Document rBvdNmemJJ9E9eGr48KaQb8zv

CHEMICAL REGULATION REPORTER -BNA A weekly review of activity affecting chemical users and manufacturers \ 1929--1979 Volume 3, Number 36 THE BUREAU OF NATIONAL AFFAIRS. INC. December 7, 1979 HIGHLIGHTS THE FIRST CHEMICALS to be considered for eight-hour period, under interim standards Environmental Protection Agency testing rules adopted by the Coast Guard pending a Supreme under Section 4 of the Toxic Substances Control Act will be acrylamide, chloromethane, and Court decision on the Occupational Safety and Health Administration benzene standard (p. chlorinated benzenes, according to an EPA of ficial. The two chemicals and the chemical group were given priority for testing by the Interagency Testing Committee (p. 1459). ENDANGERMENT would be created as a new federal felony by a bill approved by the Senate Judiciary Committee. The term wquld apply if a violator of TSCA. the Federal* Insecticide, Fungicide, and Rodenticide ' Act, or other statutes knowingly places another person "in im 1462). REVIEW PROCEDURES for EPA's premanufacture notifications are refined in a letter to be sent to the EPA Administrator's Tox ic Substances Advisory Committee. The draft letter says the agency intends to include more in formation in the public notices of PMN receipts (p. 1462). A PETITION FOR A BAN on all consumer products containing n-hexane is denied by the minent danger of death or serious bodily injury" (p. 1459). Consumer Product Safety Commission, but the issue continues to be under study (p. 1464). LATE REPORTS are still being received by EPA for the TSCA inventory of existing chemicals, even though the reporting deadline ended July 1, according to an official in EPA's Of fice of Toxic Substances, who adds that, so far, very few reports have been submitted by processors (p. 1460). THE REPRODUCTIVE TOXICITY of 2,4,5-T and Silvex and their dioxin contaminant TCDD justifies holding hearings on the remaining uses of the products, according to a decision approved by Steven D. Jellinek. head of EPA's Office of Pesticides and Toxic Substances. The hearings probably will be combined with ongoing hearings to cancel the major uses of the herbicides (p. 1460). DECISIONS TO BE MADE on chemicals sub ject to rebuttable presumption against registra tion in the next three months, and the status of several sets of EPA regulations under develop ment are outlined by agency staff members at the annual meeting of the State FIFRA Issues Research and Evaluation Group (p. 1461). HIGH PRIORITY for carcinogenesis testing by the National Cancer Institute's chemical selec tion subgroup is given to three dyes and the pesticide 2,4,5-TCP(p- 1464). A DRAFT DOCUMENT which outlines how the food, fertilizer, animal feed, and agricultural in dustries can examine their facilities for sources of potential polychlorinated biphenyl contamina tion is being reviewed by EPA prior to joint publication with the Food and Drug Administra tion and the Agriculture Department (p. 1464). PRESIDENT CARTER signs legislation giving the Department of Transportation authority to regulate pipeline transportation of petroleum and other hazardous liquids (p. 1465). SUPERFUND LEGISLATION being con sidered by a Senate committee may include provisions for the siting of hazardous waste facilities, according to a committee aide (p. 1466). EPA PLANS IN 1980 to expand the list of hazardous substances designated in the Clean Water Act and to propose hazardous substance BENZENE VAPOR EXPOSURE for spill clean-up regulations, according to an EPA tankermen and ship and towboat personnel would Office of Water Planning and Standards staff be limited to 10 parts per million over an member (p. 1467). Section 1 Copyright 1979 by The Bureau of National Affairs. Inc. 0148- 7973/79/S00.50 SL 027384 Current Report Testing FIRST SECTION 4 RULE TESTING DECISIONS TO BE MADE FOR TWO CHEMICALS, ONE GROUP Acrylamide, ehloromethnne, and chlorinated benzenes are expected to be the first chemicals considered for testing rules under Section 4 of the Toxic Substances Control Act, according to an Environmental Protection Agency official. Warren Muir. EPA's deputy assistant administrator for testing and evaluation, told an industry group December 5 that EPA's first determinations of whether or not to lest sub stances given priority for testing by the Interagency Testing Committee (ITC) will be made on these two substances and one group Muir said EPA expects to propose a rule in the first quarter of 1980 .which either would require testing for the substances or would give EPA's reasons for deciding not to do so (Current Report, October 20, p. 1285). Muir said the decisions on whether or not to test wouldionly address health effects testing Chloromethane and chlorinated benzenes were recommended for testing by the jITC in October 1977 Acrylamide was recommended for testing in April of 1978. EPA has been under considerable pressure to develop test rules for the ITC recommendations ever since the Natural Resources Defense Council brought suit against the agency for not developing test rules within one year after the sub stance was recommended for testing (May 11, p 143). The ITC has recommended 38 substances or groups of sub stances for testing under Section 4 of TSCA. Legislation SENATE PANEL APPROVES BILL MAKING ENVIRONMENTAL 'ENDANGERMENT' A FELONY A person or corporation that places others in imminent danger in violation of federal health, safety, or environmen tal laws would be guilty of a felony under a bill approved by the Senate Judiciary Committee December 4. The measure (S 1722) would create a new federal felony offense called "endangerment." A person would be guilty of endangerment if he engages in "conduct that he knows places another person in imminent danger of death or serious bodily injury" and his conduct shows an unjustified disregard of human life. To constitute a federal offense, however, the conduct, would have to occur within an area under special federal jurisdiction or be in violation of one of the following laws: Toxic Substances Control Act; Federal Insecticide. Fungicide, and Rodentieide Act; Federal Water Pollution Control Art; Solid Waste Disposal Act; Clean Air Act: Noise Control Act; Occupational Safety and Health Act; Federal Coal Mine Safely and Health Act; Food. Drug, and Cosmetic Act, Public Health Service Act; Federal Hazardous Substances Act; Outer Continental Shelf Lands Act, Marine Protection Research and Sanctuaries Act; or Rivers and Harbors Act. If the conduct shows "an extreme indifference to human life," the offense would be a "('lass D felony," carrying a penaltv of up to five years imprisonment and a fine of up to $250,000. If the circumstances show only "an unjustified disregard" of human life, the offense would be a "('lass E felony," punishable by up to two years in-prison and a fine of up to $250,000. If the violator is a corporation or other organization, the maximum fine would be $1 million Compromise Reached According to Judiciary Committee staff members, the en dangerment provision represents a compromise among the commitlee. Department of Justice, and business interests represented by the Htisiness Roundtable The original version of S. 1722, introduced by Senator Edward M Kennedy (D-Mass) September 7. contained a more comprehensive endangerment provision The initial bill would not have required a finding of "unjustified dis regard" of human life for establishing the offense. It also would have applied the penalties to conduct that endangers others and violates any law "designed to protect public health and safety In an attempt to create a bill that would have industry sup port. the committee approved a narrower version of the en dangerment provision. At this stage, the bill would have re quired a finding of "extreme indifference to human life." as a condition for establishing the offense. This version would have applied the sanctions only to conduct in violation of the Federal Coal Mine Health and Safety Act, Clean Air Act, Federal Water Pollution Control Act, Noise Control Act, or Outer Continental Shelf Lands Act Rut the Department of Justice protested the limiting of while-collar crime provisions of the bill, prompting the com mittee to reconsider The final measure lists specific health and safety laws which may involve the offense of endanger ment John Rlnuch. special counsel to the Business Roundtable, told Chemical Regulation Reporter that the Roundtable con sidered the general reference contained in the Kennedy ver sion too vague Although the final version applies to most major public safety and health laws administered by federal agencies, it does not include such laws as the Consumer Product Safety Act. the Hazardous Materials Transportation Act, or the Natural (5ns Pipeline Safety Act. The inclusion of environmental laws, including TSCA and FI-FRA, was done at the insistence of Senator Patrick Leahy (l)-Vt), Other laws, including the Occupational Safety and Health Act and the Food. Drug, and Cosmetic Act, were in cluded at the request of the Justice Department's Criminal Division According to a Criminal Division staff member, the divi sion stressed inclusion of the statutes that have given rise to the greatest practical prohlems in enforcement. He said the Occupational Safety and Health Act had the highest priority for inclusion in the view of the division. Bill Would Increase Existing Penalties The lull also includes a seetion which codifies and in some cases increases penalties for criminal offenses under nine existing environmental laws 12-7-79 Copyright `r 1979 by Tho Bu-eau of National Affairs. let. 0MB 7973'7SeS0't50 SL 027385 74920 Federal Register / Vol. 44, No. 244 / Tuesday, December 10, 1979 / Notice - Dated: December 10,1979, Frank H. Madden, AID Advisory Committee Representative. Joint Committee on Agricultural Development, Boardfor International Food andAgricultural Development. [FR Doc. 79-MM5 Filed IWM(: < 49 llti) Biuma CODE 4T10-02-M DEPARTMENT OF LABOR Occupational Safety and Health Administration Occupational Exposure to Vinyl Chloride and Polyvinyl Chloride agency: Occupational Safety and health Administration. Department of Labor. action: Request for information .on vinyl chloride and polyvinyl chloride. summary: This notice requests information on vinyl chloride (CAS No. 75-01-4) and on polyvinyl chloride (CAS No. 9002-86-2). Vinyl chloride (VC), a ( synthetic chemical, was once synthesized by the addition of hydrogeA chloride to acetylene. Cuirently, the most common route of prbduction is by the halogenation of ethylene. In this latter process, ethylene i3 reacted with hydrogen chloride and oxygen to give ethylene dichloride, which is subsequently cracked thermally to produce vinyl chloride and hydrogen chloride. Vinyl chloride is used primarily to produce polyvinyl chloride (PVC), a plastic resin, through conversion of the VC monomer into a polymer or copolymer form. Vinyl chloride is also used in the production of methyl chloroform and in the production of resins as a comonomer with vinylidene chloride. PVC is used in the manufacture of a variety of industrial and consumer products, such as containers, wrapping film, electrical insulation, and pipes. In 1975, OSHA regulated vinyl chloride as a carcinogen, based primarily on evidence of excess liver angiosarcoma incidence following VC exposure (29 CFR 1910.1017). OSHA did not regulate exposure to PVC dust in the snme standard. Therefore, it continues to be regulated as an inert or nuisance air contaminant (29 CFR 1910.1000, Table Z-3). Research since 1975 has provided considerably more information concerning the carcinogenic and other toxic effects of VC and PVC exposure. OSHA is currently in the process of evaluating the available evidence pertaining to the potential occupational health hazards of VC and of PVC and. by this notice, is requesting information related to several important issues. date: The information requested in this notice must be submitted in quadruplicate on or before February 10, 1980. address: The information requested in this notice should be submitted to the Docket Officer, Docket No. H-G34, Room S0212. U.S, Department of Labor, OSHA, 200 Constitution Avenue, N.W., Washington, D.C. 20210, (202-523-7894). FOR FURTHER INFORMATION CONTACT: Dr. Peter Infante, Office of Carcinogen Identification and Classification, Directorate of Health Standards Programs, Room N371B, U.S. Department of Labor, OSHA. 200 Constitution Avenue, N.W., Washington, D.C. 20210, (202-357-0325). SUPPLEMENTARY INFORMATION*. Background Vinyl chloride (C,H,C1: CAS No. 75.01--4: chloroethcne) is a colorless gas at room temperature and pressure. After synthesis from VC monomer, polyvinyl chloride ((CiH,Cl),,; CAS No. 900Z-0G-2; chloroethcne homopolymer) is In the form of white or colorless granules. Residual vinyl chloride monomer can become trapped in the PVC particles. However, recent processing methods can reduce considerably the amount of residual VC trapped in the polymer resins. The vinyl chloride industry can be divided into three major components: VC synthesis, VC polymerization, and PVC fabrication. It has been estimated that in the U.S., 15 plants manufacture vinyl chorfde, 43 plants polymerize polyvinyl chloride, and at least 7,500 plants are engaged in the fabrication of PVC. During 1978, 3.47 million tons of VC and 2.94 million tons of PVC were produced. The present permissible limit for occupational exposure to vinyl chloride is 1.0 ppm averaged over any 8-hour period, and 5.0 ppm averaged over any period not exceeding 15 minutes (29 CFR 1910.1017). For polyvinyl chloride dust, the standard is 15 mg/m5, averaged over any 8-hour period (29 CFR 1919.1000). Laboratory Studies Experimental bioassays have demonstrated the induction of cancer by VC at levels of exposure lower than those previously reported. In VC inhalation studies of rats. Maltoui (1) has induced liver angiosarcomas at 25 ppm and mammary carcinomas at one ppm. In addition, several different test systems have provided evidence for llic mutagenic potential of VC, i.c., F. coli, S. typhinuiriinn, S. pombn. insects, plants, Rnd cultured mammalian cells (2). VC also has been demonstrated to have a transplacental effect in rats. Inhalation exposure of pregnant rats to VC concentrations of 6,000 and 10,000 ppm have resulted in VC-dependent tumors in their offspring (1). There is also evidence from animal studies that PVC may induce nonmalignnnt respiratory disease. It has been reported that after seven months of exposure, rats and guinea pigs caged in work areas where sacks were being filled.with PVC powder developed pulmonary pathological changes and granulomatous lesions containing foreign particles thought to be PVC dust (3). Epidemiologic Studies Several investigations of employee populations have indicated that VC/ PVC exposure is associated with an increased carcinogenic risk to several organ sites in addition to the liver. A NIOSH retrospective cohort study of workers from four VC polmerization plant showed an excess number of deaths due to cancer of the liver, lung, lympho-hcmntopoietic system, and central nervous system (4). Of further concern is the finding that the carcinogenic risk may extend to industries fabricating polyvinyl chloride. A proportionate mortality study of plastic workers in Great Britain, which included PVC fabricators, demonstrated o statistically significant excess of stomach cancer (5). Also, an excess of mortality from digestive system cancer among PVC fabricators of both sexes was found by CUiazze ct. al. in the U.S. (6). Among white females in the study, observed deaths from breast and urinary tract cancers were also greater than expected. Waxweilcr et, nl. performed a detailed study of the excess lung cancer risk previously observed at a synthetic plastics and rubber plant (7). Analysis of lung cancer cases by cell type demonstrated a greater frequency oT adenocarcinomas (Type 3) and large cell undifferented (Type 4) cancer. Neither cell type is believed to be strongly assoicatcd with cigarette smoking. Of 12 chemicals analyzed, only PVC dust exposure proved to be statistically significant. The authors suggested that the excess of Type 3 and 4 lung cancer cases in this plant was related to PVC dust exposure. A recent epidemiologic study suggests that PVC may be related to pneumoconiosis (8). Employees of a polyvinyl chloride production factory in Italy were submitted to chest X-ray examination. Twenty subjects were diagnosed as having pneumoconiosis. All of these cases bad worked five or more years in departments with demonstrated PVC dust pollution. No xr '& t i .t<. i k SL 027386 Federal Register / Vol. 44, No. 244 / Tuesday, December 18. 1979 / Notices 74929 pneumoconiosis was observed in Subjects who worked in areas free of ft3VC dust. These findings are consistent with earlier case reports of pneumoconiosis among workers exposed to PVC dust (9,10). The Institute of Oncology and Tumor Center in Bologna, Italy has demonstrated a higher frequency of cytolgoically abnormal sputum cells among the workers employed in the VC/PVC Industry in contrast either to workers in the general chemical industry or to individuals who are heavy smokers (11). Epidemiologic studies also exist which demonstrate the mutagenicity of VC in humans. Chromosomal aberrations in lymphocytes of male workers, in excess of the number observed in non-exposed workers, have been reported in several studies (2). Morever, a study of miscarriages among the wives of men occupationally exposed to VC detected a significant excess in fetal mortality following the husband's exposure to VC (12). Information requested on vinyl chloride and polyvinyl chloride The date recently received by OSHA suggest that a reassessment of the known health effects of vinyl chloride and polyvinyl chloride is appropriate at this time. Additional information in 'several areas is needed before a reassessment can be completed. The requested information includes, but is not limited to. the following: (1) Experimental test results for carcinogenicity of vinyl chloride at atmospheric exposures of less than 50 ppm. (2) Studies of transplacental carcinogenic and teratogenic effects in humans or animals at any level of exposure to vinyl chloride. (3) Experimental studies of carcinogenicity and other toxic manifestions for any level of polyvinyl chloride exposure. These effects should include, but are not limited to, mutagenicity, teratogenicity, embryotoxicity, and other transplacental effects, as well as cytotoxic and cytogenetic effects on sperm cells. To the greatest extent possible, complete information concerning the industrial source of the polyvinyl chloride, the size and characteristics of the particles, and exposure levels or concentrations of PVC and residual VC should be included for each study. (4) Epidemiologic studies of either vinyl chloride or of polyvinyl chloride fl.e. cohort, cross-sectional, or casecontrol). (5) Case reports and case series of brain, lympho-hcmatopoietic, lung, and liver cancers by facility end relevant demographic variables, such as age, sex, race, date of diagnosis, date of death, date of first exposure, end length of exposure for either vinyl chloride or polyvinyl chloride. (6) Mutagenicity study results of vinyl chloride or polyvinyl chloride os measured by the analysis of human body fluids, e.q., direct mutagenic testing with peripheral blood lymphocytes, non-disjunction in humans with YFF sperm test, and in vivo cytogenetics. (7) Body burden measurements of vinyl chloride in humans. (8) For operations involving polyvinyl chloride, the types of resin in use, the concentration of vinyl chloride trapped in the resin, and the concentration of VC and PVC dust in the atmosphere where individuals are working. This information should include estimates of the particles sizes and concentrations of particles that fall within the respirable range. (9) In PVC bagging and milling operations, atmospheric levels of PVC and VC, monitoring devices used to detect VC, and the type of respirator protection program for individuals working in these operations. This should include the sensitivity and validity of analytic techniques in use. (10) Types of occupations, job classifications, and industries where exposure to either VC or PVC at any level may occur, and the numbers of employees involved in each vinyl chloride and polyvinyl chloride exposure situation, separated by sex and race. (11) Appropriate engineering controls, work practices, and personal protective equipment available to reduce levels of exposure to VC or PVC below the current standards, or to the lowest levels feasible. SUBMITTALS OF INFORMATION REQUESTED Interested persons are invited to submit written data, views, and comments with respect to the issues described abve. All communications should be submitted in quadruplicate, by February 10,1980, to the Docket Officer, Docket H-034, Room S6212, U.S. Department of Labor, 200 Constitution Avenue, N.W., Washington, D.C. 20210 (202-523-7894). References 1 lie following documents, referred to in this notice, are available for inspection und copying at the OSI (A Technical Data Center, Room Sli212, U.S. Department of Labor. 200 Constitution Avenue, N.W., Washington, D.C. .20210 1. Maltoni, C. Vinyl chloride carcinogenicity: An experimental model for carcinogenesis studies. Origins of Human Cancer, Cold Spring Harbor Laboratory, 1077, pp. 119-146. 2. Wagoner,). K,, and P. F. Infante. Vinyl chloride: A case for the use of laboratory bionssay in the regulatory control procedure. Origins of Human Cancer, Cold Spring I [arbor Laboratory. 1977. pp. 1797-1605. 3. Frongia, N,, A. Spinazzola and A. Bucarcili. Lesioni polmonari aperimentali da inalazione prolungata dl polveri di PVC in ainbicnte di lavoro: (Expernicntal lung damage from prolonged inhalation of airborne PVC dust). La Medicina del Lavoro, 65: 371-342,1974. 4. Waxwcilcr, R.)., W. Stringer,). K. Wagoner,J. Jones, H. Falk, and C. Carter. Neoplastic risk among workers exposed to vinyl chloride. Annals of the New York Academy ofSciences, 271: 40-40,1976. 5. Baxter, P.). and A. ]. Fox. Angiosarcoma of the liver in PVC fabricators. Lancet, 1; 245240.1970. ' 6. Chiazze, L, W. E. Nichols, and O. Wang. Mortality among employees of PVC fabricators. Journal of Occupational Medicine. 19: 623-628,1977. 7. Waxweiler. R,)., A. H. Smith, H. A. Tyroler, and H. Falk. An epidemiologic investigation of an excess lung cancer risk in a synthetic chemicals plant. Presented at the XIX International Congress on Occupational Health, Dubrovnik Yugoslavia, 25-30 September 1978. 8. Mastroangelo, G., M. Manno, G. Marier, G. B. Baitolucd, C. Gcmignani, G. Saladino, L. Simunato, and B. Soia. Polyvinyl chloride pneumoconiosis: Epidemiological study of exposed workers.Journal of Occupational Medicine, 21: 540-542.1979. 9. Szende. B., K. Lapis, A. Nemes, and A Pinter. Pneumoconiosis caused by the inhalation of polyvinyl chloride dust. La Medicina del Lavoro, 61:433-436,1970. 10. Amaud, A., P. Pommier de Santi, L Garbe, II. Payan. and ). Charpin. Polyvinyl chloride pneumoconiosis. Thorax, 33,19-25, 1978. 11. Maltoni, C. Precursor lesions in exposed populations as indicators of occupational cancer risk. Annals of the New York Academy ofSciences, 271:444-147,1976, 12. Infante, P. F., J. K. Wagoner, A.). McMichacl, R. f. Waxweiler, and H. Falk. Genetic risks of vinyl chloride. Lancet, 1: 734735,1976, Signed at Washington, D.C. this 12th day of December 1979. Euia Bingham. Assistant Secretary ofLabor. P'R Doc- 7S-306SS Filed 12-17-7S; B45 am] 6ILLINQ CODE 451S-H-M Pension and Welfare Benefit Programs (Prohibited Transaction Exemption 79-79; Exemption Application No. D-837) Exemption from the Prohibitions for Certain Transactions Involving College Retirement Equities Fund agency: Department of Labor. SL 027387