Document e5xONY65oxjvKbyEL1yodYQ34

MANUFACTURING CHEMISTS ASSOCIATION W. A. IA 1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D. C. 20009 (202) 483-6126 MAY i 3 m For Immediate Release CONTACT: Richard F. Blewitt (202) 483-6126, ext 282 WASHINGTON, D C , May 7 -- Vinyl chloride workers have experienced overall death rates that compare favorably to those experienced by other U. S industrial populations, according to the findings of a just-completed survey. Administered by the Manufacturing Chemists Association (MCA) on behalf of vinyl chloride and polyvinyl chloride producers, the survey was conducted by Tabershaw-Cooper Associates, Inc. It identified 8,384 past and present employees of the VC/PVC industry and had determined the vital status of 7,128. Among these individuals, 352 deaths had occurred during the period under study and death certificates had been obtained on 328 Initiated June 15, 1973, the survey showed that although the total number of such cases was small, there did appear to be suggestive dose-related increases in the incidence of cancers of the urinary organs and the brain in the longer-exposed workers, as compared with their counterparts who, at the time of death, had worked for shorter periods in jobs exposing them to vinyl chloride The study showed, however, that statistically significant differences in mortality appeared only where reported death rates were lower than that of the general population (more) AS I 000017895 Page 2 of 2 Dr. Irving R. Tabershaw, of Tabershaw-Cooper, is to report the results of the survey at a meeting to be held under the auspices of the New York Academy of Sciences May 10. MCA announced on April 16 preliminary indications that vinyl chloride exposure produced liver angiosarcomas -- a rare cancer -- in mice at several exposure levels Industrial Bio-Test Laboratories. Inc., which is conducting the MCA-administered vinyl chloride animal exposure study, informed MCA that their preliminary findings tend to confirm the findings of Professor Cesare Maltoni, an Italian scientist, who found that vinyl chloride exposure caused such cancer in rats The animal exposure study is continuing and the producers are looking at other areas for further vinyl chloride testing. ### MCA-3843 000011896 AS I MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D. C. 20009 (202) 483-6126 May 28, 1974 To: Management Contacts of Companies Supporting the Vinyl Chloride Research Program Technical Task Group on Vinyl Chloride Research Subject Important Notices in Federal Registers re Vinyl Chloride Gentlemen: On May 10, 1974, the Occupational Safety and Health Admini stration (OSHA) proposed a permanent standard for occupational exposure to vinyl chloride. In response to several requests, OSHA has scheduled an informal Hearing to begin at 9:30 AM June 25, 1974, in the Departmental Auditorium, Washington, D. C. Notice of intention to appear at the Hearings to participate in the presentation of data must be filed no later than June 17 (Federal Register May 24, 1974),, Also, published in the Federal Register May 23, 1974 was a proposal of the Consumer Product Safety Commission to ban as a hazard* ous substance any self-pressurized product (aerosol product) for house hold use containing vinyl chloride. Copies of notices, pertaining to these regulatory actions, as appearing in the Federal Registers, are enclosed. Sincerely, ya Kenneth D. Johnson, Ph.D. Secretary Technical Task Group on Vinyl Chloride Research KDJ/mw Enclosure cc: Mr. A. W. Barnes Dr. D,, P. Duffield Dr. Tiziano Garlanda 00n0n0f\11 7T 8^7 AS I PROPOSED RULSS 18303 Copied by MCA DEPARTMENT OF LABOR Occupational Safety and Health Administration [29 CFR Part 1910] (Docket OSH-36J ,, VINYL CHLORIDE; OCCUPATIONAL EXPOSURE STANDARD Hearing On May 10, 1974, notice of proposed rulemaking with regard to a permanent standard for occupational exposure to vinyl chloride was published in the Fed eral Register (39 FR 16896). The notice provides an opportunity for public par ticipation in the proceeding, by means of written submissions to be mailed to the given address, postmarked no later than June 10, 1974. The notice also per mits interested persons to file objections to the proposed standard set out in the notice and request a hearing thereon. The objections must specify the pro visions of the proposed standard to which objections are made, state the grounds for the objections, be accom panied by a summary of the evidence to be adduced at the requested hearing, and must be postmarked no later than June 10, 1974. Informal contacts with Occupational Safety and Health Administration staff have disclosed widespread interest in the proceeding, a probability of requests for a hearing, and an alleged need for more time for the submission of written com ments and the formulation of objections in accordance with the requirements of the notice. Accordingly, it has been decided to waive the requirements for objections and request for a hearing thereon and instead to set for hearing the entire pro posed standard, set forth in the May 10 notice. It is hoped that this decision will: (1) Eliminate the possible .difficulty of formulating appropriate objections with in the short period of time fixed in the notice; (2) permit full participation at the hearing, without limitation as to Is sues; and (3) expedite the proceeding, in view of the six-month provision in sec tion 6(c) of the Williams-Steiger Occu pational Safety and Health Act of 1970, and the expectation that a hearing would be requested and scheduled anyway. Therefore, pursuant to sections 6(b), 6(c), and 8(c) of the Occupational Safe ty and Health Act of 1970 (84 Stat. 1593, 1596, 1599; 29 U.S.C. 655, 657), Secretary of Labor's Order No. 12-71 (36 FR 8754) and 29 CFR Part 1911, the notice of the proposed rulemaking on vinyl chloride published on May 10, 1974 at 39 FR 16896, is hereby amended in the follow ing respects: (1) The part of the notice concerning the filing of objections and requests for hearing, in the third full paragraph of the middle column of page 16897 of the May 10 issue of the Federal Register, is withdrawn; and (2) in lieu thereof the following paragraphs arc added: Data, views, and arguments concerning the proposed standard will be received by an ad ministrative law judge, to be appointed by the Chief Administrative Law Judge of the Department of Labor at an informal hear ing to begin at 9:30 a.m, June 25, 1974 In the Departmental Auditorium on Constitution Avenue, between 12th & 14th Streets, NW., Washington, D.C. The hearing shall be conducted in accord ance with the rules of procedure In 29 CFR Part 1911. Any interested person desiring to participate at the hearing must file a notice of intention to appear with Ms. Joanne Good ell, Attn: Docket OSH-36, Occupational Safety and Health Administration, 1726 M Street, NW., Hoorn 200, U.S. Department of Labor, Washington, D.C. 20210 no later than June 17, 1974. A notice must state the name and address of the person to appear, the ca pacity in which he will appear, and the ap proximate amount of time required for his presentation. In addition, to the extent prac ticable, the notice should contain a general statement of the position to be taken with respect to any provision of the proposed standard, and of the evidence to be adduced in support of the position. In all other respects, the May 10, 1974 notice of proposed rulemaking remains unchanged. Signed this 22d day of May 1974. John H. Stender, Assistant Secretary of Labor. [FR Doc. 74-12188 Filed 5-23-74:11:15 am] No. 102--Pt. i--s FEDERAL REGISTER, VOL 39, NO, 102--FRIDAY, MAY 24, 1974 ASI 000017898 1811' Copied by MCA. CONSUMER PRODUCT SAFETY COMMISSION [ 16 CFR Part 1500 ] _ SELF-PRESSURIZED HOUSEHOLD SUB STANCES CONTAINING VINYL CHLORIDE Proposed Classification as a Banned Hazardous Substance In response to recent Information on the toxicity of vinyl chloride monomer and in response to a petition received on February 21, 1974, from the Health Re search Group, Washington, D.C., the Consumer Product Safety Commission proposes to ban as a hazardous sub stance any self-pressurized product (aerosol product) for household use con taining vinyl chloride monomer. By notice published May 9, 1974 (39 FR 16511), the Commission determined that consumer products containing vinyl chloride monomer as a propellant or ingredient are products which could create a substantial product hazard and required manufacturers of such products to submit certain information to CPSC. Section 2(f)(1)(A) of the Federal Hazardous Substances Act (15 U.S.C. 1261(f)(1) (A)) defines "hazardous sub stance" as "any substance or mixture of substances which is toxic * * * if such substance or mixture of substances may cause substantial personal injury or substantial illness during or as a proxi mate result of any customary or rea sonably foreseeable handling or use, in cluding reasonably foreseeable ingestion by children." Section 2(g) of the act states that "the term toxic shall apply to any substance * * which has the capacity to produce personal Injury or illness to man through ingestion, inhala tion, or absorption through any body surface." Section 2(q) (1) (B) of the act defines a "banned hazardous substance" as "any hazardous substance Intended, or packaged in a form suitable, for use in the household, which the Secretary [now the Commission! by regulation classifies as a `banned hazardous sub stance' on the basis of a finding that, notwithstanding such cautionary label ing as is or may be required under thi ; Act for the substance, the degree o nature of hazard involved in the pres ence or use of such substance in house holds is such that the objective of the protection of the public health and safe ty can be adequately served only by keeping such substance, when so in tended or packaged, out of the channel.) of interstate commerce." The Commission has determined that reasonable grounds exist to propose the banning of self-pressurized products for household use containing vinyl chloride on the basis of toxicity. These grounds include the following: (1) Human data. On January 22,1974, the Occupational Safety and Health Ad ministration was informed by the Na tional Institute for Occupational Safety knd Health (NISH) that the B. F. Good rich Chemical Company reported that deaths of several of its employees from a rare form of liver cancer may have been occupationally related. The employees of the B. F. Goodrich Chemical Company who died from angio sarcoma of the liver had an average exposure of approximately 19 years of vinyl chloride, at unknown concentra tions, and variable exposures to other volatile chemicals. Some employees of Union Carbide Company and Goodyear Company are also reported to have had exposure to vinyl chloride and to have died from angiosarcoma of the liver. Finally, autopsies of four deceased em ployees revealed that liver angiosarcoma tumors were histologically indistinguish able from the angiosarcoma tumors observed in Professor Maltoni's experi mental animals (see below). (2) Animal data. Professor Cesare Maltonl, of the Institute dl Oncologia, Bologna, Italy, reported on a series of experiments on the effect of exposure of rats, mice, and hamsters to vinyl chlo ride at concentrations of 10,000; 6,000; 2,500; 500; 250; and 50 ppm for varying period of time. Some of the experiments have been concluded, and others are still ongoing. The experimental results so far reported are that tumors have been ob served in groups of animals exposed to vinyl chloride at concentrations as low as 250 ppm. These data are contained in the trans cript of an "Informal Fact Finding Hear ing on Possible Hazards of Vinyl Chloride Manufacture and Use," U.S. Department of Labor, Occupational Safety and Health Administration, February If, 1974. A copy of this document is avail able for public inspection at the Office o,' the Secretary, 1750 K Street NW., Wash ington, D.C. 20207. The Commission is in receipt of a peti - tion from the Health Research Group, set forth below, "to immediately prohibi the continued use of vinyl chloride as a propellant for aerosolized consume products and to remove all products con taining vinyl chloride as a propellan o from the market because there is sub stantial evidence that vinyl chloride 1) FEDERAL REGISTER, VOL 39, NO. 101--THURSDAY, MAY I, 1974 y^Sl OOOOl'?899 18116 PROPOSED RULES carcinogenic." The petitioner cities a 1964 report that estimates that use of self-pressurized products containing vinyl chloride could result in exposure to a concentration of over 250 ppm. The Commission is also aware that the Occupational Safety and Health Ad ministration published in the Federal Register on April 5, 1074, an Emergency Temporary Standard for Exposure to Vinyl Chloride (39 FR 12342). This Emergency Standard sets an occupa tional exposure limit of 50 ppm of vinyl chloride in air. Further, the Occupational Safety and Health Administration on May 10, 1974 (39 FR 16896), proposed a standard for employee exposure at no detectable level. In addition, the Food and Drug Administration on April 22, 1974 (39 FR 14215), published a notice of proposed rule making for vinyl chlo ride as an ingredient of drug and cos metic aerosol products. The Commis sioner of FDA determined: (1) That vinyl chloride presents an unnecessary hazard to the public health when it is used as an ingredient in cosmetic aerosol products and that such use should be banned and (2) vinyl chloride, when used as an Ingredient in drug aerosol products, is not generally recognized as safe and effective, and requires an ap proved new drug application as a condi tion of marketing. In the same notice, FDA requested a recall of all drug and cosmetic aerosol products containing .vinyl chloride. Further, on April 26, 1974 (39 FR 14753), the Environmental Protection Agency published an emergency suspen sion order concerning registration for pesticide spray products containing vinyl chloride and an intent to cancel registrations. In the publication, EPA announced preliminary results of ex periments at Industrial Bio-Test Labora tories which indicate that angiosarcoma was observed in mice exposed to vinyl chloride concentrations as low as 50 ppm. EPA also announced an agency calculation showing that under reason able conditions of use of self-pressurized products, the level of exposure might be as high as 400 ppm. On the basis of the information re ferred to above, the Commission has de termined that inhalation of vinyl chlor ide may be hazardous and that any use of a self-pressurized product exposes the consumer to Inhalation of some of its contents. Therefore, the Commission has reason to believe that precautionary la beling would be insufficient to protect the public health and safety if selfpressurized household products contain ing vinyl chloride entered the channels of interstate commerce. Therefore, pursuant to provisions of the Federal Hazardous Substances Act (secs, 2 (f)(1)(A), (q), (3) (a), 74 Stat. 372, 374, as amended 30 Stat. 1304-05; 15 U.S.C. 1261 (f)(1)(A), (q), 1262(a)) and the Federal Food, Drug, and Cos metic Act (sec. 701 (e), (f), (g), 52 stat. 1055-56, as amended 70 stat. 919,72 Stat. 948; 21 U.S.C. 371 (e), (f), (g), and under authority vested in the Commis sion by the Consumer Product Safety Act (sec. 30(a), 86 Stat. 1231; 15 U.S.C. 2079(a)), the Commission proposes to amend 16 CFR Part 1500 by adding a new paragraph (a) (10) to sec. 1500.17 as follows: 1500.17 Banned hazardous substances. (a) Under the authority of section 2(q)(l)(B) of the act, the Commission declares as banned hazardous substances the following articles because they pos sess such a degree or nature of hazard that adequate cautionary labeling can not be written and the public health and safety can be served only by keep ing such articles out of interstate commerce: **4** (10) Self-pressurized products In tended or suitable for household use that contain vinyl chloride monomer. Interested persons are invited to sub mit, on or before June 24, 1974, written comments regarding this proposal. Com ments and any accompanying material should be submitted, preferably in 5 cop ies, addressed to the Secretary, Con sumer Product Safety Commission, Washington, D.C. 20207. Comments may be accompanied by a memorandum or brief in support thereof. Received com ments may be seen in the Office of the Secretary, tenth floor, 1750 K Street NW., Washington, D.C., during working hours Monday through Friday. Dated: May 20,1974. Sadye Dunn, Secretary, Consumer Product Safety Commission. The Health Research Group petition reads as follows: Before the Consumer Product Safety Commission HEALTH RESEARCH GROUP, PETITIONER To: Richard Simpson, Chairman, Consumer Product Safety Commission. Petition To Immediately Prohibit the Con tinued use of Vinyl Chloride as a Propel lant for Aerosolized Consumer Products and To Remove all Products Containing Vinyl Chloride as a propellant From the Market Because There Is Substantial Evi dence That Vinyl Chloride Is Carcinogenic I. Petitioner. Petitioner Health Research Group is a non-proflt organization engaged In public Interest research on health Issues, including consumer product safety. It is funded by public Citizen, many of whose members use aerosolized consumer products. II. Authority lor Petition and Regulation, Petitioner's authority to petition for rulemaking is the Administrative Procedure Act, 6 U.S.C. 553(e). The authority of the Con sumer Product Safety Commission to pro mulgate this rule is 15 TJ.S.C, (The Federal Hazardous Substances Act), 5 1261 (q) (2), 1262, 1263, and 1265. III. Summary of Reasons for This Petition. Vinyl chloride is a toxic substance known to be commonly used as a propellant in aero solized products. No regulations currently prohibit such use of vinyl chloride. Vinyl chloride monomer is a colorless gas which can cause acute toxicity manifested by dizziness, headache, disorientation, and unconsciousness at high concentrations. I*, has been linked to osteolytic (bone destruc tive) lesions of the hands, liver disease, and liver cancer in workers engaged in the polym erisation of polyvinyl chloride from vlr.yH chloride monomer. In one study of industrial workers exposed to vinyl chloride 30% were found to have liver enlargement. At exposure levels as low as 250 ppm, vinyl chloride has produced liver cancer in rats. Of greatest significance, since 1964 five workers engaged in miking polyvinyl chloride from vinyl monomer at one plant have died from a rare and invariably fatal form of cancer of the liver. The most recent death was Decem ber 19. 1973. This cancer has recently been diagnosed In a sixth worker in the same plant. IV. The Use or Presence of Vinyl Chloride in Consumer Products. Vinyl chloride is among the most often-used propellants in aerosol3. (Postgraduate Medicine, p. 65; Re port of the Committee on Aerosol Toxicity, p. 19: Aerosol Age, p. 47.) A 1964 report esti mated that an aerosol product sprayed in a tiny room of 282.5 cubic feet for 30 second.; would result in 0.025 % vinyl chloride by volume. (Aerosol Age. p. 47.) This level would correspond to over 250 ppm vinyl chioride in the air of a room that size,1 not unlike the size of many bathrooms in small apartments. V. Prior Regulatory Actions on Vinyl Chlo ride--1971. In 1971 under Section 6(a) of the Occupational Safety and Health Act of 1970, the Department of Labor adopted as a Federal standard a celling level of 500 ppm (1300 mg/m') for occupational exposure to vinyl chloride, based on the recommendations of the American Conference of Governmental Industrial Hygienists (ACGIH), (Federal Register of May 29, 1971). The ACGIH ha3 since recommended 200 parts per million as a revised voluntary celling value for occupa tional exposure to the chemical. (Documen tation of Threshold Limit Values, p. 477). 197-3. On May 15. 1973. the Food and Druji Administration published a notice of pr posed rule-making for the "prlor-sanctionc^ polyvinyl chloride resin," The notice proposed that the resin not be used as a component of food packaging material for use in contact with alcoholic foods, since both industry and FDA laboratory analyses had found that the vinyl chloride monomer migrates to alcohol from PVC bottles used to package distilled spirits and wine. Analytical results from in dustry confirmed that levels of up to 20 ppm of vinyl chloride were found to have migrated to the alcohol from the container after it had been stored for up to one year. The FDA concluded: "Vinyl chloride monomer as such is a poisonous and deleterious substance. FDA knows of no studies which establish a safe level of consumption when this monomer is leached from containers into alcoholic foods." (Federal Register of May 15, 1973). 1973. A July 13, 1973, FDA notice in the Federal Register extended the time for filing comments on the FDA proposal for restric tlons on polyvinyl chloride packaging, at 11 request of the plastics Industry. The not1 . stated that the Bureau of Alcohol, Toba o and Firearms of the Treasury Departmc.it (which had first authorized experimental use of PVC bottles for liquor in November, 1968) had terminated the use of PVC containers for alcoholic beverages pending final action by the FDA on the proposal. As of this date (2/21/74) the Food and Drug Administration has not finalized its proposal of May 17, 1973. 1974. In direct response to the deaths from a rare form of liver cancer of four workers at 1 Using Aerosol Age's reference that 16.5% by volume corresponds to 460 g. vinyl chloride/M3, and a conversion factor of 600 ppm=1300 rng/M3 (ACGIH.) FEDERAL REGISTER, VOL. 39, NO. 101--THURSDAY, MAY 23, 1974 OOOOH900 AS1 PROPOSED RULES 18117 me polyvinyl chloride plant, the Department Dr. Maltoni reported that he is currently Dated: Washington, D.C., February 21, of Labor published on January 30, 1974, a conducting an experiment using 300 rats 1974, request for information and a notice of a exposed to 50 ppm, since the failure of the fact-finding hearing on the possible hazards low dose of vinyl chloride to induce cancer associated with the maufacture and/or use may be a function of the small number of Respectfully submitted, Andrea M. Hricko. of vinyl chloride (Federal register Janu animals tested. Sidney M. Wolfe, M.D., ary 30, 1974). At the hearing held on Febru- In addition, Maltoni has observed two fi 2000 P. Street, N.W. #70S ry 15, 1974, the Industrial Union Depart brosing angiosarcomas in the offspring of Washington, D.C. 20036. ment of the AFL-CIO petitioned for an emer pregnant rats exposed to vinyl chloride. He gency temporary standard to prevent any stated that such fibrosing angiosarcomas References worker exposure to vinyl chloride. have never been observed as occurring spon American Conference of Government Indus VI. The Grave Danger Resulting from Ex taneously in Sprague-Dawley rats. trial Hygienists (ACGIH), Documentation posure to Vinyl Chloride--A. Acute Effects. C. other Evidence of Liver Disease. As of Threshold Limit Values, 1971, pp. 477- vinyl chloride is a gas which can cause un- early as 1961 Torkelson et al. reported that 478. -onsciousness at extremely high concentra abnormal histologic changes were noted in Bernstein, I. L., "Medical Hazards of Aero tions. Inhalation of a 2.6% concentration of the livers of rabbits after repeated exposures sols," Postgraduate Medicine, December vinyl chloride can cause dizziness, disorienta to 200 ppm of vinyl chloride. Slight liver 1972, pp. 62-68. tion and headache (ILO, p. 1466). At an 8- enlargement was noted at doses as low as 100 "Consumer Packaging", Chemical and En concentration cardiac arrythmias have ppm (Torkelson et al.). gineering News, April 12, 1971, p. 22. been observed in experimental dogs (ACGIH, A 1967 French study of 168 workers en Federal Register, Vol. 36, *No. 105, May 29, p. 477). The Committee on Aerosol Toxicity gaged in the production of FVC found liver 1971, p. 10505. has voiced concern over the use of certain enlargement in 30% of the cases studied Federal Register, Vol. 38, No. 95, May 15. gases--including vinyl chloride--as com (Suciu et al.). 1973, p. 12931. ponents of propellant/solvent systems in A later report of the health experience of Federal Register, Vol. 38, No. 134, July 13, aerosols because they are capable of produc Dow Chemical's vinyl chloride workers re 1973, p. 18684. ing "cardiac sensitization" (Committee Re vealed no overt illness, but did determine Federal Register, Vol. 39, No. 21, January 30, port, p. 19). that certain blood tests of liver function 1974, p. 3874. B. Evidence of Carcinogenicity, On Janu (e.g. beta liproprotein, the Icterus index, and International Labour Organization (ILO), ary 22, 1974, the B. F. Goodrich Company an bromosulfalein retention time) were abnor Encyclopedia of Occupational Safety and nounced that three--and it Is now known mally altered. On the basis of their findings, Health, 1972, p. 1466, five--of its Louisville, Kentucky, vinyl-chlo the authors concluded that some degree of Kubler, Hans, "The Physiological Properties ride workers had died of angiosarcoma (or liver dysfunction might result from a TLV of Aerosol Propellants," Aerosol Age, April hemangioendothelioma) of the liver, an ex for vinyl chloride of 300 ppm (Mutchier et 1964, pp. 44-50, 90-91. ceedingly rare form of liver cancer. The five al.). Maltoni, Prof, Cesare, Instltuto dl Oncologies. deaths occurred between 1964 and 1973, with Marstellar et al. reported within the past Bologna, Italy, Testimony at Department the time of development of liver cancer after few months that 19 out of 20 workers who of Labor Hearing on Vinyl Chloride, Feb i he onset of exposure to vinyl chloride in the had been exposed to vinyl chloride for iys ruary 15,1974, four workers for whom this Information is to 21 years at a FVC producing plant in Marstellar, H, J,, et al., Deutsche Med. Wirk- known from 14 to 27 years. Germany had some type of liver disease, in schaft 98:2311, 1973, cited by Dr. Irving The National Institute for Occupational cluding gross changes of the liver and spleen. Sellkoff at February 15, 1974, Department Safety and Health, estimating that only Direct inspection of the liver and spleen (by of Labor Hearing on Vinyl Chloride. twenty to thirty people dio in the United surgical operation) showed disease to he Mutchier, J. E., Kramer, C. G,, Report on States every year from this particular typo present in 14 out of the 20 workers (Marstel Relation of Exposure to State of Health of of cancer, has announced the discovery of a new occupational cancer associated with the polymerization of polyvinyl chloride from vinyl chloride, with vinyl chloride as the chief causative suspect (Statement of Dr, lar et al.). D. Evidence of Other Chromic Effects. In October 1963 osteolytic lesions were first ob served In two Belgian plastics workers who were also suffering from Raynaud's phenom Dow Chemical Workers, Gordon Confer ence, Tilton, New Hampshire, August, 1968, cited in Documentation of Threshold Limit Values, p. 278. Marcus Key, February 1, 1974). The disease enon due to constriction of the local blood Report of the Committee on Aerosol Toxicity, is invariably fatal, once cancer has been ini vessels in their hands (ILO, p. 1466), This August 4, 1972, p. 19 (Chairman: Dr. Albert tiated (Statement of Dr. Irving Sellkoff, Feb ruary 15, 1974). The carcinogenic effects of exposure to vinyl chloride have been demonstrated by Viola and Maltoni, in separate experiments. hand syndrome--termed acroosteolysis--has since been observed in over 30 workers in the United States employed in the manufacture of PVC resins (Wilson et al.), VII. Relief Requested. We request that C. Kolbye, Jr.) Samuels, Sheldon, Industrial Union Depart ment, AFL-CIO, Testimony presented February 15, 1974, at Department of Labor Viola produced angiosarcomas of the liver in the Chairman of the Consumer Product Hearing on Vinyl Chloride, citing figures rats when exposed to 30,000 ppm for 4 hours/ day, 5 days/week, for 12 months (Viola, p. 20). Maltoni has produced the same type of cancers when exposing rats to much lower doses (Statement of Prof. Cesare Maltoni, Safety Commission declare aerosolized con sumer products containing vinyl chloride to be "banned hazardous substances," under the definition of 15 U.S.C. 5 1261(q) (1) and under the authority granted the Chairman supplied by Industry sources, Sellkoff, Irving, Professor, Mt, Sinai School of Medicine, Testimony at Department of Labor Hearing, on Vinyl Chloride, Febru February 16, 1974), After 127 weeks of ex posure to vinyl chloride (4 hours/day; 5 days a week, by inhalation), Maltoni reported liver tumors in Sprague-Dawley rats at exposures as low as 250 ppm. (See table below), Results of Maltoni's Exteiumestal Studt in 1262. Moreover, under the authority of 1265, the Chairman is requested to remove from sale such consumer products contain ing vinyl chloride as propellants and to prohibit the introduction of such aerosolized products containing vinyl chloride into in ary 15,1974. Suciu, I., Drejman, I., and Valaskl. M. "Etude des Maladies dues au chlorure de Vinyle," Clinique des maladies professionals, Vol. 58, No. 4,1967 (English abstract.) Torkelson, T, B,, Oyen, F., Rowe, V. K., Exposure level-- vinyl chloride, by inhalation Number of animals exposed Number of animals developing liver angiosarcomas terstate commerce. The chronic toxicity and evidence of car cinogenicity of vinyl chloride monomer for' humans has been documented by scientific studies and clinical reports. Further use of Amer. Indust. Hyg. Assn. J., 22:354 (1961), cited in Documentation of Threshold Limit Values, p. 277. Viola, P. L., "Cancerogenlc Effect of Vinyl Chloride," Ahstr. 10th. International Can 10,000 fl,oOo ppm______ 2,500 ppm..............4 500 ppm_________ j 250 ppm 7 50 ppm____ m 72 74 67 67 64 i vinyle chloride monomer as a propellant for cer Congress, Houston, Texas (1970), p. 20. li aerosolized consumer products must be pro Wilson, R. H., et al, "Occupational Acroo hibited since there is no evidence that hu steolysis: Report of .81 Cases," JAMA, i man beings can safely be exposed to the chemical. 201:677-581,1967. [FR Doc.74-11938 Filed 6-22-74:8:45 am) No. 101--Pt. I- FEDERAL REGISTER, VOL. 39, N , 101--THURSDAY, MAY 23, 1974 ASI 000017901 MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D. C. 20009 (202) 483-6126 AK VAY ' May 13, 1974 To the Management Contacts of Companies Supporting the Vinyl Chloride Research Program and the Technical Task Group on Vinyl Chloride Research Subject: Proposed Permanent Standards for Vinyl Chloride Gentlemen: Distributed herewith are copies of the OSHA proposal in the Federal Register for Friday, May 10, with respect to permanent occupational health standards for vinyl chloride. Please note that comments and/or requests for a public hearing should be submitted to the Docket .Officer, Docket OSH-36, Room 230, 1726 M Street, N.W., Occupational Safety and Health Administration, Washington, D. C. 20210, post marked not later than June 10. Sincerely, KDJ:mb Attachment cc : Mr. A. W. Barnes D. P. Duffield, M.D. Dr. Tiziano Garlanda Kenneth D. Johnson, Ph.D. Secretary - Technical Task Group on Vinyl Chloride Research PROPOSED RULES 16897 made for an opportunity to observe record to an employee's physician on the (5) "Decontamination" means reduc monitoring by employees or their desig employee's request. Establishments con tion of vinyl chloride concentrations to nated representatives, as required by sec ducting VC operations would be required less than detectable levels. tion 8(c) (3) of the Act. to identify themselves to OSHA, and to (6) "Detectable level" means an air C. Control methods. Where detectable report incidents (accidents) resulting in borne concentration of vinyl chloride levels of VC are monitored, two pro the release of vinyl chloride. measurable by a sampling and analytical grams would be triggered; an engineer Accordingly, pursuant to sections 6(b), method capable of measuring concentra ing and work practice program to reduce Grt), and 8(c) of the Occupational tions of 1 ppm, with an accuracy of 1 levels below detectability; and while this Safety and Health Act of 1970 (84 Stat. ppm50 percent. is on-going, a respiratory protection pro 1593, 1596, 1599; 29 U.S.C. 655, 657), Sec (7) "Director" means the Director, Na gram for employees in the regulated area. retary of Labor's Order No, 12-71 (36 FR tional Institute for Occupational Safety Engineering controls and work prac 8754i and 29 CPR Part 1011, it is here and Health, or any person directed by tices are favored methods of compliance by proposed to amend 29 CPR Part 1910 him or the Secretary of Health, Educa because they tend to avoid contamina by revising 5 I9l0.93q as set forth below. tion. and Welfare to act for the Director. tion of the ambient air in the workplace. Written data, views, and arguments (8) "Emergency" means an unforseen Accordingly, it is proposed to require the concerning the proposals may be mailed circumstance or set of circumstances, re institution of engineering controls and to the Docket Officer, Docket OSH-36, sulting in the release of vinyl chloride of workpractice methods as soon as feasi Room 230, 1726 M Street, N.W., Occupa into areas occupied by employees, ble, and to require the use of respirators tional Safety and Health Administra (9) "Exposure" means actual contact pending the institution of such controls, tion, Washington, D.C. 20210, post with vinyl chloride when unprotected by to supplement such controls where they marked not later than June 10,1974. required personal protective equipment are insufficient to reduce concentrations Pursuant to 29 CPR 1911.11 (b) and and clothing. of vinyl chloride below the detectable (c), interested persons may file objec (10) "Fabricated product" means a level, in specified work situations, and tions to the proposals, requesting an in finished product or part of such product, in cases of emergency. The proposal for formal hearing with respect thereto, in made of polyvinyl chloride, entirely or in continuous flow and pressure demand accordance with the following condi part, including semifinished products types of respirators is based on the rec tions : such as film, sheet, block, bar, or extru ommendations of NIOSH, which has ob (1) The objections must include the sion stock. served leakage through chemical car name and address of the objector; (11) "OSHA Area Director" means the tridge respirators at high concentrations (2) The objections must be post Director for the Occupational Safety and of VC. A requirement would also be estab lished for the provision and use of pro tective clothing for employees in the reg ulated areas. The protective clothing would minimize skin contact with VC vapor, and would provide some measure |pf protection from splash of liquid in fthe event of a spill or rupture of equip ment. Pood, beverages, and like products would be prohibited in the regulated area. Written operational and emergency plans would be required, along with em ployee training in routine and emergency duties. Specific requirements would be established for emergency actions and for routine maintenance and decontami nation operations, including vessel entry, which are known to present particular hazards. The purposes of operational and emer gency plans and training are to apprise employees of the hazards to which they may be exposed, of the precautions they must take to avoid such hazards, and to rehearse employees in the procedures they must follow in emergencies. D. Medical surveillance. Comprehen sive requirements for employee medical examinations are proposed, including necessary tests. Some additional guid ance is included for the convenience of physicians. The proposed requirements have been recommended to OSHA by NIOSH as reasonably appropriate to de tect liver dysfunction which may be in dicative of, or predisposing to, the de velopment of liver angiosarcomas. E. Records and reports. Records of monitoring, medical examinations, and marked on or before June 10, 1974; (31 The objections must specify the provisions of the proposed rule to which objection is taken, and must state the grounds therefor; (4) Each objection must be separately stated and numbered; and (5i The objections must be accom panied by a summary of the evidence proposed to be adduced at the requested hearing. As revised, 5 1910.93q would read as follows: L910.93q Vinyl Cluoride. (a) Scope and application. (1) This section applies to any area or operation in which vinyl chloride (chloroethene), Chemical Abstracts Service Registry No. 75015, is manufactured, reacted, re leased, repackaged, stored, or used, in cluding areas and operations involving polyvinyl chloride where detectable levels of vinyl chloride are released. (2) This section does not apply to the handling or use of fabricated products made entirely or in part of polyvinyl chloride. (b> Definitions. (1) "Assistant Secre tary" means the Assistant Secretary of Labor for Occupational Safety and Health. U.S. Department of Labor or his designee. (2) "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer; and any employee who enters such an area as a designated representative of employees to exercise an opportunity to observe monitoring and measuring of vinyl chloride. Health Administration Area Office hav ing jurisdiction over the geographic area in which the establishment is located. (12) "Polyvinyl chloride" means poly vinyl chloride homopolymer or copol ymer before such is converted to a fab ricated product. (13) "Protective clothing" means clothing protective against vinyl chlo ride. (14) "Vinyl chloride" means vinyl chloride monomer. (15) "Waste resin" means any resin or other reaction products removed in the cleaning of equipment, such as ves sels and piping. (c> Reference. College' of American Pathologists, 230 N. Michigan Ave., Chi cago, Illinois 60601. ' (4) Regulated areas. (1) A regulated area shall be established where (i) vinyl chloride is manufactured, reacted, re leased, repackaged, stored, or used; or (ii> polyvinyl chloride capable of re leasing detectable levels of vinyl chlo ride is manufactured, reacted, released, repackaged, stored, or used. (2) Access to regulated areas shall be limited to authorized employees. (3) A daily roster of employees enter ing regulated areas shall be made and maintained. The rosters, or summaries thereof, shall be kept for at least 20 years, (e) Monitoring. (1) Every regulated area shall be monitored for detectable levels of vinyl chloride. (2) The monitoring shall assure that any exposure may be determined for each authorized employee with a confi dence level of 95 percent. entry to regulated areas are proposed, (3> "Closed container" means any (3^ Employees or their designated rep with provision for access by appropriate container which prevents the release of resentatives shall be afforded an oppor OSHA and NIOSH officials. Specific pro vinyl chloride to the environment. tunity to observe monitoring and measur visions for employee access to monitoring (4i "Contaminated" means capable ing required by this paragraph, records are included, as well as the re of releasing a detectable level of vinyl (i) Where exercise of an opportunity quirement to furnish a copy of a medical chloride. requires entry to an area where the use No. 92--ft. I-------10 FEDERAL REGISTER, VOL. 39, NO. 92--FRIDAY, MAY 10, 1974 AS I 000017903 Copied by MCA. 5/13/74 1G89S PROPOSED RULES DEPARTMENT OF LABOR Occupational Safety and Health Administration [29 CFR Part 1910] [Docket OSII-301 VINYL CHLORIDE Proposed Standard 1. Background. Vinyl chloride (chloroethene) Chemical Abstracts Service Registry No. 75015, is a synthetic chemi cal made by oxychlorination of ethylene or by hydrochlorination of acetylene. It is the parent compound of a series of themoplastic resin polymers and co polymers which are widely used for con tainers, wrapping film, electrical insula tion, pipe, conduit, and a variety of other products. Vinyl chloride has heen made commercially in this country since 1939 and present production is in excess of seven billion pounds per year. Vinyl chloride (VC) is a gas at am bient temperature and pressure and is a chlorinated hydrocarbon which has moderate liver toxicity. The previous standard set a ceiling value of 500 parts per million (ppm) (29 CFR 1910.93, Table G-l). On January 22, 1974, the Occupational Safety and Health Administration (OSHA) was informed by the National Institute for Occupational Safety and Health (NIOSH) that the B. P. Good rich Chemical Company reported that deaths of several of its employees from a rare liver cancer (angiosarcoma) may have been occupationally related. As a result of this notification and after con sultation with the National Institute for Occupational Safety and Health (NIOSH), and a joint inspection of the plant by OSHA, NIOSH, and the Ken tucky Department of Labor, a fact-find ing hearing on possible hazards Involved with the manufacture and use of VC was announced on January 30, 1974 (39 Pit 3074) and held on February 15, 1974. 2. Carcinogenicity of VC. Information produced at this hearing demonstrated that exposure of laboratory animals (mostly Spraguc-Dawlcy rats) to VC by inhalation at and below the then current, OSHA standard of 500 ppm induced tumors, including angiosarcomas of the liver. Professor Cesare Maltoni, of the Institute di Oncologia, Bologna, Italy, reported on a series of experiments on the effect of exposure of rats, mice, and hamsters to VC at concentrations of 10,000; 6,000; 2,500; 509; 250; and 50 ppm for varying periods of time (TR~ 43-G3). Some of the experiments have been concluded, and others are still on going. The experimental results reported were that tumors have been observed in groups of animals exposed to VC at con centrations as low as 250 ppm. No tumors were observed in the group of animals exposed to VC at a concentration of 50 ppm. It also appears that the total num ber of tumors, as well as the numbers of angiosarcomas of the liver, decreased as the concentrations of VC were reduced to 250 ppm. Another experiment by Pro fessor Maltoni was reported underway involving the exposure of 300 animals to VC at concentrations of 50 ppm, in order to assess in a more definitive way whether that level of exposure produces tumors in animals. Data reported by Torkelson, Oyen and Rowe (American' Industrial Hygiene Association J 22: 254361 (1961)) indicate that exposure to VC at concentrations of 50 ppm failed to induce tumors in rats, hamsters, rabbits, and dogs. The employees of the B. F. Goodrich Chemical Company who died from angio sarcoma of the liver had an average ex posure of approximately 19 years to vinyl chloride, at unknown concentrations, and variable exposures to other volatile chemicals. (TR 93). Some employees of Union Carbide, Firestone Tire and Rub ber, and Goodyear were also reported in post-hearing comments to have had ex posure to vinyl chloride and to have died from angiosarcoma of the liver. Finally, autopsies of four deceased employees re vealed their liver angiosarcoma tumors were histologically indistinguishable from the angiosarcoma tumors observed in Professor Maltoni's experimental animals. 3. The Emergency Temporary Stand ard. On the basis of all information available at that time, and the fact that employees were being exposed at levels around the experimentally observed ef fect level of 250 ppm, an Emergency Temporary Standard (ETS) was promul gated on April 5, 1974 (39 FR 12342) as 29 CFR 1910.93q. This standard reduced the level from a ceiling of 500 ppm to 50 ppm ceiling. It was expressly recognized that this standard limiting exposures to a 50 ppm level was intended to be a ten tative, interim standard, to be in effect no longer than six months, during which time the whole question of possible safe exposure to VC would be reconsidered more fully and in the light of more in formation, especially results of experi ments which were known to be under way at that time. 4. Additional information. On April 15, 1074, information and data were pre sented to representatives of OSHA, NIOSH and the EPA by the Industrial Bio-Test Laboratories, Northbrook, Illi nois, concerning results of animal ex posure studies with VC, sponsored by the Manufacturing Chemists Association (MCA). Although only preliminary in nature, these results revealed that 2 out of 200 mice exposed to VC concentrations of 0 ppm for 7 hours a day, five days a week, for approximately 7 months, de veloped angiosarcomas of the liver. The Industrial Bio-Test Lab data in dicate that exposure to VC at 50 ppm may well constitute a serious health haz ard to employees. Also, the question of a safe level of exposure for humans can not be determined at this time, and may continue as a matter for scientific de liberation for many years. We therefore conclude that it is now necessary to pro pose to change the 50 ppm level estab lished in the ETS to as low a level as can be detected using methodologies outlined in this proposal. (5) The proposed permanent standard. The requirements for a complete stand ard under section 6(b) of the Occupa tional Safety and Health Act of 1970 are much more comprehensive than the provisions of the ETS promulgated on April 5. The following proposals are re sponsive to the additional information on the carcinogenicity of VC, and the requirements of the Act. A. Level of exposure. The proposed standard for employee exposure is set at no detectable level, as determined by a sampling and analytical method capable of detecting vinyl chloride at concentra tions of 1 ppm with an accuracy of 1 ppm-50 percent. Although more sensi tive methods may be available now or in the future, the methodological sensitivity proposed appears to be the most feasible and generally available. A method of 1 ppm sensitivity has been recommended to OSHA by NIOSH. To minimize the number of persons at risk, a require ment would be established for regulating areas where vinyl chloride is manufac tured, reacted, stored, handled, released, repackaged, or used, including opera tions with polyvinyl chloride containing detectable levels of vinyl chloride. Access to the areas would be limited to author ized employees. B, Monitoring, A program of monitor ing would be required to establish whether there are detectable levels in regulated areas and to permit determina tion of employee exposures on an in dividual basis.. Provision would also be FEDERAL REGISTER, VOL. 39, NO. 91--FRIDAY, MAY 10, 19/4 Asl 000017904 PROPOSED RULES 1GS99 VINYL CHLORIDE CONTAMINATED MATERIAL CANCER-SUSPECT AGENT MMSFOSE OF OR DECONTAMINATE USING AUTHORIZED FRECEDURES (4) Containers of polyvinyl chloride containing detectable levels of vinyl chloride shall be labeled: POLYVINYL CHLORIDE CONTAINS VINYL CHLORIDE VINYL CHLORIDE IS A CANCER-SUSPECT AGENT ABSORBED BY BREATHING AND through skin (5) Containers of vinyl chloride shall be labeled: VINYL CHLORIDE DANGER extremely flammable gas UNDER PRESSURE MAY POLYMERIZE WITH EXPLOSIVE FORCE POISON CANCER SUSPECT AGENT AND ANESTHETIC ABSORBED BY' BREATHING AND THROUGH SKIN (6) No statement shall appear on or near any required sign, label or instruc tion, which contradicts or detracts from the effect of any required warning, in formation or instruction. (1) Maintenance and decontamina tion. (1) Emphasis shall be placed upon immediate clean up of spills, periodic in spection, prompt repair of equipment and leaks, and proper handling, storage and disposal or decontamination of materials & prevent airborne contamination and Accidental skin contact with vinyl chlo ride. Waste materials, equipment, and other sources of vinyl chloride in closed containers, may not be placed in areas of excessive temperature or sunlight since build-UD of internal pressure may result in rupture of the container, fire or explosion. (2) Waste resins or other materials contaminated with vinyl chloride shall be placed in closed containers pending dis posal or decontamination. (3) Appropriate procedures shall be developed and implemented for the de contamination or disposal of all such waste material. (4) In maintenance or repair opera tions on contaminated--systems or equipment, including vessel entry, em ployees engaged in such operations shall be (i) provided with and required to wear and use a whole-body air-supplied suit impervious to vinyl chloride, and a respirator in accordance with paragraph (g) of this section: and (ii) required to shower after removing protective equip ment. (5) Protective clothing and equipment shall be clean and dry for each use. (6) When vessels or piping systems are opened local exhaust ventilation shall be provided to remove the escaping vapor from all occupied areas. (7) (i) Vessels to be entered shall first be ventilated and monitored so that the ^^01oncentration of vinyl chloride is reduced a level within the protection factor .pability of the protective equipment. (ii' When vessels are to be entered, all piping to such vessel shall be: (A) Opened, blanked and tagged; or (B) Where Welded piping is in use, not less than 2 valves in series, which isolate the vessel from any other connection to such line, must be closed and secured. (iii) No employee shall enter a vessel, except when another employee properly trained and equipped for entry is pres ent and is observing the employee in the vessel. The observer shall have means for signalling for help in the event the employee experiences problems. Under such conditions, the observer shall sig nal for help, and shall not enter to assist the employee until another person is present to observe. (m) Transportation loading and un loading. (1) Facilities for the loading and unloading of vinyl chloride to and from containers shall have each transfer line and vapor-equalizing line equipped with vent connections, and shall have an inert gas purging system. Vent and purge effluent shall be returned to a proc ess stream or flared in a safe location. (2) Procedures shall be developed and implemented for the transfer of vinyl chloride. Written copies of such proce dures shall be provided employees en gaged in such operations, and such em ployees shall be fully trained and re hearsed in all procedures. (3) Employees engaged in transfer op erations shall be provided with and required to wear respirators in accord ance with paragraph (g) of this section. (n) Polymer handling operations. (1) Containers of polyvinyl chloride releas ing detectable levels of vinyl chloride shall be opened and transferred only under local exhaust ventilation which reduces the concentration of vinyl chlo ride below the detectable level. (2' Hot operations, such as but not limited to milling, calendering and. ex truding, which release detectable levels of vinyl chloride, shall be carried on only under local exhaust ventilation which reduces the concentration of vinyl chlo ride below the detectable level, (o) Medical surveillance. Not later than ------------------ 1974, a program of medical surveillance shall be insti tuted, and shall provide each authorized employee with an opportunity for ex aminations in accordance with this para graph. All medical examinations and procedures shall be performed by or under the supervision of a licensed Doctor of Medicine (MD) or Doctor of Osteopathy (DO). All medical examina tions and tests shall be provided without cost to the employee. (1) At the time of initial employment, or upon institution of screening, a physi cal examination shall be performed with specific attention to detecting enlarge ment of liver or spleen by abdominal palpation. (2) At the time of initial employment or upon institution of screening, and an nually thereafter, a medical history checklist shall be completed by the em ployee. This list shall include questions concerning: (i) Alcohol intake: (ii) Past history of hepatitis; (iii) Past exposure to potential hepatotoxic agents, including drugs and chemicals; (iv) Past history of blood transfu sions; and (v) Past history of hospitalizations. (3) At the time of initial employment, or upon institution of screening, a serum specimen shall be obtained for screening with respect to the following bio-chemi cal determinations of liver function: (i) Total bilirubin; (ii) Alkaline phosphatase; (iii) Serum glutamic oxalacetic trans aminase (SGOT); (iv) Serum glutamic pyruvic trans aminase (SGPT); and (v) Gamma glustamyl transpeptidase (GGTP). (4) A.dditional tests that may option ally be considered for use in screening include: (i) Lactic dehydrogenase; (ii) Serum protein determinations; (iii) Serum protein electrophoresis; and (iv' Platelet count. (5) Laboratory analyses for all biologi cal specimens included in medical exam inations shall be performed in labora tories accredited by the College of American Pathologists or licensed under 43 CFR Part 74. (6) If the results of screening required in paragraph (o) (3) of this section are normal, screening shall be repeated: (i) Every six months for employees who have been employed in vinyl chlo ride related operations for 10 years or more; and (ii) Annually for all other employees entering regulated areas. (7) If one or more liver function tests performed are abnormal, serum testing shall be repeated as soon as possible, preferably within two to four weeks. If no abnormalities are present upon re screening, serum testing shall be re peated in three months. (8) If abnormalities persist upon re screening, the employee shall be with drawn from areas where contact with vinyl chloride is possible, and an individ ualized medical workshop shall be in stituted. Suggested as initial steps are a complete physical examination and vari ous special procedures such as hepatitis B antigen determination and liver scan ning. If liver function abnormalities are determined to be unrelated to liver dis ease, the employee may be permitted to return to vinyl chloride-related employ ment, subject to individual medical evaluation. (9) A complete and accurate record of the results of medical examinations shall be made and maintained for the dura tion of employment plus five years, or for 20 years, whichever is longer. (p) Records. (1) Records of monitor ing and measuring, medical records, and regulated area entry rosters and sum maries, shall be made available for ex amination and copying upon request to authorized representatives of the Assist ant Secretary and the Director. FEDERAL REGISTER, VOL. 39, NO. 92--FRIDAY, MAY 10, 1974 AS I 000017905 16898 PROPOSED RULES of protective clothing, equipment, fa cilities, or procedures is required, such clothing, equipment, facilities, and pro cedures shall be provided to all persons entitled to exercise the opportunity, at no cost to any of them. (ii) Persons exercising the opportu nity shall be instructed regarding: (A) The toxicity and fire hazard of vinylchloride: and (B) The protective steps and measures necessary for their protection. (iii) Observers shall be permitted, without interference to the persons per forming the monitoring and measuring, to: (A) Observe all steps and procedures related to the collecting, processing, and evaluation of particular monitoring and measurement samples; <B) Record quantities and results obtained; (C) Observe the condition of monitor ing and measuring equipment; (D) Receive a demonstration of the calibration and function tests of the monitoring and measuring equipment performed on site; and (E) Examine instructions and docu ments related to the procedures and equipment for monitoring and measur ing. (4) Accurate and complete records of all required monitoring shall be made and maintained for not less than 20 years. Such a record shall (i) state the date of such monitoring and the levels determined; and (ii) identify the instru ments and methods used, (f) Engineering controls and workpractice methods. (1) Where detectable levels of vinyl chloride are measured, immediate protection shall be provided against exposure to vinyl chloride by the use of engineering controls, workpractice methods, and respirators as follows: (i) Feasible engineering controls and workpractice methods shall immediately be used to reduce airborne concentra tions of vinyl chloride below the detect able level; (ii) Wherever feasible engineering controls and w'orkpractice methods which can be instituted immediately are not sufficient to reduce concentrations of vinyl chloride below the detectable level, they shall nonetheless be used to reduce the concentrations to the lowest prac ticable level, and shall be supplemented by means of respirators in accordance with paragraph (g) of this section; (iii) Wherever no feasible engineering control or workpractice method can bo instituted immediately, immediate res piratory protection shall be provided in accordance with paragraph (g) of this section; and (iv) In any case covered by paragraph (f)(1) (ii) or (iii) of this section, the employer shall also undertake as soon as practicable a program to reduce airborne concentrations of vinyl chloride below the detectable level, or to the greatest extent feasible, solely by means of engi neering controls and workpractice meth ods and as soon as feasible. (2) There shall be tests made for process or equipment leaks and for emis sion of vinyl chloride which may result from workpractices. The frequency of these tests shall be such as to insure the integrity of equipment and adherence to proper workpractices. (g) Respiratory protection. (1) A res piratory protection program in accord ance with 5 1010.134 shall be established and implemented where respirators are required to be used by this section. (2) Respirators shall be used only in cases of emergency and where required by any other provision of this section. Respirators may not be used in lieu of feasible engineering controls or work- practice methods. <3> Respirators or combinations of respirators for protection against vinyl chloride shall be selected from among the following: (1) A positive pressure full facepiece self-contained breathing apparatus; (ii) A pressure-demand full facepiece self-contained breathing apparatus op erating in the pressme-demand mode; (iii) A combination type "C" pressuredemand full facepiece respirator oper ating in the pressure-demand mode and a pressure-demand self-contained breathing apparatus operating in the pressure-demand mode; cr (iv) A combination type "C" continu ous flow respirator and a pressuredemand self-contained breathing ap paratus operating in tho pressure-de mand mode. (h) Protective clothing. (1) Employees entering regulated areas shall be pro vided full-body protective clothing, foot wear or shoe covers, and gloves, at no cost to them, and required to wear it while in the regulated area. (2) Where polyvinyl chloride powder containing detectable levels of vinyl chloride is handled, employees shall also be: (i) Provided and required to wear headcoverings; (ii) Required to remove all protective clothing at each exit from the regulated area; and (iii) Required to shower after the last exit of the day. (3) Clean protective clothing shall be provided whenever contaminated or soiled, but not less frequently than weekly. Contaminated clothing shall be decontaminated before reuse by removal for laundering or disposal. (1) Hygiene facilities and practices. (1) Where employees are required by this section to wear protective clothing and equipment, change rooms shall be provided in accordance with ii 1910.141(e). (2) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 1910.141(d) (3). (3) Storage or consumption of food or beverages, storage or use of smoking or non-food chewing products, and the storage or application of cosmetics are prohibited in regulated areas. (j) Emergency situations, (1) A writ ten operational plan for emergency situations shall bo developed for each regulated area. (2) In the event of an emergency, ap propriate portions of the plan shall be put into operation. (i) Hazardous conditions created by tho emergency shall be eliminated and the affected area shall be decontami nated prior to the resumption of normal operations. (ii) Special medical surveillance by a physician shall be instituted within 24hours for employees present in the af fected area at the time of the emergency. (iii) Where an employee has a known contact with liquid vinyl chloride such employee shall be required to shower as soon as possible, unless contraindicated by physical injuries. <iv) An incident report on the emer gency shall be reported as required in paragraph (q) (2) of this section. (3) Each authorized employee shall be trained in a program relating to the hazards of vinyl chloride and the pre cautions for safe use. (1) The program shall include: (A) The nature of the fire hazard, and the necessary protective steps; (B) The nature of the toxic hazard, including local and systemic effects, acute and chronic effects including specifically the carcinogenic hazard; (C) The specific nature of operations which could result in exposure to vinyl chloride, and necessary protective steps: <D) The purpose for and application of the medical surveillance program; (E) The purpose for and application of decontamination practices; (F) The purpose for and significance of emergency practices and procedures: (G) The employee's specific role under normal operating or emergency condi tions; <H) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of vinyl chloride; (Ii The purpose for and application of specific first aid procedures and prac tices; (J) A review of this standard at the employee's first training and indoctri nation program and annually thereafter. (ii) All materials relating to the pro gram shall be provided upon request to authorized representatives of the Assist ant Secretary and tho Director. (k) Signs and labels. (1) Entrances to regulated areas shall be posted with signs bearing the legend: CANCER-SUSPECT AGENT AREA AUTHORIZED PERSONNEL ONLY (2) Areas containing operations cov ered in paragraph (k) (1) (4) of this sec tion shall be posted with signs bearing the legend; CANCER-SUSPECT AGENT IN THIS AREA FULL IMPERVIOUS AIR-SUPPLIED EQUIP MENT REQUIRED AUTHORIZED PERSONNEL ONLY (3) Containers of waste or other ma terials contaminated with vinyl chloride shall be labeled: FEDERAL EEGIS7ER, VOL 39, NO. 92--FRIDAY, MAY 10, 1974 Aqt ' 0Ol79oe 16900 PROPOSED RULES (2) In the event that the employer ceases to do business and there is no suc cessor to receive and retain his records for the prescribed period, these records shall be transmitted by registered mail to the Director, and each employee indi vidually notified in writing of this transfer, (3) Employees and their designated representatives shall be provided access to examine and copy records of monitor ing and measuring. (4) Former employees shall be pro vided acccs to examine and copy records reflecting their own exposures, (51 Upon written request of any em ployee, a copy oi the medical record of such employee shall be furnished to a physician designated by the employee in such request, (q) Reports. (1) Not later than the following information shall be reported to the OSHA Area Director. Any change in such information shall be reported to the OSHA Area Director within 15 days of such change. (1) The address and location of each establishment which has one or mere regulated areas; and (ii) The number of employees in each regulated area during normal operations, including maintenance. (2) Incidents which result in the re lease of vinyl chloride into any area where employees may be exposed shall bo reported in accordance with this para graph. <i> A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be made within 24 hours to the OSHA Aren Director. (ii) A written report shall be filed with the OSHA Area, Director wiibin 15 calendar days thereafter and shall in clude: (A) A specification of the amount of material released; (B) A description of the area involved and the extent of known and potential employee exposure and area affected; (C) A report on any medical treat ment of affected employees and any medical surveillance program imple mented; and (D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases. <3) Upon completion of any monitoring and measuring which discloses that any employee has actuary bee r exposed to detectable levels of vinyl chloride, each such employee shall be individually noti fied in writing. The notice shall: (i) Be delivered not later than 10 working days after completion of the monitoring and measuring; (ii) State the actual exposure in terms of concentration and time; and (in) State the steps which have been taken, are being taken, and will be taken, with specific completion dates, to termi nate the exposure and prevent a recur rence. (Secs. 6(b), 6(c), and 8(c), 84 Stat. 1593, 1596, 1599 (29 U.S.C. 655, 657); Secretary oi Labor's Order No. 12-71 (36 FR 8754)) Signed at Washington, D.C. this 6th day of May, 1974. John Stendek, Assistant Secretary of Labor. [FR Doc.74--10748 Filed 5-9-74;8;45 am] ASI 000017907 FEDERAL REGISTER, VOL 39. NO. 9!--FRIDAY, MAY 10, 1974 V } < ai 3. i d a ;t tt >0 ji lt U *- to cr 10 of cr biic b- lit ad a's osi- 1. 30. / t. iinfor nta, the r 1, .til nes, blic t of you ,# to BI- itUo aa tllO ins, j or you 1 a& the , lor gory 1 hose lan- :em- JOV- Ke- tirat roup y he : lor cer- ycar; cot* sUl, NOTICES !< >u Cctrgmy Twelve-month level of instantaneously bond akin to skin. As a flcatlons necessary to ,,.;1 restraint result of these hearings, investigation by the Commission ot conr'>` r> r i -1" f 22i ____ ______ 8,600,741 pound* (ot the Commission sinif, laboratory data, fects which could cirri'* g nri -1 -p'.it v;iiirH not more than and literature relating to the safety and risk of injury. The preamb'e > r t n; j nrt 200.000 pounds shall he In Tf3.U.f1.A. Nos. 000,0420 and 200.8143, and not more than 600.000 pounds shall he In T.S.U.S.A. Nos. use of cyanoacrylate adhesives, the Com mission concludes that, at tills time, tho consumer is not subject to an unreason able risk of injury from the fnsl-honding characteristic of cyanoacrylate ad 1115 indicates that the not' '-'Ton re quirements under sretion Finn of (tic act are applicable to prrdnel'; an1- P et to regulation under nuthoihv <T ip" a, is transferred to tho (lonmi-v.u hv --yfion 060.0402 and 380.- hesives. 30 of the Consumer Pro-'iTt, r-f'.y t 8100)* In the event that a consumer acci (15 U.S.C. 2079). Them tra>" fened nri3 *The amended subilmlta have not been dentally (or intentionally) bonds skin to include the Federal rreran'utn sub adjusted to reflect, any entries made on or skin, simple procedures such as peeling stances Act (15 U.S.C. ?TJ cf n o.), I'm ehcr October 1,107.1. (rolling) apart the bonded parts rather Poison Prevention Pact;r '".g vt of ra;o Tlio notions token with respect to the Government ol the Republic of China and than pulling apart with a dirent oppos ing action will provide relief. Accord (15 U.S.C. 1471 et seq.), ihe I mpuneMo Fabrics Act (15 U.S.C. 1191 cl , and v/lth respect to imports ot man-made fiber ingly, other than insuring compliance the Refrigerator flafrty Act n ~ us.c. t.i'tUo products from the Republic of China with the labeling provision of the Fed 1211 ct seq.). The aforni'.rntiorcd t .'-s-. Hava been determined hy the Committee for eral Hazardous Substances Act, the ferred acts have been brought H"0',r the the Implementation of Textile Agreements to Imotve foreign affairs functions of the United States. Therefore, the directions to the Commissioner of CustoniR, being ncccssaiy to the Implementation of such actions, fall within the foreign affairs exception to the rule-making provisions of 6 U.8.C. 663. Commission dees not intend to take fur ther action with regard to cyanoacrylate adhesives at this time. Tills decision docs not, however, pre clude the Commission fiom reconsider ing Its position if the receipt of addi notification requirements of stf-iiv i.j (b) of the Consumer Product GeCel.v Act because, as stated in tb" rocenbio to Part 1115: "Upon enndd'Tlnir tho numerous possibilities of ri d- (o ti - con suming public by produria idling v Ubin 7 his letter will be published Ur tlio Federal tional data or information should so the authority of these ad.-, the Commis Register. warrant. sion finds under section floui) of the Sincerely, Still M. Bodmer, Dated: May 6,1974. [Consumer Product Fddvl Act that such risks can neither bn dir.-mated nor Chairman, Committee for the im S.idye E. Dunn, reduced to a slifficirnt cdoi l in a (i -rty plementation of Textile Agree Secretary, Consumer Product fashion unless the Commit den is pot ir-ecj ments, and Deputy Assistant Sec retary for Hesources and Trade Assistance. Safety Commission. ,, [Fit Doc.74-10746 Filed 6-8-74;8:45 am] under section 15(b) of llw act. Tibs find ing by the Commission N i'-ed 0o u10 fact that none of the nw idv'-v <-[ the [FR Doc.74-10794 Hind G-B-74;8;45 am] transferred acts require nrtific'Hcn to VINYL CHLORIDE-CONTAINING be made to the Commission upon the CONSUMER PRODUCT SAFETY SELF-PRESSURIZED PRODUCTS obtaining of information v.h'dt COMMISSION CYANOACRYLATE-BASED ADHESIVES Commision Decision Regarding Cyanoacrylate-Based Adhesives The purpose of this notice Is to an nounce the Commission's decision in re tard to the action it will take concern ing cyanoacrylate based adhesives used' in or around the household. In response to a letter dated September .19, 1973, front Consumers Union, the Consumer Product Safety Commission began on Investigation into the safety aspects of cyanoacrylate bated ndhrsives. Stall information based on testing In dicated that cyanoacrylate glues are "ha.'ardous suhslrmces" within the mean ing of that, term under (he Federal haaulous Substances Act because they are eye irritants. As mjc)i, these glues fcre deemed '`misbranded" under the Act unless properly labeled. As a result of 0 Commission's investigation, the fomniis; ion stail discovered that sev eral cyanoacrylate adhesive products ktre "misbranded" under the Federal Requirement for Notification as a Potential Substantial Product Hazard The purpose of this publication is to give notice that the Consumer Product Safety Commission has determined that self-pressurized consumer products con taining vinyl chloride as a propellant or ingredient are products with a defect which could create a substantial prod uct hazard. Therefore, anyone who is manufacturing, or hns manufactured, such products is required to submit cer tain information (specified below) to this Commission. Section 15(b) of the Consumer Prod uct Safety Act (15 U.S.C. 2064(b)) re quires every manufacturer of a con sumer product distributed In commerce, and every distributor and retailer of such product, who obtains information which reasonably supports tho conclusion that such product contains a defect which could create a substantial product haz ard, to immediately inform tho Com mission of such defect, unless such manufacturer, distributor, or retailer has actual knowledge that tire Commis ably supports the exist cnee of n M'k'-Tntial product hazard, 'f he Connin'--ion hm determined this type of notification to bo essential for the pm pose of protecting the consuming public against unreason able risks of Injury associated with con sumer products * * *" Therefore, the Commission has d'd'-rmined that notifications rad b iimic for vinyl chloride-containing prodm 's ir respective of the fact that sudr products are subject to regulation urdm- i>i Fed eral Hazardous Substances Act. TIP'; de termination, however, docs not mmn that such products will ncce: sm ily ha regulated under the Consumer Pii'dn -i, Safety Act. Since a nctifif ction w.C'r section 15(b) docs not rmniiy eutoinet.ln regulation of tho product nmi-w the Con sumer Product Safety Act. the commis sion intends to regulate vinyl r containing products undo tirov 'ri' ni of the Federal Hazardous Sub Futr A* t, Additionally, tho Commission 710(03 that manufacturers of vinyl chloridecontaining consumer products in e'-raml form must provide the information m-rjfled below even tlvunh the pnrt.hniir thraidom Susbtances Act because they ' t*e not properly labeled in regard to fi'e irritancy. The Commission has taken r-tuiropriatc measures pursuant to the sion has been adequately informed of such defect. Failure to furnish informa tion required by section 15(b) is unlaw ful under section 19(a) (4) of tlio act (15 product may not have been did 1 itnic.i in commerce after May P, J07.7 dhu date of establishment rt (ho con-nnm;' Product Safety Conn'd'.-.ic'). A3 ri'P v] 1` lCial Hazardous Subslanecs Act to en U.S.C. 2068(a) (4)) and may subject a in the preamble io 16 era r-wt. 111.0, sue compliance with the Federal Haz person who so fails to civil and/or crimi manufacturers who oi'F'lu I'P'-rn-.-Fon ardous Substances Act in Mils regard. nal penalties. after May 14, 1973, that ono of their Oa February 27, 1974, lire Commission belli a hearing to obtain Information trd views on oilier safety aspects of ' i'aitai;rij']aio adhesives, particularly the To implement section 15(b) of the act, tho Commission, on February 19, 1974, published regulations <16 Cl 'lt Part 1115) In the Federal rebistek (29 I H GGG1), effective March 21, 1974, setting forth products contains a defect, which could create a substantial product- hazard, are required to comply with the rofinrihaii requirements of section 15(h) of tb- pa;; even though tile product won disMihutcd Uiaractcrtsllo of this product to almost the time, manner, end content of noli- In commerce prior to May 14, 1973. FEDERAL REGISTER, VOL. 39, NO. 91--THURSDAY, MAT 9, 19T4 AS I 000017908 NOTICES The determination that self-pressur ized consumer products containing vinyl chloride contrin a defect which could create a substantial product hazard 13 based on recent information on the pos sible t-oxicity of vinyl chloride monomer ns a propellaut or ingredient In the pro pellant-solvent system of self-pressur ized consumer products. The grounds for this determination arc as follows: (1) Human data showing production of angiosarcomas in certain individuals who have worked in plants manufactur ing polyvinyl ehloiide polymers and/or vinyl chloride monomer; and (2) Animal data showing production of various tumors, including angiosar comas, in rats exposed to inhalation of vinyl chloride monomer (Professor Ccsare Maltonl, Inslltuto di Oucologica, Bologna, Italy). These data are contained in the tran script of an `'Informal Fact Finding Hearing on Possible Hazards of Vinyl Chloride Manufacture and Use". U.3. Department of Labor, Occupational Safety and Health Administration, Feb ruary 15, 1974, A copy of this document h available for public inspection at the Office of the Secretary. Consumer Prod uct Safety Commission, 1750 K Street NW., Washington, D.C. 20207, The Commission has received a peti tion from the Health Research Group ``to immediately prohibit the continued use of vinyl chloride as n propellant for aerosolized consumer products and to remove all products containing vinyl ehloiide as a propellant from the market because there is substantial evidence that vinyl chloride is carcinogenic." A notice proposing a ban under the Federal Haz ardous Substances Act will be published in the near future and will include a copy of the petition. Accordingly, the Consumer Product Safety Commission, pursuant to section 6(c) of the Consumer Product Safety Act (15 U.H.C. 2055(c)), hereby informs manufacturers of sclf-prcssurized con sumer products containing vinyl chlo ride monomer as a propellant or ingre dient in their propellant-solvent system that the Commission considers such products to contain a defect which could create a substantial product hazard. Although 1G CFH 1115.7(a) sets forth 23 specific items of Information to be submitted in writing to the Commission, this notice, pursuant, to 5 1115.7(d), re quires that inioimatlon submitted to the Commission in this instance include only the 7 items lifted below. Additional in formation may, of course, also be sub mitted. Therefore, manufacturers of con sumer products (as that term is defined in section 3(a)(1) of the Consumer Product Safety Act (15 U.S.C. 2052(a) (1)) in rdf-pressurized form that contnin vinyl chloride monomer as a pro pellant or Ingredient in their propellant- solvent system are required, under sec tion 15(b) or the Consumer Product Safety Act (15 U.S.C. 2064(b)) and regu lations issued thereunder (10 CFR Part 1115), to provide the following informa tion in writing to Dr. Alan Ehrlich, of- flee of Standards Coordination and Ap praisal, Com,inner Pioduct Safety Com mission, Washington, D.C. 20207 (301 490-7698) on or before May 20. 1971. (1) Identification of specific self-prcssurlzod products by type and brand, in which vinyl chloride monomer Is now, or has been, used as a propellant or in gredient of the propellant-solvent sys tem; (2) Production and sales history in cluding inventory turnover i.atcs through the entire chain of distribution of vinyl chloride monomer as a propellant or In gredient of the propellant-solvent sys tem of self-pressurized products; (3) Identifying features, such as use of package designs or production codes that will identify the sclf-pressurlzcd products containing vinyl chloride mono mer as a propellant or ingredient In the propellant-solvent system; (4) Patterns of consumer usage for self-pressurized products containing vi nyl ehloiide monomer as a propellant or ingredient in the propellant-solvent sys tem, including frequency nnd duration of exposure, nnd place and purpose of use; (5) If available, acute and chronic toxicity data relative to vinyl chloride and products containing vinyl chloride; (0) If available, human experience data relative to vinyl ehloiide and prod ucts containing vinyl chloride, including adverse effects and associated disease en tities believed to be relevant; (7) If available, special studies, such as metabolic, mutagenic and teratologic studies involving vinyl chloride. In accordance with 16 CFR 1115.9, In formation submitted to the Commission in response to this notice shall be signed either by the chief executive officer of the notifying company or by the person to whom the responsibility has been dele gated In writing. Dated: May C, 1974. Eadye E. Dunn. Secretary, Consumer Product Safely Commission, |FB Doc.74-10732 Filed 5-0-74.0:45 am) tNVIRONMLNTAL PROTECTION AGENCY [OPP-32000/65] NOTICE OF RECEIPT OF APPLICATIONS FOR PESTICIDE REGISTRATION DATA TO RE CONSIDERED IN SUPPORT OF APPLICATIONS On November 19, 1973, the Environ mental Protection Agency published In the FeDEitAL Register (38 FR 31862) its interim policy with respect to the admin istration of section 3(c)(1)(D) of the Federal Insecticide, Fungicide, and Rodentietdo Act (FIFRA), as amended (86 Stat. 979), and Its procedures for Imple mentation. This policy provides that EPA will, upon receipt, of every application, publish in the Femt.ae Iicoisxrn a notlco containing the information shown be low. The labeling furnished by the appll- cant will be ava'iet 1c for cgru-i-intion at the Environment"! 1 //nicy Room Ell 3f, F"rt a'f n-i-r, .'m Olivet 8W,, Washti!"(rm '\(,\ ra n ;). On or before du'y 8, 1971, rny persoi who (a) Is or has hf-u mi applicant (b) desires to prsert a claim compen sation under cc-tion 3(c) CD (D) ngnins1 another applicant proposing to rse sup portive data p--cvio'.tsiy submit!,ai auf approved, and (c) wishr- to nresenchi opportunity for determination of reason able compensation by lb" Af':".'ni.:trat-o must notify the Admini-timo- -;;id (jj, applicant named in lb" rrnrnAL nj;t.;r;TEi of his claim by cr,tih-d mail Every sue! claimant must include, at, n, minimum the Information )P>cr) m tip-, intrrJu policy published on November 13, 1373, Applications submitted und-r 2(a) O 2(b) of the intmam pop-v in regard t< usage of existin'' s'Tcoi 1 mo data fo;- reg Istratlon will be prc c -rd in eeeordanci with existing procedures. Application: submitted under 2(c) will hr held to: the 60-day period l^fore commcncinj processing. If claims are not- received, th( application will be proces cd in norma procedure. However, if claims arc re ceived within 60 days, (ho applicant: against whom the particular claims an asserted will he advised, cif the alterna tives available under the Art. t;0 claim.' will be accepted for pos-ibic E^A adjudi cation which arc received after thi July 8,1074. Arri.rmiTo--3 u-ct -'-t r EPA Pile Symbol 33631 -73. AGRT-future Com pany. 15701) lop Fe d. Puru'-'-iJlo, Minne sota 55337. `'.Vorcrifl :fc`* I s- l'(`X Sect Protectant, active Tnrnr)i-,uts: Manet (Mangannui ruiyirerbl-di'bioerrhamate) 40.0%; IICB (IIoxscMoriit-'-n-ru-;) JO.OffMethod of Supper).: Apr'icatlon proceed! under 2(c) of Interim pou-y. EPA File Symho! s.rioi -R AORT 'utu-e C- inpany, 1570B lo'-p Pc-v-i, nviMpvuie, Min nesota 55737. "fii'r.in/in- rr Feed rat Seed Protectant. Aru-e JngrnP-nls: CftptftJ N| (trichlorornc'hyi) tliiol -`-ryrlohcx.'ne-I 2-dlearboitinW- sm.O'g; 7T neb (Mnngrmes' ethylenobledUh'--" -W'-m', 1 a POQ-,1; Idndane (Gamma j-c--'-r of nmreno llexachloride) isos'-. Mr-pr-i of Rrpport:'Ap plication precede under 2(c) of Interim policy. EPA Iteg. No. 'A ZT7. Am:-- - n Products, Inc., nrooksld* A'-'iig, A'uWcr, Pennsyl vania 10003. Amohfta l-Uhrcl TO ,-f n/gull- tor. Active Ingrr U'uuc: mu-pUip [{2-chli- roethyl) pho:,p'>' d) 3' 3%, Method of Support: App'ir-tinn p-or-rJs under 2(a) of Interim p"1 Icy. 1 EPA File Symbol nme-RFO. ri-'g Entcc, Tnc., 4635 Bomcrtcr ,-3, pcnnryl* vanln 10017 HiU r-'V-i Off, Arttvo Ingre dients: Podium iiimMbyi (Uiiiioc-rrbainati! 16.0%; Nabam (d1" ''li'n cijiyime blsdl- thlocartvamctc) is o" . M-Uiod of Support' Application yuceeqdn undi-r 2(r) r.f interim policy. EPA File Symbol n. f'l-.s Tb'Sr Cc.puto 229 Park Arcnua '' - Vert, NOW York 10003. A'UbnU--a rgmt' for IJPI.CT.--Indl'fMls Vr yl.-tt) fl'-m.lri SpA .NOVATE MI1 A7`I- u: - 1 JA7.V-, /.trednr Technical. A'ftro p'-rrrUr ,'s: 3-c)iIoro-4- ethylamlno-C-ls'ir"'rv,'"'n.r'-t ~ , tilazinr 96%. Method of Buppe-t* Apg'`"1"_LDn pro ceeds under 2(e) of Interim poJ.'cy,, ", , FEDCRAL REGISTER, VOL 39, NO. 91--THURSDAY, MAY . 1*74 ' , .i AS I 000017909 " s' \ 1CMG PROPOSED RULES - (c) The Deputy Administrator, Vet erinary Services, upon request to him. may approve other identification systems in specific cases and under such condi tions as he may prescribe if he deter mines that such systems provide the necessary information to allow for tracehack of the swine to their herd of or!gln, Any person who wishes to submit writ ten data, views or arguments concerning the proposed amendment may do so by filing them with Deputy Administrator, Veterinary Services. Animal and Plant Health Inspection Service, U.S. Depart ment of Agriculture, Hyattsville, Mary land 20782 before August 12, 1074, All writ ten submissions made pursuant to this notice will bo made available for public inspection at the Federal Build ing, 6505 Belcrest Road, Room 870, Hialtsville, Maryland 20782, during reg ular hours of business i8 am. to 4:30 pm., Monday to Friday, except holidays) In a manner convenient to the public business <7 CFR 1.27(b)). Comments submitted should bear a reference to the date and page number of this Issue in the federal Register. Done at Washington, D.C.. this 7th day of May 1074. Pierre A. Chaloux. Acting Deputy Administrator, Veterinary Services, Animal and Plant Health Inspection Service. |FR Doc.74-10802 Piled 5-0-74:8:45 am] DEPARTMENT OF LABOR Occupational Safety and Health . Administration t 29 CFR Port 1910 ] (Docket OSI1-30] VINYL CHLORIDE Proposed Standard 1. Background. Vinyl chloride (chloroethene) Chemical Abstracts Service Registry No. 75015, is a synthetic chemi cal made by oxychlorination of ethylene or by hydrochlcrlnalion of acetylene. It is the parent compound of a scries of tbcmoplastie resin polymers and co polymers which are widely used for con tainers, wrapping film, electrical insula tion, pipe, conduit, and a variety of other products. Vinyl chloride has been made commercially in this country since 1939 and present production is in excess of seven billion pounds tier year. Vinyl chloride (VC) is a gas at am bient temperature and pressure and is a chlorinated hydrocarbon which has moderate liver toxicity. The previous standard set a celling value of 500 parts per million (ppm) (29 CFR 1910.93, Table G-l). On January 22, 1974, the Occupational Snfety and Health Administration (OSHA) was informed by the National Institute for Occupational Safety and Health (NIQ3H) that the B. F. Good rich Chemical Company reported that deaths of several of its employees from a rare liver cancer (angiosarcoma) may have been occupationally related. As a result of this notification and after con sultation with the National Institute for Occupational Safety and Health (NIOSH), and a joint inspection of the plant by OSHA, NIOSH, and the Ken tucky Department of Labor, a fact-find ing hearing on possible hazards involved with the manufacture and use of VC was announced on January 30, 1974 (39 FR 3874) and held on February 15, 1974. 2. Carcinogenicity of VC. Information produced at this hearing demonstrated that exposure of laboratory animals (mostly Spragne-Dawlcy rats) to VC by Inhalation at and below the then current OSHA standard of 500 ppm induced tumois, including angiosarcomas of the liver. Professor Cesare Maltoni, of the Instituto dl Oncologia, Bologna, Italy, reported on a series of experiments on the effect of exposure of rats, mice, and hamsters to VC at concentrations of 10,000; 6,000; 2,500; 500; 250; and 50 ppm for varying periods of time (TR43-63). Some of the experiments have been concluded, and others arc still on going. The experimental results reported were that tumors have been observed in groups of animals exposed to VC at con centrations as low as 250 ppm. No tumors were observed In the group of animals exposed to VC at a concentration of 50 ppm. It also appears that the total num ber of tumors, as well as the numbers of angiosarcomas of the liver, decreased as the concentrations of VC were reduced to 250 ppm. Another experiment by Pro fessor Maltoni was reported underway involving tlic exposure of 300 animals to VC at concentrations of 50 ppiA, in order to assess in a more definitive way whether that level of exposure produces tumors in animals. Data reported by Torkelson, Oycn and Rowe (American Industrial Hygiene Association 3 22: 254361 (1961)) indicate that exposure to VC at concentrations of 50 ppm failed to induce tumors in rats, hamsters, rabbits, and dogs. The employees of the B. F. Goodrich Chemical Company who died from angio sarcoma of the liver had an average ex posure of approximately 19 years to vinyl chloride, at unknown concentrations, and variable exposures to other volatile chemicals. (TR 93). Some employees of Union Carbide, Firestone Tire and Rub ber, and Goodyear were also reported la post-hearing comments to have had ex posure to vinyl chloride and to have died from angiosarcoma of the liver. Finally, autopsies of four deceased employees re vealed their liver angiosarcoma tumors were histologically indistinguishable from the angiosarcoma tumors observed In Professor Maltonl's experimental animals. 3. The Emergency Temporary Stand ard. On the basis of all information available at that time, and the fact that employees were being exposed at level* around the experimentally observed ef fect level of 250 ppm, an Emergency Temporary Standard (ETS) was promul gated on April 5, 1974 (39 FR 12342) a 29 CFR 1910,93q. This standard reduced the level from a e-dint' cf fie a ipm. ta ppm ceiling. It v-s exi-r--'cv v' -"mUred that this standard Ifi-'i'm-T c>* 'r-.;vcs a 60 ppm level vrr- (nn-n-cM m j-n a ten tative, interim st^ndm-d. to he in effect no longer then six men*?''1. during which time the whole Qumlion of pr-dble safe exposure to VO would he rero rsidered more fully and in the fight of more in formation, csp-riaUy remits of experi ments which were known to be under way at that time. 4. Additional information. On A.p:1116. 1974, information rnd data wcie pre sented to repmsoitalives cf OCHA, NIOSH and the FTA by the TndesUial Bio-Test Laboratories, Nrrt.M'i-pov. THi- noia, concerning results of an'mal ex posure studies with VC, spom or-rt by the Manufacturing Chemists Ascription (MCA). Although only pw-Umincry in nature, these results revealed til l 2 cut; of 200 mice exposed to VC coiwciii rations of 50 ppm for 7 ham's a day. pyc days a week, for approximately 7 months, de veloped angle inreomps of the liver. The Industrial Ifio-Test Lab data in dicate that exposure to VC at 50 ppm may well constitute n rontons iwiPh haz ard to employees Aho, the Ion of a safe level of exporm-e for hums'ns can not be determined at this timr and may continue as a matter for r-'-'mitHic de liberation for many years. Wp therefore conclude that it is now nerr-myv to pro pose to change the 50 ppm level estab lished in the ETK to as low a l-vrl ns can be detected using methodologies outlined in this proposal. (5) The proposed ncrtnanevl standard. The requirements for n complete stand ard under section 6(b) of tbo Occupa tional Safety and Health Act of 1970 are much more comm'chrnsive than the provisions of the 3 TS promulgated on April 5. The following propo-nls nre re sponsive to the additional information on the carcinogenicity of- VC, and the requirements of the Act. A. Level of exposure. The proposed standard for employee m'"m o is set at no detectable level, ns d-Wmio-d by a sampling and analytical method capable of detecting vinyl chloride at concentra tions of 1 ppm with an neemrey of 1 ppm-50 percent. Although more sensi tive methods may be nvnli'|b't row or in the future, the methodnl gleet cvritivity proposed appears to be the nmst feasible and generally available. A m-C'od of 1 ppm sensitivity has ben rrroynu'.ded to OSHA by NIOSH To mirfinfim tire number of persons at ' l-fi, a r 'nuirc- ment would be cstabfi'hcd for r-"u'ating areas where vinyl eblci t,,o h n-nufactured, reacted, stored, hoocu-d, released, repackaged, or used, including opera tions with polyvinyl chimid- containing detectable levels of vinyl rhm, (o(. Acres* to the areas would be limited to author ized employees, B. Monitoring. A pregram of monitor ing would bo reqifire.l to establish whether there are detectable hods in regulated arear. and to p-Hn't'>`eim)na- tlon of employee exposures on an In dividual basis. Provision would aha be FEDERAL REGISTER, VOL 39, NO. 93--FRIDAY, MAY 10, 1974 AS I 000017910 a teneffcct which e safe idered re inxpeilmder- >ril 15, Pre>SHA, istrial ry the iation ry in 2 out xtions lays a s, de- ta in> PPm ihazn of a can1 may c deefore i prostabs can landeupa- 1070 n the jd on e reation 1 Uie posed set at by a pable ntraof 1 ensior in livity isible of 1 nded : the dire cting ifacased. )era:ning ecess hor- itorblich !s in PROPOSED RULES i 10807 niflde for an opportunity to observe record to an employee's physician on the (5) "Decontamination" means reduc monitoring by employees or their desig employee's request. Establishments con tion of vinyl chloride concentrations to nated representatives, as required by sec ducting VC operations would be required less than detectable levels, tion 8(c) (3) of the Act. to Identify themselves to OSHA, and to (6) "Detectable level" means an air C, Control methods. Where detectable report Incidents (accidents) resulting In borne concentration of vinyl chloride levels Of VC are monitored, two pro the release of vinyl chloride. measurable by a sampling and analytical grams would bo triggered; an engineer Accordingly, pursuant to sections 6(b), method capable of measuring concentra ing and work practice program to reduce 6(c), and 8(c) of the Occupational tions of l ppm. with an accuracy of 1 levels below detectability; and while this Safety and Health Act of 1870 (84 Stat. ppm50 percent. ts on-going, a respiratory protection pro 1593, 1596, 1599; 29 U.S.C. G55, 657), Sec (7) "Director" means the Diced or, Na gram for employees In the regulated area. retary of Labor's Order No. 12-71 (3G FR tional Institute for Occupational Safety Engineering controls and work prac 8754) and 29 CFR Part 1911, It is here and Health, or any per;on directed by tices are favored methods of compliance by proposed to amend 29 CFR Part 1919 him or the Secretary of Health, Educa because they tend to avoid contamina by revising S 1910.93q as set forth below. tion, and Welfare to act for the Director. tion of the ambient air in the workplace. Written data, views, and arguments (8) "Emergency" means an unforseen Accordingly, It Is proposed to require the concerning the proposals may be mailed circumstance or set of circumstances, re Institution of engineering controls and to the Docket Officer, Docket OSH-36, sulting In the release of vinyl chloride Of workpractice methods as soon as feasi Room 230, 1726 M Street, N.W., Occupa into areas occupied by employees. ble, and to require the use of respirators tional Safety and Health Administra (9) "Exposure" means actual contact pending the institution of such controls, tion, Washington, D.C. 20210, post with vinyl chloride when unprotected by to supplement such controls where they marked not later than June 10, 1974. required personal protective equipment are insufficient to reduce concentrations Pursuant to 29 CFR 1911.11 (b) and and clothing. of vinyl chloride below the detectable (c), interested persons may file objec (10) "Fabricated preduct" means a level, in specified work situations, and tions to the proposals, requesting an in finished product or part of such product, in cases of emergency. Tire proposal for formal hearing with respect thereto, in made of polyvinyl chloride, entirely or in continuous flow and pressure demand accordance with the following condi part, including semifinished products types of respirators is based on the rec tions ; such as film, sheet, block, bar, or extru ommendations of NIOSH, which has ob- (1) The objections must include the sion stock. sciwed leakage through chemical car name and address of the objector; (11) "OSHA Area Director" means the tridge respirators at high concentrations (2) The objections must be post Director for the Occupational Safety and of VC. marked on or before June 10, 1974; Health Administration Area Office hav A requirement would also be estab (3) The objections must specify the ing jurisdiction over the geographic area lished for the provision and use of pro provisions of the proposed rule to which in which the establishment is located. tective clothing for employees in the reg objection is taken, and must state the (12) "Polyvinyl chloride" means poly ulated areas. The protective clothing grounds therefor; vinyl chloride homopolymer or copol .would minimize skin contact with VC (4> Each objection must be separately ymer before such is converted to a fab vapor, and would provide some measure stated and numbered; and ricated product. of protection from splash of liquid in (5) The objections must be accom (13) "Protective clothing" means the event of a spill or rupture of equip ment. Food, beverages, and like products would be prohibited In the regulated area. Written operational and emergency plans would be required, along with em ployee training in routine and emergency duties. Specific requirements would be established for emergency actions and for routine maintenance and decontami nation operations, including vessel entry, which are known to present particular hazards. The purposes of operational and emer gency plans and training arc to apprise employees of the hazards to which they may be exposed, of the precautions they must take to avoid such hazards, and to rehearse employees in the procedures they must follow In emergencies. D. Medical surveillance. Comprehen sive requirements for employee mediral examination^ are proposed, Including necessary tests. Some additional guid ance is included for the convenience of physicians. The proposed requirements have been recommended to OSHA by NIOSH as reasonably appropriate to de tect liver dysfunction which may be in dicative of, or predisposing to, the de velopment of liver angiosarcomas. E. Records and reports. Records of monitoring, medical examinations, and panied by a summary of the evidence proposed to be adduced at the requested hearing. As revised, 1910.93q would read as follows: I9l0.93q Vinjl Chloride. (a) Scope and application. (1) 'Hiis section applies to any area or operation in which vinyl chloride (chloroetliene), Chemical Abstracts Service Registry No. 75015, is manufactured, reacted, re leased, repackaged, stored, or used, in cluding areas and operations involving polyvinyl chloride where detectable levels of vinyl clilorlde are released, (2) This section does not apply to the handling or use of fabricated products made entirely or in part of polyvinyl chloride. (b) Definitions. (1) "Assistant Secre tary" means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor or his designee. (2) "Authorized employee" means an employee whose duties require him to be In the regulated area and who has been specifically assigned by the employer; and any employee who enters such an area as a designated representative of employees to exercise an opportunity to observe monitoring and measuring of vinyl chloride. clothing protective against vinyl chlo ride, <14> "Vinyl chloride" means vinyl chloride monomer. (15) "Waste resin" means any resin or other reaction products removed in the cleaning of equipment, such as ves sels and piping. (c) Reference. College of American Pathologists, 230 N. Michigan Ave., Chi cago, Illinois 60601. (4) Regulated areas. ()) A regulated area shall be established where (i> vinyl chloride Is manufactured, reacted, re leased, repackaged, stored, or used; or (ii) polyvinyl chloride capable of re leasing detectable levels of vinyl chlo ride is manufactured, reacted, released, repackaged, stored, or used. (2) Access to regulated areas shall be limited to authorized employees. (3) A dally roster of employees enter ing regulated areas shall he made and maintained. The rosters, or summaries* thereof, shall be kept for at least 20 years. (e) Monitoring. (1) Every regulated area shall be monitored for detectable levels of vinyl chloride. (2) The monitoring shall .assure that any exposure may be determined for each authorized employee with a confi dence level of 95 percent. entry to regulated areas are proposed, (3) "Closed container" means any (3) Employees or their designated rep with provision for access by appropriate container which prevents tire release of resentatives shall be afforded an oppor 03HA and NIOSH officials, Specific pro vinyl chloride to the environment. tunity to observe monitoring and measur visions for employee access to monitoring (4) "Contaminated" means capable ing required by this paragraph, records are Included, as well as the re of releasing a detectable level of vinyl (I) Where exercise of an opportunity quirement to furnish a copy of a medical chloride. requires fntry to an area where the use No. 88--Pt. I-----10 FEDERAL REGISTER, VOL. 39, NO. 92--FRIDAT, MAY 10, 19T4 Asj 0000J79JJ  ! ' - 10398 PROPOSED RULES ; i et protective clothing, equipment, fa cilities, or procedures is required, such clothing, equipment, facilities, and pro cedures shall be provided ta all persons entitled to escrcire the opportunity, at no cost to any of them. Ul) Persons exercising the opportu nity shall be Instructed regarding: < A) Tire toxicity and fire hazard of vinyl chloride; and (H) The protective steps and measuree necessary for their protection. (Ill) Observers shall be permitted, without interference to the persons per forming the monitoring and measuring, to; (A) Observe all steps and procedures related to the collecting, processing, and evaluation of particular monitoring and measurement samples; (B) Record quantities and results obtained; (C) Observe the condition of monitor ing and measuring equipment; (D) Receive a demonstration of the calibration and function tests of the monitoring and measuring equipment performed on site; and (E) Examine Instructions and docu ments related to the procedures and equipment lor monitoring and measur ing, *4) Accurate and complete records of all required monitoring shall be made and maintained for not less than 20 years. Such a record shall <t) state the date of such monitoring and the levels determined; and (II) identify the Instru ments and methods used. (f) Engineering controls and workpracticc methods, (l) where detectable levels of vinyl chloride are measured, Immediate protection shall be provided against exposure to vinyl chloride by the use of engineering controls, workpractice methods, and respirators as follows: (I) Feasible engineering controls and workpractice methods shall Immediately be used to reduce airborne concentra tions of vinyl chloride below the detect able level; (ii) Wherever feasible engineering controls and workpractice methods which can be instituted immediately are not sufficient to reduce concentrations of vinyl chloride below the detectable level, they shall nonetheless be used to reduce the concentrations to the lowest prac ticable level, and shall be supplemented by means of respirators in accordance with paragraph (g) of this section; (hi) Wherever no feasible engineering control or workpractice method can be instituted Immediately, immediate res piratory protection shall he provided In accordance with paragraph (g) of this section: and (fv) In any case covered by paragraph (f)(1) (11) or (111) of this section, the employer shall also undertake as soon as practicable a program to reduce airborne concentrations of vinyl chloride below the detectable level, or to the greatest extent feasible, solely by means of engi neering controls and workpractice meth ods and as soon as feasible. (2) There shall bo tests made for process or equipment leaks and for emis sion of vinyl chloride which may result from workpractlec3. The frequency of these tests shall be such as to insure the Integrity of equipment and adherence to proper workpractlccs. (g) Respiratory protection. (1) A res piratory protection program In accord ance with 51010.134 shall be established and Implemented where respirators are required to be used by this section. (2) Rrspirators shall bo used only In cases of emergency and where required by any other provision of this section. Respirators may not he used in lieu of feasible engineering controls or workpractice methods. (3) Respirators or combinations of respirators for protection against vinyl chloride shall be selected from among the following: (1) A positive pressure full facepiece self-contained breathing apparatus; (II) A pressure-demand full facepiece self-contained breathing apparatus op erating In the pressure-demand mode; (iii) A combination type "C" pressuredemand full facepiece respirator oper ating in the pressure-demand mode and a pressure-demand self-contained breathing apparatus operating In the pressure-demand mode; or (iv) A combination type "C" continu ous flow respirator and a pressuredemand self-contained breathing ap paratus operating In the pressure-de mand mode. (h) Protective clothing. (1) Employees entering regulated areas shall be pro vided full-body protective clothing, foot wear or shoe covers, and gloves, at no cost to them, and required to wear It while In the regulated area. (2) Where polyvinyl chloride powder containing detectable levels of vinyl chloride is handled, employees shall also be: U) Provided and required to wear headcoverings; rii) Required to remove all protective clothing at each exit from the regulated area; and (III) Required to shower after the last exit of the day, (3) Clean protective clothing shall be provided whenever contaminated or soiled, but not less frequently than weekly. Contaminated clothing shall be decontaminated before reuse by removal for laundering or disposal. (i) Hygiene facilities and practices. (1) Where employees are required by this section to wear protective clothing and equipment, change rooms shall be provided in accordance with 1 1910.141(c). (2) Where employees are required by this section to shower, shower facilities shall be provided in accordance with 11910.141(d) (3). (3) Storage or consumption of food or beverages, storage or use of smoking or non-food chewing products, and the storage or application of cosmetics are prohibited In regulated areas. (j) Emergency ctlnnlions. (1) A writ* ten operational plrni for m^reency situations shall bo developed for each ; regulated area. ; (2) In the event of an cine' gency, ap propriate portions of the plan shall be put Into operation. (I) Hazardous conditions err ted by tlie emergency shall fin eliminated and the affected area 6>1',11 be decontami nated prior to the resumption of normal operations. (II) Special mctUcrd sinTelllooce by a physician shall be Instituted within 24- hours for employees preernt in the af fected area at the tlm of (be emergency. (III) Where an employee hn.<? a known contact with liquid vinyl chloride such employee shall be required to shower as soon os possible, unless contraindicated by physical Injuries. (iv) An Incident report, on the emer gency shall be report,ed os required In paragraph (q) (2) of this section. (3) Each atithori7',d employee shall be trained In a program relating to the hazards of vinyl 'fivlcride and the pre cautions for safe use. (t) The program shall Include: (A) The nature of the fire hazard, dnd the necessary protective steps; (B) The nature of the toxic hazard, including local and systemic effects, acute and chronic effects including specifically the carcinogenic hazard; (C) The specific nature of operations which could resu't in exposure to vinyl chloride, and necre'-ary protective steps; (D) The purpose for and application of the medical surveillance program; (E) The purpose for and application of decontamination practices; (F) The purpose for and significance of emergency practices and procedures; (0) The employee's specific role under normal operating or emergency condi tions; <H) Specific Information to nld the employee in recognition and evaluation of conditions and situations which may result In the release of vinyl chloride; (1) The purpose for and application of specific first aid procedures and prac tices; (J> A review of this standard at the employee's first training and indoctri nation program and annually thereafter. (If) All materials relating to the pro gram shall be provided upon request to authorized representatives of the Assist ant Secretary and the Director. <k> Signs and labels. <1) Entrances t regulated areas shall be posted with signs bearing the legend: CANCER- iTUf-r FCT AOPT AREA authorized nrncomurL only (2) Areas con! a fifing operations cov ered in paragraph (t) (1) (4) of Hits sec tion shall be posted with signs bearing the legend: CANCER-SUSPECT AC-VMT IN THIS AREA FULL IMPERVIOUS Alfi-niTPPUED EQUIP MENT REQUIRED AUTHORIZED PERSONNEL ONLY (S> Containers of wnte or other ma terials contaminated with vinyl chloride , shah be labeled; FEDERAL REGISTER, VOL 39, NO. *1--FRIDAY, MAY 10, 1974 ASI 000017912 A writ. icy, ap,lia.U be kted by ed and ntamlaormal * by a kin 24he afgency. known i sued ver as Seated emered In shall o the pre- . dnd zard. ects, ding tons 'inyl eps; nee i es; der . i, dl~ i. the on .ay on 1 c- ^ ie tr. y- o I PROPOSED RULES 1G809 VINYL CHLORIDE CONTAMINATES! (it) When vessels are to be entered, all MATERIAL piping to such vessel shall be; CANCER-SUSPECT AGENT (A) Opened, blanked and tagged; or DISPOSE OP on DECONTAMINATE using (B) Where welded piping Is in use, not AUTHORIZED PRECEDURE3 less than 2 valves In series, which isolate (4) Containers of polyvinyl chloride the vessel from any other connection to containing detectable levels of vinyl such line, must be closed and scoured. chloride shall be labeled: (ill) No employee shall enter a vessel, POLYVINYL CHLORIDE CONTAINS VINYL CHLORIDE VINYL CHLORIDE IS A except when another employee properly trained and equipped for entry Is pres ent and is observing the employee In the CANCER-SUSPECT AGENT vessel. The observer shall have means ABSORBED BY BREATHING AND for signalling for help In the event the THROUGH SKIN employee experiences problems. Under (5) Containers of vinyl chloride shall be labeled: such conditions, the observer shall sig nal for help, and shall not enter to assist the employee until another person Is VINYL CHLORIDE DANGER EXTREMELY FLAMMABLE GAS UNDER PRESSURE MAY POLYMERIZE WITH EXPLOSIVE FORCE present to observe. (m) Transportation loading and un loading. (1) Facilities for the loading and unloading of vinyl chloride to and from containers shall have each transfer POISON line and vapor-equalizing line equipped CANCER SUSPECT AGENT AND with vent connections, and shall have ANESTHETIC an inert gas purging system. Vent and ABSORBED BY BREATHING AND THROUGH SKIN purge effluent shall be returned to a proc ess stream or flared in a safe location. <6) No statement shall appear on or (2) Procedures shall be developed and near any required sign, label or instruc implemented for the transfer of vinyl tion, which contradicts or detracts from chloride. Written copies of such proce the effect of any required warning, in dures shall be provided employees en formation or instruction. gaged in such operations, and such em (1) Maintenance and decontamina ployees shall be fully trained and re tion. (1) Emphasis shall be placed upon hearsed In all procedures. immediate clean up of spills, periodic in (3) Employees engaged In transfer op spection, prompt repair of equipment and erations shall be provided with and leaks, and proper handling, storage and required to wear respirators in accord disposal or decontamination of materials ance with paragraph (g) of this section. to prevent airborne contamination and accidental skin contact with vinyl chlo ride. Waste materials, equipment, and other sources of vinyl chloride in closed containers, may not be placed in areas of excessive temperature or sunlight since build-up of internal pressure may result In rupture of the container, Are or explosion. (2) Waste resins or other materials contaminated with vinyl chloride shall be placed in closed containers pending dis posal or decontamination. (3) Appropriate procedures shall be developed and implemented for the de contamination or disposal of all such waste material. (4) In maintenance or repair opera tions on contaminated--systems or equipment, including vessel entry, em ployees engaged in such operations shall be (1) provided with and required to wear and use a whole-body air-supplied suit impervious to vinyl chloride, and a respirator in accordance with paragraph <B> of this section; and (11) required to shower after removing protective equip ment. (5) Protective clothing and equipment shall bo clean and dry for each use. (6) When vessels or piping systems are opened local exhaust ventilation shall bo provided to remove the escaping vapor from all occupied areas. (n) Polymer handling operations. (1) Containers of polyvinyl chloride releas ing detectable levels of vinyl chloride shall be opened and transferred only under local exhaust ventilation which reduces the concentration of vinyl chlo ride below the detectable level. (2) Hot operations, such as but not limited to milling, calendering and ex truding, which release detectable levels of vinyl chloride, shall be carried on only under local exhaust ventilation which reduces the concentration of vinyl chlo ride below the detectable level, (o) Medical surveillance. Not later than 1974, a program of medical surveillance shall be insti tuted, and shall provide each authorized employee with an opportunity for ex aminations In accordance with this para graph. All medical examinations and procedures shall be performed by or under the supervision of a licensed Doctor of Medicine (MD) or Doctor of Osteopathy (DO), All medical examina tions and tests shall be provided without cost to the employee, (1) At the time of Initial employment, or upon Institution of screening, a physi cal examination shall be performed with specific attention to detecting enlarge ment of liver or spleen by abdominal palpation. (7) (l) Vessels to be entered shall first bo ventilated and monitored so that the concentration of vinyl chloride is reduced (2) At the time of initial employment or upon Institution of screening, and an nually thereafter, a medical history checklist shall be completed by the em to a love! within the protection factor ployee. This list shall include questions capability of the protective equipment. concerning; (D Alcohol Intake; (ii) Past history of hepatitis; (ill) Past exposure to potential hepa- totoxlc agents, including drugs and chemicals; <iv) Past history of blood transfu? slons; and (v) Past history of hospitalizations. (3) At the time of in'tlal employment, or upon institution of screening, a scrum specimen shall be obtained for screening with respect to the following bio-chemi cal determinations of liver function: (I) Total bilirubin; (II) Alkaline phosphatase; (ill) Serum glutamic oxalacctle trans aminase (SOOT); (lv) Serum glutamic pyruvic trans aminase (SQPT); and (v) Gamma glustamyl Uanspcptidase (GGTP). (4) Additional tests that may option ally be considered for use in screening include: (I) Lactic dehydrogenase; (II) Serum protein determinations; (lli) Serum protein electrophoresis; and (iv) Platelet count. (5) Laboratory analyses for nil biologi cal specimens included in medical exam inations shall be performed In labora tories accredited by the College of American Pathologists or licensed under 43 CFR Part 74. (6) If the results of screening required in paragraph (o) (3) of this section are normal, screening shall be repeated: (i) Every six months for employees who have been employed In vinyl chlo ride related operations for 10 years or more; and (11) Annually for all other employees entering regulated areas. (7) If one or more liver function tests, performed are abnormal, scrum testing shall be repeated as soon m possible, preferably within two to four weeks. If no abnormalities are present upon re screening, serum testing shall be re peated in three months. (8) If abnormalities persist upon re screening, the employee shall b* with drawn from areas where contact with vinyl chloride is possible, and an Individ ualized medical workshop shall be in stituted. Suggested as Initial steps ore a complete physical examination and vari ous special procedures such as hepatitis B antigen determination and liver scan ning, If liver function abnormalities are determined to be unrelated U> liver dis ease, the employee may be permitted to return to vinyl chlorldc-relolod employ ment, subject to individual medical evaluation. (9) A complete and accurate record of the results of medical examinations shall be made and maintained for the dura tion of employment plus five years, or for 20 years, whichever Is longer. (p) Records. (1) Records of monitor ing and measuring, medical rccm ds, and regulated area entry rosters pud sum maries, shall be made available tor ex amination and copying upon request to authorized representatives of the Assist ant Secretary and the Director. R0EKAI MOIST**, VOL. 34, NO. 92--FRIDAY, MAY 10,1974 AS I 000017913 16900 PROPOSED RULES (2) In the event that the employer ceases to do business and there Is no suc cessor to receive and retain his records (Secs. 0(b), G(c). and 8(c). 84 Stat, 1G03, 1598, 1699 (29 UAC. G5G, 657); Secretary of labor's Order No. 12-71 (38 FR 8764)) conservative limitation may no longer $ be applicable, the FAA has instituted a , regulatory study project to reevaluate l for the proscribed period, these records Signed at Washington, D.C. this 6th the limitation. The study will include the, shall be transmitted by registered mail day of May, 1974. factors originally considered in estab- * to the Director, and each employee Indi John Stendeb, li3hlng the limitation as well rs any ether vidually notified In writing at this Assistant Secretary of Labor. factors found to be pertinent, Those transfer, (3) Employees and their designated [FR Doc.74-10748 Filed 6-9-74:8:45 am] factors originally considered Include pda- ! tlnent evacuation tests and demonstra representatives shall be provided access to examine and copy records of monitor DEPARTMENT OF tions, exterior slides, tho number, loca- ' tion, and size of alsl'w rnd passageways,' ing and measuring. (4) Former employees shall be pro vided acces to examine and copy records reflecting their own exposures. (51 Upon written request of any em TRANSPORTATION Federal Aviation Administration [ 14 CFR Part 25 ] [Docket No. 13606: Notice 74-19] and evacuation system reliability. Data available to the FAA on fn-servlco evacuations, slide deployments, and ' evacuation demonstrations indicate that more than 100 passengers have been ployee, a copy of the medical record of such employee shall be furnished to a TRANSPORT CATEGORY AIRPLANES evacuated through a. Typo A exit within 90 seconds. The data further indicate, physician designated by the employee In Type A Passenger Emergency Exit Capacity that Type A exit systems may have such request. <q) Reports. (1) Not later than-------- _____ the following Information shall be reported to the OSHA Area Director. Any change in such information shall be reported to the OSHA Area Director within 15 days of such change. (1) The address and location of each establishment which has one or more regulated areas; and (11) The number of employees in each regulated area during normal operations, including maintenance. (2) Incidents which result In the re lease of vinyl chloride into any area where employees may be exposed shall be reported In accordance with this para graph. (i) A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be made within 24 hours to the OSHA Area Director. (11) A written report shall be filed with the OSHA Area Director within 15 calendar days thereafter and shall In clude: (A) A specification of the amount of material released; (B) A description of the area involved and the extent of known and potential employee exposure and area affected; (C) A report on any medical treat ment of affected employees and any medical surveillance program imple mented; and <D) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to ovoid further similar releases. (3) Upon completion of any monitoring and measuring which discloses that any employee has actually been exposed to detectable levels of vinyl chloride, each sucli employee shall be Individually noti fied in writing. The notice shall: (1) Be delivered not later than 10 working days after completion of the The FAA is considering rule malting to revise the passenger seating configura tion limit that is applicable to Type A exits on transport category airplanes. Sections 25.807(c) (2) and (3) of the Federal Aviation Regulations (FARs) currently provide that for each pair of Type A exits (consisting of one on each side of the fuselage) the airplane may have a maximum passenger seating con figuration of 100. This advance notice of proposed rule making is being issued in accordance with the FAA's policy for early Institu tion of public proceedings in actions re lated to rule making. An "advance" no tice is issued to invite early public par ticipation in the identification and se lection of a course or alternate courses of action with respect to a particular rule making problem. Interested persons are Invited to par ticipate in the rule making by submitting such written data, views, or arguments as they may desire. Communications should identify the regulatory docket or notice number and be submitted in duplicate to: Federal Aviation Administration, Of fice of the Chief Counsel, Attention: Rules Docket, AGC-24, 800 Independence Avenue, S\V., Washington, D.C. 20591. Communications should be received on or before July 9, 1974, to assure proper consideration. All comments submitted will be available, both before and after the closing date for comments, for ex amination by interested persons. The regulatory provisions relating to Type A exits that are contained in ( 25.807 of the Federal Aviation Regulations were adopted by Amendment 25-15, ef fective October 24, 1907. That amend ment also established the provision. In } 25.803(c), that manufacturers show by demonstration that the maximum seat ing capacity of an airplane having a ca pacity of mare than 44 passengers con be evacuated to the ground within 90 seconds, under conditions proscribed in higher in-service reliability than wrs an ticipated at the time tho limitation was established in tho regulations. However, the FAA believes It is important to re view all relevant data on safety and cost considerations that may be applicable to any proposed charge In the Type A exit passenger seating limits Mon. To this end, the FAA solicits data, views, and argu ments from all interertert persons on the questions set forth Iwlow. Data support ing an answer should be submitted or identified sufficiently that the FAA may obtain or develop ft. 1. Do the data available on evacuation tests and in-service Incidents that relate to the evacuation capacity of Type A exits under emergency conditions indi cate that the 100 passenger limitation* may safely be Increased? 2. What reliability has been demon strated for Typo A exit systems by serv ice experience and tests? 3. What relationships may be estab lished between reliability' and passenga' emergency evacuation capability of TypeA exits? 4. How would tho emergency evacua tion capability of Type A exits be af fected by specific increases in passenger seating capacity and by specific passen ger seating configuration considerations? 5. If there are other factors that should be considered, how should the rel evant data be related to the emergency evacuation capability of Type A exit*? 6. If the commentator recommends specific passenger capacities for consid eration, what economic and safety bene fits or penalties would be associated with them? Issued in Washington, D.C,, on May 2, 1974. C. R. Mrcnr.tn. Jr., ' Ar.tina Director. Flight Standards Service. [FR Doc.74-10787 Filed 6-0-74:8:45 am] monitoring and measuring; the regulation. As discussed in the pre (ii) State the actual exposure in terms amble to Amendment 25-15, the allow of concentration and time: and able passenger seating limit of 100 that 114 CFR Fart 39} [Docket No. 74-1TV7--4-AI) f (iii) State the steps which have been taken, are being taken, and will be taken, was established for each pair of Type A exists was less than the evacuation ca pacity that had been demonstrated by AIRWORTHINESS DIRECTIVES Bering Model 737-100/200 Soriee with specific completion dates, to termi test. As a result of receiving data and nate the exposure and prevent a recur Information tending to Indicate that The Federal Aviation Admiotstraticr rence. sonic of the considerations leading to the Is considering amending Fart 39 of tin 000017914 FEDERAL KEGISTER, VOL. 39, NO. M--KUOAY, MAY 10* 1974 AS I 1