### OPTIONS FOR REVISING CEB  S METHOD FOR SCREENING-LEVEL ESTIMATES OFDERMAL EXPOSURE

FINAL REP ORT JUNE, 2000

Chemical Engineering Branch Economics, Exposure an d Technology DivisionOptions for Revisi ng CEB Dermal Method - Final 06/00

i 

### SUMMARY The purpose of this report is to present options and a recommendation for revising the Chemical Engineering Branch  s (CEB  s) Dermal Exposure Assessment method based on the results of the 1996

peer reviewed

research titled: Occupational De rmal Exposure Asse

ssment - A Review of Method

ologies and Fie

ld Data, as well as other recent dermal exposure studies. CEB  s current method for dermal exposure assessment presents factors for calculation of potential dermal e

xposure based on: " an estimate of the skin surface area of the hands " values of the quantity of material typically remaining on the skin derived from a laboratory study ( Q  value) " judgements as to the types of common industrial activities that could be associated with th

e available data " judgements on whe ther the potentia

l for exposure for

an activity

is best characterized

as  routine  or  incidental  " judgements on the number of hands (

total skin surface

area potentially exposed) for vari

ous worker activ

ities The scope of this report was on the first three aspects of the CEB method for dermal assessments mentioned above. It does not address the judgements regarding routine or incidental or total skin surfa

ce area. Those

are worthwhile t

opics to address a

s part of the ong

oing effort to refine the CEB d

ermal method but we

re not part of the

scope of this eff

ort. Key findings and recommendations from the peer revie wed research report and other recent studies judged to be applicable to revising the CEB method are listed below. 6. Revise estimate of skin surface area of the hand (Recommendation in peer reviewed research report). 7.

 Q  values from 1984 Versar report (used in current CEB method) were updated in 1992 final report 8. Available data indicate a maximum dermal retention of 10 mg/cm2 for solids and 4 to 10 mg/cm2 for l

iquids (Conclusion in

Peer Reviewed Re

search report) 9.

 Q  values for liquids derived from field monitoring studies (albeit pesticide handling) are available from PHED (Pesticide Handlers Exposure Database). (Data analyzed and presented in peer reviewe d research report). 10. Field monitoring

data for solids is no

w available for a

ssessment of exposur

e in solids handling activities. (Current CEB method uses laboratory data for liquids in assessments of exposure in solids handling activities). 11. High quality data is available from PMN dermal monitoring study (non-pesticide field data for a liquid) 12. Use data from the other parts of the body with the current CEB methodOptions for Revisi ng CEB Dermal Method - Final 06/00

ii (Recommendation of the Peer Reviewed Research). 13. Guidance for qualitative assessments of dermal exposure is available to be incorporated into form al CEB Dermal Method. (Gui dance in CEB Manual (CEB, 1991) used historically by CEB in PMN review prog ram). Nine different options were developed ranging from doing nothing to an option which incorporated al

l of the key f

indings and rec

ommendations mentio

ned above. The in

itial recommended option was the option which incorporated all. This option was presented to CEB for review. The results of this review resulted in the following modifications to the recommended option. 1. The terms  routine  and  incidental  branch are left in the CEB method for now but it will be noted that they reflect typical CEB judg ements of the likelihood of contact for the e

xample activities. 2. The term  activity  used in CEB Manual and options is changed to  Type of Contact  and each type of contact will have a unique name to help CEB distinguish between the assumptions associated with each. 3. The highest values in ranges with term  up to  will be used since this table is for screening-le

vel purposes. 4. The methodology for assessing exposure to other parts of the body needs more development and input from risk assessors so it won  t be included as part of the CEB method for now. The proposed revised CEB method for screening-level assessments of dermal exposure consists of 2 tables: Hands (liquids and solids) and qualitative assessments. These tables are presented below.Options for Revisi ng CEB Dermal Method - Final 06/00

iii Table 1: Factor

s for Screening-Lev

el Assessments

of Dermal Exposure

to the Hands

Type of Contact 1 Typical Examples S 2 (cm 2) Q 3

(mg/cm 2) Resulting Dermal

Contact (mg) Routine, direc

t handling of solids - 2 hands" Filling/dumping containers of powders, fl

akes, granul

es" Weighing powder/ scooping /mixing (i.e., dye weighing)" Handling wet or dri

ed material in a filtration and drying process up to 3100 4

Routine co ntact with surfaces - 2 hands - solids" Handling bags of solid materials (clo sed or em pty) up to 1100 4

Routine immersion, 2 hands - l

iquids"

Handling wet sur

faces" Spray painting 840 1.3 - 10.3 up to 8,700

Routine co ntact, 2 hands - l

iquids"

Maintenance" Manual cleaning of equipment" Filling drum w ith liquid 840 0.7 - 2.1 up to 1,800

Incidental co ntact, 2 hands - l iquids"

Connecting transfer line 840 0.7 - 2.1 up to 1,800

Incidental co ntact, 1 hand - li quids"

Sampling" Ladling liquid /bench sca le liquid tr

ansfer 420 0.7 - 2.1 up to 900

Notes: 1- The term s  routine  and  incidental  reflect typical CE B judge ments on likelih ood of co ntact for the exa mple activities. 2 - Values of the skin surface area of t he hands taken from: EPA Exposure Factors Handb ook, 1997 and are the mean values for men 3 - Selected ranges of  Q  Values for liq uid handling activities taken fro m: EPA , 1992. A Labora tory Meth od to Determine t

he Retent

ion of Li quids on t

he Surface of Hands, Exposure Eval uation Di

vision, Office of Poll

ution Preventi on and Toxic, USEPA, EPA 747-R-92-003, Sept ember, 1992. 4 - Values fo r dermal co ntact for solids h andling activities were taken fro m: Lansink, 1 996. Lan sink, C.J.M ., M.S.C . Breelen, J . Marqu art, and J.J. va n Hemm en: Skin Ex posure to Calcium C arbonate in the Paint Ind ustry. Preliminar y Mod eling of Skin E xposure L evels to Po wders B ased on F ield Data (T NO R eport V 96.064 ). Rijswijk, The Nether

lands: TNO Nutrition a nd Food Research

Insti tute, 1996.
Further details on deriv ation of this t able can be f

ound in: CEB, 2000.

Options f

or Revisi ng CEB  s Method forOptions for Revisi ng CEB Dermal Method - Final 06/00

iv Screenin g-Level Estimat es of Dermal

Exposure. Final Repor t. 06/01/

00. Table 2: CEB Method for Screening-Level Assessments of Dermal Exposure - Qualitative Assessments 1
Category Dermal Assessment - Corrosi ves (pH >12, pH <2) Negligible - Materi als at temper atures >140 deg.

F (60 deg.

C) Negligible - Cast Solids ( such as mo lded plastics )/PMN in matrices such as extruded p ellets Ex. Chemical is an additive f or plastics. It has been physicall y mixed and incorporat ed into a plast

ic pellet but not chem ically reacted a way. Non-Q uantifiable (Some su rface conta ct may occu r if manually

transf erred) Work ers handling th e plastic in the for m of pellets could get su rface conta ct with the chem ical additive.

-  Dry  surface coatings (e.g., fiber spin finishes) Non-Quantifiabl e (If manual handling is necessary and there is an indi

cation t hat the materia l may abra

de from the surface, quantif

y contact wi

th finger s/palms as appropriate) - Gases/Vapors Non-Quantifiabl e (Some contact may occur in the absence of protective clothing) Notes: 1 - Reference: (CEB, 1991). Chemical Engineering Branch Manua l for the Preparation of Engineering Assessmen

ts, Washi

ngton, D.C.: Offi

ce of Toxic Su

bstances, U.S. Envi

ronmental

Protecti on Agency,

1991.


### Other Guidance f

or Use Screening-Level

- The estimates of dermal contact presented in the table are intended for use in screening-level assessments of the type that CEB prepa res for the new chemicals program. They provide an estimate of potential dermal exposure and do not take into account the protection from th

e use of gloves. More Refined Asse

ssments - If there is a need for a more refined assessment, CEB assessors can re

view the studies in m

ore detail to dete

rmine a more appr

opriate estimate

for their situation. However, to ensure consistency, these more refined assessments should be re viewed and sav ed i n a  Derm al  sub dir ect ory o n th e K: \Gro up\C EB di rect ory. Exposure Descrip

tors- Based on reviews of the applicable field data, the values reported in Table 1 provide

exposure estimates

that fall in the uppe

r end of the rang

e and represen

t a conservative estimate of exposure. For use in individual assessments, CEB exposure assessorsOptions for Revisi ng CEB Dermal Method - Final 06/00

v will need to evalua

te case-specif

ic information and

the details of the v

arious studies cite

d in this report to determine the appropriate exposure descriptors (i.e.  bounding  ,  high-end  ,  what-if  ) for their individual case. Guidance on exposure descriptors can be found in EPA, 1992. 

### Exposure to Other Parts of the Body One of the recommendations of the peer reviewed research report wa s to use data on exposure to other parts of the body with the current CEB method. This resulted from review of the available data from the literature as well as PHED that showed exposure to other parts of the bod y. Th is w as al so s how n in the prev iou sly m ent ion ed d erm al e xpo sur e st udy u nde rta ken by a PMN submitter. Recommended factors for estimating dermal exposure to other parts of the body are presented in this report. These values were taken from the estimated 90 thpercentile deposition from the PHED database. CEB believes that further development and input from risk assessors is needed before presenting an approach for estimating exposure to other parts of the body . This area has been identified as one

of the areas for

further develop

ment as part of CEB

 s effort to continu

ously improve its assessment methodologies. The available data show that hand exposure constitutes the majority of the total body exposure. 

### Part of Ongoing Effort CEB regards the revised tables as the logical next step in development of its dermal assessment methodology. As with all of its methodologies, improvement is an ongoing process. Areas that CEB plans to address in the future in addition to assessments of exposure to other parts of the body

include revisiting

the judgements of

routine and incide

ntal exposure and th

eir application to the Exposure Based Policy and Peer review of the revised table.Options for Revisi ng CEB Dermal Method - Final 06/00

vi ACKNOWLEDGMEN

TS The primary author of this report was Greg Mace k of the Chemical Engineering Branch (CEB). Special acknowledgment is given to Cathy Fehr enbacher, formerly of CEB, who was project leader for the dermal research that serves as the primary basis for the recommended revisions to the current CEB dermal method. This report was reviewed by members of CEB and their comments have been incorporated into the recommended option. In particular, comments from CEB staff members Scott Prothero and

John Blouin and Bra

nch Chief, Nhan N

guyen we re instrumental in developing the recommended option.Options for Revisi ng CEB Dermal Method - Final 06/00

vii 

### TABLE OF CONTENTS

PAGE

SUMMARY i to v ACKNOWLEDGMEN

TS vi INTRODUCTION ix SECTION 1 - CEB  S CURRENT METHOD 1.1 to 1.2 SECTION 2 - NEW INFORMATION ON DERMAL EXPOSURE 2.1 to 2.3

ASSESSMENT SECTION 3 - OPTIONS F OR REVISING THE CEB METHOD 3.1 to 3.15 SECTION 4 - RECOMMEN DATION 4.1 to 4.4 REFERENCES R-1 APPENDIX 1. DATA FROM DER

MAL EXPOSURE STUDI ES USED TO REVISED THE CEB METHOD 1.1 Pesticide Handle rs Exposure Databas

e A-2 to A-6 1.2 USEPA, 1992a. A Laboratory Method to Determine A-7 to A-8 the Retention of Liquids on the Surface of the Ha nds 1.3 EPA Exposure Factors Handbook, 1997 (Final Report) A-9 to A-10 1.4 USEPA, 1992b. Exposure and Release Estimations for A-11 to A-15 Filter Press and Tray Dryer Operations Based on Pilot Plant Data

.Options for Revisi ng CEB Dermal Method - Final 06/00

viii 1.5 Skin Exposure to Calcium Carbonate in the Paint Industry - A-16 to A-21 Lansink, et. al., 1996. 1.6 Worker Derma

l Exposure to Trichlo

roketone, A-22 to A-26 Anonymous,1996 2. CEB REVIEW OF RECO MMENDED OPTION A-27 to A-30Options for Revisi ng CEB Dermal Method - Final 06/00

ix 

### INTRODUCTION The Chemical Engineering Branch (CEB) of EPA  s Office of Pollution Prevention and Toxics (OPPT) has the responsibility of preparing assessments of occupational exposure for chemicals the EPA

reviews under th

e Toxic Substances Co

ntrol Act (TSCA). I

deally, the

se assessments are based on field monitoring data for the chemical being evaluated. I n the absence of such data (almost always the case for new chemica l reviews), CEB relies on data on analogous substances, generic scenarios, regulatory standards, or models to develop estimates of potential exposure. Two important routes of exposure that CEB considers are the inhalation and dermal routes. The focus of this report is on the CEB  s assessments of exposure via the dermal route. CEB currently uses a method based on laboratory experiments that obtained estimates of the quantity of chemical retained on a unit area of the skin for various ac tivities. Dermal exposure estimates are the

n developed by

extrapolating the

se quantities over

the total surface

area of skin exposed. CEB undertook research for the purpose of validating and improving its dermal method. Specific objectives of the research included providing a literature search of monitoring data on dermal exposure and making recommendations to improve the CEB method based on the literature search and evaluation. The results of the research are pre sented in the peer-reviewed report, Occupational De rmal Exposure Asse

ssment - A Review of

Methodologies a

nd Field Data, (SAIC, 1996). This report presents options for revising CEB  s Dermal Exposure Assessment method based on the results of that research effort as well as other recent reports re lated to the assessment of dermal exposure . A review of CEB

 s current derma

l exposure assessme

nt method is presented in Section 1. A summary of the SAIC report and the other recent studies that have been published sin

ce CEB  s original derma

l assessment method

was developed is p

resented in Section 2 (More detailed summaries of the studies are provided in the appendix). Options for revising CEB  s method are pres ented in Section 3 a

nd the recommende

d option is given in Section 4.Options for Revisi ng CEB Dermal Method - Final 06/00

1.1 

### SECTION 1 - CEB  S CURRENT METHOD CEB  s current method for assessing dermal exposure is described in detail in the CEB Engineering M

anual (CEB, 1991 ). The method prov ides guidance f

or qualitative ass

essment in cases where a quantitative estimate should not be made such as for corrosive or high temperature materials. For quantitative assessments, the following equation is used to develop estimates of the potential dermal dose rate (amount available for absorption). D = SQC where: D = dermal potential dose rate, mg/day S = surface are

a of contact, cm2 Q = amount retaine

d on the skin, mg/c

m2 C = concentration of chemical of concern, percent by weight Estimates of the amount of chemical retained on the skin were derived from an experimental study by Versar (Ver sar, 1984). In the Versar study, experiments were performed to measure the amount of exposure to hands for various types of activities. Experiments were performed on six liqu

ids of various visc

osities. The resul

ts for immersion ra

nged from 4.99 to 13.85 mg/cm2. The results for activities such as wiping up a spill or wiping the hands with a contaminated cloth, and for the amount remaining when the hands were  partially  wiped with a clean cloth after immersion suggested a range of 1 to 3 mg/cm2. CEB made an assum

ption that the exper

imental data for l

iquids could also be

applied to assessments for powders. CEB then made judgements as to the type of common industrial activities that could be associated with the activity measured by Versar. Estimates of surface area were der

ived from Poppendo

rf and Leff

ingwell (1982).

This resulted in the

following table which is CEB  s current dermal exposure assessment method.Options for Revisi ng CEB Dermal Method - Final 06/00

1.2 Table 3: Typical Factors for Calculation of Dermal Exposure

Activity Typical Examples S 1 (cm 2) Q 2

(mg/cm 2) Resulting Typi cal Contact 3(mg) Routine immersion, 2 hands" Handling wet sur

faces" Filling/dumping containers of powders, fl

akes, granul

es" Spray painting 1,300 5-14 6,500 to 18,200

Routine co ntact, 2 hands" Maintenance/manual cleaning of equipment" Unloading filter cake" Changing fil

ter" Filling drum w ith liquid 1,300 1-3 1,300 to 3,900

Routine co ntact, 1 hand 650 1-3 650 to 1,950
Incidental co ntact, 2 hands" Connecting transfer line" Weighing powder/ scooping /mixing (i.e., dye weighing) 1,300 1-3 1,300 to 3,900

Incidental co ntact, 1 hand" Sampling" Ladling liquid /bench sca le liquid tr

ansfer 650 1-3 650 to 1,950

1 Popen dorf and L effingwell 198 2. S is surface a rea of conta ct. 2Versar 1984. Q is quantity typically remaini ng on skin. 3 These estimates also must be adjusted by the concentration of t he chemical in the mixture and the percent of t he hand exposed i

f this is less tha

n what woul

d be typical. Concen

trati ons that change over

time due t

o evaporati

on or other factors also should be accounted for.Options for Revisi ng CEB Dermal Method - Final 06/00

2.1 

### SECTION 2 - NEW INFORMATION ON DERMAL EXPOSURE ASSESSMENT

Since CEB  s dermal method was developed, the aforementioned research project for the purposes of valida

ting and improving

the method has bee

n completed, and s

everal other re

ports on dermal exposure assessment issues have become available. These are identified below along with key information from the report that could be applied to CEB  s dermal method. The report title, author and year are provided and a summary of the key data contained in the report are provided. A more detailed reference can be found in the referenc e section of this report and a more detailed summary of the data is provided in the appendix.. 1. Occupational De

rmal Exposure Asse

ssment - A Review of

Methodologies a

nd Field Data

, SAIC, 1996. This peer reviewed research report was prepared by SAIC under contract to EPA/CEB. The objectives of this report were to: " Provide a literature search of monitoring data on dermal exposure. This included the open literatu

re as well as data

in the Pesticide Ha

ndlers Exposure Da

tabase (PHED) maintaine

d by EPA  s Office of Pestic ides. " Evaluate the CEB method and revise or identify additional values and input parameters (e.g., quantity remained on the skin, skin surface area) for predicting dermal exposure under various exposure scenarios " Make recommendations to improve the CEB method based on the literature search and evaluation Key conclusions of the research are listed below. 1. The CEB method currently only asse sses hand exposure. The field monitoring studies routinely included evaluation of exposure to other parts of the body , even though hand exposure often constitutes the majority of the total body exposure 2. The value of hand surface area

used by CEB i

s not current. 3. The current input parameters for hand exposure using the CEB method are found to be very similar to the PHED data. The PHED data for other parts of the body could be used with the CEB method.Options for Revisi ng CEB Dermal Method - Final 06/00

2.2 4. Available data in the literature indicate a maximum dermal retention of 10 mg/cm2 for solids and 4 to 10 mg/cm2 for liquid. 5. The deposition approach currently used by CEB is appropriate for solid or particulate media. The dermal absorption approach whereby a skin permeation coefficient is used to estimate absorbed dose directly, is theoretically more appropriate for evaluating exposure to chemicals in a liquid media. Recommendations for improving the CEB method. 1. The EPA (1987) values for skin surface area should be used. (Note: the values for hands and forearms were 820 and 1210 cm2 respectively)

. 2. Current  Q  values used by CEB generate exposure estimates that fall in the upper range of the distribution of the applicable field data. However, characterization of CEB estimates as b

ounding estimate

s should be reeva

luated for some op

erations. 3. Data from PHED for other parts of the body should be used with the current CEB method. 4. The skin permeation approach is more appropriate for estimating dermal absorption for liquid media but further development is needed before this will be a viable approac

h for industrial sc

enarios. Data on dermal exposure from the PHED database is provided in Appendix 1.1. 2. A Laboratory Method to Determine the Retention of L iquids on the Surface of the Hands - EPA, 1992a This was the final report of the work first presented in the 1984 Versar draft. The data on the three water-based liquids from the earlier report were dropped from this report be cause of uncertainties in the data. This updated report also provided a more rigorous treatment of the earlier data on the remaining 3 liquids. The updated data is presented in Appendix 1.2. 3. EPA Exposure Facto

rs Handbook, 1997 (

Final Report) This reference provides agency sta ndards for exposure factors to be used in assessments. The mean value for the skin surface area of the hands for men based on measur ed data is 840 cm2, in contrast to the estimate of 1300 cm2 that CEB currently uses from the Popendorf model. A table of skin surface area for various parts of the body presented in the EPA Exposure Factors Handbook can be found in Appendix 1.3.Options for Revisi ng CEB Dermal Method - Final 06/00

2.3 4. Exposure and Release Estimations for Filter Press and Tray Dry er Operations Based on Pilot Plant Data, USEPA, 1992b. This study measured dermal exposure during unloading of a filter ca ke from a plate and frame filter press and subsequent loading of a stationary tra y dryer. Details and re

sults are presented in Appendix 1.4. 5. S kin Exp osu re t o Ca lci um C arbo nat e in the Pai nt In dus try - Lansink, et. al., 1996. This was a dermal monitoring study conducted during the manufacture of powdered paint. Exposures were monitored for workers involved in weighing, dumping and handling of bags. Details and results are presented in Appendix 1.5. 6. Worker Dermal Exposure to Trichloroketone , Anonymous,1996 This report prese

nts the results of a

dermal monitoring

study conduc

ted by a PMN submitter. Exposure was measured for chemical operators and workers involved in maintenance activities. A detailed summary is presented in Appendix 1.6.Options for Revisi ng CEB Dermal Method - Final 06/00

3.1 

### SECTION 3 - OPTIONS FOR REVISING THE CEB METHOD This section presents a range of potential options for revising the CEB method based on the studies previously described. Option 1 - Do Nothing This is not a viable option. At a minimum, CEB needs to follow the recommendation from the peer reviewed research report that stated our current value for skin surface area is not current and recommended adopting the value from EPA, 1987a. Option 2 -Exposure Factors Handbook (EFH) skin surface area of hand, Current Q  values This option would incorporate the recommendation of revising the skin surface area estimate for the h

and. Also, using th

e  Q  values from the 1984 Versar repor t would maintain consistency with EAB. However, using the  Q  values from the 1984 report would ignore the fact that the experiments were redone and the data on the water-based liquids was ultimately disca rded in the 1992 final report. It would also set a bad precedent by giving higher weight to a draft report than to a final, which w

ould undermine the

credibility

of the method. I

t also would continu

e the use of the highly questionable and frequently criticized value of 14 mg/cm2 for immersion which would also ignore

one of the importa

nt findings from th

e 1996 researc

h report that ava

ilable data in the literature indicate a maximum dermal retention of 4 to 10 mg/cm2 for liquids and 10 mg/cm2 for solids. Therefore, this option is also not a viable option. Option 3 - Option 2 Plus  Q  values from EPA, 1992b This option would incorporate the 1996 report  s findings on skin surface area and maximum dermal retention for liquids and solids from available data, and use the  Q  values from the final re

port of the Versa

r research. Al

l 3 of these facto

rs would signific

antly incre

ase the credibility of the CEB method. Using the EFH values for skin surfac e area would also make CEB consistent with the Office of Pesticides. This is the minimum option for CEB to consider and would result in the following table.Options for Revisi ng CEB Dermal Method - Final 06/00

3.2 Table 4: Typical Factors for Calculation of Dermal Exposure

Activity Typical Examples S 1 (cm 2) Q 2

(mg/cm 2) Resulting Typi cal Contact (mg) Routine immersion, 2 hands" Handling wet sur

faces" Filling/dumping containers of powders, fl

akes, granul

es" Spray painting 840 1.3 - 10.3 1,100 to 8,700

Routine co ntact, 2 hands" Maintenance/manual cleaning of equipment" Unloading filter cake" Changing fil

ter" Filling drum w ith liquid 840 0.7 - 2.1 590 to 1,800

Routine co ntact, 1 hand 420 0.7 - 2.1 290 to 880
Incidental co ntact, 2 hands" Connecting transfer line" Weighing powder/ scooping /mixing (i.e., dye weighing) 840 0.7 - 2.1 590 to 1,800

Incidental co ntact, 1 hand" Sampling" Ladling liquid /bench sca le liquid tr

ansfer 420 0.7 - 2.1 290 to 880

Notes: 1 - Values taken f

rom EPA Exposure Fact ors Handbook, 1997 2 - Values taken f

rom Versar,

1992 Option 4 - Option 3 plus  Q  values from PHED database (as reported in SAIC, 1996). The SAIC rese

arch report inve

stigated the PHED

database to find d

ermal monitoring

data that could be compared to the CEB method. Data on open mixing of aqueous suspensions or solutions was judged to be comparable to activities addressed by the CEB method such as f illing of drums with liquid and ladling liquid/bench scale liquid transfer. The PHED  Q  values expressed as 90 thpercentile estimated exposure with 4 hrs of exposure using time normalized data ranged from 0.5 - 1.8 mg/cm2.Options for Revisi ng CEB Dermal Method - Final 06/00

3.3 This option incorporates these data into the CEB dermal assessment table. The only net changes from option 3 are to change the  Q  value range from 0.7 - 2.1 to 0.5 - 2.1 and to report that the basis for t

his range is both V

ersar, 1992 and PH

ED. There are s

ignificant adva

ntages to doing this in terms of the credibility of the CEB method. One, it now expands the basis of the CEB  Q  values from laboratory simulation to include actual field monitoring data (albeit for pesticides). I

t also addresses a

regularly voiced criticism o

f the current CEB

method that it doesn  t utilize data available from another EPA program office. The dermal table for this option is as follows. Table 5: Typical Factors for Calculation of Dermal Exposure

Activity Typical Examples S 1 (cm 2) Q

(mg/cm 2) Resulting Typi cal Contact (mg) Routine immersion, 2 hands" Handling wet sur

faces" Filling/dumping containers of powders, fl

akes, granul

es" Spray painting 840 1.3 - 10.3 2 1,100 to 8,700

Routine co ntact, 2 hands" Maintenance/manual cleaning of equipment" Unloading filter cake" Changing fil

ter" Filling drum w ith liquid 840 0.5 - 2.1 2,3 420 to 1,800

Routine co ntact, 1 hand 420 0.5 - 2.1 2,3 210 to 880
Incidental co ntact, 2 hands" Connecting transfer line" Weighing powder/ scooping /mixing (i.e., dye weighing) 840 0.5 - 2.1 2,3 420 to 1,800

Incidental co ntact, 1 hand" Sampling" Ladling liquid /bench sca le liquid tr

ansfer 420 0.5 - 2.1 2,3 210 to 880

Notes: 1 - Values taken f

rom EPA Exposure Fact ors Handbook, 1997 2 - Values taken f

rom Versar,

1992 3 - PHED (as report

ed in SAIC, 1996)Options for Revisi ng CEB Dermal Method - Final 06/00

3.4 Option 5 - Option 4 (for liquids) Plus Separate Table for Solids (  Q  or mg/day exposure taken from PHED (as reported in SAIC, 1996), USEPA, 1992 and Lansink, et.al., 1996). The current CEB method and the tables in the previous options all use data on dermal exposure to liquids as a basis for making estimates for solids. At the time the CEB method was developed, data on dermal exposure to solids was unavailable so the Versar liquid data was the best data available. However, data on solids is now available (as described in Section 2 and presented in the Appendix). This option utilizes the solids data as a more appropriate basis for estimating dermal exposure to powders in keeping with CEB  s exposure assessment hierarchy as summarized below. CEB  s Exposure Assessment Hierarchy (in decreasing order of preference) 1. Monitoring data for the substance of concern 2. Data on analogous substances 3. Generic scenarios 4. Regulatory standards 5. Models In this option, assessment factors for activities involving solids are derived from the available data o

n solids exposure fr

om the PHED databa

se, EPA, 1992 and L

ansink, 1996. This data is summarized below.
# Worker Activity Data Summary 1 Filter cake removal 0.05 - 0.79 mg/cm2 (0.30 mg/cm 2 - avg) USEPA, 1992
2 Loading of tray dry er 0.01 to 0.083 mg/cm 2 (0.046 mg/c m2 - avg) USEPA, 1992
3 Tray Unloading 0.006 to 0.088 mg/c m2 (0.039 mg/c m2 - avg) USEPA, 1992
4 Open mixing of wett able powder 0.79 mg/cm2 (mean) 1.7 mg/cm2 (90%) PHED (as reporte d in SAIC, 1996) 5 Collection of raw material 139 to 1090 mg 476 mg(mean) 1064 mg (90%) Lansink, 1996

6 Manual Weighing 247 to 2511 mg 685 mg(mean) Lansink, 1996Options for Revisi ng CEB Dermal Method - Final 06/00 # Worker Activity Data Summary

3.5 7 Manual Dumping 123 to 4214 mg 888 mg (mean) 3046 mg(90%) Lansink, 1996

8 Collection and removal of empty bag

s 53 to 1042 mg

215 mg (mean) 1039 mg (90%) Lansink, 1996

In deciding

what values to use

for a dermal ass

essment factors t

able, it was usefu

l to consider the purp

ose of the table. T

he dermal assess

ment factor table

is intended for use

in screening-level assessments, therefore values that would result in a conservative, scre ening-level estimate were chosen. For each activity, this consisted of the 90% value s where available or the high-end of the range if the 90% value was not given. This selection of conser vative values could be further emphasized by changing the name of the table to  Factors for Screening-Level Assessments of De

rmal Exposures 

. The dermal exposure assessment factor tables for liquids and solids for this option are provided below.Options for Revisi ng CEB Dermal Method - Final 06/00

3.6 Table 6a: Factor

s for Screening-Lev

el Assessments

of Dermal Exposure

- Liquids

Activity Typical Examples S 1 (cm 2) Q

(mg/cm 2) Resulting Typi cal Contact (mg) Routine immersion, 2 hands" Handling wet sur

faces" Spray painting 840 1.3 - 10.3 2 1,100 to 8,700

Routine co ntact, 2 hands" Maintenance/manual cleaning of equipment" Filling drum w ith liquid 840 0.5 - 2.1 2,3 420 to 1,800

Routine co ntact, 1 hand 420 0.5 - 2.1 2,3 210 to 880
Incidental co ntact, 2 hands" Connecting transfer line 840 0.5 - 2.1 2,3 420 to 1,800

Incidental co ntact, 1 hand" Sampling" Ladling liquid /bench sca le liquid tr

ansfer 420 0.5 - 2.1 2,3 210 to 880

Notes: 1 - Values taken f

rom EPA Exposure Fact ors Handbook, 1997 2 - Values taken f

rom Versar,

1992 3 - PHED (as report

ed in SAIC, 1996)Options for Revisi ng CEB Dermal Method - Final 06/00

3.7 Table 6b: Factor

s for Screening-Lev

el Assessments

of Dermal Exposure

- solids

Activity Typical Examples S 1 (cm 2) Q

(mg/cm 2) Resulting Dermal

Contact (mg) Routine co ntact, 2 hands" Filling/dumping containers of powders, fl

akes, granul

es 1400-3000 2

Routine co ntact, 2 hands" Unloading filter cake" Changing fil

ter" Handling bags of raw materials (full or empty) 840 0.8 3 660 1100 4

Incidental co ntact, 2 hands" Weighing powder/ scooping /mixing (i.e., dye weighing)" Loading, unloadin

g tray dryer 840 0.1 3 1400 - 2500 2

100

Notes: 1 - Values taken f

rom EPA Exposure Fact ors Handbook, 1997 2 - Low-end of range f

rom PHED (as reported in SAIC, 1996) 90 th percentile estimate of

1.7 mg/cm2 for open mixing of

wettabl e powders and 840 c

m2 surface

area. Hig

h-end of r

ange from La

nsink, 1996 3 - Values taken f

rom USEPA, 1992 4 - Lansi nk, 1996 The activity,  Handling bags of raw materials (full or empty) wa s not previously part of CEB  s dermal assessment factors table. The issue of the appropriate selection of terms such as

 routine  and  incidental  to characterize the frequency

of contact is not pa

rt of the scope of

this paper. This activity has been included in the  routine  contact category because that would be more conservative from EPA  s standpoint for risk screening purposes. On another note, the activity of  filling/dumping of powder, flakes, and granules  is no longer categorized as  routine immersion  since the immersion data for liquids from the EPA, 1992 report is no longer used as a basis for estimate.Options for Revisi ng CEB Dermal Method - Final 06/00

3.8 Option 6 - Option 5 Plus Use of Data on Liquids from PMN Study One study that has not yet been utilized in developing the above options is the study performed by a PMN submitter (Anonymous, 1996). This study did yield some useful data and this option discusses the possibility of incorporating this data into the table of factors for screening-le

vel assessments of

dermal exposure to

liquids. The data from the study is summarized below. Table 7: Data from

PMN Study Activity Data (Exposure to t he hands) (mg) Process Operators 2.42; 0.016; 0.0069; 0.0027; 0.0025; 0.512 Maintenance mechanics 0.008; 0.005; 0.00086; 505.2 1 ; 310.1 1 Note: 1- this activity

included repair

of a leaky p

ump In considering whether to add case-specific monitoring da ta to a table of factors for screening-level assessments, the key question to ask is:  Is there enough information in the study to make a case tha

t the result could b

e considered re

presentative of

a reasonable wo

rst-case exposure?  If so, then the data from the study could be considere d for incorporation into the table. For the case of process operators, no such case can be made. Althoug h the study does provide descript

ions of the duties, t

here is not enoug

h information to co

nclude that the re

sults obtained on the day of monitoring include a high-end result. The data may in fact be at the lower-end of the

potential exposure

range. Furthe

r monitoring would

need to be done to g

et a better understa

nding of the exposu

re potential for t

his activity.

Therefore, the

data for this activity, a lthough useful fo

r the PMN specific

assessment it was d

eveloped for, a

nd useful in general by

CEB for more ref

ined estimates of d

ermal exposure, is

not appropriate f

or inclusion in a table of facto

rs for screenin

g-level assess

ments. The data on the maintenance mechanics is a different story. I t does seem to include a condition that coul

d be considered r

easonable worst

-case (repair

of pump leaks). Th

is is evidenced by the fact that the exposure for these workers is more than 4 or ders of magnitude greater than the exposure for workers who did not repair leaking pumps. In consideri

ng whether to inc

orporate this dat

a, it is useful to re

fer to the Option 5 t

able for liquids which pr

esents a range

of 420 to 1800 mg fo

r maintenance. T

he result from the

PMNOptions for Revisi ng CEB Dermal Method - Final 06/00

3.9 study already falls within this range so one option is to keep the factors as they are and note that it is further suppor

ted by data f

rom a field study

. The alternative

would be to presen

t a specific estimate for main

tenance - pump re

pair. Although a

ttractive, it is ar

gued here that

this is less preferable because it sets a precedent for over complicating the ta ble by presenting very

casespecific factors (Do we also include maintenance - distillation column repair, maintenance - dry er repair, etc.?) I

t can also be arg

ued that this would a

lso be less credib

le since more dat

a would need to be gathe

red to say w

ith confidence th

at the high-end

estimate of exposur

e for pump repair is only up to 505 mg and for general maintenanc e it is up to 1800 mg. Therefore, the

only net cha

nge caused by

including the re

sults from the PMN stu

dy is to expand the basis for the estimate for maintenance/manual cleaning of equipment in the Option 5 liquids table. Tabl

e 1a from Option 5 w

ould now look as foll

ows. Table 8a: Factor

s for Screening-Lev

el Assessments

of Dermal Exposure

- Liquids

Activity Typical Examples S 1 (cm 2) Q

(mg/cm 2) Resulting Dermal

Contact (mg) Routine immersion, 2 hands" Handling wet sur

faces" Spray painting 840 1.3 - 10.3 2 1,100 to 8,700

Routine co ntact, 2 hands" Maintenance/manual cleaning of equipment 840 0.5 - 2.1 2,3 420 to 1,800 2,3,4

Routine co ntact, 2 hands" Filling drum w ith liquid 840 0.5 - 2.1 2,3 420 to 1,800
Incidental co ntact, 2 hands" Connecting transfer line 840 0.5 - 2.1 2,3 420 to 1,800

Incidental co ntact, 1 hand" Sampling" Ladling liquid /bench sca le liquid tr

ansfer 420 0.5 - 2.1 2,3 210 to 880

Notes: 1 - Values taken f

rom EPA Exposure Fact ors Handbook, 1997 2 - Values taken f

rom Versar,

1992 3 - PHED (as report

ed in SAIC, 1996) 4 - Anonymous, 1996Options for Revisi ng CEB Dermal Method - Final 06/00

3.10 Option 7 - Option 6 Plus Grouping Data from Similar Solids Activities This option explores t

he possibility

of grouping da

ta from similar soli

ds activities to simplify the solids table. Previous options sep

arated the resu

lts from the pilot pla

nt filtration study

into separate estimates for unloading filter cake/changing the filter and loading/unloading tray dryer. The problem in doing that is that the data set is limited (only 1 pilot-scale study), and g ives a result of 100 mg for loading/unloading tray dry er that is significantly lower than for the other activities. Inferring that exposure for this activity is significa ntly lower than for other solid handling activities is hard to defend given the limited data it is based on. It also goes against the intent of these tables to pr

esent conserva

tive estimates for

screening pur

poses. A more preferred approach would be to view the activities of filter unloading and tray dryer loading/unloading more gener ally and classify the activity as,  Handling wet or dried material in a filtration and drying process  . The high-end result measured for unloading filter cake could still be used as the screening-level assessment factor for this more gene rally described activity. Previous options also had separate assessments for the activities of  filling/dumping conta iners of pow der, f

lakes , granu les  , and for  weigh ing po wder/ scoop ing/m ixin g  . The S AIC research report recommended applying the same PHED data to both activities. The data from the Lansink, 1996 study showed small differences in the resulting e xposure from these activities. Clustering these two activity descriptions into one group would be consistent with these two reports and have the added advantage of simplifying the solids table. The liquids table f

or this option would b

e the same as for

option 6. The solids ta

ble incorporating t

hese changes w

ould look as follows

.Options for Revisi ng CEB Dermal Method - Final 06/00

3.11 Table 8b: Factor

s for Screening-Lev

el Assessments

of Dermal Exposure

- solids

Activity Typical Examples S 1 (cm 2) Q

(mg/cm 2) Resulting

Dermal Contact (mg) Routine co ntact, 2 hands" Filling/dumping containers of powders, fl

akes, granul

es" Weighing powder/ scooping /mixing (i.e., dye weighing) 1400 - 3000 2

Routine co ntact, 2 hands" Handling wet or dried material in a filtration and drying process 840 0.8 3 660

Routine contact" Handling ba

gs of raw

materia ls (fu ll or empty) 1100 4

Notes: 1 - Values taken f

rom EPA Exposure Fact ors Handbook, 1997 2 - Low-end of range f

rom PHED (as reported in SAIC, 1996) 90 th percentile estimate of

1.7 mg/cm2 for open mixing of

wettabl e powders and 840 c

m2 surface

area. Hig

h-end of r

ange from La

nsink, 1996 3 - Values taken f

rom USEPA, 1992 4 - Lansi nk, 1996 Option 8 - Option 7 Plus Dermal Assessment Factors for Other Parts of the Body As previously discussed, CEB  s peer reviewed dermal research report recommended that the data from the PHED for other parts of the body should be used with the current CEB method. Table 8-1 from that report is reproduced below.Options for Revisi ng CEB Dermal Method - Final 06/00

3.12 Table 8-1 from SAIC, 1996: Recommended Dermal Retention Rates as Input paramet ers for the CEB Dermal Exposure Estimating Method Dermal Retention (ug/cm2) Body Section Mixing of Aqueous Suspension Mixing of Soluti on Mixing of Wettable Powder with L iquid Dry Mixing of Granu le Head/Face 15 15 10 20 Shoulder 10 10 110 50 Upper Arms 1 5

 30 Chest 60 40 120 60 Back 10 10 100 10 Forearms 10 50 240 240 Thigh 110 30 90 160 Shin or Calf

 30 30

 Ankle 10

 1


These values were taken from the estimated 90thpercentile deposition from the PHED database. The judgement given in the report was that the liquid mixing results could be applied to CEB  s activities of filling drums with liquid and ladling liquid/bench scale liquid transfer. The solid mixing results could be applied to the activities of filling, dumping containers of powder, flakes, granules and weighing powder/scooping/mixing. The resulting assessment factors for other parts of the body based on these data ar e presented below.Options for Revisi ng CEB Dermal Method - Final 06/00

3.13 Table 9: Factors for Screening-Level Assessments of Dermal Exposure to Other Parts of the Body for Work Act

ivities Involving Tran

sfer of Liquids (Filling dr ums with liquid, ladling liquid, bench-scale liquid transfer)

Body Section S 1 (cm 2) Q 2

(mg/cm 2) Resulting Dermal Contact 3(mg) Head/Face 1180 0.015 20 Shoulders 1319 0.010 15 Upper Arms 1430 0.001 - 0.005 1 - 10 Chest 1550 0.040 - 0.060 60 - 90 Back 1550 0.010 20 Forearms 1140 0.010 - 0.050 10 - 50 Thigh 1980 0.030 - 0.110 60 - 200 Shin or Ca lf 2070 0.030 60 Ankle 1120 0.010 10 Notes: 1 - Values taken from EPA Exposure Factors Handb ook, 1997 except for Shoulders, Back and Chest which were derived f rom Percenta

ges in Popendor

f anatomi

c model (CEB, 1991) an d the tot al mean su

rface ar ea for men of

1.94 m2 (EPA, 1997) 2 - Values taken f

rom Table 8-1 i

n SAIC, 1996 3 - Values ro unded to nearest 10 (as in 10, 20 etc.)Options for Revisi ng CEB Dermal Method - Final 06/00

3.14 Table 10: Factors for Screening-Level Assessments of Dermal Exposure to Other Parts of the Body for Work Activities Involving Transfer of Solids (filling, dumping containers of powder, flakes, granule s and weighing powder/scoop ing/mixing

)

Body Section S 1 (cm 2) Q 2

(mg/cm 2) Resulting Dermal Contact 3(mg) Head/Face 1180 0.010 - 0.020 10 - 20 Shoulders 1319 0.050 - 0.110 70 - 150 Upper Arms 1430 0.030 40 Chest 1550 0.060 - 0.120 90 - 190 Back 1550 0.010 - 0.100 20 - 160 Forearms 1140 0.240 270 Thigh 1980 0.090 - 0.160 180 - 320 Shin or Ca lf 2070 0.030 60 Ankle 1120 0.001 1 Notes: 1 - Values taken from EPA Exposure Factors Handb ook, 1997 except for Shoulders, Back and Chest which were derived f rom Percenta

ges in Popendor

f anatomi

c model (CEB, 1991) an d the tot al mean su

rface ar ea for men of

1.94 m2 (EPA, 1997) 2 - Values taken f

rom Table 8-1 i

n SAIC, 1996 3 - Values ro unded to nearest 10 (as in 10, 20 etc.) Option 9 - Option 8 Plus

Formal Inco

rporation of CEB

Guidance for Qu

alitative Assessme

nts into CEB Dermal Method The CEB Manual pr

esents guidanc

e for qualitative

assessments of de

rmal exposure in cases where dermal exposure can  t be quantified. This guidance has been used historically by CEB in assessments for new and existing chemicals. In this option, the guidance would be formally incorporated into the CEB method for Screening-L evel Assessments of Dermal Exposure. This guidance is presented in the table below.Options for Revisi ng CEB Dermal Method - Final 06/00

3.15 Table 11: CEB Method for Screening-Level Assessments of Dermal Exposure - Qualitative Assessments Category Dermal Assessm ent - Corrosives (pH >12, pH <2) Negligible - Materials at temperatures >140 deg. F (60 deg. C) Negligible - Cast Solids (such a

s molded plastics)/

PMN in matrices such a

s extruded pellets Ex. C hemic al is a n addi tive for pla stics . It has been physically mixed and incorporated into a plastic pellet but not chemically reacted away. Non-Quantifiabl e(Some surface contact may occur if manually transferred) Workers handling the plastic in the form of pellets could get surface contact with the chemical additive.

-  Dry  surface coatin

gs (e.g., fibe

r spin finishes) Non-Quantifiable (If manual ha ndling is necessary and there is an indication that the material may abrade from the surface, quantify contact with fingers/palms as appropriate) - Gases/Vapors Non-Quantifiable (Some contact may occur in the absence o f protectiv e clothing)Options for Revisi ng CEB Dermal Method - Final 06/00

4.1 

### SECTION 4 - RECOMMENDATION Based on review of the available information, the following key factors have been identified for consideration in revising the current CEB method. 1. Revise estimate of skin surface ar

ea of the hand (Re

commendation in SAI

C, 1996). 2. Replace  Q  values from 1984 Versar report with the EPA, 1992a report (experiments wer

e redone - 1992 w

as final report) 3. Available data indicate a maximum dermal retention of 4 to 10 mg/cm2 for liquids and 10 mg/c

m2 (Conclusion in Pee

r Reviewed Resea

rch report) 4. Use  Q  values from PHED database. (Data from actual field monitoring and from other EPA program office.) 5. Use data from dermal studies w solids for solids handling activities (more appropriate basis than liquids data) 6. Use data from PMN dermal monitoring study (non-pesticide field data for a liquid) 7. Use data from the other parts of the body with the current CEB method (Recommendation of the Peer Reviewed Research). 8. Formally adopt historical guidance for qualitative assessments as part of of ficial CEB Dermal method.Options for Revisi ng CEB Dermal Method - Final 06/00

4.2 The following ta

ble illustrates whi

ch factors are

included by

the 9 different o

ptions. Table 12: Key Factors Addressed in Each Option Key Factor Option 1 Opti o n

2 Option

3 Option

4 Optio n

5 Option

6 Optio n

7 Option

8 Option

9 Revise skin s

urface area x x x x x x x x Use EPA, 1992a

 Q  values x x x x x x x
Max. Dermal retent ion for l iquids and solids of 10 mg/cm2 x x x x x x x

Use PHED Data for liquids x x x x x x
Use solids data x x x x x Use dat a f rom PMN study x x x x
Use PHED data from other part

s of body x x Adopt CEB qualitati ve guidance x
The recommended option is #9 since it incorporates all of the key factors. This option along with the remainder of this report was presented to the Chemical Engineering B ranch for review and comme

nt. A summary

of this review; inc

luding issues, co

mments, and respon

ses, is presented in Appendix B of this report. This internal review resulted in the following modifications to the recommended option. 1. The terms  routine  and  incidental  branch are left in the CEB method for now but it will be noted that they

reflect ty pical CEB judge

ments of the likelih

ood of contact fo

r the example activities. 2. The term  activity  used in CEB Manual and options is changed to  Type of Contact  and each type of contact will have a unique name to help CEB distinguish betwe en the assumptions associated with each.Options for Revisi ng CEB Dermal Method - Final 06/00

4.3 3. The highes t values in ranges with t erm  up to  will be use d since thi s table is for screenin glevel purposes. 4. The methodology for assessing exposure to other parts of the body needs more development and input from risk assessors so it won  t be included as part of the CEB method for now.
Incorporat

ing these modific

ations resulted in t

he following tab

le which along w

ith table for qualitative assessments (Table 11) is the recommended option for revising CEB  s method for screening-le

vel dermal assessments.Options for Revisi ng CEB Dermal Method - Final 06/00

4.4 Table 13: Factor

s for Screening-Lev

el Assessments

of Dermal Exposure

to the Hands

Type of Contact 1 Typical Examples S 2 (cm 2) Q 3

(mg/cm 2) Resulting Dermal

Contact (mg) Routine, direc

t handling of solids - 2 hands" Filling/dumping containers of powders, fl

akes, granul

es" Weighing powder/ scooping /mixing (i.e., dye weighing)" Handling wet or dri

ed material in a filtration and drying process up to 3100 4

Routine co ntact with surfaces - 2 hands - solids" Handling bags of solid materials (clo sed or em pty) up to 1100 4

Routine immersion, 2 hands - l

iquids"

Handling wet sur

faces" Spray painting 840 1.3 - 10.3 up to 8,700

Routine co ntact, 2 hands - l

iquids"

Maintenance" Manual cleaning of equipment" Filling drum w ith liquid 840 0.7 - 2.1 up to 1,800

Incidental co ntact, 2 hands - l iquids"

Connecting transfer line 840 0.7 - 2.1 up to 1,800

Incidental co ntact, 1 hand - li quids"

Sampling" Ladling liquid /bench sca le liquid tr

ansfer 420 0.7 - 2.1 up to 900

Notes: 1- The term s  routine  and  incidental  reflect typical CE B judge ments on likelih ood of co ntact for the exa mple activities. 2 - Values of the skin surface area of t he hands taken from: EPA Exposure Factors Handb ook, 1997 and are the mean values for men 3 - Selected ranges of  Q  Values for liq uid handling activities taken fro m: EPA , 1992. A Labora tory Meth od to Determine t

he Retent

ion of Li quids on t

he Surface of Hands, Exposure Eval uation Di

vision, Office of Poll

ution Preventi on and Toxic, USEPA, EPA 747-R-92-003, Sept ember, 1992. 4 - Values fo r dermal co ntact for solids h andling activities were taken fro m: Lansink, 1 996. Lan sink, C.J.M ., M.S.C . Breelen, J . Marqu art, and J.J. va n Hemm en: Skin Ex posure to Calcium C arbonate in the Paint Ind ustry. Preliminar y Mod eling of Skin E xposure L evels to Po wders B ased on F ield Data (T NO R eport V 96.064 ). Rijswijk, The Nether

lands: TNO Nutrition a nd Food Research

Insti tute, 1996.Options for Revisi ng CEB Dermal Method - Final 06/00

R-1 

### REFERENCES (Anonymous, 1996) Anonymous, Worker Dermal Exposure to Trichloroketone, data submitted

to EPA for the Prema

nufacture Notif

ication Program

. (CEB, 1991) Chemical E ngineering Bra nch Manual for the Prepa ration of En gineering

Assessments, Washington, D.C.: Office of Toxic Substances, U.S. Environmental Protection Agency, 1991. (EPA, 1997) Exposure Factors Handbook - Volume 1: General Factors. USEPA, ORD,

August 1997. EPA/600 /P-95/002Fa (EPA, 1992a) A Laboratory Method to Determine the Retention of L iquids on the Surface of Hands, Exposure Evaluation Division, Office of Pollution Prevention and Toxic, USEPA, EPA 747-R-92-003, September, 1992. (EPA, 1992b) Exposure and Release Estimations for Filter Press and Tray Dry er Operations Based on Pilot Plant Data, Office of Research and Development, Risk Reduction Engineering Laboratory , USEPA, March 1992, EPA/600/R-92/039. (EPA, 1992c) Guidelines for Exposure Assessment. FR Vol. 57, No. 104, May 29, 1992. (EPA, 1987) Pesticide Assessment Guidelines, Subdivision U, Application Exposure

Monitoring, Office of Pesticide Programs, Washington, D.C., 1987, EPA 540/9-87/127. (Lansink, 1996) Lansink, C.J.M., M.S.C. Breelen, J. Marquart, and J.J. van Hemmen: Skin

Exp osu re t o Ca lci um C arbo nat e in the Pai nt In dus try. Pre lim ina ry Modeling of Skin Exposure Levels to Powders Based on Field Data (TNO Report V 96.064). Rijswijk, The Netherlands: TNO Nutrition and Food Research Institute, 1996. (Popendorf and Popendorf, W.J., and J.T. Leffingw ell, Regulatory

organophospha

te Leffingwell, 1982) pesticide residues for farm worker protection, Residue Rev ., 82: 125 - 201. (SAIC, 1996) Science Applica tions Interna

tional Corporation

. Occupational D

ermal Exposure Assessment - A Review of Methodologies and Field Data. Final Report. Prepared for the U.S. EPA, Office of Pollution Prevention and Toxic, Chemical Engineering Branch. September 30, 1996. (Versar, 1984) Versar, Inc., Exposure Assessment for Retention of Chemical Liquids onOptions for Revisi ng CEB Dermal Method - Final 06/00

R-1 Hands, Washington, D.C., Exposure Evaluation Division, U.S. Environmental Protection Agency, Contract No. 68-01-6271Options for Revisi ng CEB Dermal Method - Final 06/00

A-1 

### APPENDIX 1. DATA FROM DERMAL STU DIES USED TO REVISE THE CEB METHOD 1.1 Pesticide Handle rs Exposure Databas

e 1.2 USEPA, 1992a. A Laboratory Method to Determine the Retention of Liquids on the Surface of the Hands 1.3 EPA Exposure Factors Handbook, 1997 (Final Report) 1.4 USEPA, 1992b. Exposur e and Release Estim

ations for Filter

Press and Tray Dryer Operations Based on Pilot Plant Data

. 1.5 Skin Exposure to Calcium Carbonate in the Paint Industry - Lansink, et. al., 1996. 1.6 Worker Derma

l Exposure to Trichlo

roketone, Anonymous,1996 

### 2. CEB Review of Rec

ommended OptionOptions for Revisi ng CEB Dermal Method - Final 06/00

A-2 

### 1.1 Pesticide H

andlers Exposure DatabaseOptions for Revisi ng CEB Dermal Method - Final 06/00

A-3 PHED DATA FOR MIXING/LOADING OF SOLIDS (as reported in SAIC, 1996. Occupational Dermal Exposure Assessment - A Review of Methodologies and Field Data, Prepared for CEB) Source: Mixer-Loader

from PHED Databa

se Description: The PHED (Pesticide Handlers Exposure Database) is a generic database containing measured inhalation and dermal exposure data for workers involved in the handling or application of pesticides in the field. The database is designed to allow prediction of pesticide exposure during mixing/loading, application, and flagging operations, based on any selected combination of for

mulation type

s, mixing/loading p

rocedures, app

lication equipmen

t, procedures, clothing scenario or other parameters that may e relevant to exposure. It contains exposure data generated by the EPA and pesticide reg istrants. In submitting the data, each registrant is required to develop the information following EPA guidelines and use the standard Exposure s urvey forms for record keepi ng. The database contains 1700 records total. There are 556 records with dermal exposure data under the mixe

r loader file. Th

ere are 4 ty

pes of solid formula

tions handled - we

ttable powder, dry flowable solid, dust and granules. There ar e 5 types of liquid formulations handled - emulsifiable concentrate, aqueous suspension, micro encapsulated, solution, and undiluted liquid.. There are 3 types of mixing methods, (1) - open, (2) closed, mecha nical pump; (3) closed, gravity feed. Results - Solids TABLE 1: Estimated Gross Dermal Deposition Normalized by Quantity of Chemical Handled (ug/cm2/lb) and Time (ug/cm2/hr) from PHED for Wettable Powder in Bags with Open Mixing
Body Section Number of

Measurements Mean

(ug/cm2/lb) 90 thPercentile

(ug/cm2/lb) Mean

(ug/cm2/ hr) 90 thPercentile

(ug/cm2/ hr) head 10 0.039 0.075 0.7217 2.110 neck front 0 neck back 0 shoulder 13 0.2062 0.4742 8.4135 27.16Options for Revisi ng CEB Dermal Method - Final 06/00 Body Section Number of

Measurements Mean

(ug/cm2/lb) 90 thPercentile

(ug/cm2/lb) Mean

(ug/cm2/ hr) 90 thPercentile

(ug/cm2/ hr)

A-5 upper arms 0 chest 16 0.1322 0.2143 8.9699 28.56 back 16 0.0666 0.1323 7.0829 25.60 forearms 18 0.9216 1.7605 15.438 59.04 thigh 16 0.3992 0.5127 8.7805 22.73 shin 4 0.0893 0.1754 3.7546 8.129 calf 0 ankle 4 0.0458 0.0850 0.0542 0.136 hands 7 18.991 53.21 197.48 419.51
TABLE 2: Estimated Gross Dermal Deposition Normalized by Quantity of Chemical Handled (ug/cm2/lb) and Time (ug/cm2/hr) from PHED for Wettable Powder in Packets with Open Mixing
Body Section Number of

Measurements Mean

(ug/cm2/lb) 90 thPercentile

(ug/cm2/lb) Mean

(ug/cm2/ hr) 90 thPercentile

(ug/cm2/ hr) head 15 0.0027 0.0098 0.0996 0.4865 neck front 3 0.0009 0.0014 0.0360 0.0638 neck back 6 0.0004 0.0006 0.0142 0.0295 shoulder 6 0.0013 0.0020 0.0102 0.0150 upper arms 0 chest 15 0.0028 0.0098 0.1044 0.4865 back 15 0.0026 0.0098 0.0953 0.4865 forearms 15 0.0072 0.0098 0.2384 0.5358 thigh 15 0.0218 0.0808 0.7704 2.928 shin 3 0.0004 0.0005 0.0162 0.0258 calf 6 0.0032 0.0066 0.0300 0.0703 ankle 3 0.0011 0.0023 0.0407 0.0938 hands 5 0.0265 0.0557 0.0954 2.185 PHED DATA FOR MIXING/LOADING OF LIQUIDSOptions for Revisi ng CEB Dermal Method - Final 06/00

A-6 Results - Liquids TABLE 3: Estimated Gross Dermal Deposition Normalized by Quantity of Chemical Handled (ug/cm2/gal) and Time (ug/cm2/hr) from PHED for Aqueous Suspension with Open Mixing
Body Section Number of

Measurements Mean

(ug/cm2/gal)* 90 thPercentile

(ug/cm2/gal) Mean

(ug/cm2/hr)* 90 thPercentile

(ug/cm2/ hr) head 15 0.1668/0.0100 0.0584 2.7576 3.215 neck front 0 neck back 0 shoulder 16 0.0292 0.0325 1.6373/0.4056 1.626 upper arms 6 0.0083 0.0142 0.1111 0.2118 chest 16 0.5980/0.0040 0.2919 29.166/0.7839 15.90 back 16 0.0200 0.0442 1.1407 2.600 forearms 6 0.0934 0.1776 1.1038 2.157 thigh 16 0.4971 1.1067 19.825 28.40 shin 10 5.1433 5.6337 318.58/42.53 272.06 calf 0 ankle 6 0.0809 0.1993 1.1945 2.921 hands 16 10.685 33.42 180.55 444.27 * where two number

s are present

ed, the fi rst is t he estimat

ed mean and the second is t he median TABLE 4: Estimated Gross Dermal Deposition Normalized by Quantity of Chemical Handled (ug/cm2/ga

l) and Time (ug/cm

2/hr) from PHED

for Solution with Open Mixing
Body Section Number of

Measurements Mean

(ug/cm2/gal)* 90 thPercentile

(ug/cm2/gal) Mean

(ug/cm2/hr)* 90 thPercentile

(ug/cm2/ hr) head 23 0.0267 0.0742 0.0667 3.253 neck front 0 neck back 0 shoulder 16 0.0334 0.0626 0.0699 2.095 upper arms 16 0.0067 0.0100 0.0224 1.142Options for Revisi ng CEB Dermal Method - Final 06/00 Body Section Number of

Measurements Mean

(ug/cm2/gal)* 90 thPercentile

(ug/cm2/gal) Mean

(ug/cm2/hr)* 90 thPercentile

(ug/cm2/ hr)

A-6 chest 23 0.0734 0.2519 0.6729 9.127 back 23 0.0467 0.0384 0.0656 1.496 forearms 23 0.0692 0.1351 0.7528 13.25 thigh 23 0.2769 0.2093 5.2377 7.443 shin 0 calf 7 0.0058 0.0125 0.1671 6.599 ankle 16 4.3643 14.04 1.4623 88.25 hands 6 0.1665 0.3005 3.5577 115.2 * where two number

s are present

ed, the fi rst is t he estimat

ed mean and the second is t he medianOptions for Revisi ng CEB Dermal Method - Final 06/00

A-7 

### 1.2 USEPA, 1992a. A Laborator y Method to Deter

mine the Retent

ion of Liquids on the Surface of the HandsOptions for Revisi ng CEB Dermal Method - Final 06/00

A-8 Table 1: Surface Ret

ention Rates of Sele

cted Liquids on the Hands U nder Various Experimental Co

nditions
Mineral Oil (mg/cm2) Cooking Oil

(mg/cm2) Bath Oil

(mg/cm2) Initial wipe Initial film thickness of liquids on hands 1.36 2.07 1.49 Film thickness after partial wipe 0.54 0.75 0.51 Film thickness after full wipe 0.24 0.32 0.17 Secondary wipe Initial film thickness of liquids on hands 1.22 1.72 1.34 Film thickness after partial wipe 0.41 0.48 0.41 Film thickness after full wipe 0.05 0.06 0.07 Immersion Estimated film thickness of liquid on hand 10.33 6.02 5.94 Estimated film thick

ness of liquid remaining after partial wipe 1.75 1.33 1.34 Handling a rag Initial film thic

kness of liquid on pa

lms 1.43 1.38 1.76 Film thickness after partial wipe 0.38 0.31 0.46 Film thickness after partial wipe 0.11 0.01 0.18 Spill Cleanup Estimated Init

ial film thickness o

f liquid on hand 1.07 0.67 0.77
Estimated film thick

ness of liquid remaining after partial wipe 0.48 0.47 0.41Options for Revisi ng CEB Dermal Method - Final 06/00

A-9 

### 1.3 EPA Exposure Factors Handbook, 1997 (Final Report)Options for Revisi ng CEB Dermal Method - Final 06/00

A-10 Table 1: Estimates of Skin Surface Area

Men Women Body Part N Mean Min - Max N Mean Min - Max Head 32 1180 900 - 1610 57 1110 953 - 1270
Trunk (Incl. neck) 32 5690 3060 - 8930 57 5420 4370 - 8670
Upper Extremities 48 3190 1690 - 4290 57 2760 2150 - 3330 Arms 32 2280 1090 - 2920 13 2100 1930 - 2350 Upper Arms 6 1430 1220 - 1560 Forearms 6 1140 945 - 1360 Hands 32 840 596 - 1130 12 746 639 - 824

Lower Extremities 48 6360 2830 - 8680 57 6260 4920 - 8090 Legs 32 5050 2210 - 6560 13 4880 4230 - 5850 Thighs 32 1980 1280 - 4030 13 2580 2580 - 3600 Lower Legs 32 2070 930 - 2960 13 1940 1650 - 2290 Feet 32 1120 611 - 1560 13 975 834 - 1150

TOTAL 19,400 16600 - 22800 16900 14500 - 20900Options for Revisi ng CEB Dermal Method - Final 06/00

A-11 

### 1.4 USEPA, 1992b.

Exposure and Release Estimations for F ilter Press and Tray Dryer Operations Based on Pilot Plant Data

.Options for Revisi ng CEB Dermal Method - Final 06/00

A-12 Exposure and Release Estimations for Filter Press and Tray Dry er Operations Based on Pilot Plant Data, USEPA, 1992b. A summary of this study and the measurements of der mal exposure is presented below. Process: Pilot plant utilizing a plate and frame filter press and a stationary tray dryer. A 10% slurry of calcium carbonate in water to y ield approximately 100 kg of dry calcium ca rbonate. Eight experiments were performed. Dermal exposure measured for the activities of filter cake removal, t ray loading and t ray unloading. Monitoring Method: Hand and forearm rinses were performed as per EPA Pesticide Assessment Guidelines. Operator placed one hand inside a bag until the top of the bag extended above the elbow. Approximately 200 ml of milli Q water were poured over the operators forear m. With the bag wrapped tightly around the upper arm of the operator, a field sampling technician rubbed the water in the bag

over the surfac

e of the operator

s hand and forea

rms to wash calciu

m carbonate particles from th

e skin. The opera

tor jiggled is ha

nd/forearm to sha

ke water drople

ts off the skin surface into the

bag. The water

was then poured f

rom the bag into a

glass sample jar

. The rinse procedure was repeated a second time on the same hand/forearm of the oper ator. After the one hand/forearm ha

d been rinsed two t

imes, the other ha

nd/forearm was w

ashed using the s

eparate rinse solution. The rinse water for the right and left hand/forearm rinses were combined into a single sample container.

Data Available: Raw experimental d

ata include the sa

mple volume (in lite

rs) of the derma

l sample obtained from the rinsing of both hands and forearms of the operator and the calcium con cent rat ion in t he s amp le ( mg/ L). T he ca lci um w as co nve rte d to CaC O3 b y mul tip lyin g by a conversion fac

tor of 2.497. Ther

efore mg of exposure to CaCO3 was o btained as follows: Sample volume (L) x Calcium concentration in sample (mg/L) x 2.497 = mg CaCO3 Dermal exposure in mg/cm2 was obtained by dividing the above result in mg by 1980 cm2 (surface area of hands and forearms as per Exposure Factors ha ndbook) Data is also available on the duration of the worker activity and the amount of mater ial processed.Options for Revisi ng CEB Dermal Method - Final 06/00

A-13 Results 1. Activity: filter cake removal Description: Plate and frame filter press. Worker used a spatula to scrape wet filter cake from the filter cloth and the plate and frames of the filter press into the collection bin. Dermal exposure occurred to both the hands and the forearms. Hands were observed to come into contact with the filter cake throughout the operation. Forearms would rub against the filter cloths, plates and frames. Workers processe d 60.5 to 72.9 kg, dr

y weight ba

sis, in a plate and f

rame filter pre

ss obtained from a chemical manufacturing plant Table 1: Dermal Exposure for Filter Cake Removal

Experimen t # Exposure Duration (min) Dermal Ex posure to hands and fore

arms (mg) Dermal Exposure (mg/cm2) 1 111 101 0.051 2 54 520 0.26 3 73 221 0.112 4 72 1560 0.79 Average 601 0.30

2. Activity: Loading of Tray Dryer Description: Operators used a shovel to transfer wet cake from the collection bin onto the dry er tray. The blade of the shovel was used to level the calcium carbona te on the dryer tray. Ha

nds were observed to come into contact with the calcium carbonate as the operator reac hed into the collection bin with the shovel and as he carried the trays into the dry er. A spatula was also used to break up the filter cake and to maneuver the filter cake around the tray surface. This activity involved loading 75.5 to 122.5 kg of product (100%) into a tray dryer.Options for Revisi ng CEB Dermal Method - Final 06/00

A-14 Table 2: Dermal Exposure for Loading of Tray Dryer

Experimen t # Exposure Duration (min) Dermal Ex posure to hands and fore

arms (mg) Dermal Exposure (mg/cm2) 1 17 19.8 0.01 2 16 25.5 0.013 3 33 164 0.083 4 10 62 0.031 5 9 143 0.072 6 14 70.2 0.035 7 25 143 0.072 8 12 93.6 0.047 Average 90.1 0.046

3. Activity: Tray Unloading Description: Dryer was at 120 deg. C. Tray s were hot and workers wore gloves in removing the trays from the dryer. Worker would tile the tray into the collection bin allowing the calcium carbonate to slide into the collection bin. This would cause a dust cloud to be generated. A spatula was used to scrape the residual from the tray into the bin. Operators f urther banged the tray against the side of the collection bin and then banged the spatula against the tray to get as much of the produc

t into the bin as possib

le. Dermal exposur

e during this ope

ration was due to fine solids falling

into the workers g

loves. This activity involved unloading 75.5 to 122.5 kg of product (100%) from a tray dryer Table 3: Dermal

Exposure for Tray Unloading
Experimen t # Exposure Duration (min) Dermal Ex posure to hands and fore

arms (mg) Dermal Exposure (mg/cm2) 1 17 12.5 0.006Options for Revisi ng CEB Dermal Method - Final 06/00 Experimen t # Exposure Duration (min) Dermal Ex posure to hands and fore

arms (mg) Dermal Exposure (mg/cm2)

A-15 2 9 166.4 0.084 3 6 13.8 0.007 4 6 83.2 0.042 5 7 174.2 0.088 6 5 93.6 0.047 7 7 39 0.020 8 5 28.6 0.014 Average 76.4 0.039Options for Revisi ng CEB Dermal Method - Final 06/00

A-16 

### 1.5 Skin Exposure

to Calc ium Car bonate in the Paint Indust ry - Lansink, et. al., 1996.Options for Revisi ng CEB Dermal Method - Final 06/00

A-17 Ski n Ex pos ure t o Ca lci um C arbo nat e in the Pai nt In dus try - Lansink, et. al., 1996. This was a dermal monitoring study conducted during the manufacture of powdered paint. Exposures were monitored for workers involved in weighing, dumping and handling of bags. Details and results are presented in Appendix 1.5. A summary of this study on dermal exposure is provided below. Process: Manufacture of powdered paint. The chosen substance for monitoring is calcium carbonate. Measurements were taken in ten different paint factories. The g oal was to sample 2 workers per site

for a total of 20 sa

mples. Monitoring Method Monitored with 100% cotton gloves to cover the forearm. Workers wore the cotton gloves until the activity finished or up to 30 minutes. After the activity (e.g. collection and removal of empty bags) was finished, gloves were carefully removed from the hands of the workers by the investigator, stored by placing in a polyethylene 1- liter bottle. Samples were extracted with 1.2N

HCL and analy

zed with atomic abso

rption spectrome

try (AAS) f

lame technique. During the different activities the workers wore the cotton gloves until the activity was finished. When the activity took longer than 30 minutes, new sampling gloves were supplied.

Data Available For e ach a cti vit y: - number of samples - exposure duration - quantities handl

ed (# of bags, ma

ss of material) - Min, Max, 10%, 90%, geometric mean exposures - In addition, regression analyses w ere performed to examine the affect of exposure duration, number of bags handled and amount of calcium carbonate handled on exposure. Results and conclusions from these analyses are presented.Options for Revisi ng CEB Dermal Method - Final 06/00

A-18 Results

a. Overall Summary Data Table 1: Mg of ca

lcium carbonate

. # Activity No. of Samples Range

(mg) 10%

(mg) 90%

(mg) Geometric

Mean (mg) 1 Collection of Raw Material 12 139 to 1090 243 1064 476
2 Manual Weighing 6 247 to 2511 685 3 Manual Dumping 19 123 to 4214 216 3046 888 4 Collection and removal of empty bags 14 53 to 1042 55 1039 215

Table 2: Mg of calcium carbonate/hour of exposure

. # Activity No. of Samples Range

(mg) 10%

(mg) 90%

(mg) Geometric

Mean (mg) 1 Collection of Raw Material 12 N.a. N.a. N.a. N.a.
3 Manual Dumping 19 2893 - 32709 4317 26419 10829
4 Collection and removal of empty bags 14 N.a. N.a. N.a. N.a. Where: N.a. = Not applicable (correlation between exposure and duration was not found)Options for Revisi ng CEB Dermal Method - Final 06/00

A-19 Table 3: Mg of calcium carbonate/bag handled

. # Activity No. of Samples Range

(mg) 10%

(mg) 90%

(mg) Geometric

Mean (mg) 1 Collection of Raw Material 12 N.a. N.a. N.a. N.a.
3 Manual Dumping 19 39 - 527 47 217 126 4 Collection and removal of empty bags 14 5.8 - 117 6.1. 86.6 24 Where: N.a. = Not applicable (correlation between exposure and number of bags handled wa s not found) Table 4: Mg of ca

lcium carbonate

/kg of calcium c

arbonate

. # Activity No. of Samples Range

(mg) 10%

(mg) 90%

(mg) Geometric

Mean (mg) 1 Collection of Raw Material 12 N.a. N.a. N.a. N.a.
3 Manual Dumping 19 1.6 - 19.2 1.9 8.7 5.0 4 Collection and removal of empty bags 14 N.a. N.a. N.a. N.a. Where: N.a. = Not applicable (correlation between exposure and kg of calcium car bonate was not found)Options for Revisi ng CEB Dermal Method - Final 06/00

A-20 b. Summaries by

Worker Activity 1. Activity: Collection of raw material Description: Manual collection of raw material (in bags), including bags of calcium ca rbonate, on a pallet or (flat

) car in the store

house of raw mate

rials and transpo

rtation of the raw

material to the place of production. Duration lasted from 1-7 minutes Number of bags: 2-11 Results: 13 samples Range: 139 to 1090

mg 10%: 243 mg 90%: 1064 mg Geometric mean:476 mg No correlation between frequency of contac t and exposure. 2. Activity: Manual weighing Description: Manual weighing of the amount of calcium carbonate (powder) out of bag s, tons, or cans on a balance and collecting the weighed amount in a bag or a can on a pallet. Opened bag was put on the weigher. The calcium carbonate was scooped from the bag into another bag and then the weighe

d calcium carbon

ate was placed o

n the ground or a

pallet. Event: 2-5 minutes 3-38 kg of CaCO3 handled Results: 6 measure

ments Range: 247 to 2511mg Mean: 685 mg 3. Activity: Manual Dumping Description: Cutting bag open, lifting to dumping shelf, emptying into mixer or lifting bag to the dumping shelf, cutting open, dumping the bag into the mixer. Higher exposures resulted when workers swept ma

terial directly

with hands into mixing

vessel. Event: 1-15 minOptions for Revisi ng CEB Dermal Method - Final 06/00

A-21 2-24 bags 10 - 1000 kg of CaCO3 Results: 22 samples Range: 123 to 4214

mg Geometric mean:888 mg 10%: 216 mg 90%: 3046 mg Significant correlation found between exposure and duration, number of bags handled and amount of calcium carbonate handled.

4. Activit y: Collectio n and Remov al of empty Bags Description: Empty bags were brought into a barrel or to a bale press. The exposure occurred by pushing the bags together. Event: 1-3 min 1-24 bags Results: 17 samples Range: 53 to 1042 m g 10%: 55 mg 90%: 1039 mg Geometric mean:215 mg Based on regression analysis, the number of bag s handled was found to have an impact on exposure. There was no correlation of exposure with duration.Options for Revisi ng CEB Dermal Method - Final 06/00

A-22 

### 1.6 Worker Dermal Exposure to Trichloroketone ,Anonymous,1996Options for Revisi ng CEB Dermal Method - Final 06/00

A-23 Worker Dermal Exposure to Trichloroketone , Anonymous,1996 This report prese

nts the results of a

dermal monitoring

study conduc

ted by a PMN submitter. Exposure was measured for chemical operators and workers involved in maintenance activities. A summary is presented below. Process: Production of a site-limited intermediate. Dermal exposure study was conducted on one day of the p

rocess. Monitoring Method: - gloves Nitrile outer and cotton inner gloves were collected for chemical process opera tors and maintenance mechanics. Each pair of nitrile and cotton gloves were worn for a maximum of 2 hours. After the two hours the gloves were removed in a clean non-production area by unexposed personne

l wearing latex g

loves. The glove

s were placed in

a single plastic

sample bag which was then shipped to the Analytical lab. At the lab, the gloves we re removed from the bag and placed

into a jar contain

ing isopropanol.

The solution was the

n analyzed f

or PMN chemical.
- Coveralls, underwear At the end of the workday for subject employ ees, both coveralls and inner full-body underwear were carefully re moved by the subject employees and hande d to unexposed study personnel wearing latex gloves. 100 cm2 patches were cut from the garme nts for various body regions to correspond with body regions in the EPA Pesticide Assessment Guidelines, Applicator Exposure Monitoring. The patches were placed in a plastic sample bag for transport to the analytical lab. At the lab, the patches were removed and plac ed into a jar containing isopropanol. The solution was the

n analyzed f

or PMN chemical. Activity and Exposure

Duration (see att

ached)Options for Revisi ng CEB Dermal Method - Final 06/00

A-24 Data Available The analyt

ical method deter

mined the concen

tration of PMN che

mical in the sample

(in ng/ml). This raw data was converted to ng/cm2 by multiply ing by the volume of the sample and dividing by the area of the glove or cloth patch sampled. This conve rted value of ng/cm2 was converted to ng/day (or ug/day ) for various body parts by multiply ing by the estimated area of the body part. In this study, body part skin surface areas from the Pesticide Applicator Guidelines were used for this conversion. Data tables in the report include a summary of the PMN data (PMN found in samples of underwear, co

tton gloves cove

rall and nitrile g

loves, ng/cm2, no

t corrected for

recovery ), PMN lab and field rec

overy per centages, and

the PMN daily

dermal exposure to

tals, correcte

d for field recovery. The PMN daily de rmal exposure totals are presented in the tables below for operators and maintenance personnel.Options for Revisi ng CEB Dermal Method - Final 06/00

A-25 Table 1: TCK - Unprotected (Outside)-Exposure (ug/person/day) for Operators
Region of the body #1 #2 #3 #4 #5 #6 Head 1.3 0.28 0.28 0.28 0.28 0.28 Neck back 0.052 0.017 0.017 0.017 0.017 0.017 Neck front 0.21 0.035 0.035 0.035 0.035 0.035 Chest/ Stomach 5.04 0.76 0.76 0.76 0.76 0.76
Back 1.72 0.76 0.76 0.76 0.76 0.76 Arm/ Upper 3.48 0.62 0.62 0.62 0.62 0.62

Forearm 1.56 0.26 0.26 0.26 0.26 0.26 Thigh 10.92 0.83 0.83 0.83 1.92 3.24 Leg Lower 6.81 0.52 0.52 0.52 1.20 2.03 Feet 3.74 0.28 0.28 0.28 0.66 1.11 Subtotal 34.84 ug (0.035 mg) 4.37 ug

(0.004 mg) 4.37 ug

(0.004 mg) 4.37 ug

(0.004 mg) 6.52 ug

(0.006 mg) 9.12 ug

(0.009 mg) Hand 2421.7 16.39 6.92 2.75 2.5 512.04 Total 2456.51 ug (2.46 mg) 20.75 ug

(0.021 mg) 11.29 ug

(0.011 mg) 7.12 ug

(0.007 mg) 9.02 ug

(0.009 mg) 521.16 ug

(0.52 mg) Notes: #1 =  A  Operator #2 =  B  Operator #3 =  D  Operator #4 =  E  Operator #5 = Relief Operator #1 #6 = Relief Operator #2Options for Revisi ng CEB Dermal Method - Final 06/00

A-26 Table 2: TCK - Unprotected (Outside)-Exposure (ug/person/day) for Maintenance Personnel
Region of the body #1 #2 #3 #4 #5 Head 0.39 0.27 0.59 9.93 2.63 Neck back 0.017 0.017 0.017 0.86 0.12 Neck front 0.068 0.034 0.10 1.42 0.41 Chest/ Stomach 1.68 0.75 3.31 33.6 9.69
Back 0.75 0.75 0.75 28.1 3.68 Arm/ Upper 0.61 0.61 0.61 20.97 10.39

Forearm 0.25 0.25 0.25 10.66 5.85 Thigh 1.92 1.92 0.81 82.1 884.2 Leg Lower 1.19 1.19 0.51 51.15 550.88 Feet 0.66 0.66 0.27 28.15 303.2 Subtotal 7.53 ug (0.007 mg) 6.44 ug

(0.006 mg) 7.25 ug

(0.007 mg) 267 ug

(0.27 mg) 1771.07 ug

(1.77 mg) Hand 8.29 5.14 0.86 505157.21 310147.84 Total 15.82 ug (0.016 mg) 11.58 ug

(0.012 mg) 8.12 ug

(0.008 mg) 505424.21 ug

505.42 mg 311918.91 ug

(311.92 mg) Notes: #1 = Maintenance mechanic, instr/electrical #1 #2 = Maintenance mechanic, mechanical; #1 #3 = Maintenance mechanic, instr/electrical #2 #4 = Maintenance mechanic, mechanical #2 #5 = Maintenance mechanic, mechanical #3Options for Revisi ng CEB Dermal Method - Final 06/00

A-27 

### 2 CEB Review of Recommended OptionOptions for Revisi ng CEB Dermal Method - Final 06/00

A-28 

### CEB Review of Recommended Option - April a

nd May, 2000 - Issues, Comments, Responses 1. Issue: Use of  routine  and  incidental  terms Comment(1):Strike  routine  and  incidental  terms from the tab le for now until we

choose to add res s th ese j udge men ts m ore f ull y. Comment (2):Leav e in rou tin e/i nci den tal ter ms f or n ow b ecau se o f YX e xpo sur e-ba sed pol icy. Response: Agree with the c oncern. The pro

blem is the YX policy

which has  routine  contacts as part of the policy. For now the current designations will be kept a nd where there are additions to the table, they will be conservatively re garded as  routine 

.
2. Comment: Change  activity  used in CEB Manual and options to something else like

 Model  or  descriptor 

. Response: Agree.  Activity  is not the best term. I prefer  Type of Conta

ct 
.
3. Comment: Each type o f contact (or  Model  ,  Descriptor  ) must have a unique name to help CEB distinguish between the assumptions associated with each. Response: Agree

4. Issue: Dermal exposure to other parts of the body Comment (1):Needs more deve lopment work, rec

ommend dropping f

rom option we adopt

. Comment (2):Least defensible but keep because it may find use in some situations Comment (3):Leave in the detailed report but don t adopt now as part of the method pending further development Response: Was a recommendation from the Peer Reviewed Report. I would like to keep it so we don  t  lose  those results but a gree that it shou

ld be clearly

distinguished fr

om the hands in implementation memo.Options for Revisi ng CEB Dermal Method - Final 06/00

A-29 5. Issue: Use of Range

s in table Comment (1):Use highest values in ranges only with term  up to  . Reasons: prevents exclusion of other relevant data; prevents false impression of accuracy we can give by reporting a rang e; for scr eeni ng, r isk ass ess ors wil l on ly us e th e hi ghes t va lue anyw ay. Comment (2):Ranges are OK but guidance to contractors/CEB is to report one number for assessment purposes Response: Agree that contractors should only provide one number. That is actua lly current policy and during the implementation of the revised method we can reempha size that to ERG and CEB staff. If there is a need for a more refined a ssessment, CEB assessor can review the studies in more detail to determine a more appropriate estimate for their situation. However, to ensure consistency

, these more ref

ined assessments s

hould be reviewe

d and saved in a  Dermal  sub dir ect ory o n th e K: \Gro up\C EB di rect ory. I left in the range for the liquid values to maintain consistency with the current method. 6. Comment: Exposure Descriptors need to be included. Suggested language -  Values are highest in range and are high-end estimates. For use in assessments, these value s are  what-if  estimates and may be reported as high-end values in studies from which the va lues are taken.  Response: Agree that expos ure descriptors

need to be include

d. The available

data give suppor

t that the upper end

values in the table

are high-end e

xposures. The I

mplementation Memo

will address descriptors and the basis for the high-end call.

7. Issue: Construc

ting the ranges with dat a from different stu

dies. Example: using

the PHED 90% value and Paint study 90% value together: Suggestions: - Use of liquid field data from PHED, PMN study - use primarily to dete rmine the reasonableness of our method (e.g for validation purposes). - Use of pilot plant filtration and PHED solids - use primarily to determine the reas ona ble nes s of

our met hod (e.g . fo r val ida tio n fo r dat a fro m th e pai nt s tud y)
Response: Reoriented approach to using the EPA, 1992 lab study as the base method for liquids and the paint study as the base method for solids. All the field data for liquids (PHED, PMN, other literature

data cited in SAI

C, 1996 fall within th

e Versar rang

e (even the hig

h-end values) and can be used as validation. The remaining solids data from PHED, the pilot plant filtration study and other literature data cited in SAIC, 1996 also fall within the paint study range and canOptions for Revisi ng CEB Dermal Method - Final 06/00

A-30 be used for validation.

8. Comment: Recommend adoptin g the qualitative

guidance in the

option we adopt.

9. Comments:

 ..w e can dev elo p an d ad opt an i nte rim opt ion

... ., p erha ps i mme dia tel y 

 ...get this thing on line  Response: Amen

10. Comment: Recommend Peer Review Response: Definitely. The next steps are to draft an Implementation memo to implement the method, finalize the background report and then to pursue a Peer Review