBAL 62: A Computer Program to Extrapolate Ouantal Animal Toxicity Data to Low -Doses. Prepared for the Office of Carcinogen Standards, OSHA, U.S. Department of Labor, Contract 41USC2S2C3. 32. Crump, It. S., and Howe, R. B. (1983). Review of Methods for Calculating Confidence Limits in Low Dose Extrapolation. In: (Krewski, D. ed.) Toxicological Risk Assessment. CRC Press, Inc.:Cenada (in preparation). * 33. Crump, A. S. (1982). Quantitative Assessment of Human Risk from Exposure to Carcinogens with Special Reference to Vinyl Chloride. Prepared for the Ontario Ministry of Labour, Occupational Safety end Health Division. CONFIDENTIAL DC. S. CfWf? 005523