Document 70yL1Lke0byEDX90kEkDNqJzo

America" Cyanamic Co-^ca"> One Cyna~ic p:ars Wayne. N. C747C Ge?r?e J Seiia C^a;''~,ar oi tne S&a' Presoent an- CEO October 23, 1984 Mr. Ronald A. Lang Executive Director American Industrial Health Council 1612 K Street, NW Washington, DC 20006 Dear Ron: In accordance with paragraph 7.04 of the AIHC By-Laws the Sunset committee held a meeting on October 22hd, 1984. The Committee was pleased with progress during the year toward improvement of the effectiveness and efficiency of AIHC in fulfilling its objectives. In addition an improved system of project accounting has been developed by the Finance Committee which should ensure greater control of operating costs. A Mission statement has been approved by the Executive Committee which clearly delineates AIHC objectives for continuing efforts toward the use of good science in government. The Sunset committee has concluded and recommends to the Board and the membership that there is a need for the continued existence of AIHC. Sincerely yours. GJS;lg cc: E. Blanchard R. Leet T. Reid Jr. APOO AMERICAN INDUSTRIAL HEALTH COUNCIL MISSION The mission of the American Industrial Health Council is to advocate and promote the implementation of the most advanced, sound scientific methods as a basis for the review, risk assessment, and regulation, where regulation is warranted, of substances which may pose significant chronic health risks to people without acting as an advocate for any specific substance. The Council has the following program in support of the mission. 1. The Council will establish Itself as a major informal link between scientists in Industry, the academic community and Government who are addressing chronic health hazard Issues Involving public policy decisions. 2. The Council will work to bring together the best scientific expertise the scientific community has to offer in the chronic health area and use that expertise to assist and critique Government as It develops the scien tific bases for identifying human health hazards and evaluating risks from those hazards. 3. The Council will review the scientific bases of chronic health policies developed by government, identify areas where such policies are in conflict with existing scientific knowledge and understanding and work towards their continued improvement. 4. The Council will work towards establishing within Government rules, procedures and an organizational framework which will help to insure that risk assessment is separated from risk management to the greatest degree practicable, and that regulatory decisions are based upon the best avail able scientific knowledge and methodologies, Including appropriate peer review of the science on which such government actions are based. 5. The Council will help identify gaps in scientific knowledge and make constructive contributions to advance and strengthen sound science to reduce the basis for government to use the highest estimate of life time risk assessment methodologies in Identifying and controlling possible hazards to human health. 6. The Council will work to become a significant information resource on chronic health policies for industry, the media, Congress and opinion leaders, providing Information broadly with respect to the scientific basis of public concerns over hazards stemming from exposure to potentially toxic substances. Where appropriate, inform key professionals (e.g., journalists, social scientists, lawyers) on sound science principles, working with and through other organizations in interdisciplinary activities. APOOC Recommended 1985 AIHC Budget Upon the recommendation of the Finance Committee, The Board of Direc tors recommends approval of an expenditure budget for 1985 of $1,498,800, a 6% increase over the 1984 budget. The budget details are attached. The dues rate of $25 per million dollars sales, the minimum dues of $250 and the maximum dues of $30,000 will remain the same in 1985 as In 1984. Income in 1985, based on this dues structure and no major change in 1985 membership, is estimated at $1,395,500, a 2% decrease from 1984 income. The income raised will cover 93% of budgeted expenditures. The deficit will be covered by reducing the current carry-over contingency fund to an estimated $40,000. The Finance Comnittee and Board believe that a contingency fund mod erately higher than the estimated amount should be carried, and they will develop a proposal to achieve this. The Board, therefore, recommends that the Membership adopt the budget as proposed. AP00036693 Recommended 1985 AIHC Budget Counsel Convni ttees: Associations _ Board/Executlve-/ Legal Membership Public Affairs Conmunicatl ons Scientific & Subcommittees - 43.7 2.0 - 10.0 3.0 160.0 Subtotal 218.7 Communi- . - Personnel cations Expenses-/ Other-/ & Overhead Total - 2.0 - .5 2.0 80.0 5.0 89.5 1.2 16.8 .5 1.5 3.0 4.0 10.0 37.0 - 2.0 - - - 5.0 7.0 7.0 139.0 1.0 12.0 16.0 108.0 160.0 443.0 8.2 203.5 3.5 14.0 31.0 195.0 340.0 795.2 Task Forces: EPA J3SHA i Science Policy ! FDA , CPSC State Resource Dep. Subtotal 23.0 10.0 14.0 6.0 5.0 40.0 98-0 2.0 2.0 - 1.0 - 1.0 1.0 - .5 5.0 10.0 7.0 IS.5 48.0 - 15.0 - 24.0 - 15.0 .5 11.0 - 34.0 .5 147.0 75.0 26.0 39.0 22.0 17.0 S9.0 268.0 Project Fund: Operations: Mailing Reproduction Counsel Disbursements Subtotal 220.0 35.3 27.0 40.0 102.3 Administration: Personnel/Overhead Administration Expenses* Including telephone Subtotal 44.0 TOTAL 316.7 96.5 52.5 7.5 634.0 1/ Staff travel* meeting rooms, dinners, luncheons, etc. 1/ Consultant expenses, honoraria, speaker expenses, etc. 3/ Includes administration of Finance, Nomination and Sunset Conmlttees. 44.0 69.3 113.3 $1.498.8 AP00036694 PROXY BALLOT (Please Return Promptly) TO: Ms. Lydia Calvello AIHC 1075 Central Park Avenue Scarsdale, New York 10583 Our company does not presently plan to be represented at the November 89th Annual Meeting. Our votes with respect to the Recommendations of the AIHC Sunset Comnittee and proposed slate of candidates for Board of Direc tors, Class of 1987 are as follows: A. Recorimendation of the Sunset Committee: _____ Approve _____ Disapprove Comments ______ _____________________ B. Slate of Candidates for Board of Directors, Class of 1987: Approve _____Disapprove Consents C. Recommended 1985 Operating Budget of $1,498,800: _____Approve ______Disapprove Comments Date Voting Representative Company (Designated Contact - Signature) AP00036695 Panelists' Profiles DR. WILLIAM AHLW1 was named Chancellor (or MealBi Affairs at Duhe University In May 1903. Prior lo lhaL served as Vice President-- Health Affairs for Iff prars,3SweUas professor ofsurgery He has seived as a consultant lolltc Deportment ofHealth. Critical Ion and (Welfare on medical education Ik Isa member of the Institutes ofMcdfdttc. tire national Academy of Sciences, the American Medical Association (where he currently serves on an advisory committee on medical science), the National library of Medicine and the American Surgical Association. DR. ROBERT BARKER Isa Wochem1stwho has beenInvolved in teaching, academic research and administration for the past 30 years. He is currently provost at Cornell University. Dc Barker hasan active research program with emphasis in the moiecutar structure of cell surfaces. He has served as Directorofthe Division of biologi cal Sciences and then as Vice President for research and advanced studies at ComeB. tie has also served as Consultant to NHL hAV national Research Council national Board ofMedical examiners, and other research-oriented hisUtutionsand universities. JACKSON B. BROWNING, Corporate Director, health. Safety& environmental Affairs. Union Carbide Corporation; Is a member of die American Institute ofChemical engineers, on the Board of Directors and executive Committee ofthe American Industrial Mealth Council, and chairman ofHs Science Policy 1*3* Porcc chairman ofthe Chemkad Manufacturer Association Public Com pensation fish Group and on the Ciecutiw Committee ofthe Chemical Industry Institute onbxlmiogy DOUGLAS M. COSTLE Is Counsel to the law firm ofWakl, Harkrater Rr Ross, Washington. DjC; Counsel to hie law llrm ofUpdike, Kely and SpeHacy PC. Connecticut, and an Adjunct Professor. John r. Kennedy School ofGovernment Harvard Unheislty He served as Administrator ofthe Environmental Protection Agency from 1977 to 1961. He U a member of the Board of Directors and Chairman ofthe Executive Committee ofthe Environmental Testing and Certi fication Corporation. HewJersey a trustee ofthe Keystone Center and Member of Board of Dlrectors,Ctean SHes. Me is the U.S. Chair man of the US-USSR Joint Committee on Cooperation In the field ofEnvironmental Protection. Mr. Costte b a graduate ofHarvard University and the UnlwersJtyofChicago Law 5chool. PETER BARTOMIUTT is a partner in the Washington. DC law firm ofCovington 6C Burling, specializingin food and drug law and in government regulation of health and safety. Trom 1971 to 197S he wasChlefCounsel for the Pood and Drug Administration, tic presently serves on marryprestigiousacMsory bodies and main tains directorshipson boards in government professional societies, academia, and Industry Hr. Hutt holds degrees Bom rate. Harvard and Newfork University. ROBERT J. MOOLEHAAR, PhJ>v Prefect Director. Health and Environmental Sciences, the Dow Chemical Company Prior to July 1963. he was DirectorofEnvironmenial sciences Research Lab. health and Environments Services al Dow tte Is Chairman of the American Industrial Health Council Scientific Committee, he is a member ofthe U.5. Business and IndustryAcMsory Committee (Chemical Subcommittee) to advise Ihe LLS- government on the OECD chemicals projpanv U3. Industry advisor, representing BIAC to advise CPA In mattersrelating to the updating ofhealth and environmental test methodsforOECD. DR. ROBERT OLSOM, M.D.. Ph.D.. Professor of Pharmacology and Medicine at the State University of hew fork at Stony Brook. Pre vtously he was ProfessorofBlochemistiyandMedlcincattheUnhersity ofPittsburgh School ofMedicine. As a researcher. Dr. Olson has done extensive work In the fields of metabolism, endocrinology, toxicoiogr and nutrition In both anbnals and man. Special empiiasb in lib research was on the metabolism of tumor tissue. He holds a PhD. In biochemistry from SL Louis University and an MX), from the Harvord Medical School. AIHC Perspectives on Science, Risk Assessment and Public Chronic Health Hazard Policy Annual Meeting of American Industrial Health Council Thursday, November 29,1984 8AM-2PM Mayflower hotel 1127 Connecticut Avenue, MW Washington. DC i ! I AP00036 AP00036697 AIHC Annual Meeting Program AIHC AlHC's Annual Meeting for 1984will feature presenta tions by individuals who will offer real-world prespectives on the chronic health hazard policy-making process. Speakers include former regulatory agency officials, prominent university scien tists and key industry repre sentatives. Ample time will be allotted in the program for audience discussion and participation. The mission oftheAmerican Industrial Health Council fs to advocate andpromote the Impfementation ofthe most advanced, soundscientific methods as a basisforthe review, riskassess ment, and regulation (where regulation is warranted) ofsub stances which maypose sig nificant chronic health risks to people. AIHC does not and wtU not actas an advocate farany specificproduct orsubstance. (Time Is scheduled for Q & A each session) &00 Registration 8:50 9:15 AIHC Business Meeting Reportofthe Sunset Committee and Vote 1984 Financial Report Presentation of 1985 Budgetand Vote Report of the nominations Committee and Election ofhew Members ofthe Board Richard H- LedAIHC Chairman Executive Vice President Standard Oil Company (Indiana) Remarks by AlllC Wee Chairman Toy E Reid Executive Vice President Eastman KodaHComparty Prospects for the Use of Qualify Science in Regulatory Decision-Making on Chronic Health and Related Environmental Issues-- An PDA and CPA Update and a Look Ahead Moderator Edwin L. Behrens. Chairman AIHC Public Affairs Committee Associate Director. Technical Affairs The Procter Gamble Company Panelists; Peter hutt Covington Ct Burling Former ChiefCounsel, FDA Douglas PL Coslle Wakl. HariiraderSr Ross FormerAdministrator. EPA 1015 11:15 12:00 12:50 The Role ofAcademia in the Formation of Public Science Policy Moderator Carl Umland, Vice-Chairman AIHCScientific Committee Environmental Health Coordinator Exxon Chemical Americas Panelists: Dr. Robert Barker Provost Cornell University Dr. William Anlyan Chancellor for Health Affairs tx Professorof 5urgery Duke Medical Center Dr. Robert E. Olson Prolessor of Pharmacology Ot Medicine State Universityof Hew Ybrk at Stony Brook AIHC: ALink with Scientists In Industry, Academia, and Government on Addressing Chronic health Hazard Issues Involving Public Policy Decisions Moderator Leonard J.Guarraia, Chairman EPA Task force Director. Regulatory Affairs Monsanto Company Panelists: Robert J. Moolenaar. Chairman Al11C Scientific Committee 'Project Director. I icallh St Environmental Sciences The DowChemical Company Jackson B. Browning Chairman Al IK Science Policy Task Force Corporate Director--Health, Safety 8r Environmental Affairs Union Carbide Corporation Cocktail Reception Luncheon Alvin L Aim. Deputy Administrator. Environmental Protection Agency "Tire Role of Science in Regulatory Policy St Risk Managentcnt" 1 > x *5 "V~r~r \i ; r * -- -- -1* . u M S \ *. M MU /V r* 1 1 H x _J ... ,rJ . - '- ` - -7 - - J AIHC ANNUAL MEETING TO FEATUREPAST EPAHEAD, FORMERFDA COUNSEL On November 29, Douglas M. Cosrle, EPA Administrator during the Carter Administration, and Peter Hurt, former FDA Counsel, will talk about current and future prospects for sound science at the EPA and FDA. They will be addressing attendees at AIHC's Annual Meeting at the Mayflower Hotel Washington, D.C. in a session moderated by Edwin L Behrens, AIHC's Public Affairs Committee Chairman. Another program segment will address the role of academia in the formation of public policy. That session will be moderated by Carl Umland, Vice Chairman ofAIHC's Scientific Committee. The panelists are: Dr. Robert Barker, Provost at Cornell University; Dr. William Anlyan, Chancellor for Health Affairs and Professor of Surgery at Duke . *7 W-. Medical Center; and Dr. Robert E Olson, Professor of Pharmacology 6c Medicine at the State University of New York, Stony Brook. The final panel will discuss an integral part of AIHC's mission; how AIHC can serve as a link between scientists in industry, academia and government -- describing current programs and future plans. Leonard J. Guamia, Chairman of AIHC's EPA Task Force will moderace a panel consisting of Robert J. Moolenaar, AIHC Scientific Committee Chairman, and Jackson B. Browning, Chairman of AIHC's Science Policy Task Force. Registration information for the AIHC Annual Meeting can be obtained by calling AIHC's New Yotk office (914) 7254492. VicCteLj \T..swf-.c f. - i.- L** SCIENTIFIC WORKSHOP OFFERS CURRENT CARCINOGENICITY CRITERIA Findings Published in Major Scientific Journal An interdisciplinary panel on carcino genicity concluded that "Characterization of human risk always requires interdiscipli nary evaluation ofthe entire array ofdata on a case-bv-case basis." Convened at the request of the American Industrial Health Council, and chaired by Dr. Philippe Shubik of Oxford University1, the panel of prestigious scientists set out to re-evaiuate the criteria for assessing whether or not a substance causes cancer. Their findings were published on August 17 in the major peer-review journal Science. The panel fulfilled a recommendation made in a 1977 report by the Committee on Environmental Carcinogenesis ofthe National Cancel Advisory Board, which called for continuing scientific review of the issue. The panel reached significant conclusions regarding the value of epidemiology, long term bioassays, and short-term tests in the overall assessment process to determine chemical carcinogenicity. Epidemiological Studies. The panel noted that human data provides the only direct evidence that a chemical produces cancer in man. Although the value of negative epidemiology is limited, since it is impossible to prove a negative, these results are useful in indicating the limits within which a specific type of exposure will not affect the incidence of cancer in man. (See SCIENTIFIC WORKSHOP, page 2) From the Editor.................................. 2 AIHC Networking GeneratesPraise ... 3 New AIHC Projects AppnweJ ............. .4 In Brief............................................................5 Conferences.......................................... 6 AP00036698 From the Editor ON COMMUNICATING RISKS: HOW ARB WE DOING? Discovering and publicizing '`new" poten tial chronic health hazards are things our society does welL You know the litany of past "discoveries"; Love Canal nitrites, saccharin, dioxin, formaldehyde, EDB. That's not to say that these things pose zero risk. Nothing poses zero risk. The point is, all risks need to be evaluated and compared with known risks, known benefics, the risks and costs of regulatory controls, and uncertainties. And yes, ways must be found to compare apples with oranges. What we have not yet learned to do well is to assess a hazard's potential for human harm with precision, and precisely convey that information in a way that is relevant to an individual who may face the consequences of exposure. And until we know the specific mechanisms of chronic disease causation, we must do the best with what we have. There is growing recognition that we are not doing the best that we can with what we have -- the "we" being all of us involved in Sc science and health policy processes; industry, government, consumer groups, the news media and the scientific community. This writer's purpose is not to assess blame. Responsibility to first develop sound scien tific information, and only then to com municate, understand, and act on the basis ofthat information, rests with all of us. Now for the good news Organizations representing diverse interests are doing things to improve the flow of good information through the govemment-industry-scienttfic communitymedia pipeline. Some examples; - Workshops and conferences on "Science, Health Risks and the Media" separately sponsored by Boston University, The University of North Carolina, Georgetown University, Cornell University, the Harvard School of Public Health and the Foundation for American Communication. - NIEHS Task Force III mandated by Congress to recommend areas of promise for research in the environmental health sciences, has included a panel for information exchange in its work. -A major research project on "Risk Perception, Risk Acceptance and Risk Communication: Assessment of the State of Knowledge" is being conducted at the University of Southern California, funded by a grant from the National Science Foundation. -A pilot program "to enhance the quality ofreporting ofenvironmental health issues by the media" has been proposed by the University of Massachusetts. - The National Cancer Institute is soliciting proposals tor a cancer communications system -- for dissemination and interpre tation of information regarding the cause, prevention, detection and treatment of cancer. -- A three year pilot project that will help students and the general public understand the uses and hazards of chemicals is under way at the University ofCalifornia's Lawrence Hall of Science in Berkeley. -- A formal program in Science and Environmental Reporting is in it's third year at New York University; a Science Com munications Center is taking shape at the University of Missouri. These are only a few examples of programs to improve risk communications -- evidence that the importance of the rela tionship between public understanding and sound chronic health hazard policy has been fully recognbfd. And what's more important, we are doing something about it. Perhaps, in the near future, we can point to risk communication as something else that we AIHC SCIENTIFIC WORKSHOP, from page 1 Long-term Bioassavs. The panel pointed out that these tests often produce different patterns of tumor development in test animals. These patterns most likely represent different mechanisms having different significance to human risk. They should be recognized as such. Each experi ment must be assessed individually and different weights of evidence accorded for purposes of extrapolation to humans. Short-term Tests. The panelstressed that these tests alone are not adequate co determine carcinogenicity. Although scien tists hoped that earlv tissue changes would he found that would predict carcinogenicity, until now, the overall performance ofshort term tests has been accurate only 50 to 70 percent of the time. Pharmacokinetics. The panel also said special attention must be given to the pharmacokinetics Uhe observance of actions of ,1 substance in the body over a period of time) ofchemical carcinogens. For example, at elevated doses, the body may be unable to clear the chemical as rapidly as admini stered and toxic concentrations may be reached. This and other variables in the pharmacokinetics of carcinogens limits extrapolation of metabolic data from test species to the human situation. In conclusion, no single in vitro test can exactly mimic pharmacokinetic parameters in animal testa Extrapolation from Experimental (Animal) Data. Since animal experiments are usually conducted with higher exposure levels than those normally encountered by humans, risk must be estimated by extrapo lating results from these high doses to the lower doses experienced by humans. This process is fraught with uncertainty. Therefore, pending further scientific understanding of cancer mechanisms, statistical methodologies should be developed to incorporate all the variables. This includes pharmacokinetic data and the time between exposure and tumor development, the amount ofexposure and the duration ofexposure and compering risks. Although some regulator,' agencies emphasize a worst case or upper confidence level based on the models used, the most _probable estimates should always be pre sented. together with the upper and lower confidence limits of the estimates. Overall Assessment Process. In the past there has been great reliance on tumor incidences in any animal srudv. The panel concluded that a full scientific evaluation to characterize risk must not only consider positive animal tests but must also look at evidence from short-term tests, human population studies, oiometric analyses and metabolism studies, as well os any other relevant information. A single method alone cannot produce a reliable estimate of a chemical's risk to man. but together they could provide an estimate that can be given a higher degree of confidence. fm 2 AP00036699 AIHC NETWORKING GENERATES PRAISE AND COMMITTMENT Cdwird I. Cthbme, PhD.: Fiofcuor. Enwrcvnm*l Heeldi Propvn Univenitf ofMnuchuxto Scientific and governmental health hazard policy makers have praised AlHCs Com munications Networking Program. Through this program, independent scientists are winning the support of "influentials" in academia and government for AlHC's position that regulation of chronic health hazards be based on sound science. The program is a broadened version of AlHC's Media Tour Program. It featured independent scientists who were interviewed by broadcast and print journalists in selected markets. Now, the scientists participating in the program aiso visit their scientific peers in government and academia, as well as other government officials involved in the regula tion of chronic health hazards. Two networking efforts have taken place so far this year. In May, Dr. Edward Calabrese, (Professor in the Environmental Health Program at the University of Massa chusetts at Amherst) visited San Francisco and Sacramento, California. He spoke with people like Dr. Gordon Duffy, Secretary of the California Department of Environmental Affairs and Dr. Howard Maccabee, Director of the Radiation Oncology Center in Walnut Creek, California. They both" agreed with Dr. Calabrese's premise that Robert E. Olnn, M.O: Profetw of Phmucc4og> & Medidne. SUNY Stony Brook scientists must be more involved early on in the policy-making process for chronic health hazards. In August, Dr. Robert Olson (Professor of Pharmacology and Medicine at SUNY, Stony Brook) visited Boston and Providence. There, people like Dr. Brian MacMahon, Chairman of the Epidemiology Department at Harvard, and Dr. Peter Goldman, Director ofthe Food and Nutrition Labora tory at Harvard, said they would be interested in appropriate future participation in AIHC issues. This type of scientific commitment will be extremely valuable as chronic health hazard issues arise on the national and local levels. The recenc call for comments by the Office ofScience and Technology Policy on its Document on Chemical Carcinogens is one example of a situation where the support of the independent scientific com munity would be very helpfuL The need for external scientific input on the forthcoming EPA study on cancer and air pollution is another example. A networking program is scheduled for Louisiana the week of October 22. Future networking efforts are planned for Texas and New Jersey. BOOKS A usefol overview of developmental toxicity processes and assessment methods can be found in Principles for Evaluating Health Risks to Progeny Associated with Exposure to Chemicals DuringPregnancy. Described as the "'collective views of an international group of experts," it was published this year by the World Health Organization as number 30 in their Environ mental Health criteria series. Elements of Risk: The Chemical Industry and Its Threat to America, was written by Cathy Trost and published by N.Y. Times Books. New York City. The book is not the "expose" that its title and pre-publication promotional materials would lead you to expect. The book beuins with an objective, almost positive history ofthe U.S. chemical industry's development, later to be contrasted with accounts of alleged health effects and individual suffering linked to chemical exposure. Workers at Risk by Dorothy Nelkin and Michael S. Brown. University of Chicago Press, focuses on the perceptions and concerns of people in a wide range of occupations who work with chemicals. Seventy five such individuals were inter viewed. Their responses, as well as comments from spokesmen for industry, government, universities and unions, provide the basis for this book. The Good News Is The Bad News Is Wrong by Ben Wattenberg, has been published by Simon &. Schuster, New York City. As the titles implies, the book refuces the liturgies of the apocalvptics on health (and other) risks posed to our society's LEGAL DECISIONS: FETUS PROTECTION POLICY In 1982, the Fourth Circuit Court of Appeals in the Olin case (697 F. 2d 1172) held rhac plaintiffs had made a prima facie case ofsex discrimination under Title VII of rhe Civil Rights Act by the fetus protection policy and sent the case back to the trial court to determine whether there was scienrific/medical support for the policy rhat would justify the policy under rhe business necessity rule. The trial court held the policy justified (585 F. Supp. 1447) and, in a confused procedural posture, the case has been appealed back to the Fourth Circuit. On August 24, 1984 the Federal Court of Appeals for the Disrricc of Columbia Circuit ruled that the American Cyanamid policy was not in violation of the OSH Act A fetal protection policy, the court ruled, is not a "hazard" of employment under the general duty clause. The Title VII discrimi nation issue was settled and the court did not address that issue. Oil, Chemical and Atomic Workers International Union v. American Cyanamid Company, #81-1687, August 24. 1984. 3 AP00036700 NEW AIHC PROJECTS APPROVED AIHC is an effective organization, but its resources are limited. Setting priorities for the use'ofAIHC's resources is an important function ofthe AIHC Executive Committee. Before a project is submitted to the Executive Committee for consideration, a series ofquestions must be addressed in the proposal What is the project's objective? What u/ili it achieve? Hew does this project and what it will achieve relate to AIHC's mission.7 Why is AIHC undertaking this project rather than another organization? Hou; much will it cost? What priority is placed on the project by the proposing committee? The following projects withstood the scrutiny of the AIHC Executive Committee, and were approved on August 29. Project #071: Scientific Outreach Program Submitted by the AIHC Scientific Committee; Robert J. Moolenaar, Chairman, Oral presentation by Carl Umland, ViceChairman. OBJECTIVE: Establish effective, regular contact with a broad spectrum ofinfluential scientists for exchange of views on chronic health hazard public policy issues. This is an effort to convince them to become involved in dialogues with government and the media to promote sound science as the basis for government decisions. Project #073; Animal-to-Man Extrapolation Workshop Submitted by the AIHC Risk Assessment Subcommittee; Donald Hughes, Chairman. OBJECTIVE: Reassess the scientific basis for extrapolation of animal carcinogenicity data to humans, both qualitatively and quantitatively. Project #042.1: Epidemiology - Risk Assessment Symposium Submitted by the Epidemiology Sub committee; Martin J. Reape, Chairman OBJECTIVE: Define and promote the role and valid application of epidemiology in the conduct of human health risk assessment. Project #045.1: Continued Promotion and Distribution of "Cancer, Pollution and the Workplace" booklet. Submitted by the Communications Com mittee; Phillip H.L Schneider. Chairman. OBJECTIVE Continue promotion and distribution ofa well-written, well-received booklet which in lay language, puts in perspective what is known about industrially- AIHC NTP BLUE RIBBON PANEL REPORT FILED The blue ribbon scientific committee reviewing che NTP program filed its report with the NTP Board ofScientific Counselors on August 17, 1984. The panel report did not recommend basic changes in the NTP program. The report did recommend that the technical reports indicate both the quality of the data and the possible relevance to human risk assessment. The report pointed out that because ofpotentially "immense economic and public health importance of the results", it is important that good laboratory practices be followed and studies be evaluated for quality assurance. (The AIHC quality assurance subcommittee has strongly urged that NTP strengthen the quality assurance audit program.) Since the predictive value of a study depends on the quality of the study design and the conduct and interpretation of the results, the report recommends NTP re-evaluate selected "old" bioassays that serve as a basis for regulatory decisions. The report also urges animal tests of known human carcinogens as an additional method of ensuring the integrity and credibility of the program. Chairman Doull, speaking of the report, said that regulatory decision-making was not part of the responsibility of the NTP or the blue ribbon committee. Discussion on regulatory aspects of toxicity testing was dropped in the final report. SIX MONTH AIR TOXICS STUDY Late in July the press carried stories about a new study of air toxics completed in six months, hence the name. The draft study contained an estimate of 2.010 cases of cancer due to air pollution. AIHC has reviewed the draft study and expects a public briefing and release in the near future, after peer review. The study uses Cancer Assessment Group upper confidence limits unit risks and depends on population exposure estimates. The draft study recog nises that the data are not such as to support a scientifically sound estimate. EPA has Indicated thar it does not intend to use the study for regulatory purposes but to develop a policy on "air toxics" as part of the "fast Hack" program to review alleged toxic air pollutants. A new policy staff has been appointed with instructions to report by year end. The study has already had some practical results. NRDC issuing EPA for the decision (49 Fed. Reg. 31680) not to regulate polycyclic organic matter (POM) under 112 of the Clean Air Act; NRDC has cited the draft study as indicating that POM may be the cause of more than 800 cancer cases- EPA has reissued the draft study with a disclaimer and a cover memorandum pointing out some of the limitations of the study. EPA also has solicited informal peer review. Notwithstanding these develop ments, the findings ofthe study continue to be cited in EPA-sponsored publications without qualification, including in the September issues ofthe EPAJournal AIHC 4 AIHC SPEAKS October 4 - U.S. Operating Committee of Ecological and Toxicological Associ ation of the Dyestuffs Manufacturing Industry * E Behrens and R. Moolenaar provided USOC with an overview and discussion of AIHC activities. ' October 11 -- Statf and Territorial Air foliation Program Administrators Associ ation of Local Air Pollution Control Officials. F. Hoerger will offer an AIHC perspective on the framework for risk assessment and risk management for hazardous air pollutants. ^ November 13-New York Urdvemcy J. Browning and R. long join N.Y.U. pathologist Dr. Harry Demopouloe fas a full day's discussion of the role of journalists In public health policy devel opment. The participating audience will be graduate students in N.Y.U.'* Science and Environmental Reporting Program. ___ AP00036701 IN BRIEF: SCIENCE AND POLICY DEVELOPMENTS Interagency Risk Management Council Peer review and pttblic participation. A1HC has written to Dr. Henney (NCI) and Dr. Miller (FDA) co-chairpersons of the IRMC subcommittee on cancer risk assessment guidelines with proposals for public participation in the work of the subcommittee through informal peer review of drafts and a scientific workshop. AlHC has written a similar letter to Dr. Anderson (EPA) chairperson of the IRMC subcommittee on reproductive effects risk assessment The work plan of the sub committee includes preparation of a back ground paper by a contractor. AIHC has proposed an opportunity for public comment in that process. AIHC has also suggested a scientific consensus workshop on reproductive effects. Toxic Torts/Causation Issues YCL Postrion. On July 26th the National Conference of State Legislatures adopted a resolution on hazardous waste and victims' compensation. The resolution calls upon the federal government to determine health :ttects from exposure. The resolution urges that federal health effects studies be designed to be admissible in victims' compensation cases. It also calls for review of state laws on victims' compensation. As pan of the study of health effects, NCSL urges the federal government to seek independent scientific review of the federal research efforts. "An active peer review approach should characterize all such research in order to establish a consensus to the greatest extent possible." OSHA New deputies. Robert Rowland, the new OSHA Administrator, has announced some changes in the administrative structure. Pat Tyson will be deputy assistant secretary for federal and state operations, technical support, and health and safety standards. Michel Korbey will be deputy assistant secretary for public affairs, administration policy development, legislative affairs and regulatory analysis. Jane A. Matheson will be deputy assistant secretary for field operations. Korbey and Matheson came from the Occupational Safety and Health Review Commission which Rowland chaired before coming to OSHA. UAREP Study. The scientific study by UAREP (commissioned by industrial groups) of injury to members of the puplic from exposure to waste dumps is expected to be released in November. The report was prepared by the Executive Scientific Panel on Health Aspects of Disposal of Selected Waste Chemicals formed by the Universities Associated for Research and Education in Pathology. AIHC is a non-contributing sponsor of the study. EPA SAB Nominations. EPA has requested nominations to fill 10-15 positions on the Science Advisory Board in the next year. Nominations are to have been submitted by September 28th, 49 Fed Reg. 33169. Risk assessment guidelines. EPA has announced a program of publishing six risk assessment guidelines by November 1st. A number of the draft guidelines are now out for informal peer review (carcinogenicity, mutagenicity, exposure) and EPA expects to be on schedule for all six. AIHC has nominated scientists as informal peer AIHC CORNELL SPONSORS FORUM ON "TOXIC CHEMICALS AND THE MEDIA" The tremendous increase in information 'on toxic chemicals transmitted to the public through the media has had a profound impact on the public's perception of risk. In view ofthis, the Cornell University Institute for Comparative and Environmental Toxi cology (ICET) recently hosted a 1 Vi day symposium, "Toxic Chemicals and the Media." Led by ICET director, Christohcr F. Wilkinson, seminar participants from the scientific community, government, industry and public interest groups evaluated the complexities of the risk communication process. Dr. Charles Powers. President of Clean Sites. Inc., Washington. D.C. noted in his plenary address the puhlic's sense of panic about toxic waste. He said that language is the kev to understanding and interpreting tact from fiction and that reporters must "sift through the muck for clarity." John Frawley, General Manager, Health and Environment, Hercules, Inc., emphasized that science is not absolute, and that oftentimes it consists of judgements rather than facts. He also said that there is a bias in the media which falls somewhere between informing and influencing the public. Problems inherent in science reporting were addressed by Gannett News Service reporter Rae Tyson. Lack of consensus among scientists, advocacy science, lack of accessibility to experts, scientists' failure to appreciate deadlines, and the lack of understanding of these issues among his own peers were specifically cited. Other seminar participants included: Michael Gruber, Branch Chief Integrated Environmental Management Division, EPA Dr. Fred Pehme, President of the Society of Toxicology and Ruth Norris, Senior Editor of Audubon. Recommendations to improve the flow of information between the scientific com munity included: background sessions with scientific experts in the scientific arena, wider shanng of current information on issues, better access to scientists and scientists' understanding of reporter's deadlines. AIHC ANNUAL MEETING NOVEMBER 29, 1984 MAYFLOWER HOTEL WASHINGTON, D.C 5 AP00036702 I October 23 - 25 October 28-29 November 12 --14 November 13 -- 16 November 15 -16 December 4-5 December 7-8 CONFERENCES, SEMINARS, AND SYMPOSIA Advances in Health Risk Assessment for Systemic Toxicants and Chemical Mixtures. Presented by the U.S. EPA Environmental Criteria and Assessment Office, Cincinnati, Ohio. Will present results of EPA-sponsored research. Contact Ms. Jo Ann Duchene, ICA1R, Life Systems, Inc, Cleveland, Ohio (216) 464-3291. Seventh ORNL Life Sciences Symposium: Indoor Air and Human Health. Hosted by the Oak Ridge National Laboratory, sponsored by U.S. Department of Energy, EPA and Tennessee Valley Authority. Will focus on the health implications of the major categories of airborne pollutants in indoor environments. Contact Lois Szluha at the Oak Ridge National Laboratory (615) 576-2109. Principles and Mechanisms of Neurotoxicity. Sponsored by and held at The Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland. Contact Dr. J. Com at Johns Hopkins (301) 955-2609. Third International Conference: Safety Evaluation and Regulation of Chemicals. Sponsored by the American College ofToxicology and the U.S. EPA Office ofToxic Substances, organized by The Boston Universitv School of Medicine. To be held at the Nova Park Hotel, Zurich, Switzerland. Contact F. Homburger at The BioResearch Institute, Inc, Cambridge, MA (617) 864-8735. Conference on Health Effects of Acid Precipitation. Sponsored by NIEHS and U.S. EPA, to be held at NIEHS facility at Research Triangle Park, North Carolina. Contact Mary Hogan at NIEHS (919) 541-7620. Risk Assessment and Alternatives to Animal Testing. To be held in Montreal Canada. Contact Dr. Gordon Krip, Sociery of Toxicology, PO Box 517, Beaconsfield, PQ H9W 5V1. (514) 695-7920 ext. 431. Second Annual Recent Advances in Occupational Cancer. San Francisco, California. Contact Extension Programs in Medical Education, Room 569-U, University of California, San Francisco, CA (415) 661-4251. EPA/SAB ON QUANTITATIVE RISK ASSESSMENT MODELS In a detailed written opinion dated August 17th. a Special Committee of the Science Advisory Board concluded the EPA report did not provide adequare scientific support for regulatory decisions on radionuclides. In reviewing the EPA cancer risk estimation the SAB concluded that use of a single generally recognized-asconservative model (the linear non-threshold model) was "scientifically inappropriate." The '`preferred approach" would be to present a range of models so the risk manager would be more fully informed. In a strongly worded letter, the National Resources Defense Council has urged EPA to issue emissions standards for radio nuclides despite the SAB's criticism of EPA's risk assessment. NRDC accused the SAB of overstepping its proper functions by making policy comments. Should NRDC seek to enforce the court-ordeTed October 23 deadline, the case could involve important issues as to the SAB's role and EPA's risk estimation methods. EPA is also looking at different approaches for substance-specific quantitative risk assessment. For example, EPA and OMB are reported to be in discussions to evaluate methods of risk assessment for coke oven emissions less conservative than the 95*96 upper confidence limit, using the linear multistage model One more item: Dr. Elizabeth Anderson (Director of EPA's Office of Health and Environmental Risk Assessment) published an article in Risk Analysis (Vol 3, No. 4, 1983) '`Quantitative Approaches in Use to Assess Cancer Risk". The article is an explanation of, and argument for, EPA's current methodology. The American Industrial Health Council is a coalition of industrial firms and trade associations concerned with ensuring that the best available science is used as a basis for the regulation ofsubstances which pose significant chronic health risks to people. We believe chat reliance upon sound science throughout the regulatory process results in effective and reasonable regula tion, when regulation is warranted. Comments and inqu iries may be addressed to The Editor in care of the New York office. American Industrial Health Council 1075 Central Park Avenue Scarsdale, New York 10583 (914) 725-1492 1612 K Street N.W. Washington, D.C. 20006 (202) 659-0060 AP00036703