Document KkZyoMdv7VJnr7zgeOMdvNvx

TECHNICAL INFORMATION COMMUNITY HEALTH EFFECTS OF VINYL CHLORIDE Prepared By: The Vinyl Institute Health, Safety tc Environment Committee Issued: August 1, 1986 ThU report has been prepared by the Health, Safety and Environment Committee of the Vinyl Institute as a service to its members and their eustomers and is based on literature informs* tioa believed to be accurate. No warranty or guaranty, expressed or implied, is made for the accuracy or completeness of the information provided herein and neither the Vinyl Institute nor its members or contributors assume any responsibility for the accuracy or completeness of the information contained in this document. The Vinyl Institute. A Division of The Society of the Plastics Industry. Inc. Wayne Interchange Plaza U. 755 Route 46 West, Wayne. New Jersey 07470. (201) 690-9299 AP00024771 I. SUMMARY THIS DOCUMENT REVIEWS THE TOXICITY AND HUMAN HEALTH EFFECTS OF ABIENT EXPOSURE TO VINYL CHLORIDE (VC), THE RAW MATERIAL USED IN THE PRODUCTION OF POLYVINYL CHLORIDE (PVC). IT SUMMARIZES THE EXTENSIVE AND RIGOROUS FEDERAL REGULATION OF THE VC/PVC INDUS TRY, AND COMPARES QUANTITATIVE RISK ASSESSMENTS WITH ACTUAL HEALTH OBSERVATIONS OF INDIVIDUALS IN NON-OCCUPATIONAL SETTINGS. A REVIEW OF THE WORLD SCIENTIFIC LITERATURE SHOWS NO COMMUNITY HEALTH IMPACTS ASSOCIATED WITH EXPOSURE TO VC EMISSIONS FROM VC/PVC MANUFACTURING FACILITIES. II. INTRODUCTION VINYL CHLORIDE IS THE BASIC BUILDING BLOCK FOR PRODUCING THE MOST VERSATILE PLASTIC YET DEVELOPED -- POLYVINYL CHLORIDE AND ITS COPOLYMERS WITH OTHER MONOMERS. MOST OF THE SEVEN BILLION POUNDS OF VC PRODUCED ANNUALLY IN THE UNITED STATES IS CONVERTED INTO PVC USED IN THOUSANDS OF PRODUCTS IN THE HOME AND IN INDUSTRY -- PRODUCTS SUCH AS WALLCOVERINGS, UPHOLSTERY, FLOOR ING, HOUSE SIDING, WATER PIPES, SEWER PIPES, LUGGAGE, CLOTHING, AUTOMOTIVE PARTS, AND MEDICAL DEVICES, FOOD WRAP, WINDOWS, DOORS AND WIRE INSULATION, GARDEN HOSES, AND PHONOGRAPH RECORDS. PVC IS A POLYMER PRODUCED FROM VC THROUGH A CHEMICAL REACTION CALLED POLYMERIZATION. VC IS CONVERTED INTO PVC BY SUSPENSION, EMULSION, BULK OR SOLUTION POLYMERIZATION METHODS. PVC RESINS CAN BE EXTRUDED, MOLDED OR CALENDARED INTO DIVERSE SHAPES, SIZES, AND COLORS. MECHANICAL CHARACTERISTICS CAN BE CONTROLLED TO PRODUCE FORMS THAT ARE RIGID, FLEXIBLE, OR IN A LIQUID FORM SUCH A LATEXES, PASTES AND ADHESIVES. VINYL CHLORIDE BECAME OF INDUSTRIAL IMPORTANCE APPROXIMATELY FIFTY YEARS AGO WHEN SEMON (1933) DISCOVERED THAT THE POLYMER COULD BE CONVERTED INTO USEFUL ARTICLES BY PLASTICIZATION WITH PHTHALATE ESTERS. COMMERCIAL DEVELOPMENT BEGAN FIRST IN EUROPE AND THEN IN THE UNITED STATES IN THE LATE 1930'S. IT WAS NOT UNTIL THE EARLY 1950'S THAT WIDESPREAD CONSUMER APPLICATIONS DEVELOPED. PVC IS NOW A MATURE PRODUCT, AND ITS GROWTH RATE FALLS IN STEP WITH THE GROSS NATIONAL PRODUCT. AP00024772 -2- III. HEALTH HISTORY ACUTE TOXICITY VINYL CHLORIDE IS A STRONG ANESTHETIC AT 8-12% IN ANIMALS AND HUMANS. DEATH FOLLOWS RAPIDLY AFTER UNCONSCIOUSNESS SETS IN IF EXPOSURE IS NOT REDUCED QUICKLY (PATTY ET AL., 1930). NO MAJOR HISTOLOGICAL CHANGES WERE REPORTED AFTER 100 DAYS AT EXPOSURES OF 50,000 PPM (KUEBLER, 1964). REVERSIBLE liver EFFECTS AT 100-500 PPM LED TO A RECOMMENDATION OF A 50 PPM TWA EXPOSURE LIMIT (TORKELSON, OYEN, AND ROWE, 1961), BUT THE AMERICAN CONFERENCE OF GOVERNMENTAL INDUSTRIAL HYGIENISTS ADOPTED INSTEAD A RECOMMENDATION BY YALE SCIENTISTS OF 500 PPM. THIS IS THE VALUE LATER ACCEPTED BY OSHA AND IT SERVED UNTIL 1974. LEHMAN AND FLURY (1943) TERMED VINYL CHLORIDE TO BE "ONE OF THE LEAST DANGEROUS OF THE CHLORINATED HYDROCARBONS". THERE ARE NO OTHER KNOWN ACUTE HUMAN PHYSIOLOGICAL EFFECTS FROM VINYL CHLORIDE EXPOSURE. THE ODOR THRESHOLD IS ABOUT 1,000 PPM. THE HIGH HEAT OF VAPORIZATION CAUSES A SUBSTANTIAL PART OF A LARGE SPILL TO LIQUIFY AND PRESENTS THE DANGER OF FROSTBITE. VINYL CHLORIDE IS FLAMMABLE OVER THE RANGE OF 3.6-33% IN AIR, AND EXTREME CARE MUST BE TAKEN TO AVOID SPILLS AND LEAKS FOR THAT REASONS. MOST MEASUREMENT AND WARNING SYSTEMS WERE DE SIGNED TO HOLD PLANT ATMOSPHERES BELOW THE FLAMMABLE LIMITS. RETROSPECTIVE ESTIMATES OF TYPICAL TIME-WEIGHTED AVERAGE PERSON AL EXPOSURES FOR POLYMERIZATION WORKERS IN ENGLAND HAVE BEEN ESTIMATED (BARNES, 1980) AS FOLLOWS: 1945 to 1955 1955 TO 1960 1960 to 1970 Mid 1973 1975 1,000 PPM (OR ABOVE) 400 to 500 300 TO 400 150 5 IN SOME JOBS, PARTICULARLY THE CLEANING OF POLYMERIZATION REACTORS, EXPOSURES IN THE THOUSANDS OF PPM RANGE WERE EXPERI ENCED FOR SHORT PERIODS. (SEE PURCHASE, ET AL, 1985 AND BARR, 1986 FOR REVIEWS OF THE TOXICITY OF VC). CHRONIC HEALTH EFFECTS THE FIRST CLEAR INDICATION OF CHRONIC HEALTH PROBLEMS ASSOCIATED WITH VC CAME IN THE 1960'S IN MEN WHO ENTERED VC POLYMERIZATION AP00024773 I -3- REACTORS TO REMOVE BUILD-UP OF POLYMER FROM THE WALLS. SOME OF THESE MEN DEVELOPED ACRO-OSTEOLYSISr A DISEASE RESULTING IN SOFTENING OF BONES IN THE FINGERS (SUCIU, ET AL, 1963; HARRIS AND ADAMS, 1967; COOK, ET AL 1981). MODIFICATION OF WORKING PRACTICES HAS LED TO THE ELIMINATION OF THIS DISEASE IN WORKERS IN PVC PLANTS. IN THE LATE 1960's, PROFESSOR P.L. VIOLA OF THE SOLVAY COMPANY TRIED TO REPRODUCE ACRO-OSTEOLYSIS IN RATS BY EXPOSING THEM TO HIGH CONCENTRATIONS OF VC FOR LONG PERIODS. HE FAILED TO PRODUCE ACRO-OSTEOLYSIS, BUT HE REPORTED AN INCREASE IN INCIDENCE OF A VARIETY OF TUMORS AT VARIOUS SITES. FOR THE FIRST TIME, IT HAD BEEN SUGGESTED THAT VC WAS AN ANIMAL CARCINOGEN. (VIOLA, 1960, 1970; VIOLA, BIGOTTI AND CAPUTO, 1971). AS A DIRECT RESULT OF THE VIOLA WORK, FOUR WEST EUROPEAN VC/PVC MANUFACTURING COMPANIES IN ITALY, FRANCE, BELGIUM AND ENGLAND SUPPORTED A COMPREHENSIVE STUDY OF THE ANIMAL TOXICOLOGY OF VC BY PROFESSOR C. MALTONI, DIRECTOR OF THE INSTITUTE OF ONCOLOGY AT BOLOGNA. MALTONI'S WORK WHICH EXTENDED OVER EIGHT YEARS HAS PROVED TO BE THE MOST COMPREHENSIVE STUDY OF VC TOXICOLOGY (MALTONI ET AL, 1984). BY THE END OF 1972, MALTONI HAD FOUND A RARE TUMOR, ANGIOSARCOMA OF THE LIVER (ASL) , IN SOME OF THE EXPOSED RATS AND CONFIRMED THAT VC IS INDEED AN ANIMAL CARCINOGEN. THESE EARLY FINDINGS WERE REPORTED AT AN INTERNA TIONAL SYMPOSIUM IN 1973 (MALTONI, 1977). MALTONI RECOMMENDED EPIDEMIOLOGICAL INVESTIGATIONS AND MEDICAL CONTROLS OF EXPOSED WORKERS AND EARLY IN 1974, A U.S. COMPANY ANNOUNCED THAT THEY HAD FOUND THREE ASL CASES IN EMPLOYEES AT ONE OF THEIR PVC POLYMERIZATION PLANTS. THIS FINDING LED TO THE CONCLUSION THAT VC WAS A HUMAN CARCINOGEN BECAUSE IT GAVE RISE TO A RARE TUMOR WHOSE ONLY OTHER KNOWN ETIOLOGICAL AGENTS IN MAN WERE THORIUM DIOXIDE, ARSENIC AND POSSIBLY ANABOLIC STERIODS. ASL IS A VERY RARE TUMOR. LESS THAN 20 CASES. PER YEAR FROM ALL THESE CAUSES OCCUR IN THIS COUNTRY. A REVIEW (POPPER, ET AL, 1978) OF ALL CASES REPORTED IN THE UNITED STATES FOR THE PERIOD 1964-1974 REVEALED 167 CASES, OF WHICH 19 WERE ASCRIBED AT THAT TIME TO OCCUPATIONAL VC EXPOSURE, 26 TO THORIUM DIOXIDES GIVEN MEDICALLY, AND 9 TO ARSENIC IN FOWLER'S SOLUTION, ALSO USED MEDICALLY. THE REMAINDER WERE OF UNKNOWN ETIOLOGY, WITH NO CONNECTION TO VC. THE HIGH LEVEL OF INTEREST IN THIS SPECIFIC TUMOR IS SUCH THAT ANY SUBSEQUENT CASES ASSOCIATED WITH ENVIRON MENTAL EXPOSURE TO VC WOULD MOST CERTAINLY HAVE BEEN REPORTED, AND NONE HAVE. FOR A TIME NIOSH PUBLISHED A SUMMARY OF AP00024774 -4- VC-RELATED CASES (FALK, ET AL 1981), BUT THIS TASK WAS TAKEN OVER FIRST BY JOHN STAFFORD OF ICI, ENGLAND (FOREMAN, ET AL 1985) AND LATER BY BRIAN BENNETT ALSO OF ICI. THE 1986 UPDATE OF VC-RELATED ASL CASES SHOWS A TOTAL OF 38 CASES IN THE UNITED STATES AND 120 WORLDWIDE. ALL OF THESE CASES INVOLVE HIGH OCCUPATIONAL EXPOSURES TO VC. THE AVERAGE ASL LATENCY PERIOD (YEARS FROM FIRST EXPOSURE TO DIAGNOSIS) IN THE UNITED STATES HAS BEEN 25 YEARS, BUT WITH A MEDIAN OF ABOUT 22 YEARS. THE LATENCY PERIOD IN EUROPE, PARTIC ULARLY IN GERMANY, HAS BEEN SOMEWHAT SHORTER, APPROXIMATELY 19 YEARS. ALL THE U.S. OCCUPATIONAL CASES, AND ALMOST ALL SUCH CASES IN THE REST OF THE WORLD ARE CLOSELY ASSOCIATED WITH THE JOB OF REACTOR CLEANING, WHICH WAS ONCE DONE MANUALLY AT THE END OF THE POLYMERIZATION CYCLE. THERE IS CLUSTERING OF CASES IN RELATIVELY FEW PLANTS AND THE MAJORITY OF PLANTS HAVE HAD NO CASES. DIFFERING WORK PROGRAMS AND JOB PROGRESSIONS MAY HAVE HAD SOME EFFECT ON REDUCING RATES AT VARIOUS PLANTS. AN INDUSTRY-SPONSORED EPIDEMIOLOGICAL SURVEY OF WORKERS IN THE VC/PVC INDUSTRY COVERED 8,384 MEN WITH AT LEAST ONE YEAR OF EXPOSURE BEFORE 1973 (TABERSHAW AND GAFFEY, 1974). THE EXPECTED EXCESS OF ASL WAS FOUND. THERE WAS ALSO SUGGESTIONS OF AN EXCESS OF CANCERS AT OTHER SITES. THIS STUDY WAS EXPANDED TO 10,173 WORKERS (COOPER, 1981), WHERE SUGGESTED EXCESS OF BRAIN AND RESPIRATORY CANCERS CONTINUED TO BE SEEN WITHOUT, HOWEVER, AN ASSOCIATION BETWEEN THE BRAIN CANCER AND EXPOSURE. IN ADDITION, MOST OF THE LUNG CANCER CASES COME FROM THE SAME FACILITY, WITH MANY PLANTS HAVING NO CASES. A FOLLOW-UP STUDY OF THIS EXPANDED COHORT TO DETERMINE THE STATUS OF THE WORKERS AS OF THE END OF 1980 IS UNDERWAY. SEVERAL STUDIES HAVE BEEN MADE OF THE GENERAL POPULATION USING ASL AS THE MARKER DISEASE IN AN EFFORT TO DETECT AN ASSOCIATION WITH POSSIBLE ENVIRONMENTAL EXPOSURE TO VC. THERE WAS NO ASSOCIATION WITH LIVING NEAR A PLANT MANUFACTURING OR USING VC IN THE GENERAL U.S. SURVEY CONDUCTED BY THE CENTER FOR DISEASE CONTROL (POPPER ET AL, 1978; FALK, ET AL, 1981). BRADY ET AL, (1977) SURVEYED 26 ASL DEATHS IN NEW YORK STATE BETWEEN 1970 AND 1975, AND FOUND FIVE WHO LIVED NEARER PLANTS HANDLING VC THAN DID THEIR MATCHED CONTROLS, BUT COULD NOT ESTABLISH A DIRECT CONNECTION WITH THE DISEASE TO EXPOSURE. TEN CASES OF ASL IN WISCONSIN WERE EXAMINED FOR POSSIBLE CONNECTION WITH VC EXPO SURE, AND NONE WAS FOUND (FIECHTNER ET AL, 1976). BAXTER ET AL, AP00024775 -5- (1977) FOUND NO RELATIONSHIP BETWEEN DISTANCE OF RESIDENCE FROM VC EMITTERS AND THE 47 CASES OF ASL IN THE GENERAL POPULATION OF GREAT BRITAIN REPORTED IN 1963-1973. A LATER UPDATE (BAXTER ET AL, 1980) FOUND ONE CASE WHERE THE PERSON HAD LIVED THE LAST SIX YEARS OF HIS LIFE NEAR A PVC PLANT AND THREE CASES WHERE THE MEN HAD WORKED IN THE PLASTICS FABRICATING INDUSTRY, BUT FOR WHOM THERE WERE NO RECORDS TO INDICATE EXPOSURE TO VC. THE LACK OF RELATIONSHIP BETWEEN RESIDENCE NEAR VINYL CHLORIDE OPERATIONS AND CASES OF UNKNOWN ETIOLOGY WAS CONFIRMED. SARIC ET AL, (1976) STUDIED THE DEATHS DURING THE YEARS 1968-1971 IN AN AREA SURROUNDING A PVC PLANT THAT HAD BEEN IN OPERATION SINCE 1949 AND IN WHICH THREE WORKERS HAD DIED OF ASL. NO RELATION SHIP WAS FOUND FOR LIVER OR FOR LUNCH OR BRONCHIAL CANCER AND PLACE OF RESIDENCE FOR THE GENERAL POPULATION. A SIMILAR STUDY FOR COMMUNITIES NEAR A SWEDISH PLANT THAT HAD OPERATED SINCE 1945 AND HAD FOUND FOUR ASL CASES SHOWED (ELINDER AND PERSHAGEN, 1978) NO UNEXPECTED ELEVATION OF FETAL MORTALITY, DEATHS FROM ALL CANCERS, OR CANCER OF THE LIVER OR LUNGS DURING THE YEARS 1961-1984. PANCREATIC CANCER IN MALES WAS ELEVATED IN THE AGE GROUP OVER 60. ALL ASL CASES IN HOLLAND SINCE 1950 (27 CASES) WERE STUDIED, AND NONE HAD ANY TRACEABLE CONTACT WITH VC (DALDERUP ET AL, 1976). ITURRA (1976) OBSERVED AN EXCESS OF CANCER DEATHS IN A CITY IN CANADA WITH A PVC PLANT COMPARED TO A SIMILAR NEARBY CITY. THIS DIFFERENCE WAS PRINCIPALLY FOUND IN MALES AGED 20 TO 64, WHICH IS NOT INDICATIVE OF A GENERAL POLLUTION EFFECT. THE AUTHOR DREW NO CONCLUSION AS TO WHY THE CONDITION EXISTED. REPRESENTATIVES OF THE ENVIRONMENTAL PROTECTION AGENCY HAVE STATED THAT IT HAS BEEN UNABLE TO ESTABLISH A LINK BETWEEN LIVING NEAR VC MANUFACTURING AND USING PLANTS AND ASL. THERE ARE ABOUT 20 CASES OF ASL PER YEAR IN . THE UNITED STATES THAT CANNOT BE ASCRIBED TO ONE OF THE KNOW CAUSES OF THE DIS EASE. THERE ARE ALSO ABOUT 5 IN EUROPE EACH YEAR. ACCORDINGLY, THERE WILL BE ONE CASE OF ASL AMONG THE 5 MILLION - 5 MILE NEIGHBORS OF VC/PVC FACILITIES ABOUT EVERY TWO YEARS BY CHANCE ALONE. THIS HAS BEEN SEEN IN THE STUDIES IN NEW YORK BY BRADY, ET AL, (1970), AND IN CONNECTICUT (HEATH AND LANDRIGAN, 1974). THESE STATES HAVE CANCER REGISTRIES, WHICH ARE OF GREAT VALUE. IN ONE CASE, A JURY AWARD WAS MADE TO THE ESTATE OF AN INDIVIDU AL WHO DIED OF ASL, AND WHO HAD LIVED THE LAST FOUR YEARS OF HIS LIFE NEAR A PVC PLANT. INASMUCH AS THAT PERSON ALSO HAD OCCUPA TIONAL EXPOSURE TO VC AND EXPOSURE TO OTHER ASL CAUSATIVE AGENTS, IT CANNOT BE CONCLUDED THAT AMBIENT VC EXPOSURE CAUSED HIS ASL (IN RE GRASSO, CIVIL ACTION NO. 78-1562, D.N.J.). AP00024776 -6- A THOROUGH STUDY (CHIAZ2E, ET AL, (1977), CHXA22E, (1980) OF MORE THAN 15,000 EMPLOYEES OF PVC FABRICATORS FOUND NO EVIDENCE OF VC-RELATED HEALTH EFFECTS IN THAT GROUP, WHICH WAS ESTIMATED TO HAVE BEEN EXPOSED TO AT LEAST 15 PPM VC FOR MANY YEARS. THE DISEASE ASL IS OFTEN DIFFICULT TO DIAGNOSE (BLOCK 1974; HEATH, FLAK AND CREECH, 1975), IS ALMOST INVARIABLY FATAL WITHIN A SHORT TIME, AND PRESENTS A VARIETY OF SYMPTOMS, INCLUDING PORTAL FIBROSIS AND HYPERTENSION WITH SPLENOMEGALY AND VARICES, PROLIFERATION OF THE SINUSOIDAL LINING, MEGALOCYTOSIA AND THROMBOCYTOPENIA (THOMAS AND POPPER, 1975; GEDIGK ET AL, 1975). METASTASIS IS FREQUENTLY INVOLVED. THESE SYMPTOMS ARE VERY SIMILAR TO THOSE SEEN IN THE MOUSE (SCHAFFNER, 1978) AND RAT (FERON AND KREES, 1979) AND THE PATHOLOGY ALSO IS SIMILAR (GORDON ET AL, 1975). NO REALLY ADEQUATE EARLY WARNING TESTS HAVE BEEN DEVISED (WHELAN ET AL, 1976; LANGBEIN ET AL, 1983; TAMBURRO AND GREENBERG, 1981), ALTHOUGH THE GAMMAGLUTAMYL TRANSPEPSIDASE TEST IS PROMISING, TOGETHER WITH ICG CLEARANCE AND SGOT. RADIOGRAPHIC LIVER SCANS AND TOMOGRAPHY AND SONOGRAPHY (KOISCHWITZ ET AL, 1981) ARE SAID TO BE USEFUL CONFIRMATORY TESTS. IN SUMMARY, VC IS A CLASSICAL PROCARCINOGEN, AND IS CLEARLY A HUMAN CARCINOGEN, CAUSING ASL IN A SMALL PERCENTAGE OF HIGHLYEXPOSED WORKERS. THERE IS SUGGESTIVE EVIDENCE THAT IT MAY BE A WEAK GENERAL CARCINOGEN AT HIGH CONCENTRATIONS, PERHAPS THROUGH AN IMMUNOSUPPRESSIVE MECHANISM, BUT MORE DATA ARE REQUIRED TO CONFIRM THIS SUSPICION. SEVERAL STUDIES OF LARGE POPULATION HAVE NOT SHOWN A CONNECTION BETWEEN GENERAL AMBIENT EXPOSURE AND AN INCREASED INCIDENCE OF CANCER. IV. FEDERAL REGULATION OF VC/PVC INDUSTRY THE PRIMARY FEDERAL AGENCIES REGULATING THE Vq/PVC INDUSTRY ARE THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA), WHICH IS PART OF THE U.S. DEPARTMENT OF LABOR, THE U.S. ENVIRONMENTAL PROTECTION AGENCY (EPA), AND THE FOOD AND DRUG ADMINISTRATION (FDA). OSHA REGULATION FOCUSES ON WORKER HEALTH WHILE EPA ADDRESSES THE CONTROL OF CHEMICALS OUTSIDE THE WORKPLACE. FDA OVERSEES USES OF PVC THAT INVOLVE FOOD, DRUGS, COSMETICS, AND MEDICAL DEVICES. A. THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION THE ALLOWABLE OCCUPATIONAL EXPOSURE FOR VINYL CHLORIDE OF 1 PPM ON AN 8-HOUR TIME WEIGHTED AVERAGE (TWA) IS SET BY THE AP00024777 -7- OSHA WORKPLACE STANDARDS AT 29CFR1910.1017. THIS WAS ADOPTED IN 1974, AFTER EXTENSIVE PUBLIC HEARINGS, AND BECAME EFFECTIVE IN APRIL 1975. OSHA FIRST SET AN EMERGEN CY TEMPORARY STANDARD OF 50 PPM AND PROPOSED A PERMANENT LIMIT OF NONDETECTABLE EXPOSURE BY A TEST SENSITIVE TO 1 PPM. OSHA THEN PROMULGATED A FINAL STANDARD OF AN 8-HOUR TWA OF 1 PPM, AND A 15-MINUTE CEILING OF 5 PPM. IN BRIEF, THE REGULATION SETS: 1. A LEVEL OF 0.5 PPM VC BELOW WHICH NO ACTION IS RE QUIRED. THIS GENERALLY EXEMPTS MOST PVC FABRICATION PLANTS AND LABORATORIES AND MANY MONOMER PLANTS. 2. A REGULATED AREA WHERE EXPOSURES ARE ABOVE 0.5 PPM WHICH RESTRICTS ENTRY TO AUTHORIZED PERSONS. 3. MEDICAL EXAMINATION REQUIREMENTS AND EXPOSURE RECORD RETENTION FOR SPECIFIED EMPLOYEES. 4. A LIST OF ACCEPTABLE RESPIRATORS. 5. MONITORING AND ALARM SYSTEMS FOR THE WORKPLACE, AND ROUTINE MEASUREMENT OF WORKER EXPOSURE. 6. LABELING AND SIGNS FOR REGULATED AREAS AND CONTAINERS OF VINYL CHLORIDE AND PVC. 7. WORK PROCEDURES FOR HAZARDOUS OPERATIONS. 8. TRAINING PROGRAMS FOR EMPLOYEES. OSHA ALSO HAS A HAZARD COMMUNICATION STANDARD (HCS), 29CFR1910.1200, which provides labeling requirements COMPLEMENTARY TO THE OSHA VINYL CHLORIDE STANDARD. ARTI CLES MADE FROM PVC ARE EXEMPT FROM LABELING REQUIREMENTS UNDER THE STANDARD. B. ENVIRONMENTAL PROTECTION AGENCY EPA REGULATES THE RELEASE OF VINYL CHLORIDE UNDER SEVERAL STATUTES, INCLUDING THE CLEAN AIR ACT, CLEAN WATER ACT, SAFE DRINKING WATER ACT, RESOURCE CONSERVATION AND RECOVERY ACT AP00024778 i! -8- (rcra), comprehensive environmental response, compensation AND LIABILITY ACT (CERCLA OR SUPERFUND), AND THE TOXIC SUBSTANCES CONTROL ACT (TSCA). 1. AIR STANOARD (40CFR61.60) The epa standard established in 1976 specified the FOLLOWING CONDITIONS: A. FUGITIVE EMISSIONS CONTROLS BY LEAK PATROLS AND DESIGN STANDARDS FOR PUMP AND COMPRESSOR SEALS, AGITATORS, AND LOADING DEVICES. B. WORK PRACTICES FOR VESSEL OPENINGS AND SAMPLING. C. STRIPPING REQUIREMENTS FOR RESIDUAL MONOMER IN RESINS AND WASTEWATER. D. ABATEMENT OF SPECIFIED POINT SOURCE EMISSIONS TO 10 PPM. PROHIBITION OF RELIEF VALVE DISCHARGES, EXCEPT E` FOR EMERGENCIES. F. EXTENSIVE MONITORING, REPORTING AND RECORDKEEPING REQUIREMENTS. G. SPECIFIC ANALYTICAL PROCEDURES. EPA ESTIMATED THAT THIS STANDARD WOULD RESULT IN A 95\ REDUCTION OF VC EMISSIONS TO THE ATMOSPHERE FROM VC/PVC MANUFACTURING PLANTS AND REDUCE THE 5 MILE ANNUAL AVERAGE VC AMBIENT AIR CONCENTRATION FROM 17 PARTS PER BILLION (PPB) TO LESS THAN 1 PPB. 2. WATER REGULATIONS VINYL CHLORIDE IS LISTED AS A PRIORITY POLLUTANT UNDER SECTION 307(A) OF THE CLEAN AIR ACT, AND A WATER QUALITY CRITERIA DOCUMENT HAS BEEN PREPARED. THIS SUBJECTS VC AND PVC MANUFACTURING PLANTS TO SPECIAL CONSIDERATIONS WHEN WASTE WATER DISCHARGE PERMITS ARE ISSUED PURSUANT TO EPA REGULATIONS. AP00024779 -9- AS PART OF ITS REGULATION OF CARCINOGENS IN DRINKING WATER, EPA HAS PUBLISHED A FINAL RECOMMENDED MAXIMUM CONTAMINANT LEVEL (RMCL - A NON-BINDING GUIDELINE) FOR VC IN DRINKING WATER OF ZERO (SEE 50FR46880, NOVEMBER 13, 1985 FOR THIS AMENDMENT TO 40CFR 141.50). HOWEVER, EPA INDICATED THAT A "JUSTIFIABLE" WAY TO DETERMINE THE ABSENCE OF VINYL CHLORIDE WOULD BE BY SETTING A DEFINED, STATE-OF-THE-ART DETECTION LIMIT SENSITIVE TO APPROXIMATELY 1 PPB. (49FR24,330, 24,347 - June 12, 1984). epa has also proposed a maximum CONTAMINANT LEVEL OF 1 PPB FOR VINYL CHLORIDE IN DRINKING WATER. (SEE 50FR46,902 - NOVEMBER 13, 1985). 3. WASTE AND SPILL REGULATION THE EPA ISSUED A RULE UNDER WHICH CERTAIN VC MANUFAC TURING DISTALLATION RESIDUES ARE LISTED AS HAZARDOUS WASTES WHEN DISPOSED (49FR5308). THIS RULE REQUIRES THAT ALL SUCH WASTES ARE TO BE DISPOSED OF ONLY BY RCRA-APPROVED PROCEDURES. WHEN DISPOSED OF, COMMERCIAL GRADE VC IS CLASSIFIED AS A HAZARDOUS WASTE UNDER THE RESOURCE CONSERVATION AND RECOVERY ACT (RCRA), BECAUSE OF ITS TOXIC AND IGNITABLE CHARACTERISTICS. ANY DISPOSAL IS SUBJECT TO REGULATION UNDER RCRA. EPA HAS PROPOSED ADDITIONAL RCRA REGULATIONS (51 FR 21648, june 13, 1986) which apply to all wastes CONTAINING VC. THESE PROPOSED REGULATIONS DEFINE WASTES AS HAZARDOUS WHEN THE VC LEVEL IN THE EXTRACT BY A SPECIFIED TEST METHOD EXCEEDS 50 PPB. CONGRESS HAS SPECIFIED AN INTERIM 1 POUND REPORTABLE QUANTITY FOR VINYL CHLORIDE. RELEASES TO THE ENVIRONMENT IN EXCESS OF 1 POUND ARE REGULATED UNDER CERCLA. 4. NEW PRODUCT MANUFACTURE The epa also administers the toxic substances control ACT (TSCA) WHICH ESTABLISHES HEALTH AND ENVIRONMENTAL REGULATIONS FOR BOTH NEW AND EXISTING SUBSTANCES. NO ONE MAY MANUFACTURE OR USE A SUBSTANCE WHICH IS NOT ON THE AGENCY'S OFFICIAL INVENTORY, UNLESS THE PREMANUFACTURING NOTICE PROCEDURES ARE FOLLOWED. AP00024780 -10- C. FOOD AND DRUG ADMINISTRATION PVC IS WIDELY USED FOR FOOD CONTACT APPLICATIONS. IN EARLY 1986, THE FOOD AND DRUG ADMINISTRATION (FDA) CONFIRMED THE SAFETY OF PVC FOR ALL FOOD-CONTACT APPLICATIONS AND WITH DREW AN OUTSTANDING PROPOSAL TO LIMIT ITS USE IN FOOD PACKAGING. (SEE 51FR4173 - FEBRUARY 3, 1986). AN ACCOMPA NYING NEW PROPOSAL WOULD SET VARIOUS RESIDUAL VINYL CHLO RIDE LEVELS FOR DIFFERENT FOOD CONTACT MATERIALS. AMONG OTHER THINGS, FDA FOUND THAT "VASTLY IMPROVED PRODUCTION TECHNOLOGY (SINCE 1975) HAS MADE IT POSSIBLE FOR MANUFAC TURERS TO SUCCEED IN REDUCING THE LEVEL OF RESIDUAL VINYL CHLORIDE MONOMER IN VINYL CHLORIDE POLYMER." THE COMMENT PERIOD ON THE FEBRUARY 3, 1986 FDA PROPOSAL CLOSED ON JUNE 5, 1986 WITHOUT ANY ADVERSE COMMENTS ON THE HEALTH OR SAFETY OF PVC. THIS FOA PROCEEDING LENDS FURTHER SUPPORT TO THE INHERENT SAFETY OF HUMAN EXPOSURE TO PVC. FDA REGULATES THE USE OF PVC IN MEDICAL DEVICES AND DRUG PACKAGING ON A CASE-BY-CASE BASIS. V. COMMUNITY HEALTH CONCERNS AS WAS DISCUSSED IN SECTION IV, VC IS A VERY STRICTLY REGULATED SUBSTANCE. THE EPA ESTIMATED THAT THE 1976 STANDARD WOULD REDUCE THE ANNUAL AVERAGE EXPOSURE OF THE PERSONS LIVING WITHIN 5 MILES OF VC/PVC FACILITIES BY 95% (FROM 17 PPB TO ABOUT 0.85 PPB). AN EPA REPORT (185) STATES THAT CURRENT INDUSTRY PERFOR MANCE HAS RESULTED IN ACTUAL EMISSIONS THAT ARE SIGNIFICANTLY LESS THAN THAT PREDICTED AMOUNT. MANY AUTHORS HAVE ATTEMPTED TO DEVELOP QUANTITATIVE RISK ASSESS MENTS FOR LOW LEVEL EXPOSURES TO VC. (SEE BARR, 1982 AND PURCHASE, 1985 FOR REVIEWS). SOME HAVE INCORPORATED HUMAN DATA (gehring, et al, 1979, anderson, et al, 1980, purchase et al, 1985) AND ONLY THESE PREDICT RESULTS WHICH ARE COMPATIBLE WITH THE ABSENCE OF ANY OBSERVED EFFECTS ON HUMANS FROM AMBIENT EXPOSURES. THE REMAINING ESTIMATES ALL USED VARIATIONS OF THE EPA UPPER LIMIT MODEL (ANDERSON 1983) AND OVERSTATE THE PROBA BILITY OF RISK BY SEVERAL ORDERS OF MAGNITUDE. THERE IS NO CONFIRMED CASE ON RECORD IN WHICH A MEMBER OF THE GENERAL POPULATION HAS BEEN HARMED BY EXPOSURE TO VINYL CHLO RIDE. THAT FACT SETS THE UPPER LIMIT OF LIFETIME RISK AT LESS THAN 0.3 PREDICTED CASES OF CANCER PER 1 MILLION FOR EXPOSURE TO 1 PPM OF VC. BECAUSE THE DATA SHOW THAT INDUSTRY EMISSIONS HAVE AP00024781 -11- BEEN REDUCED BY 99.99% (RATHER THAN THE 95% ESTIMATED BY EPA) , THE ACTUAL RISK IS LESS THAN 0.1 CASE OF CANCER IN THE NEXT 70 YEARS AMONG THE 5 MILLION PRESUMED TO BE EXPOSED TO VC FROM LIVING WITHIN 5 MILES OF A VC/PVC FACILITY. DR. RICHARD WILSON OF HARVARD (1979) HAS ATTEMPTED TO HELP PEOPLE UNDERSTAND THIS METHOD OF STATING THE RISKS OF EVERY DAY OCCURRENCES. EACH OF THE FOLLOWING ACTIVITIES FOR EXAMPLE, IS PREDICTED TO RESULT IN ONE DEATH PER MILLION PEOPLE: SMOKING 1.4 CIGARETTES (DUE TO CANCER, HEART DISEASE); DRINKING 1/2 LITER OF WINE (DUE TO CIRRHOSIS OF THE LIVER),' TRAVELING 6 MINUTES BY CANOE, 10 MILES BY BICYCLE, 300 MILES BY CAR, OR 1,000 MILES BY JET (DUE TO AN ACCIDENT); AND HAVING ONE CHEST X-RAY TAKEN IN A GOOD HOSPITAL (DUE TO CANCER BY RADIATION). WE CONCLUDE, THEREFORE, THAT THERE IS NO BASIS FOR CONCERN BY PERSONS LIVING NEAR VC-USING OR PRODUCING FACILITIES FOR ANY HEALTH EFFECTS FROM EXPOSURE TO AMBIENT CONCENTRATIONS OF VC NOW BEING EXPERIENCED. AP00024782 Biblioeraphy Anderson, EL., (1983) Quantitative Approach*! in Uss to Assess Cancer Risk. Ride Analysis 3, ITT. Barr, J.T., (1982) Rials Aaaesiment for Vinyl Chloride in Perapective. Presented at the TSth Annual Meeting of the Air Pollution Control Aaaociation, Mew Orleans, Louisiana, in June. Berr, J.T., (1086) Safety and Environmental Concerns in Resin Manufacture, in. Encyclopedia of PVC., Second Edition, Volume I, L.l. Nasa and C.A. Heiberger, eds., Marcel Deklter, Inc., New York. Barnes, A.W. , (1980) Vinyl Chloride end the Production of PVC, Proc. Royal Soc. Med., 69, Baxter, P.J., Anthony, P.P., McSween, end Scheuer, P.J., (1977) Br. Med. J,, II, 919. Baxter, P.J., Anthony, P.P., McSween, R.N.M., and Scheuer, P.J., (1980) Br. J. Ind. Med. 37, Block, J.B., (1974) J. Ky. Med. Auoc., 72(9),, 483. Brady, J., Liberator*, F., Harper, P., Greenwald, P., Burnett, W., Davies, J.N.P., Bishop, M., Polio A., and Vianna, N., (197T) J. National Cancer Institute, 59, 1383. Cook, W.A., Grave, P.M., Dinman, B.D., and Magnuson, H.J., (1981) Occupational Acro-osteolysil II. industrial hygiene study. Arch. Enr. Health, 22, 74. An Cooper, C., Environmental Health Perspective., 41, 101 (1931). Dalderup, L.M., Freni, S.C., Bras, G., and Bronckhorst, F.B., (1976) Lancet, I., 246; J. Occup. Med. 17, 288 (19TB). Elinder, C.G., and Pershagen, G., (1978) Pilot Study Concerning the Mortality in Njurunda Community, Swedish Nature Conservancy Board, April. Environmental Protection Agency (EPA), (1988) Report 450/3-85-002 "Vinyl Chloride: Standard'. Relief Valve Discharge Falk, H., Herbert, J., Crowley, S., Ishak, K.G., Thornes, L.B., Popper, J.H., and Caldwell, G.C., (1981) Environmental Health Prospect., 41, 107. Fsron, V.J., and Kreea, R., (1979) Toxicology 13, 131. Fiechtner, J., Reyes, C., Rentmesster, K., and Skinner, H.G., (1976) Morbid, Mortal, Weekly Rep., (Center For Disease Control), 25, 57. Foreman, P., Bennett, B., Stafford, J., and Doll, R,, (1985). Exposure to Vinyl Chloride and Angiosarcoma of the Liver: A Report of the Regiater of Casea, Br. J. Ind. Med. 42, 750. Gedigk, p., ;Muller, R., and BechteUheimer, H. (1975) Am. New York Academy of Science*, 246, 278. Gordon, D.E., Thomas, L.B., Calandra, J.C., Popper, H., (197S) and Kent, C., Int. Aead. Pathol. Mectinf, Naw Orleans, March 5th, abstracted In Lab. Inveet., 32(8), 8 (1975). Harrie, D.K., andAdame, W.G.F. (1967) Acro-oeteolyele Occurring Vinyl Chloride, Brit. Med. J.f 3, 712. in Men Engaged in the Polymeriaation of Heath, C.W., Landrigan, P.S. (1974) Hemangioaareomaof the Liver, Connecticut Public Health Service,C.D.C. Atlanta, Report EPf 74-104-1. 9 October. Heath, C.W., Flak, K., and Creech, S.L. (1975) Jr., alto Environment. Res., 14, 66 (1977). Am. New York Academy of Sciencea, 246, 331. Sea Hosl, D.G., Kaplan, N.L., and Anderson, M.W., (1983) Implication of Non-Linear Kinatica on Risk Estimations in Carcinogtn. Scisncs 219, 1032, Iturra, H., (1976) Proc. Air Environ. Specialty Conf., Pittsburgh, Pennaylvania, p. 96. Koiachwits, D., Mareteller, H.J., Laekner, K., Brecht, G., and Brecht, T., (1981) Forschr, Rontgenstr., 134(3), 283. Kuebler, H., (1964) Aeroeol Age 9(14) 44. AP00024783 Kusmack,AM., And McCaughy, R.E., (1975) QuantitativeRisk Assessment For Chloride, US. EPA, Washington, D.C., December 5. Community Exposure to Vinyl Langbein, G.t Permanetter, W., and Diets, A., (1983) Dtsch. Med. Wochenschr., 108, 741. Lehman, L.B., and Baltimore. Fluty, F., (1943) Toxicology and Hygiene of Industrial Solvents, Williams and Wilkins, Maltoni, C., (1977) OccupationalCarcinogenesis. Second International Symposium on Cancer Detection and Prevention, Bologna in Advances in Tumour Prevention, Detection, and Characterisation, Excsrpta Mediea 3,26. Maltoni, C., Lefsmins, G., CUlbenti, A., Cotti, G., and Cametti, D., (1984) Experimental Research on Vinyl Chloride Carcinogenesis, Prineston Scientific Pub., Princeton, New Jersey. Marcus, W., (1076) Comments During Hearing on the Vinyl Chloride Standard, EPA, Washington, D.C., February 3rd, Transcript, p. 43. Patty, F.A., Yant, W.P., and Waite, C.F., (1930) Public Health Report 45, (1963). Popper, H., Thomas, L.B., Telles, N.C., Falk, H.,and Sellkoff, I.J., (1978) Am. J. Pathol., 92, 349. Purchase, Stafford, A.J., and Paddle, G.M., (1985) Vinyl Chloride, A Cancer Case Study in Toxicological Risk Assessment, Volume 11, D.B. Clayton, D., Knewskl, and R. Monroe, CRC Press, Boca Raton, Florida. Saric, M., Kulcar, Z., Zorica, M., and Gelie, J., (1976) Environment. Health Perspective., 17, 189. Schaffncr, F, (1978) Falk Symposium, 25, p. 169. Semon, W.L., (1933) U.S. Patent 1,929,453, October 18th. Sudu, J., Drejman, I., and Vataskli, M., (1963) Contributions to ths Study of Disease by Vinyl Chloride Med. International 15, 967. Tabershaw, I.R., and Gaffey, W.R., (1974) J. Occup. Med., 16, 609. Tamburro, C.H., and Greenberg, R., (1981) Environmental Health Perspective, 41, 117. Thomas, L.B., and Popper K.t (1975) Am. New York Academy of Sciences 246. Torkeison, T.R., Oyen, F., and Rowe, V.K., (1061) American Industrial Hygiene Association, J.22, 354. Viols, P.L., (1969) Pathology of Vinyl Chloride. Occupational Health, Tokyo. Proceedings of the 16th International Congress on Viola, P.L., (1970) Pathology of Vinyl Chloride, Med. Lavoro, 61, 174. Viola, P.L., Bigotti, A., and Caputo, A., (1971) Oncogenic Response of Chloride, Cancer Res. 31.516. Rat Skin, Lungs and Bones to Vinyl Whelan, J.G., Creech, J.L., and Tamburro, C.H., (1976) Radiology 118(3), 549. Wilson, R., (1979) Analysing the Risks of Life, Technology Review, M.I.T.,- 81(4). EXHIBIT 14 CHEMICAL INVENTORY REQUIREMENTS SUMMARY SHEET TITLE III SECTION: 312 o Emergency and Hazardous Chemical Inventory Forms CHEMICAL APPLICABILITY "Hazardous chemical" as defined in OSHA Hazard Communication Standard (29 CFR 1910.1200(c)); substances required to have a MSDS under this OSHA regulation. FACILITY APPLICABILITY: Any facility required by OSHA Hazard Communication Standard to prepare or have available a MSDS for a "hazardous chemical"; currently includes facilities in SIC Codes 20-39. FACILITY REQUIREMENTS: o Submit an emergency and hazardous chemical inventory form (Tier I) to LEPC, SERC, local fire department. (Tier II submittal optional in lieu of Tier I). PROPOSED THRESHOLDS: For 1987, amounts equal to or greater than lb,ClOO lbs in preceding year. For 1988, 500 lbs to 10,000 lbs. For 1989, all chemicals not yet submitted (any above zero). DEADLINE: No later than March 1, 1988, and annually thereafter. o Upon request from LEPC, SERC, local fire department; submit Tier II. PROPOSED THRESHOLDS: Zero. PROPOSED DEADLINE: Within 30 days of receipt of request. o Upon request from local fire department, allow fire department to conduct on-site inspection and provide specific location information. -55- AP00024785 i Mo. 11 541:2501 NOTIFICATION. REPORTING. AND RECORDKEEPING Annual Emergency and Hazardous Chemical Inventory Reporting ----------------------------------------------- POLICY GUIDE ----------------------------------------------- There are two community right-to-know sections that require facilities to inform certain state and local entities about the presence and amounts of hazardous chemicals they keep on site: Section 311 and 312. Section 311 requires facilities that must prepare or have available material data safety sheets (MSDS) under Occupa tional Safety and Health Administration (OSHA) regulations to submit either copies of their MSDSs or a list of chemicals for which an MSDS is available at the facility to: The local emergency planning committee. The state emergency response commission. The local fire department. This is a one-time reporting requirement, with the lists of MSDSs due on Oct 17,1987. The OSHA standard originally applied only to employers in the manufacturing sector. Under a court-ordered expansion of the Hazard Communication standard announced by OSHA in August 1987, all employers were to begin keeping MSDSs on May 23,1988. However, a stay of the expansion was issued by a federal appeals court in May 1988 and upheld in June 1988, delaying the effective date of the expanded standard. The U.S. Court of Appeals for the Third Circuit then ruled July 8,1988, that the stay of the expanded Hazard Communication standard pertains only to employers in the construction industry. This court action means that all employers in the non manufacturing sector, with the exception of the construction industry, must comply with all basic provisions of the hazard communication standard by June 24,1988. These employers also must submit MSDS information to state and local groups and lire departments by September 24,1988, under EPCRA Section 311. The applicability of the OSHA standard to construction industry employers has yet to be determined by the courts. Under Section 311, any updates to MSDSs or lists of the documents are due within 90 days after the owner/operator of a facility is first required to prepare or have available an MSDS for a specific hazardous chemical under OSHA regulations. Also, if there is significant new information on an MSDS that was submit ted previously, a revised MSDS must be submitted. EPA encourages facilities to submit lists of chemicals rather than MSDSs. If you submit a list of chemicals, an MSDS for any chemical on the list must be submitted to the local planning committee upon the local planning committee's request If you submit a list of chemicals rather than individual MSDSs: Include the chemical name or common name of the chemical and any hazardous component as provided on the MSDS. Group the chemicals on the list according to the five hazard categories defined by EPA (See p. 541:1001). The five categories were consolidated from the 23 physical and health hazard categories established under OSHA regulations. (See p. 531:4001 for the OSHA Hazard Communication Standard). Facilities that must submit MSDSs or lists of the documents to state and local groups under Section 311 also are required to submit chemical inventory information on those substances annually to the same groups under Section 312. Full text of the final EPA inventory reporting rule governing Section 311 and 312 requirements begins on p. 541:2511. ------------------------------------ -- APPLICATION OF POLICY---------------------------------------- Who Must Report The OSHA Hazard Communication Standard applies to all employers in both the manufacturing and non-manufacturing sectors, with the exception of construction industry employers. Any facility that is subject to the OSHA standard also may be required to submit MSDS information under EPCRA Section K* I Copyright till by The Binw of Natlml Affairs. Iso. 0-8717t-MM//*K50 AP00024786 / 541:2502 NOTIFICATION, REPORTING, AND RECORDKEEPING No. II 311 and chemical inventory information under EPCRA Section 312 if certain conditions are met. Threshold Levels for Reporting The law empowers the EPA administrator to set threshold quantities for hazardous chemicals below which a facility would be exempt from Section 311's MSDS reporting requirements. Thresholds for reporting and MSDS purposes are the same in sections 311 and 312. EPA has imposed a phase-in of the threshold lim its for MSDS submissions and Tier I inventory re ports (see below) under Section 312. In the first and second years, a threshold of 10,000 pounds is used. In the third year, the threshold drops to its permanent level of zero. These were made final by EPA on Oct. 15,1987. EPA said, however, that it would study the zero permanent threshold further to determine whether or not it should be raised. For chemicals on the list of extremely hazardous substances in Section 302 of the act, EPA said the reporting threshold is either 500 pounds or the threshold planning quantity listed for the substance, whichever is lower. NOTE: The thresholds do not apply to requests for information made by the local planning committees. They can ask for information on any substances for which an MSDS is necessary regardless of quantities of those substances that a facility might have on hand. Exempt Substances Regulations issued by the Occupational Safety and Health Administration and by EPA under EPCRA exempt some chemicals from reporting. The com bined list of exemptions and exceptions follows: Any food or food additive, drug or cosmetic reg ulated by the Food and Drug administration. Any substance to the extent it is used for per sonal, family or household purposes, or is present in the same form and concentration as a product pack aged for distribution and use by the general public. The term "form" refers to the packaging rather than the physical characteristics of the product. Any substance to the extent it ia used in a re search laboratory or a hospital or other medical fa cility under the direct supervision of a technically- qualified person. Any substance to the extent it is used in routine agricultural operations or is a fertilizer held for sale by a retailer to the ultimate customer. Any hazardous waste as defined by the Solid Waste Disposal Act. Tobacco or tobacco products. Wood or wood products. Articles which are manufactured items. Such articles must meet a three-part test: they are formed to a specific shape of design during manufacture: they have end use functions dependent in whole or in part upon the shape or design in end use: and they do not release, or otherwise result in exposure to haz ardous chemicals under normal conditions of use. Mixtures For mixtures of hazardous chemicals, you can sub mit an MSDS for, or by identifying on a list, each element or compound in the mixture which is a haz ardous chemical. Or, you can submit an MSDS for, or identifying on a list, the mixture itself. Under EPA regulations, if the mixture is reported as a sin gle entity on an MSDS list, the hazardous compo nents do not have to be reported. If the element or compound option is selected, and is contained in more than one mixture, only one MSDS or listing is necessary. NOTE: Whichever option is selected for reporting mixtures under Section Sll also must befollowed for Section S12 inventory reporting "where practicable, " according to EPA. Consistency in reporting may not always be possible; for example, the percentage of hazardous components in a mixture may not be known. Section 312 Inventory Reporting The owner or operator of a facility required to submit an MSDS or list of chemicals under Section 311 also is subject to the provisions of Section 312. Under Section 312, the owners/operators are re quired to submit an emergency and hazardous chem ical inventory form to the same three entities that received the MSDS or lists: the state emergency re sponse commission, the local emergency planning committee, and the local fire department. There are two reporting "tiers" under Section 312. According to EPA, states may require the submission of only Tier II information or other state developed forms, provided ail federal chemical inventory reporting re quirements are met. Tier I Reporting Facilities that meet the threshold planning re quirements must submit Tier I forms or comparable forms that each state may have developed to use in lieu of the federal forms. Tier 1 includes aggregate information for each applicable hazard category: An estimate (in ranges) of the maximum amount of chemicals for each category present at the facility at any time during the preceding calendar year. An estimate (in ranges) of the average daily amount of chemicals in each category. The general location within the facility of the hazardous chemicals in each category. fU|kt-T.KMw Ptouiat GuUt 0-671T&-935M/88/IO+.S0 30 AP00024787 No. 7 ANNUAL CHEMICAL INVENTORY REPORTING 541:2503 The form containing Tier I information (EPA's fi nal Tier I form appears beginning on p. 541:2551) must be submitted beginning March 1, 1988. and an nually thereafter. This form will contain data pertain ing to the preceding calendar year. Tier II Reporting Tier II information must be submitted only in re sponse to a request from the local committee, the state commission, or the fire department with jurisdiction over the facility. Tier II information is chemical-spe cific and more detailed with respect to location and manner of storage than the Tier I information. Tier II information that must be provided upon request in cludes: The chemical name or the common name as indi cated on the MSDS. An estimate (in ranges) of the maximum amount of the chemical present at any time during the preced ing calendar year. . A brief description of the manner of storage of the chemical. The location of the chemical at the facility. An indication of whether the owner elects to withhold location information from disclosure to the public. Any person can ask the state emergency response commission or the local emergency planning commit tee for Tier II information from a specific facility re lating to the preceding calendar year. If the information is in the possession of the state commission or the local committee, it must be provid ed to the requestor. If the information is not in the possession of the state commission or the local committee that received the request, either of those entities must request Tier II information from the facility concerning chemicals stored in excess of 10,000 pounds at any time during the preceding calendar year. To obtain Tier II information on other chemicals at the facility, the requestor must submit a general statement explaining why the information is needed. The local emergency planning committee or state emergency response commission will evaluate the re quest and decide whether to seek the information from the facility. If either of these panels asks for the information, you must provide it or ri3k penalties (see p. 551:4001 for a discussion of penalties). NOTE: All Tier II information obtained by a state commission or a local committee is available to the public, including the person who requested the infor mation. However, if the owner or operator of a facili ty requests it, location information on specific chemi cals will be withheld from public disclosure EPA's final Tier II form appears beginning on p. 541:2575. Additional State and Local Requirements States and localities, under their own laws and ordi nances, may require facility owners to submit infor mation that is supplemental to the Section 311 and 312 requirements. Tlie Emergency Planning and Com munity Right-To-Know Act preserves their authority to do so. However, the form and content of any MSDS required from a facility owner or operator under state or local law must be identical in form and content to the MSDS required under Section 311. For either MSDS or inventory reporting under Section 312, a state or local community may require the submission of additional sheets attached to the MSDS or invento ry forms. EPA said the final inventory forms are to be considered uniform formats for reporting, but that state or local governments can include additional data requirements as they deem necessary. Copyrifkt * IMS by Tb Bureau of Nation! Afiin, lae. 0-87179-939-1/8S/SO+.5O IS AP00024788 EXHIBIT 15 TOXIC CHEMICAL RELEASE SUMMARY SHEET TITLE III SECTION: 313 o Toxic Chemical Release Forms CHEMICAL APPLICABILITY: "Toxic chemicals", under Section 313(c), are those chemicals on the list in Committee Print Number 99-169 of the Senate Committee on Environmental and Public Works, titled "Toxic Chemicals Subject to Section 313 of the Emergency Planning and Community Right-to-Know Act of 1986" (see Appendix F of this manual). FACILITY APPLICABILITY: Any facility with 10 or more full-time employees in SIC Codes 20-39 which manufactured, processed, or otherwise used a toxic chemical in excess of the thresholds (see Appendix G of this manual). FACILITY REQUIREMENTS; Submit to U.S. EPA and designated state agency the toxic chemical release form for each toxic chemical above threshold. THRESHOLDS: For a chemical used, 10,000 lbs per year. For a chemical manufactured or processed in 1987, 75,000 lbs per year; in 1988, 50,000 lbs per year; in 1989, 25,000 lbs per year. DEADLINE: No later than July 1, 1988 for the preceding year and annually thereafter by July 1 for preceding year. -63- AP00024789