Document vBY91BNOx8wKapQZnmjr6Kg39

Health research group zaaa p street, n. w. WASHINGTON. O. C. 20036 March 3, 1974 Office of Standards Attention: Docket OSH-36 Occupational Safety and Health Administration Room 203 1726 M Street Washington, D.C. 20210 Dear Sir or Madam: The enclosed information is submitted (in triplicate) to the Department of Labor in accordance jwith our request to participate in the Department's oral proceedings on February 15, 1974, with respect to the "possible hazards associated with the manufacture and/or use of vinyl chloride," 39 Fed. Reg., 3974 (January 30, 1974). The attached petitions, requesting that the Food and Drug Administration, the Consumer Product Safety Commission, and the Environmental Protection Agency prohibit the continued use of vinyl chloride as a propellant in aerosolized products, were filed with the agencies on February 21, 1974. They are submitted for the consideration of the Department of Labor since such use of vinyl chloride presents the possibility of exposure to the chemical by thousands of workers not engaged in the production of vinyl chloride or polyvinyl chloride, but rather who are engaged in the process of packaging aerosols or who use aerosol products on the Job (e.g. the use of hairsprays by hairdressers). Thank you for your consideration. Respectfully Submitted, Bertram R. Cottine QmJjjjlW. IkUkr' Andrea M. Hricko BOR 009821 s Health re: earch Group 2000 P THEET. N. W. WASHINGTON, D. C. 2D036 Bl 2-0320 February 21, 1974 Mr. Russell Train, Administrator Environmental Protection Agency Washington, D.C. Dear Mr. Train: As you know, a rapidly rising number of cases of liver cancer (angiosarcoma) are being discovered in workers exposed to vinyl chloride. Combined with other human evidence of liver disease, an earlier study showing cancer in animals, and a recent study in animals demonstrating carcinogenicity with exposures as low as 250 parts per million, it appears that another common chemical has joined the growing list of environmental carcinogens. Although the major use of vinyl chloride monomer is to make polyvinyl chloride (PVC), several percent of the billions of pounds of vinyl chloride manufactured each- year goes into the production of other goods. We have learned that a significant amount of vinyl chloride is used as an aerosol propellant in consumer products. It is known to have been used as a propellant in insecticide cans in 1964 and there is no indication that its use as such a propellant has been curtailed since that time. (Aerosol Age, April 1964, p. 47.) In that same article, the levels of vinyl chloride, under conditions where hair spray was being used, were shown to exceed 250 parts per million. (See calculations on page 2 of petition.) Several requests for action are detailed in the attached petition. In addition, we request that you make public the brand names of all aerosol pesticide products presently marketed or marketed at any time in the past which contain vinyl chloride as a propellant. When matters of health and grave danger are at stake, the public has the right to be fully informed about the dangers it faces or has faced from using particular brand name products--regardless of the public relations damage that certain companies may suffer. All those people who have been exposed at any time to products containing vinyl chloride should be made aware of this so that they can inform their physicians. Thank you for your consideration. B0R 009822 Sincerely yours, BEFORE THE ENVIRONMENTAL PROTECTION *GENCY HEALTH RESEARCH GROUP Petitioner To: Russell Train, Administrator Environmental Protection Agency PETITION TO IMMEDIATELY SUSPEND ALL PESTICIDE PRODUCTS WHICH UTILIZE VINYL CHLORIDE AS A PROPELLANT BECAUSE THERE IS SUBSTANTIAL EVIDENCE THAT VINYL CHLORIDE IS A CARCINOGEN I. Petitioner Petitioner Health Research Group is a non-profit organization engaged in public interest research on health issues, including pestldide safety. It is funded by Public Citizen, many of whose members use aerosolized household pesticides. II. Authority for Petition and Regulation Petitioner's authority to petition for rule-making is the Administrative Procedure Act, 5 U.S.C. 553 (e). The authority o.f the Environmental Protection Agency to promulgate this rule is 7 U.S.C. (The Federal Insecticide, Fungicides and Rodentlcide Act, "FIFRA", as amended, 1972) 136(q)(1)(G), 136d, 136j(a)(1)(E), and 136K. * III. Summary of Reasons for This Petition Vinyl chloride is a toxic substance known to be commonly used as a propellant in aerosolized products. It is known to have been used as a propellant in insecticide cans in 1961*, and there is no indication that its use as such a propellant has been curtailed since that time. No regulations currently prohibit such use of, vinyl chloride. -2-3- Vlnyl chloride. monomer ts a colorless gas which can cause acute toxicity manifested by dizziness, headache, dis orientation, and unconsciousness at high concentrations. It has been linked to osteolytic (bone destructive) lesions of the hands, liver disease, and liver cancer in workers encased in the polymerisation of polyvinyl chloride from vinyl chloride monomer. In one study of in dustrial 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. i Of greatest significance, since 1964 five workers engaged In making polyvinyl chloride from vinyl chloride monomer at one plant have died from a rare and Invariably fatal form of cancer of the liver. The most recent death was December 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 Pesticide Products Vinyl chloride i& among the most often-used propellants in aerosols (Postgraduate Medicine. p. 65; Report of the Committee on Aerosol Toxicity, p. 19) and is known to have been used in the past as a propellant in insecticide sprays (Aerosol Age, p. 47). - A 1964 report estimated that an aerosol product sprayed in a tiny room of 282.5 cubic feet for 30 seconds would result in 0.025? vinyl chloride by volume (Aerosol Age, p. 47.) This level would correspond to over 250 ppm vinyl chloride in th air of a room that size,* not unlike the size of many bathrooms in small apartments. Using Aerosol Age's reference that 16.5? by volume corresponds to 460 g. vinyl chlorlde/M^, and a conversion factor of 500 odd 1300 mg/M3 (ACGIH.) V BOR 009824 Prior Regulatory Actions on Vinyl Chloride 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 ceiling 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. Hay 29, 1971). The ACGIH has since recommended 200 pants per -million as a revised voluntary oellln'g value for occupational exposure to the chemical. (Documentation of Threshold Limit Values, p. ^77). 1973. On Hay 15, 1973, the Food and Drug Administration published a notice of proposed rule-making for the `priorsanctioned 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 th vinyl chloride monomer migrates to alcohol from PVC bottles used to package distilled spirits and wine. Analytical results from Industry confirmed that levels of up to 20 ppm of vinyl chloride were found to have migrated t 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.11 (Federal Register. Hay 15, 1573). 1973. A July 13, 1973, FDA notice in the Federal Register extended the time for filing comments on the FDA proposal for restrictions on polyvinyl chloride packaging, at the request of the plastics Industry. The notice stated that the Bureau of Alcohol, Tobacco and Firearms of the Treasury Department (vrhich 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 009825 BOB -5- 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 Hay 17, 1973. 1974. In direct response to the deaths from a rare form of liver cancer of four workers at one polyvinyl chloride plant, the Department of Labor published on January 30, 1974 a request for Information and a notice of a fact-flndinc hearing on the possible hazards associated with the manu facture and/or use of vinyl chloride (Federal Register, January 30, 1974). At the hearing held on February 15, 1974, the Industrial Union Department of the AFL-CIO petitioned for an emergency temporary standard to prevent any worker exposure to vinyl chloride. VI. The Grave Danger Resulting from Sjfoosure to Vinyl Chloride A. Acute Effects Vinyl chloride is a-gas which can cause unconsciousness at extremely high concentrations. Inhalation of a 2.52 con- ** centraticn of vinyl chloride can cause dizziness, dis orientation and headache (ILO, p. 1466). At an 8-122 con centration cardiac arrythmias have been observed in experi mental dogs (ACGIH, p. 477). The Committee on Aerosol Toxicity has voiced concern over the use of certain gases-- including vinyl chloride--as components of propellant/ solvent systems in aerosols because they are capabl of pro ducing "cardiac sensitization" (Committee Report, p. 19). ''"v 3. Evidence of Carcinogenicity On January 22, 1974, the 3.F. Goodrich Company announced that three--and it is now known five--of its Louisville, Kentucky, vinyl-chloride workers'had died of angiosarcoma (or hemangioendothelioma) of the liver,' an exceedingly rare form of liver cancer. The five deaths occurred between 1964 and 1973, with the time of development of liver cancer after the onset of exposure to vinyl chloride in the four, workers for whom thl3 information is known from 14 to 27 years. BOR 009826 -6- Tbe national Institute for Occupational Safety and Health, estimating that only twenty to thirty people die in the United States every year from this particular type of cancer, has announced the discovery of a new occupational cancer associated with the polymerisation of polyvinyl chloride from vinyl chloride, with vinyl chloride as the chief causative suspect (Statement of Dr. Marcus Key, February 1, 1974). The disease Is invariably fatal, once cancer has heen initiated (Statement of Dr. Irving Selikoff, February 15, 1974). The carcinogenic effects of exposure to vinyl chloride have been demonstrated by Viola and Maltoni, in separate experi ments. Viola produced angiosarcomas of the live:* in 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, February 15, 1974). After 127 weeks of exposure to vinyl chloride (4 houra^day; 5 days a week, by inhalation), Maltoni reported liver tumors in Sprague-Dawley rats at exposures as low as 250 ppm. (Se table below). Results Of Maltoni1s Sxoerimental Study Exposure levelvinyl chloride, by Inhalation .10,000 ppn 6,000 ppm 2,500 opn 500 ppm 250 ppm 50 ppra it of animals exposed 69 72 74 67 67 54 if of animals developing liver angiosarcomas 6 11 9 7 2 .0 Dr. Maltoni reported that he is currently conducting an experiment using 300 rats exposed to 50 ppm, since the failure of the low dose of vinyl chloride to induce cancer may be a function of the small number of animals tested. In addition, Maltoni has observed two fibrosing angiosarcomas in the offspring of pregnant rats exposed to vinyl chloride. BOR 009827 -7- He stated that such fibrosing angiosarcomas have never been observed as occurring spontaneously in Sprague-Dawley rats. C. Other Evidence of Liver Disease As early as 1961 Torkelson et al. reported that abnormal histologic changes were noted in the livers of rabbits after repeated exposures to 200 ppm of vinyl chloride. Slight liver enlargement was noted at doses as low as 100 ppm (Torkelson et al.). A 1967 French study of 163 workers engaged in the production of PVC found liver enlargement in 302 of the cases studied (Suciu et al.). A later report of the health experience of Dow Chemical's vinyl chloride workers revealed no overt Illness, but did determine that certain blood tests of liver function, (e.g. beta liproprotein, the icterus index, and bromosulfalein retention time) were abnormally altered. On the basis of their findings, the authors concluded that some degree of liver dysfunction might result from a TLV for vinyl chloride of 300 ppm (Ilutchler et al.). Marstellar et al. reported within the past few months that 19 out of 20 workers who had been exposed to vinyl chloride for 1-1/2 to 21 years at a PVC producing plant in Germany had some type of liver disease, including gross changes of the liver and spleen. Direct inspection of the liver and spleen (by surgical operation) showed disease to be present in 1$ out of the 20 workers (Marstellar et al.). D. Evidence of Other Chronic Effects In Octoyer 1963 Osteolytic lesions v/ere first observed in two Belgian plastics workers who were also suffering from Raynaud's phenomenon due to constriction of the local blood vessels in their hands (ILO, p. 1466). This hand syndrome--termed acroosteolysis--has since been observed in over 30 workers in the United States employed in the manufacture of PVC r sins (Wilson et al.). BOR 009828 VII. Relief Requested The Administrator of Che Environmental Protection Agency regulates pesticides under the Federal Insecticide, Fungicide and Rodenticide Act, as amended in 1972 ("FIFRA.") "Pesticides" are defined in FIFRA, 7 U.S.C. 136 (u) as including "any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest...." As a propellant of such a pesticide, vinyl chloride is necessarily included in the mixture of substances. t 7 U.S.C, 136d(c) imposes upon the Administrator the duty to issue a suspension order for any pesticide if the Administrator determines that action is necessary to prevent an imminent hazard...." 7 U.S.C. 136d(b) imposes upon the Administrator a duty to cancel a pesticide if it "appears_to the Administrator that a pesticide or its labeling or other material required to be submitted does not comply with provisions of this Act or when used in accordance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment...." A pesticide is '"misbranded" if the "label does not contain a warning or caution statement which may be necessary, and if complied with, together with any requirements imposed under* Section a(d) of this title, are adequate to protect health and environment." Therefore, a "misbranded" pesticide does not "comply with provisions of this Act." A pesticide must be deemed "misbranded" if no directions for use on a label would be adequate to protect the health of the user or those exposed to a pesticide. The chronic toxicity and evidence of carcinogenicity of vinyl chloride monomer for' human beings has been documented by experimental studies and by clinical reports. Further use of vinyl chloride -9- monomer as a propellant for aerosolized products must be prohibited since there is no evidence that human beings can safely be exposed to the chemical. Therefore, no label directions can be considered adequate to protect the public health and any pesticide product containing vinyl chloride as a propellant must be deemed "misbranded," Further, under 7 U.S.C. $ 136K the Administrator of the Environmental Protection Agency has the authority to stop the sale of or to seize any pesticide that is "misbranded." Respectfully submitted. Dated: Washington, D.C. 21 February 1974 Andrea M. Hricko -- Sidn< ,, (W 2000 P Street, N.W. #708 Washington, D.C. 20036 l BR 009830 Amerlcan Conference or Government,..< .1 > .>.istri> 1 hygienists (ACGIH), documentation of Three 'Id 1-tmtl Values, 1971, pp, IJ77-4TTI: Barnstgin, I -C., "Medical Hazards *c.< Medicine, December 1972, pp. f>2- ' " To-* , raduat>> "" "Consumer Pa:kaging", Chemical and . 1971, P. 22. oerlj-t PcJai-al Rents'er, Vol. 36, Ho. 105, n-f J y<v April 12, 10505. Federal Register, Vol. 38, No. 95, fla.i 12931. Federal Register, Vol. 3C, Ho. 134, Jui ij. Federal Rerister. Vol. 39., Ho. 21, Tan- 3", f * - 1864, *9-;- p. 387*f' International Labour Organization IL0), Eo< LOted: a of Occupational Safety and. Health. 197?. WE- Kubler, Hans, "The Physiological Propel tie-'.'. .f Aero col* Propellants," Aerosol Are, April 1964, pp. *4-50, 90-91. Ma'.toul, Prof. Cesare, Instituta di On-uJogi..;.?,, ,3olognr.v Italy, Testimony at department of tabor Hearing on VU^l Chloride, February 15, i974. .larstej-lar, H.J., et al.Deutsche ii&d. Wlrk&chaft 9ft;23.i.i, 197?-, cited by 'Jr, Irvine Selikoff at rvbruary '"i, 1974, D-partnnr.' of Labor i*: - ih vinyl Jorid", 6 Mutch li- , 7.c-, C.Ch, Report Relation of >*y;o <vse State of `.aa?" h of 'v.- Chemical ' chars, r,ordc.-. k. ,1- '.r-.-ncc, T' 'tor, ti"t Hemp ''re, August, lvoll, cited Jr 1 .* a-c;-*r.t.ion 'thresru. Value!,, y. 271. Report of the Committee on Aerosol Toxicity, August 4, 1972, p. 19, (Chairman: Dr, Albert C. Kolbye, Jr.) Samuels, SheldOr, IndustrialUnion Department, AFL-CIO,Testing ny- pie:, inted February 15, 1574, *t Depart/^'.it -f I/' cr ."iCjjl.;,;. on \inyl Chloride, ci.ing figures suppjJ- A by Industry oca., cec Sellkoff, Irving, Professor, Rt. Sinai-Sob` of Medicine, Te: .imony at Department of Labor Hearic* n Vinyl Chloride, February 15, 1974. Suelu, 1., Drejman, I., and Va las Id, M. 'K-uf' des Maladies* dues au Chlorure de Vinyle," Clin Inue d< ma.l-u.ies professional^.*, . Vol. 58, No- 4, 1967 \English abfT Torkelson, T.R., Oycn, F,, Rowe, V.K. . 1..-.tt. Hyp Assn. J,. 22:354 tU6l), cited In Document-'^n o' `hreshold L Tilt Values, -j. 277. --- - Viola, '`-L., "Caneerogenic Effi . V:. f tr oride," fMtr. 10th. international Cancer : j-.y-fj.- _ Hr >. ton, Texrc. (T57D), * . p. "20. V/ilson, R.:i.f ez al., "OccupaUo-.i I- Aw Oi **clysis: Report of 31 Cases," JAMA, 201:577-'-8).. > -oV- BOR 009831 stealth Research Group 2000 P a TREET. N, w. WASHINGTON. . a 20036 S72-032Q February 21, 197^ Dr. Alexander M. Schmidt, Commissioner Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20852 Dear Dr. Schmidt: As you know, a rapidly rising number of cases of liver cancer (angiosarcoma) are being discovered in workers exposed to vinyl chloride. Combined with other human evidence of liver disease, an earlier study showing cancer in animals, and a recent study in animals demonstrating carcinogenicity with exposures as low as 250 parts per million, it appears that another common chemical has joined the growing list of environmental carcinogens. Although the major use of vinyl chloride monomer is to make polyvinyl chloride (PVC), several percent of the billions of pounds of vinyl chloride manufactured each year `goes r" into the production of other goods. 1 We have learned that a significant amount of vinyl chloride is used as an aerosol propellant in consumer products includii hair sprays. According to one published report (Aerosol Age, April 1964, p. 47), the levels of vinyl chloride, under conditions where hair spray was being used, can exceed 250 parts per million. (See petition, p. 2) Several requests for action are detailed in the attached petition. In addition, we request that you make public the brand names of all aerosol cosmetic products presently marketed or marketed at any time in the past which contain vinyl chloride as a propellant. When matters of health and grave danger are at stake, the public has the right to be fully informed about the dangers it faces or has faced from using particular brand name products--regardless of the public relations damage that certain companies may suffer. All those people who have been exposed at any time to product containing vinyl chloride should be made aware of this so tha they can inform their physicians. Thank you for your consideration. Sincerely yours. Cl/hiMjJfy}. [kulot' Alt Andrea M. Hricko Wolfe, M BOR 009832 BEFORE THE FOOD AND DRUG ADtlINIr 'RATION HEALTH RESEARCH GROUP ) ) Petitioner ) TO: Alexander It. Schmidt, Commissioner Food and Drug Administration PETITION TO IMMEDIATELY PROHIBIT TIE CONTINUED USE OF (1) VINYL CHLORIDE AS A PROPELLANT FOR AEROSOLIZED COSIETICS, AND OF (2) POLYVINYL CHLORIDE A3 A CONTAINER FOR ANY COSMETIC PRODUCT UHICH CAN LEACH OUT DETECTADLL AMOUNTS OF VINYL CHLORIDE FROM THE PVC, BECAUSE THERE IS SUBSTANTIAL EVIDENCE THAT VINYL CHLORIDE MONOMER IS CARCINOGENICI. II. III. I. Petitioner Petitioner Health Research Group ia a non-profit organization' engaged in public interest research on health issues, including cosmetic safety. It ia funded by Public Citizen, many of whoae members use aerosolized cosmetics and polyvinyl chloride bottles which contain cosmetics and toiletries. II. Authority for Petition And Regulation Petitioners' authority to petition for rulemaking la the Administrative Procedure Act, 5 U.S.C. 553(e). The authority of the Pood and Drug Administration to promulgate this rule is 21 U.S.C. 371(a); 361(a),(d); 331(a),(g). III. Summary of Reasons for This Petition Vinyl chloride ia a toxic substance known to be used aa a propellant in aerosolized cosmetics and suspected to be present in cosmetics containing alcohol that are packaged in polyvinyl chloride (PVO) bottles. No FDA regulations currently prohibit such uses of vinyl chlorida or PVC. . *. i * . * BOR 009833 -2- Vinyl chloride, monomer is a colorless cas which can cause acute toxicity manifested by dizziness, headache, dis orientation, and unconsciousness at high concentrations. It has been linked to osteolytic (bone destructive) lesions of the hands, liver disease, and liver cancer in workers encased in the polymerisation of polyvinyl chlorida from vinyl chloride monomer. In one study of in dustrial workers exposed to vinyl chlorida 302 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 encased in making polyvinyl chloride from vinyl chloride monomer at one plant have died from a rare and invariably fatal form of cancer of the liver. The most recent death was December 19, 1973* This cancer has recently been diagnosed in a sixth worker in the same plant. IV, Thd Use or Presence of Vinyl Chlorida in Cosmetic ProductsVinyl chloride is amcng the most often-used propellants in aerosols (Postgraduate Medicine, p. 65; Report of the Committee on Aerosol Toxicity, p. 19*), and is a propellant in hairspray3 (Aerosol Age, p. 47 and an industry source, January, 1974.) A 1964 report estimated that spraying hairspray in a tiny room of 282.5 cubic feet for 30 seconds would result in 0.0252 vinyl chloride by volume (Aerosol Age. p. 47). Tills level would cor respond to over 250 ppn vinyl chloride in the air of a room that size,1" not unlike the size of many bathrooms in 3mall apartments. Polyvinyl chloride (PVC) is produced by the polymerisation of vinyl chloride. About 46 million pounds of PVC were used in plastic bottles in 1970. Plastic bottles (?VC and polyethylene tocether) comprise about 352 of the toiletries and cosmetics aUsing Aerosol Are1 s' reference tliat lo.52'by volume corresponds to 430 g, vinyl chlorlde/l^ an<j a conversion factor of 500 ppm 1J0G BOR 009834 packaging market (Chemical and Engineering itews. April 12, 1971, P- 22). After the manufacture of PVC, about 500 to 3000 ppn of vinyl chloride i3 entrapped in the PVC resin (Statement of Sheldon Samuels, February 15, 1974). The vinyl chloride monomer--in. FDA's own tests--has been found to migrate out of PVC containers into the alcoholic beveraces they con tain. (See follovfinc discussion). To our knowledge, no tests have been conducted to determine whether other alcohol or organic solvent-containing liquids (e.g.,bath lotion or perfume can also leach detectable amounts of vinyl chloride from their polyvinyl chloride containers. BOR 009835 -H- V. Prior Regulatory Actions on Vinyl C'nlu-j.de 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 celllnG level of 500 ppm (1300 mg/rn^) for occupational exposure to vinyl chloride, based on the recommendations of the American Conference of Governmental Industrial Hygienists (ACGIH), (Federal Register, Hay 29, 1971). The ACGIH has since recommended 200 pattca per million as a revised voluntary ceiling value for occupational exposure to the chemical. (Documentation of Threshold Limit Values, p. 477)1973. On May 15, 1973, the Food and Drug Administration published a notice of proposed rule-making for the `priorsanctioned 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 monoraer migrates to alcohol from PVC bottl s;. used to package distilled spirits and wine. Analytical results from industry 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. 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 restrictions on polyvinyl chloride packaging, at the request of the plastics industry. The notice stated that the Bureau of Alcohol, Tobacco and Firearms of the Treasury Department (which had first authorized experimental use of PVC bottles for liquor in November, 1963) had terminated the use of PVC containers for alcoholic beverages pending final BOR 009836 -5 action by the FDA on the proposal. As of this date' , (2/21/7) the Pood 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 one polyvinyl chloride plant, the Department of Labor published on January 30, 1974 a request for Information and a notice of a fact-finding hearing on the possible hazards associated with the manu facture and/or use of vinyl chloride (Federal Register, January 30, 1974). At the hearing held on February 15, 1974, * the Industrial Union Department of the AFL-CIO petitioned for an emergency temporary standard to prevent any worker exposure to vinyl chloride. VI. The Grave Danger Resulting from Exposure to Vinyl Chloride A. Acute Effects Vinyl chloride is a gas which can cause unconsciousness atextremely higl concentrations. Inhalation of a 2.5? con centration of vinyl chloride can cause dizziness, dis orientation and headache (ILO, p. 1466). At an 8-12? con centration cardiac arrythmias have been observed in experi mental dogs (ACGIH, p. 477). The Committee on Aerosol Toxicity has voiced concern over the U3e of certain gases-- Including vinyl chloride--as components of propellant/ solvent systems in aerosols because they are capable of pro ducing "cardiac sensitization" (Committee Report, p. 19). 3. Svldence of Carcinogenicity On January 22, 1974, the B.F. Goodrich Company, announced that three.--and it is now known five--of its Louisville, Kentucky, vinyl-chloride workers had died of angiosarcoma (or hemangioendothelioma) of the liver, an exceedingly rare form of liver cancer. The five deaths occurred between 1964 and 1973, with the time of development of liver cancer after the onset of exposure to vinyl chloride in the four workers for whom this information is known from 14 to 27* years. bor 009837 The National Institute for Occupational Safety and Health, estimating that only twenty to thirty people die In the United State: every year from this particular type of cancer, has announced the discovery of a new occupational cancer associated with the polymerisation of polyvinyl chloride from vinyl chloride, with vinyl chloride as the chief causative suspect (Statement of Dr. Marcus Key, February 1, 1974). The disease i3 Invariably fatal, once cancer has heen initiated (Statement of Dr. Irving Selikoff, February 15, 1974). The carcinogenic effects of exposure to vinyl chloride have been demonstrated by Viola and Haltoni, in separate experi ments. Viola produced angiosarcomas of the liver in rats . when exposed to 30,000 ppm for 4 hours/day, 5 days/week, for 12 months (Viola, p. 20). Haltoni .has produced the same type of cancers when exposing rats to much lower doses (Statement of Prof. Cesare Maltoni, February 15, 1974). After 127 weeks of exposure to vinyl chloride (4 hour^dayj f1 5 days a week, by inhalation), Haltoni reported liver tumors in Sprague-Dawley rats at exposures as low as 250 ppm. (See table below). Results of ilalton'i's Ixperimental Study Exposure levelvinyl chloride, by Inhalation 10,000 ppm 6,000 ?pm 2,500 ppm 500 ppm 250 ppm 50 ppm of animals exposed _____________ 69 72 74 67 67 64 if of animals developing liver angiosarcomas 6 11 9 7 2 0 Dr. Haltoni reported that he is currently conducting an experiment using 300 rats exposed to 50 ppm, since th failure of the low dose of vinyl chloride to induce cancer may b a function of the small number of animals tested. In addition, Haltoni has observed two fibrosing angiosarcomas in the offspring of'pregnant rata exposed to vinyl chloride. BOR 009838 He stated that such fibrosing angiosarcomas have never been observed as occurring spontaneously In Sprague-Dawley rats. C. Other Evidence of Liver Disease As early as 1961 Torkelson et al. reported that abnormal histologic changes were noted in the livers of rabbits after repeated exposures to 200 ppm of vinyl chloride. Slight liver enlargement was noted at doses as low as 100 ppm (Torkelson et al.). A 1967 ?rench study of 163 workers engaged in the production of PVC found liver enlargement in 30,3 of the cases studied (Suciu et al.). A later report of the health experience of Dow Chemical's vinyl chloride workers revealed no overt illness, but did determine that certain blood tests of liver function (e.g. beta liproprotein, the icterus index, and bromosulfalein retention time) were abnormally altered. On the basis of * their findings, the authors concluded that some degree of liver dysfunction might result from a TLV for vinyl chloride of 300 ppm (ilutchler et al.). Marstellar et al. reported within the past few months that 19 out of 20 workers who had been exposed to vinyl chloride for 1-1/2 to 21 years at a PVC producing plant in Germany had some type of liver disease, including gross changes of the liver and spleen. Direct inspection of the liver and spleen (by surgical operation) showed disease to be present in 1** out of the 20 workers (Uarstellar et al.). 3. Evidence of Other Chronic Effects In October 1963 osteolytic lesions were fir?t observed in two Belgian plastics workers who were also suffering from Raynaud' phenomenon due to constriction of the local blood vessels in their hands (ILO, p. 1H6G). This hand syndrome-termed acroosteolysis--has since `been observed in over 30 workers in the United States employed in the manufacture of PVC resins (V/ilson et ,al.). BOR 009839 -3- VII. Relief Requested 21 U.S.C. 5- 331(a) prohibits the ^introduction or delivery for introduction into interstate commerce of any...cosmetic that is adulterated.As defined by 21 U.S.C. $ 361(a), a cosmetic is deemed to be adulterated "if it bears or con tains any poisonous or deleterious substance which may render it injurious to users...'1 or "if its container is composed, in whole or in part, of any poisonous or deleterious sub stance which may render the contents injurious to health." Petitioners seek immediate prohibition of vinyl chloride as a constituent or propellant of aerosolized cosmetics and of polyvinyl chloride as a container for any cosmetic product which can leach out detectable amounts of vinyl chloride from the PVC, because there is substantial evidence that vinyl chloride monomer is carcinogenic. It;-mediate action is nec essary to prevent further human exposure to vinyl chloride monomer. Respectfully submitted, 1 f4 * ' / Andrea II. Hricko .1 V5 . >. ..VV :j, , Sidney II. Wolfe, II.Df Dated: Washington, D.C. 21 February, 197** 2000 ? Street, ?703 Washington, D.C. 20C36 BOR 009840 REFERENCES American Conference of Governmental Industrial Hygienists (ACGIH), Documentation of Threshold Limit Values, 1971. pp. nn~kW- Bernstein, I.L., "Medical Hazards of Aerosols,Postgraduat Medicine, December 1972, pp. 62-60. "Consumer Packaging", Chemical and Engineering News, April 12, 1971, p. 22. Federal Register, Vol. 36, No. 105, May 29, IS71, p. 10505. Federal Remister, Vol. 38, No. 95, May 15, 1973, p. 12931. Federal Register, Vol. 38, Mo. 134, July 13, 1973, p- 18684. Federal Pemister, Vol. 39, Mo. 21, January 30, 1974, p. 3374. International Labour Organization (IL0), Encyclopedia of Occupational Safety and Health. 1972, p. I486. Kubler, Hans, "The Physiological Properties of Aerosol Propellants," Aerosol Age. April 1964, pp. 44-50, 90-91. Maltoni, Prof. Cesare, Instituto di,0ncologica, Bologna, Italy, Testimony at Department of Labor Hearing on Vinyl Chloride, February 15, 1974. Marstellar, H.J., et al., Deutsche Med. Wlrkschaft 98:2311. 1973, cited by Dr. Irvlhg Selikoff at February 15, 1974, Department of Labor Hearing on Vinyl Chloride. Mutchler, J.E., Kramer, C.G., Report on Relation of Exposure to State of Health of Dow Chemical Workers, Gordon Conference, Tilton, New Hampshire, August, 1968, cited in Documentation of Threshold Limit Values, p, 278. Report of the Committee on Aerosol Toxicity, August 4, 1972, p. 19, (Chairman: Dr. Albert C. Kolbye, Jr.) Samuels, Sheldon, Industrial Union Department, AFL-CIO, Testimony presented February 15, 1974, at Department of Labor Hearing on Vinyl Chloride, citing figures supplied by industry sources Selikoff, Irving,1 Professor, Ft. Sinai School of Medicine, Testimony at Department of Labor Hearing, on Vinyl Chloride, February 15, 1974. Suciu, I., Drejman, I., and Valaski, I!. "Etude aes Maladies dues au Chlorure de Vinyle," Clinioue des maladies orofessionales. Vol. 58, Ho. 4, 1957 (English abstractT} ' Torkelson, T.R., Oyen, F., Rowe, V.K., Amer. Indust Hyg, Assn. J., 22:354 (1961), cited in Documentation of Threshold Limit Values. p. 277* Viola, P.L., "Cancerogenic Effect of Viny.l Chloride," Abstr. 10th. International Cancer Congress. Houston, Texas (1970)., pTTo. '1 Wilson, R.H., et al., "Occupational Acroosteolysis: Report of 31 Cases," JAMA. 201:577-581, 1967. BOR 009841 .ALTH Re' earch Group 200D P TREET, N. W. WASHINGTCJ l. D. C. 20036 S7.' 0320 February 21, 1974 Mr. Richard Simpson, Chairman Consumer Product Safety Commission Washington, D.C. Dear Chairman Simpson: As you know, a rapidly rising number of cases of liver cancer (angiosarcoma) are being discovered in workers exposed to vin yl chloride. Combined with other human evidence of liver disease, an earlier study showing cancer in animals, and a recent study in animals demonstrating carcinogenicity with exposures as low as 250 parts per million, it appears that another common chemical has joined the growing list of environmental carcinogens. Although the major use of vinyl chloride monomer is to make polyvinyl chloride (PVC), several percent of the billions of pounds of vinyl chloride manufactured each year goes into the production of other goods.. 4 We have learned that a significant amount of vinyl chloride is used as an aerosol propellant in consumer products. According to one published report (Aerosol Age, April 1964, p. 47), the levels of vinyl chloride, under conditions where hair spray was being used, can exceed 250 parts per million. (See petition, p. 2). Several requests for action are detailed in the attached petition. In addition, we request that you make public the brand names of all aerosol consumer products presently marketed or marketed at any time in the past which contain vinyl chloride as a propellant. When matters of health and grave danger are at stake, the public has the right to be fully informed about the dangers it faces or has faced from using, particular brand name products--regardless of the public- relations damage that certain companies may suffer. All those people who have been exposed at any time to products containing vinyl chloride should be made aware of this sd that they can inform their physicians. Thank you for your consideration. Sincerely yours, Andrea M. Hricko BOR 009842 BEFORE THE CONSUMER PRODUCT SAFETY COMMISSION HEALTH RESEARCH CROUP, Petitioner To: Richard Simpson, Chairman Consumer Product Safety Commission .' PETITION TO IMMEDIATELY PROHIBIT THE CONTINUED USE OF VINYL CHLORIDE AS A PROPELLANT FOR AEROSOLIZED CONSUMER PRODUCTS*AND TO REMOVE ALL PRODUCTS CONTAINING VINYL CHLORIDE AS A PROPELLANT FROM THE MARKET BECAUSE THERE IS SUBSTANTIAL EVIDENCE THAT VINYL CHLORIDE IS CARCINOGENIC I. Petitioner Petitioner Health Research Group is a non-profit 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 for Petition and Regulation Petitioner's authority to petition for rule-making is the ^ Administrative Procedure Act,. 5 U.S.C. 553 (e). The authority of the Consumer Product Safety Commission to promulgate this rule is 15 U.S.C. (The Federal Hazardous Substances Act), 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 aerosolized 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. It has been linked to osteolytic (bone destructive) lesions of the hands, liver disease, and liver cancer in workers engaged in the polymerisation of polyvinyl chloride from vinyl chloride monomer. In one study of industrial BOR 009843 2/3 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 making 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 December 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 aerosols (Postgraduate Medicine, p. 65; Report of the Committee on Aerosol Toxicity, p. 19; Aerosol Age, p. 47.) A 1964 report estimated that an aerosol product sprayed in a tiny roctn of 282.5 cubic feet for 30 seconds would result in 0.025% vinyl chloride by volume (Aerosol Age, p. 47.) This level would correspond to over 250 ppm vinyl chloride in the air of a room that size,* not unlike the size of many bathrooms in small apartments. Using Aerosol Age1s reference that 16.5% by volume corresponds to 460 g. vinyl chloride/M3, and a conversion factor of 500 ppm - 1300 rag/M3 (ACGIH.) BOR 009844 -4V.- .`rlor Regulatory Actions on Vinyl .lorlde 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 rag/m^) for occupational exposure to vinyl chloride, based on the recommendations of the American Conference of Governmental Industrial Hygienists (ACGIH), (Federal Register, May 29, 1971). The ACGIH has.since recommended 200 papta per -million as a revised voluntary celling value for occupational exposure to the chemical. (Documentation of Threshold Limit Values. p. 477)* 1973. On May 15, 1973, the Food and Drug Administration published a notice of proposed rule-making for the -priorsanctioned polyvinyl chloride resin.11 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 th vinyl chloride monomer migrates to alcohol from PVC bottlevs used to package distilled spirits and wine. Analytical results from industry 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 alcoholicfoods." (Federal Register. 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 restrictions on polyvinyl chloride packaging, at the request of the plastics industry. The notice stated that the Bureau of Alcohol, Tobacco and Firearms of the Treasury Department (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 BOR 009845 -5- action by the FDA on the proposal. As of this date iT-rj % (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 car.cer of four workers at one polyvinyl chloride plant, the Department of Labor published on January 30, 1974 a request for information and a notice of a fact-finding hearing on the pcs3lble hazards associated vrith the manu facture and/or use of vinyl chloride (Federal Register. January 30, 1974). At the hearing held on February 15, 1974, the Industrial Union Department of the AFL-CIO petitioned for an emergency temporary standard to prevent any worker exposure to vinyl chloride. VI. The Grave Danger Resulting from Exposure to Vlnvl Chloride A. Acute Effects Vinyl chloride Is a gas which can cause unconsciousness at Sf extremely high concentrations. Inhalation of a 2.53 con centration of vinyl chloride can cause dizziness", dis orientation and hjadache (ILO, p. 1466). At an 8-123 con centration cardiac arrythmlas have been observed in experi mental dogs (ACGIH, p. 477). The Committee on Aerosol Toxicity ha3 "oiced concern over the use of certain gases-- including vinyl chloride--as components of propellant/ solvent systems in aerosols because they are capable of pro ducing !`cardiac sensJtisation1' (Committee Report, p. 19). 3. Evidence of Carcinogenicity On January 22, 1974, the 3.F. Goodrich Company announced that three--and it is now known five--of its Louisville, Kentucky, vinyl-chloride workers had died of angiosarcoma (or hemangioendothelioma) of the liver, an exceedingly rare form of liver cancer. The five deaths occurred betw en 1964 and 1973, with the time of development of liver cancer after the onset of exposure to vinyl chloride in the four * workers for whom this information is known from 14 to 27. years. BOR 009846 -6 The National Institute for Occupational Rafctj v ` Health, estimating that only twenty to thirty .eop)'1 d)> vhe United States every year from 'h!u u .... '.t ^aice has announced the discovery of a i-C" -v.io' ^ i vfUu-.er associated with the polymerisat >r -.lyv,n.*! tiU'jide from vinyl chloride, with vinyi - i. >': u; ' i.ef causative suspect (Statement o> . us-.us ' > uruary 1, 197*0. The disease is invariable ( ' .i , o :? . -u har heen initiated (Statement of Di- 3e3''.. , Fe.iuary 15, 197*0. The carcinogenic effects of exj.'. " to vin^' nlO"ide have been demonstrated by Viola and Ui-nt, in r-. irate experi ments. Viola produced angiosaj < of the 11 vr" in "ats when exposed to 30,000 ppm for u-urs/dey, 5 days/weok, for 12 months (Viola, p. '20). ^c'foni V. ~ prody-ed th same type of cancers when exposing i to much, lo-or dtses (Statement of Prof. Cesare Malt Peb^i="-y 15. `^t). After 127 weeks of exposure to ,1 cnl'i 'de ('. t:.r:v uiyi 5 days a week, by inhalation), toni rept 't-i ` ' *'*-r 'rs in Sprague-Dawley rats at expos us as low as 250 ppm. (See table below). Results of Ilaltoni's Ex-r11 .ental Study Exposure level- vinyl chloride, by inhalation if of animal-i exposed H cf animals Ci n loping liver- angiosarcomas 10,000 ppm 6,000 ppm 2,500 ppm 500 ppm 250 ppm 50 ppm 69 72 7*1 67 67 64 6 u 9 7 2 0 Dr. Maltonl reported that he is cuccntly londu-'^InE ar. experiment using 300 rats exposed to 50 ppm, tlnct the failure of the low dose of vinyl chloride to indues cancer may be a function of the small number of eii .'.als tested. In addition, ilaltoni has observec tv.a fibre.; tug on giosarcomas in the offspring of pregnant rats exposed to vinyl chloride. BOR 009847 -7- IU ,, . ted that such fibrosing angiosarcomas have never been . ;ed as occurring spontaneously in Sprague-Dawley rats. -?.f, ^her evidence of Liver Disease A- w'.iriy as 1961 Torkelson et al. reported that abnormal h'.itoLogic changes were no^ed in the livers of rabbits after repeated exposures to 200 ppm of vinyl chloride. Slight liver enlargement was noted at doses as low as 100 ppm (Torkelson et al.). A 1967 French study of 163 workers engaged in the production of PVC found liver enlargement in 30? of the cases studied (Suein et ``.l..). A later report of the health experience of Dow Chemical's vinyl cnloride workers revealed no overt illness, but did determine that certain blood tests of liver function (e.g. beta liprorrotein, the Icterus index, and bromosulfalein 'ftti'-.i', "t on - iwj} vitv abnormally altered. On th*' burl- of t iiiif -'i,*:c.itigs, <-he authors concluded that some uag. :e of If'ci' rvr-i vrirt1 on ;..i ght result from ft TLV for vir/.' chloride of 300 ppm (iiutchler et ai.). Marstellar et al. reported within the past few months that 19 out of 20 workers who nad been exposed to vinyl chloride for 1-1/2 to 21 years at a PVC producing plant in Germany had some type of liver disease, including gross changes of the liver and spleen. Direct inspection of the liver and .spleen (by surgical operation) showed disease to be present ih 1*1 out of the 20 worker.. (Marstellar et al.). 3, Evidence of Other Chronic Effects In October 1963 osteolytic lesions were first observed in twe Belgian plastics workers who were also suffering from Raynaud phenomenon due to constriction of the local blood vessels in their hands (ILO, p. It66). This hand syndrome--termed acroostcolysis--has since been observed In over 30 workers in the t'nlted States employed in the manufacture of PVC resin (Ivtlsori et al.). 009848 -8 VII. Relief Requested We request that the Chairman of the Consumer Product Safety Commission declare aerosolized consumer products containing vinyl chloride to be "banned hazardous substances," under the definition of 15 U.S.C. $ 1261(q)Cl) and under the authority granted the Chairman in $1262. Moreover, under the authority of $1265, the Chairman is requested to remove from sale such consumer products containing . vinyl chloride as propellants and to prohibit the introduction of * such aerosolized products containing vinyl chloride into interstate commerce. The chronic toxicity and evidence of carcinogenicity of vinyl chloride monomer for humans has been documented by scientific studies and clinical reports. Further use of vinyl chloride monomer as a propellant for aerosolized consumer products must, be prohibited since there is no evidence that human beings can safely be exposed to the chemical. .. - Respectfully submitted Dated: Washington, D.C. 21 February 1974 Sidney M.'-Wol^, M.D. 2000 P Street, N.W. #708 Washington, D.C. 20036 . BOR 009849 REFERENCES American Conference of Governmental Industrial Hygienists (ACGIII), Documentation o_f Threshold Limit Values. 1971, pp. 477-47BT Bernstein, I.L., '`Medical Hazards of Aerosols," Postgraduate Medicine, December 1972, pp. 62-68. "Consumer Packaging", Chemical and Engineering News, April 12, 1971, P. 22. Federal Register, Vol. 36, Wo. 105, May 29, 1971, p. 10505. Federal Register, Vol. 38, No. 95, May 15, 1973, p. 12931. Federal Register, Vol. 3C, No. 134, July 13, 1973, P- 18684. Federal Register, Vol. 39j Mo. 21, January 30, 1974, p. 3874. International Labour Organization (ILO), Encyclopedia of Occupational Safety and Health, 1972, p. 1466. Rubier, Hans, "The Physiolocical Properties of Aerosol Propellants," Aerosol Ape, April 1964, pp. 44--50, 90-91. Maltoni, Prof. Cesare, Instituto di Oncologica, Bologna, Italy, Testimony at Department of Labor Hearing on Vinyl Chloride, February 15, 1974, Marstellar, H.J., et al., Deutsche Med. Wlrkschaft 98:2311, 1973, cited by Dr. Irving Selikoff at February 15, 1974, Department of Labor Hearing on Vinyl Chloride. Mutchler, J.E., Kramer, C.G., Report on Relation of Exposure 0 State of Health of Dow Chemical Workers, Gordon Conference, Tilton, New Hampshire, August, 1968, cited in Documentation of Threshold Limit Values, p. 278. Report of the Committee on Aerosol Toxicity, August 4, 1972, p. 19, (Chairman: Dr. Albert C. Kolbye, Jr.) Samuels, Sheldon, Industrial-Union Department, AFL-CIQ, Testimony presented February 15, 1974, at Department of Labor Hearing on Vinyl Chloride, citing figures supplied by industry sources Selikoff, Irving, Professor, Ht. Sinai School of Medicine, Testimony at Department of Labor Hearing, on Vinyl Chloride, February 15, 1974. Suciu, I., Drejman, I., and Valasld., I!. "Etude des Maladies dues au Chlorure de Vlnyle," Cllnloue des maladies professionals. Vol. 58, No. 4, 1967 (English abstractT) Torkelson, T.R., Oyen, F., Rowe, V.K., Amer. Indust. Hyg. Assn. J., 22:354 (1961), cited in Documentation of Threshold Limit Values, p. 277. Viola, P.L., "Canceropenic Effect of Vinyl Chloride," Abstr. 10th. International Cancer Congress. Houston, Texas (197)* p. 20. Wilson, R.H., et al., "Occupational Acroosteolysia: Report of 31 Cases," JAMA, 201:577-581, 1967. BOR 009850