Document 2qYmQKNNq4GVmKYLmxwga9ag5

' 1835 K Street, N. W. Suite 402 Washington, D. C. 20006 IMPACT 0: SAFETY, HEALTH AND ENVIRONMENTAL REGULATIONS ON MEDICAL PRACTICE IN INDUSTRY ' Certain-Teed Corporation Occupational Medicine Seminar PAValley Forge, June 16-17, 1977; Morton Corn, Ph.D, ^PLAINTIFF'S llilEXHIBlt'IS :;ASA-114, v. INTRODUCTION . I It is an honor to be invited to address this group. t was MY -'RIVI LEGE "0 ACCEPT THE INVITATION A,ND MV PLEASURE TO BE WITH YOU TODAY. Mr. Kittlestadt informed ME THAT the majority of those in THE AUDIENCE ARE PART-TIME EMPLOYEES OF THE CERTAIN-TEED CORPOR ATION, PHYSICIANS WHO PROVIDE SERVICE TO Ce*TAIN"TeED. It IS THE PURPOSE OF MY PRESENTATION TODAY "O CALL ATTENTION TO THE EVOLV ING concepts of Federal regulation of safety, health and environ U.S.ment in the and their implications for professionals with RESPONSIBILITY IN THESE AREAS. THERE ARE EXTENSIVE PROFESSIONAL RAMIFICATIONS OF THESE CHANGING PHILOSOPHIES TO THE INDIVIDUAL PRACTITIONER. It IS EVEN MORE DIFFICULT TO TRANSLATE THESE IM PACTS TO THE ROLE OF THOSE FULFILLING A PART-TIME MEDICAL RESPON SIBILITY., THAN IT IS TO RELATE THEM TO THOSE SERVING AS FULL-TIME HER 0000916 2 CORPORATE OCCUPATIONAL PHYSICIANS. In FACT, IT WILL BE YOUR RE' SPON.ABILITY TO SUPERIMPOSE ON MY PRESENTATION THE ADAPTATION OF THE -`ART-TIME PHYSICIAN TO THE RESPONSIBILITIES AND NEEDS DE" SCRIMED. $ First, we should recognize that much of what will be discus sed :s controversial. This is a period of transition, im the SENSE OF CHANGES FROM THAT WHICH EXISTED PRI DR TO THE LATE 1960's IN THE FIELDS OF OCCUPATIONAL SAFETY AND HEA_TH AND THE ENVIRON MENT. Also, it is a transition in the more immediate sense of THE NEW ADMINISTRATION IN WASHINGTON. It IS ALREADY IN THE PRO CESS OF ALTERING SOME OF THE PROCEDURES AND APPROACHES THAT WERE FORMULATED DURING THE PREVIOUS -ADMINISTRATION. . In 1959 THERE WERE VERY FEW REGULATIONS AFFECTING THE CHEMI- +' CAL INDUSTRY AND THE ENVIRONMENT, EITHER THE ENVIRONMENT OUTSIDE OR INSIDE THE WORKING FACILITY. SOME OF THE ACTS, LAWS AND REGU" .^ LATIONS WHICH HAVE SINCE COME INTO EFFECT ARE AS FOLLOWS: The Clean Air Act; The Clean Water Act; The Occupational Safe ty and Health Act; The Mine Safety and Health Act; The Coastal Zone HER 0000917 3 r-ANAfEKENT AcTj THE ENDANGERED SPECIES Ad; IHE ENERGY SUPPLY AND Envii.onmental Coordination Act;'The Federal Environmental Pestici de. Control Act; The Federal Insecticide, Fungicide and Rodenticide Act; The Fish and Wildlife Coordination Act; The Hazardous Mater- 9 ials Transportation Act; The Marine Protection Research and Sanctu aries Act; The Resources Conservation and Recovery Act; The Solid 4 Waste Disposal Act; the new Toxic Substances Control Act; The Trans portation Safety Act; and the Consjmer Product Safety Act. Virtual ly ALL OF THESE STATUTES DEEPLY IN/OLVE THE SCIENTIFIC, TECHNICAL AND BUSINESS COMMUNITIES AND YET T^SE GROUPS HAVE ONLY OF LATE'BE COME AWARE OF THE RELEVANCE OF THIS LEGISLATION TO THEIR EVERYDAY ' LIFE, AND TO THEM IN THEIR ROLES AS PRACTICING PROFESSIONALS AND BUSINESSMEN. THERE IS LITTLE DOUBT THAT IN RETROSPECT THE PAST 10 TO 15 YEARS WILL BE CHARACTERIZED BY MANY AS A PERIOD OF MAJOR Federal initiatives to regulate technological and scientific as pects OF OUR COMPLEX SOCIETY. A RECENT ISSUE OF BUSINESS WEEK DE" VOTES ITS MAJOR STORY TO THIS SUBJECT, WHICH IT CALLS "GOVERNMENT intervention". Almost all of the aforementioned statutes are de voted TO REGULATING THE CHEMICAL ENVIRONMENT. HER 0000918 TO FURTHER STRESS THE EXTENT-OF GOVERNMENT INVOLVEMENT, LET US BRIEFLY LOOK AT THE STAFFING'OF SELECTED FEDERAL REGULATORY agencies. The Environmental Protection Agency now employs ap- prox:mately 10..000; the proposed E?A budget offered by the Carter i administration adds over 600 POSITIONS, 182 OF which WILL BE ALLO CATE) TO ADMINISTERING THE NEW TOXIC SUBSTANCES CONTROL ACT. In FACT. AT THE RECENT APPROPRIATIONS HEARINGS FOR EPA, HR. JOHN Quar.es, Actins Administrator of the Agency, informed the Com mittee THAT BY 1980 THE-ADMINISTRATION OF Th E TOXIC SlBSTANCES Control Act would require an Agency about ThE size of the Food and Drug Administration, that is, about 7,000 persons and a $250 c X 10 annual budget. . ' The Occupational Safety and Health Administration employs approximately 2,700; the Mine Enforcement and Safety Administra tion employs approximately 2,400; the Food and Drug Administration employs about 7,000. The Consumer Product Safety Commission: 900. These are substantial numbers of Federally employed regulators. All told, I believe there are somewhere in the neighborhood of 85,COO Federal employees performing regulatory funcj{pmc MUTrH HER 0000919 5 COULE AFFECT IFE PROFESSIONAL SCIENTIFIC AND TECHNICAL COMMUNITY. The employment figures for the sta*'e and local governments employ ING /DDITIONAL INDIVIDUALS FOR DUTIES RELATE.) TO THE SAME STATUTES, AND fONITORED EY THE FEDERAL GOVERNMENT IN THEIR ACTIVITIES, ARE HARDCR TO COME BY AND I CANNOT OFFER THEM HE*E. There can be enormous and dramatic repercussions of regulatory - ACTION IN THE AREA OF SCIENTIFIC DECISION MAKING. THE MOST RECENT EXAMPLES OF THIS ARE THE jfoOD AND DRUG ADMINISTRATION BAN ON SAC CHARIN, CALLED FOR BY THE DELANEY CLAUSE IN THE PURE FOOD AND Drug and Cosmetics Act of 1958, and the Federal Court decision TO HALT CONSTRUCTION OF THE TELLICO DAM IN THE TENNESSEE VALLEY Authority elec"ricity generating grid, on the basis of the provis ions of the Endangered Species Act of 1973. It is not my purpose to argue the merits of either of these CASES HERE. SUFFICE IT TO SAY THAT THE PUBLIC IS THOROUGHLY CON -^ FUSED WITH RESPECT TO THE MERITS OF BOTH DECISIONS. FURTHERMORE, IN BOTH CASES, THERE ARE VALID SCIENTIFIC ARGUMENTS WHICH COULD SUPPORT OR REFUTE THE DECISIONS REACHED. In OTHER WORDS, DECIS IONS SUCH AS THESE TWO ARE, INDEED, ON THE FOREFRONT CF OUR KNOWLEDGE HER 0000920 6 OF THE PARTICULAR SUBJECTS INVOLVED/ AND RECUIRE EXTRAPOLATION FROM THE AVAILABLE DATA BASE/ WITH ALL THE INDIVIDUAL SUBJECTIVE DISTORTIONS INHERENT IN SUCH EXTRAPOLATION.' In THE CASE OF THE Delahey Clause., the flexibility of the regulator is ncn-existent; the statute incorporates the extrapolation;cf effects to man on the jasis of a zero exposure threshold for carcinogen response by animals. How SHOULD MEMBERS OF THE MEDICAL/ SCIENTIFIC/ TECHNICAL AND BUSINESS COMMUNITIES RELATE TO THESE LEGISLATIVE PRODUCTS? WHAT OPTIONS ARE AVAILABLE? WHAT HAS BEEN OUR ROLES TO DATE? FlRS.T/ LET JS EXAMINE THE NATURE OF THE REGULATORY ENABLING LEGISLATION AND THEN PROCEED TO THESE QUESTIONS. Most statutes have both general and specific provisions. The SPECIFIC PROVISIONS OF THE AcT LEA/E LITTLE FLEXIBILITY FOR THE AD MINISTRATOR. Again/ the Delaney Clause is an example of specifi CTSHAcity. The numerous consensus safety standards adopted by are ILLUSTRATIVE OF VERY SPECIFIC REGULATIONS. THERE ARE NUMEROUS OTHER EXAMPLES IN THE ACTS MENTIONED EARLIER. HOWEVER/ IT IS MORE i HER 0000921 7 COMMON FOR THE STATUTE TO LAY OUT.A BROAD DIRECTION FOR THE ADMIN~ ISTR/TION OF THE ACT AND TO CHARGE THOSE, WHO THROUGH APPOINTIVE OR CIVIL SERVICE QUALIFICATIONS ARI; ENTRUSTED TO ENFORCE THE STAT" ' UTE, TO CONSTRUCT DETAILED ADMINISTRATIVE DIRECTIVES FOR THE RE" GULA'ORY FORCE IN THE FIELD. EXAMPLES OF THIS APPROACH ARE THE RULES FOR STATIONARY SOURCE EMISSIONS TO THE ATMOSPHERE, WHICH THE m EPA . SSUES UNDER THE AUTHORITY OF THE CLEAN AlR A.CT. EPA SPECIFIES THE STANDARDS THAT WILL BE MET, THE MANNER OF TESTING THE STATION ARY SOURCE, AND THE REPORTING SCHEME FOR RESULTS OF SUCH TESTING. IN THE CASE OF THE OCCUPATIONAL SacETY AND HEALTH ACT, THE STAT UTE -STATES THAT STANDARDS MUST BE ADOPTED FOR THE WORKPLACE. A ' PROCEDURE IS PRESENTED FOR ARRIVING AT SUCH STANDARDS. THUS, THE Agency can form an advisory committee to gather information in pub lic hearings. Once a proposal is pramed by the Agency, with or without the aid of an advisory committee, there must be a public HEARING. A PUBLIC COMMENTARY PERIOD FOLLOWING THE PUBLIC HEARING IS REQUIRED. WlTHIN A SPECIFIED PERIOD OF TIME THE AGENCY MUST THEN PROMULGATE A FINAL STANDARD. THE EFFECTIVE DATE OF THE STANDARD HER 0000922 a IS SPECIFIED, USUALLY 90 OR 180\DAYS FOLLOWING THE PROMULGATION. With this procedure, the constraints of the Agency are that the STANDARD PROMULGATED MUST RELFECT THE PUBLIC RECORD GATHERED BO"H DURHG THE HEARING PROCESS AND THROUGH WRITTEN COMMENTARY TO THE # Agency. For those unhappy with the regulatory standards promul gated in this manner, recourse can be made to the Occupational Safety and Health Commission, which was established by the Occu pational Safety and Health Act. The Commission is composed of THREE INDIVIDUALS WHO RULE ON THE MERITS OF EACH CONTEST. If THE DECISION OF THE COMMISSION IS NOT SATISFACTORY TO THE REGULATEE, THEN THE CHALLENGE TO THE AGENCY AND THE REGULATORY COMMISSION DE CISION CAN BE ESCALATED TO THE.FEDERAL COURT OF APPEALS AND, IF _ NECESSARY, TO THE SUPREME COURT. THIS COURSE OF EVENTS DOES OCCUR. For example, the right of entry to the employer premises by OSHA INSPECTORS IS 3EING CHALLENGED UNDER THE BlLL OF RIGHTS RIGHT TO * PRIVACY AND NECESSITY FOR A SEARCH WARRANT. THIS CHALLENGE IS NOW BEFORE THE SUPREME COURT. In OTHER STATUTES, THE DIRECT ROUTE TO the Court of Appeals is more common. A result of the challenge to i HER 0000923 9 THE REGULATORS AGENCY IS USUALLY A STAY OF THE.REGULATION UNTIL SUCI TIME AS THE COURT RULES ON THE MERITS OF THE CASE. Within this framework of administrative procedures, where can THE MEMBERS OF THE SCIENTIFIC, MEDICAL AND BUSINESS COMMUNITIES CONTRIBUTE OR, IF NECESSARY, INTRUDE? THE VERY FIRST STAGE OF IN VOLVEMENT IS AT THE ADVISORY LEVEL. THE ENVIRONMENTAL PROTECTION ' Agefcy has a Science Advisory Board which rtfers to the Administra tor MATTERS OF SCIENTIFIC CONCERN THE ADMINISTRATOR MAY ALSO RE FER to the Board matters for investigation. Many of the agencies PERFORM THEIR OWN RESEARCH. EPA HAS A VERY EXTENSIVE RESEARCH PRO GRAM, BUDGETED IN THE NEIGHBORHOOD OF $60~70 MILLION A YEAR. THE Occupational Safety and Health Administration is serviced by the - National Institute of Occupational Safety and Health cor its re Msearch; the ine Enforcement Safety Agency is serviced in its re search by the Bureau of Mines. Certain agencies conduct their own FDA,research, such as In general, the National Institutes of Health service a wide variety of agencies. Much of the research is performed through contractural mechanisms with qualified invest igators outside of government. The opportunity for the introduction .......................................... -.... -- ------------ ---------- --- ~ -------- HER 0000924 10 OF 1-ATA INTO THE DIALOGUE IS MA.INLY THROUGH THE MECHANISM OF RE~ SEAF CH, BUT IN THE REGULATORY AREAS THAT WE ARE DISCUSSING HERE THE RESEARCH HAS NOTORIOUSLY LAGGED THE MONJMENTAL NEEDS FOR DATA, AN ILLUSTRATION OF THE INADEQUACY OF CJRRENT KNOWLEDGE RE" # LATFS TO THE MORE THAN .10,000 PAGES OF PUBLIC RECORD ACCUMULATED PR ICR TO PROMULGATION BY OSHA OF A STANDARD FOR WORKP-ACE EXPOS URE TO COKE OVEN EMISSIONS. THE AVAILABLE DATA PROVIDED AN IN ADEQUATE DOSE-RESPONSE CURVE FOR COKE OVEN EMISSIONS; BY DOSE" RESPONSE CURVE I MEAN WHAT QUANTITY OF EMISSIONS INHALED FOR WHAT PER!OD OF TIME WOULD CAUSE WHAT INCIDENCE OF LUNG CANCER IN THOSE exposed? Furthermore, the specific agent causing the cancer was ' UNKNOWN; A SURROGATE MEASURE QF THE ACTIVE AGENT WAS SELECTED AS THAT WHICH HAD TO BE MONITORED TO BE SURE THAT COKE OVEN EMISSIONS WERE NOT EXCESSIVE. THE OTHER ASPECT OF THE COKE OVEN STANDARD THAT REQUIRED SCIENTIFIC AND TECHNOLOGICAL INPUT WAS THE SPECIFI CATION OF ENGINEERING CONTROLS FOR COKE OVENS. THE AGENCY' INCLUDED IN THE STANDARD VERY SPECIFIC CONTROLS WHICH WOULD HAVE TO BE IN STALLED BY CERTAIN FUTURE DATES. ALL OF THESE ABOVE MATTERS DREW HER 0000925 11 EXTENSIVE COMMENT FROM THE PUBLIC AND FROM "HE SCIENTIFIC AND EN GINEERING COMMUNITIES. THE FINAL STANDARD WAS PROMULGATED AND OCCUPIED APPROXIMATELY THREE TO FCOJR PAGES' !N THE FEDERAL REGISTER, BUT ABOUT FORTY PAGES WERE DEVOTED TO EXPLA MING, ON THE BASIS OF f THE PUBLIC RECORD, THE REASONS FOF: INCLUSION OF ITEMS IN THE ADOPTED STANDARD ON THE BASIS OF l.ESSrTHAN-COMPLETE DATA. 9 ' OSHAIn MANY CASES, THE procedures are not followed by regula tory AGENCIES. IN MANY REGULATIONS THERE IS NO PROVISION FOR PUB LIC HEARING OR OTHER ADMINISTRATIVE PROCEDURES THAT WOULD BRING' RULEMAKING INTO THE PUBLIC DOMAIN. In THESE CASES, WHEN A RULE APPEARS IN THE FEDERAL REGISTER, !T IS A FI ML REGULATION ADOPTED * by. the Agency. According to BUSINESS WEEK, about 72,000 Federal Register pages of regulations appeared in 1075, increased from 54,COO in 1970. The submission of data and arguments by the sci entific COMMUNITY AND OTHERS HAS, HOPEFULLY, OCCURRED DURING THE PERIOD PRECEDING ADOPTION OF THE REGULATION, AT LEAST BY CONSULT ANTS AND ADVISORY COMMITTEES. ALL ADVISORY COMMITTEE MEETINGS ARE NOW OPEN TO THE PUBLIC AND THERE ARE, CERTAINLY IN THE CASE OF EN VIRONMENTAL REGULATIONS, PUBLIC INTEREST GROUPS PRESENT. . her 0000926 12 The SEPARATION OF FACT FROM. OPINION IN THE OFFERING OF AD VICE IS CRUCIAL. IT WAS MY EXPERIENCE THAT SOME VERY REPUTABLE CONSULTANTS WOULD OFTEN CONFUSE THESE TWO MATTERS AND NOT DOCU" MEN! THEIR OPINIONS. ARE VERY IMPRESSIVE. 4 OFTEN, THE CREDENTIALS OF SUCH INDIVIDUALS 0 The INFORMED PUBLIC A>JD EVEN THE REASONABLY WELL INFORMED AGENCY MEMBERS ARE CONFUSED B( THEIR TESTIMONY OR THE INTENT OF THE TESTIMONY, WHEN FACT AND OPINION ARE NOT SEPAR ATED OR APPROPRIATELY REFERENCED. Another facet of the presentation of s:ientific testimony as PART OF THE REGULATORY PROCESS IN THE UNITED STATES IS THAT THE SAME PERSONS TEND TO ACT IN THE PROCEEDINGS. THERE IS A SMALL CADRE OF THE SCIENTIFIC COMMUNITY WHO ARE DEEPLY INVOuVED IN PUB LIC POLICY AND THEIR NAMES TEND TO APPEAR OVER AND OVER AGAIN. The vast majority of the scientifec and tec inical community are . not involved. This is unfortunate. It appears to me that facts WILL OUT BY ONE MEANS OR ANOTHER. We HAVE ALL OBSERVED TOO MANY CASES WHERE RELUCTANT OR LATE DIVULGEMENT HAS LEAD TO MORE PROB/ LEMS FOR PRIVATE SECTOR COMPANIES THAN THE INFORMATION ITSELF. ' \ cgw`;`i.r,.yw5. - an . .n.j u iuuite.'irT,nw i HER 0000927 ......... '.f l 13 The public is very sensitive tomfe good citizen role of private CORPORATIONS. SECRECY OF INVOL'VEFENTS AND DATA CAN, I BELIEVE, ONLY HARM THE IMAGE AND THE REALITY OF CORPORATIONS AMD THEIR BE HAVIOR. . IT IS APPROPRIATE THAT WE ALSO NOTE THE'. ROLE OF THE LEGAL PROFESSION VIS-A-VIS THE SCIENTIFIC COMMUNITY IN REGULATORY AC~ TI ON3. The INTRODUCTION OF SO MANY STATUTE.1 BRINGS THE LEGAL PROFESSION VERY MUCH INTO THE PICTURE. EARLIER WE NOTED THAT THE DCCUPATIONAL SAFETY-AND HEALTH ADMINISTRATION NOW EMPLOYS APPROXIMATELY 2,700 PERSONS; APPROXIMATELY 250 OF THESE ARE LAW YERS. OF THE ONE HUNDRED THOUSAND CITATIONS FOR VIOLATIONS OF STANDARDS ISSUED BY THAT AGENCY DURING 1975 IN ITS REGULATORY FUNCTIONS, SOME SIX THOUSAND WERE CONTESTED- LAWYERS ARE VERY INVOLVED IN RESOLUTION OF SCIENTIFIC AND TECHNICAL ISSUES. As AN EXAMPLE, A MAJOR CASE IN OSHA LEGAL HISTORY WAS THE RELEVANCE '^ OF AIR AND BIOLOGICAL SAMPLING TO THE ESTABLISHMENT OF BODY BUR DENS OF LEAD. THE PROCEEDINGS OF THAT CONTEST OF CITATION READS LIKE A TOXICOLOGY-PHYSIOLOGY TEXTBOOK. THE COMPLEXITY OF MANY HER 0000928 CASE!- PLACES EXTREME BURDENS ON \TH! LEGAL COMMUNITY/ AND AN ADDED BURDEN ON THE SCIENTIFIC-TECHNICAL COMMUNITY/ TO ADOPT A COMMON LANGUAGE UNDERSTANDABLE TO BOTH. [T WAS MY EXPERIENCE THAT MANY OF TIE SOLICITORS IN THE OCCUPATIONAL SAFETY AND HEALTH AGENCY WERE VERY WELL VERSED IN SCIENTIFIC AND TECHNICAL MATTERS. IN DEED. ON SOME SUBJECTS SOME WERE BETTER VERSED THAN THEIR TECHNI CAL COUNTERPARTS IN THE AGENCY. THE SCIENTIST OR ENGINEER/ IN TURN. WAS VERY FAMILIAR WITH THE LEGAL PROCEDURES NECESSARY UNDER THE STATUTE AND WAS OFTEN CALLED U3ON TO APPEAR IN VARIOUS CON TEST". AND HEARINGS INVOLVING THE A.3ENCY, FOR THE TECHNOLOGISTSCIENTIST/ THE OVER-LAY OF FAMILIARITY WITH THE ROLE OF THE COURTS AND THE LEGAL PROFESSION IN THESE REGULATIONS IS A NECESSITY. ON THE OTHER HAND/ THERE ARE THOSE WHO BELIEVE THAT THE LEGAL PROFESSION IS TOO DEEPLY INVOLVED IN THESE MATTERS. CERTAINLY THE ENTRY OF THE LEGAL PROFESSION INTO THESE FIELDS HAS CAUSED SOME CUMBERSOME PROCEDURES WHICH INEVITABLY LEAD TO DELAY/ BUT LET US NOT FORGETTHAT THIS HAS ALSO CLARIFIED MANY ISSUES AND HAS/ IN NO UNCERTAIN TERMS/ INDICATED THE SERIOUS INTENT OF THE REGULATORY HER 0000929 * 15 AGENCIES TO BRING ABOUT SOCIETALr CHANGES IN THESE FIELDS. AND MOST IMPORTANT/ DUE PROCESS OF LAW HAS BEEN ASSURED TO ALL IN VOLVED. '` . With regard to this, perhaps the most important role of the i SCIENTIFIC-TECHNICAL-BUSINESS COMMUNITIES, THE PROVISION OF DATA AND PRESENTATION OF TESTIMONY, SOME! WORDS OF JOHN GARDNER IN HIS ' book, NO EASY VICTORIES,.are particularly pertinent. "We have all seen men with lots of bright ideas but no patience with the machinery by WHICH ideas are trans lated INTO ACTION. As A RULE, THE MACH NERY DEFEATS THEM. IT IS A PITY, BECAUSE THE PROFESSIONAL AND ACA DEMIC MAN CAN PLAY A USEFUL ROLE IN PRACTICAL AFFAIRS. HBut too often he is a dilettante. e d:ps in here or there; he gives bits of advice on a dozen fronts; he . never gets his hands dirty working with one piece of THE SOCIAL MACHINERY UNTIL HE KNOWS IT WELL. He WILL NOT TAKE THE TIME TO UNDERSTAND THE SOCIAL INSTITUTIONS AND PROCESSES BY WHICH CHANGE IS ACCOMPLISHED." And again: - "The curse of the citizen action is the glancing blow-- i A LITTLE WORK ON THIS COMMITTEE AND ON TO THE NEXT ONE; A LITTLE WORK ONTHAT COMMITTEE AND ON TO SOMETHING ELSE... NEVER GETTING FAR ENOUGH BELOW THE SURFACE TO UNDERSTAND HER 0000930 i.0 HOW THE MACHINERY WORKS Iff WHATEVER ACTIVITY HE IS TRYING TO CHANGE; JUST LINGERING LONG ENOUGH TO SIGN THE COM MITTEE REPORT, NOT STAYING LONG ENOUGH TO SEE WHAT THE . CONSEQUENCES OF THE REPORT ARE." ' There are other major provisions of regulations which should AFFECT BEHAVICR OF RESPONSIBLE MANAGERS. THUS, THERE ARE NOT ONL^ CIVIL PENALTIES IN THE OSHA AND THE TOXIC SUBSTANCES CONTROL Act, there are criminal penalties, including jail sentencing WHERE WILLFUL VIOLATIONS CAN BE DEMONSTRATED. MANY STATUTES ALSC HAVE PROVISIONS FOR CITIZEN SUITS AGAINST THOSE ADMINISTER ING the Acts at the Federal level. . How SHOULD THE MEDICAL PROFESSION RESPOND TO THESE EXTENSIVE REQUIREMENTS OF FEDERAL LEGISLATION? FlRST, YOU SHOULD RECOGNIZE, BECAUSE THOSE IN GOVERNMENT ARE COMING TO RECOGNIZE, THAT THE PRI VATE SECTOR KNOWS MORE ABOUT ITS AFFAIRS THAN MEMBERS OF THE GOVERNMENT WILL EVER KNOW. FEDERAL REGULATORY EFFORT IS DEPENDENT ON THE KNOWLEDGE CONTRIBUTED BY THE REGULATEE. YOU KNOW MORE ABOUT FEASIBLE MEDICAL PRACTICES IN THE INDUSTRY YOU ARE INVOLVED WITH THAN OSHA KNOWS. THOSE IN OSHA ARE TRYING TO MEET THEIR RESPONSI BILITIES UNDER THE ACT AND THEY WILL DO THE BEST THEY CAN. HOW DO HER 0000931 17 YOU KISH TO BE REGULATED? THE O'NLY HOPE FOR FEASIBLE REGULATIONS ' IS FCR VOLUNTEERING OF INFORMATION ON YOUR PART. , GET THE TYPE OF REGULATION YOU HELF' TO SHAPE In GENERAL, YOU As YOU MAY KNOW,, OSHA STANDARDS REQUIREMENTS INCLUDE RECORD" KEEPING, MONITORING, SPECIFIC ENGINEERING CONTROLS AND A HOST OF WORK PRACTICES, INCLUDING PROTECTIVE CLOTHING AND EQUIPMENT, JOB # ROTATION IN REGULATED AREAS, HYGIENIC FACILI"IES, LABELLING, AND . MEDICAL SURVEILLANCE. TRAINING AND EDUCATION REQUIREMENTS ARE ALSO USUALLY INCLUDED. LARGE- NUMBERS OF SPECIFIC STANDARDS DEALING WITH INDIVIDUAL CHEMICALS ARE PROJECTED FOR "HE FUTURE, THERE IS ALSO A DEVELOPMENTAL EFFORT DIRECTED AT GENERIC STANDARDS, STAN DARDS THAT CUT ACROSS INDIVIDUAL COMPOUNDS. THE MOST RECENT ILLU" _ STRATI ON OF THIS APPROACH IS THE GENERIC STANDARD ENTITLED "IDEN TIFICATION, Classification and Regulation of Carcinogens". Under Toxicthe Substances Control Act the private sector will be required ' ,^ TO PROVIDE INFORMATION ON THE INDIVIDUAL CHEMICALS USED BY EACH FIRM. The government will require the "chemical identity, production levels USES, BY-PRODUCTS, ANY HEALTH AND SAFETY STUDIES, ALLEGED ADVERSE HER 0000932 18 REACTIONS, AND OTHER FACTORS OF 'ENVIRONMENTAL SIGNIFICANCE." ALL TESTING OF NEW PRODUCTS WILL BE PERFORMED BY THE PRIVATE SECTOR WITH INFORMATION PROVIDED TO THE GOVERNMENT; < OSHAThe medical requirements under standards differ for many SUBSTANCES REGtLATED. I HAVE BROUGHT ALONG A SUMMARY DOCUMENT BY Mr. Furr, of Westinghouse Corporation in Pittsburgh, which indica TES ALL CURRENT REQUIREMENTS UNDER THE STANDARDS. It SHOULD BE NOTEI THAT THIS ADMINISTRATION HAS CONTINUED THE STRESS ON HEALTH ASPECTS OF OSHP CONCERNS RATHER THAN SAFETY ASPECTS. !)r. EuLA BlNGhAM HAS COMMITTED HERSELF TO CONTINUING THE INCREASED ATTENTION TO HEALTH HAZARDS IN THE WORK ENVIRONMENT BY INCREASING THE NUMBER OF HYGIENISTS IN THE AGENCY AND THE NUMBER Oc HEALTH STANDARDS PRO MULGATED. D .Most recently. r Bingham has indicated that standards FOR COTTON DUST, BERYLLIUM, BENZENE, ARSENIC, NICKEL AND LEAD WILL BE PROMULGATED BY THE END OF 1977. BECAUSE OF THE REQUIREMENTS OF THE STANDARDS AND THE THIRD PARTY LIABILITY POSSIBILITIES, IT IS NECESSARY TO SET UP A MAJOR DATA KEEPING FACILITY IN EACH COMPANY. IT WILL BE NECESSARY IN THE FUTURE TO HAVE READILY AVAILABLE RECORDS HER 0000933 19 OF PERSONNEL EXF'OSURE TO CHEMICALS. It WOULD BE A MISTAKE AT THIS TIME "0 THINK THAT THE "HEAT IS GOING TO DECREASE". It IS NOT. The- heat in this field is going to increase; There are certain immed.ate steps that the private se:tor and the medical profess ION C/vN TAKE TO ENSURE THAT REGULATORY ACTIVITY IN THE FUTURE IS WELL HASED. I WOULD LIKE TO REVIEW THESE. 4 . 1. There must be corporate coordinate and professional man Ipower in this field. During my tenure at OSHA addressed the Presidents and Vice-Presidents of the Petroleum Refining Associ 200 Iation., approximately men and women. asked how many had ever met or taken part in the hiring of the industrial hygienist OR SAFETY PROFESSIONAL IN THEIR-FIRM. APPROXIMATELY THREE HANDS WERE RAISED. I THEN ASKED HOW MANY HAD MET CR TAKEN PART IN THE HIRING OF THEIR CHIEF DESIGNER. VIRTUALLY EVERY HAND IN THE AU DIENCE WENT UP. The AUDIENCE DID NOT REALIZE THAT THE HEALTH AND SAFETY PERSONNEL IN THEIR ORGANIZATION IS A CRITICAL MEMBER OF THE COMPANY AND THAT THEIR FUTURE LIABILITY IS VERY MUCH DEPENDENT ON THE EFFORTS OF THAT INDIVIDUAL. THE PRIVATE SECTOR MUST PLAN FOR J HER 0000934 20 TESTING FACILITIES OR MUST MAKE'INSTITUTIONAL ARRANGEMENTS FOR UTI LIZATION OF THE TESTING FACILITIES OF OTHERS FOR CHEMICALS. HOPE FULLY, THIS WILL BE DONE ON AN ASSOCIATION V/IDE BASIS SO THAT AN INDIVIDUAL FIRM IS NOT RESPONSIBLE FOR THE "OTAL COST BURDEN. Do i. YOU, AS PHYSICIANS, KNOW THE CHEMICALS THAT ARE USED IN THE FACIL ITIES THAT YOU ARE EXAMINING MEN TO WORK IN Do YOU KNOW THE PO~ TENTIAL OF THESE CHEMICALS FOR CAUSING HARM? MANY OF THEM ARE MARKETED UNDER TRADE NAMES. ARE YOU AWARE OF THEIR INGREDIENTS? 2. Because of the'above questions, each firm must review its PROCEDURES IN HANDLING, LABELLING., MONITORING, SURVEILLANCE, ETC., OF THE CHEMICALS IN ITS INVENTORY. It MUST JUDGE THE ADEQUACY OF CURRENT PROCEDURES AND MOVE TO' IMPROVE PROCEDURES WHERE THEY ARE - INADEQUATE. If PERSONNEL ARE NOT IN HOUSE TO DO THIS, THEN SUCH SKILLED PERSONNEL MUST BE HIRED FFOM FIRMS PROVIDING THIS SERVICE YOU, AS THE PHYSICIANS CHARGED WITH THE HEALTH OF THE PEOPLE IN . THE INDUSTRY, MUST APPLY THE PRESSURE TO MANAGEMENT TO DO THIS. _ 3. The toxicological data in hand with regard to the chemi cals UTILIZED MUST BE REVIEWED. YOU ARE KEY PERSONS IN THIS RE VIEW PROCEDURE. HER 0000935 21 4. Do YDU HAVE CLOSE TIES OR ASSOCIATIONS WITH YOUR COUNTER PARTS IN OTHER PLANTS? Or DO YOU OPERATE ALONE? I DO NOT KNOVf THE PROCEDURES FOR SHARING OF KNOWLEDGE IN YOUR GROUP, BUT IT IS ESSENTIAL TO ESTABLISH SUCH PROCEDURES. ` 5. Establishment of recordkeeping and data storage. I re fer TO THIS ACTIVITY AS "DOCUMENTING THE NEGATIVE". ?RIOR TO THE - ADVEiNT OF ALL THIS REGULATION, THE PRIVATE SECTOR USED TO DOCUMENT POSITIVE CASES--CASES WHERE PEOPLE WERE HURT. TODAY IT IS NECES- SAR\ TO DOCUMENT THE NEGATIVE, TO INDICATE IN YOUR RECORDS THAT YOU! FACILITIES DID, INDEED, ADHERE TO ALL CURRENT STANDARDS AND REGULATIONS. If PERSONS ARE INJURED IN THE FUTURE AND THEY HAVE AT ONE TIME OR ANOTHER BEEN EXPOSED TO POTENTIALLY HAZARDOUS CON- . DITIONS IN YOUR FACILITY, THERE IS A HIGH PROBABILITY THAT THEY WILL ATTEMPT TO RELATE THEIR MEDICAL CONDITION TO THA** EXPOSURE. Only by documenting the negative can you avoid the associated lia BILITY. 6. Education of management personnel is crucial. This edu cational process must include the technical expert, as well as HER 0000936 22 SENIOR MANAGEMENT PERSONNEL. MANY FIRST LINE MANAGERS ARE UNAWARE OF THE RAMIFICATIONS OF THE REGULATIONS FOP THEIR JOES AND THE:R COM3ANIES. T-IEY ARE STILL LIVING EXCLUSIVELY IN THE WORLD OF PRO" ** DUCflON LINE CHECKPOINTS AT CERTAIN HOURS CF THE DAY, CHECKS OF * VOLJME PRODUCTION, QUALITY CONTROL OF PRODLCTS, ETC. THEY HAVE NOT BUILT INT3 THEIR AUTOMATIC REFLEXES THE HEALTH AND SAFETY AS PECTS OF THE ENVIRONMENT, ASPECTS AS IMPORTANT AS THE FORMER PRO DUCTION concerns. Health and safety must ee made a line management RESPONSIBILITY. It IS-A WAY OF DOING BUSINESS THAT IS WHAT THE RE GULATORY EFFORT IS ALL ABOUT. 7. IReview of medical surveillance prccedures. t is neces sary FOR MANAGEMENT TO APPRISE ITSELF OF THE ADEQUACY OF MEDICAL . SURVEILLANCE PROCEDURES,. THESE PROCEDURES ARE NOT ABSTRUSE AND DIFFICULT TO COMPREHEND. ARE YOU, AS PHYSICIANS, EXPLOITING THE MYSTIQUE OF MEDICINE? If SO, IT IS INAPPROPRIATE. f'lOST SENIOR ** MANAGEMENT PERSONNEL ARE FULLY CAPABLE OF UNDERSTANDING MEDICAL TERMINOLOGY AND THE TESTS THAT SHOULD BE PERFORMED AND THE RESULTS OBTAINED THEREFROM. It IS THE OBLIGATION OF MEDICAL SPECIALISTS . HER 0000937 23 TO MAKE THEIR WORK UNDERSTANDABLE TO THE MANAGER. IT IS ONLY TOO _ COMMON TO HAVE SENIOR MANAGEMENT PERSONNEL ASSIGN ALL RESPONSIBI- * , LITY TO THE PHYSICIAN AND NOT EVEN QUERY THE PHYSICIAN ON PROCED- URES AND RESUL"S. We COJLD FURTHER DISCUSS SPECIFIC CASES OF HOW . .I THIS HAS CAUSED MAJOR PROBLEMS TO 3USINE$S MANAGERS. Finally, are you, as an occupational physician, thinking pre ventive MEDICINE? Or are YOU IN YDUR PART-TIME RESPONSIBILITIES IN Ail INDUSTRIAL FACILITY PRACTICIMG CURATIVE OR HEROld MEDICINE? OUR MEDICAL SCHOOLS ARE STILL ORIENTED TOWARDS CURATIVE MEDICINE, BUT OCCUPATIONAL HEALTH IS A BRANCH OF PREVENTIVE MEDICINE. YOU ARE PERHAPS THE MOST IMPORTANT PERSON IN THE OCCUPATIONAL HEALTH AND SAFETY TEAM TO GIVE WEIGHT TO PREVENTIVE MEASURES IN THE FAC" . ILITY. Are YOU STILL IN THE MINDS OF THOSE IN THE PLANT, THE "DOC" THAT WILL ASSIST THEM WHEN THEY GET HURT? If THEY THINK OF YOU THAT WAY, YOU ARE NOT FULFILLING THE ROLE OF AN OCCUPATIONAL HEALTH 9 physician. Unfortunately, the profession of occupational medicine A A is under a cloud. recent code of ethics was adopted by the m erican Association of Occupational Medicine. There are charges of ' HER 0000938 THE ALLEGIANCE OF PHYSICIANS TO THEIR COMPANIES AND NOT TO THEIR CL I ENTS, THE WORKERS. ALL OF THESE CONFLICTS FACE YOU AS YOU PURSUE YOUR PROFESSIONAL ROLE. I CANNOT OVER.STRESS THE IMPOR- ' TANCE OF THAT ROLE NOR THE NEED FOR YOU TO EXAMINE IN DEPTH THE 9 WAY IN WHI.CH YOU ARE RISING TO THE DEMANDS OF THE AMERICAN WORK PLACE--DEMANDS REFLECTED-IN THE REGULATIONS WE HAVE DISCUSSED. HER 0000939