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'-

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         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

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  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

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          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

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      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':'
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  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

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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

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 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

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                  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

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  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)

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        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.

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        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)

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          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

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("..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

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        *     ,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    '   •        . .  ••

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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

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 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
                expensive—on 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                   :

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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

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        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

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        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    \     '•        ••         '

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 "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^™^', ^ w™3^0^ /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

-------
 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

-------
                                   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                                  , •

-------
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

-------
 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

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                                  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

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             '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

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|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

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  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^^^^^

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 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


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                                                                                    •                  '                          ~~

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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
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                                        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
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-------
  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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                                    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	

-------
 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/


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  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	
                                             i iiiii	i	i

-------
        (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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                     	"I	!	I	l<	I	
                                                            	in	i	
                                                             iiiiiiii	in	i	ij	i	P	i	I	if	
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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                                                                         iiii

-------
 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_ .?5e™5^.:  .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

-------

                                                                                                     	1	ii:	:=	',	i
          ;;;,;;;; i	;;;;	4.2.IS3	JMG
   !^^                             	^^^^^^^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
   !!sป
   iiiiaiimim^^^^^
   	iii'iTnibiiR, i1 iiii|iiiiiซpiiillpiiii VIIHI^    	ijiuiiun
                                                                                           	I	HIIUII'IPIIIIIII < ''l|W^^^^^
                                                                                   iM	
                                                                                 liiH^^^^^	
                                                                                                        .	i	- 	illi
                        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
                                                      Ml III IIIIIII I III
                                                                                                   IIIIIIIIIIllllllllllillI IIIIIII
                                                                                                      I,	

-------
 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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                                                                                           I1
                                                                                       n ill i iiiiiiiiiipii in
      ,"  i    "I,'  P
n i n n nil i i 11 Inn n nil in in i in n ininnnnl i in ^
                    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
                                                                                                                            -	:	:	!	lif
       'ilia	ill	4i	iiiifiitof	iiiiiii I
       	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

           IซE^^^^^^^^^^^^^^^^^


                                                                                  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

-------

                                                          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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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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        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
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  DIMETHYTLACETAMIDE, N,N
  DIMETHYLFORMAMIDE, N,N
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  ETHYLENE GLYCOL
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  ISOPROPYL ETHER
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  METHYL FORMATE
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  METHYLENE CHLORIDE
  PHENOL
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  TETRAHYDROFURAN
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30
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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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                         Pollutant Name
                                                               Number of Detections by Facility
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                                              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 ' ; \ . .;.;
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Pollutants
w/Hazard Ratio > 1
Acetonitrile
Benzene
Chloroform
Diethylamine
Heptane, n-
Hexane, n-
Methylene Chloride
Toluene
Triethylamine
Pretreatment*
POTW
w/Hazard Ratio > 1
Pollutants
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• -i
Acetonitrile
Benzene
Hexane, n-
•v ', ••. • ': ;• ' •:-', 'i 	 '.


Total Number




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3


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1.00 - 279
1.2 - 243
1.3 - 27
743
6.3 - 17
4.3
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3.1-38
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                                                                                                                           .ii	:.-	June ,19, 1998

                                                                            	
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-------
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]
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                                    Table 29.  Estimated Annual Adverse Environmental Impacts

!	i	;	!	i	i	]	•	From CWA Rule Increases in SO2 Emissions



                              IKuS'S                                      	•                    '  -            	        '•            I
Illlllllllll 	 lliilillillllHII'
	 ll
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\
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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; 	 	 ; 	 :,; 	 ;; 	 ; 	 ^

M^^^^
;•[ , . . : ' ,-
•
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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-------
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 	 ; 	 > 	
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j jllJ i. ! ... ' ' ' '| '' I1''1
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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'" ',' ,' '  ''''


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                                                                                                	>,,	i	,	ii	June 19, 199

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              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

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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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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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homes evacuated and 21 people
hospitalized. In 1991, 7 spills oc
over 3-month period. Nearby
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                                   5. REFERENCES


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                      Jl	
J^i	,!!	ii,j	:	;	si	:	,	jtw	;	,,.;	,,:	;ir	;	&	.-	;M	:	:,g	,1-	;	ฃi|	&&&	:	,	1	<^U,	i	i-i-l	i	4*lii	I	It	m
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             ^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^^


-------
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Office of Wastewater Enforcement and Compliance.
                                        R-3

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                        i
                                                                                     : ..... U.S. ..... Environment
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