Document V32gwx1zEyYOzonLxxwBa1kzj

Research & Development Department 202 Technical Service Center (conoco) Continental Oil Company P.o. Oox 1267 Ponca City. Oklahoma 74601 (405) 762-3456 s; isa. S5 CHEMICALS --.J ro RESEARCH r-o September 16, 1974 Mr. Kenneth P. Stewart Jet Stream Plastics P.O. Box 190 Siloam Springs, Arkansas 72761 Dear Ken: I am enclosing a letter we are sending to the FDA as part of our policy of making available any information we have that could contribute to a better understanding of the VCM safety question. This letter will become a part of the publicly available files of the FDA. In this case, the subject is extraction of VCM by water in a static exposure test patterned after the NSF method for metals extraction. I think the accompanying letter and data will answer most of your questions. The sources for the pipe tested are not identified in the letter to the FDA; but for your information, pipe supplied to us by your company is sample 149-B in the data table. We would be happy to have your comments or answer any questions. Thanks for supplying part of the pipe samples for the test. Sincerely, Director, Plastics Chemicals Research Division rh Enc BCC: KLS CJS FK Research & Development Department 202 Technical Service Center (conoco) Continental Oil Company P.O. Box 1267 Ponca City. Oklahoma 74601 (405) 762-3456 CHEM!CS RESEARgft-- SEP 19^74 September 16, 1974 Mr. Wayne Peek Certain-Teed Products Corporation P. 0. Box 988 McPherson, Kansas Dear Wayne: I am enclosing a letter we are sending to the FDA as part of our policy of making available any information we have that could contribute to a better understanding of the VCM safety question. This letter will become a part of the publicly available files of the FDA. In this case, the subject is extraction of VCM by water in a static exposure test patterned after the NSF method for metals extraction. I think the accompanying letter and data will answer most of your questions. The sources for the pipe tested are not identified in the letter to the FDA; but for your information, pipe supplied to us by your company is sample 149-C in the data table. We would be happy to have your comments or answer any questions. Thanks for supplying part of the pipe samples for the test. Sincerely, W. R. Sorenson Director, Plastics Chemicals Research Division rh Enc BCC: KLS CJS FK Exc ?t from "An Economic Impav and Technological Feasibility Stuay for the Compounders, Processors and Fabricators of Polyvinyl Chloride Resins"`__________________________________________________ Of the three industry layers in question, the compounders have the most exposure. Processing has less exposure by virtue of the fact that it subjects PVC compounds, which still contain' some small amounts of residual VCM to heat pressure. Fabricating, the fashioning of a finished product from an intermediate one made through processing, is the most removed from possible worker exposure to VCM. Some reasons for the feasibly higher exposure levels at the compounding layer are: (1) Compounders work with raw resin which still has much of the original residual VCM entrapped within it. This is especially true today due to the high market demand for PVC. Raw resin spends very little time in inventory between the time it is produced and the time it is compounded. The result is that the release of residual monomer, which naturally takes place over time, is limited. (2) The mixing and blending operations' accelerate the re lease of residual VCM by heating the resin. Even though venting is done above the mixers and mixer operators do not normally get near the top of an operating vessel, there is an inevitable release of residual into the ambient air of the workplace. It can be argued, however, that processors, fabricators, and processors/fabricators really do not have an exposure problem at all. Referring back to our monitoring data, 81% of all readings from both the hearings and CSKA inspections taken at these layers indicate exposure levels of one ppm (TLV) or less. The evidence becomes even stronger if allowable exposure becomes defined as an eight hour time weighted average (TWA) which allows for excursions above one ppm and gives a better picture of the true exposure level. 24 /C 7 /g a 7 0 fl0 Estimates for all of the above are not able to be made at this time. Although it would certainly be useful to be able to include these costs, particularly numbers 7 and 8, it is felt that they quite simply cannot be accurately estimated. In view of this, leaving them unanswered seems more constructive than answering them with possibly mistaken or erroneous infor mation. As alluded to in Section III, cost impact information at the compounder, processor and fabricator level is just not readily available. These industry layers seem to feel that they ought to be treated separately by any regulation and thus have not themselves examined the possible direct impact resulting from the proposed standard. The standard itself is viewed as having been written with the VCM and PVC producers in mind. Unfortunately, there also exist no good estimates of engineering costs related to compliance with the proposed standard. Again, since almost all compounders, processors and fabricators are currently operating at exposure levels well below both the Emergency Temporary Standard and the VCM and PVC producers, and since it is generally believed that the permanent ^Snell Preliminary Report, Appendix F. 7Ibid. 8Ibid. 32 standard will be less stringent than the proposed standard, aA C5** <s? 5 ro 2 possible engineering changes and the costs associated with ^ them have not in most cases, been planned for. These three industry layers have adopted a "wait and see" attitude towards the whole question of control of vinyl chloride exposure. Most firms are doing nothing, with the possible exception of some personal monitoring. The are waiting to learn what they will be required to do. Aside from the obvious difficulty this creates in trying to estimate cost impact, this situation may also produce real logistical problems once a permanent standard has been promul gated. The Department of Labor may be faced with 8,000 or more compounders, processors and fabricators all straining simultaneously to secure the same limited supply of equipment and technical expertise. The industries that provide these services and equipment will most certainly not be able to meet this sudden surge in demand, thus creating shortages and long lead times. This would be especially critical if deadlines are written into the permanent standard. The upshot of this discussion is that a comprehensive picture of cost impact has not been able to be presented. Due to the scarcity of information necessary for.making such estimates, the question of direct eccyiomic effect on the compounder, processor and fabricator level, is still an open one. 33 30830 > JtUlES A. REGULATIONS SUBCHAPTER D--DRUGS FOR HUMAN USE ditional information relating to vinyl lished in connection with occupational PART 310--NEW DRUGS chloride and polyvinyl chloride. exposure. Evidence indicates that vinyl Subpart E--Requirement* for Spacific New Drug* or Devices Data being received by the Food and chloride inhalation can result In acute Drug Administration as a result of the toxicity manifested by dizziness, head SUBCHAPTER G--COSMETICS PART 700--GENERAL Federal Register notices are being com ache, disorientation, and unconscious piled and reviewed to determine whether ness where inhaled at high concentra any additional action by the Commis tions. Studies also demonstrate carcino j Subpart B--Requirement* for Specific Cosmetic Product* sioner is needed to protect the public genic effects in animals as a result of health. inhalation exposure to vinyl chloride. Vinyl Chloride as an Ingredient of Drug and Therefore, pursuant to provisions of Furthermore, vinyl chloride has recently Cosmetic Aerosol Products the Federal Food, Drug, and Cosmetic been linked to liver disease, including In the Federal Register of April 22, Act (secs. 502, 505, 601(a), 701(a),, 52 1974 (39 FR 14215), the Commissioner of Stat. 1050-1055, as amended; 21 U.S.C. Food and Drugs issued a notice of pro- . 352, 355, 361(a), 371(a)) and under au posed rule making regarding all drug and thority delegated to the Commissioner cosmetic aerosol products containing (21 CFR 2.120), Parts 310 and 700 are liver cancer, in workers engaged in the polymerization of vinyl chloride. It is the view of the Commissioner that vinyl chloride is a deleterious substance which may render any cosmetic aerosol prod vinyl chloride as an ingredient, including amended as follows: uct that contains it as an ingredient propellant. The proposal was based on 1. By adding a new 310.506 to Sub injurious to users. Accordingly, any cos the Commissioner's determination that part to read as follows: metic aerosol product containing vinyl there are sufficient scientific data on which to base a decision that: (1) Vinyl chloride presents an unnecessary hazard 310.506 Use of vinyl chloride as an ingredient, including propellant, of aerosol drug products. chloride as an ingredient is deemed to be adulterated under section 60 Ha) of the Federal Food, Drug, and Cosmetic Act. to the public health when it is used as an ingredient in cosmetic aerosol prod ucts, and that such use should be banned: and (2) vinyl chloride, when used as an ingredient in drug aerosol prod ucts, Is not generally recognized as safe and effective, is a new drug within the meaning of section 201 (p) of the Federal Food, Drug, and Cosmetic Act, and re quires an approved new drug application as a condition of marketing. Interested persons were invited to submit comments regarding the proposal on or before May 22.1974. Comments were received from the (a) Vinyl chloride has been used as a propellant in aerosol drug preparations. Evidence indicates that vinyl chloride inhalation can result in acute toxicity manifested by dizziness, headache, dis orientation. and unconsciousness where inhaled at high concentrations. Cardiac effects, bone changes, and degenerative changes in the brain, liver, and kidneys have been reported in animals. Studies also demonstrate carcinogenic effects in animals as a result of inhalation expo sure to'vinyl chloride. Recently, vinyl chloride has been linked to liver disease, including liver cancer, in workers en (b) Any cosmetic aerosol product con taining vinyl chloride as an ingredient shipped within the jurisdiction of the act is subject to regulatory action. Effective date. This order shall be ef fective September 25, 1974. (Secs. 502, 605. 601(a), 701(a), 62 Stat. 10501055, as amended; 21 U.S.C. 352, 355, 361(a). 371(a).) Dated: August 20, 1974. Sam D. Fine, Associate Commissioner ___for Compliance. 1FH Doc.74-10657 Filed S-23-74;8:45 am) American Academy of Pediatrics, a gaged in the polymerization of vinyl municipal consumer affairs unit, and an individual. All the comments were in support of the Commissioner's proposal. chloride. (b) The Commissioner finds that there; is a lack of general recognition by quali CHAPTER II--DRUG ENFORCEMENT AD MINISTRATION, DEPARTMENT OF JUS- TICE Accordingly, the Commissioner concludes fied experts of the safety or effectiveness PART 1308--SCHEDULES OF that the regulations should be adopted as_ - of- aerosol drug preparations containing CONTROLLED SUBSTANCES - proposed. vinyl chloride as an ingredient, includ Exempt Chemical Preparations The notice of proposed rule making also requested data regarding the use of polyvinyl chloride in containers for food and cosmetics, and in devices. The Com missioner urgently requested that cer tain data be submitted on the extent of the usage of polyvinyl chloride con tainers, the rates of extraction of vinyl chloride monomer from these containers, and other matters that will pertain to the safety of these containers. The time limit for submission of data requested in the proposal was on or before June 21, 1974, However, to date, the Commissioner has received only a few responses and again requests that the pertinent information be sent to the Hearing Clerk. Food and Drug Administration, Rm. 4-65, 5600 Fishers Lane, Rockville, MD 20852, as soon as possible. A companion notice in the same issue - of the Federal Register (39 FR 14238) ing propellant. Therefore, any such prod uct containing vinyl chloride is a new drug and a new drug application ap proved under section 505 of the Federal Food, Drug, and Cosmetic Act is re quired for marketing. (c) A completed and signed "Notice of Claimed Investigational Exemption for a New Drug" (Form FD-1571), as set forth in 312.1 of this chapter, is re quired to cover clinical investigations designed to obtain evidence that such preparations are safe and effective for the purposes intended. (d> Any such drug within the juris diction of the act which is not in accord with this regulation is subject to regula tory action. 2. By adding a new 700.14 to Subpart B to read as follows: 700.1-1 Use of vinyl chloride as an in. The Administrator of the Drug En forcement Administration has received applications pursuant 1308.23 of Title 21 of the Code of Federal Regulations requesting that several chemical prepar ations containing controlled substances be granted the exemptions provided for in 1308.24 of Title 21 of the Code of Federal Regulations. The Administrator hereby finds that each of the following chemical prepara tions and mixtures is intended for lab oratory, industrial, educational, or special research purposes, is not intended for general administration to a human being or other animal, and either <a> contains no narcotic controlled sub stances and is packaged in such a form or concentration that the package quant ity docs not present any significant po tential for abuse. (b> contains either a narcotic or normarcotic controlled sub required each registrant under section grcdicnl, including propellant of cos stance and one or more adulterating or 510 of the Federal Food, Drug, and Cos metic aerosol products. denaturing agents in such a manner, metic Act to submit a list of all human (a) Vinyl chloride has been used as an combination, quantity, proportion or con drugs which are being manufactured, ingredient in cosmetic aerosol products centration, that the preparation or nur prepared, propagated, compounded, or including hair sprays. Where such aero ture does not present any potential for processed for commercial distribution and which contain vinyl chloride as an sol products are used in the confines of a small room, as is often the case, the abuse, or (c) the formulation of such preparation or mixture incorporates ingredient or are packaged in polyvinyl level of vinyl chloride to which the indi methods of denaturing or other means chloride containers. The notice also re vidual may be exposed could be signifi so that the controlled substance cannot quested registrants to furnish certain ad- cantly in excess of the safe level estab in practice be removed, and therefore FEDERAL REGISTER, VOL 39,. NO. 166--MONDAY, AUGUST 26, 1974 Thunday, Sept. 5,1974 THE WASHINGTON PGTM FOR YOUR INFORMATION Lg& ,Vinyl Chloride Link to Cancer Known in 1971 Report Says By Bob Kuttner arcoma have been reported has recommended a perma years behind where we should `Wasttlncien Post 6tf( Writer .. among U.S. chemical workers nent permissible level of zero. be." Evidence existed as early as 1971 that low doses of vinyl exposed to vinyl chloride gas, which is the base ingredient for one of the most common In addition, dozens of sumer aerosol products con "You don't automatically as sume that animal studies are con conclusive, but the industry chloride caused cancer in labo- plastics, polyvinyl chloride. taining vinyl chloride gas as should have at least notified ratory animals, according to The disclosure Jan- 22 by a propellant have been the B. F. Goodrich Co. that drawn from the market. with-'their own doctors," he added. ! "It's inexcusable that they. an internal technical report by three workers in its Louisville, In the wake of these find-!didn't tell the government."; .the World Health Organiza Ky., plant died of angiosar ings, the chemical industryjsaid Dr. Sidney Wolfe, director' tion's International Agency coma led to a crash research has been sharply criticized byjof the Nader-sponsored Health: for Research on Cancer. program by several federal cancer scientists for failing to Rescarch Group. i The researcher isn't identi agencies, including the Na fully inform either the govern "It would have been appro-, fied, but several prominent tional Institute of Occupa ment or its own plant physi priate lor them to tell us about; < U.S. cancer scientists believe tional Safety and Health and cians about the results of Eu- the European studies as soon j .he is-Dr. P. L. Viola, the Ital- the Labor Department's Occu ropean studies showing linkssas they knew," added a NIOSH : jan researcher whose earlier pational Safety and Health to cancer as early as 1971. scientist. I worfc first alerted the chemi Administration (OSHAL "If the latest report means According to the Manufac cal'-industry to the possible Consequently, OSHA adopt what it seems to mean." said turing Chemists Association, i 'carcinogenic -- cancer-causing ed : ,i emergency standard Dr. Irving Selikoff, director of the principal industry trade --effects of high doses of vi lowering exposure limit> to the Environmental Sciences association, the MCA invited; nyl chloride. vinyl chloride workers from Laboratory at Mt. Sinai Dr. Viola to discuss his study; So far, 14 deaths from a 500 parts per million to 50 School of Medicine in New with U.S. industry representa-1 . rare liver cancer called angios parts per million, and NIOSH York," then we're nearly four tives in May, 1971. The prelim inary studies showed vinyl | chemical industry sponsored, It also arranged for an epi-1, Only after B. F. Goodrich re chloride was carcinogenic at, another series of experiments; demiological survey, to studyl ported that its Louisville plan levels lion. of 30,000 parts per mil-' j by a second Italian scientist.: Dr. Caesare Maltoni. The U.S. | Manufacturing Chemists Asso- the health . exposed to records of workersl Physician, Dr. John Creech ir ...................... i dependently discovered thre vinyl chloride. j cases of angiosarcoma did th By November, 1971, the* ciation learned of Dr. Malto-| In June, 1973. at a meeting) trade association fully revea MCA was aware that concen*^ ni's studies in late 1972. Those < with NIOSH officials, indus-|the Maltoni findings to NlOSl trations of 5,000 parts per mil-! studies showed that animal tu try representatives are said to! officials, Even at that point lion "and perhaps less" also1 mors could be produced at I have down played the signifi according to NIOSH sources could cause tumors tory animals. in labora-: concentrations as j parts per million, low as or half 250 the cance ings. of the European find the MCA asked NIOSH to kee; the findings secret. According to the latest' permissible exposure levels World Health Organization re- j for workers in the United port, which summarizes a! States. meeting held last June, a labo- j However, the MCA did not ratory in Italy during thatpe-! share the information with riod--presumably Dr. Viola's: government agencies, having --was also finding that con-1 promised its European count cenlrations as low as 500 parts! erparts to keep the findings per million could cause tu-* secret. mors, including angiosarcomasi Instead, the MCA and sev of the liver. Those results J eral of its member companies ,have not yet been published. - contracted for new animal I Subsequently, the European! studies in the United States. Although the 1973 Maltoni research indicated that liver cancer could be caused at concentrations as low as 250 parts per million, NIOSH director Dr. Marcus Key told an Aug. 21 Senate hearing on vinyl chloride that at the meeting "no mention was made to us about liver cancer and no mention was made to us about the name of the Italian scientist." Dr. Maurice Johnson, Gooc rich's medical director, cor firms that he knew about th Maltoni study but said tha he saw no need to notify thcompany's plant physicians "It was by no means a finish ed study," he said. When Goodrich's Dr. Creed found the third case of angios arcoma among plant workers Dr. Johnson said, "that wa the clincher."