Document mOdpwayKOrqov5grRyye33dO

BEFORE THE UNITED STATES DEPARTMENT OF LABOR , OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION In re . EMERGENCY TEMPGRARY: STANDARD FOR OCCUPATIONAL EXPOSURE TO ASBESTOS '-rr! ;_____________________________ ) ) ) ) ) ) , . , ... OSHA Dockert No. H-.033C ;:: * 1 2 )... .. . AFFIDAVIT OF DR. KENNY SHERMAN CRUMP Kenny Sherman Crump, being first duly sworn deposes ana 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 (NIEHS). Since 1978, I 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. I 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. I have been a member of National Academy of Science paneisy including the / n". : * ; ,, AV\C*T1" J - J j'l -n. panel that earlier this year issued the report, *RsfcAssess ment in the Federal Government: Managing"'the Process!1 (OSHA Ex. 84-322). 3. Most recently, I have developed several quantita tive risk assessments for the Occupational Safety and Health Administration (OSHA). 1 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. I 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, I was asked by the Asbestos Information Association/North America (AXA/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). CONFiDENT.'Ai 005^99 -3 - 5. I have reviewed OSHA's asbestos ETS Federal Regis ter notice and its underlying quantitative risk assessments (OSHA xs. 134-1, 84-349, 84-392), as well as other asbestos risk assessments made for the government of the United Kingdom (OSHA Exs. 84-216 and 84-243) .and the Consumer Product Safety Commission (Ex. 8$r256). I. The Nature Of Quahti't'ative ^is)c'Assessment 6. Quantitative risk, assessment is inherently .uncer tain. As the NAS Committee on Risk Assessment on ^hich 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 NAS Committee listed a number of assumptions that are particularly relevant to risk assesments of asbestos. For example, in dose-response .assessment, the NAS 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 (c) "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 same crucial determination must be made, namely, as phrased in the NAS report, Mhow should one estimate the size and nature of the populations likely to be exposed." (OSHA Ex. 84-322, at 32). 8. The uncertainties inherent in quantitative risk assessment are particularly severe when one attempts to assess the risk .of a small segment of total fhuman exposure. For example, quantitative estimates of the risk to indivi duals from a lifetime of smoking cigarettes involve.uncer tainties, but even greater uncertainty exists if one attempts to assess the risk of smoking one cigarette, or 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 Fanel on which I 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. 64-322, at 156). CONFIDENTIAL 005501 - - xo. 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's risk? assessment" (OSHA Ex. 84-322, :at 157-58). The.NAS report further recommends that the agency "should discuss any important criticisms of 4 its [risk] assessment in its proposed -regulatory action . . ." (OSHA Ex 84-3-22, at 159). 11. In the absence of an independent peer review panel's scrutiny of agency risk assessments, as called for by the HAS 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 NAS Com mittee, these review procedures can be effected through agency hearings. CONFIDENTIAL 005502 - -6 -- I'M v- The Assumptions inOSHA'sAsbestos Quantitative Risk Assessment 12- In estimating health risks from exposure to asbestos fibers, OSHA makes a number of assumptions which are open to question. These include: (a) OSHA-assumes that there- is a-linear relat-dons'hip! between ^asbestos ^sxposur*^ (in-^tOims of: both' ibtensity kana;':fiuration)'5iind^heali^i4^f`febts at exposure IfeVels- low as-* 2fiberS/cc for = as short a :time as six-months. (b) OSHA assumes -that estimates of exposures in two of-.the-studies on-which-OSHA relies-are valid even-though no* exposure information was col lected "ion- the Workers "whose >ftaalth>-effects were examined in those: studies- (i>e., the Selikoff and Seidman-studies, ^OSHA^Xs. ^84-90 and 84-87 ). OSHA estimates -exposures -for-the workers studied -by Seiran-,'-sVho-*ere-New 'Jersey, `^during Wbrld^ar. Hi based-son measurements in two- "other plants,; which OSHA- states ''manufac tured :the same products* with- similar fiber and machinery," which measurementswere made 21 to 31 years later at these other plants in Texas and Pennsylvania (Ex. 84-392, at 26-27). I know of no other instance in which regulators have relied on quantitative risk assessment based on studies for CONFIDENTIAL 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 *vhich have occurred over the years. As OSHA itself states: "Exposure _ data frequently, are not available for workers exposed before 1970. Where historical exposure data are available, the tfata often have such limitations as having been collected and analyzed using industrial hygiene techniques ncf 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.M (48 Fed. Reg. 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 used 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 measurement* 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 i periods (when exposures :were highest) plus the^changes in measure ment t^chniques imply .t* theme? ais considerable uncertainty associatedwith jthermxposure estimates used by OSHA^to derivetquantitative risk estimated. (d) OSHA assumes that; no, distinctions in * .p risk should, be.made, for-different types- of asbestos or different types of:asbestos operations. (e) OSHA assumes, that each of. the eleven studies relied nponr: in.;OSHA*s..risk _ assessment should be accorded,equal, reliability^and weight in determining a: best-^estimate of? quantitative risk. ( f) OSHA assumes: that othe eleven, studies upon which-OSHA^relies to tpredict limg cancer risks are the appropriatei studies upon awhich to rely in estimating asbestos lung cancer risks. (g) OSHA assumes that the:fourrstudies 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 extrapolstable to modem 1 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. Zn the Dement study (Ex. 84-35) which OSHA did not use to estimate mesothelioma risk, 19.5 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 005506 - 10 - cancers, relative to the fibers in the Selikoff study, since the carcinogenic potencies for lung cancer estimated by OSEA were KL = 0.020 for the Selikoff study and = 0.042 for the Dement study and the potency for mesothelioma from the Selikoff study was K^j = 1.5 x 10 , this suggests a potency for mesothelioma in the Dement study of Kj^ = (0.16) (0.042)/(0.020)(1.5 x 10- ) = 5.0 x 10" . This value is y " *i * smaller than any of the four potencies for mesothelioma estimated by OSHA and is one-half the value used in OSHA's risk assessment to predict mesothelioma deaths; 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, OSHA's quantita tive risk assessment does not calculate the resultant CONFIDENTIAL 005507 - 11 - ten*fold difference in lung cancer risks for smokers and non-smokers. III. Comparisons with Risks Predicted by QSHA in Other Proceedings Where. Emergency Standards Have Not Issued________________ 16. I am familiar with, indeed I myself developed in some cases, quantitative risk assessments upon which OSHA v . ' : , \ . i-,r< c [ + z-J'SOO 9,7- . ,i >, has relied in regulatory proceedings on other substances. In several of those proceedings, OSHA's estimates of the 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 fibers/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 befit estimate of lifetime lung cancer, risk '--at- the* ^existing, 5.00.. Mg/m3 standard of 375*to 465/1000. Seethearsenicpreamble, 44 Fed. Reg. at 15360 (April 9, 1982). 18. Likewise, in its advanced notice of. proposed rulemaking on ethylene dibromide, a substance for which QSHA denied an ETS request (OSHA Ex. 64-282), OSHA noted that an excess cancer risk of 400/1000 had been predicted et the existing permissible exposure level. 46 Fed. Reg. at 61674 CONFIDENTIAL 005508 - 12 - (Dec. 18, 1981). This risk is nearly seven 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. 84-283), even though it esti mated an excess cancer risk of from 63/1000 to 152/1000 from lifetime occupational exposure at the then-existing OSHA : ; c:i :l .r-!. I t *L ?-; .i.ri standard of 50 ppm. 48 Fed. Reg. at 17293. The population * - - . ; ~ -r J fc**.5Z ; ~ 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 tNew- Evidence: in OSHA*s Asbestos Risk Agreement 20. Besides estimating risks-lower than on other substances where -an" ETS5 was- injected i- OSHA,!s; 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 terms 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 CONFIDENTIAL 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' for review for more than two years. Several, "although Trior'e recently updated, were first published in thfe tseo's and ear*i^T970's (e.q.. the Selikoff, Ex. 84-90; McDonald-Liddell, Ex. 84-65; and Enterline, Ex. 84-48 studies).\ Most of the eleven studies .9 were published between 1975 and 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 Bince 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 (cc), 48 Fed. Reg. at 51089-90. OSHA's assertion is premised on a number, of assumptions, as enumerated in 1 12. None 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. .t.ime. , 25. As OSHA itself, .notes (48 Fed. Reg* . at.. 51100), ,in each of the .eleven .studies -upon what it. relies workers were exposed to asbestos at. levels, considerably above the purrent standard of 2 fibers/cc. For example, OSHA. estimates that exposures in the Selikoff study of asbestos insulators ranged from 10 to 40 fibers/cc (Ex. .84-392, at 25), and exposure of amosite insulation, manufacturers in the Seidman study averaged 35 fibers/cc (Ex., 84-3.92, 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 0S3A states, 48 Fed. CONFIDENTIAL 005511 15 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, OSHA has found no evidence on which to rely in supporting its assumption that cumulative exposures, from exposure,at 1 fiber/cc for. twenty..years ,pose as much risk as exposures in the c.past -.tp,3fijrers^cc fox one year. None, of the studies, on which..OSHA fays it .relics demonstrate directly that phere. is increased risk for,..workers who would be exposed to 1 fiber/cc-y.ear, .the. 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 Assuming Compliance witli the 2 f/cc Standard." This table assumes that all' workers are currently exposed at no more than the 2.0 fi&ers/cc Standard. It thus determines what additional benefits OSHA calculates would be gained by reducing all worker exposures to the 0.5 fibers/cc Els 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 - 16 - for various exposure levels and durations of exposures in Table 11. 30- Based on Tables 1 and 11, I am able to calculate the same numbers in Table 4 as does OSHA, except for the category construction workers. That is, !OSHA calculates, in the first column" of'Table 4, that 57 construction worker lives will* Dir -saved *by deducingiix frCm 2:0 fibers/cc" to fibers/cc. `iJs'intf tie''same "mlihod of taicuiatrotr I use^td reconstruct the Table-4~'nuiabprs*for* other worker categories, 1 calculated that 'the. numpber ~of construction worker lives Saved over' 6 months is'17, rather than 57 as reported by OSHA. I performed the following calculations for the three categories of construction workers currently said by:-36SHA ^to-be exposed-^abbve 0.5 fibers/cc: A/C pipe workers: A/C sheet workers: [5^45& workers] x [.5 years] x [the one ,year risk at 1; f/cc. minus, the Cne "year risk at 0.5 f/cc, namely. (111-74)/100,000] .= 7.0 life... - fl /75% Wbirkebii'i" k*' 5 years ] x 10.5 .f/cc.namely. .(96-74)/ TOO ,h003 -a 1.9 "lives. Drywall removal, demolition, and renovation workers: 12,955 worker's] x [.5 '^eSts] [the one, year risk at. 2.0 f/cq Bdhtfs'thVons'yitfr Tlik'-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 appaient error in the number of lives saved among construction workers .Joy reducing exposures from 2.0 fibers/cc to 0.5 fibers/cc (i.e., 17 lives rather than OSHA's' 57 ); the assumptions used by OSHA imply that the total number of lives saved in Table 4 over a six-month period is 40, rather.than the 60 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 61% 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 tbe pre-existing 2.0 fiber standard. CONFIDENTIAL 005514 Ruston Louisiana Dr. Kenny S. Crump, being first duly sworn, deposes and says that all facts contained in the foregoing affidavit are true -'and Correct to the best of1 his* knowledge, informa tion and belief. Subscribed and sworn before me this t/iHL day" of^November y 1983 ft 3 CONFIDENT!/.' 005515 AttacKitraht ' l CURRICULUM VITAE Kenny Sherman Crump Address Office Science Research Systems, Inc. 1201 Gaines Street Ruston, Louisiana 71Z70 Telephone: {318) 255-4800 Home 1628 Hodges Road Ruston, Louisiana 71270 Telephone: (318) 255-7056 Date of Birth Place of Birth Marital Status rHTTiren--------- October -13, 3939 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 Beta 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 Professional Experience (continued) 1969 (summer) 1974-1975- 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,-Inc. Ruston, Louisiana Committees and Offices 1976-1979 Officer, Louisiana Chapter -Amerteafi ^tttifotlcal Aspffiat1on Secretary-Treasurer- -1976-T977 s'veH iL' d *4. - Vice-President 1977-197$ ' lrr-,, c ' President 1978-1979 *'r;r :L a 1978-1979 United States Congress Office of Technology Assessment;.. member of tolerance Advisory Panel-invironmeqtal Contaminants in-Food. \- 1979-1980 National Academy of Sciences; member of'THVsel Impacts Study Committee and Panel on the Health Effects of Diesel Emissions. 1980-1983 American Statistical Association; member of Committee on Statistics-and the-Enyvconment -1 1981-1982 National Academy of Sciences; membef'of'Cdmittee on Institutional Means for the Assessment of Risks to Public Health Selected Testimony Roya 1 Commi ssion on `Watters of -Health*arid Safjety'AnHihg -From^the Use -of Asbestos in Ontario August 13, 1981 (presenrted findings resulting from'revtew of asbestos health effect literature, critiques of risk assessments carried out by other investigators, and independent Congress of the Uni ted*Stalesj H6use~df "R^pr^lentiitiyes; ^Cdmmfttee-on Science and Technology May 20, 1982 (reviewed>tPA-S^carcinogen1c--r-lSk- ' assessment on formaldehyde.) Occupational Safety and Health Admlnlstratfon^HeaHng^on^Exaosure to, InorganTp Arsenic. June 18, 1962 (critiqued quantitative risk assessments and presented independent findings.) Areas of Consulting Experience Environmental Statistics Bioassay Statistical Design and Analysis Environmental Epidemiology Cancer Epidemiology Health Risk Assessment (especially cancer) CONFIDENTIAL K. S. Crump 005517 Publications in Refereed Journals 1. Crump, K. S. and Mode, C. J, (1968). A general age-dependent branching process 1. Journal of Mathematical Analysis and Applications 24, 494-508. 2. Crump, K. S. and Mode, C. J. (1969). 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 branching'process-with correla tions among siblings. Journal of Applied Probability 6, 205-210. 4. Crump, K. S. (1970). On systems ofrenewal equations. Journal-of Mathematical. Analysis and AppHcations30. No. .425-434. 5. Crump, K. S. (1970). On systems at renewal equations: The reducible case. Journal of Mathematical Analysis and Application's 30. No. 3. 517-528: " " --------- r 6. Crump, K. S. (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. ----------------- ----- 8. Crump, K. S. and Howe, R. B. (1972). Nonparametric estimation of the age of a Galton-Watson branching process. Biometrika 59, 533-538. 9. Hoel, 0. 6. and Crump, K. 5. (1974). Estimating the oeneration-time of an age-dependent branching,process. Biometrics 30, 125-235. 10. Crump, K. S. and Hoel, D. 6. (1974), Mathematical models for estimating mutation rates in cell populations. Biometrika 61. 237-252. 11. Crump, K. S. and Howe, R. B. (1974). Estimation of the age of a BellmanHarrfs branching process. Mathematical- Biosclences 19, 175-184. 12. Crump, K. S. (1975). On point processes having an ordBr statistic structure. Sankhya 37, Series A, 396-404. 13. Crump, K. S. (1976). Numerical inversion of Laplace transforms usiijg a Fourier series approximation. Journal of the Association for Computing Machinery 23. 89-96. 14. Crump, K. S., Hoel, D. 0., Langley, C. 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 6i11espie, J. H. (1976). The dispersion of a neutral allele considered as a branching process. Journal of Applied Probability 13, 208-218. ------ -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 Biosciences 33, 177-188. 19. Crump, K. S., Guess, H. A.' and Deal, K, L. (1977). Confidence intervals and tests of hypotheses inferred from animal carcinogenicity data. Biometrics 33, No. 2, 437-451. 20. Crump, K. S. and Gillespie, 3. H, (1977). The geographical distribution of a neutral allele. Theoretical Population Biology 12, 10-20. 21. Guess, H. A., Crump, K. S. and 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. Gamer, J. B., Crump, K. S., and Stephenson, J. L. (1978). Transient behavior to the single loop solute cycling model of the renal medul 1 a. Bulletin of Mathematical 81o1ogy 40, 273-300. 24. Crump, K. S. (1977). Open Query: Theoretical Problems in the modified Mantel-Bryain procedure. Biometrics 33, 752-755. 25. Crump, K. S. and 0`Young, W. C. fl979). 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. 28. Crump, K. S. (1979). Dose response problems in carcinogenesis. Biometrics 35, 157-168. 29. Daffer, P. Z., Crump, K. S., and Masterman. M. 0. (1980). Asymptotic theory for analyzing dose response survival data with application to the low-dose extrapolation problem. Mathematical Biosciences 50, 207-230. -4- K. S. Crump CONFIDENTIAL 005519 Publications In Refereed Journals .{continued) 30. Crump, K. S. (1981). An :Improved SprOcedure -for lovt-dbse -careinogenic risk assessment from animal data. Journal of Environmental Pathology and Toxocology; Vol. 5.;H6. 2.675-684. 31. Crump, K. S. (1982). Designs fordiscriminatingbetween binary dose response-models with applications to-animal carcinogenicity experiments. Communications in,Startitles; 11(4),475-393. 32. Crump, K. S. and Sims, S. E. (1982). The quantitative effect of migration upon geographic studies, (submitted). 33. Kcewski,Crump,^K:2S.v3Eafther;sfcisSaylor^iDMl^Q HoeejcR. B., Portier, C., Salsburg, D., SielKen, R. uWaridiVan Ayzfh, J. (1982). A comparison of statistical methods for-low-dose extrapolatlonrutllisingvtli^yto^tuaoursdata.^urtdamentalcand Applied Toxicoloov^ftffdceedings^of 'theotforkshopion^Btologlcal and StatisticalImplTCattoHs^of theiED*; Study^and'RelatediOata Bases) (to-appear). ^""7; 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^regulation (letter to the editor). Science, 219:4582, .236-238. 36. Crumps K. ,S.-and^Howe^eRv B?*.(1983). . The jJUltistage model with a time ^dependent dose pattern: ^Applications to carcinogenic risk assessment, (submitted) CONFIDENT!/.', K. S. Crump 005520 Other Publications, Reports, Etc. 1. Johnson, A. M. and Crump, K. S. (1976). Transient solution of a solute cycling model of the renal medulla using Laplace transforms. * Proceedings of the 1976 Summer Simulation Conference, '460-463. 2. Guess, H. A. and Crump, K. S. (1977). Best-estimate low-dose extrapolation of carcinogenicity data. -Environmental Health Perspectives 22, 149-152. 3. Guess, H. A. and Crump, K; S. (1977). Can we use animal experiments to estimate 'safe1 doses for chemical carcinogens? Environmental Health: QuantftatlvesHethods: 43-30. SIAM, .PhiladelphiaH*d.'by Alice Whittmore). : :v 4. Langley,.C.-H. and -Cramp, K.,`S. (l977). Possible advantages and disadvantages of*nontransmittedssingle-cell human.^nutaginesis assays. Zentrallaboratarlum fur Hutagenltatsprufung-fConference on population monitoring methods for detecting increased-mutation rales, 1976), 83-85. 5. Crump, K. S. (1978). Estimates of Risks to Humans from Chemical Residues in Meat. 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. 140-141 (sponsored by National 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 NT15). 10. Hoel, D. G. and Crump, K. S. (1981). Waterborne carcinogens: a scientists view. In: (R. H. Crandall and l. B. lave, eds.) The Scientific Basts of Health and Safety Regulation. The Brookings Institution, pp. 173-196. 11. Crump, K. S. and Masterman, M. 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 No. 79-600207. 6- K. S. Crump CONFIDENTIAL 005521 I Other Publications. Reports, Etc, (continued) 12. Crump, K. S. and Watson, W. W. (1979). 610BAL79: A FORTRAN Program to Extrapolate Dichotomous Animal Carcinogenicity to Low Dose. 13. Crump, K. S., Howe, R. B., Masterman, M. D. and Watson, W. W. (1980). RANK: A FORTRAN Program for Risk Assessment Using Time-tooccurrence Data. 14. Crump, K. S. and Howe, R. B. (1980). A Small Sample Study of Permutation Tests for Detecting:Teratogenic Effects. Prepared for'the Food and Drug Administration undetr Contract 223-79-2274. 15. Crump, K. S. and Wa.,on, W. W. (1980). Water Quality Criteria Calculated from Multistage and,,One-Hit Models. Prepared for the Environmental Protection Agency, Cincinnati,-Ohio. 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. end Howe, R. 8.(1980). 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, GOntract No.`68-01-5975, Task A, Subtask NO. 5 Surmary Report, 169 pages. 19. Crump, K. S. (1980). Carcinogen-based Criteria: Assessment of Uncertainties. Proceedings Of Symposium on the Development. Use and Value of Water Quallty Crlteria and Standards. George Washington University, June 23-25*' 4980, lB pages. 20. Crump, K. S. and 6uess, H. A. (1980). DrinkingWater and Cancer: Review of Recent Findings jtnd Assessment of Risks. Executive Office of the President, Council on Environmental QuaTIty, Washington, 0. C. Contract-No. EQ10AC018, 109 pages. 21. Nisbet, I. C. T., Crump, K. S., Paxton, M. B. and Turin, J. (1980). Carcinogenic Risk Assessment for Hexachlorobenzene. Prepared for the U. S. Environmental Protection Agency, Contract No. 68-01-5824, 87 pages. 22. Crump, K. S. and Guess, H. A. (1982). Drinking water and cancer. In: (L. Breslow, J. E. Fleldina and L. B. Lave, eds.) Annual Review of Public Health Vol. 3, pp. 339-357. 23. Ricci, P. F., Crouch, E. A. C., and Crump, 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. (1980). A Small Sample Study cf 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. Ir,: (ed. C. R. Richmond, P. J. Walsh, and D..Copenhaver)< Proceedings of the Third life Sciences Symposium. Health-Risk Analysis, Gatltnburq. Tennessee*-October, 1980, PP.581`492. ; 26. Crump, K. S. (1961). Issues related to carcinogenic risk `assessment 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.cance^rThe strength of the epidemiologic evidence. In: (ed. R. L. Jolley,.et al.) Water Chlorination: Environmental Impact and Health Effects, 'Volume 4' 8ook 2. Environment. Health. and-Risk, Ann Arbor Science Publishers, pp. 1481-1491. 1 -------------------- 28. Crump, K. S. and Howe R. B. (1982). Examination of-Options for Calculating Daily Intake Levels (DILS). Prepared for the Environmental Protection Agency, Order No. 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, and Public Policy and by the U. S. Environmental Protection Agency, Washington, D. C. March 2, 29,pages. 31. Howe, R. B., andXrump, K. S. (1982). GLOBAL 82: A Computer Program to Extrapolate ^Quanta) Animal toxicity Data to Low Doses. Prepared for the Office of Carcinogen Standards, OSHA, U.S. Department of Labor, Contract 41USC252C3. 32. Crump, 1C. S., and Howe, R. B. (1983). Review of Methods for Calculating Confidence Limits in Low Dose Extrapolation. In: (ICrewski, D. ed.) Toxicological Risk Assessment, CRC Press, lnc.:Canada (in preparation). 33. Crump, K. 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 and Health Division. (.uMFiDENTIAL -8- K. S. Crump 005523