99th Congress 2d Session COMMITI'EE PRINT I I COMMITrEE PRINT 99-MM OMB REVIEW OF CDC RESEARCH Impact of the Paperwork Reduction Act A REPORT PREPARED FOR THE USE OF THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS OF THE COMMITTEE ON ENERGY AND COMMERCE U.S. HOUSE OF REPRESENTATIVES OCI'OBER 1986 I I U.S. GOVERNMENT PRINTING OFFICE 64-167 0 WASHINGTON: 1986 For sale by the Superintendent of Documents, Congressional Sales Office u.s. Government Printing Office, Washington, DC 20402 WM. MICHAEL KITZMILLER, Staff Director THOMAS M. Rv AN, Chief Counsel LINDA G. STuNTZ, Minority Counsel SUBCOMMITI'EE ON OVERSIGHT AND INVESTIGATIONS JOHN D. DINGELL, Michigan, Chairman RON WYDEN, Oregon NORMAN F. LENT, New York DENNIS E. ECKART, Ohio THOMAS J. BLiLEY, JR., Virginia JIM SLA1TERY, Kansas MICHAEL G. OXLEY, Ohio GERRY SIKORSKI, Minnesota MICHAEL BILIRAK.IS, Florida JAMES H. SCHEUER, New York DAN SCHAEFER, Colorado JAMES J. FWRIO, New Jersey FRED J. ECKERT, New York THOMAS A. LUKEN, Ohio TRENT L01T, Mississippi JOHN BRYANT, Texas HENRY A. WAXMAN, California RICHARD C. SHELBY, Alabama MICHAEL F. BARRE'IT, Chief Counsel/Staff Director DEBRA ANN JACOBSON, Counsel DoNALD CoRRIGAN, Special Assistant (II) tIaR II ~I" ...,... ..... ,,!we _'-'T.• ~ • amIjI_ m ... -~ ...- '8,~, .... _ _ _ _ ,meAl . JOHN D. DINGELL. Michigan, Chairman JAMES H. SCHEUER, New York NORMAN F. LENT. New York HENRY A. WAXMAN. California EDWARD R MADIGAN, Illinois TIMOTHY E. WIRTH. Colorado CARLOS J. MOORHEAD, California PHlUP R. SHARP, Indiana MATI'HEW J. RINALDO, New Jersey JAMES J. FWRIO, New Jersey WILIJAM E. DANNEMEYER. California EDWARD J. MARKEY, Massachusetts BOB WHl'ITAKER, Kansas THOMAS A. LUKEN, Ohio THOMAS J. TAUKE, Iowa DOUG WALGREN, Pennsylvania DON RIITER, Pennsylvania BARBARA A. MIKULSKI, Maryland DAN COATS, Indiana AL SWIFI't Washington THOMAS J. BLILEY, JR., Virginia MICKEY LELAND, Texas JACK FIELDS, Texas RICHARD C. SHELBY, Alabama MICHAEL G. OXLEY. Ohio CARDISS COLLINS, Illinois HOWARD C. N1EUKJN, Utah MIKE SYNAR, Oklahoma MICHAEL BILIRAKIS, Florida W.J. "BILLY" TAUZIN, Louisiana DAN SCHAEFER, Colorado RON WYDEN, Oregon FRED J. ECKERT, New York RALPH M. HALL, Texas TRENT LO'IT, Mississippi DENNIS E. ECKART, Ohio WAYNE DOWDY, Mississippi BILL RICHARDSON, New Mexico JIM SLATI'ERY, Kansas GERRY SIKORSKI, Minnesota JOHN BRYANT, Texas JIM BATES, California ....."""'- _J"'-' _ _ ---_. ---_ COMMITrEE ON ENERGY AND COMMERCE _£_ . . . -- ........... ...... -------. .. -.-_.-.---_um._ _ .......... -'_.-- ....... --_...--- • ........... 20515 september 26, 1986 LBT'l"ER OF TRANSMITTAL ro MEMBERS OF THE OOMMITTBB ON ENERGY AND COMMERCE: Dear COlleague: It is my pleasure to transmit the attached report entitled ·OMS Review Of CDC Research: IJIlpact of the Paperwork Reduction Act.· This report was prepared, at the request of the Subcommittee, by members of the Occupational Health ProguJII of the Harvard School of PUblic Health and tbe Director of the Division of Environmental and Occupational Medicine of the Mount Sinai School of Medicine. 'l'heir report is based primadly upon a technical analysis of doclDlents provided by the Centers for Disease COntrol. 'l'be attached report docUlllents how the White House Office of Management and Budget (OMS) has abused its authority ~der the Paperwork Reduction Act in its review of research proJects of the Centers for Disease COntrol. In nUllerous cases, including ro sed studies of the health effects of dioxin and of the :Ot~tial (but as yet undocUlllented) reproductive hazards of vio;o display terminals, Ole has interfered with the substance of CDC s research under the guise of paperwork control. In each case, scientifically W'l.tutored OMS officials sought to second-guess the professional judgments of agency scientists and the aul tidisciplinary panels of outside experts. In addition, the report discloses that OMB's Office of Information and Regulatory Affairs has implemented the Paperwork Reduction Act in a biased JIIanner by discriminating against the collection of information for environmental and occupational health research. 1'be report found that OMS officials were seven tilRes more likely to reject CDC's environmental and occupational health research projects than research relating to infectious or other disease processes. Studies with a focus on reproductive hazards also were treated unfavorably by OMB. mil IV The report demonstrates that OMS has exercised its paperwork clearance functions over CDC research in a manner contrary to the public interest. Rather than minimizing the costs of information collection, the paperwork review process bas resulted in a significant diversion of tax dollars frem productive public heal th research into nonproductive paper-pushing and unnecessary contracting expenses. Rather than protecting the public against unnecessary government intrUSion, OMB has delayed, impeded, and thwarted govermtenta! research efforts designed to respond to public demands for answers to serious health questions. This report provides fUrther evidence that OMB's Office of Information and Regulatory Affairs bas flaunted Congressional intent. It will provide valuable information to the Congress as we consider the future of OMB's paperwork review office and pOSsible changes in the Pa rwork Reduction Act. John D. DingeU Chaiman S ubcommi t tee on Oversight and Investigations HARVARD SCHOOL OF PUBLIC .e!9 OCCUPATIONAL HEALTH PROGRAM ~ HEALTH •• " HUNTINGTO ............ U .. .O&TO", .... aa .. clluaETu OU'$ "'7> 7U_ ..... O 19 september 1986 John D. Dingell Chairman Subcommittee on Oversight and Investigations Committee on Energy and Commerce 2323 Rayburn Rouse Office Building WASHINGTON, DC 20515 Dear Chairman Dingell: o 25 Harch 1986 you vrote requesting tbat our group lubait a n , . . 1 t t· on of tbe Pa,er"."ork report to the Subcommittee concern lUg 1mp emen a 1 . Reduction Act with respect to programS of the CenterS for Dl~~~~ed "OMB Control In reSpOnse to your letter. the enclosed report en 1" e REVIEW OF CDC RESEARCH: IMPACT OF THE PAPERWORK REDUC:-ION ACT was prepared by the following scientists listed.bel~. T,~llt ~e:o~~w It represents the research and views of the 8clent1sts lS e e • has not been reviewed or endorsed by Harvard University. Barbara Boardman, H.D., H.P.H. Resident in Occupational Medicine Harvard School of Public Health Isn A. Greaves, M.D. Associate Professor of Cccupational Health Harvard School of Public Charles Levenstein, Ph.D., H.S.O.H. Lecturer on Occupational Health Harvard School of Public Health Philip J. Landrigan, M.D., M.Sc. Professor DirectOr, Division of Environmental and Occupational Medicine Mount Sinai School of Medicine City University of New York ~ r~n ~ ". Greaves. ASSO-;;: ,v, Prof. Occup. Healtl, CONTENTS PAGE EXECUTIVE SU~Y ••••••• ••••••• ••••••• ••••••• ••••••• •••••• 1 INTRODUCTION ••••••• ••••••• ••••••• ••••••• ••••••• ••••••• • '" 4 OKB REVIEW PROCESS UNDER TRE PAPERWORK REDUCTION ACT.. .... S THE PEEa REVIEW PROCESS ••••••• ••••••• ••••••• ••••••• ••••••• 6 CASE REVIEWS.............................................. 8 14 OKB PATTERNS OF APPROVAL AND DISAPPROVAL ••••••• ••••••• •••• Methods and Data ••••••• ••••••• ••••••• ••••••• ••••••• ••• 14 Statis tical Evalua tion ••••••• ••••••• ••••••• ••••••• •••• 16 Findin gs ••••••• ••••••• ••••••• ••••••• • o • • • • • • • • • • • • • • • • APPENDIX OF CASE STUDIES ••••••• ••••••• ••••••• ••••••• •••••• Study of Dioxiu WorkeT '. Morbid ity and Reprod uctive Effect s ••••••• ••••••• ••••••• ••••••• •••• NIOSH Reprod uctive Study of Female Video Displa y Termin al Operat ors ••••••• ••••••• ••••••• ••••• NIOSH Invest igation of Workers Exposed to MBOCA ••••••• Epidea iologic Study of Ladder Fall Injurie s ••••••• •••• Health Risks of Inform ation Proces sing ••••••• ••••••• •• Center s for Diseas e Contro l Reprod uctive Outcome Survey ••••••• ••••••• ••••••• ••••••• ••••••• ••••••• •••• ,VII) 18 21 22 26 31 33 35 36 EXECUTIVE SU1IIW!.Y In 1980. Congress enacted the Paperwork Reduction Act with the intended goal of reducing the burden of government paperwork on the general public. For the purpose of imple- menting the Act. review of all government information collection was consolidated into the Office of Information and Regulatory Affairs (OIRA) within the President I B Office of Management and Budget (OHB). At the time of passage of the Act, Congress expressed concern that this cODsolidation of review power within OMB might be subject to abuse. Because of this concern, language was inc luded in the Act specifically stating that the OM! review was not to interfere with the substantive programs and policies of agencies. OMB is required by the Act to clear all information collection requests by Federal agencies. This requirement includes the power to review scientific and medical information collection by agencies such as the Centers for Disease Control (CDC). OMB's review is for paperwork reduction purposes only. This review should be distinguished from the extensive scientific peer review which involves numerous experts in the evaluation of CDC studies. Given the initial legislative concern about the potential for OMB abuse of its Paperwork Reduction Act authorities, we reviewed the OMB clearance process 8S it has actually affected CDC studies during the period from January. 1984, to March. 1986. During this period, six major peer review studies from CDC were either significantly delayed, seriously altered in scientific design, or disapproved entirely by OMB. We evaluated the six studies systematically; all had received a thorough and appropriate review from panels of nationally recognized experts, and all were approved by the respective peer review group. The OMB review. which was superimposed on the peer review process, generally relied on single consultants rather than a panel of experts. The process was poorly documented and often demonstrated a dismaying ignorance of the fundamentals of science and public decisionmaking. Three major studies (on the health effects of dioxin, video displsy terminals, and MBOCA) were initially disapproved and then subsequently approved by OMB following Congressional inquiries. We present a summary of each of these cases here: (1) Dioxin - Concern about dioxin is broad-based with the public and relevant to several Federal agencies. Human exposures have occurred at work sites in various communities and among Vietnam veterans exposed to Agent Orange. Those concerned with government policy decisions on 1\1 2 3 dioxin exposure have argued that a clear study relating human doses to clinical outcomes is needed to evaluate the relationship of dioxin exposure and outcomes, such as birth defects, metabolic disorders, and cancer. The Whi te House Agent Orange Working Group and 8 panel of NIOSH peer reviewers agreed that the NIOSH study of dioxin-exposed workers in Newark, New Jersey and Verons, Missouri, would provide this important expoBureeffect data. Notwithstanding the impressive array of scientific panels that articulated the importance of this study and who approved its design, OMB disapproved the study. Following a Senate directive that the study should go forward, OM! approved 8 pretest of the study methodologYi the full study bas not yet been approved. Conditions imposed by OMB during its paperwork review of the dioxin study have delayed tbe initiation of tbe study substantially, have increased contracting costs by at least $270,000, and may even totally block the completion of this important study. (2) Video Display Terminals - Twelve reported clusters of abnormal birth outcomes in women working with video display terminals have caused considerable public alarm. Industry, labor, and public health professionals all agreed on the need for a definitive study on this issue by the National Institute for Occupational Safety and Health. OM! initially disapproved the study. Following two Congressional hearings which addressed the specific need for this particular study, OMS finally gave th,e study partial approval, but required the removal of important questions related to fertility and stress. Numerous experts agree that OMB's tampering with the study design has significantly weakened the study to the extent that the results will be less credible. (3) ~ - A CDC study of 500 workers in Adrian, Michigan, exposed to this carcinogenic chemical, was initially disapproved by OMB. A more limited study was finally allowed to go forward following an inquiry from. the office of Congressman John D. Dingel!. OMB's paperwork review resulted in a 6-month delay in undertaking important cancer screening in a large population at risk and may have weakened the proposed study design. Three other studies, relating to ladder falls, hazards of information processing, and reproductive outcomes of CDC workers, were totally blocked by OMB. The alteration or cancellation by OMB of approved peer reviewed CDC research is of concern. A redirection of research by an agency without public health competence has occurred in each of these six cases. Because of our concern, we reviewed all fifty-one research projects submitted by CDC to OMB from January, 1984 to Karch 1986. We assessed whether OMS's rejections fell Statistically reviewing the pattern of OM! rejections, we found that OMB was seven times more likely to reject studies with an environmental or occupational health focus than to reject studies that focused on issues such as infectious diseases or other conventional diseases. Studies with a reproductive focus, such as birth defects or venereal disease, also were more likely to be rejected by OMB. .. . Our analysis indicated a demonstrable b1as 1n the appl1cation of the Paperwork R.eduction Act clearance proceu a8 administered by OMB's Office of Information and Regulatory Affairs. The health policy implications are serious; aMI is clearly interfering with the substance of CDC research. OM! has delayed impeded, and thwarted governmental research efforts desi~ned to anSwer public demands for information on serious public health questions. Rather than mintmizing the costs of information collection, the paperwork review procels has resulted in a diversion of tax dollars from productive health research into paperwork clearance activities and unnecessary contracting costs. Reviewing the actual functioning of the Paperwork Reduction Act as administered by OKS, we find evidence that the initial legislative concern. that the administration of the Act might be subject to abuse, was indeed warranted. differen~ially on certain types of studies. 5 4 4. IlITRODUCTIOll When government agencies are mandated to engage in scientific research. questions arise concerning the scientific review process. How is the quality and the appropriateness of a study to be assessed? Who should review and monitor the study? Are those who are reviewing trained and capable of understanding the product they are reviewing? Is their review ODe that is constructive, improves the projected research, and assures that it i8 carried out in tbe moat beneficial way? These issues have become particularly salient 88 we have Been the delay. alteration, or cancellation of various research projects by the President's Office of Management and Budget (OMB). While OM! is not a scientific agency. it does have certain powers of review provided unde_r the Paperwork Reduction Act of 1980. Recently, critics of OM! have argued that the agency has been using its role as a paperwork reviewer to interfere with research proposals initiated by the Centers for Disease Control (CDC). OMB's role in such review may have gone beyond the role mandated by the Paperwork Reduction Act. Critics have claimed that it has used its power of review to redirect the focus of CDC's scientific research. A White House office with the effective power to review, alter, approve, or disapprove research by another agency is in a strong position to determine the direction that research will take. Such a process of review could affect health policy significantly. If research on particular topics 'is blocked, information is unavailable for informed decisionmaking in the public health sector. The regulatory process is thwarted because there is no data to justify regulation. Thus, the blockage of research can prevent informed action to protect the public health. We have analyzed the process by which CDC studies are reviewed by OM! under the Paperwork Reduction Act. Our goal was to evaluate how the review was affecting the research process and to assess, whether the benefits of the review justify the financial and public health costs. There are four sections of analysis: 1. 2. 3. A summary of the Paperwork Reduction Act, focusing on the provisions for review of scientific research under the Act. A review of the traditional scientific peer review process as it occurs st CDC and a comparison with the mandated OM! review process. Case histories of CDC studies disapproved or condi tionally approved by OMB to determine whether the OM! review process was appropriate and beneficial. Statist ieal analysis to evaluate whether the patterns of OMB disapproval are systematic and imply an imposed health policy bias. THE OHB REVIEW PROCESS UlIDER THE PAPERWORK REDUCTIOll ACT Under the Paperwork Reduction Act, OMB has broad authority to control the collection of information by Federal agencies. The Act applies to any "~o~lection o~ .in~orma­ tion," which is defined as "the obta1nLng or solLc1tL~g of facts or opinions by an agency through the use of wrl.tten report forms, application forms, schedules, question~i~es, reporting or recordkeeping requirements, or other sLmLlar methods •••• "} The Act requires agencies to obtain approval of all information collection requests from OMB's Office of Information and Regulatory Affairs (OIRA). The Act imposes a duty on OMB to "determine whether the collection of information by an agency is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility."2 OM! regulations implementing the Act essentially require each agency to demonstrate to OMB that its proposed information collection requests are: (a) "the least burdensome necessary for the proper performance of the agency's functions to comply with legal requirements and achieve prog~am objectives'" (b) "not duplicative of information otherwLse accessible' to the agency;" and (c) of "practical utility." As defined in the Act, the term "practical utility" means "the ability of an agency to use informati~n it c?lle~ts, particularly the capability to process such l.nformatl0n Ln a timely and useful fashion. "3 If OMB does not approve, the agency may not collect the requested information: Under the provisions of the Act, OMB must eLther deny or approve an agency's iDformati~n collectio~ request with~n 90 days. However, OMB's re~ulatLons do provld~ for,tr~co~s~der­ at ion of a disapproval Lf the agency provLdes sl.gnlfLcant new or additional information relevant to the original decision. "4 From the legislative history of the Paperwork Reduction Act it is clear that Congress intended that information coliection requests included in epidemiological studies would be subject to OMB review.5 However, it is equally clear fr~ the Act itself and its legislative history that Congress dl.d not intend to increase OMB's power over the substantive policies and programs of the agencies. In fact, the Act contains a provision which states: Note: Footnotes at end of text. 7 6 Nothing in this chapter shall be interpreted 88 increasing or decreasing the authority of the President, the Office of Management and Budget or the D~rector thereof, under the laws of the United States, w1th respect to the Bubstantive policies and programs of departments, agencies and offices •••• 6 The late Senator Jacob Javits of New York elaborated on the distinction between OMB I S paperwork review authorities and the substantive policies aDd programs of the agencies duriog the SeDate debate on the Act, as follows: I have been concerned that the method used to this worthwhile goal particularly the prov1s10n that all agency recordkeeping requirements be cleared by OM! -- could be used to undermine substantive programs. For without adequate information on which to base its decisions, an agency cannot function. The sponsors of this legislation have made very clear that nothing in the bill in any way affects OMB's authority over substantive policies and programs.... Bowever, the line between substance and procedure is not always entirely clear. While I do not believe OMB's authority over any program, whether it ~s wo~ker safety or pure food and drugs, should be, or 18, 1ncreased by this legislation •••• I will be watching its implementation very carefully.7 acc~p~ish Finally. section 3504(a) of the Act specifies that the authority of OMB must be exercised in ways that are consistent with applicable law. Bowever, the Senate Committee acknowledged that these protections might not be adequate stating: These provisions will hopefully provide adequate protection from potential abuse or political interference. But this situation merits close attention in the future. S THE PEER REVIEW PROCESS The review of scientific studies done by OMB for the purposes of the Paperwork Reduction Act differs from the ex~ensive ~nternal "peer review" to which CDC subjects its maJor stud1es. The tradition of scientific peer review is well established in scientific circles. This process involves trained scientists from related fields in the assessment of scientific research projects. Such a review is a prerequisite for funding of research in academic institutions and for publication in major scientific and medical journals. A peer review panel will be convened for a proposed study to evaluate the effectiveness of tbe proposal and to improve the research design. At CDC this scientific tradition of peer review is long-standing. For major studies, peer review panels include independent experts from various fields of science related to the study at handi panel members evaluate each study proposal. and the proposal is then reworked by the CDC scientists based on the comments of tbe reviewers. For example, a proposed study to evaluate the possibility of birth defects resulting from a given toxic exposure could be reviewed by a panel of experts from several areas. The panel might include an epidemiologist with expertise in reproductive outcomes, a toxicologist, a pathologist with expertise in the area of laboratory tests that are proposed for medical evaluation, and 8 statistician. If the study were controversial. more than one expert per area of study might be called. Copies of the study proposal would be sent to all team members. They would review the proposal and then meet with the researchers for a full discussion of possible changes in study design. Written comments would be sent to the CDC investigators. The peer review process is not rigidly defined nor does it guarantee a perfect outcome but it does bave a structure that has traditionally provided for better science for the following reasons: 1. 2. 3. There are several independent reviewers. This means that the individual prejudices of a single scientist cannot govern the approval or disapproval of a study. The scientific tradition of finding a better truth out of free debate is maintained. The reviewers come from several different areas of expertise. Thus, different aspects of the study will be reviewed by experts from that particular area. The team that reviews a study functions independently and without conflicts of interest. Four broad criteria have been proposed for evaluating peer review: adequacy, value, effectiveness, and legitimacy.9 The criteria of adequacy involves the reliability of the data, the study design, and statistical methods. Value relates to the importance of the problem addressed; in other words, low marks would be given for a patently trivial proposal. Effectiveness suggests that a study will move scientific research forward by providing needed anSwers in a current area of controversy. Legitimacy means that the study design is consistent with recognized traditions of scientific thought. The traditional scientific peer review process that is used at CDC thus involves a team of independent experts from 9 8 various fields related to 8 particular study who evaluate that study for its adequacy. value, effectiveness, and legitimacy. While scientific consensus is hardly guaranteed by the peer review process, this process enhances the likelihood that the research product that emerges will be consistent with current scientific standards. The traditional scientific peer review is 8 thorough review involving various experts who focus their discuBsioDa on the quality of the science presented. This review con- trasts with the review that is mandated under the Paperwork Reduction Act, which is intended to focus on paperwork burden and practical utility rather than on scientific Bub stance. CASE REVIEWS Tbe Paperwork Reduction Act was passed in 1980j the final rule governing its implementation has been in place more than three years. There is now a body of information available to evaluate whether the OMB clearance process has functioned in a manner that is consistent with Congressional intent. In our analysis, we conducted an in-depth evaluation of the OMB review process as it applied to six CDC studies that were either disapproved or only conditionally approved by OMB following endorsement by scientific peer review panels. These six studies comprised all of the peer reviewed research projects rejected by OMB since January, 1984 on which we had full documentation of the peer review process. Three of these studies were major studies that received only conditional acceptance. Three were fully rejected by OMB notwithstanding acceptance by the peer review panel. The review process was examined to determine whether it interfered with the substantive programs and policies of the scientific research agencies. We have focused on four areas of interest: 1. 2. 3. 4. What were the issues raised in design? What was the nature issue addressed.? What ~ review occurred? appropriate? What was the nature of the OM! final outcome? What was the effect of tbe OMS quality. and costs of the final the initial CDC study of the public health Was it adequate and review? What was the review on tbe timing, product? Analysis of each of the studies involved a review of a Bubstantial body of agency documents. We traced each CDC study from the primary proposal through the various stages of peer review. The issues raised during the peer review were scrutinized, and the subsequent proposals were reviewed to determine whether these issues were addressed adequately in the final product. Then, we evaluated the OMB review and c~par~d. OMBls review process and findings with those of the sC1ent1f1c peer review panel. Finally~ we reviewed the end product to assess the impact of the superimposed OMB review on the CDC study. The analysis for each study is rather leng~by so f~r t~e purposes of this report, a summary of the SlX studles ~s included in Table 1. The full discussion of each case 1S included in the appendix. ..... , Su..arf of Ca •• Reviews Dioxin PURPOSE Study intended to prov ide dose related data on morbidity , reproductive effect 5 not pre- viously researched in HBOCA Study would Study was de- provide definitive data on the reproduc- s igned to screen 500 workers 8KPOSad to potent animal CAr- tive haZArds ot video display terminals cinogen for bladder cancer humans Ladder Falls Study was first scient i- Information Processing Study designed as initial fie project to information- provide con- gathering step to assess rela- trolled data on this major occupational safety problem " was designed to assist regulatory " nonregUlatory utety initi- tionship between repetitive men- CDC Reproductive Outcomes Study intended to provide important baseline data for numerous epidemiological reproductive studies tal tasks and physiologic changes CO atives ISSUES *Major animal toxin causing tumors' birth defects *Public health issues, including exposures at work sites, Superfund sites, Vietn ..... 011 O~ ~ " ~~ :>. ........ OIl ~ 'u <: " ...... III III ... 0 ,;'1"'--'''' I I U profoun d concer n. . All six studies were subjec ted to extens ive peer review t. commen ers review peer the Protoc ol revisio ns baaed on study ranged from minor adjustm ents to Bubsta ntial change s in and ned redesig were ally eventu ols design but all study protoc approv ed by the peer review panels . l The results of the OM! review fell into two genera but s studie six all oved OMB initial ly disappr catego ries. In the case of the stated reason s for disapp roval varied . l rejecti on initia OMB's s, studie the dioxin , VDT, and MBOCA scient ific the of ent assessm 's office budget the on based was were not rovals disapp The study. value or quality of each ork. based on a finding of burdens ome or duplic ative paperw s ground the on study dioxin the d rejecte For exampl e, OMB that it was "unnec essary" in view of previou s dioxin OM! vetoed the initia l inform ation collec tion researc h. its reques ts for the VDT and MBOCA studies based on flaws. design major had studies these that ent aSSessm In all three of these cases, OMI relied heavily on were outsid e consul tants, who were either unprep ared or and te evalua to were they study the unfavo rably dispose d to the who raised questio Ds which already had been discuss ed by e critiqu a cases, these of all In . panels agency peer review OMS reques ted by OM! from a single consul tant or provide d to nt of from industr y consul tants overrod e the scient ific judgme the ed approv had which panel~ a multi- discip line peer review study. a The inappr opriate scient ific nature of OMB's review is three pattern that is confirm ed in further review of theBe In all of these studie s, follow ing agency appeal s studie s. OMB and expres sions of Congre ssional and public concer n, the of n redesig the on al approv te ultima its oned conditi the cases, three all in n, additio In scient ific protoc ol. s. redesig n that occurre d appear s to have weakened the studie was roval disapp OMS the cases, In the other three ical premis ed on the conclu sion that the studies lacked "pract ladder of study iologic epidem the oved disappr OM! utility ." in falls on the ground s that OSHA had initiat ed rulema king Yet, this area and therefo re new inform ation was not needed . and OMB's conclu sion disrega rded the asserti ons of both OSHA NIOSH that the propose d study would not only benefi t efforts would to revise or elimin ate OSHA's regula tions but also s. effort greatly assist volunt ary safety The studies on the health hazard s of inform ation 14 15 processing and reproductive outcomes of CDC employees were disapproved because OMB concluded that tbere vas insufficient evidence of eXisting health problems. Both of these studies were designed to investigate possible public health risks in areas that bad not been previously evaluated epidemiologically. Th.e reasoning applied by OHB i8 only justified if the haz8:d 18 already understood. Thus, if OMB'a reasoning were COD818tently applied, research into any new area would he OMB's final rules on paperwork management reduction became effective during 1983. During the time period reviewed, there were 61 submissions to OMB frolll CDC; of these submissions, 51 involved the collection of information from individuals for the purpose of scientific research. Ten submissions were non-research in nature (~, routine approval forms) and were excluded from ;he analysis. Research submissions were categor1zed by content area, into three categories: blocked. Reviewing the effect of OMB' 8 paperwork review, we find ~hat OHB, ~n agency without public health expertise, haa used 1t8 authorIty under the Paperwork Reduction Act to alter the direction of public health research proposed by public health agencies. OHB's review in these cases had several effects all of which were deleterious. Studies were delayed weaken: ed, increased in cost, or blocked altogether. Wbe~ studies are blocked Or diminished in quality, certain research find~ngs will ~e unavailable for informed decisionmaking on pub11c ~ealth 1~sues. In these cases, the quality of public health 1nformat10n and the public health decisions based on that information will be undercut. In addition. productive research reSOurces have been diverted into nonproductive paperwork review activities and unnecessary contracting cost •• OMB PATTERNS OF APPROVAL AND DISAPPROVAL Our review of the six cases demonstrated a pattern of rejection that might be interpreted as interference with the subst~nce of CDC .research. It was possible that the patterns seen 1n our rev1ev of the cases were simply an example of poor ~ureaucratic management, rather than systematic bia •• If th1s were so, it would have been likely that disapprovals would have occurred randomly across all types of studies done at CDC. In order to determine whether the Office of ~nformation and Regulatory Affairs was conducting its reviews 1n ~ manner that fell selectively on certain types of .tud1es, we made a statistical evaluation of the patterns of OMB acceptances and rejections of CDC research studies. Methods and Data Our methodology involved a review of all CDC submissions made to OMB for clearance during the period January 1984 to Mar~h 1986. CDC submissions were selected as the sample for reV1ew because CDC is an agency that does a large segment of Federally funded epidemiologic research and because CDC is not a regulatory agency (and thus the submissions are of a purely research nature). We chose to review submissions starting in 1984 because Environmental .2.I. occupational atudiea were those. that involved wort-related diaeases or exposure to env1~on­ mental pollutants. Theae studiea came from the ofh.ces of NIOSH or the Center for Environmental Health. Of the case studies we reviewed, the projects on MBOCA, VDTs, dioxin, ladder falls, and health risks of information proceasing would all fall into this category. Reproductiye studies involved questions of ~epro.ducti~e health as their pri.ary focus. Study tO~1cs 1n ~h1s category ranged from venereal disease stud1es to b1rth defect analysis. The study on reproductive outcomes of CDC employees from the CDC Birth Defects Section vas included in this grouping because the focus of the study was to provide baseline reproductive statistics. Studies that related to all ~ dieesae proces~es constituted the final category. A broad range of tOP1CS were involved including studies on childhood immunization hepatitis in renal dialysis patients, malaria in foreign traveler., sudden infant death syndrome, lov~r respiratory disease in day care centers, and leye s Syndrome. The outcome measure was the final result of OM» classification that was known to have occurred during the study period (~. acceptance, rejection, conditional acceptance). It was determined that conditional acceptances would ~e analyzed in the same category as rejections: W~ a?opted th1s approach for two reasons. 'irst, case rev1ew 1nd1cated that .ignificant efforts had to be made by parties .out~ide OMB (usually Congress) to overturn an initial OMB re)ect1o n of a study and to obtain a conditional acceptance. It was dou~t­ ful that the upgrade would have occurred under rout1ne circumstances. Second, our review indicated that implementation of the study had been delayed or the substance of the study had been altered in the cases involving conditional acceptances. We considered whether our categorization might be a measure that was confounded by other issues. T\ro possible 'irst, it was confounders were considered and rejected. 17 16 TABLE 2 considered that our categorization by topic might actually be a meaaure of studies coming from one particular office. Thu., it might be argued that a high rejection rate was occurring because one particular office produced particularly poor researcb proposals. Reviewing our categoriea, we found that the environmental/occupational category included studies from two KIOSH offices in Morgantown, West Virginia, one NIOSB office in CincinDAti~ Ohio, and from tbe Center for Environmental Healtb in Atlanta. Reproductive studies also came from aeveral different offices within CDC. ThUB, the single office theory vas rejected. Second. we considered the possibility that studies were rejected on the basis of undue coat. Cost data vere unavailable for all of the studies but an analysis of the rejected studies shoved a vide range of projected costs, . .king this confounding explanation less likely. Rejection of CDC Submissions to OMB Comparison Ri Environmental va ~ (Non-repr;ductive) Studies Conditional/ Reject Study Type Accept % Reject Environmental/ Occupational 7 14 33.0% Other/ Nonreproductive 1 21 4.5% Statistical Byaluation To analyze the pattern of OMi rejections, ve performed a statistical analysis measuring whether the pattern of rejection occurred randomly across the different content categories. A Fisher's hact Test vas used to measure statistical significance. When we compared the environmental/occupational category with the other (non-reproductive) category, we found that there vas a strong pattern of OM! rejection of these studies (see, table 2). OMB's Office of Information and Regulatory Affairs vas found to be seven times more likely to reject an environmental or occupational study than to reject a CDC study on other topics, vhich were less likely to have potential regulatory significance. The strength of this association vas highly significant, vith the likelihood of these results occurring by chance of 2 in 1000. The pattern of rejection of reproductive studies was analyzed in a similar fashion. The numbers involved in this analysis were extremely s1l811. With such small numbers, effective measurement· of statistically significant findings is difficult. Nevertheless, the pattern of rejection of these studies suggests that reproductive studies also were rejected more frequently than other studies of a non-environmental/non-occupational nature. p-.002 odds ratio 10.4 TABLE 3 Rejection of CDC SubmissioDs to OU Reproductiye Submissions va Other (Non envirOnmental) Studies Study Type Conditional/ Reject Accept % Reject Reproductive 2 6 25.0% Other 1 21 4.5% Findinas The patterns show, in our evaluation, that environmental and occupational studies were particularly subject to rejection during the OMB review procedure and. ~hat reproductive studies may have a comparable vulnerab111ty. Th ... "P.; .. ,.f"~,," ........... ., ~~_ '-~~. -~ " ., ......... ~ .. _r - .... Ii." ... .,..- 18 19 CO ~ While the intent of the OM! reviewers cannot be inferred from statistical measures, tbe differing pattern of review among studies that should presumably receive similar treatment raises serious concerns. c:::J :::n ...0 .... ~ ., LIDID __ --0 0::::J Q) -+-' =Ui co:: U --cc-g Q) Q):lI Ul .c Q) ~ :::::J -- ID > :;:;UJ t/) UID ::::J--0-0 0::::J a.tn ID 0 .... U ID dcr.J :c ::::J . . -+-' .... c.....J l- CJ c.....J a:: t/) ::::JI :!:! 0 -+-' C Q) U LoQ) CL 0 111 1:11 0 ..... 0 [JJ 0 N 0 = - We previously have discussed two possible confounders which might have accounted for our findings; office of origin of the study and cost of tbe Btudy. However, we have con- cluded that both of theBe confounders are unlikely to explain the analytical results, for reasons previously cited. Therefore, we have considered tbree other possible explanations of the selective rejection rate. First, it i. possible that OMB found that CDC I 8 peer review process for environmental, occupational, or reproductive studies contained flaws which were not apparent in other types of studies. Thus, OMB may be especially likely to reject studies on these topics, because the peer review was particularly flawed. In our view, this explanation is unlikely. The peer review of all the studies rejected by OHB involved a competent, thorough examination of the study design by a group of recognized experts in the appropriate field. Second, it is possible that the etiology of the OMB bias against environmental, occupational, and reproductive studies related to the complexity of these studies. It is generally conceded that studies relating to environmental and occupational health or reproductive outca.e involve difficult issues of study design when compared to more conventional epidemiologic studies. It is possible that OHB reviewers were more likely to reject a study where the design was controversial, hence increasing the rejection rate in those areas. While we find this explanation plausible, it raises serious public health concerns. The science involved in addressing environmental and occupational health effects and reproductive outcomes is difficult but this does not mean that they should not be studied. Decisions on the commitment of resources to public health research should involve a considered weighing of the importance of the public health issue as well as the quality of the information to be obtained. It is inappropriate to block research in important areas because the study design is not simple and straightforward. This is particularly true in epidemiological research where scientists must rely on conditions of human exposure as they find them in the real world. Difficult areas of research often require new and controversial approaches but minor imperfections perceived in the study design are no reason to abandon the research if the issue is an important public health problem. OHB reviewers, unlike CDC reviewers, are not public health professionals. Thus, they are less likely to value the public health importance of information 8S highly as 21 20 public health workers. Failure to appreciate the public health importance of environmental, occupational, and reproductive problems may have contributed to OMBls finding of "no practical utility" in some of the rejected cases. Third, it is possible that OKB's bias represents an intentional effort to block occupational, environmental, or reproductive studies that ultimately might lead to additional Federal regulation. Although the Paperwork Reduction Act does not vest OM! with the authority to interfere with proposed research on policy grounds, the increased rejection rates for occupational, environmental, and reproductive studies raises the possibility that such political interference has occurred. APPENDIX OF CASE STUDIES 22 ~ of Dioxin Worker's Morbidity and Reproductiye Bffects 23 Diamond Shamrock individuals The extreme toxicity of 2,3,7.8 tetrachlorodibenzo-pdioxin (TCDD) has been recognized for several decades. Diverse adverse health effects (morbidity), including tumorogenic and teratogenic effects have been shown 1n multiple animal studies. In humans, occupational exposure to TCDD-contaminated production is known to cause a skin disorder called chloracne. Human exposure also has been associated with derangements in liver metabolism. in endocrine and hematopoietic function, and in neurologic, psychological, and reproductive function. Human exposure to dioxin has occurred in a variety of circumstances, including worksite and environmental contamination. Questions of contamination have been raised with reference to certain Superfund aites and with reference to by-products from incineration. TCDD was a contaminant of Agent Orange, a defoliant used in Vietnam, a fact which has generated interest among veterans. The concern about dioxin is broad-based with the public and is relevant to multiple Federal agencies. The White Bouse Agent Orange Working Group (AOWG) currently functions to coordinate efforts on these issues. Though the scientific literature contains many publicatioDs related to dioxin, the literature leaves major gaps in knowledge that limit our ability to assess its effect in significant clinical situations. Buman studies related to many of the systemic effects are considered to be suggestive but not definitive. The literature is particularly lacking in data that relates human doses to clinical outc01lle. .Data that relates human exposure to the more serious types of morbidity outcomes, such as birth defects and cancer, is cODsidered by some to be insufficient to justify regulation or compensation. Dose-related information on morbidity incidence would be the basis of informed regulation, clinical assessment, and protective policy. Multiple Federal agencies <.Lh., OSHA, EPA, the Veteran IS Administration) would use this type of information in developing diozin-related policies. To establish and evaluate dose-related morbidity incidence in a human study. it is necessary to evaluate a well delineated population with quantifiable ezposures. Exposure data in lIost of the exposed populations, such aa agricultural workers and Vietnam veterans, is extremely imprecise. Worker populationa have high, long-term exposure, and exposure information on these groups is far better and more detailed. In response to the need for dose-related morbidity data, NIOSB proposed to evaluate two groups of workers ezposed to chemicals contaminated with 2,3,7,8-TCDD. The proposal involved the evaluation of 360 individuals employed at the Plant employed at in Revark.. the REPACCO, Rev Jersey and 80 Hoffman Taff/Syntex plant in Verona, Missouri. Interviews and medical teating were proposed. There were to be matched controla from the surrounding neighborhoods. Because this study would address the important question of dioxin dose-related morbidity, the White Houae Agent Orange Working Group determined that this study vas one of 11 essential studies to be completed by 1990. The peer review to which this study was subjected must be described 88 extensive. Outside review started in 1983 with scrutiny by a 12-person dioxin peer review panel. There yere subsequent panel reviews in 1984 and 1985. Additionally, the protocol was reviewed by the AOWG Science Panel in 1984. The AOWG panel meeting of September 25. 1984 reported: The Science Panel finds that both ••• the Morbidity Study [and a related Mortality Study] are well designed and carefully considered and should provide useful information on the possible long term health effects of industrial exposure to dioxin contaminated products. The Science Panel recommends that both studies procede [sic] as soon as appropriate resources can be allocated. IO With regard to the adequacy of peer review of this study, the situation was well summarized in December 1984 by one of the NIOSH peer reviewers who stated: This study is in danger of being reviewed to death -- if in fact that bas not already occurred. Surely, review by both the peer review panel of NIOSB and the Science Panel of AOWG - not once, but several times -- is superfluous and inefficient. The money spent would be better put into the conduct of the study itself. II The study was submitted to OMS pursuant to the Paperwork Reduction Act in July 1985. OMS responded to the proposal by raising extensive questions about the utility of the study and the study design, including the choice of the control population, the methods of quantifying exposure, and the power of the study to measure exposure effects. All of these questions about study design had been previously discussed. in great detail by the various peer review panels, and the panels had concluded that these issues had been addressed adequately. Nevertheless, OMB raised these questions again, and NIOSH provided the requested information. Notwithstanding NIOSB's attempts to satisfy OMBls concerns, OMB disapproved the study on November 17, 1985, 24 stating: [t]his study is unnecessary in view of the fact ~h8t wor~er8 proposed for examination are already 1Dcluded 1D NIOSH's dioxin registry study of dioxinexposed chemical workers, and since numerous dioxin exposure in the workplace studies have been conducted to which the proposed study would add little if any' further intelligence.12 ' . The OMB conclusions run counter to the findings of the varlOus expert panels in several significant ways. First, OMB's conclusions show little awareness of the nature of the scientific literature on dioxin and specifically of the need for the exposure-related data that would be provided by this study. Second, OMBls assertion that the dioxin registry data should be adequate indicates a failure to understand the difference between morbidity (disease-related) and mortality (death-related). The dioxin registry information is limited to mortality data and simply could not answer questions about the incidence of non-fatal diseases in the population nor the occurrence of birth defects in offspring of exposed individuals. These gross misconstructions of the basic science involved in the study suggest serious deficiencies in the OMB review process. NIOSH internal documents indicate that OM! had discussions prio~ to t?e disapproval with Colonel Alvin Young, Ph.D., Sen10r Pol1cy Analyst for the White House Office of Science and Technology Policy (OSTP). NIOSH documents state that Colonel Young "indicated his view that the Dow and Monsanto studies might have been enough. He said that he had not been able to justify the expenditure when compared with the need to fund radon studies." 13 These opinions clearly run counter to the approval expressed by the NIOSH review ~anel and by the Science Panel of AOWG of which Colonel Young 18 a member. OMB gave great weight to the opinions of a dissenting member of the Science Panel rather than following the recommendations of the full group. Both NIOSH and the i~volved communities elected to appeal the disapproval and presented their appeals to OM! for reconsideration through several channels. On December 6. 1985, at the behest of Senator Frank R. Lautenberg of New Jersey. the Senate Committee on Appropriations included language in its continuing appropriations measure expressing strong concern about Olm interference in the dioxin study. The report emphasized: The Committee is most concerned about a recent action by the Office of Management and Budget blocking further gathering of statistics on the Morbidity Study of Persistent Health Effects in Chemical Herbicide 25 Workers and Community Residents being conducted by the National Institute of Occupational Safety and Health (NIOSH). The Committee believes that the study should go forward without further interference from OMB.14 On December II, 1985, the Department of Health and Human Services (RRS) submitted an appeal of OMB's disapproval to Dr. Wendy Lee Gramm, Administrator of OMB's Office of Information and Regulatory Affairs. The appeal emphasized the importance of the study to the Public Health Service lias well as to other Federal agencies (.L.&.L., Science Panel, a subgroup of the White House Agent Orange Working Group; the Environmental Protection Agency. which is providing funds for this project; the Veterans Administration, etc.)." The HHS appeal aho included letters of support from the New Jersey Department of Health. On December 16, NIOSH officials met with Alvin Young of OSTP and with Mark Winer of the Statistical Policy Branch of OllA. This meeting had been arrsnged at the suggestion of Colonel Young shortly after the Senate report directed that the dioxin study should go forward. Dr. Fingerhut, the NIOSH Project Officer, and Colonel Young had further discussions the following day. From these discussions emerged Colonel Young IS suggestion for a two-phase approach to the study. which would allow the termination of the project after the first phase. 15 On January 7, 1986. Robert Bedell, Deputy Administrator of OMBls Office of Information and Regulatory Affairs, wrote to John J. OIShaughnessy of the Department of Health and Human Services and agreed lito approve a portion" of the dioxin study. According to this letter, this partial study was to include a sample size which "shall not exceed 80 snd shall be drawn exclusively from the New Jersey site." The partial study only would evaluate the methodology proposed for the full study. The sample size of this pretest is far too small to provide useful information about dioxin. Moreover, Mr. Bedell's letter underscored the conditional nature of OMB's approval. He stressed that: we continue to have reservations regarding the degree to which there will be adequate variation in exposure levels, appropriate selection of the control cases and the practical utility of study results •••• Future considerstion of the remainder of the study will be dependent on the demonstration that the objectives of the full study can be reasonably met •••• Once the technical concerns are resolved, the practical utility of the study must be demonstrated. 16 Notwithstanding OMBls approval of a portion of the dioxin study on January 7. 1986, further delays ensued. BIOSH did 26 not receive official notice of OMB'. approval of the pilot study until Marcb 24. 1986. At this point, the pretest baa DOt yet atarted. OD viII Dot make 8 determination on the full study until the pretest is complete. The history of the dioxin Btudy is bighly instructive in evaluating the effects of the paperwork review process in the research arena. In this case, the impact of OMB'. interference haa heen Bubstantial. OD'. activities have not only delayed the development of important public health informatiODi they a180 have diverted lederal dollars from productive research. According to official estimates, the two-stage study methodology imposed by OMI will increase contracting coata for the dioxin study by at least $270,000. 17 In addition, concerns have been raised that the conditions imposed by OMI may in fact weak.en the study design. Pretesting among part of a population may confound results from the study of the whole group. The public health implications of the OMI review process should be considered. Under the Paperwork Reduction Act, OMS is supposed to assesl whether data bas practical utility to the agency requesting the collection. In the case of the dioxin study, OD did not find utility where numerous other scientists did. OMB' s analysis ran counter to the findings of the BIOSH peer review panel and the Science Panel of the White House Agent Orange Working Group. Under the current version of the Act, the OMB determination takes precedence and the study is blocked, notwithstanding strong indications of the public health value of this study. More than nine months after the Senate Appropriations Committee directed OM! to cease its interference in the 'BIOSH dioxin study, approval bas been given only for a pretest. OMB's letter of January 7, 1986, mak.es clear that final approval is by no means assured. It is still possible that OM! will thwart the scientific recommendations of the professional Itaff of BIOSH, of the agency'l peer review panel, the White Bouse Agent Orange Working Group, and the Congress itself. !WWl Reproductiye ..l11!!!I. .21 lmY.k .fiU2. Display Terminal Operator. A study of reproductive outcome in video display terminal (vor) operators was initially proposed by BIOSH because various user groups were concerned about widely publicized reports that clusters of women VDT operators suffered high rates of spontaneous abortion, birth defects among their children, and other reproductive problems of pregnancy. Because these clusters of affected users were too small and the reproductive problems too varied, it vas not possible to draw any scientifically valid conclusions. BIOSH estimates tq.at'l,there are currently 7 million VDT users in the United States. The agency was concerned that given the large number of women users of reproductive age, even a small increase in birth defects or spontaneous abortion rates caused by VOTs would mesn a large increase in the absolute number of those suffering these effects. There are 12 widely reported clusters of abnormal birth outcomes related to VDT use. Interpretation of these clusters is a matter of epidemiologic controversy. There is a strong likelihood of such, clusters occurring ~y ch~nce alone in a large population. Nevertheless, there 18 ser10uS conce;n among VDT Ulers, and industry, labor, and pu~l~c health officials all agree on the need for a strong def1n~­ tive study. that would give a solid assessment of th1s problem. . In general, reproductive studies are more diff1cult. to design than other epidemiologic studies because me~lcal records on miscarriages and birth defects are not as reI lab Ie or consistent as those related to death or disease. Often these records are not included in company personnel records. Because of these factors, BIOSH chose to design a study based on worker interviews rather than on medical record surveys. For this design to be effective, it was necessary for NIOSH to find a group of VDT-exposed workers and a group of nonexposed controls for comparison. Tbe proposed study was designed to take advantage. ~f a "natural experiment," a situation where two very s~lI~lar groups of WOllen at Bell South Corporation had ver~ Sl11l11ar jobs with the exception that only one group was uSlng VOTs. According to its proposal. BIOSH planned t? comp,re pr~gnancy outcomes of women workers using VMs (d1rectory a.Slstance operators) and those who were not (long distance operators) at the Bell South Corporation. Peer review of this study involved three reproductive epidemiologists, as well as an expert in ~tress .aDd ergonomics and a statistical reviewer. The questlo D8 ra1sed were thos: that are usually controversial in retrospective reproductive studies. The most important of these concerned the issues of recall bias aDd measurement of pregnancy outcome. "Recall bias" raises the issue that women ~ho know they are exposed to possible hazards may b~ ~re llkely to report a bad birth outcome, thus bl.as1ng re~ul~s. Measurement problems involve difficulties in establ1shl.ng specific definitions of birth defects or spontaDeous abortions. Multiple recommendatioDs were made by the peer reviewers to improve the methodology. These recommendatioDs were incorporated into the revised proposal. .The general assessment of the final proposal by the peer reV1e¥ panel was that the study was well designed, vas necessary, aDd should be done. 18 The study was submitted to OM! in September, 1985. In 28 29 November. 1985, representatives of the Bell South Corporation wrote directly to Wendy L. Gramm, the Administrator of OMB'a Office of Information and Regulatory Affairs, stating that: We share the goal of resolving scientifically whether video display terminals cause adverse pregnancy outcomes. We are concerned, however, that the proposed study 8a currently designed will not provide reliable and useful scientific informatioo.19 The Bell South representatives Doted that their concernS already had been expressed to the scientific staff at NIOSH. Bell South also notified OHB that two academic epidemiologists had been retained to review the study protocol for Bell South. This review was subsequently mailed to OMB. In December, OND disapproved the VDT study citing major design flaws and a large number of irrelevant questions as reasons for its action. 20 The criticisms that OND used in its disapproval notice to NIOSH represent an abbreviated version of the critique commissioned by Bell South. Questions similar to those raised by the Bell South report were discussed by NIOSH peer reviewers though the solutions raised were different. The nature of academic differences over study design is not the issue. The process is the focus of concern. The review by Bell South's consultants i8 presented directly to OMB. OMB then uses this particular consultants' report to disapprove the study. Disapproval of the study was of significant concern to NIOSH and to representatives of VDT users. NIOSH appealed OMB I s decision in March, 1986. Congressional hearings on April 14, 1986 and June 4, 1986, addressed OMBls interference in the proposed research effort. On June 6, 1986, OKB finally approved the VDT study. However. OHB I S June 6 approval involved several major conditions, including a requirement to substantiate miscarriages by examining medical records and the elimination of questions related to stress and fertility because they are "intrusive" and "irrelevant." Removal of the questions relating to stress and fertility inv(\lved a rather subtle, but extremely important, controversy. In all epidemiologic studies, the issue of "confounding variables" arises. Confounding oCCurs when something that is not the primary issue in a study is related to outcome. For example. stress may be associated with poor pregnancy outcome. If the study group (those who used VDTs) also faced more stress than the control group (those who did not use VDTs) , it could be possible that any bad pregnancy outcomes found in the study group would be due to stress, not VDTs. Similarly, if the group using VDTs simply through random selection included more women who had impaired fertility (for example due to use of birth control or previous hysterectomy) J abnormal study results would occur unless these were corrected. The need to measure confounders is an important one but it must be weighed against the detrimental effects of meaauring too much and measuring imprecisely. In the VDT study, OMB and Bell South's consultants argued against measuring too many variables and against measuring variables that were subject to bias because of imprecise "recall't by patients. Based on these arguments, questions focusing on fertility-related issues, such 8S use of contraception, previous hysterectomy, alcohol and tobacco use, and stress were removed. Removal of these questions sparked debate. Many felt that collection of the data on fertility and stress was necessary to establish the presence or absence of important confounders in the study. It was believed that these questions were necessary to maintain a highly credible study. Teresa Schnorr, the NIOSH VDT project director, has stated: "My feeling is that those questions (on stress and fertility) were important to the study. Without them the study will be less credible." 21 At the request of Congressman Ted Weiss, Chairman of the Subcommittee on Intergovernmental Relations and Human Resources of the House Committee on Government Operations, the staff of the Office of Technology Assessment (OTA) and a highly regarded group of scientists reviewed the fertility and stress questions deleted by OM! from the VDT study. The scientific reviewers included Zena Stein, M.D., Richard Neaye, M.D.. Donald Mattison, M.D., Irving Selikoff, M.D. J and William Butler, Ph.D. The overwhelming majority concluded that the deletion of the fertility questions weakened the proposed study significantly. The OTA staff analysis concluded that: The OM! excluded questions would have provided valuable information for a study of the possible adverse reproductive effects of radiation exposure from work •••• Due to the high visibility of this study and the likely use of the conclusions by a wide variety of individuals, it is important that its conclusions be as clear as possible. The questions deleted by OMB were intended to provide important and useful information that would reduce the potential for alternative explanations of the study results. While the wording of specific questions and the order of the questionnaire might be reexamined and improved, complete deletion of questions on fertility and stress will limit the conclusions that can be drawn from this study.22 The comments of William J. Butler, Ph.D., illustrate the concern of various academic experts about OMB's deletion of 31 30 the atreB. and fertility questioDs. In a July 16, 1986 letter to Congressman WeiBB, Dr. Butler stated that: BIOSH has been given permission by OMS to conduct their study only if six changes are made in the protocol. OM! claims that these changes are needed "to correct methodological deficiencies and improve the validity of the study results. It My concerns are focused on two of the changes required by OMU. One of these changes requires the deletion of approximately sixty questions on psychological stress. OMB reasons that "( t)here is insufficient evidence relating these items to hypotheses concerning VDT exposure and adverse pregnancy outcomes." I agree that the evidence associating stress vith pregnancy outcome is inconsistent. However, occupational stress is one of the leading suspected causes of the reported association between VDT exposure and pregnancy outcome. Therefore, collecting information on stress is crucial for the thorough investigation of this occupational health issue. Additional studies will be necesssry if the stress questions are not included in the BIOSH protocol so it is a waste of resources R2t to include them. Another of OMB I s changes requires the deletion of eight questions on fertility. OHB reasons that "(m)easuring the effect of VDT exposure on fertility is not the purpose of the study." This is categorically wrong. The purpose of the study is to investigate the association between VDT exposure and adverse reproductive outcomes, including spontaneous abortions. Early spontaneous abortions are often not recognized. An increased frequency of early spontaneous abortion could thus be expressed in the form of decreased fertility. Failure to include questions on fertility will result in the inability to exsmine the association between VDT exposure and early pregnancy loss. These two changes required by OMB, though it is claimed they correct deficiencies and improve validity. severely restrict the range of scientific inquiry of the study. These restrictions will result in the study providing inconclusive results and almost guarantee that additional. equally expensive studies will need to be conducted. The protocol submitted by NIOSH to OMB had already benefited from reviews by researchers in the government and academia and was scientifically and methodologically sound.23 Evaluating the review process as it applies to the VDT study, we find that the need for a study on this issue was veIl-established. BIOSR, the BIOSR review panel, and maoy 8cientific experts, all felt that the study would fill an important need. Labor and industry agreed that a vel1documented NIOSR study would .8.i8t informed deciaioamaking on i88ue8 related to pregnant workers and VDT expo_ur,e. A panel of 5 peer reviewers diBcusBed the design extenll.vely. revisioDs were made, and the study vas approved. Following approval by the peer review panel, OM! used the Bell South co08ultants' report 88 a second 8cientific review to override the BIOSB panel, and disapprove the study. Subsequently, following Congressional inquiry, OM! approved the study with the condition that certain fertility and stress questions be removed. However, the OMB review process diverted subatanti_l resources from produ'Ctive research into paperwork clearance activities. Because BIOSH believed that the atudy should go forward, the agency made _ c01llllli.tment to seeing the study through the review process. In the VDT case, BIOSH spent $53,451 in personnel costs for pap,erwork review. 24 Thus, we see that a substantial commitment of time, effort and tn dollars had to be made to gain approval of a study that vas considered necessary and appropriate by NIOSH. These resources were diverted from actual research to manipulation of the review process. Had the clearance process at OMB resulted in an tmproved product, it might be argued that the final product Justified the costs. However, a large number of experts bell.eve tbat the OHB review resulted in a veaker study design. The original intent of the NIOSH study was to establisb an extremely credible study that would allow labor and industry to formulate policy confidently. These experts contend that this function of the study has been undermined by OMB's removal of the fertility and stress questions. Thus, we have a case where OMB'e Office of Information and Regulatory Affairs engaged in a clearance process that duplicated the function of the peer review panel, increased coats, and may have lowered the quality of the final product. NIOSH Inyestigation Ri Workers Expoaed 12 ~ This study by the Rational Institute for Occupational Safety and Health (NIOSH) was designed to evaluate the carc1nogenic risk to humans due to expos~re to 4,4' methylenebis 2-chloroaniline (MBOCA). The chea1cal bas be~n found to be carcinogenic in three species of muaaah and 1S similar in chemical structure to known human bladder carcinogens. The issue of MBOCA exposure evaluation became aD important public health issue in .1?79, in Adrian, Michigan, when state and local health off1c1als had. to close a plant and attempt a community cleanup follow~ng HBOCA contamination. The Michigan Department of Pub11c Health 32 33 requested CDC's assistance in evaluating cancer incidence amoog MBOCA manufacturing workers formerly employed by the Anderson Development Company in Adrian. Moreover~ health officials have expressed concern about MBOCA exposure because it has been estimated that' 1,300 to 33,000 U.S. workers have been exposed to MBOCA..25 Current exposures are continuing without any regulatory controls. The NIOSH study W88 designed to evaluate the 533 workers at the Adrian facility for incidence of bladder cancer and other malignant neoplasms. The study design involved the ~ollec~ion of relevant epidemiological information by 1nterv1ews and, by medical screening for posBible bladder cancer. The study was scrutinized by four peer reviewers. The reviewers determined that MBOCA exposure in worker ~opulat~oDs in general and the exposure in Adrian, Michigan 1n part1cular was a serious public health issue and warranted investigation by NIOSH. Although the peer reviewers expressed some concern about the small size of the sample and the short latency period from the time of initial exposure, they determined that tbe study design offset these weaknesses in two ways. First it sought to minimize problems posed by the small sample siz~ by measuring the incidence of disease (~, findings of bladder tumors in living workers) rather than measuring mortality (which would only count the occurrence of death from bladder tumors). Second, if a significant number of cases of disease were found during the medical screening stage of the study, NIOSH proposed to conduct an in-depth comparison of these cases and a matched group of controls to evaluate differences . exposure (a' " nested' case control study). In addition, 1n the Anderson Development workers represented the largest group of MBOCA workers, and thus, there was no better single group to study. Thus, overall, the peer reviewers felt that study should go forward. NIOSH submitted its request for review to OMB in February, 1985. In May, 1985, OMS disapproved the study stating that "the design of this study is sufficiently flawed so that the resulting data would not satisfactorily resolve the question of whether MBOCA exposure is related to bladder cancer or other types of cancer. "260MB I s disapproval was apparently based on the evaluating CODmlents of Dr. Joseph Guestworth, a statistical cODsultant for 00' s Office of Information and Regulatory Affairs. Internal NIOSH documents reveal that Dr. Guestworth Ithad perceived his role as essentially that of a scientific peer reviewer for OMB, It even though "he had received only a brief summary of the study." Moreover, Dr. Gueatworth ''was unaware that the full protocol had already been scrutinized at length by a peer review committee. He also was unaware of the strength of the toxicologic information implicating MBOCA as an animal carcinogen or of the chemical similarity between MBOCA and ••• known carcinogens to the human bladder."27 Following their initial receipt of Dr. Guestwortb's review in early April, 1985, NIOSH officials responded in detail to each of his concerns. Internal documents indicate that NIOSH was willing to discuss the scientific points more extensively with Dr. Guestworth and OMS but such discussion did not take place at this point. On May 8, 1985 I NIOSH received official notice from OMB disapproving the DOCA study. At this point, NIOSH and other supporters of the MBOCA study intensified their efforts to gain OMB approval. On July 3, 1985 J NIOSB resubmitted its proposal, supplementing it with a detailed response to the issues raised by Dr. Guestworth. On July 26, 1985, Congressman John D. Dingell of Michigan wrote to OMB Director David Stockman concerning the study. On August 23, 1985, OMS approved the study with the condition that the nested case control element be withdrawn. At this time, the MBOCA study is finally in progress although medical screening of the worker population bas not been completed. Among those already screened, NIOSB bas detected a group with urinary abnormalities that will require additional medical evaluation. Moreover, a 29-year old male, wbo is part of tbe cobort in the study, has been independently diagnosed as suffering from a papillary bladder tumor. 28 Tbe occurrence of such a tumor in a young worker is unusual. These incomplete findings are not scientifically conclusive but they do raise cause for concern. In summary, the MBOCA case suggests major inadequacies in the OD review process. In this case, an important study, which bad been endorsed by a research agency and reviewed and approved by a four-member peer review panel, was delayed for more thaD 6 months. In addition, it appears that the study might have been cancelled altogether were it not for agency concern and community and Congressional action. Evaluating the OHB review, we see that a second scientific review by a single consultant selected by OMB was superimposed on a study that previously had been adequately peer reviewed. The OMB officials and their technical consultant appeared to lack basic familiarity with the occupational medicine and public health issues addressed by the study. This second OMB review added nothing to the quality of the scienfitic product; in fact, the removal of the nested case control study weakened the overall design. Further, the OMB review resulted in a six-month delay in the medical cancer screening of several hundred individuals. Epidemiologic .ll!!9.Y .2! ~ Fall Injuries NIOSH submitted its proposed On June 27, 1984, epidemiological study of ladder fall injuries to OMS for approval. As explained by NIOSH in its supporting statement, 34 35 the underlying purpo8e of the study vas to telt the hypothesis that epidemiological methods, which had been luccessfully applied to the study of disease, could be useful in the study of traumatic injurie •• Falla from ladders were cholen by NIOSH as an accident type to test the application of epidemiological methods lince: (1) it is a persiltent type of accident (accounting for 1.4% of all workers I compensation casesi (2) it often results in severe injurYi and (3) NIOSH had targeted occupational falls as industryls number one safety problem. The application of epidemiological methods al proposed by NIOSH would permit a rare comparison of thOle suffering traumatic injuries with others taking similar ri8ks who do not luffer 8uch injuries. To date, epidemiological methods have seldom. been used in studying traumatic injuriel and never used in analyzing ladder fall injuries. In developing the study. RIOSH consulted with eighteen outside experts in the fields of safety. data collection, and epidemiology. In addition, MIOSR conducted a public meeting to discus8 the concept of epidemiology applied to traumatic injury in general and the specific protocol developed by KIOSH for use in the study of ladder falls. On September 26, 1984, OMI disapproved the Itudy. In its explanation, OMI stated: appeal emphasized that tbe ongoing OSHA ruieaaking only applied to the construction industry and that the reeults of it. atudy would be useful to OSHA in IIOdifyina ita general industry and maritime regulations. The OSHA memorandum. a180 underscored the importance of the NIOSa study in voluntary aafety effortl. It Doted that the study "viII aha be very useful" to the various public and private programs coueerned with ladder .afety. Finally, the appeal .tressed tbe i.portance of tbe study a. a model for otber occupational .afety researcb. The OSBA docuaent noted tbat "[t]his Itudy and the developaent of .uch a model iJ very important to OSBA and to the occupational safety field al a whole."l! On July 12, 1985, OMI rejected the appeal, reiterating its conclusion that the info~tion collection wa. unnecessary. OMI I. letter stated that: II. •• in the case of falls frOll ladders, we are not convinced that the study proposed il necessary for OSBA ruleeaaki~. and therefore conclude that it has no practical utility."32 In this ca.e, OMB ba. ignored the language of the Paperwork. Reduction Act, vhich defines "practical utility" as tbe liability of an agency to use information it collects, particularly tbe capability to process .uch information in a timely and uleful manner." Here, MIOSH clearly demon8trated that the proposed information collection request would lerve a variety of regulatory and non-regulatory purposel. OSHA, the primary federal user of the data resulting from this collection, i8 in the procels of revising esisting regulatioDs designed to reduce accidents from falls from ladders. Since OSHA has decided to pursue a regulatory 801ution to this problem, it i8 not neceBBary to undertake an epidemiological investigation at this time. 29 OMB offered no response to NIOSRls explanation of the underlying purpose and utility of its proposed study. On May 3, 1985. the Assi8tant Secretary for Management and Budget of the Department of Health and Human Services forwarded an appeal of ·OMl I S decision from. the Director of NIOSH. The appeal was accompanied by an endorsement by tbe Acting Assistant Secretary for Realth and a memorandum of support for the RIOSR study from. the Director of OSHA IS Directorate of Standards Development. The KIOSR appeal and the OSHA memorandum strongly rebutted OMB's aS8ertion that the proposed study wal not needed by OSHA. They explained that OSHA's current regulatory initiative to modify or revoke requirements of its ladder standards vas in the earliest Itages of development and that "OSHA needs 8S good a data base as it can obtain to make clear intelligent decisions on which standard I I requirements should be proposed for revision and which ones should be proposed for revocation."l O In addition, the SIOSR .Iul1ll IiW. R.i. Ipforytiop Processip, NIOSH estimates that more than half the U. S. workforce il engaged in what psychologists tera information processing tasks on the job. InformatioD processing within this NIOSR study vas defined as repetitive aental tasks (.L..I..... looking up telephone DUmbers). The health rist of ladder fa1l1 are easily evident to the lay reader and are fairly easily measuredi tbe hazards of strea. frOll repetitive tasts are less evident and have not been extensively evaluated. This proposed NIOSH study vas intended to relate these types of tasks with measurements of phY8ioiogic changes (.i...ah., heart rate) which may be associated with the onset of so-called strels-related diseases, such as heart disea8e. During any research procelS, tbere must be a first step; the question initially bas to be asked "is there a problem?" This study was de8igned to break new ground by evaluating the relationship between the stress of repetitive mental tasts and phY8ioiogic changes. Given the large population involved in such tasks, the establishment of such a relationship could have important public health implications. The reBearch might lead to evaluations of the workplace 8etting that could decrease the iocide6ce of stres.-related disorders. 37 36 The NIOSH study was favorably reviewed by all seven peer reviewers and the information collection request was submitted to OMB for approval in December 1984. On February 15, 1985, OMB disapproved the study. OMB's reason for the disapproval WBS that: ''URS had not provided sufficient evidence of existing bealth and safety problems."3l The purpose of the Paperwork Reduction Act bas been turned on its head in thia case. The Act was intended to avoid duplicative and unnece.sary research. However, OMB could not reject the study on this basis; instead it rejected the proposed study on the grounds that BBS did not have sufficient evidence of existing health and safety problems. Consistent application of this sort of policy by 00 would elt.inate research in any new areas of investigation. Centers 12£ Disease Control Reproductiye Outcome ~ The purpose of this study by tbe CDC Birth Defects Division was to monitor tbe reproductive outcome· of CDC employees and their spouses. The term. "reproductive outcome" includes a wide variety of results affecting reproductive health, including sterility, spontaneous abortion, miscarriage, stillbirth. and congenital defects. The initial indication of the need for the study was a cluster of abnormal birth outcomes occurring among some group a of CDC laboratory workers. Subsequent CDC review of their lab e%p08Urea indicated the presence of substances that are either mutagenic, teratogenic, or embryotoxic. As noted in the review of the VDT study, the.epidemiology of reproductive studies is u8ua11y controversial. The design of this study was therefore significant in tva important respects. First, the population to be studied consisted exclusively of CDC employees, expected to have a high awareness of medical issues because of the nature of their employment. In view of this fact. it was expected that there would be a high participation rate. Second, since the study involved a population that vas aware of epidemiologic research issues, NIOSH expected that participants also would remain involved in the study over time; thus, a strong prospective design was possible. A strong prospective reproductive study with a high participation rate had far-reaching significance. Such a study would have provided an invaluable model of a surveillance program and important baseline data on rates of spontaneous abortion and other fertility variables. Such data also would have provided the foundation needed for other studies on reproductive issues. It should be noted that baseline data from this study would have been very useful in addressing some of the questions that were raised by OMB in tbe VDT study. Peer review of this CDC study was extensive. Because of the unique nature of the study, revievers from all sections of CDC participated in analyzing the study design. The proposal was submitted to OMB on June 16, 1985. On August 27, 1985, CDC's information collection request was denied by OMB on the grounds that the study would "establish a large scale surveillance system for a problem. that apparently does not exist nor has ever been proven to exist. In the absence of clear evidence that a health problem exists or i.s likely to exist, OM! considers the proposed surve11lance system to be unnecessarily burdensome intrusive and costly."34 The proposal was resubmitted to on March 3, 1986 and disapproved again OD June 27. 1986. Once again, it appears that ONB officials have misconstrued the intent of the Paperwork Reduction Act. Surely, if CDC employees are seeking answers to health matters of concern. their atteatpta to resolve such concerns should not be blocked on the grounds that they are unnecessarily burdensDllle and intrusive. If CDC bas sufficient funds in its budget available to conduct the proposed study and the information to be derived would be valuable to the agency, the Paperwork Reduction Act does not appear to vest OIIA with authority to second-guess the agency based. on cost cODsiderations. Such action would appear to const1tute the very type of substantive interference with the public health activities of CDC prohibited by the Act. On 38 39 FOOTIIOTES BIBLIOGRAPHY AlID LIST OF KEY DOCIIMEIITS REVIEWED OMB Review Procea. 1. 2. 3. 4. 5. 6. 7. 8. 9. 44 U.S.C. I 3502 (1980). 44 U.S.C. I 3508 (1980). 5 C.F.B. I 1320.4 (1986). 5 C.F.B. ! 1320.11 (1986). S. REP. NO. 930, 96th Cong., 2d Sess. (1980). 44 U.S.C. I 3518 (1980). 126 CONGo REC. 30192 (1980). S. REP. NO. 930, 96th Cong., 2d Sess. (1980). Clark, William e. , and Hajone, G. , "The Critical Appraisal of Scientific Inquiries with Policy Implications, II Science. Technology 10, Issue 3 (Summer, 1985). m 1. Clark, William Appraisal of C.. and Hajone, G.. Scientific Inquiries ''The Critical with Policy Implications," Science. Technology and .I!!!!Y!!. Value., Vol. 10, I.sue 3 (Summer, 1985). 2. Soakolne, Colin L., "Epidemiological Re.earch, Interest Groups and the Review Procels, II Journ.l !l!. lYk!.i£ !u.!1A Policy, June 1985. !tl Document Regue.ts h Investigations 1. Letter ~ of the Subcowittee CDC InfOrmation request from John D. .sm Oyer.ight Dingell, .!!l!l Cbainun, Subcommittee on Oversight and IDve'tigationa, to Dr. Jamea D. Maaon, Director, Centers for Dilease Control 14. Dioxin-Document 10. (March 7, 1986). 15. Dioxin-Document 9. 16. Dioxin-Document 16. 44 U.S.C. I 3501 .tt HlIL (980). 5 C.F.B. I 1320 (1986). S. REP. No. 930, 96th Cong., 2d Bes •• (1980). lu.r.. .lui&!! Proce •• lIYY!!.~. Vol. 10. Dioxin-Document 6 (all documents listed hereinafter are 8u~rized in the bibliography and are on file with the Subcommittee on Oversight and Investigationa of the Committee on Energy and Commerce, U.S, Bouae of Representatives). 11. Dioxin-Document 2. 12. Dioxin-Document 5. 13. Dioxin-Document 9. 1. 2. 3. 2. 11. CDC SUDIIDary-Document 2. lB. VDTe-Document 2. 19. VOTa-Document 4. Letter of request from John D. Dingell, Chairman, Subcommittee on Oversight and Inve.tigations, to Donald J. Millar, M.D., Director, National Institute for Occupational Safety and Health (March 25, 1986). 20. VDIa-Document 5. 21. 22. 2l. 24. VDIa-Document 11. VDTa-Document 10. VDTa-Document 12. CDC Summary-Document 2. 25. MBOCA-Document 3. 26. MBOCA-Document 5. 27. MBOCA-Document 6. 28. MBOCA-Document 9. 29. 30. 31. 32. Ladder Ladder Ladder Ladder Falla-Document 6. Falla-Document 6. Falla-Document 6. Falla-Document 7. 33. Information Proce.aing-Document 3. 34. Reproductive Outcomes-Document 5. CDC SUDDer! Document. 1. * Description of suni8sions by the Centers for Disease Control to the Office of Management and Budget under the Paperwork Reduction Act, January I, 1984 to March, 1986. 2. Letter from Donald J. Millar, M.D., Director, Ifational Institute for Occupational Safety and Health. to John D. Dingell, Chairman, Subcommittee on Oversight and Investigations, regarding increa.ed co.t. resulting from OMB review (September 16, 1986). I.n. Documents Related .t2. Dioxin !1W. 1.* Chronology 2.** of events for Diozin Morbidity and Reproductive Study. Study protocol and peer review documents, including letter from Brian MacMahon. M.D •• regarding peer review (December 28, 1984). 3.* 4.* Supporting statement for application for information collection for Diozin Study. NIOSB aDswers to OMI questioDs for information (October 15, 1985). 5.* OMB notice of refusal of information collection for Diozin Study (October 17, 1985). 41 40 6.* Request for appeal of proposal for Dioxin Morbidity and Reproductive Study and 8upporting documents (November 26, 1985), including: - Letter from Robert P. Bedell. Deputy Administrator. OMB'a Office of Information and Regulatory Affaira, detailing conditions for approval of of Dioxin 4.* telephone 5.* Study. S. REP. Bo. 210, 99th Cong., 1st Sess. 32 (1985). Iey Documents Related to VDT 4.* Letter from Michael R. Taylor, Esq., King & Spalding, 5.* attorneys for Bell South Corporation, to Faye Iudicello, Office of Management and Budget, including report of Brian MacMahon, M.D., and Sally Zierler, Ph.D., reviewing protocol for the VDT Study. OMB notice of refusal of information collection for VDT 7. * S.* Study (December 13, 1985). Supporting statements and documents for appeal of OMB decision on the VDT Study (Harch, 19S6). Project Officer's sUllllD8ry of telephone conversations with OMS officials. Letter to Mark Winer, Statistical Policy Division, Office of Management and Budget, detailing BIOSH responses to report by MacMahon and Zierler (January 22.1986). 9. "0MB Approves Revised VDT Pregnancy Study. II !R .2!!. Paperwork, OMS Watch, Volume 2. No.7. July 25. 1986, p. 19. 10. "Review of Questions Deleted from a NIOSH Study of Video Display Terminal Users," staff paper prepared by the Special Projects Office of the Health Program. Office of Technology Assessment, U.S. Congress, August, 1986, p. 8. Chronology of events in review process of HBOCA Study. Proposal for study of MBOCA and peer review documents. Supporting statement for application for information collection for HBOCA.Study (February 11, 1985). Response of Elizabeth Ward, NIOSH Project Officer, to the OMS statistical reviewer (April 12, 1985). OMB notice of disapproval of information collection on MBOCA (Kay 8, 1985). 6.* Notes of . teleconference with Dr. Joseph Guestworth. Ph.D. (June 14, 1985). 7.* ~ 1.* Chronology of events in review process of VDT Study. 2. ** Proposal for Video Display Terminal Operators Study, drafts 1 and 2 and peer review documents. 3. * Supporting statement for application for information collection for VDT Study (September 30, 1985). 6. * 1.* 2.** 3.* conversatioDa related to OD review proceas OD Dioxin "0MB Decision Allows VDT Study, NIOSH Wary About OMB's Requirements," Occupational !llitt and l!Y!!!! Reporter, Bureau of National Affairs, June 12, 1986, p. 20. Letter from William J. Butler, Ph.D., Assistant Professor, University of Michigan School of Public Health, to Ted Weiss, Chairman, Subcommittee on Intergovernmental Relations and Human Resources, House Committee on Government Operations, July 16, 1986. ICey Documents Related !.2. DOCA !ll!!1 Study Dioxin (January 7, 1986). S.* OM! notification of conditional approval Study (Karch 6, 1986). 9.** Notes of meetings, discussioDa, and 10. 12. Minutes of AOWG Science PaDel from September 25. 1984. Letter of concern from New Jersey Department of Health. Response to OMB'. request for Btatistical power calculations. 7. * 11. 8.* Addendum to Paperwork Reduction Act packet on MBOCA detailing request of Michigan Health Department for assistance (August 9, 1985). Notice of OMB approval of MBOCA Study with conditions (August 23, 1985). 9. Letter from Donald J. Millar, M.D •• Director, National Institute for Occupational Safety and Health, to John Pendergrass, Assistant Secretary for Occupational Safety and Health, U.S. Department of Labor (August 7, 1986). ICey Documents R.elated .12 1.* ~ Falls llill 4.* Chronology of events in OMB review process related to Ladder Falls Study. Proposal for study of ladder falls and peer review documents. Supporting statement for application for information collection for Ladder Falls Study (June 27, 1984). NIOSH response to OMI reviewers telephone questions 5.* OM! notice of disapproval of information collection for 6.* Supporting statement and documents for appeal of OMS decision on the Ladder Falls Study (May 3, 1985), including supporting memorandum from OSHA. Notice of OM! disapproval of appeal on Ladder Falls 2.** 3.* (August 16, 1984 and August 22, 1984). Ladder Falls Study (September 26, 1984). 7.* Study (July 12, 1985). Key Documents Related to Hazards of InfOrmation Collection Study 1.* Chronology of events Processing Study. in OMB review of Information 43 42 2.** 3.* Proposal for study of Hazards of Informaton Processing and peer review documents. Notice of OHB disapproval of information collection on Hazards of Information Processing (February 26, 1985). Key Documents Related Reproductive OUtcomes 1.* ~ Study of Centers for Disease Control --- --.-_ ......... - --_c._ ..- . . . . .-. -"'-.----.... ... _1-1 ....... - ::'.:-';:... _IMK1C'JI ....::. _ ..._,~ _1.-..-..._ ........ _"'_,fIU,& .............. ..... IT,-.._~ 001 .......... .......... _1.................... ........ - ~ ...,...... .. -..- Chronology of events in OMB Review process related to CDC Reproductive Outcomes Study. ___ .. .... _..0......... .....,"", . '11.6• .,ous. of i\,prtltntatib,s 6ubtDmmittu on c9bttllillfJt .n. )nb~lI.tioM of tilt €omDritttt on ClUlV Inb (;ommatt lIU!Jingmn. lilC 20515 March 7, 1986 2.** Proposal for CDC Reproductive Outcomes Study and peer review documents. 3.* 4.* 5.* 6.* Supporting statement for application for informaton collection for CDC Reproductive Outcomes Study (June 13, 1985). CDC responses to OMB questions (July 16, 1985 and July 19, 1985). OM! Notice of Disapproval of Information Collection for CDC Reproductive Outcomes Study (August 27, 1985). Supporting statement and documents for appeal of OMB decision on CDC Reproductive Outcomes Study (November 4, 1985). 7. Dr. James O. Hason Director Centers for Disease Control Atlanta, Georgia 30333 Dear Dr. Mason: Onder Rule X of the Rules of the Bouse of Representatives, the Subcommittee on Oversight and Investigations has jurisdiction over public health matters. In fulfillment of our oversight responsibility, the Subcommittee requests tbe following information: 1. "0MB Kills Miscarriage Study of CDC Workers." 1R. .2!l Paperwork, OMB Watch, July 25, 1986, p. 8. * Document obtained in response to letter from John D. Dingell, Chairman, Subcommittee on Oversight and Investigations, to Dr. James D. Mason, Director, Centers for Disease Control (March 7, 1985). ** Document obtained in response to letter from John D. Dingell, Chairman, Subcommittee on Oversight and _Investigations, to Donald J. Millar, M.D., Director, National Institute for Occupational Safety and Health 2. For each sumission by the Centers for Disease Control (or any of its component agencies) to the Office of Management and Budget (OMS) under the Paperwork Reduction Act in 1984, 1985, and 1986 (to date), please provide: a. a brief description of the Wlder1ying project, and b. the date of the submission to OMS, the date and substance of any initial OMS response, and the date and substance of any final OHB response. Par any sumission by the Centers for Disease Control (or any of its component agencies) initially or finally disapproved by OMS under the Paperwork Reduction Act in 1984, 1985, or 1986, please provide: A. all written communications and other written materials transmitted between the Department of Bealth and Buman Services (BBS) (and/or any of its component agencies) and OMB in conjunction with OHa's consideration of the proposed project, b. all documents which relate to meetings, discussions, and telephone calls between BHS (and/or any of its component agencies) and OHa officials and/or OMS consultants concerning the proposed project; and (March 25, 1986). 44 45 DL. James O. Mason Ma reh 7, 1986 Page 2 ."""" . . ..."",,,.,, -~""'.< c. the names and titles of all officials of BaS (and/or any of its component agencies) and OMS officials and/or OMS consultants who were involved _IT.-..u._~ .00-"...",",,_ ..,,00&II. ........... _ ' _ .. ou.tT....... _ ..,.....u ........... _ '..0,,-,_". __ O... OCMA ..... _ together in meetings, discussions,. or telephone conversations concerning the proposed project and the date and subject matter of all such oral commWlications. 'iII.E>. ~OUBt of J!.tprtBtntatibtS &ubcommitttt en etlm:illtl anb JnbutiK'ltions e!~! "-<~".' ••••r- .... JWS'",_C'l"" C*I.' ...... c...--;mmtI!~ at. en::-I:r £-nc c.on;.mttc li!I ...~ington. :e~ 20515 The Subcommittee requests that the response to item 1 of this letter be delivered to our offices at 2323 Rayburn Bouse Office Building by the close of business on Monday, March 17, 1986, and that the response to item 2 be provided by Wednesday, March 26, 1986. If you have any questions concerning this request, please contact Debra Jacobson of the Subcommittee staff at (202) 225-4441. John • Dingell Chairman Subcommittee on Oversight and Investigations JDD:DJdb "'.arch 25, 1986 Donald J. Millar, M.D. Director . National Institute for Occupational safety and Health Centers for Disease Control United States Public Health Service Atlanta, Georgia 30333 Dear Dr. Millar: Under Rule X of the Rules of the c. S. Bouse of Representatives, tbe Subcommittee on OVersight and Investigations has oversight responsibility concerning public health matters. Over the years, the Subcommittee has expressed a special interest in the epidemiological research activities of the National Institute for Occupational Safety and Health (NIOSH). 'This research plays an important role in Federal regulatory programs designed to protect tbe public against hazardous substances. Our concern about impediments to NIOSe's epidemiological researcb program was highlighted in 1980 by the Subcommittee's publication of a staff report entitled -Data Transfer Restrictions Impede Epidemiological Research.In fulfillment of our oversight responsibility, the Subcommittee requests the following information concerning the Institute's epidemiological research program: 1. copies of the annual reports of the Division of Surveillance, Hazard Evaluation, and Field Studies for the years 1978 through 1985; 2. the budget and personnel levels for the Division of Surveillance, Hazard Evaluation, and Field Studies and each of its branches in Fiscal Years 1979 through 1986 and estimate~ levels fO~,Fiscal Year 1987; 3. for each epidemiological research study which .... as approved by the Division of Surveillance, Bazard EValuation, and Field Studies in Fiscal Years 1979 through 1987, please provide: 47 46 Donald J. Millar, M.D. Donald J. Millar, M.D. ~.c!"c."'! 2~. March 25, 1986 ~966 4. for ~ny NIOSS epidemiological research study which wa a. a title of the studY1 initially or finally disapproved by OMB pursuant to b. the date of initiation of the proposed project; the Paperwork Reduction Act in 1985 or 1986, please provide: c. the dates of any internal and external peer review J a. the name, affiliation, and professional title of any peer reviewers, b. all documents relating to the peer review process; the date of the division clearance of the proposed project; c. the protocol and any supplemental documentation; d. all written communications and other written materials transmitted between BDS (and/or any of its component agencies) and OMS (and/or any members of the Science Panel of the Agent Orange working Group) concerning the proposed study, e. all documents which relate to meetings, discussions, and telephone calls between aas (and/or any of its component agencies) and OMS officials (and/or OHB consultants or members of the science Panel of the Agent Orange Working Group) concerning the proposed study; f. any documents seeking cooperation or stating objections to the proposed study~ g. a summary of all oral communications relating to the peer review process; and h. the n~es and titles of all officials of BBS (and/or any of its component agencies) and OMS officials (and/or OMS consultants or members of the Science Panel of the Agent Orange Working Group) who were involved together in meetings, discussions, or telephone conversations concerning the proposed study and the date· and a summary of all such oral communications. d. f. the date of the NIOSE clearance of the proposed project; g. the dates of any additional clearances of the proposed project within the Department of Health and Human Services (BDS) U"'...e....., Centers for Disease Control, Public Health service, other HBS officials) I h. the date of any submissions to the Office of Management and Budget (OMB) under the Paperwork Reduction Act, the date and substance of any initial OMB response, the date and substance of any Institute response, and the date and substance of any final OMB response 1 i. the highest level of clearance needed for the proposed project; j. the dates of any other major steps in the review process; k. the estimated or actual cost of such studY1 1. the estimated or actual number of participants of the study, m. the number of NIOSH staff involved in the project; and n. the name of the NIOSH Project Officer, any written request (~, State request) to initiate the study; It is requested that the response to section 4 of this request be delivered to the Subcommittee's offices at 2323 Rayburn House Office Building by the close of businesS on 48 Wednesday, April 16, 1986, and that the remaining information be provided by the close of business on Wednesday, April 30, 1986. If you have any questions concerning this request, please contact Debra Jacobson of the Subcommittee staff at (202) 225-4441. John D. Dingell Chairman Subcommittee on Oversight and Investigations JDD:DJcm o