Document vByzo9k0bYxwnkz0pDBe1yJDw

MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D. C. 20009 (202) 483-6126 March L, 1974 To: TECHNICAL TASK GROUP ON VINYL CHLORIDE RESEARCH Subject: NIOSH Health Hazard Evaluation Report on "Meat Wrappers' Asthma" Gentlemen: Distributed herewith are copies of the subject report for one of the six retail establishments investi gated by NIOSH. Each is substantially identical to the others, except for the identification of the establishment involved. As you will note, NIOSH emphasizes the^lasticizer contribution to the aerosol as compared to that of poly vinyl chloride per se. Sincerely, KDJrmb Attachment cc : D. P. Duffield, M.D. Mr. D. M. Elliott Dr. Tiziano Garlanda Kenneth D. Johnson, Ph.D. Secretary Technical Task Group on Vinyl Chloride Research ftSV 0000736 Page 10 * Health Hazard Evaluation Determination In sunnary, pulmonary function tests of this small, randomly selected population of meat wrappers revealed nr> effects in comparison to a control population after one workshift of meat wrapping. Furthermore, it must be stated that this exposed study group was of general good health and free of serious symptomatology. E. Discussfon A study of meat wrapping employees is beset by various Intrinsic problems from the onset. These include the following: a) Low density dispersal of meat wrappers in any geographic area. b) No more than two or three meat wrappers employed at any typical retail store. c) Meat wrapping v/ork environments, although similar, are not strictly uniform. Differences can exist in packaging equip ment (i.e,, operating parameters), type of wrapping material ambient environmental conditions (temperature, humidity), general ventilation provisiors^work practices, and volume of meat wrapping performed. d) Work shifts for meat wrapping employees are highly variable. illa< e) There is a lack of suitable sampling and analytical methodology for the evaluation of employee exposures to PVC film decomposition products encountered in retail meat wrapping. At present, roethods_are not sensitive enough to characterize intermittent exposures or variable constant exposure via breathing zone sampling techniques. r, The above problems interrupted the completion of this preliminary s controlled scientific study. At this point, a limited amount of idata have been compiled for a population of basically healthy meat " wrappers. There remains the necessity to stuHy a sizeable population o f seriously affected meal-mappers. It is felt that such a dqdulation exists based upon scattered reports of clinical symptomatology from various medical investigators throughout the Nation. V. REFERENCES 1. Vandervort, Robert - Personal Communication by Letter with Major Film Manufacturers, 1970. 2. Vandervort, R. "Polyvinyl Chloride Meat Wrapping Film Study," unpublished USPHS, BOSh, D0IDC, Technical Assistance Report, Cincinnati, Ohio (.1971). KSV 0000737 --t- 1------------ ------------- Page 9 - Health Hazard Evaluation Determination Test No. 1 - When-all exposed (meat wrappers) were compared with all non-exposed (controls) with respect to any differencesbetween pre- and post-workshift values of FEVi and FVC, there was no significant difference at the 95% confidence level (i.e. P less than 0.05). TpEV] (35df) = -0.35 TrvC (35df) = -0.42 . P * 0.73 P - 0.67 Test No. 2 - When exposed smokers were compared with non-exposed smokers, there was no significant difference. tFEV 1 (11df) 0.22 tFVC (11df) = 0.31 P = 0.83 P s 0.76 Test No. 3 - When exposed non-smokers were compared with non-exposed non-smokers there was no significant difference. tFEV 1 (22df) = 0.55 tFVC (22df) * 0.11 P = 0.59 P = 0.90 Test No. 4 - Test No. 1 was repeated with respect to peak flow and flow at 25,50,75 and 90% of FVC. There was a significant difference for F90. h tPF (35df) * 0.47 IF25 (35df) 0.38 P * 0.64 P * 0.71 tF50 (35df) * 0.01 P = 0.99 TF75 (35df) - o.n P = 0.91 tF90 (35df) = 2.39 P = 0.02 Test No. 5 - Test No. 2 was repeated with respect to the preceding parameters and there was a significant difference for F50. fKA ' TpF TF25 tF50 tF75 tF90 (11 df) = 0.08 (11df) * 1.36 (11df) = 2.31 (llcif) = 0.38 (11df) * 0.54 P = 0.94 P = 0.20 P * 0.04 P = 0.40 P = 0.60 Test No. 6 - Test No. 3 was repeated with respect to the preceding parameters and there were significant differences for F75 and F90. tPF {22df) = 1.14 P = 0.27 tF25 (22df) = 0.98 P = 0.34 \ Tf50 (22df) = 1.61 tF75 (22df) = 2.26 P = 0.12 P = 0.03 tF90 (22df) = 2.87 P = 0.01 i/r" ftSV 0000738 Page 8 - Health Hazard Evaluation Determination Four of these workers had fifteen or more pack-years of cigarette behind them. Three meat wrappers had pre-existing susceptibility to upper respiratory symptomatology caused by severe disease processes (rheumatic fever, chronic obstructive pulmonary disease, and lung abscess). ' 2. Medical Questionnaires (Louisville Study) . ...... Seventeen meat wrappers and a control population of twenty individuals completed the questionnaire. None of the controls re ported any adverse clinical symptomatology associated with their particular form of employment. The majority of the controls worked as clerks in retail grocery stores. As a group the seventeen meat wrappers averaged nine years and three months of experience in the meat wrapping profession. FortyI five per cent of these moot wrappers complained of irritation from l film contaminants which resulted in watering and itching eyes. Th^t^per cent of the wrappers comolained of burning or dryness tjT the throat. Three wrappers (18%) stated that they experienced "painful breathing11 ana shortness of breath while working with PVC meat wrap. It is important to note that these same three individuals had a history of allergies, were on medicatiOft Ahd were under physician care. 3. Pulmonary Function Testing (Louisville Study) All pulmonary function data were analyzed by bio-statisticians at the NIOSH Appalachian Laboratory for Respiratory Diseases. The data can be summarized by examining the following statistical tests: Note: df = degrees of freedom (number of employees tested minus one) P probability that a difference occurred by chance alone. The "student t test" was used to determine whether there were significant differences between groups of individuals with respect to changes in FEV-Zs and. FVC's. To be significant, a difference between groups would have a probability of occurring by chance of less than S% or P less than 0.05. RSV 0000739 V Page.7 - Health Hazard Evaluation Determination C. Evaluation Methods 1. Medical Questionnaire The medical questionnaire consisted of twenty-six sets of Questions. Its purpose as to gather pertinent information-concerning an in dividual's past radical history, smoking history, oast occupational exposures, current respiratory status and adverse effects allegedly arising from exposure to air contaminants from pVd films. 2. Pulmonary Function Testing Each pulmonary function test required the employee to make three forced expiratory volume practice maneuvers after which three forced expiratory volume maneuvers (reproducible within 5) were recorded as flow volume loops.- A waterless, high fidelity spirometer equipped with an air temperature probe was used. The flow volume loops were displayed on a storage oscilloscope and recorded on magnetic tape. A photograph of each oscilloscope display was taken for backup. Computer analysis of flow volume loops provided the following parameters forced expiratory volume in one second (FEV1 ), and flow rates at 25,50,75 and 90 per cent of forced vital capacity (FVC). D. Evaluation Results 1. Preliminary Survey (Seattle, Washington and vicinity) ^itPPn finht-oftn meat wrappers interviewed in the preliminary survey were known to have suffered ill effects f*vim from PW1 fiJjns. Only two workers were free of any clinical symp tomatology. rinh^t had Similar race h Vn,-1 sTTm'itl-o r! ov- periencing varying degrees of sneezing, rhinnrrh^.. agd eve ir ritation. Most individuals gave a like story that the -111 effects came on from one to three hours after the commencement of meat' wrapping in the morning. The workers stated that as the workday progressed the prodromal manifestations increased in intensity. The sneezing, rhinorrhea, and throat and eye irritation would abate in the evening hours and would be non-existent during week ends and vacations. Fiyp_wrtrtrp_t experienced mo-re severe clinical symptomatology necessitating physician intervention and, on occasion, hospitali- zation. These i nm vi duaJs seemed to< suffer wvth `'occuoatl $ .11 They suffered at times with severe._d'/s~rg =. produ^iva^owoh, and nasal congestion. Onet of tnese sy-ccoe* was trom one-half to two and one-half hours after commencement of work. These ill effects led to increased absenteeism. All were on one form of medication or another. This group also stated that a period of several days away from the neat wrapping environment was rpiimeii for fchem *o feel Hfce their normal s-elves. /,' r I* RSV 0000740 Page 6 - Health Hazard Evaluation Determination Subjective estimates from union officials. university investigators, medical professionals, and meat wrappers suggest that a larg^jurnber of meat wrappers are less seriously affected. To better delineate the clinical manifestations of exposure to contaminants from PVC film decomposition a preliminary survey of meat wrapping operations was made. Five retail stores in and around Seattle, Washington were visited during August /-9, 1972. Meat wrapping operations were observed in each retail store and g-iahtper^ meat wrappers with varied work experience with PVC films were inter viewed. Each worker was questioned in an attempt to elicit symptoms of upper respiratory tract irritation, irritation of the eyes, nose, .and throat, and occupational dermatoses. Spirometrlc measurements '-^were obtained from thirteen of the meat wrappers. At the completion of this preliminary survey It was clear that a more detailed scientific study would be necessary to elucidate the full ramifications of the potential health problems associated with the use of PVC films. The assistance of the Amalgamated Meat Cutters and Butcher Workmen of North America was solicited to facilitate the location of metropolitan areas where sizeable numbers of meat wrappers were allegedly being adversely affected by air con taminants from PVC films. Following a nationwide search, the City . of Louisville, Kentucky was selected as a site fof further investi gatory research. A research protocol was developed under the guidance of_pulmonary specialists from the NIOSH Appalachian Laboratory of Occupational Respiratory Diseases. The protocol called for the administration of a health questionnaire and the conduction of pulmonary function testing on meat wrappers and suitable controls. The orientation of the questionnaire and the subsequent interview with a NIOSH physician placed emphasis on occupationally related health problems, especially respiratory health problems. On January 22, 1973, in Louisville, Kentucky, seventeen meat wrappers and twenty non-meat wrappers (office personnef~serving as controls) completed medical questionnaires and participated in pre- and post-workshift pulmonary function testing. Technical problems regarding environmental samnli-Rg prevented evaluation of employee exposure* on tho rffy + in a- number of retail estabifsjwents, meat wrappers'' exposures to contaminants from hot wine cutting of PVC meat packaging film' are intermittent and highly variable* To be useful in inter ` preting employee s.-ntoost breathing zor.e air samples would have to reflect boo a\*erage and s+iort term exposures. Although these contaminants have been measured in undiluted form near the source of generation^, there is at present no suitable method of sufficient sensitivity to measure variable breathing zone concentrations. , .^ . ' --C * * RSV 0000741 Page 5 - Health Hazard Evaluation Determination To date, three researchers have found the film plasticizer to be the. predominant~contaminant generated by the thermal decomposition of Pvil! mdat Wrapping fi lm. The oral toxicity of di-2-ethyl hexyl adipate, as determined by animal experimentation, is relatively j However, no data are currently available regarding the iny^halation toxicity of di-2-ethyl hexyl adipate. It is Interesting ' to note that one researcher, Bovee, et al. identified the plasticizer to-be diisooctyl adipate while the other two (Van Houten and Jaeger) found di-2-ethyl hexyl adipate. Diisooctyl adipate has exactly the same molecular weight as di-2-ethyl hexyl adipate and possesses very similar physical properties. Hydrogen chloride is possibly the second most important degradation product. ' riCT"can be detected at concentrations of 1-E> ppm and is disagreeable at concentrations of 5-10 ppm. Other film degradation products have been identified, but are present in small quantities when compared to the film plasticizer. These other materials include chlorinated hydrocarbons and breakdown products of film additives. Workplace concentrations of PVC film decomposition products are difficult to measure. As previously, stated, HC1 has been found in very low concentrations in the meat wrapping environment. La boratory experiments by Van Houten et al. suggest that airborne concentrations of HC1 in the plume of "smoke" directly over the hot wire can reach^jignu These measurements were made during "artificially severe operating conditions," which would rarely occur during actual meat wrapping. (It should also be noted that an employee's exposure would be to a significantly lower concentra tion than that found in the plume close to the wire. In the same study plasticizer concentrations in the plume were found as high as^J^jm^. Again, this value was found during artificially severe operating conditions. Clinical complaints allegedly resulting from exposure to air contaminants from PVC meat wrapping film were first referenced in an unpublished study conducted by HTOSH's predecessor the Bureau of Occupational Safety and Health.2 According to that investigation, state health officials in Virginia became involved with complaints from meat wrappers in the summer of 1959. Since that time complaints have come in by Tetter and teleonone from several cities across the Nation. Due to the infernal nature of most of the reports, it is difficult to accurately estimate the true number of individuals involved. However, a small group of medical investigators scattered throughout the Nation have re ported approximately 50-75 capes of pronounced clinica.1 symptoms. Page 4 - Healtl azard Evaluation Determination Manufacturers o~ Fraccing Eguirment: Automatic, Se^i-Automalic, and Hard Wraps i Cleveland-!V"v,oit Corporation, Cla.'co Division 0. B. Dove r'.no Sons, Incorporated Heat Sealing CcjiD-ient iianufacturinc Company The Hobart :'?r.;fccturing Company Package Machinery Germany Reliance Electric Company, Toledo Scales and Systems RSV 0000743 Page 3 - Health Hazard Evaluation Determination as well as from five other stores in Seattle, Washington area regarding employee exposures to the potentially toxic substances emitted from thermal decomposing^ Pf fpyri packaging films in use in the meat "department. One to three meat wrap- ping employees are employed in each of these stores and iPS subsequently exposed to the substances in question. "3 t>(<r?& IV. HEALTH HAZARD EVALUATION A. ` Description of Process * Conditions of Use Although several types of meat wrapping machines were observed during the course of this study, most machines incorporated the basic features of the "typical' hand wrapping machine shown in Figure 1. Wrapping meat involves: (1) pulling out a desired length of film, (2) wrapping the film around a tray or cut of meat, (3) severing the film from the supply roll using the hot wire cut-off. (4) folding the film ends under the package, and (5)~sealing the folded ends under the package by touching the package to the heated pad. Air contaminants generated bv the hot wire cutting.of PVC packaging films and theiT"alleged toxic effects on meat wrapping employees constitute the subject of this health hazard evaluation. There are approximately 5 T DQQ meat|.wraapino employees in the United States, according to union and industry estimates. B. Study Background and Design Polyvinyl chloride and wrapping film is made from pure PVC resin and a variety of additives. All additives must be approved by the federal Food and Drug Adminstration for use in moat packaging ma terials. These additives include plasticizers, stabilizers, antifog. agents, lubricants, and .colorants. {dioctyl adipate - di^T^ethyl^hexyl adipate"^ anlepoxidized soya or soybean oil) can comprise uDto_32j_0f the film. Sta.bH^^s (calcium-zinc stearate) anti fog agents (e.g., polyoxyethyl eneaer^ati ves of sorbitan monooleato), lubricants (e.g., stearic acid), and colorants together makeup roughly 2^6% of the film. Several investigators have attempted to identify and quantitate air contaminants generated by the hot wire cutting of. PVC film in the meat wrapping environment. Early field meaeurem^rts for hydrogen ^ chlonide (HCl) detected trace amounts (less than 1 ppm) in the vicinity cf neat wrapping operations.2 A later laboratory study of air contaminants from hot wire cutting-of PVC film confirmed the gf Hf.l and related its rate of generation together with the rate of generation of particulate to the operating of the hot wire.3 As would be expected, the production of both HCl and airborne particulate increase with increasing wire temperature. j% * 4 . v* ASV 0000744 Page 2 - Health Hazard Evaluation Determination 72-58 Based on present experience with this particular problem, it is recoirmended that the following practices be instituted: 1. Pre-employment physical examinations, including chest x-rays and pulmonary function tests be performed on all individuals entering the meat wrapping industry. (Individuals who are found to have severely compromised pulmonary function or who exhibit strong predisposition to Dulmonary disorders should not enter the meat wrapping profession.) 2. Meat wrapping machinery should be clean and well maintained. Machines with controlled low temperature cut-off wires are-to be preferred. (There 1? heed tor further study with regard to controlling contamination at-its source via new cutting mechanisms or local exhaust ventilation, etc.) 3. Meat wrapping should be conducted in well ventilated surroundings. II. DISTRIBUTION AND AVAILABILITY OF THE DETERMINATION REPORT Copies of this Determination Report are available upon request from the Hazard Evaluation Services Branch, NIOSH, U.S. Post Office Building, Room 508, 5th and Walnut Streets, Cincinnati, Ohio 45202. Copies have been sent to: a) City Foods, Seattle, Washington b) Authorized representative of emoloyees c) U. S. Department of Labor - Region X d) NIOSH - Region X e) Washington State Department of Labor and Industries * i For the purposes of informing the 1-3 affected meat wrappers the employer will promptly "post" the Determination Report in a prominent places near where affected employees work for a period of 30 calendar days. III. INTRODUCTION Section 20(a)(6) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 669 (a)(6), authorizes the Secretary of Health, Education, and Welfare, following written request by any employer or authorized representative of employees, to determine whether any substance , { normally found in the place of employment has potentially toxic Ctf/c' 1)!' effects in such concentrations as used or fouiid.------ ------------------ ' ` The National Institute for Occupational Safety and H2alth (NIOSH) received such a request from an authorized representative of the meat wrapping employees at the City Foods. Seattle. Washington, RSV 0000745 U. S. DEPAF TNT OF HEALTH, EDUCATION, AND ' FARE NATIONAL INSTnUTE FOR OCCUPATIONAL SAFETY AND HEALTH CINCINNATI, OHIO 45202 HEALTH HAZARD EVALUATION DETERMINATION REPORT 72-58 CITY FOODS SEATTLE, WASHINGTON TOXICITY DETERMINATION SEPTEMBER 1973 In response to^six requests for Health Hazard Evaluations from retail meat wrapping Smployees in and and around Seattle, Washington, regarding exposure to the thermal decomposition products of poly vinyl chloride (PVC) meat packaging fTim, a limited study of retail meat wrappers was undertaken. Although the data presented in this report did not result from direct pvafnatipn of-thework environ- Hjerjt^t the city hoods, Seattle, Washington, the finaings"o1J_this studyare generally applicable to retail meat wrapping operations using PVC meat packaging films. It has been determined that air contaminants generated by the thermal cutting of polvvinvl chiorfde (PVC) packaging films in conjunction with the wrapping of meat are to some meat wrapping employees. This determTnauonTsDaseB upon medical evidence compiled during a limited study of meat wraopers in the United States. This study involved a review of the perti nent scientific literature, consultation with researchers in this area of investigation, the collection of medical histories, clinical observations at the worksite, pulmonary function testing of meat wrappers, and consideration of wrapping procedures, equipment, and meat wrapping environmental conditions. Evidence suggests that a sizeable percentage of meat wrappers suffer from miJ4^^mfljns to include eye, no$e, and threat irritation. A portion or these affected meat wrappers who have an underlying predisposition to respiratory difficulties resulting from a variety of conditions (tobacco abuse, asthma, emphysema. and other serious respiratory diseases) experience more serious respiratory problems. These can include shortness of breath, difficulty in breathing, coughing, and general physical distress. This study has not established whether or not presently heaiihy * meat wrappers may develop respiratory difficulties after prolongs^ exposures to contaminants frpm thermal decompositior-jof PVC packaging films. Although substances in the meat wrapping environment other than those^assbciated wfth PVC films may be responsible tor the pre viously 5T3T2TT CI i f! I ca I mani festations , the available evidence strongly implies that the air contamination from thermal cutting of PVC packaging film is the causative agent. As yet, the. patho physiologic mechanism for this malady is not clearly understood. RSV 0000746 Page 11 - Health Hazard Evaluation Determination 3. Van Houten, R., A. L. Cudworth, C.H. Irvine. Evaluation and Reduction of Air Contaminants Produced by Thermo Cutting and Sealing of PVC Packaging Film, liberty Mutual Insurance Company, Hopkinton, Mass. (Unpublished). 4. Bovee, H.H., L.E. Monteith, and R.M. Orheim. Thermal Decomposition of Heat trapping Film. Department of Environmental Health, School of Public Health and Community Medicine, University of Washington. (Unpublished). 5. Vandervort, Robert - Personal Communication by telephone with Dr. Rudolph Jaeger, Associate Professor of Toxicology at Harvard University School of Public Health. 6. Patty, F.A. Industrial Hygiene and Toxicology, Vol. II, John Wiley & Sons, 1963. AUTHORSHIP AND ACKNOWLEDGEMENTS Report Prepared By: Phillip L. Polakoff, M.D. Medical Officer Robert Vandervort Industrial Hygienist Originating Office: Jerome P. Flesch, Chief Hazard Evaluation Services Branch Acknowlednements N. Leroy Lapp, M.D., ALFORD, Morgantown, West Virginia Arvin G. Apol, Regional Industrial Hygienist, Region X, Seattle, Washington Bobby J. Gunter, Ph.D., Regional Industrial Hygieniest, Region VIII, Denver, Colorado Richard Gais, Pulmonary Technician, ALFORD, Morgantown, West Virginia RSV 000074? ABSTRACT HEALTH HAZARD EVALUATION DETERMINATION REPORTS 72-53,54,55,56,57,58 Toxic Substances: Thermal decomposition products of polyvinyl chloride packaging film (primarily dl-2-ethyl hexyl adipate and hydrogen chloride). Industry: Meat/Meat Packaging Study Data: Background information; recorded clinical symptomatology; pulmonary function tests (pre-and post-shift, exposed vs. controls). Study Dates (field work): August 7-9, 1972 and January 22, 1973. Study Results: A limited study of meat wrappers was conducted. Clinical symptomatology collected from two geographically separated groups of meat wrappers is presented (18 wrappers from Seattle, Washington and vicinity; 17 wrappers from Louisville, Kentucky). Clinical symptomatology collected from other medical researchers is discussed. Pre- and post-shift pulmonary function test results are presented for a group of 17 basically healthy meat wrappers and a group of 20 controls. No significant difference between exposed meat wrappers and controls was found after one shifts exposure to wrapping meat with PVC film. No environmental measurements were made to characterize employee exposures due to the lack of suitable methods for measuring breathing zone concentrations of d-2-ethyl hexyl adipate and other PVC film thermal decomposition products encountered in retail meat wrapping. Toxicity Determination: Based on medical evidence compiled during this limited study of meat wrappers it has been determined that air contaminants generated by the thermal cutting of polyvinyl chloride (PVC) packaging films in conjunction with the wrapping of meat are potentially toxic to some meat wrapping employees. Evidence suggests that a sizeable percentage of meat wrappers suffer from mild symptoms to include eye, nose, and throat irritation. A portion of these affected wrappers, who have an underlying predisposition to respira tory difficulties, experience more serious respiratory problems. These problems can include shortness of breath, difficulty in breathing, coughing and general physical distress. This study has not established whether or not presently healthy meat wrappers may develop respiratory difficulties after prolonged chronic exposure to contaminants from thermal decomposition of PVC packaging film. Recommendations regarding pre-employment medical examinations and good work practices are made in the text of the report. RSV 0000746 U. S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY ANO HEALTH CINCINNATI, OHIO 45202 HEALTH HAZARD EVALUATION DETERMINATION REPORT 72-53 SAFEWAY STORE TUMWATER, WASHINGTON SEPTEMBER 1973 TOXICITY DETERMINATION In response to six requests for Health Hazard Evaluations from retail meat wrapping employees in and and around Seattle, Washington, regarding exposure to the thermal decomposition products of poly vinyl chloride <PVC) meat packaging film, a limited study of retail meat wrappers was undertaken. Although the data presented in this report did not result from direct evaluation of the work environ ment at the Safeway Store in Tumwater, Washington, the findings of this study are generally applicable to retail meat wrapping operations using PVC meat packaging films. It has been determined that air contaminants generated by the thermal cutting of polyvinyl chloride (PVC) packaging films in conjunction with the wrapping of meat are potentially toxic to some meat wrapping employees. This determination is based upon medical evidence compiled during a limited study of meat wrappers in the United States. This study involved a review of the perti nent scientific literature, consultation with researchers in this area of investigation, the collection of medical histories, clinical observations at the worksite, pulmonary function testing of meat wrappers, and consideration of wrapping procedures, equipment, and meat wrapping environmental conditions. Evidence suggests that a sizeable percentage of meat wrappers suffer from mild symptoms to include eye, nose, and throat irri tation. A portion of these affected meat wrappers who have an underlying predisposition to respiratory difficulties resulting from a variety of conditions (tobacco abuse, asthma, emphysema, and other serious respiratory diseases) experience more serious respiratory problems. These can include shortness of breath, difficulty in breathing, coughing, and general physical distress. This study has not established whether or not presently healthy meat wrappers may develop respiratory difficulties after prolonged exposures to contaminants from thermal decomposition of PVC packaging films. Although substances in the meat wrapping environment other than those associated with PVC films may be responsible for the pre viously stated clinical manifestations, the available evidence strongly implies that the air contamination from thermal cutting of PVC packaging film is the causative agent. As yet, the patho physiologic mechanism for this malady is not clearly understood. RSV 0000749 Page 2 - Health Hazard Evaluation Determination 72-53 Based on present experience with this particular problem, it is recommended that the following practices be instituted: 1. Pre-employment physical examinations. Including chest x-rays and pulmonary function tests be performed on all individuals entering the meat wrapping industry. (Individuals who are found to have severely compromised pulmonary function or who exhibit strong predisposition to pulmonary disorders should not enter the meat wrapping profession.) 2. Meat wrapping machinery should be clean and well maintained. Machines with controlled low temperature cut-off wires are to be preferred. (There is need for further study with regard to controlling contamination at its source via new cutting mechanisms or local exhaust ventilation, etc.) 3. Meat wrapping should be conducted in well ventilated surroundings. II. DISTRIBUTION AND AVAILABILITY OF THE DETERMINATION REPORT Copies of this Determination Report are available upon request from the Hazard Evaluation Services Branch, NIOSH, U.S. Post Office Building, Room 508, 5th and Walnut Streets, Cincinnati, Ohio 45202. Copies have been sent to: a) Safeway Store - Tunwater, Washington b) Authorized representative of employees c) U. S. Department of Labor - Region X d) NIOSH - Region X e) Washington State Department of Labor and Industries For the purposes of informing the 1-3 affected meat wrapoers the employer will promptly "post" the Determination Report in a prominent place(s) near where affected employees work for a period of 30 calendar days. III. INTRODUCTION Section 20(a)(6) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 669 (a)(6), authorizes the Secretary of Health, Education, and Welfare, following written request by any employer or authorized representative of employees, to determine whether any substance normally found in the place of employment has potentially toxic effects in such concentrations as used or found. The National Institute for Occupational Safety and Health (NIOSH) received such a request from an authorized representative of the meat wrapping employees at the Safeway Store, Tumwater, Washington, RSV 0000750 U. S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH CINCINNATI, OHIO 45202 HEALTH HAZARD EVALUATION DETERMINATION REPORT 72-54 PETERSON'S FOODTOWN OLYMPIA, WASHINGTON SEPTEMBER 1973 TOXICITY DETERMINATION In response to six requests for Health Hazard Evaluations from retail meat wrapping employees in and and around Seattle, Washington, regarding exposure to the thermal decomposition products of poly vinyl chloride (PVC) meat packaging film, a limited study of retail meat wrappers was undertaken. Although the data presented in this report did not result from direct evaluation of the work environ ment at the Peterson's Foodtown, Olympia, Washington, the findings of this study are generally applicable to retail meat wrapping operations using PVC meat packaging films. It has been determined that air contaminants generated by the thermal cutting of polyvinyl chloride (PVC) packaging films in conjunction with the wrapping of meat are potentially toxic to some meat wrapping employees. This determination is based upon medical evidence compiled during a limited study of meat wrappers in the United States. This study involved a review of the perti nent scientific literature, consultation with researchers in this area of investigation, the collection of medical histories, clinical observations at the worksite, pulmonary function testing of meat wrappers, and consideration of wrapping procedures, equipment, and meat wrapping environmental conditions. Evidence suggests that a sizeable percentage of meat wrappers suffer from mild symptoms to include eye, nose, and throat irri tation. A portion of these affected meat wrappers who have an underlying predisposition to respiratory difficulties resulting from a variety of conditions (tobacco abuse, asthma, emphysema, and other serious respiratory diseases) experience more serious respiratory prcolems. These can include shortness of breath, difficulty in breathing, coughing, and general physical distress. This study has not established whether or not presently healthy meat wrappers may develop respiratory difficulties after prolonged exposures to contaminants from thermal decomposition of PVC packaging films. Although substances in the meat wrapping environment other than those associated with PVC films may be responsible for the pre viously stated clinical manifestations, the available evidence strongly implies that the air contamination from thermal cutting of PVC packaging film is the causative agent. As yet, the patho physiologic mechanism for this malady is not clearly understood. RSV OOOQ751 Page 2 - Health Hazard Evaluation Determination 72-54 Based on present experience with this particular problem, it is recomnended that the following practices be instituted: 1. Pre-employment physical examinations, including chest x-rays and pulmonary function tests be performed on all Individuals entering the meat wrapping industry. (Individuals who are found to have severely compromised pulmonary function or who exhibit strong predisposition to pulmonary disorders should not enter the meat wrapping profession.) 2. Meat wrapping machinery should be clean and well maintained. Machines with controlled low temperature cut-off wires are to be preferred. (There is need for further study with regard to controlling contamination at its source via new cutting mechanisms or local exhaust ventilation, etc.) 3. Meat wrapping should be conducted in well ventilated surroundings. II. DISTRIBUTION AND AVAILABILITY OF THE DETERMINATION REPORT Copies of this Determination Report are available upon request from the Hazard Evaluation Services Branch, NIOSH, U.S. Post Office Building, Room 508, 5th and Walnut Streets, Cincinnati, Ohio 45202. Copies have been sent to: a) Peterson's Foodtown (Westside Center) Olympia, Washington b) Authorized representative of employees c) U. S. Department of Labor - Region X d) NIOSH - Region X e) Washington State Department of Labor and Industries For the purposes of informing the 1-3 affected meat wrappers the employer will promptly "post" the Determination Report in a prominent place(s) near where affected employees work for a period of 30 calendar days. III. INTRODUCTION Section 20(a)(6) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 669 (a)(6), authorizes the Secretary of Health, Education, and Welfare, following written request by any employer or authorized representative of employees, to determine whether any substance normally found in the place of employment has potentially toxic effects in such concentrations as used or found. The National Institute for Occupational Safety and Health (NIOSH) received such a request from an authorized representative of the meat wrapping employees at the Peterson's Foodtown, Olympia, Washington, *sv 0000752 U. S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH CINCINNATI, OHIO 45202 HEALTH HAZARD EVALUATION DETERMINATION REPORT 72-55 SAFEWAY STORE RENTUN, WASHINGTON SEPTEMBER 1973 TOXICITY DETERMINATION In response to six requests for Health Hazard Evaluations from retail meat wrapoing employees in and and around Seattle, Washington, regarding exposure to the thermal decomposition products of poly vinyl chloride (PVC) meat packaging film, a limited study of retail meat wrappers was undertaken. Although the data presented in this report did not result from direct evaluation of the work environ ment at the Safeway Store, Renton, Washington, the findings of this study are generally applicable to retail meat wrapping operations using PVC meat packaging films. It has been determined that air contaminants generated by the thermal cutting of polyvinyl chloride (PVC) packaging films in conjunction with the wrapping of meat are potentially toxic to some meat wrapping employees. This determination is based upon medical evidence compiled during a limited study of meat wrappers in the United States. This study involved a review of the perti nent scientific literature, consultation with researchers in this area of investigation, the collection of medical histories, clinical observations at the worksite, pulmonary function testing of meat wrappers, and consideration of wrapping procedures, equipment, and meat wrapping environmental conditions. Evidence suggests that a sizeable percentage of meat wrappers suffer from mild symptoms to include eye, nose, and throat irri tation. A portion of these affected meat wrappers who have an underlying predisposition to respiratory difficulties resulting from a variety of conditions (tobacco abuse, asthma, emphysema, and other serious respiratory diseases) experience more serious respiratory problems. These can include shortness of breath, difficulty in breathing, coughing, and general physical distress. This study has not established whether or not presently healthy meat wrappers may develop- respiratory difficulties after prolonged exposures to contaminants from thermal decomposition of PVC packaging films. Although substances in the meat wrapping environment other than those associated with PVC films may be responsible for the pre viously stated clinical manifestations, the available evidence strongly implies that the air contamination from thermal cutting of PVC packaging film is the causative agent. As yet, the patho physiologic mechanism for this malady is not clearly understood. RSV 0000753 Page 2 - Health Hazard Evaluation Determination 72-55 Based on present experience with this particular problem, it is recommended that the following practices be instituted: 1. Pre-employment physical examinations, including chest x-rays and pulmonary function tests be performed on all individuals entering the meat wrapping industry. (Individuals who are found to have severely compromised pulmonary function or who exhibit strong predisposition to pulmonary disorders should not enter the meat wrapping profession.) 2. Meat wrapping machinery should be clean and well maintained. Machines with controlled low temperature cut-off wires are to be preferred. (There is need for further study with regard to controlling contamination at its source via new cutting mechanisms or local exhaust ventilation, etc.) 3. Meat wrapping should be conducted in well ventilated surroundings. II. DISTRIBUTION AND AVAILABILITY OF THE DETERMINATION REPORT Copies of this Determination Report are available upon request from the Hazard Evaluation Services Branch, NIOSH, U.S. Post Office Building, Room 508, 5th and Walnut Streets, Cincinnati, Ohio 45202. Copies have been sent to: a) Safeway Store, Renton Washington b) Authorized representative of employees c) U. S. Department of Labor - Region X d) NIOSH - Region X e) Washington State Department of Labor and Industries For the purposes of informing the 1-3 affected meat wrappers the employer will promptly "post" the Determination Report in a prominent place(s) near where affected employees work for a period of 30 calendar days. HI. INTRODUCTION Section 20(a)(6) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 669 (a)(6), authorizes the Secretary of Health, Education, and Welfare, following written request by any employer or authorized representative of employees, to determine whether any substance normally found in the place of employment has potentially toxic effects in such concentrations as used or found. The National Institute for Occupational Safety and Health (NIOSH) received such a request from an authorized representative of the meat wrapping employees at the Safeway Store, Renton, Washington, RSV 0000754 U. S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH CINCINNATI, OHIO 45202 HEALTH HAZARD EVALUATION DETERMINATION REPORT 72-56 PIGGLY WIGGLY PUYALLUP, WASHINGTON SEPTEMBER 1973 TOXICITY DETERMINATION In response to six requests for Health Hazard Evaluations from retail meat wrapping employees in and and around Seattle, Washington, regarding exposure to the thermal decomposition products of poly vinyl chloride (PVC) meat packaging film, a limited study of retail meat wrappers was undertaken. Although the data presented in this report did not result from direct evaluation of the work environ ment at the Piggly Wiggly, Puyallup, Washington, the findings of this study are generally applicable to retail meat wrapping operations using OVC meat packaging films. It has been determined that air contaminants generated by the thermal cutting of polyvinyl chloride (PVC) packaging films in conjunction with the wrapping of meat are potentially toxic to some meat wrapping employees. This determination is based upon medical evidence compiled during a limited study of meat wrappers in the United States. This study involved a review of the perti nent scientific literature, consultation with researchers in this area of investigation, the collection of medical histories, clinical observations at the worksite, pulmonary function testing of meat wrappers, and consideration of wrapping procedures, equipment, and meat wrapping environmental conditions. Evidence suggests that a sizeable percentage of meat wrappers suffer from mild symptoms to include eye, nose, and throat irri tation. A portion of these affected meat wrappers who have an underlying predisposition to respiratory difficulties resulting from a variety of conditions (tobacco abuse, asthm- emphysema, and other serious respiratory diseases) experience more serious respiratory problems. These can include shortness of breath, difficulty in breathing, coughing, and general physical distress. This study has not established whether or not presently healthy meat wrappers may develop respiratory difficulties after prolonged exposures to contaminants from thermal decomposition of PVC packaging films. Although substances in the meat wrapping environment other than those associated with PVC films may be responsible for the pre viously stated clinical manifestations, the available evidence strongly implies that the air contamination from thermal cutting of PVC packaging film is the causative agent. As yet, the patho physiologic mechanism for this malady is not clearly understood. KSV 0000755 Page 2 - Health Hazard Evaluation Determination 72-56 Based on present experience with this particular problem, it is recommended that the following practices be instituted: 1. Pre-employment physical examinations, including chest x-rays and pulmonary function tests be performed on all individuals entering the meat wrapping industry. (Individuals who are found to have severely compromised pulmonary function or who exhibit strong predisposition to pulmonary disorders should not enter the meat wrapping profession.) 2. Meat wrapping machinery should be clean and well maintained. Machines with controlled low temperature cut-off wires are to be preferred. (There is need for further study with regard to controlling contamination at its source via new cutting mechanisms or local exhaust ventilation, etc.) 3. Meat wrapping should be conducted in well ventilated surroundings. II. DISTRIBUTION AND AVAILABILITY OF THE DETERMINATION REPORT Copies of this Determination Report are available upon request from the Hazard Evaluation Services Branch, NIOSH, U.S. Post Office Building, Room 508, 5th and Walnut Streets, Cincinnati, Ohio 45202. Copies have been sent to: a) Piggly Wiggly, Puyallup, Washington b) Authorized representative of employees c) U. S. Department of Labor - Region X d) NIOSH - Region X e) Washington State Department of Labor and Industries For the purposes of Informing the 1-3 affected moat wrappers the employer will promptly "post1' the Determination Report in a prominent place(s) near where affected employees work for a period of 30 calendar days. III. INTRODUCTION Section 20(a)(6) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 669 (a)(6), authorizes the Secretary of Health, Education, and Welfare, following written request by any employer or authorized representative of employees, to determine whether any substance normally found in the place of employment has potentially toxic effects in such concentrations as used or found. The National Institute for Occupational Safety and Health (NIOSH) received such a request from an authorized representative of the meat wrapping employees at the Piggly Wiggly, Puyallup, Washington RSV 0000756 U. S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH CINCINNATI, OHIO 45202 HEALTH HAZARD EVALUATION DETERMINATION REPORT 72-57 T AND R MARKET RENTON, WASHINGTON SEPTEMBER 1973 TOXICITY DETERMINATION In response to six requests for Health Hazard Evaluations from retail meat wrapping employees in and and around Seattle, Washington, regarding exposure to the thermal decomposition products of poly vinyl chloride (PVC) meat packaging film, a limited study of retail meat wrappers was undertaken. Although the data presented in this report did not result from direct evaluation of the work environ ment at the T and R Market, Renton, Washington, the findings of this study are generally applicable to retail meet wrapping opera tions using PVC meat packaging films. It has been determined that air contaminants generated by the thermal cutting of polyvinyl chloride (PVC) packaging films in conjunction with the wrapping of meat are potentially toxic to some meat wrapping employees. This determination is based upon medical evidence compiled during a limited study of meat wrappers in the United States. This study involved a review of the perti nent scientific literature, consultation with researchers in this area of investigation, the collection of medical histories, clinical observations at the worksite, pulmonary function testing of meat wrappers, and consideration of wrapping procedures, equipment, and meat wrapping environmental conditions. Evidence suggests that a sizeable percentage of meat wrappers suffer from mild symptoms to include eye, nose, and throat irri tation. A portion of these affected meat wrappers who have an underlying predisposition to respiratory difficulties resulting from a variety of conditions (tobacco abuse, asthma, emphysema, and other serious respiratory diseases) experience more serious respiratory problems. These can include shortness of breath, difficulty in breathing, coughing, and general physical distress. This study has not established whether or not presently healthy meat wrappers may develop respiratory difficulties after prolonged exposures to contaminants from thermal decomposition of PVC packaging films. Although substances in the meat wrapping environment other than those associated with PVC films may be responsible for the pre viously stated clinical manifestations, the available evidence strongly implies that the air contamination from thermal cutting of PVC packaging film is the causative agent. As yet, the patho physiologic mechanism for this malady is not clearly understood. RSV 0000757 Page 2 - Health Hazard Evaluation Determination 72-57 Based on present experience with this particular problem, it is recommended that the following practices be instituted: 1. Pre-employment physical examinations, including chest x-rays and pulmonary function tests be performed on all individuals entering the meat wrapping industry. (Individuals who are found to have severely compromised pulmonary function or who exhibit strong predisposition to pulmonary disorders should not enter the meat wrapping profession.) 2. Meat wrapping machinery should be clean and well maintained. Machines with controlled low temperature cut-off wires are to be preferred. (There is need for further study with regard to controlling contamination at its source via new cutting mechanisms or local exhaust ventilation, etc.) 3. Meat wrapping should be conducted in well ventilated surroundings. II. DISTRIBUTION AND AVAILABILITY OF THE DETERMINATION REPORT Copies of this Determination Report are available upon request from the Hazard Evaluation Services Branch, NIOSH, U.S. Post Office Building, Room 508, 5th and Walnut Streets, Cincinnati, Ohio 45202. Copies have been sent to: ;a) T and R Market, Renton, Washington b) Authorized representative of employees c) U. S. Department of Labor - Region X d) NIOSH - Region X e) Washington State Department of Labor and Industries For the purposes of informing the 1-3 affected meat wrappers the employer will promptly "post" the Determination Report in a prominent place(s) near where the affected employees work for a period of 30 calendar days. III. INTRODUCTION Section 20(a)(6) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 669 (a)(6), authorizes the Secretary of Health, Education, and Welfare, following written request by any employer or authorized representative of employees, to determine whether any substance normally found in the place of employment has potentially toxic effects in such concentrations as used or found. The National Institute for Occupational Safety and Health (NIOSH) received such a request from an authorized representative of the meat wrapping employees at the T and R Market, Renton, Washington, RSV 0000758 U. S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH CINCINNATI, OHIO 45202 HEALTH HAZARD EVALUATION DETERMINATION REPORT 72-58 CITY FOODS SEATTLE, WASHINGTON TOXICITY DETERMINATION SEPTEMBER 1973 In response to six requests for Health Hazard Evaluations from retail meat wrapping employees in and and around Seattle, Washington, regarding exposure to the thermal decomposition products of poly vinyl chloride (PVC) meat packaging film, a limited study of retail meat wrappers was undertaken. Although the data presented in this report did not result from direct evaluation of the work environ ment at the City Foods, Seattle, Washington, the findings of this study are generally applicable to retail meat wrapping operations using PVC meat packaging films. It has been determined that air contaminants generated by the thermal cutting of polyvinyl chloride (PVC) packaging films in conjunction with the wrapping of meat are potentially toxic to some meat wrapping employees. This determination is based upon medical evidence compiled during a limited study of meat wraopers in the United States. This study involved a review of the perti nent scientific literature, consultation with researchers in this area of investigation, the collection of medical histories, clinical observations at the worksite, pulmonary function testing of meat wrappers, and consideration of wrapping procedures, equipment, and meat wrapping environmental conditions. Evidence suggests that a sizeable percentage of meat wrappers suffer from mild symptoms to include eye, nose, and throat irri tation. A portion of these affected meat wrappers who have an underlying predisposition to respiratory difficulties resulting from a variety of conditions (tobacco abuse, asthma, emphysema, and other serious respiratory diseases) experience more serious respiratory problems. These can include shortness of breath, difficulty in breathing, coughing, and general physical distress. This study has not established whether or not presently healthy meat wrappers may develop respiratory difficulties after prolonged exposures to contaminants from thermal decomposition of PVC packaging films. Although substances in the meat wrapping environment other than those associated with PVC films may be responsible for the pre viously stated clinical manifestations, the available evidence strongly Implies that the air contamination from thermal cutting of PVC packaging film is the causative agent. As yet, the patho physiologic mechanism for this malady is not clearly understood. K$V 000Q759 Page 2 - Health Hazard Evaluation Determination 72-58 Based on present experience with this particular problem, it is recommended that the following practices be instituted: 1. Pre-employment physical examinations, including chest x-rays and pulmonary function tests be performed on all Individuals entering the meat wrapping industry. (Individuals who are found to have severely compromised pulmonary function or who exhibit strong predisposition to pulmonary disorders should not enter the meat wrapping profession.) 2. Meat wrapping machinery should be clean and well maintained. Machines with controlled low temperature cut-off wires are to be preferred. (There is need for further study with regard to controlling contamination at its source via new cutting mechanisms or local exhaust ventilation, etc.) 3. Meat wrapping should be conducted in well ventilated surroundings. II. DISTRIBUTION AND AVAILABILITY OF THE DETERMINATION REPORT Copies of this Determination Report are available upon request from the Hazard Evaluation Services Branch, NIOSH, U.S. Post Office Building, Room 508, 5th and Walnut Streets, Cincinnati, Ohio 45202. Copies have been sent to: a) City Foods, Seattle, Washington b) Authorized representative of emoloyees c) U. S. Department of Labor - Region X d) NIOSH - Region X e) Washington State Department of Labor and Industries For the purposes of informing the 1-3 affected meat wrappers the employer will promptly "post" the Determination Report in a prominent places near where affected employees work for a period of 30 calendar days. III. INTRODUCTION Section 20(a)(6) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 669 (a)(6), authorizes the Secretary of Health, Education, and Welfare, following written request by any employer or authorized representative of employees, to determine whether any substance normally found in the place of employment has potentially toxic effects in such concentrations as used or found. The National Institute for Occupational Safety and Health (NIOSH) received such a request from an authorized representative of the meat wrapping employees at the City Foods, Seattle, Washington, ftSV 0000760 Page 3 - Health Hazard Evaluation Determination as well as from five other stores in Seattle, Washington area regarding employee exposures to the potentially toxic substances emitted from thermal decomposition of polyvinyl (PVC) packaging films in use in the meat department. One to three meat wrap ping employees are employed in each of these stores and are subsequently exposed to the substances in question. IV. HEALTH HAZARD EVALUATION A. Description of Process - Conditions of Use Although several types of meat wrapping machines were observed during the course of this study, most machines incorporated the basic features of the "typical* hand wrapping machine shown in Figure 1. Wrapping meat involves: (1) pulling out a desired length of film, (2) wrapping the film around a tray or cut of meat, (3) severing the film from the supply roll using the hot wire cut-off, (4) folding the film ends under the package, and (5) sealing the folded ends under the package by touching the package to the heated pad. Air contaminants generated by the hot wire cutting of PVC packaging films and their alleged toxic effects on meat wrapping employees constitute the subject of this health hazard evaluation. There are approximately 75,000 meat wrapping employees in the United States, according to union and industry estimates. B. Study Background and Design Polyvinyl chloride and wrapping film is made from pure PVC resin and a variety of additives. All additives must be approved by the federal Food and Drug Adminstration for use in meat packaging ma terials. These additives include plasticizers, stabilizers, antifog agents, lubricants, and colorants. Plasticizers (dioctyl adipate di-2-ethyl hexyl adipate, and epoxidized soya or soybean oil) can comprise up to 30% of the film. Stabilizers (calcium-zinc stearate) antifog agents (e.g., polyoxyethylene derivatives of sorbitan monooleate), lubricants (e.g., stearic acid), and colorants together makeup roughly 2-6% of the film. Several investigators have attempted to identify and quantitate air contaminants generated by the hot wire cutting of PVC film in the meat wrapping environment. Early field measurements for hydrogen chloride (HC1) detected trace amounts (less than 1 ppm) in the vicinity of meat wrapping operations.2 A later laboratory study of air contaminants from hot wire cutting of PVC film confirmed the presence of HC1 and related its rate of generation together with the rate of generation of particulate to the operating temperature of the hot wire.3 As would be expected, the production of both HC1 and airborne particulate increase with increasing wire temperature. RSV 0000761 J Page 4 - Health Hazard Evaluation Determination FIGURE 1: Typical Hand-Wrapping Machine Manufacturers of Wrapping Equipment: Automatic, Semi-Automatic, and Hand Wrapping Cleveland-Detroit Corporation, Clamco Division J. B. Dove and Sons, Incorporated Heat Sealing Equipment Manufacturing Company The Hobart Manufacturing Company Package Machinery Company Reliance Electric Company, Toledo Scales and Systems RSV 0000762 Page 5 - Health Hazard Evaluation Determination To date, three researchers have found the film plasticizer to be the predominant contaminant generated by the thermal decomposition of PVC meat wrapping film. 3`^ The oral toxicity of di-2-ethyl hexyl adipate, as determined by animal experimentation, is relatively low. However, no data are currently available regarding the in halation toxicity of di-2-ethyl hexyl adipate. It is interesting to note that one researcher, Bovee, et al. identified the plasticizer to be diisooctyl adipate while the other two (Van Houten and Jaeger) found di-2-etbyl hexyl adipate. Diisooctyl adipate has exactly the same molecular weight as di-2-ethyl hexyl adipate and possesses very similar physical properties. Hydrogen chloride is possibly the second most Important degradation product. HC1 can be detected at concentrations of 1-5 ppm and is disagreeable at concentrations of 5-10 ppm. Other film degradation products have been identified, but are present in small quantities when compared to the film plasticizer. These other materials include chlorinated hydrocarbons and breakdown products of film additives. Workplace concentrations of PVC film decomposition products are difficult to measure. As previously, stated, HC1 has been found in very low concentrations in the meat wrapping environment. La boratory experiments by Van Houten et al. suggest that airborne concentrations of HC1 In the plume of "smoke1' directly over the hot wire can reach 2 ppm. These measurements were made during "artificially severe operating conditions," which would rarely occur during actual meat wrapping. (It should also be noted that an employee's exposure would be to a significantly lower concentra tion than that found in the plume close to the wire. In the same study plasticizer concentrations in the plume were found as high as 13 mg/M3. Again, this value was found during artificially severe operating conditions. Clinical complaints allegedly resulting from exposure to air contaminants from PVC meat wrapping film were first referenced in an unpublished study conducted by NIOSH's predecessor the Bureau of Occupational Safety and Health.2 According to that investigation, state health officials in Virginia became involved with complaints from meat wrappers in the summer of 1969. Since that time complaints have come in by letter and telephone from several cities across the Nation. Due to the informal nature of most of the reports, it is difficult to accurately estimate the true number of individuals involved. However, a small group of medical investigators scattered throughout the Nation have re ported approximately 50-75 cases of pronounced clinical symptoms. RSV 0000763 I Page 6 - Health Hazard Evaluation Determination Subjective estimates from union officials, university investigators, medical professionals, and meat wrappers suggest that a large number of meat wrappers are less seriously affected. To better delineate the clinical manifestations of exposure to contaminants from PVC film decomposition a preliminary survey of meat wrapping operations was made. Five retail stores in and around Seattle, Washington were visited during August 7-9, 1972. Meat wrapping operations were observed in each retail store and eighteen meat wrappers with varied work experience with PVC films were inter viewed. Each worker was questioned in an attempt to elicit symptoms of upper respiratory tract irritation, irritation of the eyes, nose, and throat, and occupational dermatoses. Spirometric measurements were obtained from thirteen of the meat wrappers. At the completion of this preliminary survey it was clear that a more detailed scientific study would be necessary to elucidate the full ramifications of the potential health problems associated with the use of PVC films. The assistance of the Amalgamated Meat Cutters and Butcher Workmen of North America was solicited to facilitate the location of metropolitan areas where sizeable numbers of meat wrappers were allegedly being adversely affected by air con taminants from PVC films. Following a nationwide search, the City of Louisville, Kentucky was selected as a site fof further investi gatory research. A research protocol was developed under the guidance of pulmonary specialists from the NIOSH Appalachian Laboratory of Occupational Respiratory Diseases. The protocol called for the administration of a health questionnaire and the conduction of pulmonary function testing on meat wrappers and suitable controls. The orientation of the questionnaire and the subsequent interview with a NIOSH physician placed emphasis on occupationally related health problems, especially respiratory health problems. On January 22, 1973, in Louisville, Kentucky, seventeen meat wrappers and twenty non-meat wrappers (office personnel serving as controls) completed medical questionnaires and participated in pre- and post-workshift pulmonary function testing. Technical problems regarding environmental sampling prevented evaluation of employee exposures on the day of testing. As observed in a number of retail establishments, meat wrappers' exposures to contaminants from hot wire cutting of PVC meat packaging film are intermittent and highly variable. To be useful in inter preting employee symptoms, breathing zone air samples would have to reflect both average and short term exposures. Although these contaminants have been measured in undiluted form near the source of generation^, there is at present no suitable method of sufficient sensitivity to measure variable breathing zone concentrations. RSV 0000764 Page 7 - Health Hazard Evaluation Determination C. Evaluation Methods 1. Medical Questionnaire The medical questionnaire consisted of twenty-six sets of questions. Its purpose as to gather pertinent information concerning an individual's past medical history, smoking history, past occupational exposures, current respiratory status and adverse effects allegedly arising from exposure to air contaminants from PVC films. 2. Pulmonary Function Testing Each pulmonary function test required the employee to make three forced expiratory volume practice maneuvers after which three forced expiratory volume maneuvers (reproducible within 5%) were recorded as flow volume loops. A waterless, high fidelity spirometer equipped with an air temperature probe was used. The flow volume loops were displayed on a storage oscilloscope and recorded on magnetic tape. A photograph of each oscilloscope display was taken for backup. Computer analysis of flow volume loops provided the following parameters forced expiratory volume in one second (FEVI ) and flow rates at 25,50,75 and 90 per cent of forced vital capacity (FVC). D. Evaluation Results 1. Preliminary Survey (Seattle, Washington and vicinity) Sixteen of the eighteen meat wrappers interviewed in the preliminary survey were known to have suffered ill effects from air contaminants from PVC films. Only two workers were free of any clinical symp tomatology. Eight had similar case histories and admitted ex periencing varying degrees of sneezing, rhinorrhea, and eye ir ritation. Most individuals gave a like story that the ill effects came on from one to three hours after the commencement of meat wrapping in the morning. The workers stated that as the workday progressed the prodromal manifestations increased in intensity. The sneezing, rhinorrhea, and throat and eye irritation would abate In the evening hours and would be non-existent during week ends and vacations. Five workers experienced more severe clinical symptomatology necessitating physician intervention and, on occasion, hospitali zation. These individuals seemed to suffer with "occupational brochiolitis." They suffered at times with severe dyspnea, productive cough, and nasal congestion. Onset of these symptoms was from one-half to two and one-half hours after commencement of work. These ill effects led to increased absenteeism. All were on one form of medication or another. This group also stated that a period of several days away from the meat wrapping environment was required for them to feel like their normal selves. RSV 0000765 Page 8 - Health Hazard Evaluation Determination Four of these workers had fifteen or more pack-years of cigarette smoking behind them. Three meat wrappers had pre-existing susceptibility to upper respiratory symptomatology caused by severe disease processes (rheumatic fever, chronic obstructive pulmonary disease, and lung abscess). 2. Medical Questionnaires (Louisville Study) Seventeen meat wrappers and a control population of twenty individuals completed the questionnaire. None of the controls re ported any adverse clinical symptomatology associated with their particular form of employment. The majority of the controls worked as clerks in retail grocery stores. As a group the seventeen meat wrappers averaged nine years and three months of experience in the meat wrapping profession. Fortyfive per cent of these meat wrappers complained of irritation from film contaminants which resulted in watering and itching eyes. Thirty per cent of the wrappers complained of burning or dryness of the throat. Three wrappers (18X) stated that they experienced "painful breathing" and shortness of breath while working with PVC meat wrap. It is Important to note that these same three individuals had a history of allergies, were on medication and were under physician care. 3. Pulmonary Function Testing (Louisville Study) All pulmonary function data were analyzed by bio-statisticians at the NIOSH Appalachian Laboratory for Respiratory Diseases. The data can be sunvnarized by examining the following statistical tests Note: df * degrees of freedom (number of employees tested minus one) P * probability that a difference occurred by chance alone. The "student t test" was used to determine whether there were significant differences between groups of individuals with respect to changes in FEV-,`s and FVC's. To be significant, a difference between groups would have a probability of occurring by chance of less than 5% or P less than 0.05. RSV 0000766 Page 9 - Health Hazard Evaluation Determination Test No. 1 - When all exposed (meat wrappers) were compared with all non-exposed (controls) with respect to any differences between pre- and post-workshift values of FEVi and FVC, there was no significant difference at the 95% confidence level (l.e. P less than 0.05). TFEVi (35df) *-0.35 TFVC (35df) --0.42 P 0.73 P = 0.67 Test No. 2 - When exposed smokers were compared with non-exposed smokers, there was no significant difference. jFEVi (lldf) * 0.22 tFVC (lldf) * 0.31 P- 0.83 P * 0.76 Test No. 3 - When exposed non-smokers were compared with non-exposed non-smokers there was no significant difference. tFEVi (22df) * 0.55 tFVC (22df) * 0.11 P - 0.59 P * 0.90 Test No. 4 - Test No. 1 was repeated with respect to peak flow and flow at 25,50,75 and 90% of FVC. There was a significant difference for F90. TPF TF25 *F50 T>75 TF90 (35df) 2 (35df) * (35df) 2 (35df) s (35df) m 0.47 0.38 0.01 0.11 2.39 P * 0.64 P - 0.71 P - 0.99 P = 0.91 P * 0.02 Test No. 5 - Test No. 2 was repeated with respect to the preceding parameters and there was a significant difference for F50. JpF tF25 TF50 JF75 tF90 (lldf) = 0.08 (lldf) * 1.36 (lldf) * 2.31 (lldf) * 0.88 (lldf) * 0.54 P * 0.94 P = 0.20 P * 0.04 P * 0.40 P * 0.60 Test No. 6 - Test No. 3 was repeated with respect to the preceding parameters and there were significant differences for F75 and F90. TPF TF25 TF50 TF75 Tpgo (22df) = 1.14 22df) = 0.98 (22df) * 1.61 (22df) * 2.26 (22df) * 2.87 P * 0.27 P * 0.34 P 0.12 P = 0.03 P = 0.01 RSV 0000767 Page 10 - Health Hazard Evaluation Determination In suranary, pulmonary function tests of this small, randomly selected population of meat wrappers revealed no gross pulmonary effects in comparison to a control population after one workshift of meat wrapping. Furthermore, it must be stated that this exposed study group was of general good health and free of serious symptomatology. E. Discussion A study of meat wrapping employees is beset by various intrinsic problems from the onset. These Include the following: a) Low density dispersal of meat wrappers In any geographic area. b) No more than two or three meat wrappers employed at any typical retail store. c) Meat wrapping work environments, although similar, are not strictly uniform. Differences can exist in packaging equip ment (l.e., operating parameters), type of wrapping material ambient environmental conditions (temperature, humidity), general ventilation provlsiors^ork practices, and volume of meat wrapping performed. d) Work shifts for meat wrapping employees are highly variable. e) There Is a lack of suitable sampling and analytical methodology for the evaluation of employee exposures to PVC film decomposition products encountered In retail meat wrapping. At present, methods are not sensitive enough to characterize intermittent exposures or variable constant exposure via breathing zone sampling techniques. The above problems Interrupted the completion of this preliminary controlled scientific study. At this point, a limited amount of data have been compiled for a population of basically healthy meat wrappers. There remains* the necessity to study a sizeable population of seriously affected meat wrappers. It is felt that such a pop ulation exists based upon scattered reports of clinical symptomatology from various medical Investigators throughout the Nation. REFERENCES 1. Vandervort, Robert - Personal Conwunication by Letter with Major Film Manufacturers, 1970. 2. Vandervort, R. "Polyvinyl Chloride Meat Wrapping Film Study," unpublished USPHS, BOSh, DOIDC, Technical Assistance Report, Cincinnati, Ohio 0971). RSV 0000768 Page 11 - Health Hazard Evaluation Determination 3. Van Houten, R., A. L. Cudworth, C.H. Irvine. Evaluation and Reduction of Air Contaminants Produced by Thermo Cutting and Sealing of PVC Packaging Film. Liberty Mutual Insurance Company, Hopklnton, Mass. (Unpublished). 4. Bovee, H.H., L.E. Montelth, and R.M. Orhelm. Thermal Decomposition of Meat Wrapping Film. Department of Environmental Health, School of Public Health and Conmunlty Medicine, University of Washington. (Unpublished). 5. Vandervort, Robert - Personal Communication by telephone with Dr. Rudolph Jaeger, Associate Professor of Toxicology at Harvard University School of Public Health. 6. Patty, F.A. Industrial Hygiene and Toxicology, Vol. II, John Wiley & Sons, 1963. AUTHORSHIP AND ACKNOWLEDGEMENTS Report Prepared By: Phillip L. Polakoff, M.D. Medical Officer Robert Vandervort Industrial Hygienist Originating Office: Jerome P. Flesch, Chief Hazard Evaluation Services Branch Acknowledqements M. Leroy Lapp, M.D., ALFORD, Morgantown, West Virginia Arvln G. Apol, Regional Industrial Hygienist, Region X, Seattle, Washington Bobby J. Gunter, Ph.D., Regional Industrial Hygienlest, Region VIII, Denver, Colorado Richard Gals, Pulmonary Technician, ALFORD, Morgantown, West Virginia RSV 0000769