Document NeB0YB9OXYaJbdXXYJVxZndZb

DRAFT #1 1/28/80 COMPANY ANNOUNCED THAT THE PLANT PHYSICIAN KY PVC PLANT HAD IDENTIFIED THREE CASES OF LIVER CANCER 'y.. EMPLOYEES. THE COMPANY SAID IT SUSPECTED THAT VINYL T BE IMPLICATED IN THE TjjgEE. DEATHS. BFG TRIGGERED ON^.0F TORY OF OCCUPATIONAL HEALfll^^^KAME THE TOPIC INE AND NEWSPAPER ARTICLES, TELEVISION SPECIALS, AND ES. VCM HAS BECOME ONE T)F THE MOST STUDIED STANDPOINT. YOU SOME CONCEPTS OF TOXICOLOGY IN GENERAL, IFICS REGARDING VINYL CHLORIDE AND POLYVINYL CHLORIDE ANSWER ANY QUESTIONS YOU MIGHT HAVE. ICED QUESTIONS LIKE "WILL THIS STUFF HURT YOU" AND I 0RTA8LE BECAUSE I KNOW THE PERSON ASKING THE QUESTION IS ANSWER: YES OR NO. BUT THAT'S A QUESTION WITHOUT YOU CAN SAY NO, IF OR YOU CAN SAY YES, BUT AND 20 MINUTES QUALIFYING YOUR ANSWER. BUT THERE ARE GOOD )R SOUNDING EVASIVE WHEN YOU TRY TO ANSWER SUCH A QUESTION. SO ... BEFORE WE START TALKING SPECIFICALLY ABOUT VCM & PVC I'D LIKE TO GIVE YOU A SHORT COURSE IN TOXICOLOGY SO THAT YOU'LL UNDERSTAND WHY ANSWERS MUST BE COMPLEX. TOXICOLOGY TOXICOLOGY BEGAN, AS YOU MIGHT SUSPECT, AS THE STUDY 0F_POISONS. AS A MATTER OF FACT, THE ROOT WORD TOXON - REFERS TO BOWS & ARROWS. MEM-20207? J-? A~- A ,, TOXIKON - \rfsON ARROW - /STUDY OF BOWS & ARROWS EST PRACTITIONERS OF TOXICOLOGY ( IN THE 16TH CENTURY) TUS VON HOHENHEIM (ALIAS PARACELSUS). HE IS LEAST) FOR HIS RECOGNITION THAT ... "ALL SUBSTANCES HONE WHICH IS NOT A POISON, j&fc RIGHT DOSE AND A REMEDY." ^ *4.. Stating that, as explained^ ^ofessor-oiil mrak ONCERNING THE SAFETY OF PESTICIDE NO HARMLESS SUBSTANCES; THERE ARE ONLY HARMLESS ALL OF THIS LEADS US TO A BASIC PREMISE OF THRESHOLD. E A RESPONSE (E.G. TOXICITY, IRRITATION, AT SOME LEVEL. BUT, A LEVEL JX^TS FOR ALL ^RESPONSE HAY-BE-EXPECTEPT ON WATER ^ '/ V WORKING TOWARD HERE IS THE CONCEPT OF DOSE - PROBABLY THE CONCEPT IN TOXICOLOGY BY THOSE NOT TRAINED IN THE FIELD. OOSE IS THE AMOUNT OF MATERIAL REQUIRED TO PRODUCE THE DESIRED AFFECT. \ I. WHEN YOUR DR. TELLS YOU TO TAKE TWO ASPIRIN & GO TO BED, HE HAS A ' REASON. IF HE TOLD YOU TO CRUMBLE ONE ASPIRIN & TAKE JUST A PINCH OF THE ; <;V POWDER, IT WOULDN'T CURE YOUR HEADACHE. IF HE TOLD YOU TO TAKE THREE BOTTLES OF ASPIRIN, IT MIGHT HAVE DRASTIC EFFECTS. ^-202080 ------" SO IT MAKES SENSE THAT AS YOU INCREASE THE DOSE YOU INCREASE THE RESPONSE ... THIS ALL LEADS US TO THE DOSE/RESP^NSE CURVE y) A * X \- 1 \T-\ V fy'y < I*K* /-- -V- ON BOARD) FOR OTHER RESPONSES EFFECTS --H2O LEAD CHROMATE EFFECTS ;RIBE: EXAMPLE OF ALCOHOL OPSET/-STOMACH NAUSEA / BALANCE CNS DEPESSANT) TOXICITY HAZARD INCREASED AGING ADDICTION^) i INHERENT PROPERTY OF THE COMPOUND LD_50, CATALOG OF ADVERSE EFFEcfs ^ ^ LIKELIHOOD OF EXPOSURE IS^ONSIDERE^CEXAMPLE: BLOCK OF LEAD, N2) LIKE MANY SUBSTANCES, VCM HAS BEEN KNOWN FOR YEARS TO HAVE SOME TOXIC PROPERTIES. BUT PRIOR TO 1974 IT WAS CONSIDERED TO BE A RATHER INNOCUOUS CHEMICAL. IT WAS KNOWN AT EXTREMELY HIGH CONCENTRATIONS TO BE AM ANESTHETIC, IN FACT IT WAS ACTUALLY USED AS AN ANESTHETIC FOR A WHILE. THE FIRST INKLING OF A POTENTIAL CHRONIC PROBLEM WAS A 1949 STUDY OF WORKERS IN A RUSSIAN PLANT. HEPATITUS WAS SEEN. BUT IT WAS CONCLUDED THAT A PCBELASTIC IZER WAS PROBABLY THE CULPRIT. . _4>lV ^EV-202081 * B&IHE DOW CHEMICAL COMPANY ON LABORATORY ANIMALS ' mm AT 100 PPM BUT A SIMILAR STUDY AT YALE FOUND THERE WAS A RECOMMENDED STANDARD DEVELOPED BY A 500 PPM FOR WORKER EXPOSURE. WHEN THE OSHACT WAS ENSUS STANDARD WAS ADOPTEofilllH^teTO LAW. #ER MILLION.) W DISEASE OF THE BONES OF THE FINGERS CALLED YC DISCOVERED AMONG SOME HEAVILY EXPOSED^REACTOR CLEANERS. IGGERED RESEARCH PROJECTS IN BOTH THE UNITED STATES MPT TO DISCOVER THE EXACT CAUSE OF THE DISEASE. fVC PRODUCER, REPORTED AT THE 10TH INTERNATIONAL IN MAY 1970 THAT HE HAD BEEN ABLE TO PRODUCE IN TEST ANIMALS AT EXTREMELY HIGH LEVELS PPM) OF VCM EXPOSURE. DR. VIOLA'S FINDINGS WERE PUBLISHED IN THE JOURNAL OF CANCER RESEARCH IN 1971. llftWSTRY BEGAN PLANS FOR MORE EXTENSIVE ANIMAL STUDIES AT / EXPOSURE MORE LIKELY TO BE ENCOUNTERED IN ACTUAL PLANT SITUATIONS. tOSiCAL STUDIES OF PLANT WORKERS WERE ALSO PLANNED. AN ANIMAL INHALATION STUDY WAS CONDUCTED UNDER THE DIRECTION OF DR. CESARE MALTONI OF ITALY. IN THE UNITED STATES THE CHEMICALS MANUFACTURERS ASSOCIATION IN JUNE 1973 ANNOUNCED THAT 17 PVC PRODUCERS HAD AGREED TO SPONSOR A STUDY OF ALL CAUSES OF DEATHS IN VINYL CHLORIDE NCEXERS. IN FEBRUARY 1373 THE INDUSTRY ALSO CONTRACTED FOR LIFETIME CHRONIC INHALATION STUDIES USING TEST ANIMALS. SOME PRELIMINARY RESULTS OF DR. MALTONI'S STUDY BECAME AVAILABLE IN EARLY 1973. DR. MALTONI HAD DETECTED A VARIETY OF TUMORS IN TEST ANIMALS AT CONCENTRATIONS AS LOW AS 250 PPM. UEV-2Q2082 1974, B.F. GOODRICH NOTIFIED GOVERNMENT OFFICIALS TIKE ANGIOSARCOMA DEATHS. IAL "I^ACT-FINDING" HEARING HELD IN FEBRUARY 1974, OSHA Y TEMPORARY STANDARD WHICH LOWERED THE MAXIMUM VCM 500 PPM TO 50 PPM. , OSHA PROPOSED A PERMAN DARD WHICH EXPOSURE TO THE "NO REQUIRE SUITS AND SELF-CONTAINED BREATHING EQUIPMENT. N6S, UP TILL THEN THE LARGEST EVER HELD BY OSHA, BEGAN JURE 25. OSHS HEARD EVIDENCE PRESENTED BY REPRESENTATIVES OF INTEREST GROUPS, SCIENTISTS AND ENGINEERS. THE EVIDENCE, OSHA PUBLISHED A PERMANENT STANDARD OF 1 LE WORKER EXPOSURE WHICH WENT INTO EFFECT ON APRIL 1, IDE COST OF COMPLIANCE RAN BETWEEN $300 AND $400 MILLION XPENDATURES PLUS YEARLY OPERATING EXPENSES. THE CONOCO PVC HAS SPENT APPROXIMATELY ARD. TO REACH COMPLIANCE WITH 5TIGATI0NS AT THE SAME TIME THE OSHA STANDARDS WERE BEING HAMMERED OUT, THE ENVIRONMENTAL PROTECTION AGENCY (EPA) BEGAN INVESTIGATIONS INTO WHETHER VCM CONSTITUTED A HAZARD TO THE HEALTH OF PERSONS LIVING IN THE VICINITY OF PVC PLANTS. AN EPA TASK FORCE, ESTABLISHED IN FEBRUARY 1974, DETERMINED THAT THERE WAS "NO SCIENTIFIC EVIDENCE TO INDICATE THAT THESE(eMISSIONsFpOSE AN ^ IMMINENT HAZARD TO PEOPLE LIVING NEAR THESE PLANTS ..." 1 /'A NONETHELESS, THE EPA SAID IT WOULD PROPOSE REGULATIONS TO REDUCE VCM EMISSIONS DRASTICALLY FROM 1974 LEVELS. yeu-202s3 INTO VINYL CHLORIDE RESULTED IN THE PUBLICATION ON THE SUBJECT: (1) A. 67-PAGE PRELIMINARY AL PROBLEMS ASSOCIATED WITH VINYL CHLORIDE -- . &- SgSSNTlFIC AND TECHNICAL ASSESSMENT REPORT ON VINYL rL CHLORIDE -- JUNE 1975, (3) A QUANTITATIVE RISK- ^EXPOSURE TO VINYL CHLORIO^^^WER 1975, AND STANDARD SUPPORT AND IMPACT 1976, SpRED INTERESTED PARTIES THE OPPORTUNITY TO MEET DISCUSS PROPOSED METHOOS OF CONTROLLING VCM EMISSIONS. EXTENSIVE STUDY AND DISCUSSIONS, THE AGENCY pCEMBER 16, 1975, A STANDARD REGULATING EMISSIONS SITP^iE AMBIENT AIR. A PUBLIC HEARING WAS HELD IN ShciM RECORD OF THE AGENCY'S INVESTIGATION OF VINYL DOCUMENTS TOTALING SOME 9,000 PAGES. , AFTER MORE THAN TWO AND A HALF YEARS OF INTENSIVE fPA PROMULGATED NATIONAL EMISSION STANDARDS FOR VINYL CHLORIDE RESIN PLANTS. EPA STANDARDS REDUCED EMISSIONS BY APPROXIMATELY 95 PERCENT FROM J, ; 1974 LEVELS. THE STANDARDS WOULD THEORETICALLY REDUCE THESE EXPOSURE LEVELS FROM APPROXIMATELY 17 PPB (STOP AND DISCUSS PARTS PER BILLION) TO LESS THAN ONE PPB AS A YEARLY AVERAGE. BASED ON EPA'S OWN CALCULATIONS, THIS COULD RESULT AT A MAXIMUM IN APPROXIMATELY ONE CASE OF ANGIOSARCOMA EVERY TWO ,, , 'VYm V / YEARS AMONG THE FIVE MILLION PEOPLE LIVING IN THE VICINITY OF THESE PLANTS/ CONSIDERED THAT MORE THAN 80,000 OF THESE PEOPLE COULD BE~EXPECTED TO DIE FROM OTHER CAUSES DURING THAT SAME TWO-YEAR PERIOD, THE THEORETICAL ONE ANGIOSARCOMA CASE WAS CONSIDERED AN ACCEPTABLE RISK BY EPA. fSR-A MOMENT AND DISCUSS THAT TERM "ACCEPTABLE RISK". Understand that there is no such thing as zero ACTIVITIES FROM GETTING OUT OF BED, TO TAKING A SHOWER, `WfVQLVE SOME AMOUNT OF RISK. EVEN NOT GETTING OUT OF BED CONSCIOUSLY OR NOT, WE I|y CHOSING TO USe$E JUDGE THE RISKS TOwBHpBLE. LET ME ES OF SOME EVERYDAY RISKS THAT HAVE BEEN QUANTIFIED: ^DIVIDUAL RISK OF FATALITY 300 chances/million' 90 CMANCES/MILLION 40 CHANCES/MILLION / ^ 9 CHANCES/MILLION j > h CHANCE /MILLION 300$LCHANCES/MI LLI ON WfYl CHLORIDE vu JANCE /MILLION 70 VS 55 MPH 50 CHANCES/MILLION CAN ASSIGN MATHEMATICAL VALUES TO RISK, IT FOLLOWS THAT WE CAN CONiMNtlSKS WHICH ARE ROUGHLY EQUIVALENT. GETTING BACK TO THE SUBJECT AT HAND, PROFESSOR RICHARD WILSON OF HARVARD UNIVERSITY HAS CALCULATED THAT THE RISK OF LIVING WITHIN FIVE MILES OF A PVC PLANT FOR ONE YEAR IS EQUIVALENT TO THE RISK OF CONTRACTING CANCER FROM EATING 1/2 TABLESPOON OF PEANUT BUTTER, OR TO THE RISK OF CONTRACTING CANCER FROM THE INCREASED COSMIC RADIATION DURING A THREE-DAY VISIT TO DENVER, COLORADO, OR TO THE HAZARD FROM SMOKING 1/15TH OF A CIGARETTE. GETTING BACK ON TRACK ... IN NOVEMBER 1976 THE ENVIRONMENTAL DEFENSE FUND FILED SUIT IN THE COURT OF APPEALS IN WASHINGTON CHALLENGING THE EFFECTIVENESS OF THE STANDARD. yEV-202085 IN PRIVATE MEETINGS FROM WHICH THE \ ALTHOUGH AN EVENTUAL RULING BY THE COURT THAT m HAD A LEGITIMATE RIGHT TO INTERVENE IN THE S SECRET NEGOTIATIONS WAS A FORMAL AGREEMENT ON > tPA AND EOF TO PROPOSE EXISTING^ WHICH HAD BEEN PROHULGA AMENDMENTS WERE PUBLISH .1977 RECEIVED OR OBTAINED NO NEW MEDICAL OR TECHNICAL JUSTIFY ANY CHANGES IN THE STANDARD. READINGS PLUS SOPHISTICATED COMPUTER PROGRAMS, ORIGINAL EPA ESTIMATE OF 17 PPB OF VINYL EXPOSURE WITHIN FIVE MILES (NEAR) OF CHLORIDE INSTALLATIONS WAS FAR TOO HIGH. DETERMINED THAT MEAN VINYL CHLORIDE CONCENTRATIONS ON/ 2.5-4.5 PPB FOR EACH UNREGULATED PLANT ARE REDUCED TO /5 >" / IS ON THE ORDER OF 0.15-0.25 PPB WHEN IN COMPLIANCE WITH -x STANDARDS. SEVERAL EXPERTS HAVE VOICED OPINIONS REGARDING ACCEPTABLE AMBIENT / CONCENTRATIONS OF VINYL CHLORIDE. DR. CARLO TUMBURRO, DIRECTOR OF A , \ v' VC RESEARCH PROGRAM AT THE UNIVERSITY OF LOUISVILLE MEDICAL SCHOOL, DR. / "v CHARLES SHAW, CHIEF OF THE MEDICAL GENETICS SECTION OF MD ANDERSON AND ! DR. MITCHELL ZAVON, PROFESSOR OF INDUSTRIAL MEDICINE AT THE UNIVERSITY , j>>>rxsf b/ sT & OF CINCINNATI HAVE ALL STATED THAT CONCENTRATIONS OF VC ON-THE ORDER OF^ 10 PPB SHOULD BE SAFE FOR HUMAN EXPOSURE. ONE LAST POINT: I MENTIONED THAT THE EPA ESTIMATED THAT AN AMBIENT LEVEL COMPLIANCE WITH ITS STANDARD COULD RESULT AT A MAXIMUM OF ONE CASE UEV-202086 mO YEARS IN AN EXPOSED POPULATION OF 5 MILLION. A VERY RARE FORM OF CANCER. THE NATIONAL WSR 78,000 DEATHS. OUT OF A POPULATION OF 5 MILLION DEATHS FROM ALL CAUSES IN TWO YEARS SO AN IOSARCOMA EVERY 2 YEARS IS NO MORE THAN WOULD A UEY-202087