Document RaG9DL84jza3gz3jk94pp6mDE

SfATB Of CAU7Q9MA-.H9AUH ANQ WItUW AQIMCY DEPARTMENT OP HEALTH OCCUPATIONAL HfALTH lUAVIILLANCI AND EVALUATION PflOOftAM (ONACP) *151 SfAKELIY WAV. NOON 04 OCBAElir. CA 94704 (419)940414) SERVICES AM&x3 OlOOt MUKMOJIAN. August 22, 1988 VIA, FACSIMILE Roger 8emste1n Director of State Government Affairs Society of the Plastics Industry, Inc. 1275 K Street* NW Suite 400 Washington, DC 20005 Dear Mr. Bernstein: Enclosed Is the revised protocol for the Plastic Pipe Worker Exposure Study. This draft (#3) of the protocol Includes changes agreed upon by all parties at our August 10th meeting. All changes made since draft #2, distributed August .LOth, are marked. At the August 10th meeting, all parties, agreed that the proposed revisions had been addressed satisfactorily* In addition,, all agreed that monitoring would begin*as soon ar the accepted revisions had been Incorporated Into the study protocol and reviewed by the California Department of Housing and Community Development, the California Pipe Trades Council, and the Society of the Plastics Industry, Inc. Consequently, we Intend to begin monitoring at plastic pipe Installation sites on Thursday, August 25th, unless we are notified of substantial discrepancies between the current protocol* and the agreements reached on August 10th. We must receive any such notification by 3:00 p.m., Wednesday, August 24th. Following is a brief summary of revisions to the protocol made between draft #2 (8/10/88) and draft #3(8/22/88). Page references are to draft #3. pTf, para 2 Work practices for installation of CPVC and PVC are similar only r when similar-sized pipes are compared. p 5, para 2 Evaluation of CPVC exposures may be done at out-of-state sites. p 6, para 2 Installation of PVC waste lines will not be used to assess Installation of CPVC water-supply piping. p 6, para 4 Most monitoring will be done In the ten California counties with the most new residential construction in 1980. Both hot days and cooler days are very likely to be Included In the monitoring. No additional steps will be taken to target hot days for monitoring. 21319001 BFG12918 08/23/1988 09:29 ESSS PANAFAX UF-600 **** 2 415 540 2908 P.02 p 7, para 2 Installation of PVC waste lines may be monitored to assess the exposures that could arise when CPVC water lines are Installed concurrently. p 8, para 3 Bulk samples of each primer and cement used at each site will be collected. Products not listed by NSF for potable water use will be noted. p 8, para 4 Samples will be kept cooled to minimize any possible changes to the substances of Interest. p 8, para S Photographs of working conditions will be taken. p 9, para 2 When necessary for logistical reasons, monitoring for DMF and for the oxygenated solvents MEK, THF, and cyclohexanone will be split between workers or between sampling days, p 9, para 4 Urinary DMF will be measured as an Index of contamination. p 11, para 3 Further explanation and justification of the sampling scheme for MEK, THF, and cyclohexanone. p 13, para 2 For category Illb exposures, there will be no limit on the number of samples to be collected per worker-day. When six or more periods of*category Illb exposure are anticipated, every-other period will be monitored. p 15, par* + For GC/MS analysis of PB decomposition products^ EPA Priority Pollutants and ten additional substances will be Identified. p 16, para. 1 For SC/MS analysis of flux decomposition products, a medium capable of collecting particulates will be used. EPA Priority Pollutants and ten additional substances will be Identified. p 16,. para 2 Lead (Pb) will be included In monitoring of solder fumes. p 16, para 5 Laboratory quality assurance will be*done for solvent samples only. For. MEK, THF, and cyclohexanone, samples will be spiked with all three substances. p 17, para 1-3 Exposure limits are now Included In the protocol, as Table 2. All exposure limits are taken from accepted values established by other agencies. The exposure limit for antimony may not protect against its possible carcinogenicity. p 17, para 4 IARC category 28 carcinogens included in list of exposures that could trigger recommendations for follow-up study. p 20, para 7 For MEK, THF, and cyclohexanone, the distribution of 15-minute exposures will be characterized and the percentage of days In which any short-term exposure limit Is exceeded will be estimated. 21319002 BFG12919 08/23/1988 09-' 30 ESSS PANAFAX UP-600 **** 3- 415 540 2903 P.03 page 22 References added. The Issue of monitoring exhaled breath for presence of solvents was again raised by the California Pipe Trades Council in a letter we received on August 15, 1988. After careful reconsideration, we have again decided that monitoring of exhaled breath would not be appropriate for this study. This decision was made in consultation with Jon Rosenberg, M.D. (member of ACGIH BEI committee), Stephen Rappaport, Ph.D. (actively engaged In exhalad-breath monitoring research), and Mitch Singal, M.D., Chief, Medical Section, Division of Surveillance, hazard Evaluation and Field Studies, NIOSN, The principal reasons for this decision are as follows: 1. Lack of Pharmacokinetic Information There Is limited information on exhaled air monitoring for MEK; there is none for cyclohexanone and THF. Minimal information necessary for biological monitoring Includes human pharmacokinetics (relationship between external and biological levels) and/or toxicodynamics (relationship between systemic toxicity and biological levels). There Is limited Information on the human pharmacokinetics of MEK; there is none for cyclohexanone and THF. There is no Information on the toxicodynamics for any of the three. The limited Information on pharmacokinetics for MEK is based on inhalation, exposure only. Dermal kinetics, particularly the time course of dermal absorption, are unknown4for MEK (as well as THF and cyclohexanone). For many chemicals a significant delay occurs between exposure to the skin and absorption and' appearance in blood and exhaled air. The appropriate time to sample exhaled air following a "short-term dermal exposure" has not been established by any field or laboratory studies. Short-term exposure limits for ambient air have been established for some substances, and short-term exposure monitoring 1st appropriate to assess such exposures. 2w..Lack of Toxicological Significance The TLV and STEL for MEK are based on its strong and objectionable odor and Irritant properties. These are contact effects and are not directly related to absorption and systemic effects. Although data are extremely limited, MEK seems to be much less potent as a general anesthetic (nervous system depressant) than as an odorant/irritant. This Is** particularly true for short-term exposures. It seems extraordinarily unlikely for CNS depression to occur as a result of short-term dermal exposure. Comparing short-term dermal exposure levels gained from exhaled air monitoring to the STEL would be inappropriate' since the STEL Is based on odor and on eye, nose and throat irritation, which do not occur as a result of dermal absorption. In fact, the BEI Committee has been questioned for recommending BEIa for any substance whose TLV is based on Irritation. Even less is known about the toxicological significance of dermal absorption of cyclohexanone and THF. Exhaled air concentrations of cyclohexanone and THF could neither be used to measure absorbed dose or to estimate risk of any health effects from short-term exposures. In his letter of August 12, 1988 Dr. Cox stated that "air and urine sampling will underestimate the seriousness and extent of dermal exposure to MEK, THr BFG12920 S006TCTZ n 08/23/1388 09:31 ESSS PPNflFAX UF-600 **** -4- 415 540 2903 P.04 and cyclohexanone." While It 1$ possible that air and urine sampling may underestimate the extent of dermal exposure In some situations* we believe that exhaled breath monitoring would add little to our knowledge of the risk from those exposures. 3* Feasibility of Measurement Exhaled breath monitoring has significant potential as an exposure assessment tool, but accurate, reliable testing methods have not yet been established. For most chemicals, Including MEK, THF, and cyclohexanone, further research is necessary before exhaled breath monitoring could be used for field studies of workplace exposures. For example, Or. Cox has recommended the method developed by Or. Michael Morgan. Unfortunately, the published report by Or. Morgan describes laboratory studies only, with no reference to field monitoring. Further, only exposures to toluene, not MEK, THF, or cyclohexanone were monitored in Dr. Morgan's study. Collection of MEK, THF, and cyclohexanone from humid exhaled breath samples poses additional problems. From laboratory to field Is a large leap, and the validity of a test system must be established with detailed workplace studies before the test can be applied to routine field monitoring. Such validation has not been done for exhaled breath monitoring of MEK, THF, or cyclohexanone. 4. Reference to BEIs Dr. Cox's letter stated that the study team has misinterpreted the ACGIH BEI Committee. Dr. Rosenberg, a member of the study team, Is a founding member of that committee', along with Dr. Thomas and Or. Lowry; with whom. Dr. Cox discussed these Issues. Dr. Cox cites Dr. Thomas as explaining that "testing both-1$ preferable to testing only one. While it Is often true, that two tests are-better than one, assuming both are valid, the Issues remain: Is there -sufficient Information to make exhaled air a valid measure of exposure? And does performing these tests add sufficient Information to justify the effort? To the first, the answer Is maybe for MEK, no for cyclohexanone and THF, and to the. second no for all three solvents. Dr. Cox stated that "the Committee did not wish to discourage other types of monitoring." The BEI Committee neither encourages nor discourages any type of biological monitoring. The activities of the Committee are confined to reviewing avellable Information to support a reference value to be used for monitoring, and to recommend such values. The lack of a BEI for a substance Is based on a determination that the Information available Is Insufficient to support a recommended value. When there is insufficient Information to recommend a value, this means that the results of monitoring cannot be compared to a reference value. In other words, the monitoring could produce results, but those results could not be adequately interpreted. In summary, in reviewing the available Information on MEK, cyclohexanone, and THF, the study team determined that there was limited Information on the kinetics of exhaled air for MEK and none for cyclohexanone and THF. There Is no toxicological basis to support biological monitoring for wy of these substances, although a decision was made to perform end-of-shlft urine monitoring on the basis of the BEI for MEK. In reviewing the avellable BFG12921 08/23/1988 09:31 ESSS PANfiFAX UF-600 **** -5- 415 540 2906 P.05 informatlon, we determined that the amount of additional Information gained from exhaled air monitoring for MEK would be extremely limited and did not justify Its Inclusion In the protocol. Thank you for considering these revisions to the study protocol; we believe that it addresses all substantive concerns that have been raised. Please contact Mr. Bellows Immediately If you have any questions about the protocol or the current revisions. LR/J8:mk cc: Bill Holliman Robert Kinderer, Ph.O S006TETZ BFG12922 08^23/1988 09* 32 ESSS PANAFftX UF-S00 **** 415 540 2908 P.06 URAFTI^ Protocol: Plastic Pipe Worker Exposure Study for discussion purposes only ST7MKA&Y To evaluate tho exposure to potentially hazardous substances experienced by plumbers during installation of chlorinated polyvinylchloride (CPVC), polybutylene (PB), and copper pipes for potable water supply, workplace air monitoring end biological monitoring will be conducted at representative construction sites. Installation of CPVC for water supply is rare In California, so monitoring will also be conducted during Installation of similar CPVC or polyvinylchloride (PVC) piping systems. Exposures associated with installation of CPVC/FVC pipe will bs monitored during at least 16 work days at a minimum, of . twelve construction sites. Exposures- to. dimethyl foraaaide' (DM7)methyl et3iyi^;:...rT:>r. ketone (MEK), tetrahydrofuran <THF), and cyclohexanone will be assessed for each worker installing CPVC/FVC pipe at each* site/- if possible; : ;:i.: I'rr- approximately 32 worker-days of monitoring are anticipated. Exposures to vapors of MEK, THP, and cyclohexanone will be characterized by . . ______ _______ ___ analyzing approximately five representative 13-minute air samples per ~ shift for each worker monitored, with high-exposure periods monitored--' - ~ - more frequently chan low-exposure periods. Detailed records of work activities throughout the day will be maintained, end during each'; 15- minute air seopling period, faotore that may affect'bXpbsur^-bijdir.*'aa. ' temperature and air flow--will be assessed. Standard statistical techniques will be used to estimate .the percentage of l5.-ninute expoeuxe.-- ^ _-- .-- .. periods in which the short-term exposure limit, la likeiy to be exceedecL ,,- ', for each substance and for the. additive effects of the three sub*canoes. '-"T ~ ' Factors that contribute significantly to high exposure levels.will be - Identified. The average 8-hour time-weighted average (TWA) exposure ... level associated with installation of CPVC/PVG pipewill be calculated *j\. for each substance, baaed on the 15-minute monitoring data and work activity records; the percentage of exposures likely to-exceed the. 8- ....... hour TWA exposure limits, will also be calculated. Tikis method is btlleved to provide the best estimates of exposure levels under a wide range of working conditions. At CPVC/FVC installation sites where the primers and oements used contain DM7; additional air monitoring and biological monitoring will be included, full-shift air samples will be used to evaluate exposure to airborne 18(7. End-of-shift urine samples will be collected to evaluate total exposure (from both inhalation and dermal absorption) and to asaass the importance of-skin contact with DM7-containing, products - The ond-of-shift urine samples--together with 4-hour HER samples for these workers--vlll also be used to evaluate total exposure and the contribution of dermal absorption for MEK. In order to evaluate any cumulative effeots of installing both CPVC/FVC and eorylonitrile-butadiene-styrene (ABS) pipe during a single fO h* Cl) g O BFG12923 tn 08/23/1988 09:32 ES3S PANAFAX UF-600 **** 415 540 29e8 P.07 DRAFT 0$; August 22, 1966 work dey or week, exposures to MEK, THF, cyclohexanone, and DMF will also be monitored at five ABS installation sites, using similar methods. For CPVC/PVC worksites at which pre-fabricated assemblies are used, exposures to CPVC/FVC dust at the prefabrication areas will be evaluated. For PB pipes held eogether with crimped mechanical joints, no potential for exposure to toxic substances during Installation was identified during walk*through Inspections of two worksites; therefore, no monitoring is planned. For PB pipes joined by thermal fusion, the potential for significant exposure seemed low during one walk-through Inspection. No systematic sampling is planned, but air samples will be collected at a minimum of two sites, and the ten substances present in highest concentration will be identified for each. Tp evaluate the exposures chat occur during installation of .copper pipe, monitoring will be conducted'during at least Wh days* at a minimum- of 8 sites. Full-shift air samples will be collected for several workers at each site (a total, of approximately 30 samples)-,, end-analyzed. . . .. for presence of antimony, tin, oopper, silver, and other metals which may be released during brazing. Using standard statistical techniques, the average exposure level end the percentage of work days during' which overexposure is likely to- occur will.be calculated for eact^ substances. * '**----* To evaluate exposures chat may be produced by thermal decomposition of eoaaeon. animal-fst fluxaar^sir samples, will, be- collected at: a.minima of.-, -. ^ tvo~aites and the ten- substance* present lxr highest: concentrstion >^U- :i_^-^ be identified. 21319C07 Protocol: Plastic Pipe Worker Exposure Study BFG12924 Page 2 08/23/1988 08:33 ESS3 PANPFAX UF-600 **** 415 540 2808 ?.08 DRAFT #3; Angusc 22, 1988 INTRODUCTION Newly-built housing units currently havo as many as six separate piping systems installsd. Ths two systems common to every unit are potable water supply and drain, waste, and vent (DWV). Other plumbing systems nay be also be required by the developer or buyer, or by local ordinance; these systems are for: natural gas, draining air conditioners and clothes-washer overflow, fire sprinklers, and garden sprinklers. The State of California is currently considering regulatory changes that would allow use of plastic pipe made from CPVC or PB for distribution of water within homes; currently, copper pipe is the only approved, commonly"used materiel. Galvanized steel pipe, while approved for water supply, is raraly used in new construction. The gosl of this study is to assess the work-relstsd health hazards essoolated with installation of three types of water'supply pipe: CPVC, PB, and copper. Although the hazards associated other piping^ materials and with other piping systems ere not themselves the* focus*bfrthis' "vV'T"r'i"-: study, installation of some other systems will also be evaluated for two reaaons: First, a plumber who installs water supply on. one day is. likely te be assigned to work on DWV or other piping on- subsequent days, so consideration must be given to cumulative exposures. Second, because CPVC is not approved or installed for water supply Tn moat of* " ........ California, an adequate number of construction sites is-not- available* for monitoring; therefore, information about patterns of exposure in similar, installations wlll.be used-to help.characterize- the. exposures.----- expected due to CPVC work; For example, selected installationsof;-. smell-diameter FVC pipes may be monitored because similar materials and work, practices are used. . .. The results of the monitoring conducted in this study.-will`be used eo characterize the exposure associated with installation o,CFVC/FVC*. PB, an copper pipe, and could be used to assess the likelihood that workers will, experience any associated adverse health affects from these exposures. However, no assessment of health status or health* effects will be performed. ; 8006TET Protocol; Plastic Pips Worker exposure Study BFG12925 Page 3 08/23/1988 09:33 ESSS PfiNAFAX UF-680 **** 415 540 2908 P.09 DRAFT #3; August 22, 2333 SITS SELECTION The fundamental goal of any selection scheme Is Co direct monitoring to sites that are both representative of normal working conditions ond~- at the sane time--diverse enough to include a broad range of conditions. In addition, a balance must be struck between using Che available monitoring period to monitor a largo number of sites, or to return repeatedly to a smaller number of sices, gathering information about the variability of exposures that occurs day-to-day at single site. For this study, several characteristics of the construction industry Impose limitations on the methods that can feasibly be used to select monitoring sites. The best available selection methods are described below, for each type of site to be evaluated. In this protocol, the term "site" refers to a construction site at which a given type of installation is monitored. At a single construction site, more than one type of Installation may be monitored (for example, both copper-water-supply-and AM waste-lines), -and*would." -- be considered as a separate site for each type- of installation*. For each day at eaoh site, the exposurss of all workers engaged in the type of installation selected will be monitored, If feasible. The average number of workers monitored at each CpVC/PVC installation site la expected to be approximately two; the- average number of plumbers to be monitored at each copper installation site is expectsd to be approximately three. -so-.: o-.v-;--* The minimum number of sites to be monitored, and the approximate number, of samples of eech. type that are to.be.collected, are...summerlaeg in Table 1 below. 21319009 Protocol: Plastic Pipe Worker Exposure Study BFG12926 Pago 4 08/23/1938 09:41 ESSS PANRFAX UF-S00 **** ) i 415 540 2908 P.ai DRAFT *3; August: 22, 1988 Table 1, Minimum number of sites and site-days to be monitored, end the approximate number of samples to be collected, for each type of pipe installation. Inatallafijgn Sites/Slta-foys Sample CPVG PrPE CFVC/PVC sites water supply 2/ A PBhtr.-----------------------------mil total 12/16 Semples by typet DHF, full-shift ocher solvents, short-term urine samples for DMF. KE& MEK. 4-hour CPVC/PVC dust 20 . 150 23 23 8 MS sites 5/ 5 Samples by type: DMF. full-shift ' other solvents, short-term urine samples for-DM7, MEK MKK, 4-hour . v r,y 'J 'Hkmfc l PE thermal. fusion !: .-*w >. 2/ 2 CORSE FIFE s/10 Semples by type: solder fumesflux fumes .* 30: ""5*' 5 rrr -v~ r '2 * . t: , * 30 2 .CtVC/ZVdsifs i ' The fact that CpVC is not currently approved for potable-water distribution by the State- of California makes difficult- the.--- - identification of CPVC water-supply installations to be monitored. In the planning of this study, plumbing inspectors (or other building department officials) from over 50 California cities were contacted. All reported that CPVC water-supply pipe is either not approved or not Installed in their areas, although several recallsd that it had been installed several years in the past. Thus, much of the evaluation of. CPVC-related exposures will done at sites in other states or at sites 0T06XE7Z vy^rocol: PldBtic Pips Worker Exposure Study BFG12927 Pegs 5 08/23^1988 03:41 ESSS PANAFAX UF-600 **** -US 540 2909 P.02 DRAFT m3; August 22, where CPVC or PVC pip# is being Installed for uses other chan potable water. Specifically, the sices selected for monitoring may include: - installation of PVC garden sprinkler systems, which is substantially similar to installation of undsr-floor CPVC watersupply plumbing; - Installation of CPVC fire sprinkler syeteas or installation of PVC condensate-drain lines, which are substantially similar to top-off of CPVC water-supply plumbing; - plumbing (especially finish work) in CPVC-plumbed mobile homes, which is substantially similar to plumbing In non-mobile CPVC- plumbed homes; - prsfabrlcation of any CPVC or PVC components; and - any other site where CPVC or PVC Is being installed under ' - ' ' conditions that are analogous to any phase of CPVC home plumbing. Sitee other than CPVC water-supply installation will be considered substantially similar to water-supply installation only if pipes of 1.25 inch diameter or lese are being installed, using work practices similar" to those used in residential construction'* This restriction-^'-1- -- intentionally exclude! monitoring of larger-dlamecer PVC waste pipe- for ,,evaluation of the exposures.expected during inatallatio*r o:iGPVChfatr^- ' -supply-systems. v-`4\ ;. * ;.r~r Monitoring will be conducted et a minimum of 12 .sites*, inoluding,.*^.,^.^,,.^^, minimum of two sices of actual CPVC water-supply installacionv the- remainder may be other sites as described above. For at least-two of' ; . 7 - the sites,. including one CPVC water-supply installation, monitoring.will ...Vyv^' . also be conducted on two subsequent days (for the sane workers, if* r* possible), for a total of at least 16 monitoring days (approximately-32. . - worker-days). Of the worker-days monitored, approximately 50% will be representative of top-off plumbing (at installations as described - ----- v above), 30% will be-representative of under-floor work,. 10%-will be finish work, and 10% will be prefabrication. Theae percentages reflect: . eh* approximate proportion of CPVC/FVC installation 10* spent in. each* ' phase during reeidentlal oonstruotlon. 21319011 Because of the difficulty of identifying appropriate sites,, any CPVC' or FVC site, identified by any meane will be considered a oandidace-for-* '*-'*--* monitoring. Suitability for monitoring will be determined by similarity of work praotioe* to those used in residential water-supply plumbing, without regard to perceived exposure levels. The search for CPVC/PVC Sites will be focussed on the ten California counties that had ehs moat new construction activity In 1266 (Los Angeles, Orsnge, San Diego, San Bernardino, Riverside, Contra Costa, Sacramento, Santa Clara, Alameda, and Ventura); these counties are expeoted to have, during the sampling period, a large number of hot days chat are typical of California during ehe construction season, net-be-limited- te-any-partieular-geegraphis - area of-the-scace-er The search will not be limited to either union or non- Pro :o1: Plmsela Pipe Worker SxpoBura Study BFG12928 Page 6 08/23/1988 09:42 E33S PANAFAX UF-600 **** 415 540 2908 P.03 DRAFT #3; August 22, 19B8 union contractor*, doth single-family hone* and multiple resldenees will be included, and at leate one cuseon hone. Exposures associated with installation of plastic (generally ABS but sometimes FVC) DOT systems will be assessed at a minimum of five sites, in order to account for possible cumulative exposure* when Installation of DOT and of CPVC water supply occurs on successive daye. If DOT installation is done concurrently with CPVC/PVC water-supply installation at any of the CPVC/PVC sites monitored, then DOT installation will be monitored at that site, to account for additive exposures when installation of both occurs on the same day. Because many plumbers work In both residential and industrial construction during their careers, one or more Industrial sites may also be evaluated to give limited information about possible cumulative lifetime exposures to the substance* used in plastic pipe installation. ' Polybutylsna Sites .......... ' PB pipe Joints are made with two different methods: crimped mechanical fittings and thermally fused joints. In neither ease ere cements or other substances used to form the Joints. Based on observations during initial walk-through Inspections, no axposuresto" toxle substances are -believed- to result from- mechanical crimpings -*.-**--r determine whether thermal fusion joining creates potentially harmful exposures, air monitoring, will, be-conducted at a minimum-of otML'sita-..t-\i.^>y-wiu^v^ Thermal fusion of FB is uncommon for: water-supply -system* inCalifornia-,so installation of fire sprinklers Is likely to be selected for monitoring. The substances reltased during fire sprinkler installation.___ are believed to be the same: as. those released during water-supply installation, even if the concentration* are different.. COpperSltes . For evaluation of exposures during Installation of copper pipe, monitoring will be conducted at a minimum of 8 sites. For at least-one- of the eltes, monitoring will also be conducted on two subsequent days-,, for a total of ae least 10 monitoring days (approximately 30 workerdays) . In addition, an attempt will be made to monitor at least: one site at which extensive rework In enclosed spaces is required,, if. such work is not included in the sites specified above. Of the plumber-daya monitored, approximately 60% will, be top-off plumbing, 30% wtlT'be under'*floor work, and 10% will be prefabrication. These percentage* reflect the approximate proportion of copper pipe installation time spene in each phase. . The sites selected for monitoring will include various geographic areas, both single-family and multiple units, and at least one custom home. At least 35% of the sites will be union sit** and at least 35% non-union. CT06T6TZ Protocol; Plsstic Pipe Worker Exposure Study BFG12929 Fags 7 r 08/23/1988 09:43 ESSS PANftFAX UF-600 **** 415 540 2908 P.04 DRAFT #3; Auguse 22, 1988 EXPOSURE MONITORING Owners1 For each alto ac which monitoring 1* conducted, the following information about the site will be collected: the number of homes to be built, the size of the homes, the number of plumbers on the site and their jobs, and the approximate amount of time required to complete each phase of the plumbing, A form for recording thiJ Information will be developed. Workers whose exposures are monitored will be interviewed to determine: their training, usual work practices, usual Job assignments, use of personal protective equipment, any health effects experienced during the day of monitoring, and any observations about unusual conditions on the day of monitoring. Workers' age, sex, and English proficiency will also be determined. Workers not monitored may also,be Interviewed. A fora for* recording the information will be developed*; Job task data, such as the number of joints glued in s day and the number glued in enclosed spaces, will also be collected for the individuals monitored. A reoord will be made of all materials used in the Installation monitored, and of the various-piping materials uaed on ths- slts. - For- sitss at which CPVC/FVC or ABS installations ars monitored, each primer ----- and-cement used will be noted, and Information about: product? formulations , will.be obtained from the. manufacturer or from the NationaL Sanitation Foundation (N87). Use of primers or cements that are not listed* with NSP for potable water will noted. Bulk samples of each, primer and. . . cement used at. each site, will;be. collected,- The most commonly used^- - . produet*aey-be~elleefcedi.~endwLll. be- analyzed to determine the* concentrations of major constituents. Manufacturers work practice- ^Vvr. -.. 3 recommendations will be noted from product containiets. ^ - ~r'/tr Flow rates of pumps used to colleot air samples will be calibrated periodically to ensure accurate knowledge of sample volume. For lowflow/ - *'* pumpe with stroke counters, calibration will be checked at least once- per week against a primary standard. Other air ssmpling ..equipment- including high-flow pumps and flow regulators--will be calibrated at lease at tha beginning and end of each sample collection period with a calibrated rotameter. Each full-shift air sample will be collected over, a period of at least seven hours or will Include ell exposure- periods, for the day; work periods will be accepted aa no-exposure-periods only ;j- If worker activities are directly observed by e member of the study team. Air samples to be analyzed for organic solvents will be frozen as soon as possible after collection, shipped on ice to the laboratory, and kapt frosen until they are analyzed. Urine samples will also be kept refrigerated or frozen. sm roG Tt z Whenever possible, photographs will be taken to document the working conditions at the sites monitored. In particular, circumstances such as spills, enclosed spaces, and unusual work practices will be photographed, Eaoh monitoring days' maximum temperature will be measured (in the shade) between 2;00 and 4:00 pm. BFG12930 Pina Worker Exposure Study Pag# 8 08/23/1988 09:43 ESSS PANftEAX UF-600 **** 415 540 2908 P.05 DRAFT #3; August 22, 19$$ Chlorinated Polyvinylchloride Pip* Several potential exposures have been identified by previous studies of plumbers installing PVC pipe, using materials and work practices similar to chose required for GFVC. The most significant exposures are: DMF, che oxygenated solvents MEK, THF, and cyclohexanone, and dusts of the saved polymer. Residual vinyl chloride monomer and phthalate plasticizers have not been detected during exposure monitoring of plumbers installing FVC pipe, and are not included in this study. Sample collection and analytical methods to be used for each substance are described below. At sices where worker exposures to both DMP and the oxygenated solvents MEK, THF, and cyclohexanone are to be monitored, and where four or more workers are performing the installation of Interest, approximately half the workers will be monitored for DMF exposure while the others are monitored for exposure to the oxygenated solvents. At sites where three or fewer workers are performing the Installation- of ' Interest, then monitoring for DMF and the oxygenacod solvents may be conducted on separate days, if simultaneous monitoring for both proves to be Impractical. '-- Dimethyl formaalde At each site selected for monitoring; CFVC, FVC, or ABS installation, presence of DMF in any of. che cements or primers tobe used-will be .established by measuring the. DMF vapor concentration, ih the headspace, of '; ~ a can Immediately after opening. The meesurement will be made with a DMF.detector tube (Draeger 10/b) with a detection limit of .10 ppm;. DMF , concentrations In the cement as low. as 1% by weight would produce vapor* `concentrations detectable by this method.1 .. .. . 'At. each site where DMF Is detected in any of tha materials to "be-used,. DMF exposure will be assessed for eaoh worker included.'ln> thestudy. In addition, DMF exposure will be assessed for at least three workers using materials with no detected DMF. Exposure' to. airborne DMF will be measured with full-shift air. samples according to HXOSK Method ^ 2004, with collection on. silica-gel and analysis, by gas chromatography. Because DMF is readily absorbed- through the skin, air concentrations alone may not adequately reflect total exposures. Therefore, total exposure (Inhalation plus skin absorption) will be assessed by measuring monomethyl formeaide (MMF) in urine. Urine will be oollected and- MMF analysed according to methods specified In the ACGXH Biological Exposure Index (BB2) for DMF; urine creatinine will also be measured.* Umetabollzod DMF in urine will also be determined ae a measure of gross contamination of the urine samples, since this substance is present only at very low levels even in highly exposed workers. The time of previous void before urine collection will be noted. The minimum- number of samples to be collected cannot be determined In advance, since the proportion of worksites with DMF present Is not known. Monitoring for DMF may be discontinued after air and urine samples have been collected for 20 worker'days. BFG12931 Protocol: Plastic Pipa Worker Exposure Study Page 9 kT06TST2 08/23/1988 09:44 ESSS PANAFAX UF-600 **** 415 540 2909 P.06 DRAFT m3; August 22, 1998 For each worker included in biological monitoring, the extant of contact batwaan workers1 skin and Che primers and cements used will be qualitatively assessed, and ranked on a three-level scale: LflXftl_____Definition _ _ _______ __ Light skin contact less than 25 cm2 (approximately one finger) at any time, OR skin contact less than 10 times par day Heavy skin contact 25*100 cm2, more than 10 times per day, OR skin contact greater than 100 cm2 (whole hand, one side) at any time Gloves cotton or leather gloves worn during at.least 50% of joints . glued. Because DM? is primarily a systemic toxicant, short-term level's of DM7 exposure will not be measured. Oxygenated Solvents - General Approach <" For the oxygenated solvents MEK, THF, and cyclohexanone, current NIOSH and ACGIH exposure Limits are sat to prevent acute irritation. In. _ animal studies,, chronic toxicity has been observed only at? levels:''" ^ substantially above chose which most people find objectionable.. In ' previous studies of exposure to MEK, THF,. acid, cyclohexanone during^ . J --- . - ' plastic pipe Installation, short-term exposures have been much ^closer. to^^' their respective short-term exposure limits than full-shift exposures-, :r . have been to their 8-hour TWA exposure limits. Therefore, monitoring will focus on short-term (15 minute) exposure measurements. For each worker whose exposures to CPVC/PVG ara; monitorod, several 15-minute air samples will, be collected during, the work day and analysed for MEK, THF, and oyolohexanone. Detailed records of work activities throughout die day will be.kept. The resulting data will be used In two ways: first, to characterize the distribution of short-term exposures, and second, to estimate the mean and variance of 8-hour TWA'exposuresassociated with CPVC/FVC installation. In order to maximise the precision of exposure estimates derived from the short-term monitoring data, monitoring will be concentrated during the highest exposure periods. This method of characterizing Che distribution of 8-hour TWA exposures has two important advntagea--for this study--over the more traditional method of collecting full-shift samples only: 1) Data collected at CPVC/PVC sites other than actual CPVC watersupply Installations can validly be used by this method to ^ ^ Cjo M 0 Protocol: Plastic Pips Worker Exposure Study BFG12932 tn Page 10 08/23/1988 09:45 ESSS PGNAFAX UF-600 **** 415 540 2908 P.07 DRAFT #3; August 22, 1?3$ calculate tha exposures expected during CPVC water-supply Installation and the factors affecting those axpoourea, even though the full-shift exposures may not be comparable. This Is because the exposures that occur during various tasks are believed to be comparable among Installations, but the time devoted to various*tasks differs among Installations. In calculating Che exposure expected during CPVC water-supply Installation, the periods spent In each task or exposure category will be based on the periods spent in those categories during water-supply installation only. 2) The data collected will be sufficient not only to estimate 6-hour TVA exposures but also to analyze the factors that affect those exposures. Knowledge of these factors could then be used to calculate estimates of 6-hour TWA exposures under conditions that did not happen to occur at any of Che sices monitored. For example, knowing the separate effects of ambient temperature and _____ u of prolonged work in enclosed spaces, the 8-hour TVA exposure'of-a * ~ -- worker spending 3 hours working under a floor and 5 hours above the floor--in 100 F heat--could be calculated.. The methods used to asaoss these fActors are described in the data analysis section. A stratified random sampling scheme, such as that-described here, is - the beat available method for characterizing the distribution of 13- minuce exposures,, ineluding the percentage-that exceed the- short-term: , exposure limit.4 Information about the mean and. variance^ of 15-minute c, exposures can then be used to calculate the distribution of exposure levels for any other averaging parlod of interest, Including 8-hour TVA exposures.9 The calculation.methods, including upper'and lowar--bounds'J on the variance of 8-hour TVA exposures, have been described elsewhere.9 Most Importantly, tha mean exposure level is identical for. all averaging -- ;_ times. For work activities in which the amount of time spent in various' . .. . V:'- exposure categories can be determined, an estimate of the average 8-hour- . THA derived by this method may have even less uncertainty with It than does a similar estimate based on 8-hour TVA samples taken for the same number of worker-days.7 MEK, THF, and cyclohexanone are all volatile solvents. The main variable factors expected to affect their air concentrations are, in order of descending Importance: concentration in products used, ventilation, number of joints to bs glued in a given period,- and temperature. Skin contact has bean suggested as an additional factor that contributes to total exposure, but its effect Is not known. Information on each-of these factors will be collected during each 15minute monitoring period. The basic steps of water-supply installation (prefabrication, under floor, topping-off, and finish work) involve many similar easks. Tha tasks can be grouped into five exposure categories, based on two major factors that can be determined at the time of monitoring* the number of joints per unit time, and the presence or absence of structures enclosing the work space. These categories of exposure are shown below: 21313016 Protocol: Plastic Pip* Worker Exposure Study BFG12933 Pmge 11 08/23/1988 09=45 ESSS PANAFAX UF-600 **** 415 540 2908 P.08 DRAFT #3; August 22, 198$ I. Ho joints glued in 15 minute period He. Spec* HOT enclosed; 1-7 joints per 15 minutes Zlb. Specs HOT enclosed; >7 joints per 15 minutes tile. Enclosed space; 1-7 joints per 15 minutes IZXb. Enclosed space; >7 joints per 15 minutes Based on existing exposure data, the categories above are listed in ascending order o likely exposure level. Each type of plumbing work can he characterized by various periods of exposure in Che above oategories. For example, under-floor water-supply work often involves many 15-minute periods in category 11a while joints ere tepidly cemented in place, hut scarcely any work in categories Ilia or Xllb, because no enclossd spaces ars involved. - Top-off typically features mai^y periods. In either XXa or Ilia, depending on the house plan and.on the' whether. exterior sheathing has bssn applied. Top-off may also include periods o category Xllb exposure whenever the under-floor plumbing needs to be repaired or redone. Finish plumbing is characterized by e few perloda of category Ilia or XXXb exposure when plumbers work in cabinets connecting fixtures. For this categorization, enclosed end unenclosed spaces will Include-the- following: -- Enclosed; - inside e house where air flow is blocked-by. exterior walls- (or sheathing), windows, and doors attio, with roof covering on, between joists or- closely spaced beams which- are. .covered above, inside cabinet or in enclosed soffet, under floor level, with floor in place, or worker's breeching zone in trench; Unenclosed; inside s house, before exterior walla, windows,, and doors have been installed, outdoors, exoept in trench, or pipe In trench, but breathing zone out of trench dUrlhg gluing. For this categorization, a workers' breathing zone will-be considered eo be in a trench or between joists or under the floor only If the nose itself Is in Che space described. Exposure category will be determined by the working conditions during the majority of each 15-minute period. Air Monitoring A systematic sampling scheme will be used to ensure Chet the highest exposure categories ere monitored most frequently, butt that within each exposure category, the periods selected will be representative. For eaoh exposure category, the pattern for determining which 15-minute 21319017 Protocol: Plastic Pips Worker Exposure Study BFG12934 Page 12 08/23/1988 09^46 ESSS PPNAFfiX UF-600 **## 415 540 2908 P.39 DMT #3; August 22, 1988 periods are to bo monitored during each plumber-day, and the approximate total number of air samples to be collected, la os follows: Catseorv Freouencv Total I lie lib Ilia one-half of all site-days once per plumber-day every-other period in category ovary-other period in category S 52 64 64 mb every period in category 32 A coin flip at the beginning of the day will be used to determine whether category Z monitoring will be done and whether, che,.category lib and HI* periods monitored will be the odd or even periods,. According to " their order during the day. the maximum number of samples to be collected fer-any- in category I through Ilia for any worker-day is three. I six or more periods In category IIlb are anticipated for any worker-day, then every-ocher such period, rather then every period, will be monitored. Monitoring periods will be selected according to the working conditions anticipated during che upcoming 15-mlnute period. If the working conditlone are not as anticipated, then the exposure category of the-period monitored will be reclassifled according to* the -V-T*--. condftlons- that actually occurred. If a scheduled nonltor1ng,,perlod IS- T-.'-.'V '. missed, the next period In che some exposure category will be monitored Instead. For each 15-minute monitoring period, information about, the number -of jhince glued and the air temparature and average air flow 'lhi.the worker's breathing zone will be recorded. The pattern of exposures- will"-T'A" be-- recorded as accurately ee possible throughout the work day (not only - - during monitoring periods) according to che five-category scheme above. Monitoring of alt- three oxygenated solvents simultaneously is. Important so that additive exposures con be evaluatedr unfortunately; this will require use of two different media side-by-side. Monitoring for MEK and cyclohexanone will be conducted according, to MIOSH Method 2500, with collection on Ambersorb XE-347 and analysis by gas > chromatography.* This Is the standard method for MEK but not for cyclohexanone; however, previous laboratory studies have indicated that Ambersorb may be s better sorbent for cyclohexanone than Is charcoal.* Monitoring for THF will be conducted according to N10SH Method 1609, with collection on activated charcoal and analysis by gas chromatography.10 For at least 10 samples, all three components will be analysed In both the Ambersorb and charcoal samples collected side-byside. If the weighted average discrepancy between the two methods for each substance is 20% or less, further monitoring will be done with only one monitoring medium. If the weighted average discrepancy is more than 20% for any substance, both sampling media will be used for the remainder of sampling, but analyses will be done for each substance only for air samples collected on the better medium. Protocol: Plastic Plpm Worker exposure Study BFG12935 Page 12 08/23/1988 09M6 cSSS PANAFAX UP-600 **** 415 540 2909 P.i0 DRAFT #3; August 22, 19$9 Biological Monitoring Of the oxygenated solvents, MEK in particular is believed to be readily absorbed through the akin, jo biological monitoring is considered an important adjunct to air monitoring. The ACG1H has adopted a BEIfor MEK, based on measurement of MEK in end-of-shife urine samples. Sufficient Information la not presently available to assess exposures to THF or cyclohexanone using urine or exhaled-air Indices. For each participating worker for whom a urine sample is collected for DMF monitoring, MEK will be measured in the same sample. To obtain corresponding long-term TWA exposure information, airborne MSK will be monitored during the Last 4 hours of the shift, using collection on activated charcoal passive monitors (3M) and analysis by gas chromatography. This collection method was selected for two reasons; 1) all three previous studies establishing the correlation between airborne MEK exposure end urine MEK concentration have based that correlation on air samples collected with charcoal passive dosimeters during^the I'sstf.*^ four hours of the work shift,11,12,13 so this collection method oust be used for the data collected in this study to be compared with previous results; and 2) MEK is eliminated rapidly from the body (tj.2 < 2 hr), so exposures early in the day make little contribution to tne amount of MEK In end-of-shlft urine. ^ T- At least 20 plumber-day* will be included in the biological monitoring for MEK. If necessary, this monitoring-will:.Include some---workers who are not using DMF-contalnlhg. products. ExtantL.of skin, contact during tho four-hour monitoring period will be assessed according to the three-level scale described above. Although BEIs are not establlahed for THF and cyclohexanone, these-.will. also be measured in the urine end 4-hour saaplee collected. The resulting data will be used to generate hypotheses about patterns of. . exposure or the contribution of skin absorption, ss described below. Continuous exposure profiles Continuous, aoment-by-moment exposure profiles will be recorded for at lease ten workers, performing the basic operations--prefabrication, under-floor, top-off, and finish. A total of a lease two hours, including typical tasks, will be profiled for each worker. Measurements will be made with a photoionization meter (H-Nu or equivalent); such an instrument gives an approximate measure of the total airborne concentration of photoionlzable organic molecules. MEK, THF, and cyolohexanone all have very similar photoionization sensltlvltes, so variations in the relative proportions of the three substances will not substantially affect data collected by this method. Since previous studies of plastic pipe installation have found chat the vapor* present in highest concentration were THF and MEK, the moment-by-moment profile is expected to reflect predominantly the concentrations of these two solvents. The toxicology of these two substances (and of DKF and cyclohexanone) suggests that assessment of combined exposure Is biologically meaningful, since the two are likely to have an addlelve effect in producing irritation or CMS depression. The information 21319019 Protocol: Plmstlc Pipe Worker Exposure Study BFG12936 Page 14 08/23/1588 09i47 ESSS PANAFAX UF-600 **** 415 340 2909 P.11 DRAFT #3; August 22, 1989 gained will bo semi-quantitative, and will bo used only co provldo detailed characterizations of exposure patterns wlchin various 15-minute periods. CPVC/PVC Duet On construction sites, CPVC/PVC pipe le most often cut with a knifeedged manual tool--either clippers or a rolling-wheel tubing cutter-- that creates no dust. Portable reciprocating saws era used infrequently, and are expected to create little dust, especially In the respirable else range. The operation moot likely to produce CPVC/PVC duet is cutting with a high-speed circular cut-off saw during prefebrlcation. If this task le performed for any of the sites monitored, full-shift monitoring for CPVC/PVC dust will be conducted In the prefebrlcation area. Full-shift CPVC/PVC dust monitoring will also be conducted if high-speed sawing of PVC pipe Is done st any of the construction sites monitored. Zf no high-speed saving, of CPVC/PVC is. ........ done for any of the sites selscced, no monitoring for. CEVC/FVCdust will be done. ' For each site monitored, measurement of exposure to total particulates (or total inaplrable particulates) and total respirable ......... . .. particulates will be made by collection of personal or area air ssntplas on pre-walghad 37 nn-Teflon filters, with gravimetric analysis. Cyclonepreselectors meeting the ACGIH criteria for raspirabla dust14 will be used in collecting the respirable- dust samples: Filters will be retained for one year foe analysis by a more specific technique If such ' a technique becomes available. Such analysis is not a part of this study. Polybutylmx* Pips In-order to assess qualitatively the production of any decomposition products during thermal fusion, at least two sir samples will be oolleeted with suitable media and analyzed by gas chromatography-mass spectrometry. In previous studies, various aldehydes and organic acids have been the prinolpel components produced by oxidative thermal deoompositition of polyolefin*;1* the collection: media used will be capable of retaining these..substances. The presence of any substances on the EPA Priority Pollutant list will be identified. The ten additional subetaneae substaneee present in highest concentration will also be Identified. Copper Pipe Vhile soldering copper pipe joints, plumbers ars most, likely co be exposed to solder fumes and to flux fumes and decomposition products. California plumbers currently use fluxes composed primarily of animal fats. Because animal fat fluxes are believed to have less toxicity than acid fluxes or fluoride fluxes, and because the thermal decomposition products are not known, no syseematlc exposure measurements will be made. In order co assess qualitatively che production of flux decomposition products during brazing, at least two air samples will be collected on suitable media and analyzed by gas chromatography-mass 21319020 Protocol; Plastic Pipe Worker Exposure Study Page IS 08/23/1988 09=48 ESSS PANRFAX UF-600 **** 415 540 2908 P.12 DRAFT #3; August 22, 1988 spectrometry (GC-KS). As for ?B decomposition products, the media will be capable of collecting aldehydes and organic acids. Because flux decomposition produces particulate as well as vaporized substances, a second medium capable of collecting aerosols will be used. The presence of eny substances on the EPA Priority Pollutant list will be identified. The ten additional substances present in highest concentration will be identified. Solder fumes will be monitored according to HXOSH Method 7300, with collection of full-shift air samples on 37 mm cellulose ester filters and analysis by Inductively coupled plasma spectroscopy or by acomie absorption spectrophotometry. The principal constituents of currently allowable solders (tin, copper, silver, and antimony) can all ba measured with this method. The same methods will be used to measure lead fumes, since plumbers at some worksites use 50%-lead solder for installation of copper DWV lines, and may somatlnaa Improperly use that solder for water-supply installation as wall. At least 20 plumber-days, will, be sampled, including both.under-floor and top-off work, and prefabrication if any is done for the sites sampled. Mo biological monitoring for exposure to metal fumes will be conducted, because lead is no longer allowable in solders used for potable water systems, and no biological indices of exposure are presently available for antimony (3b), copper (Cu), silver (Ag), or tin <Sn). Other exposures At some construction sites, plumbers may have exposures in addition to those listed above, which-could .occur during, installation of anytype... of pipe. The most common of/ehsse are exposure-to noise and to silica. . The industrial hygienists may elect.to measure these exposures as appropriata, using standard"techniques. Quality assurance To provide information about the integrity of the. sample handling methods and laboratory analyses Co boused, a limited quality assuranceprogram will be included. For each of the major types of solvent samples to be collected, (full-shift air samples for OKF-and-selder femes, 4-houx air samples for KEK, 13-minute air samples for HEX, THF, and eyolohexasone, and urine samples for BMP, MHF, and KEK) a* minimum of three spiked samples will be prepared by the laboratories performing the analyses, delivered to CFHF, and returned blind to the laboratory for analysis along with actual field samples. For KEK, THF, and cyclohexanone, all three substances will be mixed and splkad onto a single sample, and the mixture analyzed blind. For each type of sample listed above, field blanks will also be submitted blind for analysis. The number of field blanks for each type of sample will be at least 10% of the total number of samples, up to 10 field blank# of each type. Z J .3 3 .9 0 Z i Protocol: Plastic Pipe Worker Exposure study Page 18 08/23/1988 12^20 ES3S PfiNAFPiX UF-800 **** 415 540 290S P.01 DRAFT *3; Auguee 22, 1922 EVALUATION CRITERIA Units s - ethe t - data *beeeme * knew*-te - via -b tween- development - ef skis pro teael-and-final-reporting?-evaluation-criteria-for-BHFT-HEKr-THFr eyelehexaneneT'SbT~6u7 -Ag7-and-Sn-vill-be-based-en-estsbliahed'A6U2H-aad NIGSH-erlEeriar -as-shevn-in-Table-2T-- fA-texieity-evaiuatien-*-thase substanees-hAS-net-yet-been-eeiftpletedT-se-?abie-2-iS`aet-lneiwdad-vith thls-draft-ef-the-samp ling-preteselr--A-complete-set-ef-evaluation erlteria-vill-be-distribui5ed-by-AugMet-iS7-1988} - -Any-substaneee aensured- in-the-sanpUe-but-net-shevn-in-Table-2-will-be-Judged according-te-the-telovant-NICSH-Reeomuended-Ixpesure-Limit? - if-any?-*r ACUIH-TLYt--Zf-the-estimate-ef-the-9Sth-pereeatilo-ef-the-exposure distribuklen-exeeeds-the-xalevant-expeswre-limlt-fev-eny-substaneer reeenmendetiens-aay-be-made-fer'fellev-up-inYesttgatien-er-for-medieal surveillanee-ef-health-affeets-related-te-khe-expesure* The expoauro limits co bo used for evaluation of exposures to DMF, MEK, TH7, cyclohexanone, Sbf Cu, Ag, Pb, and Sn ara shown in Tabla- 2. . . These exposure limits are taken from*values-established by.U.$. OSHA:: comprehensive standards, N10SH Recommended Exposure Limits, and ACGXH TLVs, listed in order of preference. For antimony, animal evidence'-supported by limited epidemiologic data--suggests that it is carcinogenic, but it has not been evaluated by ZARC; the exposure' limit listed in Table 2 may not protect against caroinogeniclty. Any substances measured in the- air* samples but not shown In Table 2 will be evaluated according co tha relevant, exposure limits established by the same agencies. Concentrations* of HMF and HER* in urine-will be-'evaluated -according to their established* ACQ1H..JlEIa of* 40 ag/s..t.HWlw. and 2 rag/L, respectively. If new data'become available indicating that any of these exposure limits sre not sufficiently protective* of worker health, revised evaluation criteria*-will be..used and. a*, full Justification, of the... revisions provided. If the estimate of the 95th percentile of the exposure distribution- exceeds the relevant exposure limit for any substance, recommendations:- may be made for follow-up Investigation, or for medical surveillance- of. health effects related to- the exposure. .. .' For the samples of volatilized organic compounds, collected during, PB .. thermal fusion and during copper/flux soldering, further study may be. recommended if any of the ten principal components identlfisd by GC-MS 21319022- Protocol: Pl&acic Pipe VorJcer Exposure Study BFG12939 Fage 17 08/23/1988 09-'48 ESSS PPNAFAX UF-600 **** 415 540 2908 P.13 DRAFT #3/ August 22, 1938 Table 2. Exposure Hales to be used for evaluation of worker exposures aeesured. ____ EXPOSURE LIMIT ______SOURCE Subetsnee OMF -Hour TWA 10 ppm 15-Mlnute none 8-Hove 13-Minute A,0 -- HEX 200 ppm 300 ppm N.A.O A THP 200 ppm 250 ppm AfO A cyclohexanone 25 ppm /^75 pp~^) N,A A(excursion limit) antimony copper lead silver tin 0.3 mg/m3 * none 0.2 mg/n3 none 0.05 mg/m3 none 0.`01 mg/m3 none 2 mg/m3 none H,A,0 A o. 0 A,0 -- -- ........ .. -. *Does nob address the potential carcinogenic risk of antimony. ~ i SiUlEflftELi N- -- HIOSH Recommended Exposure Limits, as listed in-Morbidity and Mortality Weekly Report 1986;33(ls):li-33s. .............____, A"*-- American Conference of Governmental Industrial Hygienists. Threshold Limit Values and Biological Exposure Indices- for 1987* 1988. 0 - US OSHA Regulations;29 CTR 1910. ______________ EZOGrgT M Protocol.* PIsmCIc Plpo Worker Exposure Study BFG12940 Page 18 08/23/1988 09:49 ESSS PANAFAX UF-600 **** 415 540 2908 P .14 DRAFT *3; Augusc 22, 19Q8 DATA ANALYSIS General For each substance and typo of installation monitored, appropriate statistical methods will be used to estimate the mean exposure level and to evaluate the variability of exposure levels. For any individual exposures that exceed the exposure limit cited in the Evaluation Criteria section, the conditions associated with those overexposurea will be tabulated. When sufficient data are available, the proportion of total variability that occurs among sites, among workers in a single site, and day-to-day for Individual workars will be evaluated. For exposures to DMF, MEK, THF, and cyclohexanone, the relative contributions of the various factors affecting exposure levels (such as air flow, temperature, or skin contact) will be assessed. For each subatanee and each exposure category, exposure levels will be assumed to be lognonnally distributed, unless the data Indicate that suoh an assumption is unwarranted. The parameters of a lognormal distribution (geometric mean and gecmeerio standard deviation) will be used to describe the data and to calculate arithmetic meansand x variances. _____ For substance* present in individual air. samples* at. levels* below the analytical limit of quantitation (LOQ), a value of one-half-theLOQ- will . ^ ~-- 'be? assigned? Sample values which, seem to reflect extraordinarily. high^ or low concentrations will be assessed with a standard test for homogeneity'of data. Values unlikely to have originated-from-, the same--.. underlying data sat as the rest of the sample group (with a-cot^idencs^- ^.^ J^' -^ ** of 0.99), and with no apparent contributing factors, will be rejected. For each* air sample collected, sample volume will be calculated.from the sample duration and the calibration flow rates, assuming that.any . changes In flow rate between calibrations have been linear during periods of pump operation. .. Unless otherwise specified, s confidence level, of 0.95 will be used for all statistical tests*. For each average exposure level and aach estimate of the fraction of exposures likely to exceed the relevant exposure limit, the 95* confidence interval will also be reported, if sufficient data are available. Dimethyl formaalda Monitoring for DMF will produco two types of data for each. worker sampled: concentrations of DMF in full-shift air samples and concentrations of DMF in end-of-shlft urine, as wall as Information about working conditions during the days monitored and the extent of skin contact with primers and cements. Estimates will be calculated of Che average 8-hour TWA exposure level, Che variance of exposure levels, and the fraction of exposures likely to exceed the 8-hour exposure limit. Standard multiple 21319024 Protocol.1 Plastic Pips Worker Exposure Study BFG12941 Psga 19 08/23/1338 03:49 ESSS PPNAFPX LF-600 **** 4155402308 P.15 DRAFT #3; August 22, 19$6 regression techniques will be used to assess the strength of association between airborne exposure to DMF and several job factors which Day affect exposure levels: the number of joints glued, the daily high temperature, the concentration of DMF in the products used, and the amount of time spent gluing In enclosed spaces. Estimates will be calculated of the average urinary MMF concentration, the variance of MMF concentrations, and the percentage of workdays for which the end-of-shift urinary MMF concentration is likely to exeeed the BEI. Analysis of covariance techniques will be used to assess the differences In adjusted mean urinary MMF levels among the three skin-contact groups, and the association between urinary MMF level and concentration of DMF In the products used, independent of airborne DMF levels. The correlation between airborne DMF and urinary MMF will be compared to that found in previous studies. MET, THF, and cyclohexanone Monitoring for MEK, THF, and cyclohexanone will produce data of four types: 15-minute exposure levels and the amount of time spene In each exposure category (I-Illb) for all workers monitored, and urine concentrations and 4-hour exposure levels for workers Included in biological monitoring, Accompanying data on working conditions during the monitoring periods and on extent of skin contact will also be available. The cut-off for periods of concentrated gluing was set at'seven . . - ^ C Joints per 15 minutes based on field observations during walk-through inspections. During a typical day, 3-10 such periods are anticipated.. If: the cut-off proves to put too many or too few exposure-periods in-, categories lib and 11 lb-(and thus impedes data analysis by putting too few of the measurements in any of the categories) then a new cut-off may be selected to better balance the number of measurements In each category. - For each 15-minute air sample, the additive dose of the three solvents will be calculated as: Du " WsteiMk + <WSTBLnr + ck/5TKWc where Du is the additive dose for the 15-mlnute period; e^, and are the air concentrations of MEK, THF, and cyclohexanone; and STSl^gg, CTR^g, end STEl^ ere the short-term exposure limits *for! MEK, THF, and cyclohexanone, as shown in Table 2. Exposure levels measured in 15-minute air samples will be grouped by the exposure category, I-IIIb. Within each exposure category, the average exposure level, variance, and percentage of 15-minute periods likely to exceed the short-term exposure limit will be calculated for each substance and for the additive does. Based on the distribution of exposures in the five categories and on the amount of time spent working in each eaeegory during CPVC watersupply Installation, the average 15-minute exposure level will be 21319025 Protocol; Plastic Pipe Worker Exposure -Study BFG12942 Page 20 08/23/1988 09=50 ESSS PANAFAX UF-600 **** 415 540 2908 P.16 DRAFT *3; August 22, 19$3 estimated for all periods throughout the day, for aach substance and for additive doaa. The variance of the 15-minute exposure levels and the percentage of all 15-minute exposures that exceed the relevant shorttern exposure limits will also be estimated. The percentage of workerdays in which any of the short-term exposure limits will be exceeded during any 15-mlnute period will be estimated. For aach exposure category, analysis of covariance techniques will be used to assess the strength of association between airborne exposure levels for each substance and several Job factors which may affect exposure lavels: Che number of Joints glued, the breathing-zone temperature, the breathing-2one air flow rate, and the concentration of each substance in the products used. Differences in adjusted means between the exposure categories will also be assessed. The average 8-hour TWA exposures expected for workers installing CFVC water-supply systems will be estimated from the short-term monitoring data for each substance as: c8 - (tyCj + tjj.-O,,. + cIJb-Cltt + Wcin. + *WW/32 where o. is the average 8-hour TWA exposure expected during CFVC water-supply installation; are the number of 15-mlnute periods spent in each exposure category by workers monitored during CFVC water- supply Installation only; ci"ciixs are the average 15-minute concentrations for each category among all types of OPVC/FVC installations; and 32 is the number of 15-minute periods ihuan. 8-hour day. Individual 8-hour TWA exposures will not be reported, because they cannot be- reliably calculated from the data to be collected^ <Tha-- average 8-hour additive doawwill be calculated as: D. " <W + da + ``etc where D# is the 8-hour additive dose; and d^, d^,-and d^. are the estimated average 8-hour TWA exposure levels to the three substances divided by their 8-hour TWA exposure limits (as shown in Tabled). When sufflenc data are available,, the variance of expeoted 8-hour TWA exposures and the fraction.exceeding the 8-hour TWA exposure limit will be calculated for each substance and for 8-hour additive dose. For workers involved in biological monitoring, the average urinary HEX concentration, variance, and percentage of workdays for which urinary MIX is likely to excsed the 5EI will be calculated. Analysis of covariance techniques will be used to assess the differences In adjusted mean urinary HEX levels among the three skin-contact groups and the association between urinary MIX level and concentration of MIX. In the products used. Independent of 4-hour airborne HEX levels. The correlation between airborne and urinary HEX will be compared to that found in previous studies. The average MEK exposure as measured by the 4-hour samples will be compared with the average estimated 8-hour TWA value derived from short-term sampling data. ? & Protocol; Plmselc Pips Worker Exposure Study BFG12943 Psgs 21 08^23/1988 09:51 ESSS PGNAFPX 11F-600 **** 4155402908 P.17 DRAFT #3; August 22, 198a CPVC dust Results- reported will Include the percentage of housing construction sites monitored for which CPVC/PVC was prefabricated (with saving), estimates of the mean exposure levels to CPVC/PVC dust and respirable CPVC/PVC dust, and the variance of these exposure levels, Polybucylan* charm*l fusion by-produocs For eeeh sample, the most likely chemical identities will be reported for the can compounds present at highest concentration, along with approximate concentration data. Because of the sampling uncertainties involved, exact chemical identities and concentrations may noe be available. Sold** fumes For each element detected in solder' fumes,, estimates wiirbe/ calculated of the average, exposure level, the variance of exposure levels, and the percentage of exposures likely to exceed the exposure limits. The various factors that might affect exposure levels to solder fumes will not be specifically assessed; rather each will be considered to contribute to overall variability. Fluir fumer For each sample, the most likely chemical identities .will. be*, reported* , for the ten compounds present at highest concentration, along with approximate concentration data. Because of the sampling uncertainties, involved, exact chemical Identities and concentrations may not: ba available. i 4Z06TT Protocol< Plastic Pipe Vorkar Exposuro Study BFG12944 Pmg* 22 08/23/1988 09:SI ESSS PANftFAX UF-600 **** 415 540 2908 P.1S DRAFT #3? August 22, 1999 REFERENCES *Letehnlts K, Foster A. Drager detector tube handbook, sixth edition, Dragerverk AG Lubeok, 1985;73. 2U.s. Department of Health and Human Services. NIOSH manual of analytical methods, second edition, 1984;2004. American Conference of governmental Industrial Hygienists Inc. Documentation of the threshold limit values and biological exposure indices 1986, fifth edition;209-210, BEI 63-BEI 65. `Levy ps, Leaeshov S. Sampling for Health Professionals. Belmont, California: Lifetime Learning Publications, 1980. *Rappaport S. Personal communication, 1988, *Spear R, Selvin S, Francis H. The influence of averaging time on. the distribution of exposures. Am Ind Hyg Assoc J 1986;47:365-368. 7Hlcas, K. Unpublished paper, available from M. tficas, Hazard EvaluationSystem and Information Service, California Department of Healeh Services, 2151 Berkeley Way, Room 504, Berkeley, CA, ,94704, *U.S. Department of Health and-Human- Services. HIOSH manual of. analytical methods, second edition,*1984;2500. *Lavln JO, Carleborg L. Evaluation of solid sorbents for sampling* ketones In work-room air. Ann Oocup Hyg 1987; 31:31-38. iBU.S. Department of Health and Human- Services. HIOSH analytical nathoda, second edition,. 1984; 1609. of uMlyasaka M, Kumai Mt Koizumi A, Watanabe T, Kurasako K, Sato K. Iked* M. Biological Monitoring of occupational exposure to methyl ethyl ketone by means of urinalysis for methy ethyl ketone itself. Int Aroh Occup Environ Health 1982;50:131-137. uGhittori 9, Imbrlanl K, Parzagno C, Capodagllo The urinary concantratien of solvents as a biological indicator of exposure: proposal foe the biological, equivalent exposure limit for nine solvents. Am Ind Hyg Assoc J 1987;48<9):786-790, 1,Perbelllni L, Brugnone F, Moszo P, Cocheo V, Caretta D. Methyl ethyl ketone exposure in Industrial vorkers. Int Arch Oooup Environ Health 1984;54:73-81. uAmerican Conference of governmental Industrial Hygienists Inc. Documentation of the threshold limit values and biological exposura Indices 1986, Fifth edition; 524. lsHo A, Jacobsson 5, Pfaffli P, Itting A, Frostllng H. Degradation .products of plastlos. Scand J Work Environ Health 1982;8(suppl 2):17- 21 szosierz Protocol: Piaetie Pipe Worker Exposura study BFG12945 Page 23 08/23/1988 09:52 ESSS PANAFAX UF-600 **** 415 343 2908 P.19 DRAFT 03: August 22, 198$ ^International Agency foe Research on Cancer. Biennial Report, 19861987, Lyon: World Health Organization, 1987;41-44. 21319029 ProtocolPlastic Pipe Worker Exposure Study BFG12946 Page 2A rt