Document G5LKp1Z6mnV8davVE9z0ZG854

tfcvensber IS, 19S2 03 Mr. Jstjs 3. Ker.-derscn Chairrxn of the Board Trie .Anericar. Industrial Health Cour^ril LC~5 Central Park Avenue Scarsdale, NY 12533 Cte3r Mr. Herder sen. Or. May 12, LS82, the Sxecctive Crrcnittee of the Board accepted the resignation of Mr. w. C. Krstrei of Procter & Garble as Wether of both the A2HC Board of Directors and E<ecutive Cccnitt&e. The Executive Ccrzr.ittee and Board of Directors subsequently elected roe to fill out me hijance of Mr. Krunrei's term for 1982. with the Board's concurrence that Mr. F. Ifland sssuroe a seat or. the Board to complete the balsas* of Mr. Krurorei's tern {ending November, 5815, I air surritting try resignation fsens both the Board and Execs* rive ccmittee of the Joericar. Industrial Health Council, I have been privileged to represent Procter & Gsrrhle these past sveral norths,"and it'has been a pleasure verking vith you, in particu lar. I lock forward to continuing to serve the Board and Executive Ccranittee interests, as iray be appropriate, ir. sy continued capacity as Chatman of the Public Affairs cmrittM. css F. Lang F, Ifland SLXT8 330, iOi X STRXST. N\ V.. HVSSI.VOTON, . C, 5COO. SO* S33-Sf*0<> AP00036522 A1HC PROJECT REQUEST Dit e October 13, 1982 No. 042 APPROVED: 10/12/82 Project Title: Epidemiology State-of-the-Art Position Paper U Objective: To promote the fundamental importance of sound epidemiology as a disciplined science to gain understanding of the critical factors which influence chronic disease in human populations. Epidemiology provides the only real link available for relating hazards and potential risks identified in laboratory studies to evaluations of actual risk to humans from exposures to those hazards. 8ecause of the often imperfect nature of available data, there continues to be either frequent misuse of epidemiological information by ex trapolation to claims far beyond the limits of the date {e.g., the "Estimates Paper") or, a tendency to discount the value of the science by placing unrealistic restrictions on its validity (e.g., the OSHA Cancer Policy). AIHC has had to respond to both of these problems on a broad front over the past several years. Most recently, three papers have appeared under the cornnon authorship of Dr. Marvin Schneiderman variously in a Congressional hearing, an MIT publication, and a publication of the Environmental Law Institute (ELI) called "Teratoqenesis, Carcinogenesis, and Mutagenesis." The latter directly attempts to refute the_Dol1-Peto work undertaken for OTA and published last year in the JNCI. The Epidemiology Subcommittee has responded forcefully to the first two publications and believes a detailed critique of the third is also required. However, we believe this information can best be used in examples of the problems to be addressed in peer-review discussions of a positive epidemiology state-of-the-art position paper. We would expect to seek the participation of eminent epidemiologists, such as Doll, Peto, Higginson, Cole, McMahon, Higgins, Tyroler, Lilienfeld, etc. for a symposium similar to those used successfully for the "Framework" and "Risk Agreement" reviews. This would be published and used to promote sound epidemiology for incorporation into emerging governmental chronic disease policy. Strategy: 1) Epidemiology Subcommittee develop outline of position paper - Oct. 2) Contract with Environmental Health Associates (.EHA) - Last Qtr. T982 a) Critique of ELI paper; b) Review of AIHC comments on epidemiological evidence for occupational/air/water cancer policies; c) Oraft of ~ state-of-the-art position paper. 3) Develop peer-review forum - 1st Half 1983 4) Seek publication in appropriate peer-reviewed journal -Last Qtr. 1983 5) Work with Science Policy Task Fprce - Ongoing Funding Reouirements: ------------------- $50,000 nil'O'OT' 32,000 2,000 2,000 Contract & conslutations with EHA Peer-review Symposium Legal and general contract support Public Relations support EPIDEMIOLOGY SUBCOMMITTEE AP00036523 Project Title: Objective; Strategy: DATE; NOVEMBER 17, 1932 NO. : 043 AIHC PROJECT REQUEST 11 Establishment of a State Resource Deployment Task Force To provide appropriate AIHC assistance to state industry organizations concerned with chronic health hazard issues. (This proposal is a modified version of Project Request #034, approved May 11, 1982 and funded for 1982 at the level of $30,000. $6,657 has been expended through October 1982.) Legislative and regulatory activities involving chronic health hazard issues have been increasing in a number of states. Actions and decisions on some of these will have an important precedent impact throughout the country. This Task Force will help coordinate the- technical and scien tific resources from industry to better address the chronic health policy issues at the state and local levels. The new Task Force would greatly facilitate availability and management of industry's scientific resources in the chronic health hazard area. Its function would be to form ad hoc groups of representatives from companies with in terests in the states where chronic health policies are being developed. The Task Force would identify key issues and assist in the coordination where assistance may be needed. The necessary inter-company liaison and detailed management of a particular issue would be handled by company representatives with direct interests in that state. AIHC's scientific resources and ex perience in dealing with chronic health hazard issues would be used to assist and support these ad hoc company activities with the criterion of selecting the issues being consideration for national policy implications. The Task Force would work through and with other organ izations operating at the state level, such as CIC or COC. It would coordinate its activities with national organizations including CMA, SPI and API, to avoid dupli cation or overlap of activities. It would work with state and local groups in the following ways: 1) Make available all relevant AIHC materials developed for addressing chronic health hazard issues, such as the "Framework Docu ment", comments on the OSHA cancer policy and the scientific aspects of air pollution. AP00036524 Funding Requirements: (Dec. 1982 Dec. 1983) -2- 2) Provide advice to help local organizations manage these issues. 3) Assist in the development of industry re sources to help local organizations manage these issues. 4) Provide names and promote contact of scien tific experts from industry and academia who could be called upon by the ad hoc group or state organization to participate in public meetings and hearings where these issues are addressed. 5) Provide assistance and advice on dealing with the media. 6) Provide limited legal advice in relation to the above policies. 7) Provide for advice and assistance :n re viewing or helping prepare scientific'papers and statements which could be used at hearings, public meetings, etc. $100,000 ($23,343 of this from project />034) General Support $20,000 Legal 50,000 Public Relations 10,000 Consultants, etc. 20,000 General Support: Covers meetings and general expenses for the new Task Force, air fare and travel expenses where necessary for staff to consult with state organizations and corporate ad hoc groups. Legal: Provides for legal participation in Task Force activities, limited assistance in terms of telephone advice to state groups and help in reviewing some of the issue papers which may be needed at the state or local level. Counsel will be used as a resource to the Task Force in its adaptation of AIHC material for issues of generic concern. Public Relations: Out-of-pocket expenses involved with providing PR advice and assistance, including some travel, in connection with state problems. AP00036525 -3- Consultants, etc.: Provides limited emergency funds where it may be desirable for AIHC to pay some expenses for ascientific consultant either in preparing a paper or ap pearing at a hearing. No witnesses will be provided to a state industry group in a state or local hearing unless there was prior clearance from the Task Force, and every attempt will be made to have state groups be financially independent. Also provides some reserve funds for unanticipated activities which may arise as this project develops. Executive Committee * J. o AP00036526 * i.! v or. r . I I-, 14 KOk njKTHKR ISlViRhiA'iTON! f ./iu t * ffuii Jc A re. a r rum;/ ?.0C- /fin-l i 71 VirLrtv J ^92 ry* RELKAStj wrjjNfc'SDA'f, MOVtyhF.k 12*. 1M.* KAtfKlWTnK, Nf>V. 17 -- A &ruup ol prestigious *Munriftt.s today atujAi,ncJ strvftp. support of n proposal railing lot* the fomarJfln uf a "blur til>lon'* -er.l.iAl science pnnel fn is;pvnvt Cle actmtilic bawl* foe *ji'r.iai^nj5 by fr.dulTA] regulatory aypl-ric.ietf. Dr. .lohu (.lhaitmAn of thtt peer t^viev rk mwjj, r^lii pruaa briefing arf^nd***, "Our giniip bC-HcveS that if uu*'h a jiahuI werff estaM iuhed there would b* a gi-nrral improvement in th/- TugulAtery ptoresB, r-Tihani'nd ?i untlf iu Input by ugenry yuientl at S, And au im proved pubilr ioARr of regulatory di;r.ii/m-rr.a}`i nj: with less confroTsl-atieu. and nur frsqu*nt consensu# between p**nu3 #nd ag*n**y. " TUn group's suppose i tbr result of an eafmsiv sclent i t lo fi^i'T ravl^w and evaluation nl "a Frara^vork (nT Sound In Fedtrval Ttocidinn M#Mng" a documuat developed by the American Industrial Health Council (A bc'.'^d-ba***^ coalition nf iiidu.utt i-*1 lltja* and trade flnsuc* lArions). A central nleaent oi AiHC'v propo#Al ix fbu ei'i'ntioi; nf aii Independent **" pan*! . Thp peer misw voek uroup hr.is pur more - tu*fhcc a womplut* rrpocC on this lj.ne. lu Or. Hip.jjinsuii said chc proposed panel's r *$pnnr? tbi.li ty would he Co uci^nti fieaily nasvtf* ch huui'in ridk proaunC'-H hy substance!i under regulatory review. Govtjrnsacut Af?cm:i6d vuuLd cnkte this scientific uaa'fd^enc into auu>>unt before fnnklug reguinfnry decisions. Or. HlJlginsutl noted Chat "th* propusrd panel would ermine Liu? validity and iiiai tation* o sui*ntiilc data available nrv alle^-jdly hftnrduuu Subntiiuw^S brought before the panel foe ev* I u/it Lull, Hope fully this would reduce regulatory and i*f,inlaCiv<? tirliohs hasud on deficient., Inappropriate or fxrraueou* data." A aClontiilc xdviaOr CO Unlwra Ltied AxnouiaC*d for R*s#.irch and Education in Pathviogy (tlARbH), Or, HigginsMh in the fontur E/^rutive Director nf the World Health Ocg* ni sal Lonf 9 InCutOrtHonul Aftrncy for Res<nreh u Canr.e . Dr. Hfggiuson uuld hr agreed tn purr'ici'pec* In the work group bac-nune, "Much oi my career work had b<*u directed 4C `inLubilghing u solid sei>nM l Lu cnnrteusua on iaisu** whet* rhure art legitimate differences of ns i etiCl f i r. opinion aud i.mr.eru lory. I think the 1<1ra ut a Central Selene* Panel offers a.n*c* real solutions in hulplnn to jolvu tula dilemma." Anothu_ renowned participant, Ot . Tom Miy* 'iacx`lt>hd tSte fl.lfuru Of rho jjrupnso.d science pa;*I. _ lie Suggested that "pdnrl muuib*rg would he selected strictly for their evpeitlsc. Tv the fixtuitc ponr;ibl*, this paneL ffli'fflhecs would h-'v^ to be free irim puliciCJ*! and eOnnoraic viessurus and aliould have rucugnixftd prestige am; authority; this would give panel - more - AP00036528 rrcu^onW.it irapacC.in aij appropriate quarter#. ' ' Or. Miva i Dean of the School of Pharmacy and ilhuLrnsan ul rho CuiTi rulum in ToricolOfty at tliO School i Medirine nr the L'n j vcjjj 1 r.y of North C^rnllu# and p**t president of the Society of Tu>;l on lut,y. He wrnt yil To nay* "the w*.fk gioup sugiv t aO char Lh* l>nLral !5ciu<*r. TaueJ would he bedt nnnijcl^rod with the National Aradtriity of Sc 1? nr eu, Although an affiliation with nnuthei institution was not is-Xf Inded ,r<Vii y individual or ergaulaatiun could* gol-mit an i-Auue for cOiisiduf atior fo the Central Scieiicr Taued. Such proposals would ho cunnldereii `die- uietinnury' by Lh* panel. However, Cougrons Of luwidu of lederal agenrinu coyld subtflf r*i;su** tu ClV* pau*l for 'mandatory* review. "The work group ai*a support ud other agprr.Lu of the A1WC proposal inrludinf,: utir^ngthening th* panel* already in ?>1nce *r regulatory agencirr; as w*ll e* consul atreugthcnlnft of the n^uncy sriutn.e r.apaM 11L lv * dC suggested by AtKC.1' Dr. Miya noted that th* nnnugnrewuut of the poor t*vitsv 16 particularly Litf?ly iu Hjht of thu lurcresc generated by a rccwit prasldonrtal vota of an EF> reseArr.h appropriations bill ou tht*. ground? that it would detract Crotti the to] i science in EFA actions. The l.*lll would hav* weakened the scientific bus* of the F.PA'k Science Advisory heard (a good er.dinplo of An in-Uona egenry science psnrl ) by broadening Bu.*rd member-- phip co include a nuuihor or special inter**? groups, (.including mt.eu. industry, labor, academia. cOfigwneEft) . Tula would detract from th* necessary freedom ftoin outbid* pressure* and objectivity needed lot* such d pAnoi ut fcoard to be effnrtiv*. #tf AP00036529 AIHC AMERICAN INDUSTRIAL HEALTH COUNCIL, INC. 1075 CENTRAL PARK AVENUE SCARSDALE, NEW YORK 10583 (914) 725-1492 IT November 4, 1982 TO: SCIENTIFIC COMMITTEE SCIENCE POLICY TASK FORCE EPIDEMIOLOGY SUBCOMMITTEE MUTAGENICITY SUBCOMMITTEE QUANTITATIVE RISK ASSESSMENT SUBCOMMITTE PUBLIC AFFAIRS COMMITTEE COMMITTEE AND TASK FORCE CHAIRMEN OSTP DRAFT CANCER POLICY Gent!emen: The Office of Science and Technology Policy has completed the first part of a two part document to characterize and Identify potential human carcinogens. Part I, which is a review of the state-of-the-art of the science underlying the methods of identification and characterization of carcinogens, is attached. Part II, which suggests the principles to guide Federal regulatory agencies in the identification and regulation of carcinogens, will be available the first part of next year. The OST? has requested that the review be completed by Friday, December 3, so that they can proceed with the necessary revisions to Part I prior to develop ment of the Part II principles. Conments should be coordinated through Or. Robert Moolenaar, Chairman, Sci entific Coirnrittee. If I can be of any further assistance, or answer any ques tions, please do not hesitate to call ((202) 659-QQ60). Sincerely, Attachment leonard Guarrala, Ph.O. Director, Government Affairs WASHINGTON OFFICE: 1612 < STREET. N. W.. WASHINGTON, 0. C. 20006 [202] 459-0060 AP00036530 EXECUTIVE OFFICE OF THE PRESIDENT OFFICE OF SCIENCE AND TECHNOLOGY POLICY WASHINGTON, DC 20600 November 2, 1982 #0V 2 1982 Dear EC: For the last several months, an interagency work group convened by this office has been developing a document the ultimate purpose of which is to guide Federal agencies in their efforts to identify and characterize potential human carcinogens. That document will comprise two parts: Fart I will review the state-of-the-art of the science underlying methods of identification and characterization; Part II will suggest principles to guide Federal regulatory agencies in their use of those methods. The first complete draft of Part I has just been prepared by the work group, and we are eager to receive comments and suggestions on this initial effort. For that reason, my colleagues have asked that I send the draft out for peer review by a limited number of individuals knowledgeable about the scientific basis for carcinogen assessment. Accordingly, the purpose of this letter is to ask that you assist our effort to develop a more rational basis for carci nogen assessment by reviewing the draft of Part I of the document dealing with the state-off-the-science, circa 1982. We will use the comments and suggestions you provide to refine and improve this document so that, to the degree possible, it is an accurate reflection of that state. I realize that I am requesting a considerable commitment of time and energy. Let me make several points: * We are requesting peer review early to help guide our later efforts and to begin a dialogue intended eventually to help develop a consensus'on the most appropriate approaches to assessing carcinogens. * The enclosed is a rough draft. Each section has been written by a different Individual or group, thus the variety of styles and formats and the range of specificity and depth.* * The final Part I will need to be relatively short and generally understandable by policy-makers. AP0003653I 2 We are seeking constructive criticism and specific recommendations on how to improve the accuracy and completeness of our document. To the degree possible. Part I is to be an objective statement of the state-ofthe-scienee from which principles on carcinogen assessment methods can be extracted. 0 We would appreciate direct, crisp responses rather than dissertations. Your comments can be in any form which is understandable, including marginal comments on the draft itself. Needless to say, my colleagues and I will greatly appreciate the time and effort you put into this review and will incor porate your recommendations as fully as possible. We hope to have all reviews in by Friday, December 3, so that we can proceed with the necessary revisions of Part I and the develop ment of Part II principles. Many thanks, in advance, for your contribution to this effort. Best wishes. Enclosure Denis J. Prager Assistant Director Mr. Edwin Behrens Chairman Public Affairs Committee AIHC Proctor & Gamble 1801 K Street, N.W. Washington, D.C. 20006 ccs Jay Keyworth AP00036532 DRAFT POTENTIAL HUMAN CARCINOGENS; METHODS FOR IDENTIFICATION AND CHARACTERIZATION PART I: CURRENT VIEWS DISCUSSION DRAFT Regulatory Work Group on Science and Technology Office of Science and Technology Policy Executive Office of the President October 1, 1982 DRAFT i AP00036533 DRAFT CHAPTER I PREAMBLE 2: DRAFT AP00036534 DRAFT PREAMBLE -^ The Background; Perception of Cancer Cancer has been a major public health concern of the Federal government for many years. Data indicate (1} that this disease-- the second leading cause of death in the U.S.--will, on the average, strike one of every four of our citizens and claim the life of one in five. Although heart and circulatory disease result in roughly twice as many deaths each year, cancer produces a particularly strong reaction in the public mind because of its often lengthy and progressive course, the uncertainties which surround its origins ("causes"), and the perceived lack of progress in developing reliable cures. (i The picture is not as bleak as it once was. Remarkable progress has been made in a number of areas of cancer research. Through the efforts of the National Cancer Institute (NCZ), founded in 1937, and.other public and private institutions significant advances., have been made over the years. New forms and regimens of treatment, clearer insights into the origins and mechanisms of cancer-'development, and introduction of new methods of detection--all combine to present an ever-changing picture which can give the American people increasing hope for the future in the battle against this disease. DRAFT AP00036535 At the same time public concern about cancer--its cause, prevention and cure--remains high. Da.ta have been presented that suggest that many cancers are due to environmental, as opposed to genetic, factors (2), and, by implication, are preventable If sufficient precautions are taken* In this spirit Congress has over the years held hearings, enacted legislation, established agencies, and appropriated funds to address various aspects of the problem. (See Table I.) Besides these efforts, many of which focus on chemical substances as potential causes of cancer, the Federal government has made additional commitments to the investigation of the disease. For example, the National Cancer Act of 1971 expanded activities at NCI. The National Institute of Occupational Safety and Health (NIOSH), the National Institute for Environmental Health Sciences (NIEHS), the National Center for Toxicological Research (NCTR) have been established to conduct research on a number of health concerns, including cancer. Also, the National-'Toxicology Program (NT?) has been formed within the Department of Health and Human Services (HHS) to coordinate much of the Federal testing of chemicals for toxicity, including carcinogenic activity. Each of the legislative acts in Table I contains elements which are products of the thinking which existed at the time of enactment. Because of developments in the scientific understanding of cancer, such thinking has evolved over the years. Consequently, these acts are not uniform in their view of 2- - APOOO36536 the disease, the role chemical substances might play in its incidence, and what ought to be done about such potential carcinogens. For'example, when Congress passed the so-called Delaney amendment to the Federal Food, Drug, and Cosmetics Act (FFDCA) in 1958, the focus was on the intentional addition of cancer-causing substances (as shown in animal tests) to the food supply. This amendment reflected the general notion that the country should strive to remove carinogens from the human environment, a belief based on the concept that any exposure entails some level of risk and that all risk should be eliminated. Prevailing opinion shifted from this view in the ensuing years (3). By the 1970s, legislative thinking had reached the point that the notion of complete removal of all animal carcinogens was being replaced by consideration of risks and benefits, as reflected in acts such as the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). r1 This evolution in legislative perception was contemporaneous with rapid advances in analytical chemistry made during the 1960s and 1970s. Where prudent policy might once have called for zero" (that is, non-detectabie) araourits of carcinogens, the increasing capability of scientists1 to detect ever smaller amounts of materials (the "vanishing zero" phenomenon (4)) called this policy into question. As residues of known and suspected carcinogens were reported in the parts per trillion (ppt) and sub-ppt range, the health implications of these data increasingly 2x -3- AP00036537 became the subject of debate. 25 Even more recently, recognition of the contributions of "lifestyle" (i.e., the free choices associated with diet, drink, and personal preferences) (5) has highlighted the more complex problems which confront the regulatory agencies in playing an appropriate role in protecting people from excess risk of cancer. The judicial branch has also entered the social debate as evidenced by the Supreme Court decision on benzene (6), which points out the need for scientific judgments which are sound and objective. The Purpose: A Consensus View of the Federal Government Because of these developments in the legislative, scientific, and judicial scenes, the Federal government has periodically produced statements which have summarized the then current state of knowledge on cancer (.7), The intent of such documents has been to generate a consensus view of the science ("principles") which would serve as a .common foundation upon which to base rational regulatory cancer policy. The present report, the latest in the continuing series of such statements, is prompted at this time by what the agencies believe to be the significant advances in science which should affect the manner in which the regulatory bodies deal with suspected carcinogens. The purpose of this document, then, is to -4- AP00036538 articulate a view of chemicals and cancer that the agencies hold in common today and that can serve as the basis for separate, but consistent, regulatory cancer policies- which these agencies can tailor to meet the requirements of the legislative acts they are charged to implement. 23 This paper is the result of the combined efforts of the following agencies, under the direction of the Office of Science and Technology Policy (OSTP): Consumer Product Safety Commission (CPSC) Environmental Protection Agency (EFA) Food and Drug.Administration (FDA) Food Safety Inspection Service (FSIS) of the US Department of Agriculture (USDA) Occupational Safety and Health Administration (OSHA) National Cancer Institute (NCI) National Center for Toxicological Research (NCTR) The Context: Ris)c Determination This document is written in the context of decisions by the regulatory agencies which involve the assessment of carcinogenic risks posed by chemical substances. The scientific inputs to these evaluations can be best appreciated by examining the decision making process in slightly greater detail. Risk can be conceived of as being composed of two aspects. -5- AP00036539 each of which can be addressed by science: hazard and exposure."Hazard" refers to the inherent toxicty of the substance and is deduced from the results of structure/activity relationships, In vitro tests, whole animals tests, epideraiolgical studies, and the like.* "Exposure" refers to the amount of the substance that comes into contact with an organism in the such a way that a toxic reaction can be manifested. 2'.' The "risk" is estimated by coupling the results of the exposure and hazard assessments. If either the hazard or exposure approaches zero, the risk also goes to zero. Operationally, the risk assessor must first consider the weight of the evidence that the chemical substances is likely to be a human carcinogen. The field of toxicology has accomodated itself to dealing with many of the complications which arise in this process; e.g. , use of animal data to anticipate effects in humans. Next, various means are available for quantitatively estimating the dose-response relationship at low doses. Then, additional data, assumptions, and judgments are used to generate quantitative estimates of the exposures likely to be encountered. Finally, the exposure assessment is overlaid on the dose-response relationship to generate an estimate of the risk. Some legislation calls for action in the presence of any risk. More recent forms of legislation utilize the concept of * The European Community uses the term "risk" where we have used the term "hazard" and vice versa. 6- - AP00036540 unreasonable risk/ which denotes a condition in which the risks outweigh the benefits. A spectrum of approved responses may be available to bring 'the risks and benefits into appropriate balance* The Content: A Consensus View of the Scientific Input to Risk Assessment Part I of this document is divided into six separate chapters/ each addressing the current information in an area of science utilized in the cancer risk assessment process. These chapters, taken in toto, provide the underlying support for the cancer risk assessment principles articulated in Part II, which are the basis for the cancer policies of the regulatory agencies. To read Part II without a full appreciation of the material in Part I is to invite oversimplification and misinterpretation. I1 The first chapter examines the current state of epidemiological knowledge surrounding cancer. Data collected during the past 50 years allows the construction of trends in cancer i/icidence/mortality. within the past decade there has been considerable discussion about the presence or impending presence of a cancer epidemic due to the growth of the chemical industry in this country following World War II. This chapter discusses the evidence for such a phenomenon, together with evidence for other suggested etiologies of cancer. -7- AP0003654I 20 The remaining`chapters discuss recent scientific developments that impact upon the various elements of cancer risk assessment, which, in turn, leads to regulatory decisions on chemicals substances. Recent advances in our understanding of the mechanisms of carcinogenesis are treated in Chapter 2. The simplified, conservative view of cancer held by many in the regulatory agencies IS years ago suggested direct attack on the genetic information of the organism. While the picture is far from clear today, it is increasingly evident that 'all carcinogens are not created equal" and that different groups of chemicals act to generate cancer through different mechanisms. A general consensus has evolved which describes cancer as a multi stage process involving a variety of events including metabolism, initiation, promotion, proliferation, and repair. The chapter highlights some of these advances in our understanding which have implications in the way we assess cancer risk. At the same time, the material also suggests the vast1 amount of information that remains to be collected and analysed. % Chapter 3 examines short-term testing and the connection between genotoxicity and carcinogenicity. Tests for gene mutation, chromosomal aberation, DMA damage and repair, and cellular (morphologic) transformation have provided valuable information on the potential for chemical substances to cause cancer. While the field is currently characterized by great activity, the data generated must be carefully analyzed and -3- AP00036542 verified before implications for cancer risk assessment can be - accurately drawn. t , The fourth chapter contains a review of the long-term animal bioassay which figures so prominently in our assessment of cancer risk. The discussion includes a critical examination of problems inherent in the bioassay technique as currently practiced. These problems underlie some of the controversies and uncertainties which surround the interpretation of results of even wellplanned, well-conducted studies. 30 In addition to these chapters which examine factors associated with hazard assessment. Part II contains a discussion of exposure assessment, the equally important consideration leading to a determination of risk. As Chapter 5 points out, following a period of initial development, the field of exposure assessment has been marked by significant progess in the areas of monitoring data, computer modeling, transformation and transport of chemicals, and laboratory approaches to determining the behavior of chemicals in the environment. At the same time uncertainties remain in the procedures used to estimate important parameters associated with particular exposure senarios. Any. risk assessment will necessarily be affected by these limitations. Chapter 6 discusses how the hazard and exposure elements of the preceding five chapters are used as inputs to the qualitative -9- AP00036543 and quantitative cancer risk assessment procedures* A common, if not highlighted theme,, of each chapter is the uncertainty surrounding some aspects of the scientific information used in risk assessment process. Some of the major data gaps leading to such uncertainties are discussed In an . appendix to Part II that identifies areas in which additional research could reduce or remove some of the uncertainties. Xn some Instances a fairly well developed data base may already exist and yet there is controversy about how to interpret the data. The Appendix identifies these areas as appropriate subjects for consensus forums which would seek to focus scientific discussion on the issues and to move toward some generally agreed upon resolution of them. 31 Part XX contains the summary statements (principles) of science and science policy interpreration stemming from Part I that will serve as the common foundation for the cancer policies of eaeh off the regulatory agencies. By first agreeing to this set of principles, the agencies will be able to generate policies which, while tailored to the requirements of the different legislative acts, will still be consistent with each other, providing reasonable assurances that human health will be protected from unreasonable risks posed by carcinogens. -10- AP00036544 TABLE I (1) FEDERAL LAWS RELATED TO EXPOSURES TO TOXIC SUBSTANCES Legislation Agency Area of Concern Food, Drug, and Cosmetics Act (1932, amended 1953, 1960, 1962, 1968, 1976) FDA Food, drugs, cosmetics, food additives, color additives, new drugs, animal and feed additives, and medical devices Federal Insecticide, Fungicide and Rodenticide Act (1946, amended 1972) Dangerous Cargo Act (1952) EPA Pesticides DOT-- USCG Water shipment of toxic materials Atomic Energy Act (1954) Federal Hazardous Substances Act (1966) Wholesome Heat Act (1967) Wholesome Poultry Products Act (1968) Egg Products Inspection Act (1970) Poison Prevention Packaging Act (1970) Clean Air Act (1970, amended 1974, 1977) Hazardous Materials Transportation Act (1972) Federal Water Pollution Control Act (1972, amended 1977, 1978) Marine Protection, Research and Sanctuaries Act (1972) Consumer Product Safety Act (1972) NRC CPSC USDA CPSC EPA DOT EPA EPA CPSC Radioactive substances Toxic household products Food, feed, color additives, and pesticide residues Dangerous consumer products Air Pollutants Transport of hazardous materials Water Pollutants Ocean dumping Dangerous consumer products -11- AP00036545 Lead-based Paint Poison Prevention Act (1973, amended, 1976) C?SC Lead paint in federallyfunded housing Safe Drinking Water Act (1974, amended 1977) SPA Drinking water contaminants Resource Conservation and Recovery Act (1976) SPA Hazardous wastes Toxic Substances Control Act (1976) EPA Hazardous chemicals not govered by other laws Comprehensive Environmental Response, Compensation, and Liability Act (1981) SPA Hazardous substances, pollutants and contaminants * Also requires pre-market evaluation of all chemical substances except food additives, drugs, pesticides, alcohol, and tobacco* (1) Adpated from "Chemical Substances Designation", EPA Contract No. 68-01-6038, Dec. 1981. -12- AP00036546 REFERENCES 1. Public Health Service, Healthy People; The Surgeon General's Report on Health Promotion ano-Disease prevention, PHS Puo. So.^9-55-71, 1979,----------- ------------------------------------------------:---------- 2. For example/ a. World Health Organization, Prevention of Cancer, Technical Report No. 276, 1964. b. Higginson, J., 'Present Trends in Cancer Epidemiology", Proc. Canadian Cancer Conf., 8:40--75, 1969. c. Wynder, e. <^T and Gori, G;B., 'Contribution to Cancer Incidence: An Epidemiological Exercise", J. Nat. Cane. Inst., 58:825-832, 1977. 3. For example, "Report of the Secretary's Commission on Pesticides and Their Relationship to Environmental Heal-th" (Mrak Commission), US Department of Health, Education and Welfare, Dec. 1969. 4. Zweig, Gunter, "The Vanishing Zero--Ten Years Later", J. Assoc. Off. Anal. Chem., 61:229-248, 1978. 5. For example, Doll, R. and Peto, R. , "The Cause of Cancer: Quantitative Estimate of Avoidable Risk of Cancer in the United States Today", J. Nat. Cane. Inst., 66:1191-1308, 1981. 6 Industrial Union Department, AFL-CIO vs. American Petroleum Institute ec'ai., 448 usbu/, lasu. 7. a. b. c. d. National Cancer Advisory Board, General Criteria for Assessing the Evidence for Carcinogenicity of,Chemical Substances", J. Nat. Cane. Inst.'5Bx54i-465, 1977. Office of Science and Technology'Policy, "Identification, Characterization and Control of Potential Human Carcinogens: A Framework for Federal Decision Making", Feb. 1, 1979., Interagency Regulatory Liaison Group, "Scientific Basis for Identification of Potential Carcinogens and Estimates of Risk", Fed Reg. 33:39858-39879, 1979. Office of Technology Assessment, Assessment of Technologies for Determining Cancer Riaxs from the Environment, June 1981. !. -13- AP00036547 AMERICAN INDUSTRIAL HEALTH COUNCIL Lfc i 612 < S7525T. N w.. SUITS 508. v/^SHi sSTOM. D.C. (202) ti 5-0060 October 27, 1982 Mr. Geoffrey M. Karny Project Director Office of Technology Assessment Washington, D.C. 20S10 33 Re: Draft OTA Report Entitled "The Role of Genetic Testing in the Prevention of Occupational Illness'1________ Dear Mr. Karny: In a separate letter of this date we are transmitting to you the preliminary comments of the AI32C Mutagenicity Subcommittee on Parts II and III of the Draft Report entitled "The Role of Genetic Testing in the Prevention of Occupational Illness". In addition to those comments, we have one further observation concerning pages 226 and 227 of the Draft Report. The discussion on those pages concerning the Dow Chemical Company, a member of AIHC, is highly inappropriate. The discussion is easily subject to misinterpretation and, more over, appears to be beyond the scope of the Report. We strongly urge that it be deleted. Enclosure nw vC"< Or-iCE: iC` CENT L PARK AVENUE. SCARSDAIE. MY 10583 |9K) 1492 AP00036548 s AMERICAN INDUSTRIAL HEALTH COUNCIL 161? K S7Rc;7. N w., SUl7 303, W>Sh:nG7C^. D.C. * >202) 6S9-0060 October 27, 19R2 Mr. Geoffrey M. Karny Project Director Office of Technology Assessment Washington, D.C- 2D510 Re: Draft OTA Report Entitled "The Role of Genetic Testing in the Prevention of Occupational Illness Dear Mr. Karny: The enclosed memorandum summarizes a number of pre liminary comments on Parts II and III of the Draft Report of the Office of Technology Assessment entitled "The Role of Genetic Testing in the Prevention of Occupational Illness". The comments are the result of the initial expedited review of the Draft Report by the AIHC Mutagenicity Subcommittee and are not intended to encompass an exhaustive critique of the document. The Draft Report appears to be well-balanced and carefully considered. Our review has led us to make a number Of suggestions, however, which we feel would improve the docu ment and help avoid misinterpretation. Because of the limited time available, we were unable to conduct the thorough review and analysis that the document merits. In particular, the potential use of genetic testing should not be taken out of context. There currently exists a growing body of literature concerning the toxicity of substances in animal experimentation and methods of extrapolating to estimate occupational risks. Animal testing and risk assessment will continue to be used whether or not genetic testing proves to be a useful tool in the prevention of occupational illness. The role of genetic testing must be viewed, not in a vacuum, but in a proper perspective with other available mechanisms to reduce occupational risks. If you have any questions concerning these comments, olease do not hesitate to contact Dr. Joseph Irr at: `(302) 366-5293. Very truly your Enclosure Guarraia, Ph.D Direeitor, Government Relations Department n\V YC*K CFPiC 075 CSNTRAL PAe.< AVtfMUS. SCARSDaU NIY (0583 |9 14} ;? 1492 AP00036549 1 AMERICAN INDUSTRIAL HEALTH COUNCIL 1412 X S? $ SET. N.W.. SUITE 3 cs. was-.'. sjGTCn, D.c i202 ) tS*.006C Preliminary Comments on Parts II and III of the OTA Draft Report Entitled "The Role of Genetic Testing in the Prevention off Occupational Illness" After a preliminary review, the American Industrial Health Council ("AIHC") Mutagenicity Subcommittee has the following observations concerning the .Draft Report: 1. Page 82. With regard to the first- paragraph, it has been observed that shin cells in older individuals may remain viable despite changes in the number of chromosomes. With regard to the second paragraph, there is evi dence concerning the mechanism by which radiation causes chro mosomal aberrations. The second sentence in the second paragraph should be revised to delete the reference to fibroblasts, since there are no direct preparations of fibroblasts. 2>. Page 83. With regard to the discussion of sister chromatid exchange, it would seem appropriate to include a more detailed description of the phenomenon. The description at page 83 is much too brief. 3. Page 88. The Draft Report fails to recognize the variations in estimates of the number of chemicals which are both carcinogens and mutagens. The Gene-Tox Program is expected to provide further information on this topic. The N=w YCR< Or?!CS: '075 CENTRAL PARK AVnUE. SCARSDALg, NY 10583 (914) 725-U92 AP00036550 1U) second sentence in the second paragraph should be revised as follows: "Many cf the chemicals 'knowo to cause cancer in ani mals are also known to cause mutations in in vitro test stu dies." 4. Page 106. Table 1 is misleading. No test has a predictive value of .99. The table suggests that an inappro priately high level of specificity is needed, which may result in the nonuse of valuable tests. 5. Page 109. The entire final paragraph should be deleted. Under the Occupational Safety and Health Act if a chemical is a potential human carcinogen and if it is known that workers are "significantly exposed" to the chemical, expo sure levels will be reduced. We doubt that OTA intends to sug gest that the initial response to such -significant" exposure will be to conduct a monitoring program. As noted above, the potential'use of monitoring programs must be placed in its pro per perspective. 6. Page 110. The first sentence in the second par agraph should be changed to recognize that only some of such agents cause mutations and chromosomal damage. 7. Page 112. The discussion of cytogenetic moni toring should be revised to put such studies in proper perspec tive. Such studies may be one of many mechanisms available to determine safe levels of exposure. -2- AP00036551 3. Pace 113. With recarc to the second paragraph. the statement about the potential use of cytogenetics may be unwarranted. Cytogenetics may not identify certain exposures which, nevertheless, are hazardous. The first sentence in the third paragraph is highly misleading. It suggests that cancer is causally associated with chromosomal aberration. Such an association has not been demonstrated. In addition, it is debatable whether the animal literature linking mutagens with carconogens is "large". 9. Page 114. The last paragraph is internally inconsistent. The statements regarding.limitations are cor rect. However, they do not support the reference to "good agreement" in the third sentence. 10. Page 117. In the last sentence, the reference to "expected" breast cancer seems inappropriate. We would sug gest that the sentence read "the time of onset for breast can cer has not been earlier than would be predicted on the basis of studies in unexposed populations." 11. Page 119. The first full paragraph requires revision to' clarify that all references are to radiation. 12. Page 120. The first full paragraph suggests human experimentation. mal studies. Perhaps the reference should be to ani 13. Page 127. Table 1 has a high potential to be misleading. First, it ambiguously includes such "chemicals" as 3o -3- AP00036552 petroleum vapors, cytostatic drugs, hair dyes, pesticides and spray adhesives. Second, the resales are listed as positive or negative. This unfairly suggests that these studies are equivalent and that no findings are ambiguous. The table could easily be taken out of context. 14. Pace 129. The statement of conclusions is fairly stated and balanced. However, as noted above, it does not put cytogenetic testing in the context of other testing and risk assessment methodologies. 15. Page 133. Table 2 does* not appear to add any thing to the Draft Report. It is also easily susceptible to misinterpretation and does not appear to be explained in the text. 16. Page 151. The word "tremendous" in the second paragraph seems to be inappropriate. 17. Page 152. Table 1 needs further explanation. 18. Page 153. Table 2 repeats the error discussed above by attempting to summarize in a single table the results of a number of studies. It is also easily misinterpreted as suggesting an occupational cause for the various mutagenetic endpoints monitored in the occupationally defined populations - Many of these studies were discredited in the Dabney paper. (Dabney, Betty J., Ph.D., "The Role of Human Genetic Monitoring in the Workplace", Journal of Occupational Medicine, Vol 23, Mo. 9 (Septembner 1981)). -4- AP00036553 19. Chapter 11. This chapter fails to recognize the 'tr.croversy surrounding the premise that enzyme level moni toring is a cood indicator cf disease. The studies cited have not been reproduced. Extensive review has been undertaken by J.R. Gillette of the National Institutes of Health. 20. Page 174. The discussion of other characterized genetic traits is also very controversial. The hypotheses appear to be overstated in the Draft Report. 21. Page 180. THe same comments apply to the dis cussion of less well characterized genetic traits. 42 4 -5- AP00036554 THE VHITE HOUSE Office cf the ?ress Secretary For Immediate Release ,October 22 1992 r>. 4 TO THE SENATE OF THE (JNITED STATES: I am returning without ay signature S. 2*77, the "Environmental Research, Development and Demonstration Act of 1983." It should tie understood that av disapproval of this legislation will in no wav interfere with the conduct of any of the research programs of the Environmental Protection Agency. Pursuant to the Department cf Housing and Urban Development -- Independent Agencies Appropriations Act of 1983, which I signed into law on September 30, 1982, ETA will spend $220.8 million on its research activities in fiscal year 1983. The appropriations authorized for research in 1983 are'10 percent hicher than in 1982, reflecting this Administrationrs commitment to putting environmental regulation on the soundest possible scientific footlnc. Vhile S. 2577 is unacceptable as a whole, I want to commend Congressman Cooper Evans of Iowa for contrlbuciag to this bill an amendment to authorize the Senior Environmental Assistance Program. Congressman Evans* amendment provides the authority for ERA to continue promoting meaningful employment opportunities for older Americana in Federal, State, and local agencies, as they accomplish important short-term environmental protection projects. The amendment is based on a highly successful demon stration project carried out by SPA In conjunction with the Administration on Aging and the Department of Labor. 1 believe the amendment would further this Administration's goals cf providing productive, meaningful emplovraent to older workers, and providing the benefits of a aleanar, safer environment to future generations. nevertheless, enactment of S. 2577 would represent a major step backward in achieving the goal cf assuring that our vitally important environmental research prognms reflect the best Judgment of tha scientific community, unhampered bv partisan or interest group politics. S. 2377 would mandate that the ?A Science Advisory Board membership include representatives from "States, industry, labor, academia, consumers, and the general public." This requirement runs counter to the basic premise of modern scientific thought as an objective undertaking in whieh the views of special interests have no role. The purpose of the Science Advisory Board is to aoply the universally accepted principles of scientific peer review to the research conclusions that will form the basis far E?A regulations, a function that must remain above interest group politics. In addition, under the statutes governing actual promulgation of S?A rules, the Administrator is obligated to seek public comment from sny and all interested parties and to mljn such comment in shaping final rules. That Is the stage of the rulemaking process at whieh inveLvement of special Lntcrest viewpoints is appropriate, not the earlier stage of developing a sound scientific understanding of the research findings that may be relevant to a particular rulemaking or class cf rules. more 10VE31 AP00036555 2 Environmental regulation involves scientific, political, social, and eccnooic judgaencs. The laws sanditlng protection of our air, water, and land against narsful pollution reflect this necessity to balance a wide range of factors. Sut for the entire regulatory process to function effectively, it oust have as itj starting point an objectively developed review of the state of scientific Knowledge. The Science Advisory Board is vital to the preparation of this objective scientific review; to require that tba Board become a political entity, with representatives from various special interests, would completely undermine the use of scientific Knowledge In SPA rulemaking. The aaintenanee of a free, essentially seif-eoveraing scientific research community is one of the great strengths of our Nation. To undermine this tradition by requiring that the scientists appointed to the SPA Science Advisory Board wear the label of "Industry" or "labor" or "consumer* is a modern-day version of LysenKoism to whioh I must strongly object. la addition to imposing these new requirements oa the procedures for selecting the CPA Science Advisory Beard, S. 2977 contains a number of other abjeotionable features. It authorises spending that ie $46.U million above the previously enacted appropriation bill; it mandates an increase in the proportion of funds devoted to basie research from 15 percent to 20 percent, whioh will take funds away from high-priority researoh needed for the support of rogulatory proceedings; it maudstea a duplicativa and wasteful effort to create another national environmental aoniCoring network; and it mandates a number of research activities that are Inconsistent with the previously enacted eppropriation. For these reasons, am returning 3. 2577 without my signature. 50 80HAL0 REAGAN THE WHITE HOUSE, October 22, 1982. t*t# AP00036556 SCIENCE POLICY ISSUES IN 19S3 RE AIHC INVOLVEMENT DISCUSSION BACKGROUND MATERIALS (Re: Agenda Item 6, November 30, 1982, Board of Directors Meeting) Attachments Page 2 . AIHC Guidelines for Assessing Legislative Involvement (approved by the Executive Committee, October 13, 1982) Page 5 Memorandum to the Executive Committee re Scientific Issues in Pending Third Party Liability Legislation Page 7 Page 10 Page 26 .Jage 30 Page 31 .. Memorandum on Legislative Concerns Arising from the "Grad" Report . Science Issues in other Legislation before the 98th Congress . Science Projects in Support of AIHC Policy Objectives . Public Relations Projects in Support of AIHC Policy Objectives . AIHC Resource Management for Effective Assistance to 5tate Organizations (Establishment of a State Resource Deployment Task Force) 01 AP00036557 September 3, 1982 0 TO: Carcnittee and Task Force Chairman FPCM: The AIHC Public Affairs Cocimittee SUBJECT: Guidelines for Assessing Legislative Involvement These guidelines have been prepared by the Public Affairs Committee to help provide a rationale for assessing legislative situations for likely AIHC involvenent. Peri odically, AIHC members express an interest in certain legislation and ask about possible AIHC involvement; AIHC is at times approached by Congressional Members or staff for appearances or other involvement in issues of legislative interest; and the potential for an increased incidence of generic science policy issues in the next Congress all suggested that guidelines for use in evaluating such involvement by AIHC would be helpful. These guidelines are consistent with the responsibilities of the Public Affairs Ccrmittee which include, "developing appropriate strategies for responding to ger mane legislative, regulatory, and Administrative proposals." Nothing in these guidelines, however, is intended to alter AIHCs prescribed processes for deciding legislative involvement. For example, since AIHC is not primarily a lobbying or ganization, no decision for direct legislative involvement requiring registration as a lobby group can be made without prior approval by the Executive Cocmittee. t It is expected that the primary function of these guidelines will be to facilitate camuinication and understanding. ELB: jkra Sr-Ti BeHrKs^efoirman Public Affairs Coimittee AP00036558 SJIDELrNES FOR ASSESSING LEGISLATIVE INVOLVEMENT AIHC Public Affairs Committee Q3 I. Occasions for potential AIHC involvement with the Congress (e.g., on legisla tion/ visits with Members and staff, or in testimony) should be limited to instances that substantially involve generic policy issues related to chronic health concerns te.g., carcinogenicity, mutagenicity, or similar effects). The relationship need not be direct. For example, legislation addressing the role of science in federal regulatory decision making processes could be ap propriate for AIHC involvement, if the organizational concepts or precedents would have potential application to the chronic health interests of the re spective agencies (e.g., CPSC, EPA, FDA, OSHA, etc.). The generic issues should be sufficiently material to legislation so that AIHC involvement will not have the appearance of being too closely associated with federal actions related to specific materials or industry-specific concerns. Where a science or other generic policy issue is material to a legislative interest, it is not necessary that AIHC support or oppose the total thrust of the legislation if our participation is confined to addressing issues of spe cific Interest to AIK. II- Direct participation by AIHC should generally be limited to those instances of legislative involvement where there is a reasonable likelihood that the legist latlon will prevail. In prevailing, it may not be necessary that the legislation actually be enac ted into law, but it should stand a good chance of passage in the respective Chamber (Blouse or Senate) where AIHC involvement is contemplated. AIHC has unique expertise, but limited resources; so involvenent in any given instance should be balanced against other opportunities for advancing AXHC's policy objectives to the interest of its total membership. Also to be bal anced against the benefits likely to result fran AIHC participation, should the legislation pass, are the risks attendant upon participation in any legis lative effort, particularly if the effort should fail. The Public Affairs Ccnmittee is perhaps uniquely constituted to assist in these assessments. III. For reasons of efficiency and limited resources, it will generally be found that AIHC can best serve its legislative needs by contributing to the efforts of otheiT more broadly based organizations. in " The determination of whether or not AIHC should become directly involved in an issue will have to be decided on a case-by-case basis considering AXHC's re sources, interests, and overall program needs. AP00036559 GUIDELINES FOR ASSESSING LEGISLATIVE INVOLVEMENT AIHC Public Affairs Ccrmittee Page Two 04 The resource requirements for pursuing a legislative objective can be substan tial. AIHC will want to review each potential legislative involvement against the following considerations: First, is there a generic science or other policy issue represented by the legislation that is sufficiently unique to require the expertise of the AIHC? If so, what involvement by AIHC maximizes use of that expertise? Etor example, offering testimony may constitute an appropriate role for AIHC by providing focus for our proposals and an arena for advancing our views. But the resource-intensive follow up that lobbying^ entails may be better provided by those with the broader legislative issues in mind and having more extensive means. Second, do issues, where they coincide with the interests and objectives of the AIHC, represent the major thrust of the legislation, or are they inciden tal to the legislation even though important to AIHC? Identifying which groups have the more preponderant stake in the outcome of a given legislation will- be important in deciding whether AIHC's involvement should be direct or suppor tive of others. Public Affairs Camittee September 3, 1982 AP00036560 ,r,i ;rnru 14 i i/il to AMERICAN INDUSTRIAL HEALTH COUNCIL 1075 CENTRAL PARK AVENUE SCARSDALE. NEW YORK 10523 (9! 4] 725-K92 October 20, 1982 Oo MEMORANDUM FOR THE AIHC EXECUTIVE COMMITTEE Re: Scientific issues in pending third-party liability legislation A basic objective of AIHC has been to support sound scientific principles in the determination of causality with regard to the relationship between exposure to alleged hazardous substances and human health effects. Measures replacing sound scientific principles with legal or factual presumptions have been gaining currency in regulatory legislation and legislative proposals. Examples are the listing of 65 generic compounds in 307 (a) of the 1977 Clean Water Act Amendments and the pending proposed Clean Air Act Amendments which would add a list of specific compounds under S 112 of the Clean Air Act. These same scientific issues will arise in the reauthorization next Congress of TSCA, Safe Drinking Water Act, FIFRA, RCRA, and other environ mental statutes. Similar proposals are being advanced with regard to legislation that would establish liability and/or compensation schemes governing third party injury alleged to result from ex posure to hazardous substances. In pending product liability reform legislation, moreover, there are both provisions that would diminish the role of sound scientific evidence in establishing liability and provisions whose deletion from the draft legislation would further detract from the role of science in determining causality and other elements of liability. Thus, there is a clear role for AIHC in opposing provisions that replace scientific demon stration with presumptions or unwarranted uses of inadequate data. Some key current issues are: 1. Hazardous Waste Liability The proposals contained in the report of the Superfund S 301(e) Study Group, the "Grad Report" (see Memorandum on Legis lative Concerns Arising from the "Grad Report", dated October 11, 1982) include the suggestion that, in establishing the right to Tier One no-fault compensation, the claimant be entitled to bene fit from a serious of rebuttable presumptions which would ease the claimant's burden of proof. These presumptions would be based on findings by government agencies; the scientific validity of such findings cannot be assured. Neither the fact that the pre sumptions would be rebuttable nor the fact that the Study Group recommends that "an appropriate rule-making procedure should be AP00036561 followed to assure the scientific accuracy of the results" is sufficient to guarantee that liability will not be imposed on "he basis of invalid or inadequate scientific procedures. Senai ^tor Stafford f(R^ -VT)\ Uha^ sc announced h<ii s0 i\nt*i t+-eftnt*i\oa*np* wto^ ^pu. . sh for legislation embodying the Grad Report recommendations on compensation. 0 2. The Miller Bill H.R. 5735, introduced by Cong. Miller (D-CA) would establish a system of workmen's compensation for disability or death arising from exposure to asbestos or uranium ore. The bill would create presumptions of causality with respect to certain diseases if exposure occurred in the course of employment In some cases these would be irrebuttable. 3. Product Liability Legislation Th e Kasten-Gorton bill, S. 2631, as reported out by the Senate Comme rce Committee presents a combination of issues (attenu' ation of the causality showing required by current law and de letion of a requirement that expert testimony be supported by objective evid ence) whose result, if not changed, could be to make findings of causality possible on a basis devoid of sound scientific suppor t. Other provisions in the bill' as reported, if they survive the legislative process, will strengthen the role of science in k ey elements of liability. Conclusion Support for sound science in these legislative initia tives is fully consistent with AlHC's position and no other group to our knowledge is focussing on these questions. Wil liamvr. McCarville Chairman Scientific Committee -2- AP00036562 UNIVERSITY OF CALIFORNIA, DAVIS BCRKXLEY OAVtS IR'INS LOS menu RIVXMJDC BAN* OICCO SAX FRANCISCO SANTA BARBARA SANTA CHUT DAVID S. SAXON Pr'-udmi at the Umxcruttj EMIL M. C'AuAffWIor EMnxRnAtuKt Univtnity Home Oavii, California 93610 November 2, 1982 34 Dr. M. J. Sloan, Manager Regulatory Affairs, Health, Environmental Support Shell Oil Company 1025 Connecticut Ave., N.W. Washington, D. C. 20036 Safety and , Suite 200 Dear Joe: I have been working with people at the State Chamber of Commerce and also Mr. Riley of the Pacific Gas and Electric Company in connection with the proposed actions to be taken by the Air Resources Board and the State Department of Public Health. I have gone over their statements very carefully and X must say they are, in the least, shocking. The general attitude seems to be that there are so many uncertainties because of the lack of needed research that they are not going to wait; they are going to make their judgments in the absence of reliable information and sound science. X have written letters to both of them and am enclosing copies that I sent to the people at the State Board of Health and Air Resources Board. Riley, of the Pacific Gas and Electric Company, is so impressed with the results of the Aspen Conference, he would like to arrange for such a meeting in the State of California for the state of California. X would like to know how you feel this. about A new book has just come out entitled "Genetic Toxicology-- An Agricultural Perspective." This was the result of a conference held at the Davis campus some time ago and has been edited by Dr. Raymond Fleck. It is published by the Plenum Press. You might like to look at this because it overlaps with some of things we have been talking about. ^ AP00036563 Dr. M. J. Sloan. -2- November 2, 1982 35 In any event, Joe, I will be looking forward to hearing from you on this whole situation and whether or not you think a move in California in the direction of the Aspen activity would be desirable. Kindest personal regards. /} Enclosures AP00036564 October 21- IS92 ms. Mary Nichols Air Resources Board 1102 Q Street Sacramento, California 95314 Dear Ms. Nichols: The meeting of your group. to be held on October 27 has cose to my attention and I would certainly like to attend, but unfortu nately, I must be at another meeting in San. Francisco at that tine. The nesting I aa referring to, of course, is the board's proposed amendment 1 to Title 17 regarding Emission of Toxic Air Contaminants. I have read your statement and must say a great deal of work has gone into its preparation and it does contain a great deal of information* I am concerned, however, .as to whether or not the approval and acceptance of the new amendment should ba done without adequate, sound, scientific review and consideration. feel so strongly on this, because only last July X was invited to attend a meeting in Aspen, Colorado, held under the auspices of the American Industry Health Council,and under the direction of John Higginson, formerly the head of the United Nations Cancer Research institute at Lyon, France. Dr. Higginson was prompted to call a group of scientists together because he saw the need for the formation and development of a prestigious, scientific group, independent of all regulatory agencies, reporting directly to Congress and the President, to review scientific mattars that might result in decisions and regulations. v A good example of something that night be reviewed by such a scientific group is the amendment you are considering. I might point out that the background for this scientific organization has been developed and I am sure you can obtain a copy of it from Dr. Higginson at Universities Associated for Scsearch and Education in Pathology, Inc., 5550 Rockville Pike, Bethesda, Maryland 20814, if you so desire. AP00036565 Ms. Ilary Nichols -2- October 21e 1982 37 It is now in the hands of Dr. Jar.es Martin, or in other words Ccngressnan Martin, who will deal with it at the Congressional level. X think something like this is needed in California to review an amendment such as that being proposed by your organization. Since time is a matter of importance however, I would suggest that a committee be appointed by some neutral organization, such as the University of California. X would further suggest that the President of the University be asked to call on some of his colleagues to help appoint such a committee that might review your proposal. Most certainly we need sound science in all these matters. X am sure you would agree with me on this. You and your colleagues have done an enormous amount of work in this area, and it does merit serious consideration by an impartial scientific panel. Kindest personal regards. Emil M. Mrak V AP00036566 October 21, 1982 38 Dr. Robert Stephens 714 P Street, Room 599 Sacramento, California 95814 Dear Dr. Stephens: The workshop you are to hold on October 22 has just come to my attention. Most certainly I would like to attend this gathering and participate, but unfortunately Z have firm commitments on October 22, and cannot possibly do it. I am therefore, taking the liberty of writing to you and especially so since I have read the document entitled "Carcinogen Identification Policy: A Statement of Science as a Basis for Policy." I must say an enormous amount of work has gone into the preparation of this document and it does contain a great deal of information. Z am bothered by the fact that no science review committee has been proposed to review the science upon which proposed regulations would be based. 1 feel very strongly on this because just recently X participated in a workshop that had developed a proposal for Congress to establish a prestigious scientific panel that would be independent of all regulatory agencies and one that would report to Congress and the President. The purpose of this panel would be to set up ad hoe committees to study scientific decisions, judgments, regulations and 30 forth that might be proposed by the regulatory agencies. The scientific studies would be made public and the agencies would be informed of the scientific considerations and could accept them or reject ttiem. In any event, the report would finally go to Congress. I certainly think, we need something like this in California and especially since some of these regulations are based on scientific information. I would suggest that the .University of California be called upon to establish an interim scientific panel of the type I have outlined. I would further suggest that the President of the University be asked to discuss the matter with other leaders on various campus1 for the purpose of setting up an impartial AP00036567 Dr- Robert Stephens -2- Octoter 21 1932 scientific panel that might include members not only of the University, but others in the state. I hope you do not mind me taking the liberty of making this suggestion. I hope you find it a constructive one. Kindest personal regards. Emil K. Mrak \ AP00036568 Appendix III Sunset Coimittee Meeting Report AP00036569 SUNSET COMMITTEE REPORT FOR 1982 ANNUAL MEETING The Sunset Committee has met to consider whether AIHC should continue its existence in 1983. The present administration has taken a number of steps which can lead to implementation of policies AIHC has long advocated. Those policies are of critical importance, and AIHC has earned a solid reputation as a credible, scientifically sound voice In their support. In short, we believe our goals are in sight, and that AIHC must continue its work until our reconmendations are adopted by Government. We hope that goal can be attained In 1983 and reconmend that AIHC continue its work during the next year. Paul F. Oreffice, Chairman H. Barclay Morley James B. Henderson George 0. Sella, Jr. AP00036570 Appendix IV 1983 AIHC Budget AP00036571 Committees: Associations Board/Exec. Coirm.--2/ Legal Public Affairs Public Relations Scientific Task Forces: EPA OSHA Science Policy FDA CPSC Administrative Personnel/Overhead Admin. Exp. Legal Exp. Pro.iects TOTAL RECOMMENDED 1983 AIHC BUDGET Legal 155,000 44,000 4,000 10,000 2,000 95,000 PR 86,000 2,000 84,000 Expenses^ 34,600 1,000 22,000 3,000 3,600 5,000 1983 Total 275,600 1,000 66,000 4,000 15,000 89,600 100,000 1982 Est. Exd. 268,600 1,000 65,000 3,000 15,000 89,600 95,000 47,500 20,000 10,000 11,500 5,000 1,000 3,700 1,000 1,000 500 1,000 200 51,200 21,000 11,000 12,000 6,000 1,200 24,700 3,200 11,000 4,500 6,000 0 569.000 484,000 40,000 45,000 278.000^ 567,000 487,000 40,000 40,000 444,537 202,500 86,000 38,300 1 .173,800 1,304,837 ^Staff, travel, direct expenses and hotel meeting rooms, dinners and lunches , etc. -^Includes administration of Finance, Nominating and Sunset Committees -^Funds anticipated to be allocated to 1983 projects requested by Chairmen. See attached list. AP00036572 Appendix V New Member Nominations AP00036573 NEW MEMBER NOMINATIONS* 1983 BOARD OF DIRECTORS AMERICAN INDUSTRIAL HEALTH COUNCIL Class of 1985 Charles E. Brooks, Senior Vice President, W. R. Grace J Company ' Edward W. Callahan, Vice President-Environmental Affairs, Allied Corporation Conner M. Fay, Senior Vice President, Clairol Divlsion-Bristol Myers Richard H. Leet, President, Amoco Chemicals Corporation Donald Powell, Senior Vice President, Champion International *' George J. Sella, President, American Cyanamid Company Monte C. Throdahl, Senior Vice President, Monsanto Company *As recommended by 1982 Nominating Committee AP00036574 Appendix VI Officer and Committee Memberships AP00036575 RECOMMENDATIONS 1983 OFFICERS Chairman: George 0. Sella, Jr., American Cyanamid Company Vice Chairman: Richard H. Leet, Amoco Chemical Corporation Treasurer: Daniel McGrade, Stauffer Chemical Company EXECUTIVE DIRECTOR Ronald A. Lang MEMBERSHIP OF THE 1983 EXECUTIVE COMMITTEE Mr. Richard H. Leet, Chairman Amoco Chemical Corporation Mr. Jackson B. Browning Union Carbide Corporation Mr. George J. Sella, Jr. American Cyanamid Company Dr. Elwood P. Blanchard E.I. Du Pont De Nemours & Co. Inc. Mr. Monte C. Throdahl Monsanto Company Mr. Toy F. Reid Eastman Kodak Company Mr. Ronald A. Lang American Industrial Health Council MEMBERSHIP OF THE SUNSET COMMITTEE Mr. Paul F. Oreffice, Chairman Dow Chemical USA Mr. Richard H. Leet Amoco Chemical Corporation Mr. James B. Henderson Shell Chemical Company Mr. George J. Sella, Jr. American Cyanamid Company MEMBERSHIP OF THE COMMITTEE ON NOMINATIONS Mr. George J. Sella, Jr., Chairman American Cyanamid Company Mr. Richard H. Leet Amoco Chemical Corporation Dr. H. Barclay Morley -- Stauffer Chemical Company -- . AP00036576 NOVEMBER 23, 1982 1983 DUES/MEMBERSHIP REPORT Budgeted 1983 Dues Income Paid Dues (5) Corrmi tments Received (69) Outstanding Commitments (9) Resignations (4) $1,129,225* 30,450 991 ,475 133,950 53,000 Projected 1983 Income $1,155,875 Resignations Gulf Oil **Halcon Hilton Davis Hooker Chemical Pilot Chemical **U.S. Borax * Provides $100,000 reserve for membership loss from 1982 dues ** Not included in 1983 income estimates AP00036577 Appendix VII Report to the Membership in 1982 AP00036578 INTEROFFICE MEMORANDUM jQ Prrtm Distribution " A. J. Diglto Distribution: D. F. Baker P. L. T. Brian E. C. Crossland L. Dale E. Donley F. Emde G. G. Handley B. S. Horten W. 0. Kenderick J. M. Norwood R. Oeler D. 0. Phillips J. K. Spata L. Tucci Subject Data 17 November 1982 CMA supports EPA and OSHA Admini strati ons (Location, organization, or oooartmant] Corporate Environmental Activities (Location, Organization, or oopartmant) Please find attached a Chemical Week article on CMA's support of the administrations' EPA and OSHA agencies and the major issues in these areas. AJDtcsm Attachment (320) AP00036579 dMdrQ, CMA's chief applauds the regulators It's just as well that the Chemical Man it could. Now it's mainly inspecting the goods in the U. S. The association is ufacturers Assn.--whose member com kinds of plants that have the most acci also concerned about the European panies account fbr well over 90T5- of dents, and it's seeking preventive mea Common Market's current consideration U. S. production of industrial chemi sures. Says Simeral: "We think Auchter of the Vredling proposal, which would cals--switched to its present name, Wil is the first [OSHA chief) who has tried require multinational companies to pro liam G- Simeral, the new chairman of to reduce the number of accidents by vide more detailed disclosure of their what several years ago was the Manu figuring out how to keep people safe." worldwide financial and operating data. facturing Chemists Assn., is not a .Water and dollars. While the direction Simeral, the younger son of a me chemist at all--he's a PhD physicist. Jat both EPA and OSHA has changed. chanical engineer, was born in Portland. He's also a member of DuPont's board jSimeral is convinced that the chemical Ore., but grew up in Lancaster, Pa.. of directors and of its executive commit industry must keep trying to get Con and entered that city's Franklin and tee, and one of the company's four ex gress to amend relevant laws, especially Marshall College, which he later served ecutive vice-presidents- On top of that, those aealing with water~ Quality. He as a trustee. He went on to the Univer Simeral is one of the chemical indus contends that since Con try's leading authorities on the technol gress wrote those laws, ogy and economics of the plastics busi the industry's use of ness, chairman of the board of the "best practicable technol Wilmington (Del.) Medical Center, and a ogy" has generally re golfer and skier. duced the concentration As CMA's chairman, the 56-year-old of toxic contaminants to Simeral succeeds Paul F. Oreffice, Dow levels that do not war Chemical's president and chief execu- rant further concern. "Our view," Simeral EPA officials `are running at us hard, but at least they are willing to listen' explains, "is that instead of requiring every U. S. plant to install `best available technology' on the mere assumption tive officer. Like his predecessor, Si that it is needed, the law meral believes the association must should be rewritten to push for basic changes in the laws gov measure the quality of erning various regulatory agencies, par the water. And if the wa ticularly the Environmental Protection ter quality is already Agency and the Occupational Safety good enough," he pleads, and Health Administration. Meanwhile, "don't make us spend bil however, he feels the industry should lions of dollars more." support the policies of the agencies' pre A crossroad. Simeral sent chiefs--EPA's Anne M. Gorsuch was elected to CMA's and OSHA's Thorne G. Auchter. board and to its execu A welcome change. Simeral, a notably tive committee in June articulate speaker, emphasizes CMA's 1978. That was when the backing for the two officials, "We're de 110-year-old association lighted with Anne Gorsuch and the new was being transformed EPA," he says. "But it's not because from a relatively quiet, they're pushovers. She is no pushover. low-profile group to an Mrs. Gorsuch and the EPA are fair. We advocacy organization can talk to them." that would defend the in Simeral complains that the media dustry's interests on ev have sometimes made it seem that un ery current issue. sity of Michigan to get his MS and PhD der Gorsuch's EPA, anything goes. "We .1 Right now, Simeral says, the biggest! degrees, and then in 1953 joined Du Jthink that EPA is moving very deliber [issues for the association are environ-! Pont to work as a physicist in the com ately to enforce the law," he says. nental. These include the "Superfund'' pany's experimental station near Wil "We're finding that they're running at program for cleaning up hazardous mington. He had never thought of us hard to make sure the regulations (dump sites, the proposed revisions of working for a chemical company, but are dealt with. But they are also trying lthe Clean Air Act and the Clean Water was attracted to Du Pont's basic re to institute good science into technical j Act, protection of groundwater, and search in polymer physics. There he decisions, and they are at least willing [proposals for curbing "add rain." helped develop a new method for mak jto listen to our data." j- International issues represent a rela- ing Du Pont's But&cite polyvinyl buty- 1 Simeral commends Auchter for im ( tively new area for CMA, Simeral notes. ral, which is best known as a laminating proving OSHA's plant inspection policy. ' In this category are foreign-trade prob layer in safety glass. Formerly, the agency seemed to be in- lems, such as the alleged dumping of In 1959, he began a five-year stint in ^ discriminately inspecting all the plants dyestuffs and synthetic-fiber textile DuPont's Washington Works at Par- 44 Gwraeal Ww/Novembar io, 1982 AP00036580 kersburg, W. Va. Initially, he managed a research group supporting the startup of a plant to make the first melt-fabricable version of a Teflon fluoropolymer. By the time he left that location, he had also worked on three other major resin products: Deirin acetals, ZyteJ nylons, and Lucite methacrylates. He continued in research management positions for the Plastics Dept, until 1969, when he | `If the water quality Is already good enough, don't make us spend billions' became director of the department's Commercial Resins Div. That was the first time he ran a profit center. In his managerial posts after that, he alternated between corporate R&D and the Plastics Dept., which he headed in 1976 when it absorbed the Film Dept. One year later, he moved up into corpo rate management as a director, a mem ber of the executive committee, and a senior vice-president. Last year, in the reorganization that followed Du Pont's acquisition of Con oco, he was elected an executive vicepresident As an executive committee member, he handles Kaison with three departments--certtral R&D. employee relations, and Biochemicals, Simeral is "a tough boss, but good and fair," according to Howard E. Sim mons, director of the Central Research and Development Dept, He observes that Simeral "doesn't simply operate with one or two top lieutenants; he likes to interact broadly up and down the line to get details from all levels." Noting that Simeral has been striving to get a corporate arm around the diverse re search activities carried on throughout the company, Simmons remarks that "to carry this out at this time, Bill is just what Du Pont needs." He's also just what CMA needs, ac cording to Dow's Oreflke. "I've nothing but the highest praise for Bill Simeral," Oreffice says. "His effectiveness as a leader of the industry' has been proven. He will be a very fine CMA chairman." Simeral and his wife, the former Eliz abeth Louise Ross of Beaver Falls, Pa., live in Centreville, Del., a Wilmington suburb. They have two daughters and two sons, one of whom is a Du Pont salesman. The family members occa sionally gather at their vacation home in Colorado for golfing and skiing. D fUrsv,n ------ - AP0003658I (A 'P/tcducZ^) INTEROFFICE MEMORANDUM j0 J. M. Norwood From A- J- D^llO cc: P. L. T. Brian Subject Date 16 November 1982 CMA Survey of Chemical Company Activities Safety__________________________________ (Location, Organisation, or 0c*f(mnl| Corporate Environmental Activities (Location, Organisation, or Dapartmant) As requested, please find attached the completed CMA Survey on Chemical Company Activities to reduce unreasonable risk. The survey was completed by contributions fran John Barr, Ernie Blades, Gene Handwerk, and Tony Diglio. The information will be maintained confidentially by Peat, Marwick, Mitchell and Company. It will be used by CMA solely in an aggregate form. The survey is to be mailed directly to Peat, Marwick, Mitchell and Company by November 30, 1982 in the envelope marked Confidential provided herewith. AJD:csm Attachment 13201 AP00036582 O M .X SURVEY OF CHEMICAL COMPANY ACTIVITIES TO REDUCE UNREASONABLE RISK Ctf^ CHEMICAL MANUFACTURERS ASSOCIATION 2501 M Street, N.W. Washington, D.C. 20037 ) PURPOSE; To survey the chemical industry's commitment to reducing, unreasonable risk to health and the environment. BENEFITS To demonstrate to policy makers and the general public the degree to which the chemical industry is ensuring the safety of chemicals* f Please return this survey form by November 30, 1982. Thank you for participating in this important effort. i AP00036583 SURVEY OF CHEMICAL COMPANY ACTIVITIES TO REDUCE UNREASONABLE RISK The U.S. chemical industry needs information to demonstrate its commitment to controlling and reducing unreasonable risk to health and the environment. This is a survey to identify that information. The results are intended to: . present the U.S. chemical industry's efforts to reduce unreasonable risk for the TSCA reauthorization hearings; . support the regulatory positions of the chemical industry; . provide performance and compliance documentation for the public; and . provide feedback to participating companies on the industry's effort to control and reduce chemical risks. Instructions for Completing the Questionnaire This is a survey of the U.S. chemical industry's activities to reduce unreasonable risk in calendar year 1981. For the purposes of this survey, the industry is defined as all domes tic sales plus domestic based exports of products in SIC code 28 (chemicals and allied products), excluding 283 (drugs). This definition must be used in completing the questionnaire for your U.S. chemical business, unless specific requests are made for other information. The questionnaire contains five major sections, addressing: I. General Company Information; II. Chemical Hazard Assessment; III. Chemical Hazard Communication; IV. Chemical Hazard Control; and v. Environmental control costs. Each section contains three to eight subsections with specific instructions for completing each question. The questionnaire is printed so that the sections can be separated and distribu ted to appropriate personnel for completion. If you do sepa rate the questionnaire, please copy these instructions and send them with the portion(s) of the questionnaire being distributed. AP00036584 The questionnaire is designed to minimize the effort required to respond. Therefore informed estimates are acceptable where exact data is not available. We are not requesting that major internal studies be undertaken to complete the questionnaire. If you have any problems in completing the questionnaire# please call Mr. Deems Buell of Peat, Marwick, Mitchell & Co. at (202) 223-9525. Confidentiality of Questionnaire Responses Completing the questionnaire requires the disclosure of business information that many companies will consider confidential. To assure that responses are maintained confidentially during and after the survey, CMA is using Peat, Marwick, Mitchell & Co., a major public accounting and management consulting firm, to conduct the survey and evaluate the survey results. The information released at the conclusion of the survey will be in aggregated form to protect the identity of individual respondents. To provide additional assurance to your company, a confidentiality agreement is enclosed for your company to enter into with Peat, Marwick, Mitchell & Co. Your response will be maintained as confidential even if your company does not enter into this agreement. Responding to the survey All participating companies must return their completed questionnaire by November 30, 1982. To limit follow up, a postcard is enclosed for your company to complete and return soon as a decision has been made about participating in the survey. as A return envelope is enclosed for submitting your completed questionnaire. If you do not use this envelope, please mark your return envelope "CONFIDENTIAL" and mail it to: Peat, Marwick, Mitchell & Co. 1990 K street, N.w. Washington, D.C. 20006 ATTN: Mr. Deems Buell AP00036585 CONFIDENTIALITY AGREEMENT This agreement, effective upon its execution, is between Peat, Marwick, Mitchell & Co. (hereinafter Peat Marwick) and the company below. Peat Marwick has contracted with the Chemical Manufacturers Association (CMA) to obtain data on chemical company activities to reduce unreasonable risk. This data will be used by CMA solely in an aggregate form which precludes identification of information sources. This data will be used to com ment on existing and proposed regulations and to provide feedback to par ticipating companies. Peat Marwick will obtain the data by means of a written questionnaire and, in a limited number of ,cases, will call companies who have responded to the ques tionnaire but clarification is required. Peat Marwick agrees: To use its best efforts to treat all company data obtained in the course of this survey as confidential, including but not limited to: storing confidential data in physically secure facilities; limiting access to the data solely to employees who need to see the data; separating and storing separately such portions of the questionnaire as may contain codes or other identification relating to the identity of the submitting company, and not releasing your response in an unaggregated form without your express permission. ABy By --*-- \ ) Title Principal Title Director, Environmental Activities Company Peat, Marwick, Mitchell & Co. Company Air Products and Chemicals, Inc. Date May 28, 1982 Date 16 November 1982 AP00036586 TABLE OF CONTENTS CURRENT ACTIVITIES TO REDUCE UNREASONABLE RISK I. GENERAL COMPANY INFORMATION A. Company Information B. Management Attention to Health and Environmental Matters C. Organization II. CHEMICAL HAZARD ASSESSMENT A. Chemical Hazard Assessment Review B Testing C. TSCA Premanufacture Notification (PMN) D. TSCA 8(e) Reports III. HAZARD COMMUNICATION A. MSDS B. Labels C. Information Systems D. Training IV. HAZARD CONTROL A. Listings of Chemicals B. Industrial Hygiene Program C. Health Effects Monitoring D. Emergency Response E. Internal Health/Environmental Compliance Audits/Reviews F. Transportation G. waste Disposal Procedures V.Environmental Control Costs A. capital investment B. Operation and Maintenance (OSM) Costs C. Staffing PAGE 1 3 4 5 5 6 8 9 11 11 13 13 14 15 15 16 16 17 18 19 20 21 21 22 22 AP00036587 SECTION I. GENERAL COMPANY INFORMATION This section will identify general information about your company. The results from this section of the questionnaire will establish the baseline for analyzing all of your survey responses. I. A. Company Information Specific company information is essential to the survey for standardizing responses. The questions below request information about your entire company's activities (world-wide) and your company's chemical business (world-wide and U.S.). For this survey, a chemical business is defined by products in SIC code 28, excluding 283, and a U.S. chemical business is defined as domestic sales plus domestic based exports of products in SIC code 28, excluding 283. Your responses to the remainder of the questionnaire must be based on your U.S. chemical business, unless a question specifically states otherwise. Supporting functions provided by other areas of your company should be considered to be a part of your U.S. chemical business on a proportional basis when possible. A.l Provide the following information about your company's activities for the 1981 calendar year. 1,1 Total company sales (world-wide) in millions of dollars $ 1,650 (15814s) 1.2 Total company employment (world wide) at calendar year end 16,200 1.3 Total world-wide chemical/product sales (all sales of products in SIC Code 28, exluding 283) in millions of dollars $ 575 (19814s) 1.4 Total number of employees at calendar year end associated with your world wide chemical/product sales (ref. question 1.3) 1,900 1 AP00036588 1.5 Total U.S. chemical/product sales (domestic sales plus domestic based exports of products in SIC code 28, excluding 283) in millions of dollars $ 575 (1981$s) 2.6 Total number of employees at calendar year end associated with your U.S. chemical/product sales (ref. question 1.5) 1,900 1.7 Total number of chemical products (count all product distinctions except package size as individual products) associated with your U.S. chemical/product sales (ref. question 1.5) 325+* 1.8 Identify the major products associated with your 1931 U.S. chemical/product sales (ref. question 1.5) by checking the appropriate SIC codes below. (Consider major chemical product categories to represent at least 10% of your total U.S. chemical/product sales.) SIC Code 281 282 284 285 286 287 289 Title Industrial Inorganic Chemicals Plastics and Synthetics Toilet Preparations Paints and Allied Products Industrial Organic chemicals Agricultural Chemicals Miscellaneous Chemical Products A.2 What is your company's name? Air Products and Chemicals, Inc. X X X X A.3 Who is your company's principal contact in completing the questionnaire, their job title, and telephone number? J. T. Barr Mgr., Regulatory Response (215 81-8343 Name Job Title Telephone Number *Does not include special blends, formulations. 2 AP00036589 I. s. Management Attention to Health and Environmental Matters The following questions will determine the attention that management devotes to health and environmental matters. For each question, check (s/) all appropriate answers or provide the requested information. B.1 What is the highest level in your company that is routinely involved in health and environmental matters concerning your U.S. chemical business? (check appropriate response) BOARD OF DIRECTORS PRESIDENT CORPORATE VICE-PRESIDENT VICE-PRESIDENT DEPARTMENT HEAD OTHER (SPECIFY): _________ _________ X _________ _________ B.2 Does your company have formal policies that address the following health and environmental concerns and are these policies publicly available? (check appropriate responses) INTERNAL POLICY PUBLICLY AVAILABLE MEDICAL PRODUCT SAFETY WORKER SAFETY TRANSPORTATION HAZARDOUS WASTES ENVIRONMENT DISASTER PLANS OTHER (SPECIFY) YES NO YES NO XX B.3 Please provide any specific examples that demonstrate your management's approach for dealing with health and environmental matters. Strong emphasis on health/safety/environment at CEO level. Excellent "safety and environmental records. Active corporate and divisional "departments dedicated to H/S/E. 3 AP00036590 I. c. Organization The following questions will find how companies have organized their U.S. chemical business to carry out their environmental and health policies. For each question? check (V) all appropriate answers or provide the requested information. C.l Do you have one or more groups whose sole function is dealing with health or environmental matters? X YES ________NO C.2 Use the matrix below to provide a count of all the health/ environmental specialists (internal personnel plus outside consultants) that your U.S. chemical business used in calendar year 1981. Present all specialists on an equi valent full-time basis according to their most appropriate health/environmental function. Do not double count. (In completing the matrix? product safety is defined as a function that includes coordination' and development of hazard communication and regulatory compliance programs making use of other health information. Worker safety is defined as a function that includes occuptional safety and employee health monitoring. Health is defined as a function that includes human, animal, and environmental research and assessment.) ifEClALim PUNCTIOm WhHi Sfftrry 3 TfmporcMon Safvty LjMinf Air PotiuoM Cawpa< Witw feUvaon Coiiliul Hwantoua Warn MmoKMm OtfMr'i ISptdfy} i n 29 46 2 5 10 1 18 3 9 16 5 8 42 1 1 1| Numlr oI Equiv*<ot PulMlnw Sbaeislini These assignments are not always as clear-cut as shown. AP00036591 SECTION II, CHEMICAL HAZARD ASSESSMENT In this section we would like to know what youc company is doing to identify chemical hazards to health and the environ ment within your U.S. chemical business. Hazard assessment is sometimes called loss prevention or product safety review; it involves the determination of a hazard's presence or absence through the review of available data such as toxicity, environ mental fate, and physical/chemical properties to evaluate the potential for harm or need for additional information. II, A. Chemical Hazard Assessment Review we need to know what your company is doing to assess chemical hazards. For each question, check (>/) ell appropriate answers or provide the requested information. A.1 Do you have a program for chemical hazard assessment? X YES _________NO If the answer is NO, skip to question II.Q.l. A.2 About what percent of the time do you perform chemical hazard assessments when you have; New Products 100 % New Processes 100 % Any Formulation Changes N.A.% A.3 Which of the following events typically trigger a chemical hazard assessment for existing products or existing processes. (Check all appropriate answers) Routine Process Change New Data New product Use Employee concern Consumer concern New regulatory requirements * * *~ * _________ _____________ Other (Specify) 5 A.4 What technical specialties were involved in your chemical hazard assessment program daring 1981? all appropriate answers.) (check Specialties TOXICOLOGY LEGAL REGULATORY ENGINEERING ENVIRONMENTAL SAFETY ANALYTICAL (CHEMIST) MEDICAL INDUSTRIAL HYGIENE R & D/TECHNICAL PRODUCTION SPECIFY OTHERS: Internal Personnel X ---------X-------------------X---------- ---------7----------- ---------X---------- Outside Consultants X ------------------------------------------------------------------------------------------------------------- 7---------- 7----------J------- ----------------------------- ---------- A.5 Do you have a chemical hazard assessment committee(s)? X Yes _________ No 5.1 If yes, in approximately what year was your committee(s) started? 1975 A.6 Does your company conduct formal environmental health and safety reviews for the design of new plants or equipment projects? X yes NO B. Testing Toxicity testing can be helpful to determine whether a substance could pose a hazard. This testing * is defined to include animal, environmental, .epidemiological, clinical, toxicological, etc. . For each question, check {>/) all appropriate | answers or provide the requested information. B. l* Does your company have toxicity tests performed to evaluate the health effects or environmental effects of chemicals? Y YES _________NO If the answer is NO, skip to question II.C.l. 6 AP00036593 1.1 In approximately what year did your company begin performing toxicity tests? 1960's B.2 Toxicity testing programs often overlap between testing in support of a company's U.S. chemical business and testing in support of a company's other activities. To simplify estimating U.S, chemical business toxicity testing efforts, provide the following information on the entire toxicity testing program(s) within your company in 1981 that provides all support for your U.S. chemical business. Include both human health effects and environmental effects testing. 2.1 Equivalent full-time technical staff directly involved in the toxicity testing program. 2.2 Number of new substances/products tested (don't count individual tests) 0.2 10 2.3 Number of existing substances/products tested (don't count individual tests) 2 2.4 Annual operating expense of in-house toxicity testing 4 (1981 4s) 2.5 Annual expense of contracted toxicity testing $ 20K (1981 $s) 2.6 Annual expense of toxicity testing performed in cooperative research programs A 80 K (1981 $s] B.3 Based on your answer to B.2, estimate the percentage total testing expense that was attributable to your U.S. chemical business. 100 % of B.4 Estimate the replacement value of your toxicity testing facilities that were in place during 1981 for the toxicity testing program described in question B.2. $ ----- (1981 $s) 7 AP00036594 B.5 Do you have examples which demonstrate changes in your testing program during the past ten years? (Consider planning, protocols, auditing, recordkeeping, types of studies, and reporting.) Went to outside testing, internal auditing supported CIIT, CMA, SPI, etc. More genetic tests and compliance tests expanded MSDS coverage, quality assurance programs, utilized computer data storage/search. C. TSCA Premanufacture Notification (PMN) The impact of PMN may be different depending on company size and the products involved. The questions below will indicate the factors that affect your U.S. chemical business. For each question, check {>/) all appropriate answers or provide the requested information. C.l Do you have a procedure for determining that a PMN is required? x YES _________NO C.2 Have you declined to manufacture any new chemicals because of the time or cost of PMN compliance? YES X NO If yes, how many due to: Please explain Time Cost C.3 How many PMN*s did your company submit in: 1979 0 1980 1 1981 3 If none, skip to question II.D.l. C.4 How many of your PMN substances, reported in C.3, have actually been or are likely to be commercialized? i 8 AP00036595 D. TSCA 8(e) Reports An 8{e) report informs EPA that a chemical may present a substantial risk to health or the environment. For each question, check (</) all appropriate answers or provide the requested information. D.l Do you have a company procedure in place for considering 8(e) reports? X YES NO If the answer is NO, skip to question II.D.4. 1.1 What are the sources of information that initiate an 8(e) review? (Check all appropriate answers) TOXICOLOGY RESEARCH PRODUCTION (EMPLOYEES) CUSTOMER/CONSUMER REPORT DATA FROM SUPPLIERS OTHER (SPECIFY) Literature/other company reports. X T T 1.2 Approximately how many people are normally involved in your company's 8(e) review procedure?6 D.2 Has your company filed at least one 8(e) report? X YES _________NO 2.1 If yes, whom do you advise of your 8(e) reports? (Check all appropriate answers) CUSTOMERS CO-PRODUCERS EMPLOYEES OTHERS (SPECIFY) N.A. ~X ~ X 9 AP00036596 D.3 Has the information provided on 8(e) reports prepared by your company or any other company been used for your Material Safety Data Sheets (MSDS's)? (Check appropriate answers) Always Sometimes Never Your own 8(e) reports Other 8(e) reports _________ N.fl.____________ ___________ N.a. ~ _______ _________ 3.1 Has this information been used in your industrial hygiene practices? (Check appropriate answers) Your own 8(e) reports Other 8(e) reports Always * * Sometimes ___ _____________ Never _____ _______ 10 AP00036597 SECTION III. HAZARD COMMUNICATION This section will identify what chemical companies are doing to inform employees and customers about chemical hazards. III. A. MSDS The Material Safety Data Sheet (MSDS) is a source of information about a chemical. This question will deter mine how extensively they are used to transmit informa tion. For each question, check (V) all appropriate answers or provide the requested information. A.l What systems do you use to communicate information about chemical products. (Check all appropriate answers) MSDS LABELS PRODUCT BULLETIN X X 5T LETTERS TRAINING T POISON CONTROL CENTERS ___ OTHER (SPECIFY) Chemcard. chemtrec video tapes Environmental and safety meetings" (If you do not use MSDSS, skip to question iii.b.1) A.2 Do you send MSDSs to your customers? appropriate answers) (Check all UPON THE FIRST SHIPMENT ONLY UPON EVERY SHIPMENT ON REQUEST WHEN UPDATED OTHER (SPECIFY) X sometimes * ~* 11 AP00036598 A.3 Approximately what percent of your purchased chemicals and chemical products were covered by MSDSs in 1981? Purchased Chemicals 90+ % Chemical Products 100 % A.4 is the information provided on your MSDS more, the same, or less then that called for on OSHA Form 20? More The Same Less X _________ _________ A.5 How often do you review and update your MSDSs? ANNUALLY AS NEW INFORMATION BECOMES AVAILABLE OTHER (SPECIFY). . ,, 2-3 years routinely X A.6 Do you maintain files of MSDS's? X YES NO If the answer is NO, skip to question III.5.1 6.1 Are these MSDS's available to company personnel? X YES NO 6.2 Arethese MSDS's available to the public? X YES On request NO 12 AP00036599 III. B. Labels Labeling provides information to customers and employees. The following questions will indicate the type of information transmitted and the proportion of chemical products for which such information is provided. For this question, check ( y/) all appropriate answers. B.l Typically, which of the following pieces of information appeared on your chemical product labels in 1981. PRODUCT OR TRADE NAME COMMON NAME CODE NUMBER CHEMICAL NAME NAME OF MANUFACTURER CAS NUMBER HAZARD IDENTIFICATION PRECAUTIONS FOR USE EMERGENCY PROCEDURES CONTAINER DISPOSAL COMPANY ADDRESS TELEPHONE CONTACT OTHER (specify) X___ X___ X J 7" x x j x III* C. information Systems Information systems identify, communicate, and record information on chemicals. For each question, check (vO all appropriate answers. C.l Do you formally maintain the following information at either a corporate, divisional or local level? LISTS OF CHEMICALS USED LISTS OF CHEMICALS PRODUCED WORK HISTORY WORK SITE EXPOSURES MEDICAL RECORDS SIGNIFICANT ADVERSE EFFECTS CUSTOMER COMPLAINTS EMPLOYEE COMPLAINTS 13 AP00036600 C.2 Do you have procedures established to respond to and safety questions raised by: health CUSTOMERS X yeS _____NO EMPLOYEES _*_YES _____NO III. D. Training Training frequently involves communicating infor mation on chemical hazards and teaches people how to avoid those hazards. We would like to obtain information on the areas in which you train your employees. for this question, check (</) all appropriate answers. D.l In which areas do your chemical plant employees and supervisory) receive training? (Check all appropriate answers) (hourly Chemical Plant Employees AREAS OF TRAINING HOURLY SUPERVISORY CHEMICAL HAZARDS WORKPLACE SAFETY HANDLING Of MATERIALS EMERGENCY RESPONSE OFF THE JOB SAFETY REGULATORY COMPLIANCE OTHER (SPECIFY) Product Hazard Rev. Transport Safety X X X X X X X X X X X X X X T 14 AP00036601 SECTION IV. HA2ARD CONTROL This section will identify what chemical companies are doing to control hazards that have been identified. IV. A Listing of Chemicals Lists of chemicals that management can use questions will identify information is used. are ready sources of information to control hazards. The following items that are listed and how the For each question# check (vO all appropriate answers or provide the requested information. A.l Does your company maintain complete lists of the follow ing materials? If yes# approximately when was this practice started? YES WHEN NO STARTED PRODUCTS RAW MATERIALS AND SEG- REGATED INTERMEDIATES SOLID WASTES EFFLUENTS EMISSIONS OTHER (SPECIFY) X _Xr T -- long ago If the answer is NO in each case skip to question IV.B.1 A.2 Are internal chemical lists used to: MEET REGULATORY REQUIREMENTS? MAINTAIN INTERNAL CONTROL? RESEARCH HEALTH AND SAFETY? OTHER (SPECIFY) YES X X X NO ___ ___ ___ 15 AP00036602 IV. B. Industrial Hygiene Program Industrial hygiene or similar programs are designed to protect workers from chemical hazards. For each question, check (/) all appropriate answers or provide the requested information. B.l Do you have an industrial hygiene program or a similar program performing the same functions? X YES _________NO If the answer is NO, skip to question IV.C.l B.2 How many total industrial hygienists and/or trained hygiene technicians were used in your U.S. chemical business in 1981 on an equivalent full-time basis? 4 B.3 What areas of operation does your industrial hygiene or similar program address? (Check appropriate items.) MANUFACTURING MAINTENANCE INCOMING RAW MATERIALS PROCESSING PACKAGING STORAGE TRANSPORTATION LABORATORY PRODUCT USE DISPOSAL OTHER (SPECIFY) 1 1 A X X. X. X_ X T IV. C. Health Effects Monitoring Health effects monitoring provides an early warning of work-related health problems. C.l Does your company perform periodic reviews of their employees' medical histories? (check appropriate answer) ALL EMPLOYEES X SELECTED GROUP(S) OF EMPLOYEES (SPECIFY) Exposed workers; Manufacturing, R&D, regular visitors, etc. DOES NOT PERFORM REVIEW 16 AP00036603 IV. D. Emergency Response The following questions seek to find out the types of emergency response teams that companies maintain and the training that they receive. These teams could include fire brigades, first aid teams, or chemical spills teams. For each question, check (vO all appropriate answers or provide the requested information. D.l Does your company have emergency response teams for: Fire Control First Aid Chemical Spills or Releases Other (Specify) Mutual Aid__________ Transportation If you do not have emergency response teams for chemical spills or releases, skip to question IV.E.1 D.2 Indicate the number of trained emergency response person nel for chemical spills or releases inside and outside of your facilities (emergency site activities and all activities) that your company maintained in the U.S. in 1981. Emergency Site Activities _______ Unknown - Teams All Emergency Activities _______ At most sites. D.3 Do your company's emergency response teams respond to outside emergencies not involving your products? x YES _________NO 17 AP00036604 IV. E, Internal Health/Envireminenta1 Compliance Audits/Reviews Internal health/environmental compliance audits/reviews are one means that companies use to ensure that they are following health and environmental policies and regulations. The following questions will determine how extensively u.S. chemical companies use this management tool. For each question, check (yO all appropriate answers or provide the requested information. E.l Does your company have an internal health, environmental, or other type of compliance audit program? x YES _________NO If the answer is NO, skip to question IV.F.l E.2 Indicate below which programs you have, the approximate year started, and approximate frequency that each type of audit is conducted on an annual basis. If yes, approx. Frequency YES NO Year Started Audit is Conducted Health compliance audits/reviews X Early 70's Varies 1-2 years Environmental compli ance audits/reviews X Mid 70's Varies 1-2 years other (specify) E.3 What skills are represented in conducting and reviewing the audits identified in E.2? (check appropriate answers) Others Specified in E.2 Health Environmental Legal Technical Management Other (specify) Manufacturing internal Audits uutside analytical X X X X l 1 X X T X 18 AP00036605 IV. F. Transportation Transportation safety is an important element in reducing the public's risk from chemicals. The following questions seek to determine what your company is doing concerning transportation. For each question, check (</) all appropriate answers. F.l Does your company train its personnel to understand transportation safety regulations and standards? X YES _________NO F.2 Does your company have a transportation procedures manual? X YES NO F.3 If you have procedures, are the following items included in the transportation procedures manual? LOADING/UNLOADING HANDLING PACKAGING LABELING PLACARDING INSPECTION SPILL/EMERGENCY OTHER (SPECIFY). Applicable Regulations YES X X X * * X NO F.4 Does your company provide precautionary information beyond Department of Transportation (DOT) standards for identifying the hazardous nature of chemicals in transit? X YES NO your company use: YES NO LABELS PLACARDS WRITTEN INSTRUCTIONS VERBAL INSTRUCTIONS OTHER (SPECIFY) Corporate group UiviSioiial prattled X y X A -- 19 AP00036606 F,6 Are your company products listed with CHEMTREC? X YES _______ NO F.7 Does your company maintain its own transportation emergency hotline? X YES _______ NO IV. G. Waste Disposal Procedures We would like to determine how companies handle their chemical wastes. For the following question, check () the appropriate answers. G.l In recent years, has your company been using proportion ately more, the same, or less of the following waste disposal methods for your chemical wastes? Indicate in the right-hand column if the method has not been used recently. (Check appropriate answers) RECENT USE OF DISPOSAL METHODS MORE SAME LESS METHOD NOT USED RECENTLY RECYCLED STORED ON-SITE STORED OFF-SITE INCINERATED: ON-SITE OPF-SITE LANDFILLED: ON-SITE OFF-SITE -X---- ------ ---------- -- -- zzz x i-- -------- -------------- x T --r zz -- OTHER (SPECIFY) Biodegradation Chemical-fixation ___ X X 20 AP00036607 SECTION V. ENVIRONMENTAL CONTROL COSTS This section will serve to update the estimated cost to the U.S. chemical industry of end-of-process pollution control. Please provide the following information for your U.S. chemical business, defined as domestic sales plus domestic based exports of products in SIC code 28 (excluding 283). In cases where your pollution control facilities serve company activities beyond your U. S. chemical business, answer the following questions using appropriate estimates of the proportion dedicated to your U.S. chemical business. One source of information for this section may be_'submittals to the Census Bureau on Form MA-200. For the purposes of the survey, pollution control facilities fall into three major categories; air, water, and solid waste. Use the following definitions of these pollutants to complete Section V. Air pollutants are airborne substances including particulates (dust, fly ash, smoke), sulfur oxides, nitrogen oxides, carbon monoxide, hydrocarbons, odors, fluorides, lead and other heavy metals, radioactive and toxic substances. Water pollutants are waterborne substances including phosphate, nitrates(trites), substances that generate chemical biochemical oxygen demand, solids, acids, bases, heavy metals, radioactive and toxic substances, synthetic organic molecules, harmful microbes, oil, grease, dyes, and heat. or Solid waste includes garbage, trash, sewage sludge, dredged spoil, incinerator residue, wrecked or discarded equipment, biological and chemical wastes, radioactive and other toxic materials. Include solid waste produced as a result of air and water pollutant abatement. V. A. Capital Investment Estimate your capital investment in pollution control facilities (original installed cost) during calendar years 1981, 1980, 1979, 1978, and 1977 for end-of-process waste treatment/disposal. (Ranges may used.) be 1981 (installed 1980 (installed cost) cost) Air Pollution control (l^aj s's) $ (198(1 Va) Water Pollution Control_______ $ 2.0 (198^'s) $ TTSTTfT Solid Waste Disposal 2.5 (19^ $'s) (1980 's) (Continued to next page) 21 AP00036608 V. A. Capital Investment (Con't.) 1979 (installed 1978 (installed 1977 (installed cost) cost) cost) $ 6.5 (1979 IFsT $ 4.7 (1978 S's) $ 3.5 (1977 STs) $ 3.0 (1979 S's) $ 3.1 (1978 S's) $ 3.6 (1977 S's) $ 2.1 (1979 S '' s) $ 1.0 (1978 S''s) $ 0.5 (l"77 TTT V. B. Operation and Maintenance (O&M) Costa Estimate your 1981, 1980, 1979, 1978, and 1977 annual osM costs for end-of-process waste treatment/disposal. (Ranges may be used.) 1981 1980 1979 1978 1977 V. C. Staffing Air Pollution Control $ 8.8 (1951 4' s) $ 6.0 (1980 4* S) $ 4.0 (1979 4' s) $ 2.7 (1978 4* si $ 2.5 (1977 4' s) Water Pollution Control $ 6.0 (1981 $ 1 s) $ 5.0 (1980 $ ' s) $ 4.0 (1979 $ 1 s) $ 3.8 ("1978"$ 'si $ 4.0 (1977 $ ' S) Solid waste Disposal *- (1981 S's) $ 2.3 (1980 $ 1 s) S 1.6 (1979 S's) $ 1.0 (1978 $ 1s) $ 0-5 (1977 S's) Estimate the equivalent number of full-time personnel (operations, maintenance, engineering, administration, etc.) dedicated to operating and maintaining your pollution control facilities in 1981, 1979, and 1977 at calendar year end. Air Pollution Control Water Pollution Control 1981 1979 1977 80 78 70 18* 18 18 45 4b 45 *Cannot assign to various sources accurately. Solid Waste Disposal 27 2b 22 22 AP00036609