Document wr76RqDxdyjZGXnO3bdrwnZoo

MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D. C. 20009 (202) 483-6126 'A May 2, 1974 To: MANAGEMENT CONTACTS OF COMPANIES SUPPORTING THE VINYL CHLORIDE RESEARCH PROGRAM TECHNICAL TASK GROUP ON VINYL CHLORIDE RESEARCH Subject: NIOSH Request for Proposal for Study of Vinyl Chloride Exposures Gentlemen: Enclosed herewith are the Statement of Work and Scope of Work sections of a request for proposal (No. CDC-99-OSH-128(4)) issued by NIOSH last March 28, and just now called to my at tention. This material is being distributed for your in formation, so that you may be prepared to handle contractor visits should they select one or more of your plants for study. 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 ASX 000017865 .\ l Copied by MCA. '5/2/74 STATF'^NT OF WORK A. Background an'! Purnosn , Information recently ha?; been made available to the National Institute for Occupational Safety and Health (NTOSH) that indicates a serious :.i ;I:I; prrM'. pot-.-nt ial lv exists in workers involved with the polymerization of vinyl chloride to polyvinyl chloride and polyvir.-. I chloride copolymers. Preliminary mortality information 'J concerning one vinyl chloride polymerization plant ha;; revealed there is a definite excess of deaths due to angiosarcoma of the liver in workers that have been Involved with this processing. ! '/ It has been reported by Imperial Chemical Industries of Great Britain that angiosarcomas of the liver develop in animals exposed to vinyl chloride. Since vinyl chloride is definitely present in the environs of the plant mentioned above, vinyl chloride has been postulated to be an etiologlc agent In the above mentioned excess employee deaths. : Since there is a large work force Involved with vinyl chloride poly merization processing, NIOSH immediately initiated an extensive epidemiological investigation (including environmental surveys) into vinyl chloride polymerization operations and workers thereof. Vinyl chloride exposures, of course, also can occur in the produc tion of the monomer and may occur in the processing of the polyvinyl chloride and its copolymers and during the commercial and industrial use of these polymers. Because these polymers have widespread use and there is potential for quite a large number of persons to be exposed to vinyl chloride, in addition to those people working in polymerization operations, there is a need to document the extent of vinyl chloride exposures in operations other than polymerization processing. '/The purpose of this contract is to document past and present worker 'exposures to vinyl chloride during (1) the monomer production and jthe (2) processing of polyvinyl chloride and polyvinyl chloride i copolymers. In addition to documenting worker exposures, to vinyl chloride, information on work practics, environmental control pro cedures, industrial hygiene practices and worker exposures to other known liver toxins also will be documented. These data will be utilized to ascertain the extent of worker exposures to vinyl chloride 1 and possibly other liver_ toxins so that the possible health effects i impact in the industry can be determined and appropriate priorities for corrective measures, If needed, can be set. If vinyl chloride exposures are considered to be significant in these areas, then a very critical, lock at possible general exposures will be made. ASi 000017Dee Enclosure 1 B. Scope of Work 1. The Contractor shall furnish the necessary personnel, material, services, faciliti or,, and otherwise do all things necessary for or incident to tho performance of work set forth herein. Speci fically, the Contractor shall perform the following: Task I. Vtnvl Chloride Monomer Production x' There are 15 plants in the United States that produce vinyle chloride monomer according to NlwSil information (Attachment A). From these 15 plants, and any other plants that the contractor identifies, three plants shall h; selected for on-site environmental/industrial hyglenaa surveys. Within SO days of the initiation of the contract, the con tractor shall present to the project officer (s) the list of vinyl chloride monomer plants and polymer processing plants that have been choosen for the environmental/industrial hygiene surveys. This pre sentation rk 11 include the basis for the selection. The actual surveys shall notcommence until this information has been reviewed and approved by the project officer (s). Maximum review time shall be five working days. The criteria for selection shall include, but not be limited to: (1) information gained from preliminary site visits; (2) information gained from literature searches; (3) information gained from personal contacts; (4) the representativeness of the plants to Industrywide operations; (5) the plants having the greatest potential for work ex posure to ^inyl chloride; (6) the plants having the greatest gradient of worker exposures to vinyl chloride; (7) the availability of historical inplant, air measurements of vinyl chloride; and 03T the plants having the longest history of vinyl chloride monomer production. The surveys at the selected three plants shall consist of documenting past and present worker exposures to vinyl chloride and past and present work practices, environmental control procedures and industrial hygiene practices that involve the reduction of worker exposures to vinyl chloride. At a minimum, the following specific information shall be obtained and/or constructed: (1) a general description of the vinyl chloride monomer pro cessing operation: (2) d-hour daily tine-w'eighted average exposures (TWAs) of vinyl chloride for each different job-type/job-operation in the monomer processing area, including a specific job description for each of the job-types; (3) general area (stationary) samples of vinyl chloride in areas of suspected high concentrations; (4) raw material and product lists and quantities therof that relate to the past and present vinyl chloride levels; (5) ventilation design and ventilation measurements, including documentation of dates of ventilation changes and the extent of changes and how they relate to past and present vinyl chloride levels; (6) documentation of past and present environmental control procedures and work practices that have been instituted to lover tvinyl chloride levels and how they relate to past and present vinyl chloride levels; (7) photo graphs, sketches, etc. to document existing conditions; and (H) documen tation of past and present industrial hygiene practices, including utili zation of protective clothing (i.e. type, frequency of change, laundering practices, etc.), protective devices (i.e,, respirator-usage, frequency type, etc.) lour e / pricticea, shower requirements, eating, smoking and drinking t Ir '.lection nr^as, etc. AS I 000017867 r 4 Task II. Processing of Polyvinyl Chloride and Polyvinyl CMoridc Ccpolyt^nj Environmantal/industrial hygiene surveys shall be conducted in pro duction -irons where rolyvinyl chloride end polyvinyl chloride co polymers* are processed including, but not limited to, the following operations: (1) compounding; (2) extrusion; (3) molding; (4) calenderir: (5) thermoforming; (6) binding; (7) foams; (8) fibers; and (9) plastisol processing. The surveys shall be conducted so that each processing operation is sampled at three different plants (locations). The criteria for the selection of these three plants shall include, but net be limited to: (1) information gained from preliminary site visits; (2) information gained from literature searches; (3) information gained from personal contacts; (4) representativeness of the operations to in dustrywide processing; (5) operations having greatest potential for workeexposures to vinyl chloride; (6) operations having the .greatest gradient of worker exposures to vinyl chloride; (7) availability of historical inplant air measurements of vinyl chloride; and (8) the operations having the longest history of polymer processing. The information that shall be obtained and/or constructed shall be the same as the eight items listed above for thevinyl chloride monomer production operations. In addition, to these eight items nast and present Th'4 worker exposures to other knew:; liver-toxins (if preserrej including, but not limited to, mercury, 2,2 dichlorovinyl dimethyl phosphate, ozone, dioxans, beryllium, lead, di methyl nitrosamine, arsenic, (amyl, methyl, ethyl, butyl, propl and vinyl) acetate-, cesser, trichloroethylene, carbontetrachloride, arsine and tetrahydrofuran shall be measured and/or constructed. Task III. Sample Collection and Data Analyses All vinyl chloride sampling and analytical techniques shall be specified In the contract proposal. If sampling is required for other known liver toxins, the sampling and analytical procedures must be approved by the project officer(s) prior to use by the contractor. The contractor should be cognizant of the fact that vinyl chloride is considered a potential human liver carcinogen and all employees and agents of the contractor should be provided with appropriate protective equiprar: These equipment needs will be discussed with the project officer(s) prior to the field surveys. 4t The sample collection shall be conducted in such a manner as to provide statistically valid data that are representative of present worker ex posures (categorized by different job-types) to vinyl chloride and other liver toxins, if found. Past worker exposures (by job-type) shall be constructed based on the Information that is collected on the changes in processing, ventilation, environmental control, work practices and indust rial hygiene practices that have occurred over the years and on historical * Polyvinyl chloride-acetate, polyvinyl chloride-propylene and polyvinyl chloride vinylidene chloride AS I 0000X7868 air sampling data (preferably personal sampling data) collected in the plant, if deemed reliable and accurate. All assumptions tl t are made in arriving at the constructed concentrations shall be pre sented. All of tiie above information cn processing changes, ventilatic changes, etc. shall be presented as part of the report on the surveys. As i 0000J7869 MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D. C. 20009 (202) 483-6126 ^ ma v May 1, 1974 To: TECHNICAL TASK GROUP ON VINYL CHLORIDE RESEARCH Subject: Federal Register Notice re Suspension of Registration of Pesticide Sprays Containing Vinyl Chloride Propellant Gentlemen: Enclosed herewith is the subject notice from the Federal Register for Friday, April 26, 1974. Sincerely, KDJ:mb Secretary Technical Task Group on Vinyl Chloride Research Attachment cc : Mr. A. W. Barnes D. P. Duffield, M.D* Dr. Tiziano Garlanda ASI 00l7870 NOTICES 14753 VINYL CHLORIDE Emergency Suspension Order Concerning Registrations for Certain Products and Intent to Cancel negotiations Notice is hereby given of the emergency suspension of, end notice of intent to cancel the registrations, under the Fed eral Insecticide, Fungicide, and Rodenticide Act, as amended ("FIFRA"; 7 U.S.C. 135 ct seq., 7 U.S.C. IDS et seq.), of all pesticide spray products containing vinyl chloride, whether as an active or inert ingredient, for uses in the home, food handling establishments, hospitals or in enclosed areas. Concurrent with this notice of suspension and notice of intent to cancel, the Environmental Protection Agency, is requesting that all existent stock of such products be recalled by the manufacturers. Findings of Fact 1. In January 1974, it was reported that four workers who had had intimate occupational contact with vinyl chloride had died from angiosarcoma of the liver. 2. Angiosarcoma of the liver is an ex tremely rare form of cancer. Data from the Third National Cancer Eurvoy, con ducted by the National Cancer Institute over the three-year period, 1969 to 1971, indicates that the number of cases of angiosarcoma of the liver expected in any one year could range from 11 to 53 for the total United States population. 3. On February 15, 1974, an Italian scientist. Professor Cesarc Maltoni of the Bologna Institute of Oncology, re ported on an experiment in which rats exposed to vinyl chloride gas for four hours per day, live days per week, for 127 weeks developed angiosarcoma of tho liver. These cancers were found at an in creasing frequency at several dosages, beginning at 250 ppm and above, but not at 50 ppm, the lowest dosage tested. 4. Since the first occupational reports this year, several more cases of angiosar coma of the liver have been confirmed, bringing the total number of these can cers among occupationally exposed work ers in the United States to twelve. Two additional deaths from angiosarcoma have been reported among occupationally exposed workers outside of tho United States. The evidence relating vinyl chlo- exposure and these deaths is cir cumstantial, but strongly suggestive of a causal relationship, especially when com bined with animal data. 5. In 1973, the Manufacturing Chem ists Association contracted v/ith Indus trial Bio-Test Laboratories, me. of Northbrook, Illinois, to conduct labora tory studies exposing mice and ham sters as well as rats to vinyl chloride gas. While this experiment is not yet com pleted, there have been a high number of deaths among the test animals, controls as well as exposed. In the course of exam ining these animals to determine tho cause of death, a significant number of the dead mice in the exposed group showed tumors of various sorts. Two cases of angiosarcoma ef the liver were observed In mice exposed to 59 ppm vinyl chloride in the air, four cases of the rare cancer in mice exposed to 290 ppm, and in seventeen of those expose! to 2,503 ppm. No angiosarcomas have been found in the rats or hamsters that have died during the course of tho experiment. The significance of those figures is still not fully understood because data on the deaths in the control group of mice has not yet been fully analyzed. Nevertheless, the observation of a dosage-related pat tern of occurrence of this rare form of cancer, coupled with the previous results in Italy, provides strong evidence that exposure to vinyl chloride can cause liver cancer. G. Seventeen manufacturers have reg istered pesticidal aerosols in which vinyl chloride was one of the inert ingredients, and thus unlisted on the label. These manufacturers plus their distributors ac count for 41 different brand name prod ucts. Vinyl chloride is used as a propel lant component in such aerosols. 7. Although all of these mniifacturcrs state that they have stepped vmri chloride as a propellant, some as early as May 1973, there are at least an esti mated 19,000 cans of such products in commercial channels. 8. Last Friday, I learned of prelimi nary testing and calculations done by EPA involving tho use of an aerosol con taining vinyl chloride shewing that a 30 second release of the aerosol could result in a concentration as high as 403 ppm in the air. In a separate test, preliminary results showed that after as long as four days, only about 1% of the vinyl chlo ride gas v/ou'd dissipate under conditions whore the exposure area was not venti lated and little, If any, light was present. Calculations based on this information, assuming three changes of air per hour in an enclosed area, and experiments by EPA scientists measuring vinyl chloride levels following spraying in the home would indicate that a detectable concen tration of vinyl chloride could still per sist for several hours after spraying. 9. Exposure to vinyl chloride has been associated with a significant number of cases of a rare liver cancor in experi mental rats and mice, and in humans. Although vinyl chloride is apparently no FEDERAL REGISTER, VOL 39, NO. 82--FRIDAY, APRIL 26, 1974 ASI 000017871 lt7ZZ NOTICES longer being used as a propellant in pes ticides, some stocks remain on the mar ket. The use of these pesticides in an en closed space, even in short bursts (e.g., 30 seconds), could result in exposure levels similar to those which have produced angiosarcomas in test animals. Tire health implications for humans at theso levels for short exposure periods are un determined, but it is prudent to assume that any exposure at these levels will have increased the risk of cancer should tho strongly suspected causal relation ship between vinyl chloride and cancer be finally confirmed. 10. The benefits of the use of vinyl chloride as a propellant are very small because several suitable substitutes exist winch, in fact, are frequently used. Al though tho number of pesticide products containing vinyl chloride presently in commercial channels or in use is not thought to bo substantial, the risk of continuing such use in the face of acceptable substitutes is unjustified. 11. Attached to this order arc the names of tho pesticide products contain ing vinyl chloride which are known by this Agency to be registered for uses in tho homo, food handling establishments, hospitals or in enclosed areas. There rwy be others. Conclusions Section 6(c) of FIFRA provides for the suspension of a registration of a pes ticide if the Administrator determines that action is necessary to prevent an imminent hazard during the time re quired for cancellation proceedings un der section G. Section 6(c) also provides for issuance of an emergency order of suspension by the Administrator in the event he finds that an emergency exists that docs not permit the holding of an expedited hearing on the question of sus pension before issuing an order. The statute also provides a general definition of the term "imminent hazard" in sec tion 2<D which states that "imminent hazard" means a situation which exists when the continued use of a pesticide during the time required for cancellation would be likely to result in unreasonable adverse effects on the environment. A determination of unreasonable adverse effects on the environment must con sider the degree of risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of tho use of any pesti cide (Section 2(bb)). The evidence available at this time Indicates the presence of a clear risk to human health from continued exposure to vinyl chloride. Indeed, this chemical presents a most unusual case because the rare form of cancer found in occupa tional workers can be readily demon strated in test animals. Thus wo are faced with a substantial risk to human health upon continued exposure to vinyl chloride. The existence of this risk would reamre a compelling demonstration of benefits to justify the continued use of the product pending the outcome of cither cancellation proceedings or any hearing pursuant to section 6(c) (2) of FIFRA. Present information indicates that most, if not all manufacturers of pesti cides containing vinyl chlorides as a pro pellant, arc willing to utilize substitute substances for this purpose. The En vironmental Protection Agency has already received several applications for amended registrations to eliminate vinyl chloride as an ingredient. It is my under standing that similar amendment appli cations will be forthcoming from other manufacturers. Thus, there is no indi cation that elimination of use of these products pending completion of suspen sion and cancellation proceedings will have any effects upon availability of tho associated aerosol pesticides. Indeed, in the course of investigating use of those products prior to this orde -, instances were discovered of previous voluntary discontinuance of the use of vinyl chlo ride as a propellant (without amended registrations having been submitted or issued). Although voluntary discontinue,nco of the use of the substance is a commenda ble development, significant quantities of pesticide products containing vinyl chlo ride have previously beer, distributed and are now in retail outlets or in actual use. In addition, although the Environmental Protection Agency desires, whenever pos sible, to secure voluntary compliance rather than proceeding by order, the time required to insure that such compli ance has actually taken place would necessarily delay achieving the most rapid possible nationwide cessation of the sale of products containing vinyl chloride, and the recall of existing stocks. Therefore, I have concluded that in view of the substantial risk from continued use of vinyl chloride, and the absence of any significant benefit from its con tinued use pending completion of can cellation proceedings pursuant to section 6, an imminent hazard does exist under the terms of section G(c) of FIFRA and an emergency does exist which does not permit delay of suspension pending a possible hearing pursuant to section 6(c) (2) prior to issuance of an order of suspension. Indeed, I find that as a result of the above findings of fact, particularly the recent results of Agency testing, that immediate action is required. Emergency Suspension Order and Notice op Intent to Cancel In accordance with the attached find ings and conclusions, it is hereby ordered that the registrations for all pesticide products containing vinyl chloride, whether as an active or inert ingredient, be suspended immediately for all uses in the home, food hurdling establish ments, hospitals, or in enclosed areas. I also serve notice of my intent to cancel such registration within 30 days from the receipt of this notice by the regis trant, or publication of this order in the Federal Register (April 2G, 1C74), which ever occurs later, unless tho regis trant makes the necessary corrections to tts registration. These pesticide products containing vinyl chloride may not be legally shipped in interstate commerce. Dated: April 24,1074. Russell E. Train, Administrator. Indoor Aerosol Pesticides Affected dy Today's So,-TENSION Product Company Brulln Bug Bomb____ Paracide with Savin__ Demert Haw Roach, Ant and Wasp Killer. Cobra International Roach, Ant end Wasp Killer. Rcxall Ant and Roach Killer. W,v ween Ant & Roach Killer. Flea Killer for Dogs and Cats. Barcolene Spray Dis infectant. Coop Dairy Insecticide for Milk Houses and Animals. Excelclde 16-oz. Aero sol Bomb. Navy Brand Thrifty 50 Mothrld Moth Froofer Mothrld Moth Procter Cedar Scented or Activated Moth Proof Spray Cedarized. Nokout 25 Aerosol In secticide. Strike--'Wasp and Hornet. Rollout 35 Insecticide. Sprits Metered Air San ltlzer. Anchor Flea. Lice and Tick Eomb. F-L-T Bomb-"............. WAYNE, Flea, Lice and Tick. Rodgers' Insecticide and Repellent. Total Release Insect Fogger. Crown "Total" Com plete Release Insect Fogger. Erulin & Co. Carson Chemicals, Inc. Demort. A Daugherty. Cobra International [O]- Rexall Drug Co. [DJ. Walgreen Labora tories, Inc. [D]. Chase Products Co. The Karcolene Co. Farmland Indus tries, Inc. The Huge Co. ITavy Brand Mfg. Co. [DJ. IIy,'"T Corp. Liberty Products Co. [D]. Hysan Ccrp. Albert Woods Wholesale [DJ. Hysan Corp. Hysan Corp. Philips-Roxano, Inc. Elo-Ceutlc Laboratories |DJ, Allied Mills, Inc, [D]. Jay Rodgers Co. Epray-Chem Corp. Crown Chemicals, Inc. [D] Roberts' "Total" Com Roberts Laborato plete Release Insect ries [D] Fogger. Chaperone Flea & Tick Sudbury Laboratory . Killer. Pyrethrin Insecticide Pressurised Dairy Insecticide. COOP Pyrethrin In secticide Pressurized Dairy Insecticide. Mid-Am Brand Pyre thrin Insecticide Pressurized Dairy Insecticide. Woodbury Chemical Co. Farmland Indus tries, Inc. [D] Mid-American Dairymen, Inc. [D] [D]--Distributor of Product Listed Above [FR Doc.74-3719 Filed 4-25-74:8:45 am] FEDERAL REGISiER, VOL. 39, MO. C2--n.lEAY, APRIL 26, 1974 ASI 000017872 MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D. C. 20009 (202) 483-6126 ALBERT C. CLARK VICE PRESIDENT TECHNICAL DIRECTOR To the Occupational Health (Medical) Contacts of MCA Member Firms ;h. a. k. APR 2 21974 Dear Sirs; One of our member companies has expressed interest in a study of the carcinogenic potential of vinylidene chloride. It has been recommended that MCA call a meeting of representa tives of those manufacturers and users having an interest in a collective approach to a technical information-gathering program which may involve funded research. A meeting to explore the breadth of such interest is scheduled for Wednesday, May 15, in MCA's Conference Room, be ginning at 10:00 AM, If your company might wish to actively participate in and support such a joint program, you are invited to arrange for representation at the meeting. Limit ing the attendance to no more than two persons from each company would be appreciated. Please let me know by telephone or TELEX (89-617) if your company plans to be represented, advising the name of your representative(s). Sincerely cc: Plastics Committee Members Vinyl Chloride Research Contacts and Contacts suggested by proposer: Dr. B,, W. Duck, BP Chemicals Dr. H. J. Kiefer, Glidden-Durkee Division of SCM Corporation Mr. Henry Weigl, Standard Brands, Inc. Mr. James White, White Chemical Corporation ACC:tp April 18, 1974 ASI 000017873