Document JN9yjr5Xew4OgBnQyQyrrMGDO

before the UNITED STATES DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION WASHINGTON, O.C. 20210 In Re: ) ) The Proposed Regulations of the United Ststes ) Occupetlonal Safety and Health Administration ) for the Identification, Classification and ) Regulation of ToxicSubstances Posing a j Potential OccupationalCarcinogenicRisk To ) Humans ) OSHA Docket No. 090 April 4, 1978 Statement of Darrel D. Douglas This Statement Was Requested By The United States Occupational Safety and Health Administration GAF 15821 A commentary on the US Department of Labor's Occupational Safety and Health Administration Proposal published, October 4, 1977, to adopt regulations concerning, "Identification, Classfication and Regulation of Toxic Substances Posing a Potential Occupational Carcinogenic Risk." by Darrel D. Douglas Los Alamos, New Mexico March 27, 1978 I am a Registered Professional Engineer and am Certified in the Comprehensive Practice of Industrial Hygiene. I haves been employed in industrial hygiene for 22 years by both private industry and governmental agencies. For over half that period I was Chief Industrial Hygiene Engineer and Director of Occu pational Health for the State of Oregon. Presently I am employed by the Los Alamos Scientific Laboratory {LASL) as Leader, Respirator Research and Development Section. My commentary is made at the request of the United States Department of Labor (DOL) as a private consultant and the views I express do not necessarily represent those of the LASL. INTRODUCTION According to the preamble of this document, there should be no exposure to carcinogen a goal not always possible to achieve. Since a basic premise of this document is that risk increases as the intensity of exposure rises withoutaa no effect threshold, it is necessary to keep the exposure level to the lowest feasible concentration. My concern is the use of respirators for protection from carcinogens. It is stated in this document that respirators are a secondary means of exposure control. They are to be used only while engineering controls are being installed; to supple ment engineering controls when they are notadequate; and for maintenance and repair operations. Their use is restricted because of the effort necessary to be expended by both employer and employee to insure that the protection sought is received. It is necessary for the employer to analyze the exposure, choose the proper respirator, train the employee, insure that the respirator is used correctly on the job, and be watchful that the conditions of use do not change significantly. The employee must continue in his everyday assignments while wearing a device which affects his ease of breathing, impairs his vision and reduces his efficiency. 2 It is important to emphasize that respirators generally remain the secondary means of control for chemical carcinogens and toxic chemicals generally. Respirators are not as satis factory a method of control as engineering and work practice controls for most employees. However it must be remembered that for some segments of the workforce, especially maintenance employees, engineering controls may not be effective and respirators will have to be the primary means of protection. For many types of respirators face fit is crucial to their effective use. It is difficult to get a good face fit because of the variation in the shape of the human face. Also the shape changes when people make facial movements such as when talking, smiling or frowning. Facial hair interferes with proper fit. Presently face fit also presents a major problem for women. Most respirators currently in use.have been designed to fit the male facial configuration. Respirators also may create safety problems. They make communications difficult, reduce vision and sometimes reduce employee efficiency. Some respirators make hearing difficult and all make speech more difficult. Where communications are important, special microphones inside the respirators need to be considered. Persons wearing glasses may also have difficulties with both half-face and full-face respirators. Zf prescription glasses are needed, then special lenses must be installed in full face piece respirators. Most respirators are uncomfortable and facial irritation can be associated with their use. To overcame these and other difficulties associated with respirator use, requires an excellent respirator program. Such a program places substantial burdens on both employers and employees. If just one element of the program is neglected, the protection given by the respirators, will be substantially reduced. A first class respirator program is neither inexpensive nor easy to carryout. Less than an excellent program, or a respirator program which is written but not carried out will not provide adequate protection to the employees. The respirators will not be worn because they are unconfortable, of it worn they will leak because they will not have been properly fitted or maintained. GAF 15822 3 It is also advantageous for the best health protection, to utilize engineering controls to the lowest level feasible even if supplementary respirator use is needed for some employees, to provide appropriate exposure reductions. The engineering controls will reduce the number of employees on respirators. The lower exposure levels resulting from the engineering controls will permit the use of simple less confining and easier to use respirators. Finally, lower background levels will reduce the potential exposure for those employees who have not been properly fitted to their respirator or who do..not wear them conscientiously. A litany of the problems of respirator use as a means of control does not eliminate their use. Supplementing engineering controls and maintenance operations may require the use of respirators for an indefinite period in order to give needed health protection. Properly selected and fitted respirators, backed up with an excellent respirator program can reduce employee exposures to carcinogens to very low levels indeed. It should be remembered that the protection afforded to employees by engineering controls may end with the control operator or assembly line employee. The maintenance staff which works different hours from those of the production employees can be exposed to hazardous concentration of toxic materials during their routine maintenance operations and may require respirators. It is important that precautions in the use of respirators be carefully delineated. RESPIRATOR SELECTION Proposed Section 6(c) Model Standard for a Category I Toxic Substance as outlined in 1990.150 (Emergency Tempoary Standard) and 1990.160 (Final Standard) requires that the Permissible Exposure Limit (PEL) be set at the lowest feasible level see 1910.0000(c). 1910.0000(h) which permits the use of respirators also specifies that the employee's exposure must be reduced within the PEL. In addition, the respirator program must meet the requirements of 1910.134 and states that a respirator selection table is to be provided. Respirators under 1910.150, the emergency standard, may be used more liberally than is the case for the permanent standard, 1910.160. Immediate respirator use would be sanctioned during the period of detesming and installing engineering controls. When the permanent standard is in affect respirators may be used only during the installation of engineering controls; during maintenance and to supplement engineering controls in case they are not adequate to reduce the contaminant concen tration below the PEL. There should be no difference in the respirators provided for either category. 4 A respirator selection table is required to be published with each standard. Considering the statement that a no effect threshold does not exist for carcinogenic materials, it is prudent that the efficiency of the respirator used be known. The ratio of the PEL to the actual contaminant concentration will influence the choice of respirator. Respirator efficiency is measured by the respirator Protection Factor (PF) and defined as: Contaminant concentration outside repirator PF - ----------------------------------------------------------------------------------- Contaminant concentration inside respirator A PF of 50 indicates that the leakage inside the respirator is 21 of the outside concentration. A PF of 100 indicates that the leakage inside the respirator is 1% of the outside concen tration. This concept has been widely publicized by E.C. Hyatt in his publication "Respirator Protection Factors." Mr. Hyatt quantitatively assessed the efficiency of various types of respirators, determined their effectiveness, and summarized the results. His summary table from the publication is shown in Table Z. l GAF 15823 TABLE I RESPIRATOR PROTECTION FACTORS'1 Type Respirator L Air-Purifying A. Particulate* removing Single-use,* dust* Quarter-mask, dust* Half-mask, dust* Half* or Quarter-mask, fume* Half* 01 Quarter-ma.J<, High-Effidencyk Foil-Facepiece, High-Efficiency Powered, High-Efficiency, ail endoturet Powered, dun or fume, all enclosures & Oaand Vapor-Ramoving* Half-Mask Poll-Facepiece Atmosphere-Supplying A. -SuppUed-Ab Demand, Half-mask Demand, Full-Facepiece Hose Mask Without Blower, Full-Facepiece Prsecure-Demand, Half-Mask* Pressure-Demand, Full-Facepiece1 Hose Mask With Blbwer, FuU-Facapiece Continuous-Flow, Half-Mask1* Continuous-Flow, Full-Paeapiece1 Continuous-Flow, Hood, Helmet, or Suit"* B. Self-Contained Breathing Apparatus (SCBA) Open-Circuit, Demand, Full-Facepiece Open-Circuit, Pressure-demand Full-Facepiece ClosedCircuit, Oxygen Tank-type, FuU-Facepleee TO. Combination Raspbator A- Any combination of ab-purifying and atmoaphara supplying respirator. B. Any combination of mppliod-ob . raapkitor and an SCSA. Facepiece k Plrnrarc Protection Factor m m - s s 10 10 10 50 1000 X* 10 60 - 10 - 60 - 60 1000 2000 60 1000 2000 2000 m 60 10 000* - 60 Uaa minimum protection factor liatad abora for typo of moda of operation. Eaeaptioa: Combination auppUsd-ab reapbaton, in proaaaro-demand or other poajtiva praaaure moda, with an auxiliary aaif-oontainad sir supply, and a full facepiece, should uaa tha FT for proaanra demand SCBA. Note: Table I ia not to be reproduced without the accompanying footnotes. Fm1m<w far Ritpiritif PrttediM Fmmt Table t "Tbearerafl pflMim a/fnHrd hy i {jm mfitnHiw (Men (aod andafntwiiH) may he defined In term* f it penteel inn foctnr <PD. The PPtoa mV..*urf f the degree prmeei *n iflW>4 hy t muiflw. defined m the ratio of the ronrentrattonafcnmeminani in the amWmt atimaphere In that makfe the rnchaurr (uaoaJIv inside the fifrywitl under rrmriittom Fmmp. Reupif**1** nluaiJd be eJeried w*that the cnaemtrat ton inhaled by the rvir wilt not (Mid the i|>pfnprtoie limit. The recommended rwpimfof !> are attainm and ue guidee, Md ehnwld only ha ued when the employer Ha* trtihltohed $ minimal errvptable rtrptratur program as drfind in Seriton .1 c4 rhe ANSI 7A1M9I9 Standard. Hi addition in facepiece*. ehto include* any type of enrloeura * covering of (ha vmrtr'i breathing xnnt. uch uppiicd*air hirato. helmet*: or Mura. 'Inchidee dud*. mtot*. and fume* only. Don nnt apply when mao nr vapnn art ahaorbtd nn portkuiatea and may ba vnlatiUtad or for particulate* mUhle a< room temperature. * ample: Coke mrm imimtow*. *Any atncto'uaa dual rmpirator (with ar without *iN oat apeciAcally laatad again* a aperifled cnr.teminaat. *8laglt*uar duaf mpiratme have hatn trated again* aabeatpa and cotton dual and could ba migoed a PP of lt> toe thraa paflioiUin. M>ul OKar Men to a duat irapinMit appwnd by lha atlica dual fat and Modes all type* of medio. that to* both nandrgmdable methane*! type madia and degradabto main* fanpttcnotrd ami toll or nabinaiaa m*4eynfhetto feUmedia (Fm fillar rvfvm to a foma fenpivomr approved bv tbt (tod flime lot. AH typao of mtdia art Madid. Htob-tffirknry fUlar rrtora to a hirh^efflciency particulate mfurater. Tht (Uler muat bt at too* PJ?r efficiency again* OJUoi OOP In bt appiwved. ba atMflnrd. turned on duM or fume filter eflieteocy Ux ftperific mntamment. Ifar gome ard vepnn. a PK alumld only bt loimaH whan puWbhed tew data indicate tht aartridge or canitirr haa adequate enchant efficiency and earner lift tor a epenfir gaa or tapar. to additbm. tha Pf ehnuld not ba appliad in m<r wpr omwiraim that are: (I) Immediately dangmui* in lift. (21 above tha tower tipknee limit, tad (31 nun rye irmat ton whan natog a half-mack. kA paailtoe pfrwniie auppttoda<r rtapiminr eguipprd with a balfcaaah faerptort mav not ho aa ataUe on tha fart aa a full faerptort. Theratine, tha PP renmmnodtd half that Ux a aintlar device equipped with a full faerptort. *A pntolive prrwurr auppltod.air rvopinMnr equipped with t tot! factpierr pnumtoa eye pratedton but ie not appimved Ux u*e in atmnephrrra tmmediuieh* dancemue in life, it it neogiiiard that tha farrptrra trnboga. when a pmitivr prrraunr to maintained. *bmW lw tha lima aa an rCIIA nprraltd in the pnaitive prrwmrr mode. Kow.wrr. in nophaMir that it haairaOy to mi tor mu nr wry uw. the Pf to limited to jm. Tha Aiipi pt the wpHtod-air hid. uii. nr hfimrt (with a minimum nf 170 litara/min of air) may drtermine ila orerali rtfirirocy and pruterl mm. fix taamoto. whrn working wu h t he anaa orrr the bail omit hnd draw the nmtaminant intu rhe 'nd hmtrhinc are. Thia owy be vrmwoehy wroringaahnrt hood under a rtwi nroveruMo. Jttaer limit4nnietfird by the egmey muat hr mneidrrwd Iwfnre wine in renin a typno <4 eim*wphrec. TV SCUA ttfwralfd in thr pnutire prewuit mode haa been tested net a aetorted .11 mao panel and thr farrptorr Irekngr rrcnedrdaa <0.01*7 pmatratimt. '.Vrrtorr, a PKof lOOtte to rtremmindril. At thia lima, tha towrr limit of dried too 0.0V; dnao not wormnt liMiog a . higher nmh r. A pwilive premier SCUA Ux an t|nknnwn onrewntim to irewmended. 21da to wieutwt with the 10l** chat in Itoted. Il toewanttol in hare an rmentrnre tow* tor out hi unknown fimmumtinoa. A cumbmaiion ip|4ird*nir fr^fHoinr in prriurw demand or a'her prattler prr*uvr mode, with eiitilianr nrtf-rrmUined me aupptr. a atoa irmmmenrirtl tor ant in unimman cnnrmtrattona id contaminant immrtliatrly ilancemun la fito. Other liimatiuna. nurh aa akin abaorpthm of HCN ur tntiuok. ovuat bt mmaidered. GAF 15824 s The Respirator Selection Table, if OSHA follows its past practice, will be constructed using the NIOSH/OSHA Respirator Decision Logic which incorporates the Protection Factor (PF) concept and table proposed by Hyatt. Since the publication of the PF document in 1975, further research in the area of respirator PFs has been carried on, principally at LASL. A review of this later data indicates a need to revise some aspects of Mr. Hyatt's PF Table. For example, some of Hyatt's recommendations were analogies based on test data for devices which were assumed to act in a similar way. Hyatt stressed that when additional data becomes available his PF table should be modified. A summary of the modifications proposed are given in Table II. Table II PROTECTION FACTORS FOR RESPIRATORS For Routine Pse Air Purifying Respirators For Particulates Respirator Fit Testing Qualitative Quantitative Half Mask Full Facepiece Use High Efficiency Filters only Use High Efficienty Filters only For Gases anf Vapors Lifetime of the cartridge or canister must be specified. Half Mask Full Facepiece Powered Air Purifying Atmosphere-Supplying Respirators 10 50 10 50 2000 50 500 50 500 Continuous Flow, Half or Full Facepiece with belt mounted regulator valve, minimum air flow of 4 CFM 1000 Continuous Flow, Hood or Helmet with belt mounted regulator valve, minimum air flow of 6 CFM 1000 Pressure-demand, Half or Full Facepiece 2000 Self-Contained Breathing Apparatus Pressure-Demand Mode 10000 6 A comparison of tables I and II reveals several differences: 1* All Hyatt's PF data was obtained using male subjects. Later PF test data from LASL using both female and male subjects reveals some differences from Hyatt's recommend ations. the results are in reasonable agreement with Hyatts PFs for larger faces (predominately male test sub jects) . Lower PFs were obtained for the smaller faces (predominately female test subjects). Careful fitting is required to enable women to achieve the PFs given. 2. Table IX specifies only high efficiency filters for air-purifying respirators. Some dust filters use a resin felt which degrades when exposed the high temperature and/or heat. Considering the need for assured protection from carcinogens, the use of such dust filters is not recommended. 3. A serious problem with the use of odor as a warning property is the dependence upon the human nose, which is highly variable in its ability to detect odors. A brief exposure to a high concentration of same materials may anesthetize the olfactory bulbs for a period of time, this reduces the chances of detecting the concentration coming through the cartrida. It is recommended that finite use times.be established for all sorption cartridges and canisters instead of relying on the sense of smell as the end of life indicator. 4. Under Atmosphere-Supplying Respirators the Demand Mode category has been omitted. Recent data published by Hack? indicates that the protection provided by these devices is poor. Since both Contineous-Flow and PressureDemand Respirators are available as replacements, the amission of these devices should not be missed. 5. the PFs for Continuous-Flow Respirators, both tight fitting and loose fitting has been reduced from 2000 to 1000. Data published by Hack? and Douglas? indicates the need for this reduction. 6. The PF for Atmosphere-Supplying Pressure-Demand Half Mask Respirator has been raised from lOffO to 2000 based on Hack's? data. GAF 15825 7 7. The category of Atmosphere-Supplying Continlfcous-Flow Suit has been omitted. The present design of two piece suits provides poor protection under common conditions of use. Such a suit should not be used without prior quantatitive fit testing. 8. The category of Demand Mode Self Contained Breathing Apparatus (SCBA) has been omitted. Based on the data ob tained by Hack3 when testing Atmosphere-Supplying Respira tors, the poor PF provided by Demand Mode SCBA should not be high enough to warrant their use. 9. A column designating PFs for Half and Full Facepiece Respirators when quantitative fit testing is carried out has been added. They are identical with the PFs advocated by Hyatt for quantitative fit testing. A procedure to be followed for quantitative fit testing is now being prepared by Dr. John O'Neill, OSHA. The NIOSH/OSHA Respirator Decision Logic provides a good basis for devising respirator selection tables for specific chemicals. The above suggestions will improve that process. 1 would recommend, if it has not already been done so, that the Decision Logic be made part of the record of this hearing. Respirator Fitting Changes affecting the respirator selection have been suggested above. After the respirator has been selected, 1910.134 specifies a series of steps to be taken to insure that the respirator user is familiar with the respirator and that it will be used properly. The series of steps is sparsely out lined and needs some additions to insure that the employee who is to be exposed to carcinogen will have the protection necessary. 1910.134 (e)(5) specifies:, "Training shall provide the men an opportunity to handle the respirator, have it fitted pro perly, test its face-piece-to-face seal, wear it in normal air for a long familiarity period, and finally to wear it in a test atmosphere." Of importance to the protection provided the user is the test of the respirator faceseal. PF data refered to previously shows that smaller faces, primarily female, have a more dif ficult time obtaining a good seal than do larger faces. The qualitative tests usually prescribe for this purpose is an isoamyl acetate or irritant fume test which consists of 8 holding a isoamyl acetate saturated cloth close to the faceseal or blowing irritant fume near the faceseal. The importance of obtaining protection when exposed to carcinogen makes it necessary to improve the isoamyl acetate test that is used. This test should be done only after the subjects ability to detect isoamyl acetate at a level of 2 parts per million (ppm) has been determined. The isoamyl acetate test should be done in a hood or room into which sufficient isoamyl acetate to produce a concentration of 100 ppm. A series of exercises which stretch the head and neck up, down and sideways should be performed while in the isoamyl atmosphere. The fit test is not satisfactory if the subject detects isoamyl acetate. Respirator Programs Respirator programs require a continual committment in management time and money to be successful. The necessity of cleaning and maintaining respirators requires an estimated addition of 2 employees for every 100 employees using res pirators. This does not include the manpower necessary to insure that the user is initially trained and fitted with a respirator. Additional demands upon management include the necessity of frequent review of the workplace. If atmosphere-supplying respirators are used, monitoring the air supplied to the user is necessary. As the PEL decreases the problems arising from contamination of the air will be necessary prior to delivery to the user of the air line respirator. This can be a costly process. The obligation of supplying, fitting, maintaining and cleaning respirators should be on the employer. The average employee does not have the training or facilities to properly carryout these tasks. To provide guidance on these matters and a good respirator program generally, OSSA should consider publishing model programs for employers of various sizes. OAF 15826 -9 - References 1. E. C. Hyatt, "Respirator Protection Factors," LA-6084-MS, September, 1975, Los Alamos Scientific Laboratory 2. A. L. Hack, O. D. Bradley, A. Trujillo. "Respirator Studies for the Nuclear Regulatory Commission, October 1, 1976, through September 30, 1977, Protection for SuppliedAir Respirators," LA-7098-PR, January 1978, Los Alamos Scientific Laboratory. 3. D. D. Douglas, P. R. Hesch, P. L. Lowry, "Supplied-A Hood Report," LA-NUREG-6612-MS, December, 1967, Los Alam. Scientific Laboratory. 4. T. 0. Davis, 0. D. Bradley, A. Trujillo, D. D. Douglas, "Respirator Studies for the DOE Division of Operational and Environmental Safety, October 1, 1976 through September 30, 1977, " LA-6969-PR, To be published, Los Alamos Scientific Laboratory. (1092A) Curriculum Vitae Darrel D. Douglas March 10, 1978 Birth: December 8, 1930, Sidney, Montana. Bene Address: 117 Beryl, Los Alamos, New Mexico, 87544. Business Address: Los Alamos Scientific Laboratory PO Box 1663, MS-986, Los Alamos, New Mexico, 87545 Telephone: Business, 1-505-667-7342 Hone, ' 1-505-672-1563 Education: 1. BS in Civil Engineering, University of Washington, 1954 2. Continuing education courses in noise, ventilation, heat stress, health physics, epidemiology, human anatomy and physiology, and management. Employment, Industrial Hygiene: 1. Industrial Hygiene Engineer, Los Angeles City Health Department, 1954-1955, 1955-1957 2. Industrial Hygiene Engineer, Boeing Company, 1957-1960 3. Industrial Hygiene Engineer, University of Washington, 1960-1961 4. Chief Industrial Hygiene Engineer, Oregon State Board of Health, 1961-1971 5. Director, Occupational Health, Oregon State Board of Health, 1971-1974 6. Assistant Professor of Environmental Medicine, Univ ersity of Oregon Medical School, 1965-1974 7. Industrial Hygiene Engineer, Los Alamos Scientific Lab oratory, 1974-1975 8. Leader, Respirator Research and Development Section, Los Alamos Scientific Laboratory, 1975-Present gap 15827 2 Licenses: 1. Registered Professional Engineer, State of Oregon, July, 1962 2. Certified in the Comprehensive Practice of Industrial Hygiene, July, 1965. Professional Societies: 1. American Industrial Hygiene Association, member since 1957. 2. American Conference of Governmental Industrial Hygien ists, member since 1964. Member, Board of Directors, 1971-1978, Chairman of Conference, 1976-1977. Publications: 1. Douglas, D.D., "Mercury Poisoning," Oregon State Health Bulletin, 1966. 2. Douglas, D. D., "Industrial Audiometrie Testing in Oregon," National Safety News, 1973. 3. Morton, W. E., Crawford, E. D., Mar ids, R. A., Douglas, D. D., Freed, V. H., "Hypertension in Oregon PesticideFormulation Workers," Journal of Occupational Medicine, March 197S, Volume 17, No. 3 4. Douglas, D.D., "Respirator Studies for the Nuclear Reg ulatory Commission, July 1, 1974 - June 30, 1975, LA-NUREG-6427-PR, Los Alamos Scientific Laboratory. 5. Douglas, D.D., Revoir, W.H., Pritchard, J.A., Hack, A.L. Geoffrion, L.A., Davis, T.O., Lowry, P.L., Richards, C.P., Wheat, L.D., Bustos, J.M., Hesch, P.R., "Res piratory Studies of the National Institute for Occu pational Safety and Health," July 1, 1974 - June 30, 1975, LA-6386-PR, LASL. 6. Douglas, D.D., Back, A.L., Davis, T.O., Shafer, C., Moore, T.O., Richards, C.P., Revoir, W.H., "Respirator Studies for Energy Research and Development Administra tion, Division of Safety, Standards, and Compliance," July 1, 1974 -June 30, 1975, LA-6426-PR, LASL. 7. Douglas, D.D., Hack, A.L., Held, B.J., Revoir W.H., "Energy Research and Development Adm.nistration Division of Safety Standards, and Compliance Respirator Manual," LA-6370-M, 1976, LASL. 3 8. Douglas, D.D., Hesch, P.R., Cowry, P.L., "Supplied-Air Hoods Report," LA-NUREG--6612-MS, 1976, LASL. 9. Lowry, P.L., Hack, A.L., Yasuda, S.K., Wheat, L.D., Bustos, J.M., Douglas, D.D., "Respirator Studies Cor the National Institute Cor Occupational SaCety and Health," July 1, 1975 - June 30, 1976, LA-6722-PR, LASL. 10. Hack, A.L., GeoCCrion, L.A., Douglas, D.D., "Respirator Evaluation Dsing Anthropometric Test Panels," to be pub lished in the American Industrial Hygiene Association Journal. GAF 15828