United States
Environmental Protection
Agency
Office of Water
4303
EPA821-B-88-008
July 1998
&EPA
Environmental Assessment Of The
Final Effluent Limitations
Guidelines And Standards For
The Pharmaceutical Manufacturing
Industry
f.
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ENVIRONMENTAL ASSESSMENT OF THE
FINAL EFFLUENT GUIDELINES
, , - , FOR THE
PHARMACEUTICAL MANUFACTURING INDUSTRY
Volume I
Filial Report
U.S. Environmental Protection Agency-
Office of Water
Office of Science and Technology
Standards and Applied Science Division
401 M Street, S.W.
, Washington, D.C. 20460
Patricia Harrigan
Richard Healy
Task Managers
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ACKNOWLEDGMENTS AND DISCLAIMER
This report has been reviewed and approved for publication by the Standards and Applied
Science Division, Office of Science and Technology. This report was prepared with the support
of Versar, Inc. (Contract 68-W6-0023) under the direction and review of the Office of Science
311(1 Techn9logy. Neither the United States Government nor any of its employees, contractors,
subcontraclors, or their employees make any warranty, expressed or implied, or assumes any legal
liability or responsibility for any third party's use of or the results of such use of any information,
apparatus^ product, or process discussed in this report, or represents that its use by such party
would not infringe on privately owned rights.
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TABLE OF CONTENTS
Page No.
ACKNOWLEDGEMENTS AND DISCLAIMER . . , . . . i
EXECUTIVE SUMMARY . ....... .". ... . . . . . . . . .... ... ix
1. INTRODUCTION .... . . . . ......... . . ....... ... . . ; . . . i
2. METHODOLOGY . . ... . ., . . . . . '...'... ...,:. ... ..... 5
2.1 Projected Water Quality Impacts . . . .'. . . ". . .,. . . . . ... . . . _'. . . ... . . . 5
2.1.1 Comparison of Instream Concentrations with Ambient Water
Quality Criteria (AWQC)/Impacts at POTWs ................. 5
2.1.1.1 Direct Discharging Facilities.. .................... 6
2.1.1.2 Indirect Discharging Facilities 9
2.1.1.3 Assumptions and Limitations 12
.2.1.2 Estimation of Human Health Risks and Benefits 13
2.1.2.1 Fish Tissue . . . ..... .-" ] ; 14
2.1.2.2 Drinking Water 17
2.1.2.3 Assumptions and Limitations ,..,,........ 18
2.1.3 Estunation of Environmental Benefits . . . . . . ...'..' 19
2.1.3.1 Assumptions and Limitations ....... /'. . ... . 21
2.1.4 Estunation of POTW Benefits . ... ......:. . . .... . ." ] [',[ . 22
2.1.4.1 Reductions in Interference, Passthrough and Sewage
Sludge Contamination Problems . . . . . .... . . 22
2.1.4.2 Reductions in Analytical Costs .................. .25
2.1.4.3 Assumptions and Limitations 27
2.2 Projected Air Quality Impacts . 27
2.2.1 Estimation of Human Health Risks and Benefits (Carcinogenic/
Systemic) .....:..... . . ........ . . ........... '. 28
2.2.1.1 Preliminary Screening , .......... 29
2.2.1.2 , Atmospheric Dispersion Modeling 31
2.2.1.3 'Risk Calculations ................ ... . . . ..... 32
, 2.2.1.4 Assumptions and Caveats . . . . . .... . . 33
: 2.2.2 .Estimation of POTW Occupational Risks and Benefits .......... 34
2.2.2:1 Assumptions and Limitations 36
2.2.3 Estunation of Human Health/Agricultural Risks and Benefits
(Ozone Precursors) . . ... ... . . ... 37
2.2.3J VOCValuation Methodology . .\ ...... .40
. 2.2.3.2 PM Valuation Methodology 41
, 2.2.3.3 SQ2 Valuation Methodology 41
2.2.4.5 Potential Benefits Categories Not Quantified .......... 42
2.2.3.4 Assumptions and Caveats ... . . '. .44
u
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TABLE OF CONTENTS (Continued)
Page No.
2.3 Pollutant Fate and Toxicity 45
2.3.1 Pollutants of Concern Identification 46
2.3.2 Compilation of Physical-Chemical and Toxicity Data 46
2.3.3 Categorization Assessment 50
2.3.4 Assumptions and Limitations 55
2.4 Documented Environmental Impacts 56
3. DATA SOURCES . 57
3.1 Water Quality Impacts , [[ ...... 57
3.1.1 Facility-Specific Data 57
3.1.2 Information Used to Evaluate POTW Operations 58
3.1.3 Water Quality Criteria (WQC) ............. 59
3,1,3.1 Aquatic Life 59
3.1.3.2 Human Health . ... ........ , . . , , ........... 60
? I-4 ^fonnation Used to Evaluate Human Health Risks and Benefits ... 64
3.1,5 Information Used to Evaluate Environmental Benefits 64
3.1,6 Information Used to Evaluate POTW Benefits ' . . 65
3.2 Air Quality Impacts . 66
1-2.1 Facility-Specific Data . . ....." 66
3.2.2 Population and Climatologic Data ! 67
3.2.3 Information Used to Evaluate Human Health Risks and Benefits ... 67
3.3 Pollutant Fate and Toxicity 69
3.4 Documented Environmental Impacts 69
4. SUMMARY OF RESULTS ............. ... _ 70
4.1 Projected Water Quality Impacts ' ' [[ " ]'. JQ
4.1.1 Comparison of Instream Concentrations with Ambient Water
Quality Criteria '.'. . .' . '. .'. 70
" 4.1.1.1 Direct Discharges . . . /t. . ......:.... 71
4.1.1.2 Indirect Discharges 72
4.1.2 Estimation of Human Health Risks^ and Benefits 74
4.1.2.1 Direct Discharges 74
,4.1.2,2 Indirect Discharges . 75
4.1.3 Estimation of Environmental Benefits . . . ... . . . . 76
4.1.3.1 Direct Discharges . ". 77
4.1-3,2 Indirect Discharges ............ 77
4.1.3.3 Additional Environmental Benefits 78
4.1.4 Estimation of POTW Benefits . ....... ; . 79
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TABLE OF CONTENTS (Continued)
4.2
4.3
4.4
4.5
- , Page No.
Projected Air Quality Impacts ... : ..... 79
4.2.1 Human Health Risks and Benefits (Carcinogenic/Systemic) .... ... 80
4.2.1.1 CWA Section 308 Pharmaceutical Questionnaire Data 80
4.2.1.2 CWA Final Rule ....:....,.. 81
4.2.1.3 MACTFinal Rule . . . " . '. 82
POTW Occupational Risks and Benefits 83
Human Health/Agricultural Risks and Benefits (Ozone Precursors) 84
4.2.3.1 CWA Final Rule ... . . . . . .......... 84
4-2.3.2 MACT Final Rule ." \'\ 35
Total Potential Annual Economic Benefits .........;............ 87
Pollutant Fate and Toxicity .... 87
Documented Environmental Impacts ......................... 88
4.2.2
4.2.3
5. REFERENCES
R-l
IV
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VOLUME II
". , . . . '; ' .-* Page No.
Appendix A Memoranda ....',, A-l
Appendix B Pharmaceutical Manufacturing Facility-Specific Data B-l
Appendix C National Oceanic and Atmospheric Administration's (NOAA)
Dissolved Concentration Potentials (DCPs) . C-l
i" III" ' " " ., '" i I,*'" '! , - ' '!' ,,'' ' .. ' ' ' ป, ' '' t. , , '' '''," ' ' , ' '' ', \ ",'",, 1' ':, J ,.,lli!il!1'1
Appendix D Water Quality Analysis Data Parameters . . . , D-l
Appendix E Risks and Benefits Analysis Information E-l
AppendixF Air Quality Analyses ... F 1
, , ' , ' , fc , , * , ' /, " > , ', u ' . ,. .. ! ,
Appendix G Direct Discharger Analysis at Current (Baseline) and
BAT Treatment Levels G-l
Appendix H Indirect Discharger Analysis of Current (Baseline) and
Pretreatment Pretreatment Levels H-l
Appendix! POTW Analysis at Current (Baseline) and
Pretreatment Levels I_l
Appendix J Direct Discharger Risks and Benefits Analysis at Current
(Baseline) and BAT Treatment Levels j-1
Appendix K indirect Discharger Analysis at Current (Baseline) and
Pretreatment Treatment Levels K-l
Appendix L Air Quality Analysis Results L-l
,:>.! iK-li-i .'.iil. jilliiM, <:, 111
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VOLUME n
Page No.
Appendix A Memoranda ... ..... A-l
Appendix B Pharmaceutical Manufacturing Facility-Specific Data B-l
Appendix C National Oceanic and Atmospheric Administration's (NOAA)
Dissolved Concentration Potentials (DCPs) . . . . C-l
Appendix D Water Quality Analysis Data Parameters D-l
Appendix E Risks and Benefits Analysis Information ...........;.......,.... E-l
Appendix F Air Quality Analyses Information ,...,.... , . . F-l
Appendix G Direct Discharger Analysis at Current and BAT Treatment Levels G-l
Appendix H Indirect Discharger Analysis at Current and PSES Treatment Levels .... H-l
Appendix I POTW Analysis at Current and PSES Treatment Levels ............ 1-1
Appendix! Direct Discharger Risks and Benefits Analysis at Current
and BAT Treatment Levels . . . J-l
Appendix K
Appendix L Air Quality Analyses Results '. . . . . .......... L-l
Indirect Discharger Risks and Benefits Analysis at Current and
PSES Treatment Levels K-l
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Jiff t i1-!"1;1 rift
LIST OF TABLES
1! ill: :
.!'"',I
; ' .'' ' ', ' : '' - .:"- Page No.
_' ',/" ,' i " , ...'. " ' , 1 !'_.' ,i', " *
Table 1. Frequency of Evaluated Pollutants from 14 AC Direct Pharmaceutical
Manufacturing Facilities Discharging to 14 Receiving Streams 90
Table 2. Summary of Modeled Pollutant Loadings for AC Direct and Indirect
Pharmaceutical Manufacturers 91
I. . , "Vl' ".I'll " ' 1. : I'!' '" ' . I' "", " ' ' 'Si, ' r ...... . . .^i .;|i
Table 3. Summary of Projected Criteria Excursions for AC Direct Pharmaceutical
Dischargers 92
Table 4. Summary of Pollutants Projected to Exceed Criteria for AC Direct
Pharmaceutical Dischargers .93
Table 5. Frequency of Evaluated Pollutants from 3 BD Direct Pharmaceutical
Maim Facilities Discharging to 3 Receiving Streams 94
Table 6. Summary of Modeled Pollutant Loadings for BD Direct and Indirect
Pharmaceutical Manufacturers . . 95
Table 7. Summary of Projected Criteria Excursions for BD Direct Pharmaceutical
Dischargers "... ;. 96
Table 8. Frequency of Evaluated Pollutants from 61 AC Indirect Pharmaceutical
Manufacturing Facilities Which Discharge to 43 POTWS on 42 Receiving
Streams 97
Table 9. Summary of Projected Criteria Excursions for AC Indirect Pharmaceutical
Dischargers 95
Table 10. Summary of Pollutants Projected to Exceed Criteria for AC Indirect
Pharrnaceutical Dischargers . . , . 99
Table 11. Summary of Projected POTW Inhibition and Sludge Contamination
Problems from AC Indirect Pharmaceutical Dischargers 100
Table 12.
-, : L ,' ', r
Summary of Pollutants From AC Indirect Pharmaceutical Dischargers
Projected to Cause POTW Inhibition and Sludge Contamination Problems ... 101
VI
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LIST OF TABLES (continued)
; Table 13.
Table 14.
Table 15.
Table 16.
Table 17.
Table 18.
.Table 19.
Table 20.
Table 21.
Table 22.
Table 23.
Table 24.
".' Page No.
Frequency of Evaluated Pollutants from 52 BD Indirect Pharmaceutical
Manufacturing Facilities Which Discharge to 43 POTWS on 43
Receiving Streams ....... ...... ............... .......... 102
Summary of Projected Criteria Excursions for BD Indirect Pharmaceutical
Dischargers ....... ..... ...... ........... ........ 103
Summary of Projected POTW Inhibition and Sludge Contamination Problems
from BD Indirect Pharmaceutical Dischargers ............. 104
Siunmary of Potential Human Health Impacts for AC/BD Direct
Pharmaceutical Dischargers (Fish Tissue Consumption) ..... .......... 105
Summary of Potential Human Health Impacts for AC/BD Direct
Pharmaceutical Dischargers (Drinking Water Consumption) ............ 106
Summary of Potential Human Health Impacts for AC/BD Indirect
Pharmaceutical Dischargers (Fish Tissue Consumption) . . . ..... ....... 107
Summary of Pollutants Projected to Cause Human Health Impacts for AC/BD
Indirect Pharmaceutical Dischargers (Fish Tissue Consumption) ..... .... 108
Summary of Potential Human Health Impacts for AC/BD Indirect
Pharmaceutical Dischargers (Drinking Water Consumption) ......... ... 109
Summary of Pollutants Projected to Cause Human Health Impacts for AC/BD
Indirect Pharmaceutical Dischargers (Drinking Water Consumption) ...... 110
Summary of Environmental (Recreational) Benefits for Direct and Indirect
Pharmaceutical Dischargers ........ ...... . . .........
Summary of Air Quality Modeling Analysis for Pharmaceutical Fugitive
Emissions (308 Questionnaire Loadings) ...... ....... . ...... ..... 112
Summary of Air Quality Modeling Analysis for Pharmaceutical Fugitive
Emissions (CWA Rule Loadings Removals) . . ..... ...... ...... , ; 113
VII
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LIST OF TABLES (continued)
Page No.
Table 25.
Table 26.
Table 27.
Table28.
Table 29.
Table 30.
* . '' "
Table 31.
Table 32.
Table 33.
Table 34.
Table 35.
Table 36.
table 37.
Table 38.
. Estimated Annual Human Health Benefits From Cancer Risk Reductions
(1990 dollars) . . . .... ____ '.".'...'..'.',.'. .". . . '."/'.' ........... 114
Summary of Air Quality Modeling Analysis for Pharmaceutical Fugitive
Emissions (MACT Rule Loading Removals) ....................... 1 15
Summary of Potential POTW Occupational Exposure Impacts for
Pharmaceutical Indirect Discharges . . ............... ..... ...... 116
Estimated Annual Human Health Benefits From CWA Rule Reductions in
VOC Emissions (1990 dollars) .......... . . ......... ..... !"ll7
Estimated Annual Adverse Environmental Impacts From CWA Rule Increases
in SO2 Emissions (1990 dollars) . . ....... .......... ..... ..... 118
Total Monetized Benefits From CWA Rule Reductions in Ozone Precursors ..119
!' !'v:ii ," :-': .I'' '':', :' : ';; .'. " '" ,,,",:'
Estimated Annual Human Health Benefits From MACT Rule Reductions
in VOC Emissions (1990 dollars) . . . . ... .". . . . . .'.'". ..!...
Estimated Annual Adverse Environmental Impacts From MACT Rule
Increases in SO2 Emissions (1990 dollars) ... ..... ... . . .... ...... 121
Total Monetized Benefits from MACT Rule Reductions in Ozone Precursors . . 122
Potential Annual Economic Benefits for the Pharmaceutical Industry From the
|OT
(millions of 1990 dollars) ........ ............... . . . ...... ... 123
Potential Fate and Toxiciry of Pollutants .....'.'. ........ ',..'. ...... 124
Toxicants Exhibiting Systemic and Other Adverse Effects ........ : . ____ ... 125
Human Carcinogens Evaluated, Weight-of-Evidence Classifications, and
Target Organs ................. ....... '....' .............. . . ........ 126
Environmental Impact Case Studies of Pharmaceutical Manufacturing
Wastes ............... ...... . . . ...... '.'....'....'. '..'.'
127
Table 39. Pharmaceutical Facilities Included on State 304(L) Short Lists ... ...... 132
vm
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EXECUTIVE SUMMARY
This report presents an assessment of the water quality-related and air quality-related
benefits from the Clean Water Act (CWA) final effluent limitations guidelines for the
Pharmaceutical Manufacturing Industry, as well as the benefits expected to accrue from the
corresponding Maximum Achievable Control Technology (MACT) standards under the Clean Air
Act (CAA). This assessment considers the benefits expected to result from implementation of
these rules due to reductions in effluent loadings and ah" emissions^1.' A variety of human health,
environmental, and publicly-owned treatment works (POTW) benefits might result from these
reductions. The assessment includes a qualitative description of each benefit category and
provides quantitative estimates of economic (monetized) benefits for those benefit categories for
which there are sufficient data to develop such estimates.
Specifically, the report first presents an assessment of the water quality benefits of
controlling the discharge of wastewater from pharmaceutical manufacturing facilities to surface
waters and POTWs. The U.S. Environmental Protection Agency (EPA) estimates instream
pollutant concentrations of direct and indirect discharges at current, BAT (Best Available
Technology), and PSES (Pretreatment Standards for Existing Sources) levels by using stream
dilution modeling. The potential impacts and benefits to aquatic life are projected by comparing
the modeled instream pollutant concentrations to published EPA aquatic life criteria guidance or
to toxic effect levels. Potential adverse human health effects and benefits are projected by: (1)
comparing estimated instream concentrations to health-based water quality toxic effect levels or
criteria; and (2) estimating the potential reduction of carcinogenic risk and noncarcinogenic hazard
(systemic) from consuming contaminated fish or .drinking water. Upper-bound individual cancer
risks, population risks, and systemic hazards are estimated using modeled instream pollutant
concentrations and standard EPA assumptions. Modeled pollutant concentrations in fish and
- drinking water are used to estimate cancer risk and systemic hazards among the general
Revised pollutant loadings have been received since this assessment was completed based on earlier loadings (August
1997). Because the revised loadings are not significantly different (changes were less than 2 percent) from the loadings
used for the assessment, the assessment was not redone using the revised loadings.
IX
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1 ill I'M' iiii"!'!,!!' i
population, sport anglers and their families, and subsistence anglers and then- families. EPA used
the findings from the analyses of reduced occurrence of instream pollutant concentrations in excess
of both aquatic life and human health criteria or toxic effect levels to assess improvements in
recreational fishing habitats that are impacted by pharmaceutical waste water discharges
(environmental benefits). These improvements hi aquatic habitats are then expected to improve
the quality and value of recreational fishing opportunities and ndnuse (intrinsic) values of the
:;' , i HM i.i.i ' ,i '. '..'' > . V',;. i . . - ' ,.., , .; '.jii,, " i ;" '(,,
receiving streams.
Potential inhibition of operations at POTWs and sewage sludge contamination (thereby
limiting its use for land application) are also evaluated based on current and final pretreatment
levels. Inhibition of POTW operations is estimated by comparing modeled POTW influent
concentrations to available inhibition levels; contamination of sewage sludge is estimated by
comparing projected pollutant concentrations in sewage sludge to available EPA regulatory
standards. POTW economic benefits are estimated, if applicable, on the basis of the incremental
quantity of sludge that, as a result of reduced pollutant discharges to POTWs, meets criteria for
the generally less expensive disposal methods, namely land application and surface disposal.
In addition to the assessment of the water quality benefits, an assessment of the air quality
benefits of controlling air emissions associated with pharmaceutical manufacturing facilities is
presented in this report. Air quality benefits are assessed based on potential carcinogenic risks and
noncarcinpgenic hazard to the general public from on-site fugitive emissions from open-air
Settling, neutralization, equalization, or treatment tanks using an air dispersion model. Three
modeling estimates are made based on reduction in pollutant loads - one based on responses to the
1990 CWA Section 308 Questionnaire and two based on conservative engineering loading
estimates using the 308 Questionnaire data. Potential risks and benefits to POTW workers from
occupational exposures to a toxic mixture of gases partitioning from influent wastewater also are
quantified by comparing modeled vapor-phase pollutant concentrations to the American
Conference of Governmental Industrial Hygienists (ACGlH) threshold limit values (TLVs). In
addition, potential risks and benefits to the general public and the environment from on-site
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fugitive emissions of ozone precursors (i.e., volatile organic compound [VOC] emissions) are
assessed using a benefits-transfer approach developed by the Office of Air Quality Planning and
Standards (OAQPS). Estimates of the average value per megagram (Mg) reduction in VOC
emissions are applied to the estimated total reduction in VOC emissions hi nonattainment areas;
as well as in all areas (nonattainment and attainment) due to the rules.
EPA monetizes the estimated benefits for reductions hi air emissions of ozone precursors,
cancer risk reductions, improvements in recreational fishing opportunities and improvements in
intrinsic value, but is unable to quantify the dollar magnitude of .benefits from the other benefit
categories. Due to data limitations, the benefit estimates of some categories could not be
differentiated between CWA and MACT requirements.
>/'.'- ; '
In addition, the potential fate and toxicity of pollutants of concern associated with
pharmaceutical manufacturing wastewater are evaluated based on known characteristics of each
chemical. Published literature, newspaper articles and studies are also reviewed and State and
Regional environmental agencies are contacted for evidence of documented environmental impacts
on aquatic life, human health, POTW operations, and on the quality of receiving water and
ambient air.
These analyses are performed for discharges from AC and BD pharmaceutical
manufacturing facilities. This report provides the results of these analyses, organized by the
benefit category and by the type of discharge (direct and indirect).
Projected Water Quality Impacts
Comparison of Instream Concentrations with Ambient Water Quality Criteria
(AWQC)/Impacts at POTWs
The results of. this analysis identify the water quality benefits of controlling discharges
(CWA and MACT rules) from pharmaceutical manufacturing facilities to surface waters and
XI
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.Y",1 i i" ', i,"' ,ii ,,'i in Jn'iiv ' ' i'1" , "!i " 'ป ii ,' i i i - , , ' ' ' , ' ,l ป', ii1 i. i , ' , ' ' ; .,111, . '. ii" i lam1', i,,;
POTWs. Potential aquatic life and human health impacts on receiving water quality and on POTW
operations and then: receiving streams for AC and BD direct and indirect discharges are
* '" i . .': i*!'' "|"'i*i " " ,' "" i"'1 .i-1.-1 ' ":'1 '' " : "": '.' ",'"?, "ji1:1' '''':,' . '' ' ill il
summarized.
(a) Direct Discharges
The water quality modeling results for 14 direct AC facilities discharging 32 pollutants to
14 receiving streams indicatethat at current discharge levels, uistream pollutant concentrations
of 1 pollutant (using a target risk of 10"6 (1E-6) for carcinogens) is projected to exceed human
health criteria or toxic effect levels (developed for water and organisms consumption) hi i
receiving stream. Instream pollutant concentrations are also projected to exceed acute and
chronic aquatic life criteria or toxic effect levels in 1 other receiving stream due to the discharge
of 2 pollutants. The BAT regulatory option will eliminate all excursions. Under the BAT
regulatoryoption, pollutant loadings are reduced 95 percent.
The water quality modeling results for 3 direct BD facilities discharging 6 pollutants to 3
receiving streams indicate that at current and BAT treatment levels no excursions of human
health criteria or toxic effect levels or of aquatic life criteria or toxic effect levels are projected
Pollutant loadings are reduced 95 percent.
I ., .1. , . , ' 'I , . ,- ', ''.!', ' . 1 . ' ' ' " . , . ., ' ' , ' I ; I-
(b) indirect Discharges
The potential effects of PQTW wastewater discharges on receiving stream water quality
are evaluated at current and pretreatment discharge levels for 61 AC facilities that discharge 34
r1;,!1 ; .. -.!", , "IK i':iii!iil1 ' '.,*:. :':".'. . -" (''..:'!. ii' ^-v,.:' .; ' :' . ' ' '.n1.1'. '. .><:i.-.i m
polhitants to 43 POTWs whh outfalls on 42 receivmg streams. Modeling results indicate that at
.V'current discharge levels, uistream concentrations of 3 pollutants (usuig a target risk of 10"6 (1E-6)
for carcinogens) are projected to only exceed human health criteria or toxic effect levels
(developed for water and organisms consumption) in 3 receiving streams. The projected
excursions are eliminated at pretreatment discharge levels. Modeled uistream pollutant
',,i,'' . " '",,/ : ;ii . 1, , ' . ' , ' i "'i1 ',""'"'! ,- , ' ' , ,| mil '
, '' ,.'!!' '" ! ' .' ' i , " " ' i, ,f : .,''' .,"''' i i il
"'. ',;,"' '. \ ' ' ' ':''..'.' xii . . .
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concentrations are not projected to exceed acute or chronic aquatic life criteria or toxic effect
levels or human health criteria or toxic effect levels (developed for organisms cbnsumption
only). Under the pretreatment regulatory option, pollutant loadings are reduced 67 percent.
In addition, the potential impacts of 65 indirect AC facilities, which discharge to 46
POTWs, are evaluated in terms of inhibition of POTW operation (additional facilities were
evaluated in the POTW assessment than for the surface water assessment due to data availability).
No pollutants are evaluated for potential sludge contamination problems since EPA sludge
criterion are not available for any of the,pollutants of concern. At current discharge levels,
inhibition from 5 pollutants are projected at 3 of the POTWs receiving wastewater discharges.
The pretreatment regulatory option reduces inhibition problems to 3 pollutants at the same 3
POTWs.
Water quality modeling results for the 52 BD facilities that discharge 15 pollutants to 43
POTWs with outfalls on 43 receiving streams indicate that at both current and pretreatment
discharge levels, no instream pollutant concentrations are expected to exceed human health
criteria or toxic effect levels or aquatic life criteria or toxic effect levels. Pollutant loadings are
reduced 83 percent.
In addition, the potential impacts of 58 indirect BD facilities, which discharge: to 48
POTWs, are evaluated in terms of inhibition of POTW operation. No sludge criterion are
available to evaluate potential sludge contamination problems. No inhibition problems are
projected to occur at current or pretreatment discharge levels.
'''-'.', '
Human Health Risks and Benefits
The results of this analysis identify the potential benefits of the CWA and MACT final
rules to human health by estimating the risks (carcinogenic and systemic effects) associated with
xui
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current and reduced pollutant levels in fish tissue and drinking water. Risks are estimated for
recreational (sport) and subsistence anglers and their families, as well as the general population.
The excess annual cancer cases at current discharge levels and, therefore, at BAT and
pretreatment discharge levels, are projected to be far less than 0.0001 for all populations
evaluated from the ingestion of contaminated fish and drinking water for both direct and indirect
'' ,,!! n'i1 ril .,.' .: .I'lil,?'ซ "n'l:
AC/BD pharmaceutical wastewater discharges. Thus, while the final rules are expected to reduce
risk to acceptable levels [i.e., below 10"6 (1E-6)], because of the small estimated cancer incidence,
the magnitude of the human health benefits is negligible. In addition, no systemic hazard
reductions are expected to result from reduced exposure to contaminated fish tissue or drinking
water based on the estimated hazard calculated for each receiving stream.
Environmental Benefits
!
The CWA final effluent guidelines and MACT rule are expected to generate environmental
!:!i , '' Wf!" '*'*)''.'.,' ",' ^,v,;:,. wฐ'. ...., ;. M, . " - : >: . .<,,, ; .',. ,v...-: ',$'. ., c
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$441,000 - 1990 dollars ($153,000 to $543,000 - 1997 dollars/CCI6'2). In addition, the estimate
of the nonuse (intrinsic) benefits .to the general public, as a result of the same improvements in
water quality, ranges from at least $62,000 to $220,500 - 1990 dollars ($76,500 to $271,500 -
1997 dollars). These nonuse benefits are estimated as one-half of the recreational benefits and may
be significantly underestimated. All of the monetized benefits can be solely attributed to the CWA
rule.
For the indirect pharmaceutical facilities, instream concentrations in excess of AWQC are
projected to be completely eliminated at 3 receiving streams as a result of the pretreatment
regulatory option. The resulting estimate of the increase in value of recreational fishing to anglers
ranges from $295,000 to $1,054,000 - 1990 dollars ($363,000 to $1,298,000 * 1997 dollars/CCI).
In addition, the estimate of the nonuse (intrinsic) benefits to the general public, as a result of the
same improvements in water quality, ranges from $147,500 to $527,000 - 1990 dollars ($181,500
to $649,000 - 1997 dollars). Monetized benefits of ,$108,000 to $387,000 - 1990 dollars
($133,000 to $476,000 - 1997 dollars/CCI) of the recreational benefits and $54,000 to $194,000 -
1990 dollars ($66,500 to $238,000 - 1997 dollars) of the intrinsic benefits can be solely attributed
to the CWA rule.
There are a number of additional use and nonuse benefits associated with the final rules that
could not be monetized. The monetized recreational benefits are estimated only for fishing by
recreational anglers, although there are other categories of recreational and other use benefits that
could not be monetized. An example of these additional benefits includes enhanced
water-dependent recreation other than fishing. There are also nonmonetized benefits that are
. nonuse values, such as benefits to wildlife, threatened or endangered species, and biodiversity
benefits: Rather than attempt the difficult task of enumerating, quantifying, and monetizing these
nonuse benefits, EPA calculated nonuse benefits as 50 percent of the use value for.recreational
fishing. This value of 50 percent is a reasonable approximation of the total nonuse value for a
population compared to the total use value for that population. This approximation should be
e-2
Using Construction Cost Index (CCI) as an escalator.
xv
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applied to the total use value for the affected population; in this case, all of the direct uses of the
affected reaches (including fishing, hiking, and boating). However, since this approximation was
only applied to recreational fishing benefits for recreational anglers, it does not take into account
noniise values for non-anglers or for the uses other than fishing by anglers. Therefore, EPA has
estimated only a portion of the nonuse benefits for the final standards.
POTW Benefits
111 " i ' ' '' -. "
Both the CWArule and the MACT rule areexpected to generate benefits based on the
improvement of conditions at POTWs. Benefits include reduced interference, passthrough and
sewage contamination problems, as well as reductions in costs potentially incurred by POTWs in
analyzing toxic pollutants and determining whether, and the appropriate level at which, to set local
limits. Although these benefits to POTWs might be substantial, none of these benefits are
quantified due to data limitations.
Projected Air Quality Impacts
Human Health Risks and Benefits (Carcinogenic/Systemic)
The potential air quality benefits of controlling fugitive air emissions from direct and
indirect discharging pharmaceutical manufacturing facilities are quantified for three sets of fugitive
emissions from onsite treatment.
- IV ' II . ,ซ -i ;,, . , ._ , , ; - : . ,t; _ ',.. ,. ; _ -, . . -,_ ',''.. '
. . ,!;;! - , ,; . ,v .''," ,.. . ; : , . , ' "" " '. , ;;,; : ., v ," ' , .",' '';
Based on the 1990 CWA Section 308 Pharmaceutical Questionnaire data, approximately
452,000 people nationwide are projected to be exposed to risk levels exceeding 10"6 (1E-6).
Potential benefits include a reduction of O.Q49 in excess annual cancer occurrences. Methylene
chloride has the largest impact of any single chemical. In addition, the air modeling analysis
projects that approximately 11,000 people would benefit from reduced exposure to methyl
cellosolve which is associated with systemic effects.
xvi
",'LUIS' li'i'!!1'-
-------
The air quality modeling analysis of the CWA final rule projects approximately 1 million
people (1990 population), at cancer risk levels exceeding 10"6 (1E-6), would benefit from the air
load reduction. The load reduction would provide a benefit of 0.15 reduced annual cancer case
occurrences. This estimated decrease hi cancer risk results from reductions in emissions of 4
carcinogens: benzene, .chloroform, 1,2-dichloroethane, and methylene chloride. The estimated
monetized value of the human health benefits from these cancer risk reductions ranges from
$285,000 to $1.53 million - 1990 dollars ($351,000 to $1.88 million - 1997 dollars/CCI). In
addition, the air modeling analysis projects that approximately 32; 300 individuals would benefit
from the reduced exposure to four identified toxic pollutants (ammonia, chlorobenzene, methyl
cellosolve, and triethylamine) associated with systemic effects.
The air quality modeling analysis of the MACT final rule projects 4.1 million people (1990
population) at cancer risk levels exceeding 10'6 (1E-6), would benefit from the air load reduction.
The load reduction would provide a benefit of 0.88 reduced annual cancer case occurrences. This
estimated decrease in cancer risk results from reductions in emissions of 3 carcinogens-
chloroform, 1,2-dichloroethane, and methylene chloride. The estimated monetized value of the
human health benefits from these cancer risk reductions ranges from $1.67 million to $8.98
million - 1990 dollars ($2.06 million to $11.1 million - 1997 dollars/CCI) annually. In addition,
the air modeling analysis projects that approximately 370,000 individuals would benefit from the
reduced exposure to four toxic pollutants (ammonia, 4-methyl-2-pentanone, methyl cellosolve, and
triethylamine) associated with systemic effects. It is estimated that the cancer risk and systemic
hazard will be further reduced due to reductions in fugitive air emissions from process, vents,
storage tanks, and equipment leaks. However, these reductions were not quantified due to lack
of site-specific data. .
POTW Occupational Risks and Benefits
Risks to POTW workers from exposure to toxics are evaluated under current conditions
and under final pretre,atment standards. Occupational exposure levels at POTWs are modeled
xvn
-------
based on the mixture of vapors that can partition out of influent water into the surrounding air.
Risks to poTW workers are evaluated comparing these estimated exposure levels to occupational
TLVs. The CWA rule and the MACT rule are expected to reduce occupational risk at 9 of the
|J ""'i!'i'!i!" 'i'iii '"! ':'.'' "' ^H' '1'" ' ' ,' "' ป' , ' ' '",." '" '" , , '"ป' 'f'V!!!1 '! A! !,'"' v " ,' ";'!'1 ' ": ,!, 'I1' '' ',:!!' ' , ",' "' ,:! ir"'!'1 1i:,i i''1''"iiilBi" 'P'1^
14 POTWs where workers are potentially at risk due to exposure to primarily acetonitrile,
benzene, chloroform, diethylamine, n-heptane, n-hexane, methylene chloride, toluene, and
triethylamine. Reductions of occupational risk at five of the 9 POTWs can be solely attributed to
the CWA rule. Data are not available to monetize this benefit.
'' :Vi" iv:, ' ; '.;,'. .;'" - j1 '. ' , '' ' '/,; : ''',: " :, " ' ' ' | :':': _ /,/- " / "% ' 1-, '-'
Human Health/Agricultural Risks and Benefits
Both the CWA final rule and the MACT final rule will result in a reduction in VOC
emissions and a subsequent increase in emissions of paniculate matter (PM) and sulfur dioxide
!. ' ,"' J JlSli ,;;i!i!!J'1 ' , ' ซ, ",,. "' ',''i.r, i :' y ,-' , " , ,, | : , , , i '; , ^ ' - , , p, "\ [ , ; ' ,',,,, : '!,!,:, " ' \ ' \ ,< rl1 i , ' ',., ''i ' V1*1. .irri
(SO2). Controlling VOC emissions is beneficial because some VOCs are precursors to
).".. ' ' < '.ft I If i ""- .'' ' ' '. " .,' " !,'.',.' ''; SJ: -r '>.. ,.;- ...''.."! "', . .,'.' '" H :'"' '!' ' .-' ''"ป <'.\ ''
ground-level ozone, which negatively impacts human health and the environment. The technology
selected for controlling VOC emissions (steam stripping) requires the consumption of energy.
It.1 ',,'' ' 'in1 I'll i-'ll i if, "i',,",l '! ' . '' . .'" ' '' .,.*! ' 'ii''. "'iivi't,,', .' i"1. '!:. "i .' ';, "A , ' I1 f r T>i i: ,:
Increased energy consumption results in increased emissions of PM and SO2- These byproducts
of increased energy use can cause adverse environmental impacts and are, therefore, subtracted
from the benefits associated with the control of VOCs. Benefits are estimated using the
methodology and data summarized in the November 5, 1997 OAQPS Memorandum titled,
"Benefits-Transfer Analysis for Pulp and Paper."
EPA estimates that the CWA final rule will reduce VOC emissions from wastewater (an
estimated 50 AC/BD Indirect facilities) in nonattainment areas alone by 1,254 Mg per year and
in all areas by 3,608 Mg per year. The CWA rule will also result in an increase in PM emissions
by 20 Mg per year and an increase in SO2 emissions of 52.1 Mg. Total monetized air benefits
^: from _&. CWA rule reduction of ozone precursors (VOC emissions) from wastewater, after
correction for PM and SO2 increases, range from an adverse environmental impact of $0.162
million - 1990 dollars ($0.199 million - 1997 dollars/CCI) to a benefit of $7.51 million - 1990
i, i ' pi1
xvm
-------
Considering the wastewater plank only (an estimated 23 AC Direct/Indirect facilities), it
is estimated that the MACT rule will result in reductions m VOC emissions in nonattainment areas
alone, and in all areas of 2,057 Mg per year to 16,619 Mg per year, respectively. It is estimated
that the MACT rule will also produce benefits due to reductions in fugitive VOC emissions from
process vents, storage tanks, and equipment leaks at an estimated 101 facilities (1,278 Mg to 4,027
Mg, respectively. In addition, the MACT final rule (wastewater) will result in an increase in' PM
emissions by 4.2 Mg per year and an increase in SO2 emissions of 11.0 Mg. The total monetized
air benefits from the MACT rule reductions of ozone precursors from wastewater only, after
correction for PM and SO2 increases,, range from $0.848 million to $36.7 million - 1990 dollars
($1.04millionto $45.2 million - 1997 dollars/CCI). In addition, based on the analysis of the 101
pharmaceutical manufacturing facilities covered by the MACT rule, it is estimated that the
reductions in fugitive VOC emissions from process vents, storage tanks, and equipment leaks
would result in a range of monetized air benefits of $0.625 million to $8.90 million - 1990 dollars
($0.769 million to $11.0 million - 1997 dollars/CCI). Adverse impacts due to increased energy
consumption from control of these planks are not quantified due to data limitations. The total
monetized benefits from reductions in VOC emissions from all four planks are estimated to be
$1.48 million to $45.6 million - 1990 dollars ($1.82 million to $56.1 million - 1997 dollars/CCI).
Total Potential Annual Economic Benefits
. The estimated total annual monetized, benefits resulting from the CWA final effluent
limitations guidelines and the wastewater emissions control portion of the MACT rule will range
from $752,000to $11.3 million - 1990 dollars ($926,000 to $13.9 million - 1997 dollars/CCI) (Table
ES-1). This range includes $280,000 to $1.0 million - 1990 dollars ($345,000 to $1.23 million -
-1997 dollars/CCI) of the environmental benefits .that cannot be differentiated between the CWA rule
and the wastewater portion of the MACT standard. The annual monetized benefits resulting solely
from the MACT final rule are estimated to range from $3.15 million to $54.6 million - 1990 dollars
($3.88 million to $67.2 million - 1997 dollars/CCI). The ranges reflect the uncertainty in evaluating
the effects of the final rules and in placing a dollar value on these effects. These monetized benefits
xix
-------
i Ti/K ,:'
'': .' , ill .-.'I, ., -,.- y
'Si!'
ranges do not reflect many of the benefit categories expected to result under the final rules, including
reduced systemic human health hazards; improved POTW operations/conditions; and improved
, i i i . , i' ii!';,ii; A. I':WK '< ", "UN" . A ,* i,,, " ' " ,' ,,," ,'.!',':, ' ." i!" ,' t ,./, ', " ,'ซ"r "M ",: ,n!< 1i i , ' L .'*'!"",, .'" 'ti,,, i;,,"''. '",' ' f'1 ; ! ': 'ir '! H;: ^'S'1!1!!:'1. hF"
worker health at POTWs. Therefore, the reported benefit estimate understates the total benefits of
the final rules.
t : '* '
Pollutant Fate and Toxicity
t !ป!
EPA initially identified 47 potential pollutants of concern in wastestreams from
pharmaceutical facilities. These pollutants are evaluated to assess then" potential fate and toxicity
based on: known characteristics of each chemical.
"' 'i,. i''j4}' Ml >.'-.' ' '"..I1. '...* " J" ;'''''' :;' ' '. I '. ,,.. *>']<' ." '".'I ; r '.' ..[.;',. " .' .,['' i '. - i: "'"&, A1
Most of the 47 pollutants have at least one known toxic effect. Based on available
physical-chemical properties, and aquatic life and human health toxicity data for the 47
pharmaceutical pollutants, 3 exhibit moderate to high toxicity to aquatic life; 23 are human
! *
systemic toxicants; 7 are classified as known or probable human carcinogens; 9 have drinking
water values, all with enforceable health-based maximum contaminant levels (MCLs); 9 are
designated by EPA as priority pollutants; and 20 are designated by EPA as hazardous air
pollutants (HAPs). In terms of projected environmental partitioning among media, 29 of the
polmtants are moderately to highly volatile (potentially causing risk to exposed populations via
mhalation); 4 have a moderate to high potential to bioaccumulate in aquatic biota (potentially
accumulating in the food chain and causing increased risk to higher trophic level organisms and
to exposed human populations via fish and shellfish consumption); none are moderately to highly
adsorptive to solids; and 9 are resistant to or slowly biodegraded.
The environmental assessment focuses mainly on identified compounds with quantifiable
foxic or carcinogenic effects. This leads to a potentially large underestimation of benefits, because
some significant pollutant characterizations are not considered. .For example, this report does not
'i.;.|; ',: "'-i; '.!*;ป 'I'B '.'!' " :'.":;,, ",.'"* .;ii. -;;; , i:i'1,/1" ? \ - . ./., ' v^, ;;':'"v':'
-------
demand [COD]) or reduced toxicity associated with COD in the effluents. The discharge of these
pollutants may have significant adverse effects on the environment! For example, habitat
degradation can result from TSS loads that reduce light penetration and primary productivity, and
from accumulation of solid particles that alter benthic spawning grounds and feeding habitats.
COD and BOD levels can deplete oxygen levels, which may result in mortality or other adverse
effects hi fish, as well as reduced biological diversity.
The benefits of COD reduction extend beyond reducing oxygen depletion, since COD also
represents the presence of organic chemicals in a wastestream. Due to a lack of analytical
methods, not all of the compounds represented by COD are identified. In this benefits assessment,
specifically identified compounds represent only 2.2 million pounds of the 11.5 million pounds
of COD projected to be removed, even when using the total theoretical oxygen demand of
compounds including VOCs which may not be measured as COD. This limits the estimate of
benefits, because me analysis relies on comparing instream concentrations to established criteria,
and there are obviously no established criteria for unidentified, compounds. However, there is
inherent value in reducing pollutant loads, despite (or perhaps due to) the lack of quantifiable
effects. ,
'The benefits analyses are further limited because they concentrate on projected excursions
from established minimum standards, and do not account for protection of higher quality
conditions. Likewise, they do not account for prevention of future impacts which could occur due
to increased effluent loadings.
Documented Environmental Impacts
Documented environmental impacts on aquatic life, human health, POTW operations, and
receiving stream water quality are also summarized in this assessment. The summaries are based
on a review of literature abstracts, State 305(b) reports, newspaper articles, the Pharmaceutical
Outreach Questionnaire, and State 304(1) Short Lists. Sixteen (16) studies noted environmental
xxi
-------
j|:ji,'',impacts from pharmaceutical manufacturing. Impacts included: (1) human health problems
(worker exposure and population) such as dizziness, nausea, respiratory and dermal problems and
endocrine dysfunction (reproductive); (2) aquatic life effects, such as fish kills; (3) effects on the
quality of receiving waters, groundwater, soils, sediments, and drinking water; and
(4) impairments to POTW operations. In addition, 4 pharmaceutical manufacturing facilities aire
identified by States as being point sources causing water quality problems and are included on their
304(1) Short List. State and Regional environmental agencies are also contacted for documented
impacts due to discharge from pharmaceutical facilities. State contacts indicate the need for
National effluent guidelines for the industry. Problems with discharges of organic chemicals, oil
I'i'i " "!!! P1 i, ,,'ft i , , !"!' ' ' " ",ป" ' ',, '.'," , I,' ,", ''',,', ' ',' i i" .' ,,, . ; i.1 . !|, |jj,, , '',
and grease, BOD/COD and with groundwater contamination are noted.
XX11
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Table ES-1. Potential Annual Economic Benefits for the Pharmaceutical Industry
From the CWA Final Effluent Guidelines and the CAA MACT Rule
(millions of 1990 dollars/1997 dollars)
Benefits Category
Reduced Emissions of Ozone Precursors
Reduced Cancer Risk
Improved Environmental Conditions
Improved POTW Operations (Inhibition and
Sludge Contamination), Occupational
Conditions
Reduced Systemic Risk
TOTAL Monetized Benefits
Estimated Economic Benefit
CWA RULE
Low
-$Q.162/-$0.199
$0.285/$0.351
$0.629/$0.774
Unquantified
Unquantified
$0.752/$0.926
High
$7.51/$9.25
$1.53/$1.88
$2.24/$2.76
Unquantified
Unquantified
$11.3/$13.9
MACT RULE
Low
$1.48/$1.82
$1.67/$2.06
Unquantified
Unquantified
Unquantified
$3.15/$3.88
High
$45.6/$56.1
$8.98/$ll.l
Unquantified
Unquantified
Unquantified
$54.6/$67.2
NOTE: CWA rule benefits include a portion of environmental monetized benefits that cannot be solely attributed to
the CWA rule ($280,000 - $1 million, $1990/$345,000 - $1.23 million, $1997). Specifically, two facilities
included in the modeling were required to have MACT strippers and were also costed for additional strippers
to meet the CWA effluent guidelines. Overall removals due to these strippers cannot be differentiated
between MACT and CWA requirements.
The MACT rule benefit values of reduced ozone precursor emissions from the wastewater plank include
adverse impacts related to increased energy consumption. Adverse impacts due to increased energy
consumption from control of the other planks are not quantified due to data limitations.
XXlll
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H - , ;f : !,, ;,"< I ."HI -
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1. INTRODUCTION
The purpose of this report is to present an assessment of the benefits from the Clean Water
Act (CWA) final effluent limitations guidelines for the Pharmaceutical Manufacturing Industry,
as well as the benefits expected to accrue from the corresponding Maximum Achievable Control
Technology (MACT) standards under the Clean Air Act (CAA). This assessment considers the
human health, environmental, and publicly-owned treatment works (POTW) benefits due to
reductions in effluent loadings and air emissions from four source planks (wastewater for CWA
rule and wastewater, process vents, storage tanks, and equipment leaks for MACT rale)1 expected
to result with implementation of these rules. The assessment includes a qualitative description of
each benefit category. In addition it provides quantitative estimates of economic (monetized)
benefits for those benefit categories for which there are sufficient data to develop such estimates.
Specifically, the report presents (1) an assessment of the water quality benefits of controlling the
discharge of wastewater from pharmaceutical manufacturing facilities to surface waters and
publicly-owned treatment works (POTWs), and (2) an assessment of the air quality benefits of
controlling onsite fugitive emissions to ambient air from open-air wastewater treatment, process
vents, storage tanks, and equipment leaks at pharmaceutical manufacturing facilities and
volatilization of chemical discharges at POTWs. Potential aquatic life and human health impacts
of direct discharges on receiving stream water quality and of indirect discharges on POTWs and
their receiving streams are projected at current, BAT (Best Available Technology), arid PSES
(Pretreatment Standards for Existing Sources) levels by quantifying pollutant releases and by using
stream modeling techniques. Potential human health impacts from fugitive air emissions are
projected using an air dispersion model and a benefits-transfer.analysis. Risks to POTW workers,
who may be exposed to pollutants volatilizing from influent wastewaters, are also estimated.
A variety of human health, environmental, and POTW benefits might result from
reductions in effluent loadings and reductions in emissions of volatile organic compounds (VOCs)
Revised pollutant loadings have been received since this assessment was completed based on earlier loadings (August
1997). Because the revised loadings are not significantly different (changes were less than 2 percent) from the loadings
used for the assessment, the assessment was not redone using the revised loadings.
-'"'' '...' 1 '
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to air as a result of the final regulations. The potential benefits to human health are evaluated by:
(1) comparing estimated histream concentrations to health-based water quality toxic effect levels
or U.S. Environmental Protection Agency (EPA) published water quality criteria; and (2)
estimating the potential reduction of carcinogenic risk and noncarcinogenic hazard (systemic) from
ronsuming contaminated fish or drinking water, and from fugitive ah" emissions. Potential benefits
to k^an health (and agriculture) are also estimated based on reductions in emissions to air of
ozone HecHEsors (i-e-r reactions in Yoc emissions). Potential ecological and recreational
benefits |enyironmental) are projected by estimating improvements hi recreational fishhig habitats,
rncludrng intrinsic benefits. Benefits to POTWs are estimated based on reduced pass-through and
sewage sludge contamination problems (thereby increasing the number of allowable sludge uses
or disposal options), reductions hi interference, improvements hi worker health, and reductions
hi analytical costs. EPA monetizes the estimated benefits for reductions hi air emissions of ozone
I " in i " ii?l flit, , "Vl.il!ii . ' '" . ซ ป , " :i,i - ป', '"'' >' I- ','' ป ', '!, ', ': ,,',1.,,'ii','"' ' ,' ," O. ,' ' |!hi' jvc;' , ,, ;r,, j,,,,, , , | , ,!, ,, ..,, ,: i,'/, 1,1,!,., ,r , ,,,.' ;r, , lii,' ^;~w
precursors, cancer risk reductions, nnprovements hi recreational fishhig opportunities, and
improvements hi intrinsic value, but is unable to quantify the dollar magnitude of benefits from
other benefit categories. Due to data limitations, the benefit estimates of some categories could
not be differentiated between CWA and MACT requirements. In addition, the potential fate and
:;,;;;! ,,' ' '!"" I '' , ,' iljIJi;, 'J,,;ij;jjjijj!! "" ri,1,,,, " h " "ปi;, i ;/ ""' *!, ," ' , ' ,'' ,, ' '!," ',,,, . :li" '! , *", ; ,, , :< : w1} n,; ,! ..''i1 i ,, 'i , -IT,., , ,, i.,,.. , ,,,,
toxipity of pollutants of concern associated with pharmaceutical manufacturhig wastewater are
evaluated based on known characteristics of each chemical. Recent literature and studies are also
reviewed for evidence of documented envkqnmental hnpacts (e.g., case studies) on aquatic life,
human health, and POTW operations and for hnpacts on the quality of receiving water and
ambient air.
The environmental assessment focuses mainly on identified compounds with quantifiable
' ' ' ,. ,' "' ; i""'.if. i ' /-..'I ','', '' '! .iP.'ii'i ' A' : '"i!'"' "'i',','1.!!, '' 'i .:Ji ' i1! i, ' '',i', ''. " '' " '' ', i"n' '%, "iiii!" ,i' 'iS' .'ป''!
toxic or carcinogenic effects. This leads to a potentially large underestimation of benefits, because
111 ; '.:... ;'S,: .','.( ;":;",. I"-'!:,:';!1;"; ' ;";111;,.1 -'' . :,."v,"', I; 'i11';";"'!'!1'!' '":l ..'': '.!',: 'Pi,* I1''1-!! ilf!'. ;
some significant pollutant characterizations are not considered. For example, this report does not
evaluate impacts associated with reduced paniculate load (measured as total suspended solids
USS], oxygen demand (measured as biological oxygen demand [BOD] and chemical oxygen
.3!]demaKL.[CppJ) or reduced to'xicity associated with COD hi the effluents. The discharge of these
'H/i r ' ,i,| '''!"',;!t*11 ''i1?1!;.!! ;, .,, i"1,,,1, :";,il"l|lii!!!l!i:1:!if,!:;!1,11'1 :B: ' ,, :'' /'i! i, !| "f *::,ซ:'", 'L,, ; 1|,lซ1'1';,',""' ' .''",'''" "< "V1;, ''"' 'l!i;,!'! ' '"? ;"i:'"' '"!'11;1 .":""'l'.ii V'1 '.'" 1'1!!i!,i!"111'1' . '".' ,""!' ''.Iv",1!1!*'* il'^ifS! '''Si'1.'1''1 H
pollutants may have significant adverse effects on the envu-onment. For example, habitat
-------
degradation can result from TSS loads that reduce light penetration and primary productivity, and
from accumulation of solid particles that alter benthic spawning grounds and feeding habitats.
COD and BOD levels can deplete oxygen levels, which may result in mortality or other adverse
effects in fish, as well as reduced biological diversity.
The benefits of COD reduction extend beyond reducing oxygen depletion, since COD also
represents the presence of organic chemicals hi a wastestream. Due to a lack of analytical
methods, not all of the compounds represented by COD are .identified. In this benefits assessment,
specifically identified compounds represent only 2.2 million pounds of the 11.5 million pounds
of COD projected to be removed, even when using the total theoretical oxygen .demand of
compounds including VOCs which may not be measured as COD. This limits the estimate of
benefits, because the analysis relies on comparing mstream concentrations to established criteria,
and there are obviously no established criteria for unidentified compounds. However, there is
inherent value in reducing pollutant loads, despite (or perhaps due to) the lack of quantifiable
effects.
The benefits analyses are further limited because they concentrate on projected excursions
from established minimum standards, and do not account for protection of higher quality
conditions. Likewise, they do not account for prevention of future impacts which could occur due
to increased effluent loadings.
The following sections of this report describe: (1) the methodology used hi the evaluation
of projected water and air quality impacts for direct and indirect discharging facilities and potential
human health risks and benefits (including assumptions and caveats) and in me evaluation of
documented environmental impacts; (2) data sources used for evaluating water and air quality
impacts such as plant-specific data, information used to evaluate POTW operations, water quality
criteria, population and climatologic data, and information used to evaluate human health risks and
benefits; (3) a summary of the results of this analysis; and (4) a complete list of references cited
-------
y^*0"8 aPPendices presented in Volume II provide additional detail on the
specific information addressed in this main report.
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2. METHODOLOGY
2.1 Projected Water Quality Impacts
The water quality impacts and associated risks/benefits of pharmaceutical manufacturing
discharges are evaluated by: (1) comparing projected instream concentrations with ambient water
quality criteria,2 (2) estimating the human health risks and benefits associated with the
consumption of fish and drinking water from waterbodies impacted by the pharmaceutical
industry, (3) estimating the environmental benefits associated with improved recreational fishing
habitats on impacted waterbodies, and (4) estimating the benefits to POTWs based on reduced
sewage sludge contamination, and inhibition of POTW operations. These analyses are performed
for 17 direct pharmaceutical facilities and 113 indirect pharmaceutical facilities The
methodologies used in this evaluation are described in detail below.
2.1.1 Comparison of Instream Concentrations with Ambient Water Quality Criteria
(AWQC)/Impacts at POTWs
Current and BAT/PSES pollutant releases are quantified and compared, and potential
aquatic life and human health impacts resulting from current and BAT/PSES pollutant releases are
evaluated using stream modeling techniques. Projected instream concentrations for each pollutant
are compared to EPA water quality criteria guidance or to toxic effect levels (i.e., lowest reported
or estimated toxic concentration) for pollutants for which no EPA water quality criteria or, for
pollutants for which no water quality criteria have been developed. Inhibition of POTW operation
and sludge contamination are also evaluated. The following three sections (i.e., Section 2.1.1.1
through Section 2.1.1.3) describe the methodology and assumptions used for evaluating the impact
of direct and indirect discharging facilities.
7
In performing this analysis, EPA used guidance documents published by EPA that recommend numeric human health
and aquatic life water quality criteria for numerous pollutants. States often consult these guidance documents when
adopting water quality criteria as part of their water-quality standards. However, because those State adopted criteria
may vary, EPA used the nationwide criteria guidance as the most representative values.
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2.1.1.1 Direct Discharging FacUities
ii '
Using a stream dilution model that does not account for fate processes, other than complete
111 i . ' i i r \
immediate mixing, projected instream concentrations are calculated at current and BAT levels for
stream segments with 14 AC and 3 BD3 direct discharging facilities. For stream segments with
multiple pharmaceutical facilities, pollutant loadings are summed, if applicable, before
concentrations are calculated. The dilution model used for estimating instream concentrations is
as follows.
C ' = LIOD
:* FF + SF
x CF
(Eq. 1)
where:
0,
L
1 ', '. ( miiiiii,
OD
'FJF
SF
instream pollutant concentration (micrograms per liter Lug/L])
facility pollutant loading (pounds/year [Ibs/year]))
facility operation (days/year)
facility flow (million gallons/day [gal/day]))
receiving stream flow (million gal/day)
conversion factors for units
lit' ; ป >, i.
The facility-specific data (i.e., pollutant loading, operating days, facility flow, and stream
ill I i1 , , ,' , , ; I1!!!!;,.!:, ii .if!'i,11 ' ,'' ' JJi ' ,",';!' , . ' ' !! ', " ,,, ', ,,| ' ,;' ' - ซ'.VI" '" , ' ".'iSi'lli'1!" :, , " , ' ' ';;; '.!,..,, ? .',, iป' . ' '',.', (< :.!ป! , ,',!'! :|l"i'',!,!!!": ,i! ,,,!i,!l||li.
flow) used in Eq. 1 are derived from various sources as described in Section 3.1.1 of this report.
One of three receiving stream flow conditions (1Q10 low flow, 7Q10 low flow, and harmonic
mean flow) is used for the two treatment levels; use depends on the type of criterion or toxic effect
level intended for comparison. The IQIO and 7Q10 flows are the lowest 1-day and the lowest
consecutive 7-day average flow during any 10-year period, respectively, and are used to estimate
I i,, ป,, ijuijii,,'!" 5',',1'j!1 ':.; ; ". "^ ' ;i: i ".'"i"1'; ' '! , .. ''''". ;;, \ " ';' :,., i >!!,"!"'," I ""' ' 1'''1' ' ,"'"*'' I":' '" ' '^!1,,'",,ป!', ''""' ";!1 " '1"1"1 ? ', ;" '"'I ' ,'1,1' t, J":1,' lil!!!!!'ซ
potential acute and chronic aquatic life impacts, respectively, as recommended in the Technical
Support Document for Water Quality-based Toxics Control (U.S. EPA, 1991a). The harmonic
AC facilities use |gnnentation or chemical synthesis processes and BD facilities use extraction, mixing, compounding
and formulating processes.
in - . i
-------
mean flow is defined as the inverse mean of reciprocal daily arithmetic mean flow values and is
used to estimate potential human health impacts. EPA recommends the long-term harmonic mean
flow as the design flow for assessing potential human health impacts because it provides a more
conservative estimate than the arithmetic mean flow. 7Q10 flows are not appropriate for assessing
potential human health impacts, because they have no consistent relationship with the long-term
mean dilution. , -
For assessing impacts on aquatic life, the facility operating days are used to represent the
exposure duration; the calculated instream concentration is thus the average concentration on days
the facility is discharging wastewater. For assuming long-term human health impacts, the
operating days (exposure duration) are set at 365 days; the calculated instream concentration is
tiius the average concentration on all days of the year. Although this calculation for human health
impacts leads to a lower calculated concentration because of the additional dilution from days
when the facility is not in operation, it is consistent with the conservative assumption that the
target population is present to consume drinking water and contaminated fish every day for an
entire lifetime.
Because stream flows are not available for hydrologically complex waters such as bays,
estuaries, and oceans, site-specific critical dilution factors (CDFs) or estuarine dissolved
concentration potentials (DCPs) are used to predict pollutant concentrations for facilities
discharging to estuaries and bays as follows.
FF
I CDF
(Eq. 2)
where:
L
QD =
estuary pollutant concentration Gug/L)
facility pollutant loading (Ibs/year)
facility operation (days/year)
-------
FF
CDF
CF
facility flow (million gal/day)
critical dilution factor
conversion factors for units
J: Lx DCP x CF
ซ" :, BL
(Eq. 3)
where: ,,.. , " .,.".,. ' , . ,
C..S = estuary pollutant concentration Cug/L)
L = , facility pollutant loading (Ibs/year)
DCP = dissolved concentration potential (milligrams per liter [mg/L])
CF = , conversion factor for units t . , ': ii.
BL = benchmark load (10,6o6 tons/year)
Site-specific critical dilution factors are obtained from a survey of States and Regions conducted
by EPA's Office of Pollution Prevention and Toxics (OPPT) (Mixing Zone Dilution Factors for
New Chemical Exposure Assessments, draft report, U.S. EPA, 1992a) Acute CDFs are used to
evaluate acute aquatic life effects; whereas, chronic CDFs are used to evaluate chronic aquatic life
or adverse human health effects. It is assumed that the drinking water intake and fishing location
are at the edge of the chronic mixing zone.
The Strategic Assessment Branch of the National Oceanic and Atmospheric
Administration's (NOAA) Ocean Assessments Division has developed DCPs based on freshwater
inflow and salinity gradients to predict pollutant concentrations in each estuary in the National
Estuarine Inventory (NEI) Data Atlas. These DCPs are applied to predict concentrations. They
do not consider pollutant fate and are designed strictly to simulate concentrations of nonreactive
i "I ,'i'1. I;,, "hill1!!,:,! nu'lill . I , " i! ,i ป : fW,, ' f.r ',.,' '.,..' ,'!'' ! n ,'!'V ii ; , v,.i ',','', ,'H .' ' , i'fa' ';i \ti ' , i 1 ,'.,,ป!,, H, ป" ,!i,, i ป I ,ป. " IF ป,'i, 'ill ,1ป!.].'", ;. - ' ,'i , . il"1 k li.i ,','!, ulWl ,'!i!|!:, !>
dissolved substances under well-mixed steady-state conditions given an annual load of 10,000 tons.
In addition, the DCPs reflect the predicted estuary-wide response and may not be indicative of site-
specific locations.
-------
Water quality excursions are determined by dividing the projected instream (Eq. 1) or
estuary (Eq. 2 and Eq. 3) pollutant concentrations by EPA AWQC or toxic effect levels. A value
greater than 1.0 indicates an excursion.
2.1.1.2 Indirect Discharging Facilities
Assessing the impacts of indirect discharging pharmaceutical facilities is a two-stage
process. First, water quality impacts are evaluated as described hr Section (a) below. Next,
impacts on POTWs are considered as described in Section (b) that follows.
(a) Water Quality Impacts
A stream dilution model is used to project receiving stream impacts resulting from releases
by 61 AC and 52 BD indirect discharging facilities as shown in Eq. 4. For stream segments with
multiple pharmaceutical facilities, pollutant loadings are summed, if applicable, before
concentrations are calculated. The facility-specific data used in Eq. 4 are derived from various
sources as described in Section 3.1.1 of this report. Three receiving stream flow conditions (1Q10
low flow, 7Q10 low flow, and harmonic mean flow) are used for current and PSES treatment
levels. Pollutant concentrations are predicted for POTWs located on bays and estuaries using site-
specific CDFs or NOAA's DCP calculations (Eq. 5 and Eq, 6).
Cis = (LfOD) x
(l-TMT) x CF
PF + SF.
(Eq. 4)
where:
Cis = , instream pollutant concentration Og/L)
L = facility pollutant loading (Ibs/year)
Op = facility operation (days/year;)
TMT POTW treatment removal efficiency
PF = POTW flow (million gal/day)
-------
SF
CF
receiving stream flow (million gal/day)
conversion factors for units
LI OP x (l-TMT)\
PF )
x~CF\l CDF
(Eq. 5)
where:
L
OD
'PF .....
''CDF
,CF""
r'3 I,.' Jiiij
"is, where:
DCP =
CF;:' ""=
estuary pollutant concentration Gug/L)
facility pollutant loading (Ibs/year)
facility operation (days/year)
POTW treatment removal efficiency
POTW flow (million gal/day)
critical dilution factor
conversion factors for units
= L x <-I-T> x DCP x CF
BL
estuary pollutant concentration (wg/L)
facility pollutant loading (Ibs/year)
POTW treatment removal efficiency
dissolved concentration potential (mg/L)
conversion factors for units
benchmark load (10,000 tons/year)
(Eq. 6)
Potential impacts on freshwater quality are determined by comparing projected instream
pollutant concentrations (Eq. 4) at reported POTW flows and at 1Q10 low, 7Q10 low, and
harmonic mean receiving stream flows with EPA water quality criteria or toxic effect levels for
W i" "''! ' ' 'vii'iliii i rtf VJiN ''.. , ," ,',! "! ' , ,J'||,,," '.I'.,',,;!, 'I'/" ปป ' ' "',' " , :,,', ' .: , '' , !, ,?!' .'l' .!ซ,.', ; ,i" . ; ;, v!'1'1!. .'!; K :,!,:ป '("I1 ''i:' 'i'1'.!',:.1 ' "' ''" -l!l I'l"1!11.1!, ' ' f'"i,' ', , 'i;/*'.,"*" k'i'lP,
the protection of aquatic life and human health; projected estuary pollutant concentrations (Eq. 5
""and Eq. 6)', based on CDFs or DCPs, are compared to EPA water quality criteria or toxic effect
levels to determine impacts. Water quality criteria excursions are determined by dividing the
projected instream or estuary pollutant concentration by the EPA AWQC or toxic effect levels!
10
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(See Section 2.1.1.1 for discussion of stream flow conditions, application of CDFs or DCPs,
assignment of exposure duration, and comparison with criteria or toxic effect levels.) A value
greater than 1.0 indicates an excursion.
(b) Impacts on POTWs
The impacts of pharmaceutical manufacturing discharges on POTW operations are
evaluated for the potential to inhibit POTW processes (Lei, inhibition of microbial degradation)
and to limit land use or disposal of POTW sludges. Inhibition of POTW operations is determined
by dividing calculated POTW influent levels (Eq.' 7) with chemical-specific inhibition threshold
levels. Excursions are indicated by a value greater than 1.0.
.
PI
pF
(Eq.7)
where:
Cpi . = POTW influent concentration Cug/L).
L = facility pollutant loading (Ibs/year)
OD = facility operation (days/year)
PF = POTW flow (million gal/day)
CF = conversion factors for units
Limitations on sludge use (for land application) is evaluated, if applicable, by dividing projected
pollutant concentrations in sludge (Eq. 8) by available EPA-developed criteria values for sludge.
A value greater than 1.0 indicates an excursion. '
CSP = CPi x TMTx PARTx SGF
(Eq. 8)
where:
"sp
sludge pollutant concentration (milligrams per kilogram [mg/kg])
11
-------
("..In - ! MM ..i ii* ': ; ii,
ซjf..; | ,|< i, jiFji,. ' .1 i!|;,r
i in i: , it i
iW' .W1 '
IrillW1 iWilli
Cpi = POTW influent concentration C"g/L)
TMT = POTW treatment removal efficiency
PART = chemical-specific sludge partition factor
SGF = sludge generation factor (5.96 mg/kg per ^g/L)
Facility-specific data and information used to evaluate POTWs are derived from the
sources described in Sections 3.1.1 and 3.1.2. For facilities that discharge to the same POTW,
their individual loadings are summed before the POTW influent arid sludge concentrations are
calculated.
The partition factor is a measure of the tendency for the pollutant to partition in sludge
when it is removed from wastewater. For predicting sludge generation, the model assumes that
i'^OQ P01"1*18 of sludge are generated for each million gallons of wastewater processed (Metcalf
& Eddy, 1972). This results in a sludge generation factor of 5.96 mg/kg per /ug/L (that is, for
every 1 fjg/L of pollutant removed from wastewater and partitioned to sludge, the concentration
in sludge is 5.96 mg/kg dry weight).
2.1.1.3 Assumptions and Limitations
The following major assumptions and limitations are associated with this analysis:
Background concentrations of each pollutant, both in the receiving stream and in
the POTW influent, are equal to zero; therefore, only the impacts of discharging
facilities are evaluated.
An exposure duration of 365 days is used to determine the likelihood of actual
excursions of human health criteria or toxic effect levels
ihl I I If' h
Complete mixing of discharge flow and stream flow occurs across the stream at the
discharge point. This mixing results in the calculation of an "average stream"
concentration even though the actual concentration may vary across the width and
depth of the stream.
i'i . i i n
The process water at each facility and the water discharged to a POTW are
obtained from a source other than the receiving stream.
'*' . t
12
-------
* ,The pollutant load to the receiving stream is assumed to be continuous and is
assumed to be representative of long-term facility operations. This assumption may
overestimate risks to human health and aquatic life.
1Q10 and 7Q10 receiving stream flow rates are used to estimate aquatic life
impacts, and harmonic mean flow rates are used to estimate human health impacts.
1Q10 low flows are estimated using the results of a regression analysis conducted
by Versar for EPA's OPPT of 1Q10 and 7Q10 flows from representative U.S.
rivers and streams (Upgrade of Flow'Statistics Used toEstimateSurface Water
Chemical Concentrations for Aquatic and Human Exposure Assessment, Versar,
1992). Harmonic mean flows are estimated from the mean and 7Q10 flows as
recommended in the Technical Support Document for Water-Quality-based Toxics
Control (U.S. EPA, 1991a). These flows may not be the same as those used by
specific states to assess impacts.
Pollutant fate processes such as sediment adsorption, volatilization, and hydrolysis
are not considered. This may result inestimated mstream concentrations that are
environmentally conservative (higher),
* Pollutants without a specific POTW treatment removal efficiency, provided by
EPA or found in the literature are assigned a removal efficiency of zero; pollutants
without a specific partition factor are assigned a value of zero.
Sludge criteria levels are only available for seven pollutants - arsenic, cadmium,
copper, lead, mercury, selenium, and zinc.
Water quality criteria or toxic effect levels developed for freshwater organisms are
used in the analysis of facilities discharguig to estuaries or bays.
. Of those facilities reporting a wastewater discharge, the number of facilities
modeled was limited by available data on receiving streams and POTWs.
2.1.2 Estimation of Human Health Risks and Benefits
The potential benefits to human health expected to result from the CWA final rule and the
MACT final rule are evaluated by estimating the risks (carcinogenic and noncarcinogenic hazard
[systemic]) associated with reducing pollutant levels in fish tissue and drinking water from current
to BAT/PSES treatment levels. Reduction in carcinogenic risks is monetized using estimated
willingness-to-pay values for avoiding premature mortality. The following three sections describe
13
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the methodology and assumptions used to evaluate the human health risks and benefits from the
consumption of fish tissue and drinking water derived from water bodies impacted by AC and BD
ill I I I I I I
direct and indirect discharging facilities.
i in
2.1.2.1 Fish Tissue
To determine the potential benefits, in terms of reduced cancer cases, associated with
i *
reducing levels in fish tissue, lifetime average daily doses (LADDs) and individual risk levels are
I
estimated for each pollutant discharged from a facility based on the instream pollutant
concentrations calculated at current and BAT/PSES treatment levels in the site-specific stream
dilution analysis (see Section 2.1.1). Estimates are presented for sport anglers, subsistence anglers
and the general population. LADDs are calculated as follows.
LADD = (C x IR * BCF x F x D ) / ( BW x LT )
(Eq. 9)
where:
LADE) .....
M
- ,-BOF
F
D
BW
LT
potential lifetime average daily dose (milligrams per kilogram per day
[mg/kg-day])
exposure concentration (mg/L)
ingestion rate (see Section 2.1.2.3 - Assumptions)
bipconcentration factor, (liters per kilogram [L/kg])
(whole body x 0.5)
frequency duration (365 days/year)
exposure duration (70 years)
body weight (70 kg)
lifetime (70 years x 365 days/year)
Individual risks are calculated as follows:
R = LADD x SF
(Eq. 10)
14
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where:
R
LADD
SF
individual.risk level
potential lifetime average daily dose (mg/kg-day)
potency slope factor (mg/kg-day)-1 '
The estimated individual pollutant risk levels are then applied to the potentially exposed
populations of sport anglers, subsistence anglers, and the general population to estimate the
potential number of excess annual cancer cases occurring over the life of the population. The
number of excess cancer cases is then summed on a pollutant, facility, and overall industry basis.
The number of reduced cancer cases are assumed to be the difference between the estimated risks
at current and BAT/PSES treatment levels.
A monetary value of benefits to society from avoided cancer cases is estimated if current
wastewater discharges result in excess annual cancer cases with a magnitude significant enough
to affect the analysis. The valuation of benefits is based on estimates of society's willingness-to-
pay to avoid the risk of cancer-related premature mortality. Although it is not certain that all
cancer cases will result in death, to develop a worst case estimate for this analysis, avoided cancer
cases are valued on the basis of avoided mortality. To value mortality, a range of values
recommended by an EPA, Office of Policy, Planning and Evaluation (OPPE) review of studies
quantifying individuals' willingness-to-pay to avoid risks to life is used (Fisher, Chestnut, and
Violette, 1989; and Violette and Chestnut, 1986). The reviewed studies used hedonic wage and
contingent valuation analyses in labor markets to estimate the amounts that individuals are willing
to pay to avoid slight increases in risk of mortality or will need to be compensated to accept a
slight increase hi risk of mortality. The willingness-to-pay values estimated in these studies are
associated with small changes in the probability of mortality. To estimate a willingness-to-pay for
avoiding certain or high probability mortality events, they are extrapolated to the value for a 100.
percent probability event.4 The resulting estimates of the value of a "statistical life saved" are used
to value regulatory effects that are expected to reduce the incidence of mortality
These estimates, however, do not represent the willingness-to-pay to avoid the certainty of death.
.'."''''. 15 ' . .
-------
IB, m^m
if ซ;;:(.', iifji
Biiliii'T 11"'1 r I' "'Mil'!''
ST.,!''1,.! 'U'-i Xfl
I'C'S'i.i 'I"!::.,::1 I" III'"!
'MBWill .W:ซ:fflซi"SI:';',!; : ;
IK ",H ,;:;,. MiiEi .soil ". ..."
MS11:!! :yivt
::;:fl.^','' i''.!i..-5'
of $1.6 to $8._5
=million (1986 dollars) for valurng an avoided event of premature mortality or a statistical life
saved. A more recent survey of value of life studies by Viscusi (1992) also supports mis range
with the finding that value of life estimates are clustered in the range of $3 to $7 million (1990
dollars). For this analysis, the figures recommended hi the OPPE study are adjusted to 1990
(jisi't 'ij,;" ' ' ""v;1"!1"1, !f:iงi, ' liiBi'^i','", ':::! ...... t'^'S'fs.^':",11!'^ '' 'l'i';';;j"::'1'" li :: ' '"I:,' v 'i >;'i"i V1;('.; li1;!'1':'1: i''^''^''^,': SiS-vs1""1 $ : ' "i i-,:,1:,!;1 ^N'"'^"-''"'1'; ^^.i-.-'.'r'.^ - v"-"S'^i::S: I'V
using the relative change in the Employment Cost Index of Total Compensation for All Civilian
'Workers i fro'in" 1986 to 1990 (20 percent). Basing the adjustment in the wiliingness-tOTpay values
on change : in ^ nominal Gross Domestic Product (GDP) instead of change hi inflation, accounts for
the expectation that willingness-to^pay-to avoid risk is a normal economic good, and, accordingly,
sSciery's willingness-to-pay to avoid risk will increase as national income increases. Updating the
OPPE 1986 value to 1990 dollars yields a range of $1.9 to $10.2 million.
Potential reductions in risks due to reproductive, developmental, or other chronic and
subchronic toxic effects are estimated by comparing the estimated average daily dose and the oral
reference dose (RfD) for a given chemical pollutant as follows:
HQ = OR1IRJD
(Eq. 11)
'""-": Where:
HQ
ORI
RfD
hazard quotient
oral intake (LADD x BW, mg/day)
reference dose (mg/day assuming a body weight of 70 kg)
A hazard index (i.e., sum of individual pollutant hazard quotients) is then calculated for
each facility or receiving stream. A hazard index greater than 1.0 indicates that toxic effects may
occur in exposed populations. The size of the subpopulations affected are summed and compared
at the various treatment levels to assess benefits in terms of reduced systemic toxicity. While a
monetary value of benefits to society associated with a reduction in the number of individuals
16
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exposed to pollutant levels likely to result in systemic health effects could not be estimated, any
reduction in risk is expected to yield human health-related benefits.
2.1.2.2 Drinking Water
Potential benefits associated with reducing levels in drinking water are determined in a
similar manner. LADDs for drinking water consumption are calculated as follows:
LADD = (C x IR x F x D ) / ( BW x LT )
(Eq. 12)
where:
LADD
C
IR
F
D
BW
LT
potential lifetime average daily dose (mg/kg-day)
exposure concentration (mg/L)
ingestion rate (2L/day)
frequency duration (365 days/year)
exposure duration (70 years)
body weight (70 kg)
lifetime (70 years x 365 days/year)-
Estimated individual pollutant risk levels greater than 10'6 (1E-6) are applied to the population
served downstream by any drinking water utilities within 50 miles from each discharge site to
determine the number of excess annual cancer cases that may occur during the life of the
population. Systemic toxicant effects are evaluated by estimating the sizes of populations exposed
to pollutants from a given facility, the sum of whose individual hazard quotients yields a hazard
index (HI) greater than 1.0. A monetary value of benefits to society from avoided cancer cases
is estimated, if applicable, as described in Section 2.1.2.1. :
17
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2.1.2.3 Assumptions and Limitations
The following major assumptions and limitations are associated with the Human Health
Risks and Benefits Analysis.
A linear relationship is assumed between pollutant loading reductions and
benefits attributed to the clean-up of surface waters.
Synergistic effects of multiple chemicals on aquatic ecosystems are not assessed.
Therefore, the total benefit of reducing toxics may be underestimated.
The total number of persons who might consume recreationally caught fish and
the number;that rely upon fish on a subsistencebasis''in' each State is estimated,
in part, by assuming that these anglers regularly share their catch with family
members. Therefore, the number of anglers in each State is multiplied by the
average household size in each State The remainder of the population of'these"
States is assumed to be the "general population" consuming commercially caught
,., ,.., , fish: , ,/_; ' ;
Five percent of the resident anglers in a given State are assumed to be
subsistence anglers; the other 95 percent are assumed to be sport anglers.
Commercially or recreationally valuable species are assumed to occur or be
taken in the vicinity of the discharges included hi the evaluation.
Ingestion rates of 6.5 grams per day for the general population, 30 grams per
day (30 years) + 6.5 grams per day (40 years) for sport anglers, and 140 grams
per day for subsistence anglers are used in the analysis of fish tissue (Exposure
Favors Handbook, U.S. EPA, 1989a).
..' ;',' ,:" '. '''h",,i,!. i.';,,>' L ป' -i'l > .:',^^j.. i1:* , f . \. >:>*\-'."ซ*^ '"''', V'1 i;,,,;i,M,"i:!,'i!i!.; "' '' >. TV1' -. :!;;:,.,:' ':, i;,'1.,,, ,':: ":<^'%, \ Wi .>
* All rivers or estuaries within a State are equally fished by any of that State's
resident Anglers and the fish are consumed only by the population within mat
'State. , ' '' ' ", , ' ;". "" '.
Populations potentially exposed to discharges to rivers or estuaries that border
more than one State are estimated baseci only on populations within the State in
which the facility is located.
18
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The size of the population potentially exposed, to fish caught in an impacted
water body in a given State is estimated based on the ratio of impacted river
miles to total river miles in that State or impacted estuary square miles to total
estuary square miles in that State. The number of miles potentially impacted by
a facility's discharge is assumed to be 50 miles for rivers and the total surface
area of the various estuarine zones for estuaries.
2.1.3 Estimation of Environmental Benefits
The CWA final effluent guidelines and the MACT rule are expected to generate
environmental benefits by improving water quality. These improvements in water quality are
expected to result from reduced loadings of toxic substances in the effluent of the regulated
facilities. The potential environmental benefits of the final regulations are evaluated by estimating
improvements in the recreational fishing habitats that are impacted by pharmaceutical wastewater
discharges. Stream segments are first identified for which the proposed regulation is expected to
eliminate all occurrences of pollutant concentrations in excess of both aquatic life and human
health AWQC or toxic effect levels. (See Section 2.1.1.) The elimination of pollutant
concentrations in excess of AWQC is expected to result in significant improvements in aquatic
habitats. These improvements in aquatic habitats are then expected to improve the quality and
value of recreational fishing opportunities and nonuse (intrinsic) value of the receiving streams.
The estimation of the monetary value to society of improved recreational fishing opportunities is
based on the concept of a "contaminant-free fishery" as presented by Lyke (1993).
Research by Lyke (1993) shows that anglers may place a significantly higher value on a
contaminant-free fishery than a fishery with some level of contamination. Specifically, Lyke
estimates the consumer surplus5 associated with Wisconsin's recreational Lake Michigan trout and
salmon fishery, and the additional value of the fishery if it was completely free of contaminants
affecting aquatic life and human health. Lyke's results are based on two analyses:
Consumer surplus is generally recognized as the best measure from a theoretical basis for valuing the net economic
welfare or benefit to consumers from consuming a particular good or service. An increase or decrease in consumer
surplus for particular goods or services as the result of regulation is a primary measure of the gain or loss in consumer
welfare resulting from the regulation. .
19
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1. A multiple site, trip generation, travel cost model was used to estimate net
benefits associated with the fishery under baseline (i.e., contaminated)
conditions. _,_ .'.,.. , , ' ,, . , , ., h. ,.,_
2. A contingent valuation model was used to estimate willingness-to-pay values for
the fishery if it was free of contaminants.
Both analyses used data collected from licensed anglers before the 1990 season. The estimated
incremental benefit values associated with freeing the fishery of contaminants range from 11.1
percent to 31.3 percent of the value of the fishery under current conditions.
To estimate the' gain in value of stream segments identified as showing improvements in
aquatic habitats as a result of the final regulations, the baseline recreational fishery value of the
stream segments are estimated on the basis of estimated annual person-days of fishing per segment
and estimated values per person-day of fishing. Annual person-days of fishing per segment are
calculated using estimates of the affected (exposed) recreational fishing populations. (See Section
!liซ " i' V i1 ",,,'i"' ,'i/,!: .I'li'viiC'i',"'','u ?" iซ ."iifm'.ij:ปj ii< '', ( ,i ' .',/ j iii i "i ' i : ',','in,,'i "'Sp1,. |i''i' 'ซii,''iii'1'1:**!!,!'*, i , v' i i1'1,,; '!" i "';; i, 1'iV ,',,ซ ,''ซ',<""K ฐ''.i" j1* i,'',!!!!!:i! ,'\\ ! ;ik"flii ".'vii ". ฐ!i i'!1*1 :i' 'iiiifjjii'i' llV!1]
2.1.2.) The number of anglers are multiplied by estimates of the average number of fishing days
per angler in each State to estimate the total number of fishing days for each segment. The
baseline value for each fishery is then calculated by multiplying the estimated total number of
I ",", "vi,1!!! '' iflii"! "' !'!",'ill"' !. ' i,l'", i: i" ! " I I
fishing days by an estimate of the net benefit that anglers receive from a day of fishing where net
i|||( i i 11 INI ,-',; Slrii'iVvriiiii "'i*'!}, V1 "$.',''!.' ' i i i il 11 ป iiiiiii i
benefit represents the total value of the fishing day exclusive of any fishing-related costs (license
fee, travel costs, bait, etc.) incurred by the angler. In this analysis, a range of median net benefit
* 'in/ i, v; ,' ,,'i; ,;,';,, i ' ! " ! i;!'I '|J .'i*!?;1!;!: 'J'11*!!1*';1 !"*! '
values for warm water and cold water fishing days, $25.79 and $32.66, respectively, in 1990
dollars is used. Summing over all benefiting stream segments provides a total baseline recreational
i
fishing value of pharmaceutical stream segments that are expected to benefit by elimination of
pollutant concentrations in excess of AWQC.
To estimate the increase hi value resulting from elimination of pollutant concentrations in
excess of AWQC, the baseline value for benefiting stream segments are multiplied by the
incremental gain in value associated with achievement of the "contaminant-free" condition. As
noted above, Lyke's estimate of the increase in value ranged from11.1 percent to 31.3 percent
20
-------
Multiplying by these values yields a range of expected increase in value for the pharmaceutical
stream segments, expected to benefit by elimination of pollutant concentrations in excess of
AWQC.
In addition, nonuse (intrinsic) benefits to the general public, as a result of. the same
improvements in water quality, as described above, are expected. These nonuse benefits (option
values, aesthetics, existence values, and request values) are based on the premise that individuals
who never visit or otherwise use a natural resource might nevertheless be affected by changes in
its status or quality (Fisher and Raucher, 1984). Nonuse benefits are not associated, with current
use of the affected ecosystem or habitat, but arise rather from 1) the realization of the
improvement in the affected ecosystem or habitat resulting from reduced effluent discharges, and
2) the value that individuals place on the potential for use sometime in the future. Nonuse benefits
can be substantial for some resources and are conservatively estimated as one-half of the
recreational benefits (Fisher and Raucher, 1984). Since this approximation was only applied to
recreational fishing benefits for recreational anglers, it does not take into account nonuse values
for non-anglers or for the uses other than fishing by anglers. Therefore, EPA estimated only a
portion of the nonuse benefits.
2.1.3.1 Assumptions and Limitations
The following major assumptions and limitations are associated with the Environmental
Benefits Analysis: .
Background concentrations of the pharmaceutical pollutants of concern in the
receiving stream are not considered.
The estimated benefit of unproved recreational fishing opportunities is only a
limited measure of the value to society of the improvements in aquatic habitats
expected to result from the proposed regulation; increased assimilation capacity
of the receiving stream, improvements in taste and odor, or improvements to
other recreational activities, such as swimming, boating, water skiing and
wildlife observation^ are not addressed.
21
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Significant simplifications and uncertainties are included in the assessment. This
may overestimate or underestimate the monetary value to society of improved
recreational fishing opportunities. (See Sections 2.1.1.3 and 2.1.2.3.)
Potential overlap in valuation of improved recreational fishing opportunities and
avoided cancer cases from fish consumption may exist. This potential is
considered to be minor hi terms of numerical significance.
t *
. , i> i ni I
A portion of recreational and intrinsic benefits cannot be differentiated between
CWA and MACT requirements. Specifically, two facilities included in the
modeling were required to have MACT strippers and were also costed for
additional strippers to meet the CWA effluent guidelines.
2.1.4 Estimation of POTW Benefits
The final CWA rule establishes pretreatment standards for up to 24 pollutants discharged
MI , ' n , . ' ,'i,ii', , ,,,. i ' ii ,i i,, ' i' , ', .i;!,,.'"' i'i ,. ปi ' i .i'.' ', 'i' ." 'i'i. , I "' , ^?i MI iป
to POTWs by pharmaceutical manufacturing facilities. EPA identified the pollutants to be
addressed by pretreatment standards based on analyses of the quantity of wastewaters discharged
by facilities, pollutant concentration levels in these wastewaters, and the number of facilities that
discharge these pollutants. In addition, the MACT rule is expected to contribute to the
improvement of conditions at POTWs. Although the benefits from reducing adverse effects at
POTWs might be substantial, all of these benefits are not quantified due to data limitations.
Potential benefits to POTWs are estimated based on reduced interference, passthrough and sewage
contamination problems, as well as reductions in costs potentially incurred by POTWs in analyzing
toxic pollutants and detennming whether, and the appropriate level at which, to set local limits.
Each of these potential benefit categories is discussed below.
2.1.4.1 Reductions in Interference, Passthrough and Sewage Sludge Contamination Problems
9 ' " | J
Toxic pollutants contained in the effluent loadings of pharmaceutical plants and discharged
to POTWs can cause interference problems and/or pass through a POTW's treatment system and
potentially affect water quality or contaminate sludges generated during treatment. Interference
22
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is defined as the inhibition or disruption of POTW operations. Interference can result from large
quantities or high concentrations of toxic pollutants in effluent discharges that, might adversely
affect the operation of a POTW, potentially affecting the treatment efficiency or capacity of the
plant. Similarly, passthrough can result when toxic pollutants in effluent discharges are not
addressed by a POTW's treatment process or if the quantity or concentration of pollutants prevents
the POTW from fully treating the wastewaters. These pollutants can remain in the wastewaters
and be discharged by the POTW to surface waters. Alternatively, these pollutants can remain in
the treatment sludges. Passthrough and sludge contamination problems affect POTWs to the extent
that they prevent POTWs from meeting their permits or sewage sludge criteria.
Anecdotal evidence and analytic results indicate that such effects can occur. POTW
responses to an EPA survey addressing toxic substances in effluent discharges by pharmaceutical
manufacturers and the impact of these substances on POTW operations provides evidence that
these effluent loadings can cause inhibition problems at POTWs (Radian, 1993). For example,
one POTW indicated that high concentrations of volatile organics in a pharmaceutical facility's
effluent might have caused nitrification problems at the POTW. Another POTW stated that low-
level discharges of some compounds can affect treatment plant operations. Specifically, releases
of siloxanes affected the efficiency of the POTW's boiler and ultimately forced the plant to replace
this equipment.
The CWA final rule and, to some extent, the MACT rule are expected to help reduce
potential interference, passthrough and sewage sludge contamination problems by reducing toxic
loadings in the industry's effluent and reducing shock releases (i.e., unexpected releases that
contain high concentrations of toxic pollutants) from pharmaceutical manufacturing facilities. This
would reduce the likelihood that these releases will cause interference, passthrough, and sewage
sludge contamination problems at POTWs. Anecdotal evidence from POTWs indicate that such
effects can occur.
23
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(I
Limited evidence is available on the extent to which discharges from pharmaceutical
facilities cause POTWs to fail to comply with their permits or result in pollutant levels in sewage
sludges that exceed EPA sewage sludge criteria. There are several documented incidents of large
slug loads or accidental releases from pharmaceutical facilities that have negatively affected the
i ป . ^ i
environment, including fish kills, degradation of water quality, and odor problems.6 In addition,
currently many pollutants are not controlled in POTW permits because information is lacking on
the potential impacts of these pollutants on the environment. Although discharge and failure to
treat unregulated pollutants technically does not constitute passthrough, these pollutants enter and
potentially have negative effects on the environment.
To determine the potential benefits, in terms of reduced sewage sludge disposal costs,
1 'i
sewage sludge pollutant concentrations, if applicable, are calculated at current and proposed
pretreatment levels. (See Section 2.1.1.2.) Pollutant concentrations are then compared to sewage
sludge pollutant limits for surface disposal and land application (minimum ceiling limits and
pollutant concentration limits). If, as a result of the proposed pretreatment, a POTW meets all
pollutant limits for a sewage sludge use or disposal practice, that POTW is assumed to benefit
i ' '
from the increase in sewage sludge use or disposal options. The amount of the benefit deriving
from changes in sewage sludge use or disposal practices depends on the sewage sludge use or
disposal practices employed under current levels. This analysis assumes that POTWs choose the
least expensive sewage sludge use or disposal practice for which their sewage sludge meets
pollutant limits. POTWs with sewage sludge that qualifies for land application in the baseline are
assumed to dispose of their sewage sludge by land application; likewise, POTWs with sewage
I I ' I 1 H |
sjudge that meets surface disposal limits (but not land application ceiling or pollutant limits) are
assumed to dispose of their sewage sludge at surface disposal sites.
The economic benefit for POTWs receiving wastewater from a facility is calculated by
i
iinM the cost differential between baseline and post-compliance sludge use or disposal
6
Note that some of these releases might have been in violation of existing regulations, and thus it might be
inappropriate to attribute benefits resulting from proper control of these releases to the final rule. However, if the final
rule does reduce the likelihood of such releases, it might be argued that such benefits are attributable to the rule.
24
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practices by the quantity of sewage sludge that shifts into meeting land application (minimum
ceiling limits and pollutant concentration limits) or surface disposal limits. Using these cost
differentials, reductions in sewage sludge use or disposal costs are calculated for each POTW
(Eq. 13):
SCR = PFx Sx CD x PD x CF
where:
SCR
PF
S
CD
PD
CF
(Eq. 13)
= estimated POTW sewage sludge use or disposal cost reductions resulting
from the proposed regulation (1992 dollars)
= POTW flow (million gal/year)
= sewage sludge to wastewater ratio (1,400 Ibs (dry weight) per million
gallons of water)
= estimated cost differential between least costly composite baseline use or
disposal method for which POTW qualifies and least costly use or disposal
method for which POTW qualifies post-compliance (1992 dollars/dry
metric ton)
= percent of sewage sludge disposed
= conversion factor for units
In addition, as part of the analysis of the effects of pretreatment standards, POTW influent
levels are compared to available data on inhibition levels. Sufficient data are not available to
monetize these benefits.
2.1.4.2 Reductions in Analytical Costs
r ' -
Under the National Pretreatment Program, authorized POTWs are required to develop and
implement programs to control pollutants discharged by facilities to their systems. These local
programs set numerical limits on discharges to the POTW, based on national categorical
pretreatment standards or local limits determined by the POTW. Local limits are designed to prevent
passthrough, interference, and sewage sludge contamination, taking into account POTW-specific and
effluent-specific characteristics, as well as to implement other specific components of the National
25
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PIU'I I1! ill'IMIIil'l11 Illllillpf ^ "ซ !lliiiP'l,*liliP|i!illii,;1!!1: Illli1 l|!l|l|i Illljl''!;'^!!!!!''!1 ll| i ',::! "ill!,!"1!;l i "11 iPfvL ,|,'' l;|",!, MllllliliiifflK nlWIKl'l!':W
IlliiiU ,',':, M',, Ill iiiiii! ', iiiiltn nil,11! ! ,,'''!" :::ปป:!,; til Ill1"',," '^Kr-'t n'i" V", ., " :.'''<-'" ! !' * .'' < :'" ' 1'1'1',' ' "~"J' ' "'" ''i; ' "'"I11?!1"1'I .' ''' -'f J''1'"' '"'"''' "Vl'i' ' ' i'*'1' ' ""';' '" !i'1"ปll'>l1*.l'lviซt.1'',
Pretreatment Program (e.g., preventing discharges that might cause fire, explosion hazard, corrosive
structural damage, or worker health and safety problems).
In setting these local limits, POTWs might need to undertake analyses to determine which
pollutants warrant local limits and at what numerical level. Conducting these analyses is
expensiveon the order of hundreds ofthousands of dollars(Appendix A). Thus, establishing
pretreatment standards benefits the POTWs by allowing them to avoid the costs of performing these
analyses. In addition, it is more efficient to conduct such analyses at the national level, reducing the
ซ 'i1 i' ;] . "i r j , ,,i|. i, . '") ,iป ' , ," , , , ,i IM C?, , h
potential for duplication of effort. Several POTWs pontacted1 as part of me POTW survey indicated
that they will benefit from the estabiishment of national pretreatment standards by avoiding these
local limits development costs. In addition, they indicated that the pretreatment standards will
bolster the legal authority of the limits they set.
Reducing the pollutant load to local POTWs may eliminate some of the efforts associated
( with establishing local pollutant limits. Local limits are sometimes, required to protect against pass-
through and interference, and to protect worker health and safety. Establishing local limits involves
labor and analytical costs to determine the relative contribution of each industrial discharger and to
set limits which will be protective of the treatment works, the workers, and the receiving
environment. Several POTWs contacted in EPA's survey indicated that establishment of more
effective national pretreatment standards would help them avoid these significant costs. In addition,
they indicated that where local limits are still required, stricter national pretreatment standards will
bolster the validity of the limits they set.
Furthermore, reducing the discharge of toxic pollutants reduces the likelihood that the POTW
effluents will exhibit excessive toxicity. When POTW effluent exhibits excessive toxicity, the
h i
POTW must enact a rigorous, costly analytical program to identify and reduce the source of toxicity.
26
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2.1.4.3 Assumptions and Limitations
The following major assumptions and limitations are associated with the POTW Benefits
(sludge contamination) Analysis:
13.4 percent of the POTW sewage sludge generated in the United States is
generated at POTWs that are located too far from agricultural land and surface
disposal sites for these use or disposal practices to be economical. This
percentage of sewage sludge is not'associated with benefits from shifts to surface
disposal or land application.
Benefits expected from reduced record-keeping requirements and exemption
from certain sewage sludge management practices are not estimated.
No definitive source of cost-saving differential exists. Analysis may
overestimate or underestimate the cost differentials.
Sewage sludge use or disposal costs vary by POTW. Actual costs incurred by
POTWs affected by the pharmaceutical regulation may differ from those
estimates.
Due to the unavailability of such data, baseline pollutant loadings from all
industrial sources are not included in the analysis.
2.2 Projected Air Quality Impacts
Many of the chemicals released by pharmaceutical manufacturing facilities can exhibit
human health toxicity via the inhalation exposure route. A three-part approach is used to assess
environmental impacts from air emissions associated with pharmaceutical treatment options. The
first part assesses potential risks to the general public from onsite fugitive emissions from open-air
biological treatment using OPPT's Personal Computer Graphical Exposure Modeling System
(PCGEMS) Atmospheric Modeling Subsystem (GAMS). GAMS includes the Industrial Source
Complex Long Term (ISCLT) air dispersion model linked to site-specific weather and population
data. The second part assesses potential risks to POTW workers from occupational exposures to
a toxic mixture of gases partitioning from influent wastewater. The POTW occupational exposure
. -.-. . .-.-'. . - . ' 27 :
-------
ill 111
analysis is based on the procedure presented in Guidance to Protect POTW Workers from Toxic
and Reactive Gases and Vapors (U.S. EPA, 1992b). The third part assesses potential risks to the
1
general public and the environment from orisite fugitive emissions of ozone precursors (i.e., VOC
emissions) using a benefits transfer-approach developed by the Office of Air Quality Planning and
Standards (OAQPS) (U.S. EPA, 1997a).
II I ! I I III 1 I I I II I I 111
2.2.1 Estimation of Human Health Risks and Benefits (Carcinogenic/Systemic)
Pharmaceutical manufacturers use and release several VOCs7 that exhibit carcinogenic
and/or systemic health effects on humans and/or laboratory animals. In the near-ground
I II I I III I II I I II I II "
atmosphere, these chemicals may pose a threat to human health via inhalation. Inhalation
exposures can be quantitatively assessed using air dispersion models, information on the location
i ii i r , i *
ana source of release, mass release amounts, and population density. For the purposes of this
, ' ' ;'", ; ' 'il|l|! ," : ' ; ;'.* ' .." "' "ir
analysis, the exposed population is assumed to be the general public living in the vicinity of the
point of release.
', ' ' ..:.;;,-,':. . ' , - ,. 'i , ' ii
Three sets of fugitive emissions from onsite treatment are examined:
Data provided by industry,
i
Data generated by EPA that represent loads removed as a result of the CWA
rule; and
Data generated by EPA that represent loads removed as a result of the MACf
n i ii 11 i 11 MI i| rule.
,
The industry data are compiled from responses to the 1990 CWA Section 308
Pharmaceutical Questionnaire (U.S. EPA, 1990a). Benefits are estimated by assuming that
treatment will remove all volatile pollutants from air emissions.
i
f
For these analyses, VOCs are defined as organic pollutants with Henry's Law Constants (HLC) greater than or equal
to 2.7 x 10"* atm/m3-mole.
28
-------
The data generated by EPA that represent loads removed as a result of the GWA rule are
compiled from responses to the 1990 CWA Section 308 Pharmaceutical Questionnaire (U.S. EPA,
1990a). Reductions of emissions are calculated based on the site-specific raw loadings data for
all streams and treatment to a level equivalent to the long-term mean treatment performance
concentration for steam stripping.
The data generated by EPA that represent loads removed as a result of the MACT rule also
are compiled from the 1990 CWA Section 308 Pharmaceutical Questionnaire (U.S. EPA, 1990a).
Reductions of emissions are calculated based on the site-specific raw loadings data for streams at
major sources that can be treated cost-effectively and a removal rate of 99 percent for partially
soluble pollutants and 90 percent for soluble pollutants.
2.2.1.1 Preliminary Screening
For this assessment, site-specific air modeling is an iterative process implemented on a
facility-specific, pollutant-specific basis. A screening procedure is used to eliminate facility-
pollutant release combinations which result in potential exposures that are small compared to their
toxic effect level. The screening procedure involves calculating a hazard ratio (HAZ) based on
maximum predicted downwind concentration. HAZ is the maximum potential downwind
concentration (MAX) divided by the lowest level of concern concentration (LOG) as follows:
HAZ =
MAX
LOC
(Eq. 14)
Facility-pollutant release combinations where HAZ < 1.0 are dropped from further
analysis because the chemical concentration is highly unlikely to reach a level of concern at any
location in the vicinity of the facility. The remaining facility-pollutant release combinations
29
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Ill 111
II 111
proceed to the next level of air modeling. The greater the value for HAZ, the greater the
likelihood of harmful human health exposure.
I i II 1 i I Hill li i 11 j ^ ' h
I d L I II
The maximum potential downwind concentration is calculated using a Gaussian plume
i in i nil ii in i >! MI,;,: 'iin/iiBiiifej ;..': "i1. i1:' f .:.'; WAij.'CfK'iuti!,1'. Jan*.;1 '*<','I'iliiฃi/i;1'a'.;'; :<ฃ'j'''.:.weA:tn:.t-i'- """.si" 'Ht,,ปi*'ซiHii('i>i
dispersion equation for annual average concentration presented in the Workbook of Atmospheric
Qispersion Estimates (Turner, 1970). The maximum average annual downwind concentration
equation is:
11
X x s x u
(Eq. 15)
where,
average annual downwind concentration (mg/m3)
,ซ -, on of constants^ '(unitless) '. '"'. :
fity = Fraction of the year the wind is from direction 9 (unitless) = 0.15
Q = Annual loading (Ibs/year)
CFj .'.= .',' Conversion 'factor of 4.53E+5mg/lb
CF2 ^= Crayersion fector^of^S-'lTE-S yr/sec
X JDownwind distance where majfunum concentration occurs (m) = 40,55
s = Vertical dispersion coefficient (m) = 2.12
u = Meanrwind.speed (m/sec) = 5.5
H,, ,,"=, ilRigase''heightii(m)=i3^ ; ^ ' ^ _
The parameter input values are selected to achieve a maximum potential concentration
using reasonable assumptions for release height, fraction of the year wind blows from one
ill1,, "i, ihr: i i'i,r in i si1 lit, ,"ป,i *
direction, and wind speed; and further assuming stable atmospheric conditions, which will
dominate in the long-term. Use of this equation is conservative because k is intended to be applied
to stack releases, which tend to have more concentrated plumes than the pharmaceutical area
source releases considered here.
30
1,'nl
-------
The LOG concentrations are compiled from the following sources:
EPA unit risks (UR) for cancer at a 10'6 risk level, or EPA reference
concentrations (RfC) from the Integrated Risk Information System (IRIS) or the
Health Effects Assessment Summary Tables (HEAST);
American Council of Governmental and Industrial Hygienists (ACGIH)
Threshold Limit Values (TLVs);
Occupational Safety and Healm Administration (OSHA) permissible exposure
limits (PELs); and ;
National Institute for Occupational Safety and Health (NIOSH) recommended
exposure limits (RELs).
2.2.1.2 Atmospheric Dispersion Modeling
More complex atmospheric modeling analysis is performed on those facility-pollutant
releases identified in the screening procedure with HAZ scores greater than or equal to 1. Site-
specific modeling analysis is used to predict potential atmospheric concentrations from fugitive
releases and assess the potential impact to the surrounding population. .
The ISCLT model is used in modeling atmospheric dispersion. ISCLT is an
EPA-supported gaussian plume air dispersion model that is incorporated within PCGEMS/GAMS.
In GAMS, the ISCLT algorithms run with site-specific atmospheric profiles and U.S. Census
population data inputs. GAMS requires location identifiers such as latitude and longitude or ZIP
code, and locates the nearest STability ARray (STAR) weather data (usually airports). The STAR
data are used to predict the pollutant concentration in 16 sectors around concentric rings
surrounding the point of release. These concentrations are then linked with U.S Census data at
the block group/enumeration district (BG/ED) level to estimate exposure levels and excess annual
cancer cases. Additional information concerning the ISCLT model and the GAMS system may
be found in Industrial Source Complex (ISC) Dispersion Model User's Guide -Second Edition
(Revised) (U.S. EPA, 1987a), and GAMS Version 3.0 - User's Guide (U.S. EPA, 1990b).
31
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Input data for ISCLT are obtained through user input (site- and pollutant-specific data) and
from GAMS via STAR stations (based on the user-supplied information). The GAMS menu
driven system allows the user to select EPA regulatory defaults or input-specific parameters for
detailed analysis. Latitude and longitude coordinates are obtained from either 308 Questionnaire
responses or the Toxic Release Inventory System (TRIS), and a standard polar receptor grid is
used. The receptor (breathing individual) is assumed to be at ground level, inhale 20 mVday , and
weigh 70 kilograms (standard adult exposure factors).
Volatilization (fugitive emissions) from water treatment is modeled as an area source
ii '
release based on ISCLT equations (U.S. EPA, 1987a). The area of release is determined by
i i i i i i iiii linn 1 1 1 HI i n i < 1*1 iii
selecting parameters provided in the 308 Questionnaire based on the following hierarchy: (1) the
smallest equalization tank, (2) the smallest other tank (including stabilization and neutralization),
or (3) the average equalization tank reported in the 308 Questionnaire (i.e., 4,973 ft2). GAMS
i mini MI ' , n l i i i n i
WJuu'es ^Put of side dimension only (hi meters). Therefore, all treatment units are assumed to
be square.
2.2.1.3 Risk Calculations
........ ' ' i
ISCLT model results for each facility are run though the GAMS Exposure and Risk
Estimation (GAMSERE) procedure (U.S. EPA, 1990b) to generate LADDs associated with
1 "111 i I"! pll i i M, i i ' i i I i i >i I - 1 1
EG/ED populations and the number of excess cancer cases over background levels. The LADD
for inhalation used hi the GAMSERE procedure is given as:
LADD = (CONC x CFx IR) I BW
(Eq. 16)
where,
LADD = potential lifetime average daily dose (mg/kg-day)
CONC = annual average concentration estimate (ug/m3)
IR = daily inhalation rate (20 m3/day)
32
ii mi null in null I n mi i ' |iiiii|iiiiiii||iiiiii|iiii i|ii|i i I mi i in i ill i nil ii MIII iiiiliii|ii||ii||i in |H|i|i|ii i|i|i|i nil ii 11 ii in
-------
CF = conversion factor (0.001 mg/^ug)
BW = body weight (70 kg)
The LADD value is used to evaluate exposure for both systemic and carcinogenic
pollutants. Systemic pollutant LADD values are compared in GAMSERE to reference dose values
to estimate the population exposed to levels exceeding the reference dose. The cumulative
population exposed to greater than the reference dose are reported by BG/ED units. Excess cancer
risk over background is calculated using the a potency slope factor or a unit risk factor. To
estimate excess annual cancer risk, GAMSERE uses the following equation:
RISK = LADD x SF
(Eq. 17)
where,
RISK
LADD
SF
lifetime excess risk over background
potential lifetime average daily dose (mg/kg/day)
potency slope factor (mg/kg-day)'1
2.2.1.4 Assumptions and Caveats
The following major assumptions and limitations are associated with the Human Health
Risks and Benefits (Carcinogenic/Systemic) Analysis.
The maximum average annual downwind concentration equation (i.e., Eq. 15) is
assumed to be conservative as it is intended to be applied to stack releases, which
tend to have more concentrated plumes than the area source releases considered in
this analysis.
The screening procedure equation to calculatemaximum average annual downwind
concentration assumes the following parameter default values:
Fraction of the year the wind is from direction f(6) = 6 15;
Downwind distance for maximum concentration (X) = 40.55 m;
Vertical dispersion coefficient (s) = 2.12m; '
33
-------
Mean wind speed (u) = 5.5 m/sec;
Release height (H) = 3 m.
The exposed population is the general public living in the vicinity of the point of
release and encompassed by the standard polar grid generated in the GAMS
analysis.
' "'"<'',; ; ' "
For facilities in Puerto Rico, which had a.longitude value less than 66ฐ, a longitude
of 66ฐ O'O" was used. The PCGiMS system would not allow values less than 66ฐ
and because Puerto Rico is relatively small, this assumption is valid.
Atmospheric conditions used in the ISCLT model are based on long-term average
values and are, therefore, assumed to be stable under the assumptions used hi the
model development.
I ! ; M' i, | , |
No chemical decay rate is employed in the GAMS model. It is assumed that at
these release amounts, dispersion will likely dilute chemical concentrations to
levels far below concern prior to any significant photooxidation or scavenging.
I i 'i, ป ,,'iin. ' ,",,'!', ',::i,iii'!',, ,i 'i'.-jr M,if i' L./'jiWiiii'ii irk.ii '"..I-.''"' i!i.,,iii,i,i
-------
EPA developed guidance presented in Guidance to Protect POTW Workers from Toxic and
Reactive Gases and'Vapors (U.S. EPA, 1992b) to screen industrial discharges for potential
adverse effects on POTW workers. The general procedure for predicting the potential vapor
hazard associated with the discharge of a mixture of VOCs (U.S. EPA, 1992b) includes the
following steps:
1.
2.
3.
Determine pollutant concentrations (mg/L) in wastewater.
Obtain 8 hour/day, 40 hours/week time weighted average AGGIH TLVs in units
of mg/m3 for pollutants.
Convert aqueous phase pollutant concentration (mg/L) to vapor phase pollutant
concentrations (mg/m3) hi surrounding air using chemical-specific HLCs in the
appropriate units as follows.
(Eq. 18)
where:
Cv
H,
Vapor phase pollutant concentration (mg/m3)
Henry's Law Constant (mg/m3)/(mg/L)
Aqueous phase pollutant concentration (mg/L)
4.
5.
6.
Calculate the hazard ratio for a given pollutant by dividing the predicted
concentration from Step 3 by the threshold concentration (i.e., TLV) identified in
Step 2. s.
Sum the hazard ratios for all pollutants at the POTW.
Identify those POTW facilities with sum hazard ratios > 1, indicating potential
adverse health impacts.
This methodology assumes that equilibrium conditions exist, that HLC is a good indicator
of air-wastewater partitioning, and that the toxic effects indicated by TLVs are additive across
pollutants. In addition, there'are a number of general assumptions based on the definition of an
- . 35 \ ' '
-------
"average worker". The "average worker" is assumed to weigh 70 kilograms, work 40 hours per
Week, and be in good health. POTW effluent flow is used as a surrogate for influent flow to dilute
pollutant load estimates for the wastewater concentration calculation.
I
2.2.2.1 Assumptions and Limitations
.
The following major assumptions and limitations are made in the POTW Occupational
11 iii iiiii| i mi iii ii 11 i i i iii 11 i mi i i M i i hi iiiiiii
Risks and Benefits Analysis.
m the analysis, it is assumed that equilibrium conditions exist, that HLC is a good
indicator of air-wastewater partitioning, and that the toxic effects indicated by
TLVs are additive across pollutants.
I I I I ' | I I II n I ill
For any pollutants for which TLVs or HLCs are not available, it is assumed that
insufficient information exists for such pollutants, and therefore, they are excluded
from the analysis.
Pie guidance followed hi this analysis has two data availability limitations. First
of all, the receiving POTW for several indirect facilities was not known at the time
of the analysis. Secondly, the effluent flow for some of the receiving POTWs was
not known. These two limitations resulted in the exclusion of 14 facilities from the
analyses.
POTW effluent flow, obtained from the jgj^g Survey, is used as a surrogate for
influent flow to dilute pollutant load estimates for the wastewater concentration
calculation. POTW flow and pollutant loads are assumed to be constant throughout
the year.
The guidance followed hi this analysis (U.S. EPA, 1992b) assumes that an
""average worker": '' '
is exposed to the pollutant throughout their occupational lifetime - ages 18
to65; t J1'Z,'.',''.'Z'. Z"l'""lI-r.' , '.
works a 40-hour week;
weighs 70 kilograms;
is healthy, with no prior physical or health deficiencies; and
has a normal respiration rate.
36
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The analysis requires the following simplifying assumptions for the use of HLC to
conditions in the sewer line:
The wastewater and air temperatures at the POTW are approximately 25
degrees Celsius.
The presence of other constituents within the wastewater have no
synergistic or antagonistic effect on the volatilization of any given pollutant.
The screening approach conservatively assumes that the air flow above the
POTW unit operations is negligible, thereby, allowing equilibrium
conditions to be approximated in the headspace above the unit operations.
The screening approach assumes instantaneous attainment of vapor-liquid
equilibrium and does not consider volatilization rates
The analysis assumes that the toxic effects of the pollutants in the mixture are
additive. Therefore, hazard ratios are also additive when calculating the POTW
exposure.
2.2.3 Estimation of Human Health/Agricultural Risks and Benefits (Ozone Precursors)
Both the CWA final rule and the MACT final rule are expected to result in a reduction in
VOC emissions.8 Controlling VOC emissions is beneficial because, in addition to several VOCs
exhibiting carcinogenic and systemic effects, VOCs are precursors to ground-level ozone, which
negatively affects human health and the environment. For example, ozone has been found to
reduce lung function in humans and to reduce.agricultural crop yields. Ozone formation also
might affect tree growth, cause materials damage, and affect visibility (Krupnick and Kopp, 1988).
o
For these analyses, VOCs are defined as organic pollutants with HLC greater than or equal to 2.7 x 10* atm/m3-mole
These analyses further exclude four organic pollutants (methylene chloride, acetone, tetrachldroethene, and methyl ''
chloroform) from the estimated reductions in emissions of ozone precursors. These four organic pollutants were
identified for exclusion based on a final rule promulgated by EPA that defines VOCs for the purposes of developing
state implementation plans to attain national ambient air quality standards (NAAQS) for ozone (U.S. EPA, 1996a).
This definition excludes specified compounds that have negligible photochemical reactivity and thus do not contribute
significantly to the formation of tropospheric ozone, including the four organic compounds excluded from the analyses.
37
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Ill III III I nil1 III II P
11(111
III 111 II Hill
HilnTi I'1 'I'll !'" 'ป,: A "I'i1
Clinical and epidemiological studies have demonstrated that short-term exposure to elevated
I II II I I I I II |ll II II III I 111 III [|ll* I I I |H I M 111 UllV I Illllll I |l II
ozone concentration results in acute effects on human health. These acute effects include
respiratory and nonrespiratory symptoms, such as shortness of breath, headaches, and pain upon
| | Ul" ' W ",f I II' < V'j,; ... I. Ml ! .||H' ',!ป< .'!!:!' if <'l' \\ K "" J ' ' ,lll I i!li Vt5 * ', ' "ป' Ail'!:!!:'!1 :'"' >'< ,! :!'!' ":i!|i I '' 'Iff V ' '; , M ' n'illlH'i" JPT '"lf\, ! ' !i i1 rSG' iii! ' < i*!"1,!1 : if!!'1: t.!l ' i!1",!!1 *!' ,' ,,4 I,, Jil >, ! ' - ^AfU iil!Ki,i! il i ' 'J\- iปf . Ei'ilTilllll i''|l! KiK SSI/UK !l:,< 'Spllllllllp'1, ' ilnlii,1!!!!, ( 'ill! ,i Jll
deep inhalation; minor restricted activity days; and asthma attacks. Reductions hi ambient ozone
,! ii ;;;>ii v, \\\ : ' wi"!" i, : , "!ปi : . IB ; ซ!''. M i1 :, ' : ', i i ; if ; >; ' f. ' i ,'" - , i1!1 1 y. iii , ..... i. ..... i't . :, ;! r > " if lili|l|1||!lii| v ' ! ,'..'! , ' wi 8r;i" "' ' , "s ซ ; , ป w , , ":! :' !ป 1 11"1;1'.!:!1:!111 'X PI.' :: u ปป ! / ]; ..... , aw -' ' "- ti .1 i,i: f1 iWiifi1!!1 | . j * , " ,,1,, RI i;i : ."".if ''"Sii!1 ; ' * nr1 'laiiRi11
(1) reduced premature mortality due to ozone exposure; (2) reduced cancer risk from hazardous
"J me voc stream; (3) reduced hospital admissions for all respiratory illnesses; (4|
acute respiratory symptoms; (5) increased worker productivity; and (6) increased yields
, ^1^^', ^ w3^0^ /o^te. ...... ^This ^sessm^rt does ..... not address ^hunian
health benefits from reductions in chronic health effects nor does it address economic .welfare
benefits related to forest growth, materials damage, or visibility. The benefits associated with
38
:IW^^
*, ' - I !'.
-------
these categories could be significant, and thus the benefit estimates presented below might
understate the total benefits of the final rules.
, ' V ' ' :
Reactions between VOCs and nitrogen oxides (NOX) form ozone in the presence of
sunlight. However, ozone formation is a complicated process that is not completely understood.
This uncertainty prevents estimation of the specific changes in ozone concentrations that are likely
to occur due to the reductions in VOC emissions expected to result from the two final rules. In
these analyses, the benefits from VOC emissions reductions are evaluated assuming a linear
relationship between VOC emissions and economic benefits from reductions in ozone
concentrations, as described below. This assessment also considers the impact of increased
emissions of sulfur dioxide (SOj) and paniculate matter (PM) generated by the operation of steam
strippers that will be implemented to reduce the VOC emissions. /These byproducts of increased
energy use can cause adverse environmental impacts and were, therefore, subtracted from the total
benefits associated with the control of VOCs.
The benefits of reduced emissions of ozone precursors are evaluated applying a benefits
transfer approach. Estimates of the average value per megagram (Mg) reduction in VOC
emissions ar.e applied to the estimated total reduction in VOC emissions in nonattainment areas
as well as in all areas (nonattainment and attainment) due to me rules. Benefits are estimated using
the methodology and data summarized in the November 5,1997 OAQPS memo titled, "Benefits -
Transfer Analysis for Pulp and Paper "(Appendix A). This methodology is based on the recently
published benefits analysis provided in the Regulatory Impact Analyses for the Paniculate Matter
and Ozone National Ambient Air Quality Standards and Proposed Regional Haze Rule (U.S.
EPA, 1997b). EPA promulgated revised standards for ozone and PM in July 1997. The
Regulatory Impact Analyses (RIAs) contain.the benefits analyses conducted for the revised
standards. The benefits analyses were conducted using many sources of data such as: detailed
air quality modeling, emission inventory tracking, control strategy development, and population
statistics - all projected 'for the year 2010. These data are used in conjunction with pollutant-
specific concentration-response functions and either willingness-to-pay values or economic
39
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modeling to estimate national monetized benefits values expected to be associated with reducing
ambient concentrations of ozone and/or PM. Supporting data generated for the ozone benefits
PI ' I 'I I ' i r ii I
analysis are used to derive a $ per Mg value for VOC emission reductions while supporting data
generated for the PM benefits analysis are used to derive a benefits transfer value for SO2 and PM
emissions reductions.
The following sections present the methodology used to monetize these benefits. Further
details are available in the previously-mentioned references.
HI i i in 11 iiiii I i ill in i h II 11 nil ii MI in i i MI i i I ill III
2.2.3.1 VOC Valuation Methodology
To monetize the human health benefits associated with reductions hi VOC emissions, a
benefits-transfer-based approach is used. Specifically, the estimated reductions hi VOC emissions
are multiplied by an existing'estimate of the value per Mg reduction in VOC emissions ($489 to
$2,212 per Mg of VOC - 1990 dollars). The VOC emission reductions expected to occur due to
the final rules are estimated based on the emissions reductions data combined with information on
I " H ,
the geographical location of the affected facilities.
IP in i nil i ill 111
For these analyses, the total amount of VOC reductions are summed for facilities located
h ซ i
hi all areas, as well as for facilities located in nonattainment areas. The nonattainment areas are
those areas that would potentially violate the ozone NAAQS in the year 2010, and include the
"fbllowlng: ' ' " "' """ : ' ' """""""
Nonattainment counties hi the Aerometric Information Retrieval System (AIRS),
Air Quality Subsystem (AQS) as of November, 1997; and
-EPA Greenbpok data of^nฃnaptjamrnent areas ([and associated counties) for1-hour
"i 120 ppb standard as of November,11997.' '
40
i ii
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2.2.3.2 PM Valuation Methodology
PM represents a broad class of chemically and physically diverse substances. In most
locations, a variety of diverse activities contribute significantly to PM concentrations, including (but
not limited to): fuel combustion, agricultural and silvicultural burning, and atmospheric formation
from gaseous precursors. Ambient PM can be formed by the direct emission of particles into the
atmosphere (referred to as primary particles). Additionally, particles can be formed as a result of
chemical reaction of gases in the atmosphere (referred to as secondary particles). For example,
sulfur dioxide can convert to sulfuric acid droplets that further react with ammonium to form
paniculate sulfate (U.S. EPA, 1996b).
The treatment technology (steam stripping) used to reduce VOC emissions from wastewater
requires energy consumption which produces adverse environmental impacts. These impacts are
associated with the emissions of other pollutants, such as PM and SO2, which are generated when
fossil fuels are burned to produce energy. The adverse human health effects associated with PM
include: premature mortality; aggravation of respiratory and cardiovascular disease; changes in
lung function and increased respiratory symptoms; alterations in lung tissue and structure; and
altered respiratory tract defense mechanisms. Reduced welfare is associated with elevated
concentrations of fine particles which reduce visibility, damage materials, and cause soiling. To
calculate the monetized adverse environmental impacts due to PM emissions, a unit value ($10,823
per Mg - 1990 dollars) is multiplied by the total Mg of PM increased to yield the total monetized
impacts associated with the PM emission increases. These adverse impacts are subtracted from
the total benefits estimate for wastewater only.
2.2.3.3 SO2 Valuation Methodology
Exposure to SO2 can cause adverse health and welfare effects. The adverse human health
effects associated with SO2 are nasal irritation and breathing difficulties (especially to individuals
with respiratory diseases such as asthma). These effects occur when SO2 dissolves in the water of
41
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the respiratory tract of humans, resulting in acidity (sulfurous and sulfuric acids) which is irritating
to the pulmonary tissues. When SO2 dissolves in the atmosphere in rain, fog, or snow, the acidity
of the deposition can corrode various materials and cause damage to both aquatic and terrestrial
ecosystems. Data are not readily available at this time for estimating a direct SO2 benefits transfer
value. However, an indirect SO2 benefits per Mg value can be estimated based on the portion of the
SO2 emissions that are estimated to convert to PM.
Similar to the VOC analysis, the adverse environmental impacts of SO2 emissions are
monetized based on the geographical location of a facility. Facility-specific SO2 emission estimates
have not been made; however, an estimate of the total SO2 emissions for all facilities is available.
ซl
The SO2 emissions are assumed to be proportional to the VOC reductions from the use of the
' Mil
treatment technology. That is, if 96 percent of the VOC reduction occurs in the east, then it is
assumed that 96 percent of the total SO2 emissions will occur in the east. The total SO2 emission
increases from facilities located in the east is multiplied by a range of unit values ($4,860 to $ 10,763
per Mg of SO2 - 1990 dollars) to obtain a range of the total dollar value associated with increased
SO2 emissions in the eastern U.S. Similarly, the total SO2 emission increases from facilities located
inmewestismultipiiedDyarangeofunitvalues($3,516to$4,194perMgofSO2- 1990dollars)
to obtain a range of the total dollar value associated with increased SO2 emissions in the western
U.S. For each region, the unit values are reported as a range to reflect two alternative measures of
i i i i . i i i
premature mortality (short-term and long-term mortality). The total of the low (or high) east and
III I II I I H i i i i i i " i i i ii nil in i
west values are added to yield the low (or high) end of the range for the entire United States. These
in i nil i i " in in i ill i iiiiiii i ii i 1111 . i i i i ii i n in i in i ' i i in i ii i i ill i|i
adverse impacts are subtracted from the total benefits estimate for treatment of wastewater only-
i i in i 111 iiiiiii iiiii | I Ti i i ' n in' 'M In' i fi '
2.2.4.5 Potential Benefits Categories Not Quantified
In addition to acute health effects, ozone is believed to have chronic effects on human health.
For example, laboratory studies have observed chronic effects on animals exposed to elevated levels
) =: -: ; ; V
of ozone, including increased susceptibility to infection, decreased pulmonary function, and some
fibrotic-like lung damage, which could lead to respiratory diseases such as chronic bronchitis
HIM
i II ill I
ill 'I IIIIIII ullii
42
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(Krupnick and Kopp, 1988). The link between ozone concentration and chronic health effects in,
humans, however, is not well understood, therefore, this category of human health benefit is not
considered quantitatively in this analysis.
Ozone-induced crop yield changes might have secondary effects due to the responses of the
agricultural community to the yield change. It is a common agricultural practice to counter
decreased crop yields with increased use of fertilizer. In addition, crops suffering from the effects
of ozone are more susceptible to pestilence, prompting farmers to increase their use of pesticides.
Increased fertilizer and pesticide use represents an economic cost to agricultural producers, thus
reducing total economic surplus. Furthermore, a reduction in crop yield often leads to an increase
in the acreage of cultivated land to compensate for yield loss. Ozone-induced decisions to increase
the amount of cultivated land could lead to jthe loss of wildlife habitat, increased soil erosion, and
increased agriculture-related pollution. Increased soil erosion, fertilizer use/and pesticide use will
further increase agriculture's contribution to surface and ground-water pollution. Although the
economic implications of these secondary effects of reduced crop yields might be significant, this
analysis only considers crop productivity impacts. Estimates of the secondary environmental
impacts of reduced crop productivity, have not been identified and thus these benefits have not been
quantified. Therefore, the resulting benefit estimates will understate the agricultural-related
economic benefits of the final rule.
The potential benefits of the CWA final rule and the MACT final rule that could not be
monetized due to lack of sufficient information are summarized as follows:
43
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Unquantified Benefits Categories
!i
-------
Distributions of exposed populations from previous ozone and PM studies are
assumed to be similar. Although baseline concentrations and population densities
from previous studies will occur in a multitude of combinations, the aggregate
affect is expected to create a balancing out of variations in the true benefits per Mg
ratio across areas. Thus, the transferred ratio, on average, is assumed to be
representative.
Site-specific air emission data for the storage tank and equipment leak planks of the
MACT rule are not available. Emission reductions for these planks are estimated
based on nonsite-specific estimates assuming the same attainment/nonattainment
and VOC/hazardous air pollutant (HAP) proportions as process vents.
Potential adverse impacts due to energy consumption for the control of process
vents, storage tanks, and equipment leak planks of the MACT rule are not
quantified also due to the lack of site-specific information. VOC controls for
storage tanks may include condensers, while VOC controls for process vents may
include condensers or incineration. VOC controls for equipment leaks would not
involve mechanical devices, but rather would entail leak detection/repair programs.
Potential reductions hi VOC emissions from these same three planks are also likely
underestimated because the OAQPS list of pollutants of concern did no.t consider
VOCs that are not also classified as HAPs. Additionally, OAQPS assumed that all
HAPs would be controlled to the same level.
2.3 Pollutant Fate and Toxicity
Human and ecological exposure and risk from environmental releases of toxic chemicals
depend largely on toxic potency, inter-media partitioning, and chemical persistence. These factors
are dependent on chemical-specific properties relating to lexicological effects on living organisms,
physical state, hydrophobicity/lipophilicity, and reactivity, as well as the mechanism and media
of release and site-specific environmental conditions.
The methodology used in assessing the fate and toxicity of pollutants associated with
pharmaceutical wastewaters is comprised of three steps: (1) identification of pollutants of concern;
(2) compilation of physical-chemical and toxicity data; and (3) categorization assessment. These
steps are described in detail below. A summary of the major assumptions and limitations
associated with this methodology is also presented.
45 ."'''. .'..'
-------
I 111 ( (IIP
11(1111
III III III
II 11"
111 Id 111 III III
2.3.1 Pollutants of Concern Identification
EPA selected pollutants for concern if they met the following criteria: (1) they were found
in treatable concentrations at a number of facilities, (2) they had discharge loadings greater than
3,000 pounds per year, (3) they were treatable by technology, and (4) they were quantifiable by an
existing approved analytical method. Pollutants meeting these criteria were included in the modeling
performed for the environmental assessment. A fifth selection criteria, which required that pollutant
removals be at least 1,000 pounds per year, reduced the number of regulated pollutants. This
assessment includes notations for those benefits estimates that are affected by this reduction of
i "'""" : :""- : -": ": ; r " "'" il""'"' """ . .. , .:,, :, :
pollutants.
2.3.2 Compilation of Physical-Chemical and Toxicity Data
i r j
' " t I
The chemical specific data needed to conduct the fate and toxicity evaluation for this study
include aquatic life criteria or toxic effect data for native aquatic species, human health RfDs arid
cancer potency slope factors (SFs), EPA maximum contaminant levels (MCLs) for drinking water
protection, HLCs, soil/sediment adsorption coefficients (K^), bioconcentration factors (BCFs) for
native aquatic species, and aqueous aerobic biodegradation half-lives (BD).
i , ,
Sources of the above data include EPA ambient water quality criteria documents and
updates, EPA's Assessment Tools for the Evaluation of Risk (ASTER) and the associated
AQUatic Information REtrieval System (AQUIRE) and Environmental Research Laboratory-
Duluth fathead rninnow data base, EPA's IRIS, EPA's 1993-1995 HEAST, EPA's 1991-1996
Superfund Chemical Data Matrix (SCDM), EPA's 1989 Toxic Chemical Release Inventory
Screening Guide, Syracuse Research Corporation's CHEMFATE data base, EPA and other
government reports, scientific literature, and other primary and secondary data sources. To ensure
III I I III I I Illll Ilil I III I I IIIIII II II III inllllll \ P | Ll iii'Ji]
that the examination is as comprehensive as possible, alternative measures are taken to compile
data for chemicals for which physical-chemical property and/or toxicity data are not presented in
the sources listed above. To the extent possible, values are estimated for the chemicals using the
46
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quantitative structure-activity relationship (QSAR) model incorporated in ASTER, or for some
physical-chemical properties, utilizing published linear regression correlation equations.
(a) Aquatic Life Data
Ambient criteria or toxic effect concentration levels for the protection of aquatic life are
obtained primarily from EPA ambient water quality criteria documents and EPA's ASTER. For
several pollutants, EPA has published ambient water quality criteria- for the protection of
freshwater aquatic life from acute effects. The acute value represents a maximum allowable 1-
hour average concentration of a pollutant at any time that protects aquatic life from lethality. For
pollutants for which no acute water quality criteria have been developed by EPA, an acute value
from published aquatic toxicity test data or an estimated acute value from the ASTER QSAR
model is used. In selecting values from the literature, measured concentrations from flow-through
studies under typical pH and temperature conditions are preferred, m addition, the test organism
must be a North American resident species of fish or invertebrate. The hierarchy used to select
i '
the appropriate acute value is listed below in descending order of priority.
National acute freshwater quality criteria;
Lowest reported acute test values (96-hour LC50 for fish and 48-hour BC^LC for
J 1 1 N. ' JVT J\J
daphnids);
Lowest reported LCso test value of shorter duration, adjusted to estimate a 96-hour
exposure period;
Lowest reported LC50 test value of longer duration, up to a maximum of 2 weeks
exposure; and
Estimated 96-hour LC50 from the ASTER QSAR model.
BCF data are available from numerous data sources, including EPA ambient water quality
criteria documents and EPA's ASTER. Because measured BCF values are not available for
several chemicals, methods are used to estimate this parameter based on the octanol/water partition
47 ,
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Ill1 11 ill I1 111" 1" n 'I'll i iiU'll i|ll'"l 'I i i I 1 111 I n n'ii i ii i lii i I in I n i i|i i'i(i i I 'ซ IN MI in I ill | | ill lull, ii
i Ii
coefficient or solubility of the chemical. Such methods are detailed in Lyman et al. (1982).
Multiple values are reviewed, and a representative value is selected according to the following
guidelines:
Resident U.S. fish species are preferred over invertebrates or estimated values.
I | ; ;, | ; ' ;',, '. | ,, ' .' ; '>; , ; ' ] ] ; ; , ,; ;,( \ ,;,; i ' ,:,.;,;,;;
Edible tissue or whole fish values are preferred over nonedibleor; viscera values.
:;,;;;,"::::; ;,;; !;:,;; i:;1,;;;;::,;;;,,,'.",: ,:, ':;; ii' ;;;: ,;;,;;:,i:; l,;;,:;;l;j;i|j;;;: v;,;;;!:.,;
Estimates derived from octanol/water partition coefficients are preferred over
estimates based on solubility or other estimates, unless the estimate comes from
EPA Criteria Documents.
The most conservative value (i.e., the highest BCF) is selected among comparable candidate
values.
(b) Human Health Data
1
i in i inn n in n i I II
Human health toxicity data include chemical-specific RfD for noncarcinogenic effects and
potency SF for carcinogenic effects. RfDs and SFs are obtained first from EPA's IRIS, and
* i i J ;
secondarily from EPA's HEAST. The RfD is an estimate of a daily exposure level for the human
population, including sensitive subpopulations, that is likely to be without an appreciable risk of
' i i :
deleterious noncarcinogenic health effects over a lifetime (U.S. EPA, 198%). A chemical with
a low RfD is more toxic than a chemical with a high RfD. Noncarcinpgenic effects include
systemic effects (e.g., reproductive, immunological, neurological, circulatory, or respiratory
. , hi IH>! i.;-!'!"
toxicity), organ-specific toxicity, developmental toxicity, mutagenesis, and lethality. EPA
llilllilliliihliililllin ki Hi 1,1 11 il 11II i i I i il I Id nil llllllii Ilillll I) || ii In I 111 Pllil II In 1 11 1 ill I il i||"lli ill I i I ll| il i I 11(111 i 1 I ii , i "i
recommends a threshold level assessment approach for these systemic and other effects, because
several protective mechanisms must be overcome prior to the appearance of an adverse
noncarcinogenic effect. In contrast, EPA assumes that cancer growth can be initiated from a
single cellular event and, therefore, should not be subject to a threshold level assessment approach.
The SF is an upper bound estimate of the probability of cancer per unit intake of a chemical over
48
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a lifetime (U.S. EPA, 1989b). A chemical with a large SF has greater potential to cause cancer
than a chemical with a small SF.
\ . ' - t' . '. ' -
Other chemical designations related to, potential adverse human health effects include EPA
assignment of a concentration limit for protection of drinking water, and EPA designation as a
priority pollutant. EPA establishes drinking water criteria and standards, such as the MCL, under
authority of the Safe Drinking Water Act (SDWA). Current MCLs are available from IRIS, EPA
has designated 126 chemicals and compounds as priority pollutants under the authority of the
CWA.
/ -
(c) Physical-Chemical Property Data x
Three measures of physical-chemical properties are used to evaluate environmental fate:
HLC, K^, and BD.
HLC is the ratio of vapor pressure to solubility and is indicative of the propensity of a
chemical to volatilize from surface water (Lyman et al., 1982). The larger the HLC, the more
likely the chemical will volatilize. Most HLCs are obtained from EPA's Office of Toxic
Substances' (OTS) 1989 Toxic Chemical Release Inventory Risk Screening Guide (U.S. EPA,
1989c), the Office of Solid Waste's (OSW) Superfund Chemical Data Matrix (US. EPA, 1994),
or the QSAR system (U.S. EPA, 1993a), maintained by EPA's Environmental Research
Laboratory (ERL) in Duluth, Minnesota.
Koc is indicative of the propensity of an organic compound to adsorb to soil or sediment
particles and, therefore, partition to such media. The larger the K^, the more likely the chemical
will adsorb to solid material. Most K^s are obtained from Syracuse Research Corporation's
CHEMFATE data base and EPA's 1989 Toxic Chemical Release Inventory Risk Screening Guide.
49
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111 III
ill
BD is an empirically-derived time period when half of the chemical amount in water is
degraded by microbial action in the presence of oxygen. BD is indicative of the environmental
I i i
persistence of a chemical released into the water column. Most BDs are obtained from Howard
in i i n 11 n 11 iiiiii i iiiiiiiingi n i n n in inn i in ill in n n ii in fc i " 11 i i 11 i in 4 | '' I I i l| I
et al. (1991) and ERL-Duluth's QSAR.
2.3.3 Categorization Assessment
The objective of this generalized evaluation of fate and toxicity potential is to place
&to groups with qualitative descriptors of potential environmental behavior and impact.
These groups are based on categorization schemes derived for:
h < 1 I I I II In
.
/
Acute aquatic toxicity (high, moderate, or slight);
yolati)itv frฐm water ^h- moderate, slight, or nonvolatile);
i 1 i Hi
n I i
Adsorption to soil/sediment (high, moderate, slight, or nonadsorptive);
I
I i i 111 mil n ii mini i i i n i i n in n i i MI ii i inn n 1111111 ii i i i ii ii n in nil i n n
Bioaccumulation potential (high, moderate, slight, or nonbioaccumulative); and
Biodegradation potential (fast, moderate, slow or resistant).
~1B*s appropriate key parameters, and where sufficient data exist, these categorization
schemes identify the relative aquatic and human toxicity and bioaccumulation potential for each
chemical associated with landfill wastewater. In addition, the potential to partition to various
media (air, sediment/sludge, or water) and to persist in the environment is identified for each
chemical. These schemes are intended for screening purposes only and do not take the place of
detailed pollutant assessments analyzing all fate and transport mechanisms.
r
This evaluation also identifies chemicals that: (1) are known, probable, or possible human
carcinogens; (2) are systemic human health toxicants; (3) have EPA human health drinking water
standards; and (4) are designated as priority pollutants by EPA. The results of this analysis can
provide a qualitative indication of potential risk posed by the release of these chemicals. Actual .
50
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.risk depends on the magnitude, frequency, and duration of pollutant loading; site-specific
environmental conditions; proximity and number of human and ecological receptors; and relevant
exposure pathways. The following discussion outlines the categorization schemes. Ranges of
parameter values defining the categories are also presented.
(a) Acute Aquatic Toxicity
< - ' '
Key Parameter: Acute aquatic life criteria/LC50 or other benchmark (AT) C"g/L)
Using acute criteria or lowest reported acute test results (generally 96-hour and 48-hour
i * ' ' '''.
durations for fish and invertebrates, respectively), chemicals are grouped according to their
relative short-term effects on aquatic life.
Categorization Scheme:
AT < 100
1,000 > AT > 100
r AT > 1,000
Highly toxic
Moderately toxic
Slightly toxic
This scheme, used as a rule-of-thumb guidance by EPA's OPPT for Premanufacture Notice
(PMN) evaluations, is used to indicate chemicals that could potentially cause lethality to aquatic
life downstream of discharges.'
51
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I I i I!
(b) Volatility from Water
Key Parameter: Henry's Law constant (HLC) (atm-m3/mol)
HLC = VaPฐr
(cam)
Solubility (mol/m3)
(Eq. 19)
pin i HI i in inn
HLC is the measured or calculated ratio between vapor pressure and solubility at ambient
conditions. This parameter is used to indicate the potential for organic substances to partition to
air in a two-phase (air and water) system. A chemical's potential to volatilize from surface water
can be inferred from HLC.
Categorization Scheme:
in nili i i
HLC > ID'3
10"3 > HLC > lO'5
10'5 > HLC > 3 x 10-7
HLC < 3 x ID'7
i n ii n lip i inn it
Highly volatile
Moderately volatile
II,'1' ill liJIu'iillll!1'1!:!!!?!1'1!;
Slightly volatile
Essentially nonvolatile
This scfaeme, adopted from Lyman et al. (1982), gives an indication of chemical potential
'i!" ' '/ '"' ' ,"" '* "'"" '" ' | ""'|!'' ' ",""'" ""' ! ''"'""! ! ! ! "" " !," ' ! '""! , , "'"'""'!!'
to voladlip fjo|n process wastewater and surface water, thereby reducing the threat to aquatic life
and human health via contaminated fish consumption and drinking water, yet potentially causing
risk to exposed populations via inhalation.
i in 11 ii 11 ill
(c) Adsorption to Soil/Sediments
Key Parameter: Soil/sediment adsorption coefficient (K,,,,)
i i in n i inn n i n ill i in
II II I I i II ill II llllll|lll
i in |i nii|iilil lingซpi ii
ii i ^i iซnil ill nin i nlln
52
I I. III
-------
is a chemical-specific adsorption parameter for organic substances that is largely
independent of the properties of soil or sediment and can be used as a relative indicator of
adsorption to such media. K^ is highly inversely correlated with solubility, well correlated with
octanol-water partition coefficient, and fairly well correlated with BCF.
Categorization Scheme:
K,,, > 10,000
10,000 > KO,. > 1,000
1,000 > K^ > 10
< 10 '
Highly adsorptive
Moderately adsorptive
Slightly adsorptive
Essentially nonadsorptive
This scheme is devised to evaluate substances that may partition to solids and potentially
contaminate sediment underlying surface water or land receiving sewage sludge applications.
Although a high K^ value indicates that a chemical is more likely to partition to sediment, it also
indicates that a chemical may be less bioavailable.
(d) Bioaccumulation Potential
Key Parameter: Bioconcentration Factor (BCF)
_ Equilibrium chemical concentration in organism (wet weight)
Mean chemical concentration in water
(Eq: 20)
BCF is a good indicator of potential to accumulate in aquatic biota through uptake across
an external surface membrane.
53
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Categorization Scheme:
BCF > 500
500 > BCF > 50
50 > BCF > 5
I ll I I i 11 Ii 1 IIII 111 II i 1II III III 11 I il I ii h Mil i I
BCF < 5
High potential
Moderate potential
Slight potential
ll III nil If III I llJ I II
Nonbioaccumulative
III-
This scheme iง used to identify chemicals that may be present in fish or shellfish tissues
at higher levels than insurrounding; water. These chemicals may accumulate in the food chain and
increase exposure to higher trophic level populations, including people consuming their sport catch
or commercial seafood.
(e) Biodegradation Potential
n ll ll il I I H lllllll ll ill I i 11 I I ll M ll J|l I j,
Key Parameter: Aqueous Aerobic Biodegradation Half-life (BD) (days)
' '"hi ill ...... ' IF i1 '"ilii'i" ' ..... I, '"Sir '^'''"irV'liii ..... " 'j'r "I'l1 'lit'. ...... ,,, ,]"' ...... i'i.'vi', i"iป' i |> r ! "u : '> K 'i- ,ni mli-m '"i, ."I"!,, 'ixiVI'llhh/JJI.I ISI, lil'IOII" ir' "Oil,!:",'!:'1!* U ..... ,.'!'"iiM!!l,:' " 'Will i " VMilft,,!!,1' ..... lit "J ป ...... ป'! ' !':, 'Sl'I'ih'ia.'li'riilllllllllliJi ..... lllHiW1 iซ' ,ii,i:",li!,i'|i|
: .(KtSi'irfr.^&'iSNiyi ...... i ': rf w \ ";, ''"is! &, *r.,i ; . ซ > , :i -; . , i , :. .......... h > v *.ii liisi ....... a ซHIH t:-, ........ s -ssn 'iim> 'ww ...... :*ซ? .'..: - m *:. ..... !ซซ ...... *iii! ซ ...... ปi ^
||||i||l||iiiL ivii.j..|j "!' .Ulii'lil"' Illh'J" !li'Si"i '
IK si iii ....... i H; ii .. j ;<
mill;.,.liij-i: iiia.niซ;.j|i[jjฃ/f!JgjSj.'i 'W;fi J J^1 fyyty/g:. Iplf!!;,;l".,;|';|!;",?.!?!.!.<-**;I?'- jy;;jr i, *;.'"; ],' ^5Jl;l- "W"| ^W^fJSf!1 ' JSri^M^if.,ป****'''m*^11' "^l';4'Ii T'T- K^oSfS;
,
BLrrv^wISjQiegradatioii, photolysis, and hydrolysis are three potential mechanisms of organic
1 1! f-jiiij ;, !'^>! ...... ;;> !) jil > rif-IS ''El" ii'l l!1'-"'; -I ..... :-l"l!": ..... i:>i ' , "'" P "' 'i'1 ir'!!: ; i1 = >S!>' T'; :'! i!1":!!!!! ..... ''"M!
' , "'" P "' 'i'1 ir'!!: ; i1 = >SS!>'I T'; :'! i!1":!!!!! ..... '
chemical transformation in the environment. A ID is selected to represent chemical persistence
because of its importance and the abundance of measured or estimated data relative to other
transformation mechanisms.
iii ii 11 i n IK inn 11 iiii i 11 H in i
Categorization Scheme:
BD ^ 7
7 < BD < 28
28 < BD ^ 180
180 < BD
Fast
Moderate
Slow
Resistant
54
-------
This scheme is based on classification ranges given in a recent compilation of
environmental fate data (Howard et al., 1991). This scheme gives an indication of chemicals that
are likely to biodegrade in surface water, and therefore, not persist in the environment However,
biodegradatidn products can be less toxic, equally as toxic, or even more toxic than the parent
compound.
2.3.4 Assumptions and Limitations
t ' ' - - ' -.
The major assumptions and limitations associated with the data compilation and
categorization schemes are summarized in the following two sections.
(a) Data Compilation
If data are readily available from electronic data bases, other primary and
secondary sources are hot searched.
Much of the data are estimated and, therefore, can have a high degree of associated
uncertainty.
For some chemicals, ;neither measured nor estimated data are available for key
categorization parameters. In addition, chemicals identified for this study do not
represent a complete set of wastewater constituents. As a result, this study does
not completely assess pharmaceutical wastewater.
(b) Categorization Schemes
Receiving waterbody characteristics, pollutant loading amounts, exposed
populations, and potential exposure routes are not considered.
Placement into groups is based on arbitrary order of magnitude data breaks for
several categorization schemes. Combined with data uncertainty, this may lead to
an overstatement or understatement of the characteristics of a chemical.
Data derived from laboratory tests may not accurately reflect conditions in the
field. .
55
-------
I in
Available aquatic toxicity and bioconcentration test data may not represent the most
sensitive species.
nil i ii ii i i i in i i i ii ii i, i in i i i i in i i i ป 11 ii j innlnli i
t ' I ' \ i ' i ' II
The biodegradation potential may not be a good indicator of persistence for organic
chemicals that rapidly photoxidize or hydrolyze, since these degradation
mechanisms are not considered.
2.4 Documented Environmental Impacts
t IP
* ,ii,
Published literature and survey data have been reviewed for evidence of documented
environmental Jmpacts on aquatic life, human health, POTW operations, and the quality of
receiving water due to discharges of pollutants from pharmaceutical manufacturing. Reported
impacts on the environment and biota/effect are compiled and summarized for various studies and
are presented by study site and facility. State and Regional environmental agencies are also
contacted, ,
> ii'll!" h'S, ' 'i,ii' il'i'Shli': I'i|ill,Ai'1:1 ,,1'l'b' ""lllllllill'r,ii!l!ii"'!|:i,iii, '. /Mi ,":!'! i 'ill A L ซ, I'li,:!',"J1'!;i'lL,:!1 !;,' n"li 'I,'In!,,'Mi:1 i:-ji "i'.',;!'",:jiliiilljliyifi!'flftfti "f-K
i1'!'""!!; i llilliiiM Iliilililli'lilllllliin1 'liilllllHIiliillii itt'M.V 'li'lf'n W.iX ^li'M^illinlllliililli .it'Vtli "ii , >. ป I'll I>|1,;;1' ""III (fliik;!1!!1^ !, tl .'I " ill'''It""1111,'', l|l';"!i ''^Kti'Xf "'^'Kl^ Asi,':
111;. JEi' ili:;]!!!!!!!!!!!1"!!!!!!!; JIIHB!1!'' 'I'!1 i!"' ,i!'i'i ,! iijllllll '! ..... ':,i:J.i ^ ;|
ili " k':ปil,i,,!i ' A lปV' ' ..... ."nr
i':i< fill1 ' ซi 1 1!11"1,' ,!!!? it "^ li
"'iii;!!', m v^fi!!;:!!:!;!;!::!^'1!1:1';;;'!::!1!!::!!!: i: '\^ - iw i: .\; i liiivti^ii''^;:!'^^!!;!'^^'^!^!1!;! nninnen ^ ;'\m
"i1!:!!"! Jiiiiiiiijiij;,1:!;,1;: i \. i: :;:";,' u;ii';; \ iiii it ^: "<; i 'in ilv" >'J\;,, i, /' i< ^m iiii", 11 < ป".; i IT" j;''im,\', av\\ ">' i u;a\fi vmif > \ > Sijiilpf, v>, i1 .hjiiiiiiji I
Viflllllln"^!;!!!!.! ;,J|i|i:/'ii!'ill"i!|.|ii|]1 j.ซ' t, '*% Si i i11^^!.!;'!!''!!1!:! H'1!11' Hlir,' i "ft'ii Kn\H, v# .li 'liSiii'llllliilijIlfc "'tiiBliBli'iS-S1!1!1,!1'/!;;!!!!)^
' '
\ "; 1 ' i. ill!!:!'! < ' '< i"!" ' '!'..!'' i<' f'! "i ii' i!;1 W 1111!11;1!;!!!!1'!!! '^iiiililliliiiiii'' 'i liilllllllllli!!!!!!!1!!' .!!!!'! '^i1
4'ii, I:1"!"1,. IIIIIIH Jif ;*!Ei'ปii*
' 1
i ,1'iiiiiniijlji!1!"!1 .'tii
! ' inn: ..... ''iif'Miii'Nn H, J1 F.iiiiiiiiiiiiiiiiiiiiiiii'.ii, i;:kiii:i!aiB :' 'ii'iih'n]1:1'! a!1 ta 'aair'niii:1'";1 aaaaa, aa!ii"!a ' ILM nn, , (,i;i> /I'i"1 i-'aiiia..^-*1' , !?' "'!*ป "iii
'sai1:!:;!, : /;:Kfi\<\i! " Ji'i'vaa'paa p1 > ii"\;\\\i&!, "vP :i, ' i r " ',;i!ia! - aaiv itip' lUJi'^iftilulp:1'!!1 aiii'tiii'1' .a,1' 'iil
III III III I IIII III 1 III I IIII III IIII I
II lllll|lllllllll IIII II IIII I
56
I
i ill in
-------
3. DATA SOURCES
3.1 Water Quality Impacts
Readily available EPA and other agency data bases, models and reports are used in the
evaluation of water quality impacts. The following six sections describe the various data sources
used in the analysis. ,
3.1.1 Facility-Specific Data
EPA's Engineering and Analysis Division (EAD) provided projected pharmaceutical
facility effluent process flows, facility operating days and end-of-pipe pollutant loadings
(Appendix B) in August 1997 (U.S. EPA, 1997c). The current pollutant loadings reflect removals
attributable to the MACT standards for wastewater and wastewater collection systems. Pollutant
removals achievable are estimated using average raw waste information available from the CWA
Section 308 Pharmaceutical Questionnaire responses (U.S. EPA, 1990a) adjusted for removals
attributable to the MACT standards and the final pollutant long-term means which form the basis
of the CWA ftnai limitations and standards.
The locations of pharmaceutical manufacturing facilities on receiving streams are identified
using United States Geological Survey (USGS) cataloging and stream segment (reach) numbers
contained in EPA's Industrial Facilities Discharge (IFD) data base (U.S. EPA, 1993-1994a).
Latitude/longitude coordinates, if available, are used to locate those facilities and POTWs that
have not been assigned a reach number hi IFD. The names, locations, and the flow data for the
POTWs, to which the indirect facilities discharge, are obtained from the CWA Section 308
Pharmaceutical Questionnaire (U.S. EPA, 1990a), EPA's 1992 NEEDS Survey (U.S. EPA,
1992c), IFD, and EPA'-s Permit Compliance System (PCS) (U.S. EPA, 1993-1994b).
57
-------
'I
, The receiving stream flow data are|obtained from eer Ae W^R^tesjs^y data or from
measured streamflpw data, both of which are contained in EPA's GAGE file (U.S. EPA, 1993-
1994c). The W.E. Gates study contains calculated average and low flow statistics based on the
best available flow data an4 on drainage areas for reaches throughout the United States. The
GAGE file also includes average and low flow statistics based on measured data from USGS
I'M ,i i, i ) i'r,
gaging stations. DCPs for estuaries and bays are obtained from the Strategic Assessment Branch
of NOAA's Ocean Assessments Division (NOAA/U.S. EPA, 1989-1991) (Appendix. C). Critical
Dilution Factors are obtained from the Mixing Zone Dilution Factors for New Chemical Exposure
: Assessments (U.S. EPA, 1992a). ' ' " " ' ' [" " ' ' " [
3.1.2 Information Used to Evaluate POTW Operations
'" " ' "if
in i in i i i in i n in i n i ji i i in ii i i n i i i i i' ill i i i i ซ in i I i nil in 1 11 ii i In n ii i i ii i n i 11 in td ii i inn iv n in i i
POTW treatment efficiency removal rates are based on the median of all acclimated POTW
'"*'/!'":" ;!, , ซ iiilr
data submitted, data from a study of 50 well-operated POTWs entitled, Fate of Priority Pollutants
uniK'Hiiu ivii!',,,iiii'""ii mil, .. ป. i HIIUHPI ,s irii.i',<, mii-: .ir.uhiir .iK'iiiiiiiiinjiiiiiiiiiii,,,, 'I'.iiiiiminiii, ' TIIII .^mlr ikii.MiJi nuiAnri 'UiniiiiiJini'Mr, ,i|,, < mi, ,r,,ป ,I,ป,I,,M n ,,ฃ ^ , , ' *',,,. -^ , , " ,
in Publicly-Owned Treatment Works, commonly referred to as the "50 POTW Study" (US EPA^
1982) and acclimated data from the Report to Congress on the Discharge of Hazardous Wastes to
Publicly-Owned Treatment Works (Domestic Sewage Study) (U.S. EPA, 1986) (Appendix D).
i ipi HI in i n i n in n n i nil in inni|iiii HI i nun in in in i inn iiiiii|iiiil||iiiiiii i iiiinii i n i qi n i nun HI nun 111 n in n HIM inn inn 11 in i i in i i null in ^ niiii i in nil i inn iniiiiinnin n i il IPIII INI n i|i in nil in Hi i mini n H nil i ini|i ii n i iliii|liiiiiiiin 11 nn
Additional data for one pollutant (acetonitrile) were obtained from the Risk Reduction Engineering
Laboratory (RREL) data base (now renamed the National Risk Management Research Laboratory
data base (U.s! EPA, 1995a).
Inhibition values are obtained from Guidance Manual-for Preventing Interference at
POTWs (U.S. EPA, 1987b) and from CERCLA Site Discharges to POTWs: Guidance Manual
(U.S. EPA, 1990c). The most conservative values for activated sludge are used. For pollutants
ii i ' i ' ' I n i i i i ii 11 n ill 11
with no specific inhibition value, a value based on compound type (e.g., aromatics) is used
(Appendix D).
Sewage sludge regulatory levels, if available for the pollutants of concern, are obtained
from the Federal Register 40 CFR Part 503, Standards for the Use or Disposal of Sewage Sludge,
58
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Final Rule (October 25, 1995) (U.S. EPA, 1995b) . Pollutant limits established for the final use
or disposal of sewage sludge when the sewage sludge is applied to agricultural and non-agricultural
land are used .(Appendix D). Sludge partition factors are obtained from the Report to Congress
on the Discharge of Hazardous Wastes to Publicly-Owned Treatment Works (Domestic Sewage
Study) (U.S. EPA, 1986) (Appendix D).
3.1.3 Water Quality Criteria (WQC)
-v * . , '
The ambient criteria (or toxic effect levels) for the protection of aquatic life and human
health are obtained from a variety of sources including EPA criteria guidance documents, EPA's
ASTER, and EPA's IRIS (Appendix D). Ecological toxicity estimations are used when published
values are not available. The hierarchies used to select the appropriate aquatic life and human
health values are described in the following sections.
3.1.3.1 Aquatic Life
Water quality criteria guidance documents for many pollutants have been published by EPA
for the protection of freshwater aquatic life (acute and chronic criteria). The acute value
represents a maximum allowable 1-hour average concentration of a pollutant at any time and can
be related to acute toxic effects on aquatic life. The chronic value represents the average allowable
concentration of a toxic pollutant over a 4-day period at which a diverse genera of aquatic
organisms and their uses should not be unacceptably affected, provided that these levels are not
exceeded more than once every 3 years.
For pollutants for which no water quality criteria are developed, specific toxicity values
(acute and chronic effect concentrations reported in published literature or estimated using various
application techniques) are used. In selecting values from the literature, measured concentrations
from flow-through studies under typical pH and temperature conditions are preferred. The test
59
-------
|1 111 1 I I
nil in i i n in
organismmust bea NorthAmerican resident species offish or invertebrate. The hierarchies used
to select the appropriate acute and chronic values are listed below in descending order of priority.
.; " ,' ""' ' ' . ' . .,' ,1 :.''...--' : '' '' '. ; ;
Acute Aquatic Life Values;
National acute freshwater quality criteria;
lilt lull
Hi (lll|l III III
inn linn i nniiiiiinn
I i I ill I I lull 111 111 I lull
Lowest reported acute test values (96-hour LC50 for fish and 48-hour
EC50/LC50 for daphnids);
l hi II HI I UN I in ill HI
in i in n i i nni mi i
111 I
1 in ii i i li
(
Lowest reported LC^ test value of shorter duration, adjusted to estimate a
96-hour exposure period;
i '
Lowest reported LC50 test value of longer duration, up to a maximum of
two weeks exposure; and
i i
Estimated 96-hour LC50 from the ASTER QSAR model.
ill ii in |i 1 nil i iiini in in i n
Chronic Aquatic Life Values:
III I in 'I ill illl 11 III ill I III III 1 nil ill II1 lillii i HID 111 I l|ii|l|i|iil i|| 111 III 1
National chronic freshwater quality criteria;
I 1 llll|l||ll lllll|ll '" Hill I
Lowest reported maximum allowable toxic concentration (MATC), lowest
observable effect concentration (LOEC), or no observable effect
concentration (NOEC);
Lowest reported chronic growth or reproductive toxicity test concentration;
Estimated chronic toxicity concentration from a measured acute chronic
ratio for a less sensitive species, QSAR model, or default acuterchronic
ratio of 10:1.
11 i ii ii i in VIM i in i ii iiiiiniiiii iiiiiii i nnn 11 nil n i IN
3.1.3.2 Human Health
Water quality criteria for the protection of human health are established in terms of a
pollutant's toxic effects, including carcinogenic potential. These human health criteria values are
developed for two exposure routes: (1) ingesting the pollutant via contammated aquatic organisms
only, and (i) ingesting the pollutant via both water and contaminated aquatic organisms as follows
60
, I":: p:i! ,i h
:'ปfliKiifit'X/UtfffirXs 1*.* I)
-------
For Toxicity Protection (ingestion of organisms only)
xCF
HH =
00 IRfxBCF
(Eq. 21)
where:
RfD =
BCF =
CF
human health value Gug/L)
reference dose for a 70-kg individual (mg/day)
fish ingestion rate (0.0065 kg/day)
bioconcentration factor (liters/kg)
conversion factor for units (1,000 ^g/mg)
For Carcinogenic Protection (ingestion of organisms only)
HH = BWxRLx
00 SFx IR x BCF
(Eq. 22)
where:
BW
RL
SF
IR,
BCF
CF
human health value C"g/L) ,,
body weight (70 kg)
risk level (10'6)
cancer slope factor (mg^kg-day)"1
fish ingestion rate (0.0065 kg/day)
bioconcentration factor (liters/kg)
conversion factor for units (1,000 //g/mg)
For Toxicity Protection (ingestion of water and organisms)
RfD x CF
IRW + (IRf x BCF)
where:
(Eq. 23)
61
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1 '
', , , ',;, ,: i n:::, .: , '..:.
n i liinniiinn i nil in i in i 11 inn i liiiiiiiiini in i ii ini iiiiiiiiiiin liiiiinninn ninn nun MM i n inn nniinin in | i i n i in nil i u inn i iniinii i n i in inn i in i 11 n in i in imiiii i J11 mil 'iMiiiftiiiEriiii iiailiiiiiiviiiH^
HH^, = human health value (ju.gfL)
RfD = reference dpse for a 7Q-kg individual (mg/day)
H^ = water ingestion rate (2 liters/day)
IRf = fish ingestion rate (0.0065 kg/day)
BCF bigconcentration factor (liters/kg)
CF = conversion factor for units (1000 ^ug/mg)
i " n - " ., ' 'V ' ' ' '' ' ' ' ' ' '' ,' ' '
... ' . '' " . ' ,' ' ! * , ,, '" . ..,,:- V H ' , ! '' ' ' . .' , ''.'' !'"',.
For Carcinogenic Protection (ingestion of water and organisms)
lii| I ซKiItt^ Vllplii il 1 ;;; H; : ill I !li,i^i!B^ v ;inp: vii,, 1,1 ซji >^^
in in liiitiifiij iiiiiiiiui1 iii iMiij";' l iiiiiii i l : .":||,: ;ii UK,,, if iiiliiB iiiiiiiiiiii l ,i (i iiiiiii:, /.(IMS im Hi't'i'iiHS ill:'111' ซ!" l*'ซป,,, ' !'",ซ, '!'!, , lit > :i , iii'if'iiK i,' KilifS'iiii 'uHi! Mill tvi iitfM^tax ,y, tt ' l /(in; ป ii lei !'* lj,,. if HI 'jfjtt w i .. i, ua ' tii.ii'taiuf! ii'iniillli: i|iiiiiliปv,iiri
wwm siis-iiiiiiit'i; griHt'MAAi<(&ซ^if:i:i&&i>1 "-''""Si ''' '">^Hi11
X KL, X Cz*
(Eq. 24)
1 !i \ " i1
i , i ;''i||'||f 'lii'l'i'1,!1!;" il'!i"'i|i "'Jl'li'''!!!!"!!
v\!\i\ liiiilf" iini||i!!f H ' "i ' Iiiiiii I :r 'liii hii^Nif J '^liijiiftiliiisi".'!1 ฐi, .;liii "iliiiliiiiii1. i".' !,i|ltl.iiiii|i'' i'" I'i' i|' iiii,iป'!'ii4ป/ !"P ;inlnii.i|iir"!" f 'ill, ' Hiii.i'iiiiiiinll '"!"w f\"... vii !f i';! ''i" i' > "i i.,"': :n |i. ,ii!i' 'ii !> ni""j ~?"i v it it ,1VL'' I1' "i :i. i;i;'' i'vifi ii i. < .iii' isiiiiiS' '''iiiriilii' iiC'i NY^iiiiiiiii jปiป':i3i i i i,ป." i i.i ii,i:i lU ^St'r^ '1 iininiii|ijiiii!li':i: 'iliiliiiiiiiiiiiiiiv'i11*!"']1 "i iiiiii1' I
1.; |i|i||||i|'ii|l||ii||||||fi'i in[,,,, r |f | IIIT nfffnf i IN i f i, P i'i||iii|fi'i|iir::iiii||||h|f | {iliiiii,,!^' iiiiiiijiiiiiiiiii;,, ff liiiiligif: i yfv,,< > i|. i f.,' iiiifHf,, fi, vff iJii li'ii'iig, fJiilsE,'1.!'!!1 I,."., .iiii.,, t;!! i ,'ii "ii-1,'" ."|".'' Ci1! '!'':l ,ii'i:' s1!'. <,,i' I1':,ป<'''!'' ''l:!l: 'in 1: ' i'i '.''''ซ" *' i'.1 'i 'it "IE' '''i1 ii, i 'I'''1. 'i i'1''11!111"! i1',"1' lll|':l'li"ii!lll!l|l|IJ!!!'11'' ii!11,1 'h ii!,1 ^ , i;'!iiii!"iiii'if'i f; j n "i |i |ii|'' i ||' ii1 iii lai. .,<'' i""'1 .ifi (; i ii j1ซ' ii" (hiL n;;ป. f "iif'iTiiilif t;' finfff'> fiHi''11, liff ii '!;fi||i;||ili|||||iiii; 4 Jiiijiiifl!
^'.^ii^^i^iz^.-Z^'riri" ' im".,'"" i~"i ^'."rr.! ir"'" i.'rrrzii'~^r,!"'"'.'r.hr.,'.vi^i """.~z~i^,
; ;; i.; I- ป h ; ' | "" I1 ;.';-' | ;"'., I ;'; | ' r, i.,,,,,,1
Htt^ = human health value Cug/L)
BW = body weight (70 kg) ;
RL _ = risk level Q&6),
, SF = cancer slope factor (mg/kg-day)!
= water mgestion rate (2 liters/day)
BCF = pioconcentration factor (liters/kg)
CF = conversion factor for units (1,000 ^g/mg)
The values for ingesting water and organisms are derived by assuming an average daily ingestion
'i ' ' i i
of 2 liters of water, an average daily fish consumption rate of 6.5 grams of potentially
i ' i. i i >
contaminated fish products, and an average adult body weight of 70 kilograms (U.S. EPA, 1991a).
Values protective of carcinogenicity are used to assess the potential effects on human health, if
EPA has established a slope factor.
Protective concentration levels for carcinogens are developed hi terms of non-threshold
1 , ' i ', ' '
lifetime risk level. Criteria at a risk level of 10"6 (1E-6) are chosen for this analysis. This risk
i1 i i r i .
level indicates a probability of one additional case of cancer for every 1,000,000 persons exposed.
Toxic effects criteria for noncarcinogens include systemic effects (e.g., reproductive,
ll|lill ii i in i mini mil in i n i i |ii|i|i|iii|iii niiii ii i i iii|i|ii|iii i iiiiillliiii IN in i|ii in i ii in ii 11 ill i
l "l
i'i' i: iiixi'S iipiiR'' -liitf I
62
-------
immunological, neurological, circulatory, or respiratory toxicity), organ-specific toxicity,
developmental toxicity, mutagenesis, and lethality.
The hierarchy used to select the most appropriate human health criteria values is listed
below in descending order of priority:
Calculated human health criteria values using EPA's IRIS RfDs or SFs used hi
conjunction with adjusted 3 percent lipid BCF values derived from Ambient Water
Quality Criteria Documents (U.S. EPA, 1980); three percent is the mean lipid
content of fish tissue reported in the study from which the average daily fish
consumption rate of 6.5g/day is derived;
'' \
Calculated human health criteria values using current IRIS RfDs or SFs and
representative BCF values for common North American species of fish or
invertebrates or estimated BCF values;
Calculated human health criteria values using RfDs or SFs from EPA's HEAST
used in conjunction with adjusted 3 percent lipid BCF values derived from Ambient
Water Quality Criteria Documents (U.S. EPA, 1980);
i
Calculated human health criteria values using current RfDs or SFs from HEAST
and representative BCF values for common North American species of fish or
invertebrates or estimated BCF values;
Criteria from the Ambient Water Quality Criteria Documents (U.S. EPA, 1980);
and . ' , ' '
Calculated human health values using RfDs or SFs from data sources other than
IRIS or HEAST.
This hierarchy is based on Section 2.4.6 of the Technical Support Document for Water
Quality-based Toxics Control (U.S. EPA, 1991a), which recommends using the most current risk
information from IRIS when estimating human health risks. In cases where chemicals have both
RfDs and SFs from the same level of the hierarchy, human health values are calculated using the
formulas for carcinogenicity; which always results in the more stringent value of the two given
the risk levels employed. '
63
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11'
i i|iiiii nil iviiinnin i in nil inn i
' mi nil n inn iiiini
ill ilipn lignum ihiiiiiii
3.1.4 Information Used to Evaluate Human Health Risks and Benefits
|i|!lli|iil|ii||l|i|l|lii|i'ii|liill ll,llil n
Fjsh ingestion rates for sport anglers, subsistence anglers and the general population are
obtained from the Exposure Factors Handbook (U.S. EPA, 1989$. State population data and
. i' i .. ..., . ' } ...... ' :.;. . '. ' " . .:.)"-" ' . . ' ; - '. ; ..... \::'-. ';>" :'"
average household size are obtained from the 1995 Statistical Abstract of the United States (U.S.
I III I y. /?-!/-! ir\r\i-\ T^ '
Bureau of the Census, 1995). Data concerning the number of anglers in each state (i.e., resident
fishermen) are obtained from the 1991 National Survey of Fishing, Hunting, and Wildlife
Associated Recreation (U.S. FWS, 1991). The total number of river miles or estuary square miles
, 'within a state is obtained from the 1990 National Water Quality Inventory - Report to Congress
(U.S. EPA, 1990d). Drinking water utilities located within 50 miles downstream from each
discharge site are identified using EPA's PATHSCAN (U.S. EPA, 1996c). The population served
by a drinking water utility is obtained from EPA's Drinking Water Supply Files (U.S. EPA,
''"iiK"1996d) or Federal Reporting Data System (U.S. EPA, 1996e). Willingness-to-pay values are
!.',.,' I S^^sMSf^^K's review "of a" 1989 and "a 1986 study, ..... "fhe ....... Value "of Reducing ..... Risks ...... 'ofDeS: .................
A Note on New Evidence, (Fisher, Chestnut, and Violette, 1989), and Valuing Risks: New
Information on the Willingness to Pay for Changes in Fatal Risks (Violette and Chesnut, 1986).
ii 'I ll| i 1 1 , i i i H ' | H i ir " i il 1 i , ii, i ' i i L i ' , ...... ' ,, ซ i"j, ii
Values are adjusted to 1990, based on the relative change in the Employment Cost Index of Total
Compensation for all Civilian Workers. Information used in the evaluation is presented hi
illii'ilHIH^ lii
111 Ill l> Ii il lull II ii'lnlil (I (I11 "Illlillll I' 'IN1 Idl1 ill 'in i II t'l'l'i' i Will I Ill ' ill Ii I nil I IK! II" V {' i I mil Hi" i*&HM)tnMI>k>fntL fill Hi "
|. llniiiiiH ijS^
"II I I '! I ! i ' i. !!! !! ! . V^T" ... . . . . .......
IV Illiini d1 IK 99111 IR ,1 :;l|!|li Sinilillil'l I* IllllllpV 13^^^^^
-------
fishing days are obtained ffam Nonmarket Values from Two Decades of Research on Recreational
Demand (Walsh et al., 1990). Values are adjusted to 1990, based on the change in the Consumer
Price Index for all urban consumers, as published by the Bureau of Labor Statistics.
3.1.6 Information Used to Evaluate POTW Benefits
Sewage sludge pollutant limits for surface disposal and land application (ceiling limits and
pollutant concentration limits), if applicable, are obtained from 40 GFR Part 503 (U.S. EPA,
1995b). Cost savings from shifts in sludge use or disposal practices from composite baseline
disposal practices are obtained from the Regulatory Impact Analysis of Proposed Effluent
Limitations Guidelines and Standards for the Metal Products and Machinery Industry (Phase I)
(U.S. EPA, 1995c). Savings are adjusted to 1990 using the Construction Cost Index published
in the Engineering News Record. In this report, EPA consulted a wide variety of sources,
including:
1988 National Sewage Sludge Survey;
1985 EPA Handbook for Estimating Sludge Management Costs;
. 1989 EPA Regulatory Impact analysis of the Proposed Regulations for Sewage
Sludge Use and disposal;
Interviews with POTW operators;
Interviews with State government solid waste and waste pollution control experts;
Review of trade and technical literature on sewage sludge use or disposal practices
and costs; and
Research organizations with expertise in waste management.
Information used in the evaluation is presented in Appendix E.
65
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1(1(111
3.2 Air Quality Impacts
J I
The analyses of air quality impacts require information pertaining to the individual
Pharmaceutical manufacturing facility, the receiving POTW if indirect dischargers are occurring,
11" i ' i i
i the exposed population and long-term average atmospheric conditions in the vicinity of each
facility, and the chemicals present in the wastestream. Specific information is obtained from
III II 111 I III III II11 IN I II Illllll^ 111111 I Kill INN 111 I II I I I Illlll I I III II I I II I I III I 111 I I I ill 111'II III III 111 I I I III I III I III 11 111 I Mil I I 11)111111111111111111 III
published EPA guidance documents or quality controlled data bases maintained by EPA
' *1" Tl r^!.'r,^^SLuarters program offices, if available. Other data sources include documents or data bases
jtij'^ llllllllll 111 II III Illlll III II 11 I III IIII 111 III I II I Illlll II III 111 II III II I Illlll I I II Illlll I Illlll 11 III ' III III 11 111 Mil I l|l I II Illlll I I Illlll I III 111 II 111 I Illlll III Ifl IIII III
produced or maintained by other Federal agencies, peer reviewed literature, and secondary sources
|| i f'\ ซ ; * '*ฃ ..cited in appropriate EPA documents. The following three sections describe the various data
sources used in the analyses.
i mi
, 3.2.1 Facility-Specific Data
Information pertaining to an individual facility includes annual chemical loads, latitude and
longitude coordinates, and side dimensions and elevation of onsite biological treatment units
(Appendix F). For the analysis of fugitive emissions from open-air biological treatment, three sets
of annual chemical loads are examined. EAD provided electronic files of industry loading data,
which are based on Pharmaceutical 308, Questionnaire responses (U.S. EPA, 1990a). EAD
generated the CWA:rule:jaad[ MACT rule loading data based on site-specific raw loadings data and
5rm mean tteato^ for steam stripping (CWA rule) and the
sources that can be treated cost-effectively with a removal rate of 99 percent for partially
soluble pollutants and 90 percent for souble pollutants (MACT rule). Latitude and longitude
coordinates are obtained from 308 Questionnaire responses or from TRIS maintained by OPPT.
A single side dimension (in meters) of the onsite equalization tank was taken from surface area
ii c i h
Values provided in the Section 308 Questionnaire responses. The elevation (used as the fugitive
emission release height) is assumed to be 3 meters in all cases. OPPT also makes this assumption
I | ll I lin III "I |l 1 | | | | |h | | ^ \ f
in performing screening level exposure assessments conducted under Toxic Substances Control
Act (TSCA) authority.
66
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For the analysis of toxic vapor partitioning from influent wastewater at POTWs, the
concentration of chemical constituents in wastewater transferred to each POTW and the POTW
influent flow is required. Chemical concentrations are calculated from annual indirect loading data
provided by HAD (U.S. EPA, 1997c) and from effluent flow data. Total POTW effluent flow is
obtained from the 1992 NEEDS Survey, IFD and PCS (Appendix F).
For the analysis of onsite fugitive emissions of ozone precursors (i.e., VOC emissions),
total VOC loading reductions and geographical locations are required. Loading reductions for the
wastewater plank (CWA and MACT rules) are provided by BAD (U.S. EPA, 1997c)
(Appendix F). Loading reductions for the process vent, storage tank and equipment leak planks
(MACT rule) are obtained from OAQPS (U.S. EPA, 1998) (Appendix F). The geographical
locations, (states and counties) of the facilities are also obtained from OAQPS (U.S. EPA, 1998).
3.2.2 Population and Climatologic Data
Factors needed to help determine the potential extent and magnitude of exposure from
fugitive releases include population and long-term average atmospheric conditions, as well as the
assumed characteristics of exposed persons. The spatial population distribution surrounding a
given set of latitude and longitude coordinates is available from 1990 U.S. Census data
incorporated in the PCGEMS modeling system. PCGEMS also contains information,on long-term
average wind speed, wind direction frequency, atmospheric stability, and temperature needed to
run the ISCLT model. An average adult body weight of 70 kilograms, an average adult inhalation
rate of 20 m3 per day, and an average lifetime of 70 years are used to represent all exposed
persons. These values are reported hi the Exposure Factors Handbook (U.S. EPA* 1989a).
3.12.3 Information Used to Evaluate 'Human Health Risks and Benefits
(Carcinogenic/Systemic, POTW Occupational, Ozone Precursors)
Toxicity assessment for the fugitive emission analysis is based on the chemical-specific
ambient RfC for noncarcinogenic effects, and SF for carcinogenic effects (Appendix F). RfCs and
67
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exposure level (adjusted to concentration units by assuming a 70 kilogram body weight and a 20
day inhalation rate) for the human population, including sensitive subpopulatipns, that is
S^^1 '"' ^TO^'tX "ฃ; wiffiout an apipreciable risE of deleterious 'noncarcinogenic 'he^^erfects''ฉ^ฉ^ a
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'ilil'iKililiililiillll!,:^ H,;f>kMi4!tfira4miVfhAjB^^l4Mtt!4 I'I'IIW
s a thresholdleve] assessment approach because several protective mechanisms must
i,'ปi 'lili'iilllBilillllBII i'i, ikiilililllillillllni ilBF"'!!! B' ."IIIIIIIIII, iBlil IIBIIIII,1' 'il'illlllB .Ilinililill' HiBFIiiijIlllljlF 'B! l|l" IIIIHIH;: i|| niiilF1 ^ TlillJli^llllFFilFFBIIIIIiliri IllPnJIIpllji'f ilnllrnPllilll ,Bl ,B, iPIPUIPiPi "Pi1' I'ml n IIIIIIIIIIIIIBIiirii V! ami il1 B1 BIIIIIIFW1!'1 < "Bill BB^BBBFIIBtlBIBIII l B" ill! IFIBilnlllllllllllllF'ill IFIIIIBillB 'BinilinililFBIilllllFiLilil Pl"!!!!^!!^!!!!!''!^.!'!!!'!)!!!, '!< illMll/F1' p| illlllliillllllB , BjJ'lliiillFIIIIIFBlllllFIBIIIIFIIIJBIIIIIIIIIlBIIIBl!,!' llBlllllllillllllll'IF11
e ACGIH _TLVs,_ derived for 8-hpur iday 40-hour week exposure, are used in
irel'^'TLVs Se"^tai^'_|r^^ '
SubstancescmdPhysiad Agents and Biological Exposure Indices (ACGIH, 1995-1996). HLC,
B'IIIIIIII V l|iW^^^^^^^^ 'niim niRM iigiiiiiiti^^^^^^^^^^^^ ii!i(iiiaii!B^^^^^^^
the measured or estimated ratio of vapor pressure to solubility, is used as the air-water partition
i,!,'"')!,!
coefficient. Most HLCs are obtained from the Toxic Chemical Release Inventory Risk Screening
Guide (U.S. EPA, 1989c), or QSAR maintained by EPA's Envkonmental Research Laboratory
In Duluth, MN,
For the analysis of onsite fugitive emissions of ozone precursors, benefits are derived from
in ' ,1,1, i
evaluating ozone air quality changes. Emission increases of VOC, PM, and SO2, due to the
implementation of the control technology (Appendix F), are calculated based on emission factors
I, ' ; i , ' i ,,
from Compilation of Air Pollutant Emission Factors, Volume 1: Stationary Point and Area Sources
I1 I , K . |
(U.S. EPA, 1993b) and steam generation estimates from EAD. Nonattainment areas that would
iii mill iiiiiiii nil 11 ii lp ii i iiiiiiii in n MI ii i mi in iiiii i iiiiiiii i in i i i 11 pi i niiu i iiiiiiiiii i i i In i in i i il i in i i iiiiliiiiiiiii 11 i nil n initi i iiiii iiiiiit
-------
potentially violate the ozone NAAQS in the year 2010 are obtained from the AIRS AQS (U.S
EPA, 1997d) and from OAQPS' Greenbook Homepage (U.S. EPA, 1997e) (Appendix F).
-Valuation of pollutant load increases or decreases are obtained by using a benefits-transfer
approach as presented in the November 5, 1997 OAQPS memorandum titled, "Benefits-transfer
Analysis for Pulp and Paper" (U.S. EPA, 1997a) (Appendix A).
3-3 Pollutant Fate and Toxicity
.The chemical-specific data needed to conduct the fate and toxicity evaluation are obtained
from various sources as discussed in Section 2.3.2 of this report. Aquatic life and human health
values are -presented in Appendix D. Physical/chemical property data are also presented in
Appendix D.
3.4 Documented Environmental Impacts
^ ' '
Literature abstracts are obtained through the computerized information system DIALOG
(Knight-Ridder Information, 1993-1994) which provides access to Enviroline, Pollution Abstracts,
Aquatic Science Abstracts, and Water Resources Abstracts. Data are also obtained from the
1990/1992 State Water Quality Assessments (305(b)) Reports, the Pharmaceutical Outreach
Questionnaire (U.S. EPA, 1993c), newspaper articles (Washington Post, Baltimore Evening Sun),
and the 1990 State 304(1) short lists (U.S. EPA, 1991b). Contacts at State and Regional
environmental agencies supplied additional data concerning environmental impacts.
69
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iliiiiiiH Hi flu i iiiiliiliii|i(iiii i li (iiiiiliiiil iiiiiip in i ililliilHil iiiliiiilliiliili i w Imtin ii1 illiili in iiilliliiiiliiiii Iliiiii iiiiiiiili ii 11 iiiiiiiliiliiliilili i ill P iliiiii in Ililiii lliiiil titillK lillilliil i mi 11
4. SUMMARY OF RESULTS
This report presents an assessment of the benefits from the CWA final effluent guidelines,
as well as the benefits expected to accrue from the corresponding MACT standards under the
CAA- The following five sections present the results of the various analyses completed for this
assessment including: (1) water quality impacts; (2) air quality impacts; (3) total economic
benefits; (4) pollutant fate and toxicity; and (5) documented impacts.
,1" "ill
i 11 ' t i |
i I i ii i i I i i i i
i
.4.1 Projected Water Quality Impacts9
4.1.1 Comparison of Instream Concentrations with Ambient Water Quality Criteria10
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in 111 n ii i iiiiiiiii iiiiiii|ii i i i 11 111 i in i i i i in i i i in n i i iiiiiiiiiiiiiiii i n 11 n 111 ii i 11 mi in ID i ii ii i iiiiiiiili i niii in MI
The results of this analysis identify the water quality benefits of controlling discharges
i m , '
(CWA and MACT rules) from pharmaceutical manufacturing facilities to surface waters and
" i ,
POTWs. The following two sections summarize potential aquatic life and human health impacts
on receiving stream water quality and on POTW operations and their receiving streams for AC
1 , ' - i ' '
and BD direct and indirect discharges. All tables referred to in these sections are presented at the
I I I I i I " | | | g || ป ปf | || MM I ^ I I II 1 III |
end of Section 4. Appendices G, H, and I present the results of the stream modeling for each type
iilnnnnniii 1 i iiii 11 ii iiiiiiiiiiiiiiii iiiiiii||lillinnn iiiiiiiii i mini mi nil inniiiiiini MINI in i mini inn INI in nn in i i i INI in n inini in in in i iiiiiiiiiiiiiiii n nn 11 i n MI MI mil nun inn n n in Ii i i|ili inn iiiii||nl|ii iinill|ilill innj
of discharge, respectively.
Revised pollutant loadings have been received since this assessment was completed based on earlier loadings (August
1997). Because jhe-revised loadings are not significantly different (changes were less than 2 percent) from the loadings
used for the assessment, the assessment was not redone using the revised loadings.
'. " ' ' - "~ '"."""' i 'i
Tn performing this analysis, EPA used guidance documents published by EPA that recommend numeric human health
and aquatic life water quality criteria for numerous pollutants. States often consult these guidance documents when
adopting water quality criteria as part of their water-quality standards. However, because those State adopted criteria
may vary" EPA used the nationwide criteria guidance as the most representative values.
; ' ' : ' 70 ' ' ''" ' ' ' ' '
in
in
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4.1.1.1 Direct Discharges
(a) AC Facilities
The effects of direct wastewater discharges on receiving stream water quality are evaluated
at current and BAT treatment levels for 14 facilities discharging 32 pollutants to 14 receiving
streams (14 rivers) (Table 1). Modeled end-of-pipe ppllutant loadings for 14 facilities at current
discharge levels are 1.63 million pounds-per- year (Table 2). These loadings are reduced to 0.08
million pqunds-per-year at BAT discharge levels; a reduction of 95 percent.
Modeled instream pollutant concentrations are projected to exceed human health criteria
or toxic effect levels (developed for water and organisms consumption) in 7 percent (1 of the total
14) of the receiving streams at current discharge levels (fable 3). One (1) pollutant at current
discharge levels is projected to exceed instream criteria or toxic effect levels using a target risk
of W6 for carcinogens (Table 4). No excursions of human health criteria or toxic effect levels
are projected at BAT discharge levels (Table 3).
Instream pollutant concentrations are projected to exceed chronic aquatic life criteria or
toxic effect levels in 7 percent (1 of the total 14) of the receiving streams at current discharge
levels (Table 3). A total of 2 pollutants at current discharge levels are projected to exceed
instream criteria or toxic effect levels (Table 4). No excursions of chronic aquatic life criteria
or toxic effect levels are projected at BAT discharge levels (Table 3).
Excursions of human health criteria or toxic effect levels (developed for organisms
consumption only) and of acute aquatic life criteria or toxic effect levels are also presented in
Table 3. No excursions of human health criteria or toxic effect levels (developed for organisms
consumption only) are projected at current or BAT discharge levels. The one excursion of acute
aquatic life criteria or toxic effect levels projected at current discharge levels is eliminated at
BAT discharge levels.
71
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.,(1
BD FaciUties
The effects of direct wastewater discharges on receivhig stream water quality are evaluated
at current and BAT treatment levels for 3 facilities discharging 6 pollutants to 3 receivhig streams
(3 rivers) (Table 5). Modeled end-of-pipe pollutant loadings for 3 facilities at current discharge
levels are 15,780 pounds-per-year (Table 6). These loadings are reduced to 752 poundSrpCT-year
Id Illlllllili III IIII 1111 I Illlllllili Illlllllili Hill Illlllllili llllllA IIIII IIIII 1 111 Illlllllili Illlllllili II 1 Pill PI1! Illlllllili I ill I pip I 1 Hi Hi ill nil Jl l|l iii i 111 111 PI hi Illlllllili lllll IP ill I 11 III . 'I
, at BAT discharge levels; a reduction of 95 percent.
No excursions of human health criteria or toxic effect levels or of aquatic life criteria
:= effect levels are projected at current or BAT discharge levels (Tabte 7^'
is' " . ,!"' " , '.'., .,.'' .'.. '; ''.' ' '":, , . '.'. '; i. ' ",' ' y. Ii/
III! lllll'IIHfe^ illf'lllli, f; IllllllllillffV -inillrtllllilllV.IHIIIIIIIllllll I, ,lll, I,I4IIII,I IlililFiliFJUn^^ I It, ^IIIT Oil'1' il|IN !l,!ซ ,'!,, N'|i' ill Wfll I, 4', ,!', i, I,"! rl ii I!,,,1";,, 11 liK1 ilBlilli ,iil, l|,,i,,llllll:li'\lll,llll,|lllllll,l,ll IIII 1,1 ซI|H i,,1 iii' ,1,11 " I1 j'l,1" I'lllllillrl, lilt I!'1 III.IT ' ,! II ii,, ii'ijirlliil, : :, i,:'|,lili'li!i"lllli,i !ฃ lll.llllillllR Villllllllll^
I-Z-'I'IIII1, .'I,'!,," ,, IIll4ป3l,ซiiJiiji2|i {S/^raJ^eC QmSllfSr&BS
. ,_...... ._..... ,,
mnBflsmnBfc^)' AC Facilities
ml, ,il it, I Hill,1", I'lllil' ii! 'mil ,| t ill illiiiiNniiiilil1^ i'liiliniil ,|,i| linfl'lili ,,,ii,,|iBlil!lf Wllii1 '.lllll W III llll'ii:,1 ,!:illl';l! i't'liiliiiiul1 l'!S', !ll,^u^!llll K1^ I, m!\,;illi;:;:l,EI', Jy'' ', '!l i, ,il'l'; ,i"!"li |M' I 'I1 If '"JHIIIIilllli:, IIILSIIIIII^
ItPNiJllliIll "!!:8i"!!"i,; i Jllllil IM!!lป,t?rillHa ปlX^ ' ill til Iiii ii,,,-,,igi, "i iii,ii,|. ilS i iiiiCiii i W wKi'M i-iJiiiiiiM^^^^^ " ', 1 ruvi ''viiltiiii!1' iiiiinl,: iPaiiip11 :IlM^^
!|;; :,:;;:,:,;:;;,,;,;::,;:;;;, , ;: ;,;:;::,;;, :;;;;:,: ; :,;; ; ;;:;:;,; ::::;; ;; :;; ; ii, ;;::;;:;;;; ~;;: - ; ;;',:;,::,;;:,::,- ;, ,;;;;;;;;, ::;:;,;; :,;; ;;- ;;,' ;,;;,;, ; ; : ;;:;,;;;;, ;: ;,;;;;,;; ;;;;,;; ':,:,:;,;_, -;;i,,;:;,:,;;,i- ,;;, -:;,;.;.;;;:- ;;,;,;',; -;;,',;,;:; : . ;,;::! ;,-;;;;: ;,; ฃ;;, .i:;;:: ;,:'::;
, : =^E^^^:r:E:,:'EE[^ฃ e!lr9!?,,,,ฐf,i^l^Y jy^i^^r,.discharges of 34 pollutants on receiving stream water
quality are evaluated at current and pretreatment discharge levels, for 61 facilities, which
to 43 POTWs on 42 receivhig streams (35 rivers and 7 estuaries) (Table 8). Modeled
i i ; iii
: 2). The loadings are reduced to 3.15 million pounds-per-year after pretreatment;
Illi ,' Jillnllllllll' [llPlllilniiiililPPiiPllj iiillllill'PliL'P/lliililllLlliiili' jiiiilllillllllilllillll1 ซi|i||il|ii||ll;llllli; Jp I Jli.P llii"ซl P ,1 l,,,li 1 PP'I'PllliipiiiPPPi'illiiili'-'ilPPIiJPIP p'l i 'i' 'p P'lilli IJIPPPiip Pi'ip '/ป I", i nllllHliPJIPPPiMPii ilphPIIป:i,liซ' PliiipliillPiPliiiPiliiP";!1 liipPPipiiPlinilinnpilllrPPhPlipp,'!,!' ii!lill|l ulJIliP PiiPIn Illllliii1 IpliippllPilljlTlli!: li[||||i,P<:l niiplPllli1 ilPPUIliiP'PP'JI: "IPilliJIIIilP'f l|i,i
-------
Modeled instream pollutant concentrations are not projected to exceed chronic aquatic life
criteria or toxic effect levels at current or pretreatment discharge levels (Table 9). No
excursions of human health criteria or toxic effect levels (developed for organisms consumption
only) or of acute aquatic life criteria or toxic effect levels are projected (Table 9).
In addition, the potential impacts of 65 facilities, which discharge to 46 POTWs, are
evaluated in terms of inhibition of POTW operation and contamination of sludge.11 No pollutants
are evaluated for potential sludge contamination problems since EPA sludge criteria are not
available for any of the pollutants of concern. At current discharge levels, inhibition.problems
are projected to occur at 7 percent (3 of the 46) of the POTWs for 5 pollutants (Tables 11 and 12).
Inhibition problems are reduced after pretreatment to 3 pollutants at the same 3 POTWs.
1 -, " ' "''".* ,
(b) BD Facilities
The effects of POTW wastewater discharges of 15 pollutants on receiving stream water
quality are evaluated at current and pretreatment discharge levels, for 52 facilities, which
discharge to 43 POTWs on 43 receiving streams (30 rivers and 13 estuaries) (Table 13). Modeled
end-of-pipe pollutant loadings for 52 facilities at current discharge levels are 0.18 million pounds-
per-year (Table 6). The loadings are reduced to 0.03 million pounds-per-year after pretreatment;
a reduction of 83 percent.
No excursions of human health criteria or toxic effect levels or aquatic life criteria or
toxic effect levels are projected at current or pretreatment discharge levels (Table 14).
In addition, the potential impacts of 58 facilities, which discharge to 48 POTWs, are
evaluated in terms of inhibition of POTW operation and contamination of sludge.12 No sludge
11.12,
Additional facilities were evaluated in the POTW assessment than for the surface water assessment due to data
availability. v .'
' 73 . - ' . , .
-------
Illllllllllllllllllllllllllllll
criteria are available to evaluate potential sludge contamination problems. No inhibition problems
are projected to occur at current or pretreatment discharge levels (Table 15).
:i , ... '',,,'',
1 J i 'i',
4.1.2 Estimation of Human Health Risks and Benefits
i k,
. ' * '' "'. ' ~. ", '',''' ','' .',,''' I
The results of this analysis identify the potential benefits of the CWA and MACT final
rules to human health by estimating the risks (carcinogenic and systemic effects) associated with
i|l|lnii|i| ir I* ii ijniiil ! '.S'liii null I i ' i i| i] |iii|ivปi! ' ป min; . IK^^ Iflllllll": i CIW Aid1 Kfll'l lillV!'! nillill Hal >~i 1: i!'!1."! ill";!":1! i.:'!:!)!1!!'" I! II'K- III; f I1 >: I!:"!:"1 " i:lllil"!"l!li:ii:>'11! i'!l:< i nil1!1'!!1, i;'' 4-ii "i'l Hiniri fit f.t >!j! M Jii' win w;ป" i', jjipi; ;r . ' :i!iii!iinii:\lป
!:(!B iA SSM:m - IB iiMiii'l^^^^^^^^^^^^^^^^^^^^^^^ i^^1!!!!;!!* 111131
"L '"' "'"jf '"''! "" \ | '""': ""' ' : '" ! ::: ']""""'' ! ' ' ! "- """I \ ' ' ' """, ! " "'"
4.1.2.1 Direct Discharges
i|ii ii 111111 ซiii i ill ii
The effects of direct wastewater discharges on human health from the consumption of fish
i1
tissue and drinking water are evaluated at current and BAT treatment levels for 17 AC/BD
facilities discharging 33 pollutants to 17 receiving streams (17 rivers) (Tables 1 and 5).
llllllli Hi! 11 il il in nil i in iiiililill hill
a) Fish Tissue
i ii 11 ii
i
At current and BAT discharge levels, no total estimated individual pollutant cancer risks
i . ,, - ' >
greater than IGr (1E-6) or systemic toxicant effects (hazard index greater than 1.0) are projected
'i "ii1 ' ' ,' " ' 'i
for the general population, sport anglers or subsistence fishermen (Table 16).
fill!
74
till Jill
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(b) Drinking Water
'' "j >
At current discharge levels, 1 stream has a total estimated individual pollutant cancer risk
greater than 10'6 (1E-6) due to the discharge of 1 carcinogen (Table 17). The total estimated risk
is 2.7E-6. However, there is no drinking water utility located within 50 miles downstream of the
discharge site (i.e., total excess annual cancer cases are not projected). The risk is eliminated at
BAT discharge levels. No systemic toxicant effects (hazard index greater than 1.0) are projected
at current or BAT discharge levels (Table 17).
4.1.2.2 Indirect Discharges
The effects of POTW wastewater discharges on human health from the consumption offish
tissue and drinking water are evaluated at current and pretreatment discharge levels for 113
AC/BD facilities that discharge 34 pollutants to 86 POTWs on 85 receiving streams (65 rivers and
20 estuaries) (Tables 8 and 13).
(a) FishTissue
At current discharge levels, 1 stream, receiving the discharge from 3 facilities, has a total
estimated individual pollutant cancer risk greater than 10"6 (1E-6) due to the discharge of 3
carcinogens (Tables 18 and 19). The total estimated risk is 3.8E-6 for subsistence anglers. Total
risks greater than 10"6 (1E-6) are not projected for the general population or sport anglers. Total
excess annual cancer cases are estimated at 2.1E-5 for subsistence anglers. This risk is eliminated
at pretreatment discharge levels. Given this risk level and the size of the population exposed,
however, estimated cancer incidence is small. Thus, while the final rules are expected to reduce
the risk to acceptable levels [Le., below 10'6 (1E-6)], the magnitude of the human health benefits
is negligible. No.systemic toxicant effects (hazard index greater than 1.0) are projected
(Table 18).
75
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iiliiii i in (IKK i
(b) Drinking Water
At current discharge levels, 3 streams, receiving the discharge of 4 carcinogens from 5
facilities, have total estimated individual pollutant cancer risks greater than 10'6 (1E-6) (Tables 20
and 21). Estimated risks range from 1.4E-6 to 1.7E-5. One (1) stream, receiving foe discharge
| !'"' ! I'" ', I -: /;"h |" : "'"' '. "' | ! '""ป! "'"" !"*'" ! '""';: ' ! "": """"'"!""! , ' """'; "" : ": " ! !"!'']! ";J !,
of 2 carcinogens from 1 facility, has a drinking water utility located within 50 miles downstream.
The total estimated individual pollutant cancer risk is 1.4E-6. However, EPA has published a
. : vi " ': . . ',,' ",-. :'.',"'. '!. .''' : ';' "" ':.'.,.' ^'- .!-.-' ''' ,."S . ?:>V' $" ; .-vicV >;,;
drinking water MCL for the 2 carcinogens, and it is assumed that this drinking water treatment
systems will meet the MCL. Total excess annual cancer cases are, therefore, not projected. In
r i p
addition, no systemic toxicant effects (hazard index greater than 1.0) are projected at current or
pretreatment discharge levels (Table 20).
4.1.3 Estimation of Environmental Benefits
The CWA final effluent guidelines and MACT rule are expected to generate environmental
i i " 'I"
by improving water quality. These improvements in water quality are expected to result
",'".., , .' i ' ' . . " i , v |,
from reduced loadings of toxic substances hi the effluent of the regulated facilities. The results
of this analysis identify the potential environmental benefits of the proposed regulation by
estimating improvements hi the recreational fishing habitats that are impacted by direct and
indirect pharmaceutical wastewater discharges. Such impacts include acute and chronic toxicity,
sublethal effects on metabolic and reproductive functions, physical destruction of spawning and
iii ' i . 11
feeding habitats, and loss of prey organisms. These impacts will vary due to the diversity of
species with differing sensitivities to impacts. The following sections summarize the potential
monetary use and nonuse benefits for direct and indirect discharges, as well as additional benefits
that are not monetized. Appendices J and K present the results of the analyses for each type of
discharge and facility, respectively.
ii
76
iliiiiliiiiiiiiiiiili i iiii iiii in mi ii i iiiiiii K
IP
I I
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4.1.3.1 Direct Discharges , ,
The effects of direct wastewater discharges on aquatic habitats are evaluated at current and
BAT treatment levels for 17 AC/BD pharmaceutical facilities discharging 33 pollutants to 17
receiving streams (Tables 1, 3, 5 and 7). The final regulations are projected to completely
eliminate instream concentrations in excess of AWQC at 2 receiving streams (Table 3). Benefits
to recreational (sport) anglers, based on unproved water quality and improved value of fishing
opportunities, are estimated as follows. The monetary value of improved recreational fishing
opportunity is estimated by first calculating the baseline value of the benefiting stream segments.
From the estimated total of 43,075 person-days fished on the 2 stream segments, and the value per
person-day of recreational fishing ($25.79 and $32.66, 1990 dollars), a baseline value of
$1,111,000 to $1,410,000 is estimated for the 2 stream segments (Table 22). The value of
improving water quality in these fisheries, based on the increase in value (11.1 percent to 31.3
percent) to anglers of achieving a contaminant-free fishing area (Lyke, 1993), is then calculated.
The resulting estimate of the increase ,in value of recreational fishing to anglers ranges from
$124,000 to $441,000 (1990 dollars). In addition, the estimate of the nonuse (intrinsic) benefits
to the general public, as a result of the same improvements hi water quality, ranges from at least
$62,000 to $220,500 (1990 dollars) (Table 22). These nonuse benefits are estimated as one-half
of the recreational benefits and may be significantly underestimated. All of the monetized benefits
can be solely attributed to the CWA rule.
4.1.3.2 Indirect Discharges
The effects of indirect wastewater discharges on aquatic habitats are evaluated at current
and pretreatment levels for 113 AC/BD pharmaceutical facilities that discharge 34 pollutants to
86 POTWs with outfalls located on 85 receiving streams (Tables 8, 9, 13 and 14). The final
regulations are projected to completely eliminate instream concentrations in excess of AWQC at
3 receiving streams (Table 9). Benefits to recreational (sport) anglers, based on unproved water
quality and improved value of fishing opportunities, are estimated as follows, The monetary value
77
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l|l|l|| III Mill 1(1 I II I 11,| 11 | III) III Illllllll
lIllllB I I III Illllllll Illllllll 111 llllllllllll 111^ Illllllll
II I I |j
III II 111 III II Illllllll I III 111 111 111 III Illllllll llllllllllll Illlllllllllll
li 111 I | | ll|l|l Kill I II J I *|l
Illllllll I 111 llllllllllll I Illllllll 111 lllll||ll I 111 llll|l||lllll|llllllllll Illllllll 11 Illllllll I llllllllllll 11 111 Illllllll 11 111 llllllllllll 11 I l| Illlllllllllll
[||1" III"'
Illlllllllllll ll|llllll III 111 Illllllll
llllllllllll III llllllllllll Illllllll llllllllllll
of improved recreational fishing opportunity is estimated by first calculating the baseline value of
the benefiting stream segments. From the estimated total 103,126 person-days fished on the 3
Stream segments, and the value per person-day of recreational fishing ($25.79 and $32.66, 1990
dollars), a baseline value of $2,660,000 to $3,368,000 is estimated for the 3 stream segments
III III Illlll 1 I llllllllllll 111 Illlllllllllll II III Illllllll I Illllllll 111 111 II 111 llllllllllll II 111 II llllllllllll llllllllllll 111 II 11IIIHI ill 111 II1111II 111 III III III 111 111 II 111 III II Illllllll 111 III II Illllllll I II Illlllllllllll 1 111 I III 1 1 Illllllllllllllll 11 Illllllll I llllllllllll II III II Illlll 11 III I III I I III Illllllll 111 1 ' 111 I llllllllllll III I 111 111 llllllllllll llllllllllll 111 111 II
(Table 22). The value of improving water quality in these fisheries, based on the increase in value
' " ' ' ' , ,, _ 1 ,
(11.1 percent to 31.3 percent) to anglers of achieving a contaminant-free fishing area (Lyke,
M, i ซii ii ฐ J
1993), is then calculated. The resulting estimate of the increase in value of recreational fishing
to anglers ranges from $295,000 to $1,054,000 (1990 dollars). In addition, the estimate of the
nonuse (intrinisic} benefits to the general public, as a result of the same improvements in water
quality, ranges from $147,500 to $527,000 (1990 dollars) (Table 22). These nonuse benefits are
estimated as one-half of the recreational benefits and may be significantly underestimated.
Monetized benefits of $108,000 to $387,000 (1990 dollars) of the recreational benefits and
HI r ' i " u" i- ; n I " |i " '
$54,000 to $194,000 (1990 dollars) of the intrinsic benefits can be solely attributed to the CWA
i
rule.
4.1.3.3 Additional Environmental Benefits
iiiiiiii 11 ill 'in i iiiiii
There are a number of additional use and nonuse benefits associated with the final
standards that could not be monetized. The monetized recreational benefits are estimated only for
fishing by recreational anglers, although there are other categories of recreational and other use
benefits that could not be monetized. An example of these additional benefits includes enhanced
,i ., ii
water-dependent recreation other than fishing. There are also nonmonetized benefits that are
i i i | i ,- i , i ji ii
i nonuse values, such as benefits to wildlife, threatened or endangered species, and biodiversity
benefits.
i I
Rather than attempt the difficult task of enumerating, quantifying, and monetizing these
1 i
nonuse benefits, EPA calculated nonuse benefits as 50 percent of the use value for recreational
111 n iiiliiiii i ill iiii i 111 i iiiiili i iiiil iimi i in i ill iiiii i iiiiiiilii i i(ii(i|i i ill in 11111 n ill in ill in ill ill i iiiiiliil i 111 in ill n ii mi 111 n in 11* I in 11 ii i n in 111 iiiiiiiiii 11 iiiiii i iiiiii 111 iiiiiiii ii|ii i|iii i iiiiiiiii 11 ill iiiiiiii pi i ii in 11 11 iiiiiiii in 11 ii iiii i niiiiiii iiiiiiiiii 11 iiiii
fishing (Fisher and Raucher, 1984). This value of 50 percent is a reasonable approximation of the
II ID 11 ii1 \\ n I i i 11 PHI III n in i n IN
I I I III I n I I il ll I I ill ml II I "i i |i lulu Illllin Illlll n I n I ill mi11 n in |i n niliii II I linn illin pi 111 Illn
total nonuse value for a population compared to the total use value for that population. This
PI
78
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approximation should be applied to the total use value for the affected population; in this case* all
of the direct uses of the affected reaches (including fishing, hiking, and boating). However, since
this approximation was only applied to recreational fishing benefits for recreational anglers, it does
not take into account nonuse values for non-anglers or for the uses other than fishing by anglers.
Therefore, EPA has estimated only a portion of the nonuse benefits for the final standards.
4.1.4 Estimation of POTW Benefits
' . / . . ' .
As discussed in Section 2.1.4, both the CWA rule and the MACT rule are expected to
generate benefits based on the improvement of conditions at POTWs. Benefits include reduced
interference, passthrough and sewage contamination problems, as well as reductions in costs
potentially incurred by POTWs in analyzing toxic pollutants and determining whether, and the
appropriate level at which, to set local limits. Although these benefits to POTWs might be
substantial, none of theise benefits are quantified due to data limitations
4.2 Projected Air Quality Impacts13
The results of this analysis indicate the potential air quality risks and benefits from air
emissions associated with pharmaceutical manufacturing facilities. The following three sections
summarize: (1) potential human health risks and benefits (carcinogenic/systemic) to the general
public from onsite fugitive emissions from open-air settling, neutralization, equalization, or
treatment tanks; (2) potential risks and benefits to POTW workers from occupational exposures
to a toxic mixture of gases partitioning from influent pharmaceutical wastewater; and (3) potential
risks and benefits to the general public and the environment (agriculture) from onsite fugitive
emissions of ozone precursors (i.e., VOC emissions).
Pollutant loadings have been received since this assessment was completed based on earlier loadings (August 1997).
Because the revised loadings are not significantly different from the loadings used for the assessment, the assessment
was not redone using the revised loadings. ' '
' .' ,- 79
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E^^'.ป^^^.4 :l|iiii H^il^S:,9?l4 .Sleaefite (Carcinogenic/Systemic)
potential air quality benefits of controlling fugitive air emissions from direct and
indirect discharging pharmaceutical manufacturing facilities are presented below for the three sets
of fugitive emissions from onsite treatment.
The results of the air quality benefits are presented based on modeling a subset of the
- iii ,
overall loading data (Appendix L). The subset is defined using a screening method to rank
facility-pollutant releases based on the maximum potential downwind concentration and pollutant
levels of cpncern (Appendix L). Facilities with screening hazard ratios above 1.0 are selected for
......... ........ \ ....... ..... ' ...... ' i i
site-specific analysis. The screening procedure significantly reduces the number of
i i
facility-pollutant release combinations that are modeled.
iiiiiiiiiiiiiiiiiiii in iiiiiiiii
I I I W I II
4.2.1.1 CWA Section 308 Pharmaceutical Questionnaire Data
iii Ii i ii iii IN i ii 11111 IN ill (ii iiiiiiiii 11 i i ii illinium i ii 11 iii i ii in1 in ii i in i MI MI nil iii in i 111 in i if iii|li|ii in i in i iiiiiii i in ih ii i i i
V
The preliminary screening method evaluates 60 facilities (AC Direct/Indirect and BD
. ll II I I I' I I I > I HI II ill ! II (II III IIIIIIIII ' 111
Indirect) discharging 41 pollutants via fugitive emissions. There are 286 facility-pollutant loads,
i j . ii i ii ii i 11 i 'ii i 11 , i
releasmg 8.32 million pounds of pollutants per year.
The screening procedure identifies 25 facility-pollutant discharges with hazard ratios
. " ' ' . ' ' ' , ''." ' ;;' ',.-, ' " , ''-, ' ;> " ; '' ' '"'Si' I;1
greater than 1.0. These releases represent 8 pollutants from 19 facilities at a load of
11 " " ' " l" ;li!!;l|; j ; ' " '"
3.0 million pounds-per-year. Atmospheric modeling includes 22 facility-pollutant
, releases of 5 garcinpgens. Three additional facility-pollutant releases of 3 inoncarcinogenic/
pollutants are analyzed.
sssss ^ased on the 308 Questionnaire data, approximately 452,000 people nationwide are
ซ_6, ^___,,^_ ,,_^ -^ b'enefits incju"de
.i 2 iSiSฃli2!3 fiฃ QsSlJs Sxciss ajjnual cancer Qccu;r,rences:. Me|tylene .chloride has _flie largest
i_,i__ f " ป t -t f ....
SE^f-SBy s,mS_ .?5e5^.: .ฅ?! ?f!4j|?P5z |he air modeling analysis projects that approxima.tely
,
,
-------
11,000 people would benefit from reduced exposure to methyl cellosolve which is associated with
systemic effects.
4.2.1.2 CWA Final Rule
the preliminary screening method evaluates 73 facilities (AC/BD Indirect) discharging 30
pollutants via fugitive emissions. There are 253facility-pollutant loads, generating a potential
benefit of 14.6 million pounds of pollutants reduced per year.
The screening procedure identifies 60 facility-pollutant discharges with hazard ratios
greater than 1.0. These air modeling applications include 35 facilities with a benefit loading of
approximately 6.4 million pounds per year for 11 pollutants. These include 37 carcinogenic and
23 systemic releases of 4 carcinogens and 7 noncarcinogenic pollutants, respectively.
The air quality modeling analysis projects approximately 1 million people (1990
population), at cancer risk levels exceeding 10"6 (1E-6), would benefit from the air load reduction
(Table 24). The load reduction would provide a benefit of 0.15 reduced annual cancer case
occurrences. This estimated decrease hi cancer risk results from reductions in emissions of 4
carcinogens: benzene, chloroform, 1,2-dichloroethane, and methylene chloride. The estimated
monetized value of the human health benefits from these cancer risk reductions ranges from
$285,000 to $1.53 million (1990 dollars) (Table 25)
In addition, the air modeling analysis projects that approximately 32,300 individuals would
benefit from the reduced exposure to four identified toxic pollutants (ammonia, chlorobenzene,
methyl cellosolve, and triethylamhie) associated with systemic effects (Table 24).
81
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!^^ ^^^^^^^i^^^ 22J|s!jJjeซ ฃ&ฃ Sfe^fe^S^.i^SES^I
! patents via Sgitive emissions. TTiere are 200 fecmty-poUutant toads, generating a potential
ounds of pollutants reduced per year.
iiuK^
v IN,: ji win; ,,i,iซ^^ wmii, iiiiiiiiniiciii r IIIIIIH^^ un1 IIIIH|,IIIII inn "I'liiiiiifciniyiiwiiii
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iii'iTnibiiR, i1 iiii|iiiiiซpiiillpiiii VIIHI^ ijiuiiun
I HIIUII'IPIIIIIII < ''l|W^^^^^
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e screening procedure identified 43 facility-pollutant discharges with hazard ratios
iJB'iii'ililijjni ijjJH,,;!! i i , imnni. | 11,1 | , || , 2J,,,,,,, , i,,,,,,,,,/i, I**",I^"*,IT: iiilp,":!,^!
S 1.6. These aiir modeluig aDoIications include 17 facilities with a benefit loading of
' ' ' ...-.'
[ pollutants. These include 24 carcinogenic and
systemic releases of 3 carcinogens and 7 noncarcinogenic pollutants, respectively.
I
gxceeding 10* (1E-6), would benefit from^ the an- load reductipn (Table 26). The load
reduction would provide a benefit of 6.88 reduced annual cancer case occurrences. This estimated
decrease in cancer risk results fromieductiQns in emissions p|3 carcinogens: chloroform, 1,2-
dichloroethane, and methylene chloride. The estimated monetized value of the human health
benefits from these cancer risk reductions ranges from $1.67 million to $8.98 million (1990
dollars) annually (Table 25). It is estimated that the cancer risk will be further reduced due to
reductions in fugitive air emissions from process vents, storage tanks, and equipment leaks.
However, these reductions were not quantified due to lack of site-specific data.
',' '. '
In addition, the air modeluig analysis projects that approximately 370,000 individuals
would benefit from the reduced exposure to four toxic pollutants (ammonia, 4-methyl-2-pentanone,
methyl cellosolve, and triethylamine) associated with systemic effects (Table 26). It is also
from process vents, storage tanks, and equipment
leaks will result in reduced systemic hazard. However, these benefits are not quantified due to
data limitations.
iii 11 mil i n iiiiiiiiiiii ii i iiiii
,82
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IIIIIIIIIIllllllllllillI IIIIIII
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-------
4.2.2 POTW Occupational Risks and Benefits
Following procedures outlined in EPA's Guidance to Protect POTW Workers from Toxic
and Reactive Pases and Vapors (U.S. EPA, 1992b), risks to POTW workers from exposure to
toxics are evaluated under current conditions and under final pretreatment standards.
-, .' V ' '' " '
Toxic substances, particularly the VOCs, in effluent discharges to POTWs pose health
risks to POTW workers. This analysis evaluates effluent discharged by 98 AC/BD indirect
pharmaceutical facilities to 73 POTWs. Pollutant loadings at current discharge levels of 10.9
million pounds-per-year are reduced to 3.2 million pounds-per-year at pretreatment discharge
levels; a 71 percent decrease. Applying the approach described in Section 2.2.2, the CWA final
, * ' , .
rule and the MACT rule are expected to reduce occupational risk at 9 of the 14 POTWs where
workers are potentially at risk due to exposure to primarily acetonitrile, benzene, chloroform,
diethylamine, n-heptane, n-hexane, methylene chloride, toluene, and triethylamine (Table 27).
Specifically, a total of 14 POTWs treating 30 pollutants are identified with summed hazard
ratios greater than 1.0 at current discharge levels. Individual pollutant hazard ratios range from
3.1E-10 to 243 at current discharge levels, with 28 occurrences of 9 pollutants exceeding the
hazard ratio of 1.0 (Table 27). Benzene is associated with the greatest risk to POTW workers.
A total of 5 POTWs treating 30 pollutants are identified with summed hazard ratios greater
than 1.0 at pretreatment discharge levels. Individual pollutant hazard ratios range from 3.4 E-ll
to 26.9 with 5 occurrences of 3 pollutants exceeding the hazard ratio of 1.0 (Table 27).
Reductions of occupational risk at five POTWs (out of the 9 POTWs with reduced occupational
risk) can be solely attributed to the CWA rule. Data are not available to monetize this benefit.
83
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4.2.3 Human Health/Agricultural Risks and Benefits (Ozone Precursors)
"
Both title CWA final rule and the MACT final rule will result in a reduction in ozone
. i,!"" --"jir ; . ' ...... ' 'I;";" " ! ' . . ,,,.,, . I " i . ' ' ']', - - , ,![;.'
precursors (VOC emissions) and a subsequent increase in PM and SO2 emissions as summarized
" ......... , -Mi .', , ; i- .: . : .. , ' v^s -.l,'. : ...... ., 'i '. ..... - .f ,;'...,..#..,:
below.
ir
mi. ; ; i ii, ., ; - , i=i JAM "cm BOA Bai& ;
, ; i ::
,l',ni' 'IIillllllllllllllllli!Ill lllllillKlllllllllllllllliilHr!1 ! jllllllllllllll pIPIIJIII' IPIIIVTIIIIIli.'flllliiillilJRI,,liillllllllllllllHII'iJNllllHlllli.linilililllllllillill illllJIIlillilllllllllhi'liillPill'illj il.lllllll<ป.jliilin!,iill!'l'!|iri!''l|ii!llp!"';!!!!]|i;;ijf'iiililBirillllilllij "|l| 'nl:1 ^IliiBiL lilliPlllllljliirilnMill1' ililllllinili'illllillilpllilllliniipi.iliuilillljlh'S+lllfllllil'll' iii'p1'iJllMllllllllllllliilii'll','llliiiiilliIIIH.!.'.i.iliillllllllilllplLi II|ll"ป':iillii'!ll!l!l!!f'vllllllllli.!1 llllllllIIILlili" iililliilllilllPilhll'fi111 I",''i,111,L'' Illpil'lllllilp'", I!"!Jซi|illi|i|"|i'y 3,608 Mg per year (Table 28). Applying the estimate of the range of the value of a unit
t?^S;2sr, Sj^u^tipn |n VOC emissions as describ^Jn Jectip_n_2..2.JJ,; ;the estimated ^annual^monetized benefits
งiJ?2> range from $613,000 to $7.98 million' (1990 dollars) : ,ป ii r ......... ..... , tiiiijin "iiiiun ..... u IHI. iiiiiipi ..... iptii i:t iipiifUmf i.T'iiiniiiiniiTji.1 '191:1 ; iiiiiii|i|iiip".'::"&:.
environmgnta] impacts resulting from increases in PM emissions due to this final rule are $216,000
; ; ;; l!: ; :; (1990 doUars),
(cj ''fSO2Analysis " ' ' '"
;MlM^ .
JjiillI'll11il'illlllllll'hllllllllllllllJKllll"'!ฅซ IIIIIII|l|I;|i9lil||IIPia|;,i;,li'Vili'lltpIII Olllllllill'/ISllil'l
in SJ32, emssions, of ,5,2=1
IliS^ *f^f* :f>i* J1111^^ I
Mg (51.8 Mg eastern U.S. and 0.3 Mg western U.S.) (Table 29). Applying the estimate of the range
84
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Ilillill
iiiaiiiiiiiiiiiiiiiiiiinia iK'iaii
11!1:;!,:i|l|H!i|liliiปr ,p|t|i .|||llilli;|!l|ililliliIP!.ilil|l!ii lavUiaililllllllllliidllilllllllillll ii|llill<;i IB ill MBIBBIBBIBlCiK' Hiiilin t /n'tEHIB1: Kj
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piiiiiiiliiiiliiiiiiiilii'liilEiuiiliilii'inliiiJEiiiijiiiiiiliiiiitiiiili^ "Niiiiifhijiiiliiiiiiii1
-------
of the value of a unit increase in SO2 emissions as described in Section 2.2.3.3, it is estimated that
the annual monetized adverse environmental impacts resulting from increases in SO2 emissions due
to this final rule range from $253,000 to $559,000 (1990 dollars) (Table 29).
(d) Total Monetized Benefits
Total monetized air benefits from the CWA final rule reduction of ozone precursors (VOC
emissions) from wastewater, after correction for PM and SO2 increases, range from an adverse
environmental impact of $0.162 million (1990 dollars) to a benefit of $7.51 million (1990 dollars)
(Table 30).
4.2.3.2 MACT Final Rule
(a) VOC Analysis
Considering the wastewater plank only (an estimated 23 AC Direct/Indirect facilities), it is
* '','''
estimated that the MACT rule will result in reductions in VOC emissions in nohattainment areas
alone, and in all areas of 2,057 Mg to 16,619 Mg, respectively (Table 31). It is estimated that the
MACT rule will also produce benefits due to reductions in fugitive VOC emissions from process
vents, storage tanks, and equipment leaks at an estimated 101 facilities (1,278 Mg to 4,027 Mg,
respectively) (Table 31). Considering the wastewater plank only and applying the estimate of the
range of the value of a unit reduction of VOC emissions as described in Section 2.23.1, it is
estimated that the annual monetized benefits resulting from reductions in VOC emissions (not
including adverse impacts of byproduct emissions of PM and SO2) range from $1 million to $37
million (1990 dollars) (Table 31). The annual monetized benefits from reductions in all planks (not
including adverse impacts of byproduct emissions) is $1.6 million to $46 million (1990 dollars)
(Table 31).
85
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i-^^ 'ss
!m!i'':^
'M Analysis
_
titiat ..... .the ........ MACT ........ final ........ rule , waste water ......... will ........ result ....... in ........ an ......... increase ....... |n; ...... P
emissions by 4.2 Mg per year. Applying the estimated value of a unit increase in PM emissions as
spBBsraa ....... K^QSSSO&g ......... pi ....... Action ......... 2.23.2 ........ ,($10,823, per' Mg"-' 1990 dollars), EPA estimates" that the 'annual
gD^I ..... impacts resuitingjfromm^
............. ""' .............. [[[ : .............. ! .......... : ....................................... " ...... ' ............... " ..... : .............. ' ...................... : [[[ : ..... : [[[ ...................... : .......... ............ " ...... ' ...... "
'"" 'fn >ป * A T -' ' ' " '
SOf AMfyswr
It is also estimated that the MACT final rule (wastewater) will result in an increase in ,SQ2
emissions of 11.0 Mg (10.6 Mg eastern U.S., and 0.4 Mg western U.S.) (Table 32). Applying the
estimate o|the range of the value of a unit increase in SO2 emissions as described in Section 2.2.3.3,
,'. , ;';, ','' ',V " v i ;. ,': ". . ' ' ,'":',', ' '. ,', ,,','.': ;' , "'>,'-v -, ;. '^'.f'^/'M: *',.,-"
it is estimated that the annual monetized adverse environmental impacts resulting from increases in
I:
iti'
SO2 emissions due to this rule range from $52,900 to $116,000 (1990 dollars) (Table 32)^
(^^ wnnitaHi^iiM'&Humiimw^^^BfiKBr
ii Wiii'ov'i'i,ii 111 niiiiiiiiiibiipi1 'iBPip:pซp:::;iii:iiiiini'jiiiiiiiiiiPiiiiiiniiLi, iiihij'jiiiiiiiiiiiiiiiiiiiiiiiiiuii' iiiiii.jiiiiiiiiiiiiiiiin, i ipnipEPipppBปps;p;ipiiJB('limnHBP;:),i'iiiiiini:iiiipi'ininxii'i,,!,,,iiiiiyi Bl linnl'li PBPJlP'PlPBPPIpPii llf.llPli'l'.lillliiilli.iiJIi! PlPiPPBIiPliPPiL! ,BP,iP,BปBitปB!PBjf!B|lJ!l|p!lPP|l ."'I'll ,iil' i : ,::ii;|IPI|||ll|' :' I,, P|PPปP!piP
r" : :: riii'M^liii"1 r
fi|ia| ...... jrute ...... redi|gtioaง ...... oXozgne, precursors
...... emissions) ........ from ..... wastewater only, after correction for PM and SO2 increases, range from
) dollars) to $36.7 mjlliori (1990 dollars) (Tables 31 and 33).
-- ' . ' liti|i (((!<'ii'iH
' ' , .
|||on| based on &e analysis of the 101 pharmaceutical manufacturing facilities covered
|ซ^^^^^^^^^^^ the MACT rule, it is estimated that the reductions in fugitive VOC emissions from process vents,
|l|i|illlllllPilllllllll!!lllll!llllllllllllllPI|lllll||IIPI!ir:1lP1piP|llllllP^ IIIPPiP'PilPBPBIPIP'JII/IIIIPIPIIItlPllPPIillPppillliilBllliiillMlB/PSpiPIPPPPpPl.PMiPPPPPllPlPiP llllpillllllllllllllllllllil'IIIIIIIHillliilllllllllPII PpPpPPPPPPipiiNPlPIJJPPB'ilBPPBjiiiiiS'iy I,ซซL, nil nihinin iinnni IFIIIIII i H ,
lilannnnnnlillBpni.uiinninnnnnlpllnilkliB lilii'llnli'lliulllllilllllllilliE'llpllplllllUlljllllR iPnillinZlnBrBBiinini
Storage tanks, and equipment leaks would result in a range of monetized air benefits of $0.625
';;_,; ; :; _ _ ^million to IIJo^ niillipn '(1990 dollars] (Table ||31)|. ^Adverse impacts due 'to increased energy"
!ซ]ซ]jS !Pr;|ip||ปiปBiy:i I
I i ,- '. ~ , - :-r consumption from control of these ,p_lanks are i not quantified due to data limitations. The, total,
monetized benefits from reductions in YOG ernissipns from all four planks are estimated to be $ 1.48 I
(Table 33)." [ ' '
S .| iF|K||i|j|j||| i| i. j,;;;';;;;;;;,,;;;:";;1;;;1:;; :;::;=:,;;;,;',,;;: ":;;j "yฃ.:-'-i Kin ii,:' i .i'.iii p'i ii 'iiiiiii.ii Zii!,," "iiiiiii^n i if'5 i *f, "'. C ^
,_,
ili'iiiiH'iiii, ' ill'-11 K|iP | ' lit1 LI'i,', I np i''i|iiii|ii,''|!r'iir niill iii| r iiiii||it|PniiiH "iijiii
iii i:
i i,|iii'|,pi|i|:;n i nPinilllliliinlliiri.iilllliil'iP'ilpniliPllil'lilllPlllinl'illiiiiliiiPii'lil
-; I1,,;,; ,,:: i : :,;;,,;- :; .i:.' ::I,,:, , ,', , .'.:.i,.....; : ,:::: ;:,,;!:|r:i;,:;;
-------
43 Total Potential Annual Economic Benefits
The estimated annual monetized benefits resulting from the CWA final effluent limitations
guidelines and the wastewater emissions control portion of the M ACT rale will range from $752,000
to $11.3 million (1990 dollars) (Table 34). This range includes $285,000 to $1.0 million of the
environmental benefits that cannot be differentiated between the CWA rule and the wastewater
portion of the MACT standard.14 The annual monetized benefits resulting solely from the MACT
final rale are estimated to range from $3.15 million to $54.6 million (1990 dollars) (Table 34). The
ranges reflect the uncertainty in evaluating the effects of the final rales and in placing a dollar value
oh these effects. As previously discussed and as indicated in the table, these monetized benefits
ranges do not reflect many of the benefit categories expected to result under the final rules, including
reduced systemic human health hazards; improved POTW operations/conditions; and improved
worker health at POTWs. Therefore, the reported benefit estimate understates the total benefits of
the final rales.
4.4 Pollutant Fate and Toxicity
Human exposure, ecological exposure, and risk from environmental releases of toxic
chemicals depend largely on toxic potency, inter-media partitioning, and chemical persistence.
These factors are dependent on, chemical-specific properties relating to lexicological effects on
Hying organisms, physical state, hydrophobicity/lipophilicity, and reactivity, as well as the
mechanism and media of release and site-specific environmental conditions., Based on available
physical-chemical properties, and aquatic life and human health toxicity data for the 47
pharmaceutical pollutants, 3 exhibit moderate to high toxicity to aquatic life; 23 are human
systemic toxicants; 7 are classified'as known or probable human carcinogens; 9 have drinking
water values, all with enforceable health-based MCLs; 9 are designated by EPA as priority
Specifically, two facilities included in the modeling were required to have MACT strippers and were also costed for
additional strippers to meet the CWA effluent guidelines. Overall removals due to these strippers cannot be
Hifflar^Tltiat^H Hfปtvi7*is4 OYXfA ~.Ani-.ปAซn_.*.~
between MACT and CWA requirements.
87
-------
Ill,
pollutants; and 20 are designated by EPA as HAPs (Tables 35, 36 and 37). In terms of projected
I i I | ill I i ซIH
environmental partitioning among media, 29 of the pollutants are moderately to highly volatile
(potentially causing risk to exposed populations via inhalation); 4 have a moderate to high potential
I ill I H II il I III I I I ill I I 11 I | I n I | I I I i i III n n i i i1 i n i i 11 11 * HI
to bioaccumulate in aquatic biota (potentially accumulating in the food chain and causing increased
I | | i 1 * | i In li y ^ | | | l| H l|l H
risk to higher trophic level organisms and to exposed human populations via fish and shellfish
I
consumption); none are moderately to highly adsorptive to solids; and 9 are resistant to or slowly
biodegraded (Table 35). -
i i
4.5 Documented Environmental Impacts
i nil ii i in .
In a review of literature abstracts, State 305(b) reports, newspaper articles, and the
i ' " ..,._,.
Pharmaceutical Outreach Questionnaire, 16 studies15 noted environmental impacts from
pharmaceutical manufacturing (Table 38). Impacts included: (1) human health problems (worker
III1 ! ' !, J
exposure and population) such as dizziness, nausea, respiratory and dermal problems and
it i I i | . i , , ' r i,.
endocrine dysfunction (reproductive); (2) aquatic life effects, such as fish kills; (3) effects on the
quality of receiving waters, groundwater, soils, sediments, and drinking water; and
.'. ,' ' _ " if- ' ,11 . : ., '.I . ' ''''.,' '.," ' , ', ' ,' i V" ' , ' :'' " ' '" :: ' ',; ' ; ' .*;.!' Ii.
(4) impairments to POTW operations. In addition, 4 pharmaceutical manufacturing facilities are
identified by States as being point sources causing water quality problems and are included on their
5S5304(1) Short List. Section 304(1) of the Water Quality Act of 1987 requires States to identify
ig!|ill!f!iligggill|ii!|||gg:gill^^^ liiiiiiiiiiiiiipiiiiiiiiiiiiiiniiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiniiiiiinw , ซ , i i \ , ,ซ M, pm., m si,,,,,,, i I
iiiii;;i;ivi;;iiii||iiii|iiiiNiiiii;I |
^sS^StraMM!^ impaired by the presence of toxic substances, to identify point source discharges of
lllinnniiiliEiJIlMiln IRIIIIillllllllDllil'iqil^illA liijp iiSkiiiii] |i pin pir IIIIKINI, HHHii'iiiii'iLi'" in: < PIซII|I< mSui | |N|i||niii im" P,! ซ,.H
& ....... SSฃlฐ| ...... MJY!!!งJ ...... ฃฐ,n
!Nป.List is a list o| waters for which a State does not expect applicable water quality standards
ric or narrative) to be achieved after technology-based requirements have been met due
or substant ially i to point source discharges of Section 307(aj' toxics. A list , of
included on the 304(1) Short List are provided in Table 39. State and Regional environmental
J, i ; ; ,miij imi | i||,,,;
^g aiso contacted for documented impacts due to discharge from pharmaceutical
IIIIIIM^^^^ >i' 1 1 1111 | |ll| ||!l|ll|ll| i 1| Ill Sin , (i in r 111,1 ' ' ii||
facilities. State, contacts indjcate the need for National effluent guidelines for the industry.
groundwater contamination and worker exposure problems at six sites are not directly relevant to
resulting from wastewater discharges but are included to present a comprehensive summary. I
- "=' ';: :';' ^-- -=' * '^-- ; ' ""88
. I
^llllilElllllllllllli'llllliilllilEIEJIIllijiiiilllllFEiiliil^ lllilillljILIiiLlnlllllllllliilliilllllllfi'llJililVli!
||^^^
-------
Problems with disbharges of organic chemicals, oil and grease, BOD/COD and with groundwater
contamination are noted.
89
-------
I! lil III.! I.! I
illliiw i i i mill i in i i i ill.!)! lil i in i i ii|iiiiii ii|i^
H'l'i'i >i
' I1
Table 1. Frequency of Evaluated Pollutants from 14 AC Direct Pharmaceutical
Manufacturing Facilities Discharging to 14 Receiving Streams
l (111 I 111 III |I1IIIH Illllllllllllllll 111 lil
illllB
1 Pollutant Name
ACETONE
ACETONITRILE
AMMONIA AS N
AMYL ALCOHOL
AMYL ACETATE, n-
CHLOROFORM
CYANIDE
DICHLOROETHANE, 1,2-
DMETHYL SULFOXIDE
| DIMETHYLACETAMIDE, N,N
I DIMETHYLFORMAMIDE, N,N
ETHANOL
ETHYL ACETATE
ETHYLENE GLYCOL
FORMALDEHYDE
FORMAMIDE
HEXANE, n-
IISOPROPANOL
ISOPROPYL ACETATE
ISOPROPYL ETHER
METHANOL
METHYL ETHYL KETONE
METHYL FORMATE
METHYL ISOBUTYL KETONE
METHYLENE CHLORIDE
PHENOL
PYRIDINE
TERT-BUTYL ALCOHOL
TETRAHYDROFURAN
TOLUENE
TRffiTHYLAMINE
1 XYLENES
Number of Detections by
Facility
8
3
6
1
1
4
3-
2
1
1
2
6
5
1
5
1
3
8
1
1
7
1
2
1
5
1
1
1
3
6
1
4
Note: Only pollutants of concern present in wastewater discharges are evaluated.
|i ini'i jii ->i' , , 'i ,;, ,: IT!-: v i: iiiiiiiii ,;ซ Source: Engineering and Analysis Division (BAD), August 1997.
*l *: -
ff'JSlm
T'lTllllill'I'i'll MIIH Illilllillta
'.liilllilllllllllllplllil'IIH IlllllllillllllliillllllllW
.r.iT.aEf^s
.up j jiiniwrihi Hiiprii* 11 ill Ikijiili i, iu'lni iป iinniii'i uriM! iiii'miiniTiimi;,"' < IP n, m ',f Mil"',, if niiiuiliiii1 iniiliin iiihiriiiipi^^
I IPIIIIIHII Illlil IlllllnUIIIIIIIII'lllllli'i ill Illl 1111 IIPiHli Hi liTrHliilllMltlllllllUilillllllll Illnlllllll 'illl liNIIPXih W lllliMWIIIIIIIll^ IPJIIllllulll
' i''' , ป"i I ' i" '*' ii ป' i'" II ilii:1 p iilipiii Ilii'i'' iipi
|H^^^^
II, illlllliu!1' iiini;l;, i iililliiiif ii^^ lii|llii:l,i
H llliiia'iiiJIIiilliH^^^^^^^^
90
1 lllnB iljRaiHI.Ii ii!!?, Wff"'ป HO'liil'TillUi !il
ง!!K^^^^^^^^ ,,,,^^^^ . I.., .
j;^^^^^ - st'HA trr: Sft^ifi? E- laifet^iiSab^ ? i:-i^^^^^^ BSh-m i::1: \mf*
-------
Table 2. Summary of Modeled Pollutant Loadings for AC Direct and Indirect Pharmaceutical Manufacturers*
Current
Organics
Cyanide
Ammonia as N
Total
BAT/Pretreatment
Organics
Cyanide
Ammonia as N
Total
No. of Pollutants
No. of Facilities (Evaluated)
Loadings, pounds-per-year
Direct
1,467,320
42
159,974
1,627,336
52,803
4
28,283
81,090
32
14
=======1
Indirect
9,211,178
1,083
210,389
9,422,650
3,115,279
59
34,255
3,149,593
34
61***
Total
10,678,498
1,125
370,363
11,049,986
3,168,082
63
62,538
3,230,683
**41 .
75
* Only pollutants of concern present in wastewater discharges are evaluated.
** The same pollutant may be discharged from a number of facilities; therefore, the total does not equal the sum
of pollutants.
*** 54 of the 61 facilities evaluated had pollutants of concern present in wastewater discharges.
Version: August 1997 Loading File.
June 19, 1998
91
-------
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93
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HjiiFj. i,, iiipi 1.1! ijii'ifii ii."- :,: liijiiiii'ii!,;.!" :t .i'viajr!;,!.*!,! ymtsy,, "I {Kill1! i1 ปt ";l|v -I i" .ซm i1'ป; i Tfi<' {M"!! ill., '; r i,1!
-------
Table 6. Summary of Modeled Pollutant Loadings for BD Direct and Indirect Pharmaceutical Manufacturers*
Current
Organics
Cyanide
Ammonia as N
TOTAL
BAT/Pretreatment
Organics
Cyanide
Ammonia as N
TOTAL
No. of Pollutants
No. of Facilities (Evaluated)
Loadings, pounds-per-year
Direct
15,780
0
0
15,780
752
0
0
752
6
3
177,348
0
25
177,373
31,311
0
25
31,336
15
52***
193,128
0
25
193,153
32,063
0
25
32,088
**18
55
*
**
Only pollutants of concern present in wastewater discharges are evaluated.
The same pollutant may be discharged from a number of facilities; therefore, the total does not equal the sum
of pollutants.
*** 27 of the 52 facilities evaluated had pollutants of concern present in wastewater discharges.
Version: August 1997 Loading File.
June 19, 1998
95
-------
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tJ- i JN 1 1 Only pollutants of concern present in wastewater discharges are evaluated.
Nltl
rjr i Version: August 1997 Loading File.
t ; ! 1 ! a ฐ ฐ
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-------
Table 8. Frequency of Evaluated Pollutants from 61 AC Indirect Pharmaceutical Manufacturing Facilities
Which Discharge to 43 POTWS on 42 Receiving Streams
Pollutant Name
Number of Detections by Facility
ACETONE
ACETONITRILE
AMMONIA as N
AMYL ACETATE, n-
BENZENE '
BUTYL ACETATE, n- ,
CHLOROBENZENE
CHLOROFORM
CYANIDE
DICHLOROBENZENE, 1,2-
DICHLOROETHANE, 1,2-
DIETHYLAMINE
DIMETHYL SULFOXIDE
DIMETHYTLACETAMIDE, N,N
DIMETHYLFORMAMIDE, N,N
ETHYL ACETATE
ETHYLENE GLYCOL
FORMALDEHYDE
HEPTANE, n- ,
HEXANE.n-
ISOBUTYRALDEHYDE
ISOPROPYL ACETATE
ISOPROPYL ETHER
METHYL CELLOSOLVE
METHYL ETHYL KETONE
METHYL FORMATE
METHYL ISOBUTYL KETONE
METHYLENE CHLORIDE
PHENOL
POLYETHYLENE GLYCOL 600
TETRAHYDROFURAN
TOLUENE
TRIETHYLAMINE
XYLENES
30
10
19
2
1 "
2
4
7
5
2
3
7
10
6
19
17
7
9
10
4
2
7
2
4
3
1
6
26
6
4
13
30
10
10
Note: Only pollutants of concern present in wastewater discharges are evaluated.
Source: Engineering and Analysis Division (EAD), August, 1997.
June 19, 1998
97
-------
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Frequency of Evaluated Pollutants from 52 BD Indirect Pharmaceutical Manufacturing
Facilities Which Discharge to 43 POTWS on 43 Receiving Streams
1 '
Pollutant Name
Number of Detections by Facility
ACETONE
AMMONIA as N
AMYL ACETATE, n-
CHLOROFORM
DIMETHYL SULFOXIDE
ETHYL ACETATE
ETHYLENE GLYCOL
FORMALDEHYDE
HEXANE, n-
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PHENOL
POLYETHYLENE GLYCOL 600
TOLUENE
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Note: Only pollutants of concern present in wastewater discharges are evaluated.
Source: Engineering and Analysis Division (BAD), August 1997.
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illllllil Illilli ll|llll||l|lh 11 Illlllilllllilllliili11IIII11I1I1II I ill il|llll|lll|ll|ll|ii ilullllH^^^^ i I
I nil I igi III11 ill iiiiiiiiiiii I iiiiiili nil iillin in 11 nil ill inn ill 1111II i inn 11 ill 111 in in I 1111111 in 111 nil inn inn ill I limn 11 inpi in 11 iiliiiiiiingiiinn I nil iilinnin niiini I liiiiiinnlin iinni nil I niiiinnniln^
In I
Table 25. Estimated Annual Human Health Benefits
From Cancer Risk Reductions
(1990 dollars)
I l i ' i i * i !ซซ ])| j ! !
!"l ! , I l J'" I I ',", i in ! [I'l'l'i' I I"! I
1 ( I
Number of Excess
Cancer Cases Avoided
1990 Value of Life
(millions of dollars)
TOTAL Monetized
Benefits
OWRule
Low
0.15
$1.9
$285,000
High
0.15
$10.2
$1,530,000
MACT Rule
Low
0.88
$1.9
$1,670,000
High
0.88
$10.2
$8,980,000
II "III
114
June 19, 1998
Ji!
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Table 27. Summary of Potential POTW Occupational Exposure Impacts
for Pharmaceutical Indirect Discharges
II .' ',; .-.:
t ' ; \ . .;.;
;f' i1 : V'i
4J 1 ;; i = -:*:
Jj: ; " : t; |
f ,' : , ! i , , "r .1
:'! "I1 , ' ' IJin "!
t'l1', ' ... 'I'"1,,!
, i n, ^ p. , , ,:i| ' ,,i
'f"! , , I,,., "'' V!;
^ ii i i \ '
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!!l!Ej!i!!!!!!i!!!!l!!!!!!!!!!!!!!i!!l!!!!!!!ii!!!I!!i:!!!!!!J:![!!p!!!!!!!!!!!!!!!!!!'I!!!i!!!!!!!",!l!!ih!i!r!
li,,,jj, . , ml, ',,,,,, . "'i!'",,;
jii'F,' , ; .O;V. , '.''L.
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1
'; v"l ' ,;' ' V -'
/-ป .
v^urrciiL
POTW
w/ Hazard Ratio > 1
Pollutants
w/Hazard Ratio > 1
Acetonitrile
Benzene
Chloroform
Diethylamine
Heptane, n-
Hexane, n-
Methylene Chloride
Toluene
Triethylamine
Pretreatment*
POTW
w/Hazard Ratio > 1
Pollutants
w/ Hazard Ratio > 1
-i
Acetonitrile
Benzene
Hexane, n-
v ', . ': ; ' :-', 'i '.
Total Number
73 .
14
9
4
i
2
1
5
3
7 ,
3
2
70/73
5
30
3
.
1
1
i '
Hazard Score Range
1.00 - 279
1.2 - 243
1.3 - 27
743
6.3 - 17
4.3
1.5-8.3
3.1-38
1.2-7.1
1.3-2.3
1.5 - 19
1.04-28.2
1.02-26.9
10 o/c n
.3 - zo.y
1.02
1.03
'! ',
ij!l<]l|ljlj jiA^
Note: Includes AC and BD Indirect Facilities
I,;,,., ' ,, ^ ' , ,ji';ปj; *' ; '"'j'" , , ' " ',
VersjogAugust, 1997 Loadings
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, . ! ' ',: ' i "', ;J!;; . r'j! , i1 1 'j,: ;:.;) .. '.!... .. ; -, '. .. , /;,;',;, ;:-' .,; , ij;..^.;,,-"", /; ;i;r .. ; :',-,;:, .',{'/,-;ซ,/'
|||||||||||||||||||||||||||||||||||||||||j|||||||||||iliiillilIllilJ!^ IlilKlllllilllilli!11!!!1!!!!!11;,!!!','! dlllllliinigjhiiilipllllllllljllP^lllllllllPlliliilll^ :;|!!!l!!!l!!!!!!!i!i||li||l|!li!lili:!!l!!!lllll|llll!l!||l!!lii!iijl
1 , . .'.'' ii .,;',!', '"''"'".,. '.ij "''.is',x , ,. .';,.' ,., , ! , ';":'" I1 ;i|v"- T..ซa to ' 1000 "
.ii :.- June ,19, 1998
ft!!! li
ms,
-------
Table 28. Estimated Annual Human Health Benefits
From CWA Rule Reductions in VOC Emissions
'(1990 dollars)
-
Dollar Value per Mg
VOC Emissions Reductions (Mg)
Monetized Benefits (excluding
byproduct emissions)
Excluding Ozone Mortality
(nonattainment areas)
$489
1,254
$613,000
Including Ozone Mortality
(all areas)
$2,212
3,608
$7,980,000
June 19,1998
117
-------
"" ' ; ' ITS'! !"T!1 ii!! i11!1!""!!11'1 TTTT7!! '"I rTHT !'!T'f! I1'!'1/""!! ! WT! ! ' I !""!! ""T1 ?! ! i [I ! 1]
, ,, J |n i^,'1' i ih !||nH||i|j j| rt | ,,1 11 i* ' ; ''! ,";,l ,! ,i ''','',,,, ' illlilih'1 "
Table 29. Estimated Annual Adverse Environmental Impacts
! i ; ! i i ] From CWA Rule Increases in SO2 Emissions
IKuS'S ' - ' I
Illlllllllll lliilillillllHII'
ll
:i.
,!!''
,''i,
,i
ii;:,
\
! r
Type of Mortality
Dollar Value per Mg
SO2 Emissions
Increases (Mg)
Adverse Monetized
Impacts (due to
increased emissions)
Eastern U.S.
Short-
term
$4,860
51.8
$252,000
Long-
term
$10,763
51.8
$558,000
Western U.S.
Short-
term
$3,516
0.3
$1,100
Long-
term
$4,194
0.3
$1,300
Total U.S.
Short-
term
52.1
$253,000
Long-
* " term
_-_
52.1
$559,000
', ' ' :". ' "-.',. . Jl'"',,"",' > i. ii,. w ;,' im " ''j"j' I
-------
Table 30. Total Monetized Benefits From CWA Rule Reductions in Ozone Precursors
Pollutant
VOC
- PM
S02
TOTAL
Monetized Benefits (1990 dollars)
Low
$613,000
-$216,000 '
-$559,000
-$162,000
High
$7,980,000
-$216,000
-$253,000
$7,510,000
June 19, 1998
119
-------
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Jijtl! I , ! j Table 31. Estimated Annual Human Health Benefits
From MACT Rule Reductions in VOC Emissions
(1990 dollars)
i
1
1
!|| I
l!1'! , i"
_ Illllll
1
Ill 1 1 (1
',: , I
||i:;.':. :!; ' .:
d; ; :,; ;; ; ^
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;[ , . . : ' ,-
Dollar Value per Mg
VOC Emission Reductions (Mg)
- Wastewater
- Storage Tanks
- Equipment Leaks
Monetized Benefits (excluding byproduct emissions)
- Wastewater
- Process Vents
- Storage Tanks
- Equipment Leaks
TOTAL Monetized Benefits
Excluding Ozone
Mortality
(nonattainment
areas)
$489
2,057
936
33
309
$1,010,000
$458,000
$16,100
$151,000
$1,640,000
Including Ozone
Mortality
(all areas)
$2,212
16,619
2,949
105
973
$36,800,000
$6,520,000
$232,000
$2,150,000
$45,700,000
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: ............ : .......... i ..... . k
nl*L~
r- ,i|
isi liii : slfcr3!tifcliSte
-------
Table 32. Estimated Annual Adverse Environmental Impacts
From MACT Rule Increases in SO2 Emissions
(1990 dollars)
Type of Mortality
Dollar Value per Mg
SO2 Emissions
Increases (Mg)
Adverse Monetized
Impacts (due to
increased emissions)
Eastern U.S.
Short-
term
$4,860
10.6
$51,500
Long-
term
$10,763
10.6
$114,000
Western U.S.
Short-
term
$3,516
0.4
$1,400
Long-
term
$4,194
0.4
$1,700
Total U.S.
Short-
term
11.0
$52,900
Long-
term
_-.
11.0
$116,000
June 19,1998
121
-------
^"^"w
"^^^gggj^^1 ^^^^^^^^^gj^g^ firom,,,MM^T,,,,Rule,,,Reductipns in Ozone Precursors 1'
* ' ! n'ji : ;; : i- j - r i : ; I ' " i :,= ; : i :;; ;;:: - ซ ; : j i ;! * '' ; - a ซt : ซป
j* i; ; : j11"" ; ; : ";:"{ "i" if ' ; ! ; 't ; >
!! ; ! !!'!"" ! ""!"!"
j jllJ i. ! ... ' ' ' '| '' I1''1
i i i . i> i . ! i
I ', r : ; ; : '7:': : ; : ; ':"
||: V',, v;i , ,>,; : ,,-.
if- :1 : : IT: ;:::
; ' :
-: .: v,,, ,r
ft* r: >.' " '?- .. '
IP : "', ' ' r: . ',', ;-
Pollutant
VOC
PM
SO2
TOTAL
i , ,.,. , 'H vli , , ., 1, , ,, , . * , ,i, ;.,: ', 'i1,1 ii, : 'ii,|:,i ], ,:,,,i ,, I1' :.,,,' , 'ปM , . J,,,', . ' > ,ป, .ป :'ซ., i ', *l
Monetized Benefits ($1990)
Low
$1,640,000
-$45,500
-$116,000
$1,480,000
ffigh
$45,700,000
-445,500
-$52,900
$45,600,000
ti 1 ''ih'i' 1 IHIH1'
Hfe/ ;4
h" li' I i I,!1'' ' '"' "l '" ' ' ' ''lill'l' '''l' " II " ll'l'li'1 ' ' l'l ' I I ' ''[' ' '''' i'ij '''"lli1'1'''''!! ' "ilh'll '''lil'" ',' ,' ' ''''
' ' ' !!^^ !!!!^ ' !!,ฃ^ - li!!!!^ !|lii^^ :
"""!-^^^^
i ,''.ii '''", isf; ,",i: fe J:!ijiijh:!;:,7,:;'i'i>:i
>,, i , ii June 19, 199
I'!;,,
ial ife^ il5!!::;i^ iiiN^
-------
Table 34. Potential Annual Economic Benefits for the Pharmaceutical Industry
From the CWA Final Effluent Guidelines and the CAA JvIACT Rule
(millions of 1990 dollars)
Benefits Category
Reduced Emissions of Ozone Precursors
Reduced Cancer Risk
Improved Environmental Conditions
Improved POTW Operations (Inhibition
and Sludge Contamination),
Occupational Conditions
Reduced Systemic Risk
TOTAL Monetized Benefits
Estimated Economic Benefit
CWA RULE
Low
-$0.162
'$0.285
$0.629
Unquantified
Unquantified
$0.752
High
$7.51
$i,sa
$2.24
Unquantified
Unquantified
$11.3
MACT RULE
Low
$1.48
$1.67
Unquantified
Unquantified
Unquantified
$3.15
High
$45.6
$8.98
Unquantified
Unquantified
Unquantified
$54.6
NOTE: CWA rule benefits include a portion of environmental monetized benefits that cannot be solely attributed to
the CWA rule ($285,000 - $1 million, $1990). Specifically, two facilities included in the modeling were
required to have MACT strippers and were also costed for additional strippers to meet the CWA effluent
guidelines. Overall removals due to these strippers cannot be differentiated between MACT and CWA
requirements.
1 '" ."'' " ' ' /
The MACT rule benefit values of reduced ozone precursor emissions from the wastewater plank include
adverse impacts related to increased energy consumption. Adverse impacts due to increased energy
consumption from control of the other planks are not quantified due to data limitations.
June 19,1998
123
-------
II
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55 55 35
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-------
Table 36. Toxicants Exhibiting Systemic and Other Adverse Effects*
Toxicant
Reference Dose Target Organs and Effects
Acetone
Increased liver and kidney weights and nephrotoxicity
Acetonitrile
Decreased red blood cell count, hepatic lesions
Butanol, 1-
Hypoactivity, ataxia
Chlorobenzene
Histopathologic changes in liver
Cyanide
Weight loss, thyroid effects, and myeline degeneration
Dichlorobenzene, 1,2-
Decfeased weight gain
Dichloromethane
Liver toxicity
Dimethylformamide, N,N-
Liver effects
Dimethylaniline, N,N-
Splenomegaly, increased splenic hemosiderosis and hematopoiesis
Ethyl acetate
Incresed mortality, decreased weight
Ethylene glycdl
Kidney toxicity
Formaldehyde
Reduced weight gain, histopathology
Hexane, n-
Neuropathy, atrophy of testis
Methanol
Increased SAP and SGPT, decreased brain weight
Methoxyethanol, 2-
Testicle effects
Methyl ethyl ketone
Decreased fetal birth weights
Vlethyl isobutyl ketone
Increased liver and kidney weight, lethargy (under review)
Phenol
Reduced fetal body weight in rats
Pyridine,
Increased liver weight
Tetrahydrofuran
jver dysfunction
Toluene
-hanges in liver and kidney weights
Trichloromethane
Fatty cyst formation in liver
Xylenes
Hyperactivity, decreased body weight, increased mortality (males)
* Chemicals with EPA verified or provisional human Health-based reference doses, referred to as "systemic
toxicants."
June 19,1998
125
-------
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illiii iiiiiii iiiili^^ i iiiiiiiiiiiiiiiiii i iiiiiii iili^ iiiiiiliv iiiiiiiiiiiiiiiiii^ Iiiiiii iiiiliiiiii iiiiliiiiii iiiliiiiili iiii i in iiiiliiiiii i in I iiiiiii i in nil ililiiil ipi ii in iiiiiiiiii in iiiiiiiiiiiiiiiiii iiiiiiil iiiiiliiiiliiiliilliiiv in iiiiilliililiiillliii in 1 i iiiiiii i iliiilii iiiliiiiili i illli|ip ili|i|i|lliii iililiiii||il I
Table 37. ^-luman Carcinogens Evaluated, Weight-of-Evidence Classifications, and Target Organs
hll'l I I i
fill I I |
fS
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1
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I n
Carcinogen
1 ,2-Dichloroethane
1,4-Dioxane
Aniline
Benzene
Formaldehyde
Methylene Chloride
Trichloromethane
Weight-of-Evidence Classification
B2
B2
B2
A
Bl
B2
B2
Target Organs
Circulatory system
Liver and gall bladder
Spleen
Blood
Nasal cavity
Liver and lung
Liver, kidney
A ป Human Carcinogen
Bl = Probable Human Carcinogen (limited human data)
B2 = Probable Human Carcinogen (animal data only)
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Priority organic pollutants in receiving
wastewaters from pharmaceutical facilit
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High concentration of VOCs in receiving
wastewaters from pharmaceutical faciliti
H
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Bergen County Util
Authority
Little Ferry, New J
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High concentration of priority pollutants
chloroform, methylene chloride, toluene
well as non-priority pollutants such as
tetrahydrofuran, thiobismethane, trimeth
silanol, hydrogen sulfide, and dimethyl
disulflde in receiving wastewater from
pharmaceutical facility.
&
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1 East Hanover TWP"
New Jersey
.
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Toluene in receiving water.
13
3
i
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OH OH
Kalamazoo, Michig;
Portage Creek
>
13
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Q>
s ci
OH C,
a
C3 0
CQ U
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Puerto Rico Aquedui
Sewer Authority
Barceloneta, Puerto
127
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three workers complained of burnin
and itching about 15-30 minutes aftei
exposure to SB dust, which lasted fo:
approximately 45 - 120 minutes. Th
workers developed transient urticaria
related to skin contamination with SF
1
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In 1988, sewage service discontir
due to high concentrations of
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5. REFERENCES
American Conference of Governmental Industrial Hygienists (ACGIH). 1995-1996. Threshold
Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices
Cincinnati, Ohio. ACGIH.
Fisher, A; L. Chestnut; and D. Violette. 1989. "The Value of Reducing Risks of Death: A Note
on New Evidence. * Journal of Policy Analysis and Management, Vol. 8, No. 1.
Fisher, A; and R. Raucher. 1984. "Intrinsic Benefits of Improved Water. .Quality: Conceptual
and Empirical Perspectives." Advances in Applied Micro-Economics, Vol. 3.
Howard, P.H. Editor. 1991. Handbook of Environmental Degradation Rates. Chelsea, MI- Lewis
Publishers, Inc. . '
Knight-Ridder Information. 1993-1994. Knight-Ridder Information Database - DIALOG Knight-
Ridder Information, Inc., Palo Alto, CA. ' .
Krupnick, AJ; and R. Kopp. 1988. "The Health and Agricultural Benefits of Reductions in
Ambient Ozone in the United States." Resources for the Future, Discussion Paper QE88-10.
Lyke, A. 1993. "Discrete Choice Models to Value Changes in Environmental Quality: A Great
Lakes Case Study." Thesis submitted in partial fulfillment of the requirements for the degree of
Doctor of Philosophy (Agricultural Economics) at the University of Wisconsin-Madison.
Lyman, W.J.; W.F. Reehl; and D.H. Rosenblatt. 1982. Handbook of Chemical Property
Estimation Methods - Environmental Behavior of Organic Compounds New York NY-
McGraw-Hill Book Company. " ' *
Metcalf & Eddy, Inc. 1972, Wastewater Engineering. New York, NY: McGraw-Hill Book
Company.
National Oceanic and Atmospheric Administration and U.S. Environmental Protection Agency
1989a. Strategic Assessment of Near-Coastal Waters. "Susceptibility of East Coast Estuaries to
Nutrient Discharges: Albemarle/Pamlico Sound to Biscayne Bay." Rockville MD- Strategic
Assessment Branch. NOAA.
National Oceanic and Atmospheric Administration and U.S. Environmental Protection Agency
1989b. Strategic Assessment of Near Coastal Waters. "Susceptibility of East Coast Estuaries to
Nutrient Discharges: Passamaquoddy Bay to Chesapeake Bay." Rockville, MD- Strategic
Assessment Branch. NOAA.
R-l
-------
ii" in i
TII
hi I1!,
i If,
ii'MI i"
"15 r
National Oceanic and Atmospheric Administration and U.S. Environmental Protection Agency.
1989c. Strategic Assessment of Near Coastal Waters. "Susceptibility and Status of Gulf of
Mexico Estuaries to Nutrient Discharges." Rockville, MD: Strategic Assessment Branch.
NOAA.
II, I
Ii
iป
National Oceanic and Atmospheric Administration and U.S. Environmental Protection Agency.
1991. Strategic Assessment of Near Coastal Waters. "Susceptibility and Status of West Coast
llE^ltuaries,^^]^:!^ Discharges: San Diego Bay to Puget Sound." Rockville, MD: Strategic
Assessment Branch. NOAA.
Radian Corporation. 1993. "Summary of POTW Survey Responses." Memorandum to Frank
Sund and Ed Terry, U.S. EPA Office of Water, Engineering and Analysis Division from Kirsten
I || Mahsman, "Radian Corporation, 15 November.
1! ' '
Shortle, J.S; M. Phillips; and J. Dunn. 1988. "Economic Assessment of Crop Damages Due
to Air Pollution: The Role of Quality Effects." Environmental Pollution, 53:377-385.
i i 'i 11 ' m ^ J , i i iii ,1
'i i i ii j i i I i i , i ' i 11 i , I i. i, 111 i i i ' i i ' i i '
Turner, D.B. 1970. Workbook of Atmospheric Dispersion Estimates. Research Triangle Park,
NC: U.S. Environmental Protection Agency, Office of Air Programs.
i i
ii i in
i-
U.S. Bureau of the Census. 1995. Statistical Abstract of the United States: 1995. Washington,
DC: U.S. Bureau of the Census.
ri i lilili ( lii||l||| in i i III i i in ill HI ill ll| li il ( i i n i in i in 11 | in i n (in ill in l \ n mil up Mill i|i liii|ii|lililill||||
i I 11
U.S. Department of the Interior Fish and Wildlife Service. 1991. National Survey of Fishing, "
Hunting and "Wildlife Associated Recreation.
IE
If;"
II i
U.ง.,iiEjrvuj>nm,entalProtection.Agency. 1980. Ambient Water Quality Criteria Documents.
.Washington, DC: U.S." EPA, Office of Water. EPA 440/5-80 Series^ "[Also refers to any updated
criteria 'documents'''(EPA 440/5-85"and EPA 440/5-87' Series)] ^
,'"1 ""' ( ^ ; |(
i",": '' ,!! VI ' ' ',' ','" , ' i '
U.S. Envkpnmental Protection Agency. 1982. Fate of Priority Pollutants in Publicly-Owned
tmenl 'Wwjks 150 POTW Study." Washington, DC: U.S. EPA, Office of Water.
EPA 440/1-82/303.
U.S. Enytfpnmental Protection Agency. 1986. Report to Congress on the Discharge of Hazardous
'''>- 'Washington, DC:"ll.S."
EPA, Office of Water Regulations and Standards.
1 11
Jl
J^i ,!! ii,j : ; si : , jtw ; ,,.; ,,: ;ir ; & .- ;M : :,g ,1- ; ฃi| &&& : , 1 <^U, i i-i-l i 4*lii I It m
^ ^^^ ^___^ ^__ g___ f/5Q Dispersion
^ Washington, DC:""W-S."Environmental
Dan sSSardsI 'EPA-450/4-88-00:2Z
^1131 ....... 'Environmental .......
....... : ........
e Manucor reventin
ll!lll!l!l!llll!!EII!llll'!'!!!!!!!!!!!!!!!!!!!!!!!!!!! :!!!!!::':!!!!!!!!!!!!!,!l!!:!!!!!!!!!!!!!'!!!!!,!!!!!!!!!!!!!!!!!!:!!!!!!!!!:!!!!!!!::!!!l!!!!!!!!!!!!:!!!!!!!!!!!!!!l!' ITIIIIIIIIIrtllllll'I'T'lllTllllillllll'TII;!,:!;!"!!: ilSllllTSlllir,,;;:"!1!*:" I
,:,! i, ! -iiij f,,, I, nituhiiill,! \:\^M ,|!iji.i; Li',,-i j|,,;|,!|
iii^ii^
i^^
-------
U.S. Environmental Protection Agency. 1989a. Exposure Factors Handbook. Washington/DC:
U.S. EPA, Office of Health and Environmental Assessment. EPA/600/8-89/043.
U.S. Environmental Protection Agency. 198%. Risk Assessment Guidance for Superfund (RAGS),
Volume I, Human Health Evaluation Manual (Pan A). Washington, DC: U.S! EPA, Office of
Emergency and Remedial Response. EPA/540/1-89/002. Available from NTIS, Springfield VA
PB-90-155581. ' '
U.S. Environmental Protection Agency. 1989c. Toxic Chemical Release Inventory - Risk Screening
Guide. Washington, DC: U.S. EPA, Office of Pesticides and Toxic Substances. EPA/560/2-89-
002.
U.S. Environmental Protection Agency. 1990a. CWA Section 308 Pharmaceutical Questionnaire
Washington, DC: U.S. EPA, Office of Water, Engineering and Analysis Division.
U.S. Environmental Protection Agency^ 1990b. GAMS Version 3.0 - User's Guide. Washington,
DC; U.S. Environmental Protection Agency, Office of Pesticides and Toxic Substances. Exposure
Evaluation Division. EPA Contract No. 68-02-4281. GSC TR-32-90-010.
U.S. Environmental Protection Agency. 1990c. CERCLA Site Discharges to POTWs: Guidance
Manual. Washington, DC: U.S. EPA, Office of Emergency and Remedial Response
EPA/540/G-90/005. "
U.S. Environmental Protection Agency. 1990d. National Water Quality Inventory - Report to
Congress. Washington, DC: U.S. EPA, Office of Water.
U.S. Environmental Protection Agency. 1991a. Technical Support Document for Water Quality-
Based Toxics Control. Washington, DC: U.S. EPA, Office of Water. EPA/505/2-90-001
Available from NTIS, Springfield, VA. PB91-127415.
U.S. Environmental Protection Agency. 1991b. National 304(1) Short List Database. Compiled
from Office of Water Files dated April/May 1991. Washington, DC: U.S. EPA, Office of Water.
U.S. Environmental Protection Agency. 1992a. Mixing Zone Dilution Factors for New Chemical
Exposure Assessments, Draft Report, October 1992. Washington, DC: U.S. EPA, Contract No
68-D9-0166. Task No. 3-35.
U.S. Environmental Protection Agency. 1992b. Guidance to Protect POTW Workers from Toxic
and Reactive Gas and Vapors. Washington, DC: U.S. Environmental Protection Agency, Office
of Water. EPA 812-B-92-001. Available from NTIS, Springfield, VA. PB92-173-236.
U.S. Environmental Protection Agency. 1992c. NEEDS Survey. Washington, DC: U.S. EPA,
Office of Wastewater Enforcement and Compliance.
R-3
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i
: ..... U.S. ..... Environment
ji,,'1!-,!'' '' ""'.' ..... '.i''ซi,' ,: ..... .lillift'Y til!*. !": " . '" .MJ],,,1!, /, :,,t' In*",' "I ......... ,,!, ', V, ^. *, ,,-, 7,Mi, - - , .:!> ...... -.,.1 ...... ซ, ,
]^
Rsearich range
Protectipn Agency, Office of Air Quality Planning and Standards.
" ; ' "'!' ' '' ?"<" ' "' 'iji'lji' ' '''" ' .' ' i"' , '!' ni'"' V 'ป ""' ' ' ' " I'.' V''1'1' ''"' '' , ' ' ''' '?'' '"'" " ' ' ' I..'1' ',' ' "',,'' "!: ': '"', ' Y'i''11 ':'l|i'!
jij,,!,.,,', ; i : ,' .ij i, \f,\\:':\if\ i/ ... . H, f ' ',! , ,ป: '; ' ',i,'!, ''',, '",| , '!'-' ',!," ' ',: . '.,,:.,, , . 'i'1!:'! ', ' ,',' / .. !:!'"' /?: ./,' , ''v j'' '': '.- .,,',:''!,' ''' !!.'.!'!', HI', 'i'1?- ; "'.'/[ "''!ป
' f *!$: ^^ฃฐWent^ ,Pf'ฐlf^9n, ,r,Asency-' ' 1^^3c.'' Pharmaceutical' Outreach" Questionnaire."
^^^^ton, pC:''''U^S. ''^vkomnental'lProtection ^Agency.'!' EPA 'Cbntract"Nb.''' IS-CO^CJSl
199- 994a
1993-1994b PermitCojnpKance Sstem. Washington,
pntal Protection Agency. 1993-1994c. Gage File. Washington, DC: U.S. EPA,
^iOfriceofWetl'Mds, Oceans'and Watershed's. ' ' " " ' '
''if;' ', ; , ;,"!'"! ' '.'...', ;:!l!;., N ^ . "|.i'i':ji!j|!l|lij1 J , ' .. .,,; , ' i, '' ^ , ; i",j | ", "" ซ..' ' <| i.i||h . , i "..""a! . ,, [" " ' .,, ' "", '," """ " ' iij'"?!1'1,,1 '' , '!""" ,,'' '' T1""" ,i' " ! '''' '' '" '""j ' ' ,"' ' '!'" 1:l*|l1,1 '"";"" ,
5:i:": !:: ;; ; : ' >' ||: '^ ::;:: ::; ; ' !: ; ::::::i ฃ Fi ; '; ::P ;:: : i: \ ::: ^rr^. ^^ "?:: ^i^1*^ ?::=:;i: S !:?:; ^ ' ^ ::::: ::;: ::; :if |;| i|::|!l
|j:U.S. finvu-gnjngnlal Projection,Agency. 1994. Superfimd Chemical Data Matrix. Washington,
;l;i:
CjochipaEC oTiio: UlS'I gpA'^ Qig^g oTResear^ and DevelopnienE
':: ^::,^:M, *1_1 : :,! ;.J "i;: Jtlijfci ::!|:,:4i:i; :4Kt '^3 jii,,,:;:,;,:;: :,; ; L: :,: fft^..
. ; .. '. . , .', .. ' ;;, . ; .Jdf*1 , :, :; ,.. . : " .,;.-,: i ' ,.. '\.;\ ,::,
_ _._._.. A.gency. 1995b. Standards for the Use or Disposal of Sewage
?: Final Rules. 40CFRPart503. W October 25, 19951
||||.S., iEnvJronmgn|al, ftotection Agency. 1995c. Regulatory^ jmpact^ Anafysis_ ^Proposed Effluent
..,,,,, ^ ,f ^ ^ "-"Guidelines a^'^iandards^orThe Metal products and^ Machine^ Jndustry^ '"' ~~ ~ r:"
! it -
^
l ashngton c: U'EPAOffice of Water..'' Ep-x/ฃ2l'-R-95-023 ^
Ejm^onrneri{al jProtectiQn Agency. l996a. Retirements for Preparation, Adoption, and
" Fart' 5L WasBjogtooC ฃ>C: '"
Register. October 8, 1996.
^nyjjonmental fJjrojgctioj^S6^^ I996b. Review of the National Ambient Air' Quality
: Policy Assessment of iScientific and Technical Information.
r. Research Triangle Park, NC: Office of Air' Quality Planning and Standards.
Protection Agency'. 'l996c.' "'PATHSCAtf."Washington,'''!): '^U.S."'EPA'11'
eฃ WQAB ^Interactive Procedure.
-------
U.S. Environmental Protection Agency. 1996d. Drinking Water Supply (DWS) File. Washington,
DC: U.S. EPA, Office of Wetlands, Oceans and Watersheds.
U.S. Environmental Protection Agency. 1996e. Federal Reporting Data System (FRDS)
Washington, DC: U.S. EPA, Office of Ground Water and Drinking Water.
U.S. Environmental Protection Agency. 1997a. "Benefit-Transfer Analysis for Pulp and Paper."
Memorandum to Lisa Connor, U.S. Environmental Protection Agency, Office of Air Quality
Planning and Standards (OAQPS) from Michele McKeever, OAQPS, 5 November.
U.S. Environmental Protection Agency. 1997b. Regulatory Impact Analyses for the Paniculate
Matter and Ozone National Ambient Air Quality Standards and Proposed Regional Haze Rule.
Research Triangle Park, NC: Office of Air Quality Planning and Standards.
U.S. Environmental Protection Agency. 1997c. Pharmaceutical Manufacturing Pollutant Loading
Files. Washington, DC: U.S. EPA, Office of Water, Engineering and Analysis Division.
U.S. Environmental Protection Agency. 1997d. Aerometric Information Retrieval System (AIRS)
Air Quality Subsystem (AQS). Research Triangle Park, NC: U.S. Environmental Protection
Agency, Office of Air Quality Planning and Standards.
U.S. Environmental Protection Agency. 1997e. Greenbook Homepage: www.epa.gov/
oar/oaqps/greenbk. Research Triangle Park, NC: U^S. Environmental Protection Agency, Office
of Air Quality Planning and Standards.
- " "V _
U.S. Environmental Protection Agency. 1998. MACT Process Vents, Storage Tanks, and
Equipment Leaks Loading Files. Research Triangle Park, NC: U.S. Environmental Protection
Agency, Office of Air Quality Planning and Standards.
Versar, Inc. 1992. Upgrade of Flow Statistics Used to Estimate Surface Water Chemical
Concentrations for Aquatic and Human Exposure Assessment. Report prepared by Versar Inc. for
the U.S. EPA, Office of Pollution Prevention and Toxics.
Violette, D., and L. Chestnut.-1986. Valuing Risks: New Information on the Willingness to Pay
for Changes in Fatal Risks. Report to the U.S. EPA, Washington, DC Contract No
68-01-7047. '
Viscusi, K. 1992. Fatal Tradeoffs: Public & Private Responsibilities for Risk. New York, NY:
Oxford University Press.
Walsh, R.; D. Johnson; and J. McKean. 1990. "Nonmarket Values from Two Decades of
Research on Recreational Demand." Advances in Applied Micro-Economics, Vol. 5.
R-5
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