LETTER_ID FILE_NAME DOCKET_NUMBER EPA_LETTER_ID

6502 EPA-HQ-OW-2007-1189-0048.pdf EPA-HQ-OW-2007-1189-0048 0048

6503 EPA-HQ-OW-2007-1189-0049.pdf EPA-HQ-OW-2007-1189-0049 0049

6081 EPA-HQ-OW-2007-1189-0051.pdf EPA-HQ-OW-2007-1189-0051 0051

6504 EPA-HQ-OW-2007-1189-0052.pdf EPA-HQ-OW-2007-1189-0052 0052

6505 EPA-HQ-OW-2007-1189-0053.pdf EPA-HQ-OW-2007-1189-0053 0053

6506 EPA-HQ-OW-2007-1189-0054.pdf EPA-HQ-OW-2007-1189-0054 0054

6533 EPA-HQ-OW-2007-1189-0055.pdf EPA-HQ-OW-2007-1189-0055 0055

6507 EPA-HQ-OW-2007-1189-0057.pdf EPA-HQ-OW-2007-1189-0057 0057

6508 EPA-HQ-OW-2007-1189-0058.pdf EPA-HQ-OW-2007-1189-0058 0058

6509 EPA-HQ-OW-2007-1189-0060.pdf EPA-HQ-OW-2007-1189-0060 0060

6510 EPA-HQ-OW-2007-1189-0061.pdf EPA-HQ-OW-2007-1189-0061 0061

6511 EPA-HQ-OW-2007-1189-0062.pdf EPA-HQ-OW-2007-1189-0062 0062

6561 EPA-HQ-OW-2007-1189-0063.pdf EPA-HQ-OW-2007-1189-0063 0063

6512 EPA-HQ-OW-2007-1189-0064.pdf EPA-HQ-OW-2007-1189-0064 0064

6513 EPA-HQ-OW-2007-1189-0065.pdf EPA-HQ-OW-2007-1189-0065 0065

6514 EPA-HQ-OW-2007-1189-0066.pdf EPA-HQ-OW-2007-1189-0066 0066

6515 EPA-HQ-OW-2007-1189-0067.pdf EPA-HQ-OW-2007-1189-0067 0067

6516 EPA-HQ-OW-2007-1189-0068.pdf EPA-HQ-OW-2007-1189-0068 0068

6517 EPA-HQ-OW-2007-1189-0069.pdf EPA-HQ-OW-2007-1189-0069 0069

6518 EPA-HQ-OW-2007-1189-0070.pdf EPA-HQ-OW-2007-1189-0070 0070

6519 EPA-HQ-OW-2007-1189-0071.pdf EPA-HQ-OW-2007-1189-0071 0071

6520 EPA-HQ-OW-2007-1189-0072.pdf EPA-HQ-OW-2007-1189-0072 0072

6521 EPA-HQ-OW-2007-1189-0073.pdf EPA-HQ-OW-2007-1189-0073 0073

6522 EPA-HQ-OW-2007-1189-0074.pdf EPA-HQ-OW-2007-1189-0074 0074

6523 EPA-HQ-OW-2007-1189-0075.pdf EPA-HQ-OW-2007-1189-0075 0075

6524 EPA-HQ-OW-2007-1189-0076.pdf EPA-HQ-OW-2007-1189-0076 0076

6082 EPA-HQ-OW-2007-1189-0077.pdf EPA-HQ-OW-2007-1189-0077 0077

6525 EPA-HQ-OW-2007-1189-0078.pdf EPA-HQ-OW-2007-1189-0078 0078

6526 EPA-HQ-OW-2007-1189-0079.pdf EPA-HQ-OW-2007-1189-0079 0079

6527 EPA-HQ-OW-2007-1189-0080.pdf EPA-HQ-OW-2007-1189-0080 0080

6530 EPA-HQ-OW-2007-1189-0083.pdf EPA-HQ-OW-2007-1189-0083 0083

6531 EPA-HQ-OW-2007-1189-0084.pdf EPA-HQ-OW-2007-1189-0084 0084

6532 EPA-HQ-OW-2007-1189-0085.pdf EPA-HQ-OW-2007-1189-0085 0085

6562 EPA-HQ-OW-2007-1189-0086.pdf EPA-HQ-OW-2007-1189-0086 0086

6083 EPA-HQ-OW-2007-1189-0087.pdf EPA-HQ-OW-2007-1189-0087 0087

6534 EPA-HQ-OW-2007-1189-0088.pdf EPA-HQ-OW-2007-1189-0088 0088

6535 EPA-HQ-OW-2007-1189-0089.pdf EPA-HQ-OW-2007-1189-0089 0089

6536 EPA-HQ-OW-2007-1189-0090.pdf EPA-HQ-OW-2007-1189-0090 0090

6537 EPA-HQ-OW-2007-1189-0091.pdf EPA-HQ-OW-2007-1189-0091 0091

6538 EPA-HQ-OW-2007-1189-0092.pdf EPA-HQ-OW-2007-1189-0092 0092

6563 EPA-HQ-OW-2007-1189-0093.pdf EPA-HQ-OW-2007-1189-0093 0093

6564 EPA-HQ-OW-2007-1189-0094.pdf EPA-HQ-OW-2007-1189-0094 0094

6539 EPA-HQ-OW-2007-1189-0095.pdf EPA-HQ-OW-2007-1189-0095 0095

6540 EPA-HQ-OW-2007-1189-0096.pdf EPA-HQ-OW-2007-1189-0096 0096

6541 EPA-HQ-OW-2007-1189-0098.pdf EPA-HQ-OW-2007-1189-0098 0098

6542 EPA-HQ-OW-2007-1189-0099.pdf EPA-HQ-OW-2007-1189-0099 0099
6586 EPA-HQ-OW-2007-1189-0100.pdf EPA-HQ-OW-2007-1189-0100 0100

6543 EPA-HQ-OW-2007-1189-0101.pdf EPA-HQ-OW-2007-1189-0101 0101

6544 EPA-HQ-OW-2007-1189-0102.pdf EPA-HQ-OW-2007-1189-0102 0102

6545 EPA-HQ-OW-2007-1189-0103.pdf EPA-HQ-OW-2007-1189-0103 0103

6546 EPA-HQ-OW-2007-1189-0104.pdf EPA-HQ-OW-2007-1189-0104 0104

6547 EPA-HQ-OW-2007-1189-0105.pdf EPA-HQ-OW-2007-1189-0105 0105

6565 EPA-HQ-OW-2007-1189-0106.pdf EPA-HQ-OW-2007-1189-0106 0106

6566 EPA-HQ-OW-2007-1189-0107.pdf EPA-HQ-OW-2007-1189-0107 0107

6567 EPA-HQ-OW-2007-1189-0108.pdf EPA-HQ-OW-2007-1189-0108 0108

6568 EPA-HQ-OW-2007-1189-0110.pdf EPA-HQ-OW-2007-1189-0110 0110

6569 EPA-HQ-OW-2007-1189-0112.pdf EPA-HQ-OW-2007-1189-0112 0112

6570 EPA-HQ-OW-2007-1189-0113.pdf EPA-HQ-OW-2007-1189-0113 0113

6548 EPA-HQ-OW-2007-1189-0114.pdf EPA-HQ-OW-2007-1189-0114 0114

6549 EPA-HQ-OW-2007-1189-0115.pdf EPA-HQ-OW-2007-1189-0115 0115

6550 EPA-HQ-OW-2007-1189-0116.pdf EPA-HQ-OW-2007-1189-0116 0116

6571 EPA-HQ-OW-2007-1189-0118.pdf EPA-HQ-OW-2007-1189-0118 0118

6551 EPA-HQ-OW-2007-1189-0119.pdf EPA-HQ-OW-2007-1189-0119 0119

6552 EPA-HQ-OW-2007-1189-0120.pdf EPA-HQ-OW-2007-1189-0120 0120

6553 EPA-HQ-OW-2007-1189-0122.pdf EPA-HQ-OW-2007-1189-0122 0122

6554 EPA-HQ-OW-2007-1189-0123.pdf EPA-HQ-OW-2007-1189-0123 0123

6572 EPA-HQ-OW-2007-1189-0124.pdf EPA-HQ-OW-2007-1189-0124 0124

6555 EPA-HQ-OW-2007-1189-0126.pdf EPA-HQ-OW-2007-1189-0126 0126

6556 EPA-HQ-OW-2007-1189-0127.pdf EPA-HQ-OW-2007-1189-0127 0127

6573 EPA-HQ-OW-2007-1189-0128.pdf EPA-HQ-OW-2007-1189-0128 0128

6557 EPA-HQ-OW-2007-1189-0129.pdf EPA-HQ-OW-2007-1189-0129 0129

6574 EPA-HQ-OW-2007-1189-0130.pdf EPA-HQ-OW-2007-1189-0130 0130

6575 EPA-HQ-OW-2007-1189-0131.pdf EPA-HQ-OW-2007-1189-0131 0131

6576 EPA-HQ-OW-2007-1189-0132.pdf EPA-HQ-OW-2007-1189-0132 0132

6558 EPA-HQ-OW-2007-1189-0133.pdf EPA-HQ-OW-2007-1189-0133 0133

6577 EPA-HQ-OW-2007-1189-0134.pdf EPA-HQ-OW-2007-1189-0134 0134

6578 EPA-HQ-OW-2007-1189-0135.pdf EPA-HQ-OW-2007-1189-0135 0135

6579 EPA-HQ-OW-2007-1189-0136.pdf EPA-HQ-OW-2007-1189-0136 0136

6580 EPA-HQ-OW-2007-1189-0137.pdf EPA-HQ-OW-2007-1189-0137 0137

6581 EPA-HQ-OW-2007-1189-0138.pdf EPA-HQ-OW-2007-1189-0138 0138

6084 EPA-HQ-OW-2007-1189-0139.pdf EPA-HQ-OW-2007-1189-0139 0139

6582 EPA-HQ-OW-2007-1189-0140.pdf EPA-HQ-OW-2007-1189-0140 0140

6583 EPA-HQ-OW-2007-1189-0141.pdf EPA-HQ-OW-2007-1189-0141 0141

6584 EPA-HQ-OW-2007-1189-0142.pdf EPA-HQ-OW-2007-1189-0142 0142

6585 EPA-HQ-OW-2007-1189-0145.pdf EPA-HQ-OW-2007-1189-0145 0145

6587 EPA-HQ-OW-2007-1189-0146.pdf EPA-HQ-OW-2007-1189-0146 0146

6588 EPA-HQ-OW-2007-1189-0147.pdf EPA-HQ-OW-2007-1189-0147 0147

6601 EPA-HQ-OW-2007-1189-0148.pdf EPA-HQ-OW-2007-1189-0148 0148

6602 EPA-HQ-OW-2007-1189-0149.pdf EPA-HQ-OW-2007-1189-0149 0149

6603 EPA-HQ-OW-2007-1189-0150.pdf EPA-HQ-OW-2007-1189-0150 0150

6604 EPA-HQ-OW-2007-1189-0151.pdf EPA-HQ-OW-2007-1189-0151 0151

6605 EPA-HQ-OW-2007-1189-0152.pdf EPA-HQ-OW-2007-1189-0152 0152

6606 EPA-HQ-OW-2007-1189-0153.pdf EPA-HQ-OW-2007-1189-0153 0153
6607 EPA-HQ-OW-2007-1189-0154.pdf EPA-HQ-OW-2007-1189-0154 0154

6608 EPA-HQ-OW-2007-1189-0155.pdf EPA-HQ-OW-2007-1189-0155 0155

6609 EPA-HQ-OW-2007-1189-0156.pdf EPA-HQ-OW-2007-1189-0156 0156

6610 EPA-HQ-OW-2007-1189-0157.pdf EPA-HQ-OW-2007-1189-0157 0157

6611 EPA-HQ-OW-2007-1189-0158.pdf EPA-HQ-OW-2007-1189-0158 0158

6612 EPA-HQ-OW-2007-1189-0159.pdf EPA-HQ-OW-2007-1189-0159 0159

6613 EPA-HQ-OW-2007-1189-0160.pdf EPA-HQ-OW-2007-1189-0160 0160

6614 EPA-HQ-OW-2007-1189-0161.pdf EPA-HQ-OW-2007-1189-0161 0161

6615 EPA-HQ-OW-2007-1189-0162.pdf EPA-HQ-OW-2007-1189-0162 0162

6616 EPA-HQ-OW-2007-1189-0163.pdf EPA-HQ-OW-2007-1189-0163 0163

6621 EPA-HQ-OW-2007-1189-0164.pdf EPA-HQ-OW-2007-1189-0164 0164

6641 EPA-HQ-OW-2007-1189-0165.pdf EPA-HQ-OW-2007-1189-0165 0165

8582 EPA-HQ-OW-2007-1189-0166.pdf EPA-HQ-OW-2007-1189-0166 0166

8583 EPA-HQ-OW-2007-1189-0167.pdf EPA-HQ-OW-2007-1189-0167 0167
EPA_LETTER_ID LETTER_ID LINE_NUMBER

0051 6081 1

0051 6081 2

0051 6081 3

0051 6081 4

0051 6081 5

0051 6081 6

0051 6081 7

0051 6081 8

0051 6081 9

0051 6081 10

0051 6081 11

0051 6081 12

0051 6081 13

0051 6081 14

0051 6081 15

0051 6081 16

0051 6081 17

0051 6081 18

0051 6081 19

0051 6081 20

0051 6081 21

0051 6081 22

0051 6081 23

0051 6081 24

0051 6081 25

0051 6081 26

0051 6081 27

0051 6081 28

0051 6081 29

0051 6081 30

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0051 6081 33

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0051 6081 35

0051 6081 36

0051 6081 37

0051 6081 38

0051 6081 39

0051 6081 40

0051 6081 41

0051 6081 42

0051 6081 43
0051 6081 44

0077 60821

0077 60822

0077 60823

0077 60824

0077 60825

0077 60826

0077 60827

0077 60828

0077 60829

0077 6082 10

0077 6082 11

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0077 6082 13

0077 6082 14

0077 6082 15

0077 6082 16

0077 6082 17

0077 6082 18

0077 6082 19

0077 6082 20

0077 6082 21

0077 6082 22

0077 6082 23

0077 6082 24

0077 6082 25

0077 6082 26

0077 6082 27

0077 6082 28

0077 6082 29

0077 6082 30

0077 6082 31

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0077 6082 33

0077 6082 34

0077 6082 35

0077 6082 36

0077 6082 37

0077 6082 38

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0077 6082 70

0077 6082 71

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0077 6082 79

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0077 6082 81

0077 6082 82

0077 6082 83

0077 6082 84

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0077 6082 86

0077 6082 87
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0077 6082 89

0077 6082 90

0077 6082 91

0077 6082 92

0077 6082 93

0077 6082 94

0077 6082 95

0077 6082 96

0077 6082 97

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0077 6082 101

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0077 6082 103

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0077 6082 105

0077 6082 106

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0077 6082 109

0077 6082 110

0077 6082 111

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0077 6082 114

0077 6082 115

0077 6082 116

0077 6082 117

0087 60831

0087 60832

0087 60833

0087 60834

0087 60835

0087 60836

0087 60837

0087 60838

0087 60839

0087 6083 10

0087 6083 11

0087 6083 12

0087 6083 13

0087 6083 14
0087 6083 15

0087 6083 16

0087 6083 17

0087 6083 18

0087 6083 19

0087 6083 20

0087 6083 21

0139 60841

0139 60842

0139 60843

0139 60844

0139 60845

0139 60846

0139 60847

0139 60848

0139 60849

0139 6084 10

0139 6084 11

0139 6084 12

0139 6084 13

0139 6084 14

0139 6084 15

0139 6084 16

0139 6084 17

0139 6084 18

0139 6084 19

0139 6084 20

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0139 6084 23

0139 6084 24

0139 6084 25

0139 6084 26

0139 6084 27

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0139 6084 31

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0139 6084 40

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0139 6084 43

0139 6084 44

0139 6084 45

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0139 6084 47

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0139 6084 50

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0139 6084 60

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0139 6084 76

0139 6084 77

0139 6084 78

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0139 6084 80

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0139 6084 83

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0139 6084 100

0139 6084 101

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0139 6084 103

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0139 6084 145

0139 6084 146

0139 6084 147

0139 6084 148

0139 6084 149

0139 6084 150

0139 6084 151

0139 6084 152

0139 6084 153

0139 6084 154

0139 6084 155

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0139 6084 157

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0139 6084 161

0139 6084 162

0139 6084 163

0139 6084 164

0139 6084 165

0139 6084 166

0139 6084 167

0139 6084 168

0139 6084 169
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0139 6084 171

0139 6084 172

0139 6084 173

0139 6084 174

0139 6084 175

0139 6084 176

0139 6084 177

0139 6084 178

0139 6084 179

0139 6084 180

0139 6084 181

0139 6084 182

0139 6084 183

0139 6084 184

0139 6084 185

0139 6084 186

0139 6084 187

0139 6084 188

0139 6084 189

0139 6084 190

0139 6084 191

0139 6084 192

0139 6084 193

0139 6084 194

0139 6084 195

0139 6084 196

0139 6084 197

0139 6084 198

0139 6084 199

0139 6084 200

0139 6084 201

0139 6084 202

0139 6084 203

0139 6084 204

0139 6084 205

0139 6084 206

0139 6084 207

0139 6084 208

0139 6084 209

0139 6084 210

0139 6084 211

0139 6084 212

0139 6084 213
0139 6084 214

0139 6084 215

0139 6084 216

0139 6084 217

0139 6084 218

0139 6084 219

0139 6084 220

0139 6084 221

0139 6084 222

0139 6084 223

0139 6084 224

0139 6084 225

0139 6084 226

0139 6084 227

0139 6084 228

0139 6084 229

0139 6084 230

0139 6084 231

0139 6084 232

0139 6084 233

0139 6084 234

0139 6084 235

0139 6084 236

0139 6084 237

0139 6084 238

0139 6084 239

0139 6084 240

0139 6084 241

0139 6084 242

0139 6084 243

0139 6084 244

0139 6084 245

0139 6084 246

0048 65021

0048 65022

0048 65023

0048 65024

0048 65025

0048 65026

0048 65027

0048 65028

0048 65029

0048 6502 10

0048 6502 11
0048 6502 12

0048 6502 13

0048 6502 14

0048 6502 15

0048 6502 16

0048 6502 17

0048 6502 18

0048 6502 19

0048 6502 20

0048 6502 21

0048 6502 22

0048 6502 23

0048 6502 24

0049 65031

0049 65032

0049 65033

0049 65034

0049 65035

0049 65036

0049 65037

0049 65038

0049 65039

0049 6503 10

0049 6503 11

0049 6503 12

0049 6503 13

0049 6503 14

0049 6503 15

0049 6503 16

0049 6503 17

0049 6503 18

0049 6503 19

0049 6503 20

0049 6503 21

0049 6503 22

0052 65041

0052 65042

0052 65043

0052 65044

0052 65045

0052 65046

0052 65047

0052 65048

0052 65049
0052 6504 10

0052 6504 11

0052 6504 12

0052 6504 13

0052 6504 14

0052 6504 15

0052 6504 16

0052 6504 17

0053 65051

0053 65052

0053 65053

0053 65054

0053 65055

0053 65056

0053 65057

0053 65058

0053 65059

0053 6505 10

0053 6505 11

0053 6505 12

0053 6505 13

0053 6505 14

0053 6505 15

0053 6505 16

0053 6505 17

0053 6505 18

0053 6505 19

0053 6505 20

0053 6505 21

0054 65061

0054 65062

0054 65063

0054 65064

0054 65065

0054 65066

0054 65067

0054 65068

0054 65069

0054 6506 10

0054 6506 11

0054 6506 12

0054 6506 13

0054 6506 14

0054 6506 15
0054 6506 16

0054 6506 17

0054 6506 18

0054 6506 19

0054 6506 20

0054 6506 21

0054 6506 22

0054 6506 23

0054 6506 24

0054 6506 25

0054 6506 26

0054 6506 27

0054 6506 28

0054 6506 29

0054 6506 30

0054 6506 31

0054 6506 32

0054 6506 33

0054 6506 34

0054 6506 35

0054 6506 36

0054 6506 37

0054 6506 38

0054 6506 39

0054 6506 40

0054 6506 41

0054 6506 42

0054 6506 43

0054 6506 44

0054 6506 45

0054 6506 46

0054 6506 47

0054 6506 48

0054 6506 49

0054 6506 50

0054 6506 51

0054 6506 52

0054 6506 53

0057 65071

0057 65072

0057 65073

0057 65074

0057 65075

0057 65076
0057 6507

7

0057 65078

0057 65079

0057 6507 10

0057 6507 11

0057 6507 12

0057 6507 13

0057 6507 14

0057 6507 15

0057 6507 16

0057 6507 17

0057 6507 18

0057 6507 19

0057 6507 20

0057 6507 21

0057 6507 22

0057 6507 23

0057 6507 24

0057 6507 25

0057 6507 26

0057 6507 27

0057 6507 28

0057 6507 29

0057 6507 30

0058 65081

0058 65082

0058 65083

0058 65084

0058 65085

0058 65086

0058 65087

0058 65088

0058 65089

0058 6508 10

0058 6508 11

0058 6508 12

0060 65091

0060 65092

0060 65093

0060 65094

0060 65095

0060 65096

0061 65101

0061 65102
0061 6510

3

0061 65104

0061 65105

0061 65106

0061 65107

0061 65108

0061 65109

0061 6510 10

0061 6510 11

0061 6510 12

0061 6510 13

0061 6510 14

0061 6510 15

0061 6510 16

0062 65111

0062 65112

0062 65113

0062 65114

0062 65115

0062 65116

0062 65117

0062 65118

0062 65119

0062 6511 10

0062 6511 11

0062 6511 12

0062 6511 13

0062 6511 14

0062 6511 15

0062 6511 16

0062 6511 17

0062 6511 18

0062 6511 19

0062 6511 20

0062 6511 21

0062 6511 22

0062 6511 23

0062 6511 24

0062 6511 25

0062 6511 26

0062 6511 27

0062 6511 28

0062 6511 29

0062 6511 30
0062 6511 31

0062 6511 32

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4

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5

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LINE_TEXT

CS Title: 0051 

Company/group/association name: 

Comment: 

The following comments are my personal opinions and do not 

represent my employer, the National Institutes of Health. As 

way of background, I am a practicing microbiologist with more 

than 30 years experience, the Editor-in-Chief of the ASM Manual 

of Clinical Microbiology, editor of Topley & Wilson's 

Microbiology and Microbial Infections, author of numerous books 

and scientific publications, formerly Professor of Pathology 

and Medicine at Washington University in St. Louis, and 

currently Chief of Microbiology at the NIH Clinical Center. I 

was also a member of the Advisory Board to the EPA that helped 

formulate the Drinking Water CCL-3. My committee of experts 

spent considerable time and effort working with the EPA to 

develop objective criteria for selecting the agents and 

classifying all potential candidate agents. The criteria that 

we developed are listed in Exhibits 13, 15, 16, and 17 of this 

document. This was not a trivial exercise and we had some 

difficulties with some agents that were included in the final 

list. 

For example, Naegleria floweri is an uncommon agent associated 

with only a few cases of drinking water associated disease; 

however, disease caused by this organism (i.e., 

meningoencephalitis) is uniformly fatal. Thus, this parasite 

was included in our recommended list using the established 

selection criteria. It is my opinion that although we may have 

included some organisms where there was not uniform ageement, 

we did not exclude any organisms that we felt were appropriate 

for this. For that reason, I take exception at the inclusion of 

Helicobacter pylori and Entamoeba histolytica and the exclusion 

of Enterovirus and Rotavirus. The classification scores listed 

in Exhibit 17 do not reflect the opinion of the Expert Panel. 

H. pylori was given a score of 5.1 by the panel, E. histolytica 

as score of 7.1, Rotavirus a score of 7.2, and Enterovirus a 

score of 7.9. If the currently published list of Candidate 

Agents is to be retained, then justification for the variance 

from the panel's recommendations, particularly for inclusion of 

H. pylori and exclusion of Enterovirus, needs to be justified 
using the stated selection criteria. 

CS Title: 0077 

Company/group/association name: 

Comment: 

Comment on Proposed EPA Drinking Water Contaminant Candidate 

List 3 

Docket: EPA-HQ-OW-2007-1189 

April 25, 2008 

Pursuant to the proposed list of contaminants on the Federal 

Register, I request that: 

i) Mycobacterium avium remain on the CCL and that 

ii) Mycobacterium avium be given the significantly higher score 

it merits. 

M. avium and related strains of mycobacteria (nontuberculous 

mycobacteria, or NTM) are known water contaminants that are 

currently being assessed relative to human morbidity and 

mortality. 

Environmental Source and Infection 

In April 2008, the Centers for Disease Control convened a 

meeting of leading experts to discuss priorities for better 

surveillance and understanding of this disease. NTM Info & 

Research (NTMir), the national not-for-profit organization for 

pulmonary NTM infection, is currently funding a pilot study 

[FNi: http://www.ntminfo.org/default-aspx/p/article/id/16.aspx] 

to determine the connection between household water, which 

includes drinking water, and pulmonary NTM infection. Of five 

initial patients suffering from pulmonary NTM disease and their 

households surveyed thus far, four (or 80%) were determined to 

have lung infection identical to the strain in the water.[FNii: 

http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 
20 additional patient homes are currently being studied and 

compared to sputum. 

Epidemiology - Increasing Prevalence 

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore 

P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- 

tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 

62:661-6.] provides concrete evidence that the prevalence of 

pulmonary NTM infections is much higher than previously 

understood. A pilot study is currently in process by NAIAD and 

Kaiser Permanente of Southern California to provide a snapshot 

of the epidemiology of pulmonary NTM in the United 

States.[FNiv: 

http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] 

Health Effects 

As data is not currently collected by the CDC or any other 

agency, it is difficult to assess the mortality rates of 

pulmonary NTM in the United States until completion of the 

NAIAD/Kaiser Permanente study mentioned above. 

M. avium and other NTM cause pneumonia and other severe 

manifestations of illness frequently requiring hospitalization 

in excess of one week. Many, if not most NTM-related 

hospitalizations last more than 7 days. 

M. avium and other NTM infections can cause long term 

dysfunction or disability due to progressive and permanent loss 

of lung function. 

M. avium and other NTM's cause illness requires long-term 

physician intervention as initial treatment typically requires 

18-24 months of multi-antibiotic therapy, frequent CT scans, 

and frequent sputum testing. 
Aging Population at Greater Risk 

There appears to be an increase in pulmonary NTM infection in 

the immune competent population over age 60 with a majority 

being women.[FNv: Official ATS/IDSA Statement: Diagnosis, 

Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. 

Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in 

addition to individuals with underlying vulnerability such as 

Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune 

compromised patients (HIV/AIDS, chemotherapy), 

I believe that removing M. avium from the CCL is not in the 

public's best interest and will have a negative impact on the 

U.S. population. Pulmonary NTM disease is being diagnosed with 

increasing frequency across the United States. We request that 

the EPA continue to monitor M. Avium in the water supply and 

give it a higher score. 

Thank you for your attention and consideration in this matter. 

Sincerely, 

Philip Leitman 

President 

CS Title: 0087 

Company/group/association name: 

Comment: 

i do not agree with this letter writer who is employed by this 

company and of course writes for the companys profits. also it 

is my understanding that epa has approved every toxic chemical 

that went for approval before them for the past l7 years, 

hardly showing any regulatory action by this kind of blanket 

approval of all toxic chemicals, i also think 66 days for a 

toxic chemical to leave the soil is far far too long to be 

allowed. i do not appreciate dow chemical which has been 

involved in a sordid past, in my opinion. i think we need to 
watch toxic chemical companies far far more closely than we 

have in the past. americans are carrying around l48 toxic 

chemicals in their bodies at present. something is desperately 

wrong with a system that allows that kind of invasion. our 

birds are dying. our fish are dying and turning up with 

pustules. something is attacking earth. we need to be much much 

more careful than epa has shown itself to be. 

CS Title: 0139 

Company/group/association name: 

Comment: 

May 21, 2008 

Water Docket 

Docket ID No. EPA-HQ-OW-2007-1189 

Environmental Protection Agency 

Mail Code: 2822T 

1200 Pennsylvania Ave., NW. 

Washington, DC 20460 

To Whom it May Concern: 

In response to the notice in the Federal Register of February 

21, 2008 (Volume 73, Number 35) the Association of State 

Drinking Water Administrators (ASDWA) would like to offer 

comments on the draft third Contaminant Candidate List (CCL3). 

ASDWA supports and represents the collective interests of the 

states, territories, and the Navajo Nation in their 

administration of national drinking water program requirements 

within their states or territories including regulatory 

development and the CCL. ASDWA appreciates the opportunity to 

provide the perspective of states on this important phase of 

the regulatory process. 

* Perspectives on Overall Process to CCL: States fully 

endorse the regulatory development construct outlined in the 

1996 SDWA amendments - a process based on sound science. Most 

states do not have the resources or capacity to conduct their 

own studies on the occurrence or health effects of contaminants 
that might need control in drinking water. They rely on EPA to 

assess health risks and assemble occurrence data needed in 

order to determine whether or not contaminants warrant national 

regulations and, if so, at what levels. The CCL is the 

critical first step in this regulatory consideration and 

development process. We believe the existing process, 

including the CCL, is designed to capture the contaminants that 

have the greatest potential to pose a threat to water supplies, 

based on knowledge of their occurrence and their health risks. 

We believe this established protocol for evaluation of 

potential contaminants for regulation should be followed, 

rather than an ad hoc process. 

* Need to Consider Synergistic Effects: States believe 

the current process has serious limitations because 

contaminants are typically considered individually and not in 

mixtures/combinations. The health effects information from the 

Food and Drug Administration database on Maximum Recommended 

Daily Doses (MRDD) is derived based on the effects of single 

compounds; when in actuality, the compounds exist as mixtures 

in the environment. EPA should endeavor to address the 

cumulative and synergistic effects of these compounds as well. 

* Comments on Pharmaceuticals and Personal Care Products: 

It is appropriate to add pharmaceuticals and personal care 

products (PPCPs) to the current and future CCL lists only as 

enough information becomes available to warrant consideration 

of these chemicals for possible regulation. We collectively 

need to avoid the "knee-jerk" reaction of calling for 

regulation of specific chemicals in response to media attention 

and instead, should continue to ensure that regulations be 

based on sound science. We urge EPA to continue to carefully 

evaluate available health effect information on contaminants of 

concern. Pharmaceuticals, in particular, have a voluminous 

amount of data on health effects available as a result of FDA 

requirements associated with the use of these compounds. As a 

goal, it would be ideal to have none of these contaminants in 

the drinking water but practically, this is impossible. Thus, 

we should be guided by the premise that, if there is no 

observable health effect at levels found in drinking water 

(with an adequate margin of safety), then EPA should not set a 

standard. Resources could be better spent trying to prevent or 
minimize the amount of PPCPs that get into sources of drinking 

water in the first instance. Manufacturers and those involved 

in the distribution of these products need to be engaged in 

efforts to keep these contaminants out of the environment and, 

in providing data and information about their health effects. 

Nonetheless, public and legislative concern over 

pharmaceuticals and personal care products is not going away. 

EPA and the drinking water community need to get out ahead of 

the issue to avoid Congressional mandates prescribing a 

specific regulatory schedule. EPA should carefully review the 

data already evaluated in the CCL3 process and any new data 

reported in response to the February 21, 2008 Federal Register 

Notice to identify any contaminants in this group that could 

provide a meaningful opportunity for health risk reduction. If 

there is insufficient data on any of the PPCPs to warrant their 

inclusion on the CCL 3, EPA needs to identify these as 

candidates for additional study and consider including them in 

a future Unregulated Contaminant Monitoring Regulation. 

* Comments on Specific Contaminants Warranting Further 

Consideration: Listed below are several categories of 

contaminants of concern to state drinking water programs. We 

do not have sufficient information about these contaminants to 

categorically recommend that they appear on CCL 3 or the 

Unregulated Contaminated Monitoring (UCM) list. However, we 

ask that the Agency pay particular attention to these 

contaminants, for the reasons mentioned, and consider them for 

possible current or future CCLs or for the UCM - applying the 

statutory tests for these lists to available data and 

information. 

* Contaminants Warranting Further Analysis - Highly 

Prescribed Drugs: Water reuse is becoming an increasingly 

important tool as water systems stretch their water resources 

to meet growing demands. States want to ensure that EPA 

considers the most highly prescribed drugs and over-the-counter 

sales leaders for future health effects and occurrence study. 

Of particular concern are the antibiotics, due to the potential 

for eventual formation of resistant strains of bacteria. 
~ ACE inhibitors such as Lisinopril, Enalipril 

~ Anti-anxiety such as Aprazolam, Lorazepam, Diazepam 

~ Antiarrythmics such as Digoxin 

~ Antibiotics such as Amoxicillin, erythromycin, 

Azithromycin, and Sulfamethoxazole 

~ Anticoagulants such as Clopidogrel, warfarin 

~ Anticonvulsants such as Gabapentin, carbamazepine, 

primidone 

~ Antidepressants such as sertraline, Escitalopram, 

fluoxtine 

~ Antihistamines such as pheniramine, bromopheniramine, 

chloropheniramine, clemastine, doxylamine, diphenylhydramine, 

triprolidine 

~ Antihypertensives such as clonidine 

~ Antiosteoporietics such as alandronate, risedronate 

~ Antiulcer drugs such as esomeprazole, lansoprazole, 

pantoprazole 

~ Bronchiodilators such as albuterol, salmeterol 

~ Decongestants such as oxmetazoline, pseudoephredrine, 
xylometazoline, phenylpropylamine 

~ Antiulcer (H-2 receptor antagonists) such as 

Ranatidine, cimeitidine, famotidine, nizatidine 

~ Expectoratns such as guaifenesin 

~ Glucocorticiods such as hydrocortisone 

~ Antifungals such as haloprogin, miconazole, 

clotrmazole, butaconazole, tioconazole, terbinaifine 

~ Antismoking aids such as nicotine, continine 

* Contaminants Warranting Further Analysis -- Genotoxic 

Compounds: Genotoxic carcinogens, pharmaceuticals that are 

used for patients who, without the treatment would die, provide 

a benefit, but also may pose a health risk. The following 

compounds should be examined: 

~Flutamide 

~Methotrexate 

~Carboplatin 

~Ifosfamide 

~Megestrol 

~Cyclophosphamide 

~Bleomycin A1 

~Topotecan 

~Cisplatin 

~Mitomycin 

~Florouracil 

~Docetaxel 

~Mephalan 

~Cyclosporine 

~Procarbazine HCl 

~Mercaptopurine 

~Busulfan 
~Epirubicin 

* Additional Contaminants or Contaminant Categories of 

Concern: In addition to the contaminants previously mentioned, 

states recommend the following specific compounds for further 

analysis and consideration: 

~ Estrogenic Compounds including pro-estrogen chemicals 

and estrone 

~ 17 alpha estradiol 

[In addition to the contaminants previously mentioned, states recommend the following specific compounds for further analys

~ Carbamazepine (most frequently detected pharmaceutical 

in numerous studies; it appears to be resistant to treatment 

removal technologies and tends not to break down in the 

environment). 

Thank you for your consideration of these comments. Please 

contact me at 703-812-9507 or jtaft@asdwa.org if we can provide 

additional information or if any clarification of these 

comments is needed. 

Sincerely, 

James D. Taft 

Executive Director 

CS Title: 0048 

Company/group/association name: 

Comment: 

In the ccl criteria table for long-term health effects from 

Legionella, the answer should be "YES" to the question "Does 

the illness result in long term or permanent dysfunction or 

disability, i.e. sequelae?" 
There are many references. Here's a good one: 

Thorax 1998;53:302-307 ( April ) 

Lung infections 4 

Pathogenesis of lower respiratory tract infections due to 

Chlamydia, Mycoplasma, Legionella and viruses 

Author: Paul Andersen 

A quote from the Abstract: "Long lasting sequelae such as 

bronchiectasis, lung fibrosis, and decreased lung function are 

seen after lower respiratory tract infections" 

CS Title: 0049 

Company/group/association name: 

Comment: 

If one of the criteria for placing a candidate chemical on the 

list is the liklihood of it being found in a PWS then there 

have been some exclusions that need to be considered. 

More and more common pharmceuticals (metabolized and neat) have 

been showing-up in water testing results. Additionally, 

phthalates as a class of chemical and endocrine-disrupting 

chemicals such as bisphenol A and polyalkoxalated phenolics are 

being detected with regularity. 

I urge you to consider broadening the list to include review 

and consideration of these contaminants. 

Thank you. 

CS Title: 0052 

Company/group/association name: 

Comment: 

The Babylon Breast Cancer Coalition requests that all chemicals 

and pathogens on the Candidate Contaminant List become part of 

the standard contaminant list so that local water authorities 

and departments will receive directives to monitor these 
additional contaminants on a regular basis. 

As an organization advocating a "better safe than sorry" 

approach to environmental, public and personal health policies, 

it is the epa's moral and public obligation to protect the 

health of consumers by broadening the drinking water 

contaminant list. 

CS Title: 0053 

Company/group/association name: 

Comment: 

Our organization urges the EPA to include all of the chemical 

contaminants (CCL3) to be included as an expanded standard list 

of contaminants for monitoring in our drinking water. Water 

districts throughout our country defer to the standard EPA list 

of contaminants for guidance and the current list is lacking. 

Chemicals like permethrin on the CCL3 have been found by a 

study at Mount Sinai Medical Center to have hormonal activity 

which can lead to breast cancer and other hormonal cancers. 

Formaldehyde, also on the CCL3, is listed on the NTP list of 

carcinogens as a probable carcinogen and PFOA has been 

catergorized by EPA as a likely carcinogen. Many of the 

pesticides on the CCL3 are probable or possible carcinogens as 

well. Thank you to the EPA for protecting public health by 

adding these additional CCL3 chemicals to your current standard 

list of chemicals to be monitored by all water departments 

throughout the United States. 

CS Title: 0054 

Company/group/association name: 

Comment: 

March 17, 2008 

Water Docket 

Environmental Protection Agency 

Mailcode: 2822T 

200 Pennsylvania Ave 

NW 

Washington, DC 20460 
This letter is to convey Wisconsin Department of Agriculture, 

Trade and Consumer Protection comments regarding Docket ID No. 

EPA-HQ-OW-2007-1189. Our comments are within two specific 

areas. 

First, we fully support the addition of the ESA and OA 

metabolites of alachlor, acetochlor and metolachlor to the 

Contaminant Candidate List. These are compounds that have 

repeatedly been detected in our drinking water supplies in 

Wisconsin. For instance, in 2001 we randomly sampled over 300 

private drinking water wells throughout Wisconsin and from that 

sampling we estimated the following detection frequencies: 

alachlor ESA - 27.8% of the wells, alachlor OA - 3.7%, acetachlor 

ESA - 2.6%, metolachlor ESA - 25.2% and metolachlor OA - 6.4%. 

Second, we recommend the addition of dimethanamid and it's ESA 

and OA metabolites to the Contaminant Candidate List. Since 

this product became registered in the mid 90's we have been 

testing for the parent compound (dimethanamid) in monitoring 

wells at storage facilities throughout WI. We detect it in over 

25% of the monitoring wells where we are conducting this long 

term monitoring. 

If you have any questions or would like to learn more about the 

well sampling we have conducted in Wisconsin, you can reach me 

at 608/224-4550. 

Sincerely, 

Lori G. Bowman 

Bureau Director 

Agrichemical Management Bureau 

CS Title: 0057 

Company/group/association name: 

Comment: 

Hi, As the mother of two young children and a recent breast 
cancer survivor, I'm concerned about hazards in drinking water. 

My breast cancer was not estrogen fed nor has a heredity link 

been found to explain the cause of my cancer. Naturally, I've 

very concerned about exposure to any cancer-causing agents and 

I do my best to avoid them, as well as eat right and exercise 

to be as healthy as I can be. Knowing that cancer-causing 

agents could be in my water is indeed upsetting. How am I to 

avoid those? How are others to avoid them too? 

Already, we have an epidemic of cancer in our country (and 

world); we must now step up to the plate and reduce the 

carcinogens around us. Though advances have been made in cancer 

treatments, far too many still die of the diseases. I know, 

they are my friends and acquaintances that are dying. 

Please do your part and raise the bar for safer water. With 

global warming upon us, availability of water will certainly be 

a rising concern but if it's filled with cancer-causing agents, 

what's the point anyway? 

Thank you. Kathy Finger of SC 

CS Title: 0058 

Company/group/association name: 

Comment: 

The Contaminant Candidate List (CCL) contains currently 

unregulated contaminants that are known or anticipated to occur 

in public water systems and which may adversely impact human 

health. Many of the chemicals on the list are known or probable 

carcinogens, such as acetochlor, 1,3-butadiene, and 

formaldehyde. The EPA needs to test for and regulate these 

contaminants. 

CS Title: 0060 

Company/group/association name: 

Comment: 

I want to see these contaminants tested for and regulated. 

CS Title: 0061 

Company/group/association name: 
Comment: 

As I understand it, this proposed list would include many 

contaminants that are currently unregulated - and KNOWN to be 

carcinogens or possible carcinogens. The fact that these 

chemicals are currently unregulated is downright frightening 

given their potential threat to public health and safety. These 

contaminants absolutely MUST be tested, limits imposed and 

strictly regulated. 

J. Watkins 

Calistoga, CA 

CS Title: 0062 

Company/group/association name: 

Comment: 

April 13, 2008 

Water Docket Environmental Protection Agency Mailcode: 2822T 

1200 Pennsylvania Ave., NW. Washington, DC 20460 

These comments are being provided in response to USEPA's 

solicitation for comment in the notice [EPA-HQ-OW-2007-1189 

FRL-8559-7] that appeared in Federal Register Volume 73, Number 

35 on February 21, 2008. 

Fenamiphos is listed on the draft CCL 3 as an organophosphate 

pesticide of concern to drinking water systems. Given its 

current label and registration status, it is hard to imagine 

that fenamiphos would be a candidate for the CCL 3 or carry a 

great degree of potential to occur in drinking water. 

Please consider my comments in regards to fenamiphos and its 

appearance on the draft Contaminant Candidate List. 

The Agency has incorporated elements of the National Drinking 
Water Advisory Council (NDWAC) recommendations and adopted the 

guiding inclusionary principles in developing the Drinking 

Water Contaminant Candidate List 3 (CCL3). The two guiding 

principles as suggested by the NDWAC are that chemical 

contaminants tend to be characterized by both the toxicological 

data principle and the occurrence data principle that can be 

modeled or estimated if measurement is not possible. Guided by 

these principles and using a multi-step process of 

identification, screening, and evaluation the Agency has 

developed a draft list consisting of 92 chemical contaminants 

so characterized by the potential occurrence and adverse health 

risks they may pose to consumers of public water systems (EPA, 

2008). In the Fact Sheet: Third Drinking Water Contaminant 

List (CCL3) (EPA, 2008) the Agency has summarized the multi- 

step process as follows; 

[The commenter summarized the steps of the CCL 3 process] 1. Identifying a broad universe of potential drinking water 

contaminants (called the "CCL Universe"). EPA evaluated 284 

data sources that may identify potential chemical and microbial 

contaminants and selected a set of approximately 7,500 

contaminants from these data sources for initial consideration. 

[The commenter summarized the steps of the CCL 3 process] 2. Applying screening criteria to the CCL universe to identify 

those contaminants that should be further evaluated (the 

preliminary CCL or PCCL) based on a contaminant's potential to 

occur in public water systems and the potential for public 

health concern. 

[The commenter summarized the steps of the CCL 3 process] 3. Identifying contaminants from the PCCL to include on the CC

based on more detailed evaluation of occurrence and health 

effects and expert judgment applied in a transparent 

reproducible manner. 

[The commenter summarized the steps of the CCL 3 process] 4. Incorporating public input and expert review in the CCL 

process. 

The Agency's incorporation of the NDWAC recommendations and the 

adoption of the guiding inclusionary principles in developing 

the CCL3 provides a solid framework and a logical approach for 
the initial construction of this list. However, does the 

process allow for the possibility or the necessity of re- 

screening draft listed CCL3 contaminants after the initial 

publication of the draft list? Could changes to the 

toxicological and/or occurrence data, resulting from changes in 

the registration status of a pesticide, be sufficient to 

warrant the re-screening of the contaminant? Specifically, 

would lowering of a contaminant's potential to occur in public 

water systems and the mitigation of adverse health risks 

brought about as a result of changes to the registration of the 

pesticide fenamiphos, be enough to elicit a re-screening of 

this contaminant in order to determine if it would still remain 

on the CCL3? 

The Agency ultimately developed the Universe of chemicals 

relying on 39 of the initial 284 evaluated data sources (the 

"Universe of Data Sources"). The data sources are classified 

by whether they provided health effects data or occurrence data 

and produced a compilation of 25,980 unique substances (EPA, 

2008 a). 

The partitioning of contaminants from the universe of chemicals 

to the PCCL is determined by plotting the summation of the 

contaminants relative occurrence data elements against the 

summation of the contaminants relative health effects data 

elements as illustrated in Table 1 from the Contaminant 

Candidate List 3 Chemicals: Screening to a PCCL (EPA, 2008 b). 

A contaminant that is essentially passed to the PCCL is then 

available to become a candidate for the draft CCL3. 

Table 1, Partition for Screening to the Universe (EPA, 2008 b) 

[see PDF] 

The toxicological data principle is described by the Agency for 

its screening purposes in the CCL 3 as essentially a health 

effect/toxicity categorization of contaminants (EPA, 2008 b). 

The health effect/toxicity data elements that provide toxicity 

information fall into two major categories (EPA, 2008 a): 
* Data elements that provide dose-response information 

(potency) 

* Categorical data elements on hazard (mostly related to 

carcinogenic potential) 

The cumulative types of data elements that comprise this 

toxicity categorization or 'universe health effects' are; 

Maximum Recommended Daily Dose (MRDD), Lowest Observable 

Adverse Effects Level (LOAELs), No Observed Adverse Effect 

Level (NOAELs) Lethal Dose 50 (LD50), Tumorigenic Dose 50 

(TD50) and Reference Doses and their equivalents (RfDs and RfD- 

eq). Some data sources only include descriptive data such as 

the positive, negative, or equivocal results from National 

Toxicology Program (NTP) studies or International Agency for 

Research on Cancer (IARC) carcinogen classifications (EPA, 2008 

b). After the overall evaluation of the available data elements 

on a contaminant's universe health effects, the contaminant is 

partitioned into one of five categories of relative toxicity 

and designated as a Toxicity category 1 thru 5, with Toxicity 

category 1 considered to be most toxic. 

Thirteen of the 92 chemical contaminants on the CCL3 are 

classified as Organophosphorus pesticides (OPs). Due to the 

relative acute toxicity of this class of compounds and the fact 

that there are a little over 100 Organophosphorus compounds in 

commercial use, it is understandable that the CCL take a 

special interest in this class of pesticides. It is generally 

accepted that OPs do not persist or bioaccumulate in the 

environment, however they are acetylcholinesterase inhibitors 

that work primarily on the nervous system and their relative 

acute and chronic toxicity to aquatic species appears to be of 

great concern in the aquatic environment. Due to spray drift, 

runoff, and leaching concerns, OPs have the potential to find 

their way into public water systems (Temple and Smith, 1989). 

The OPs found on the draft list span an even distribution 

across the potential toxicity categories. 

This would appear to indicate that using the multi-step process 

developed by the Agency, of identification, screening, and 
evaluation of chemical contaminants, has been successful at 

encompassing a balanced scope as well as satisfying the 

inclusionary principle of toxicological data in the 'draft CCL' 

for the Organophosphorus class of compounds. 

Fenamiphos, CAS 22224-92-6 (ETN, 2008), is one of the 

Organophosphorus chemicals that was screened using the elements 

of the Preliminary Contaminant Candidate List (PCCL) and 

selected to appear on the Draft CCL 3. Throughout the 

screening process, it was designated by the Agency as 'Category 

2 toxicity' based on the whole of its cumulative Universe 

Health Effects data elements. Technical fenamiphos has a high 

acute oral toxicity with an LD50 (male/female) of 2.7/3.0 

mg/kg. The endpoints for the dietary risk assessment are; 

acute dietary LOAEL 0.37 mg/kg/day and chronic dietary NOAEL 

0.01 mg/kg/day and LOAEL 0.03 mg/kg/day. The Population 

Adjusted Dose (PAD) are 0.0012 and 0.0001 mg/kg/day for the 

acute and chronic dietary risk respectively. Both the acute 

and the chronic dietary risk from food are below the Agency's 

level of concern (EPA, 2002). In addition, fenamiphos is not 

classified as a human carcinogen by the American Conference of 

Governmantal Industrial Hygenists (2005). In the Interim 

Reregistration Eligibility Decision (IRED) for fenamiphos (EPA, 

2002), the Agency indicates that if the manufacturer 

incorporates all the recommended changes to the label 

registration that were outlined by the decision, and that the 

use on extremely vulnerable soils is phased-out by May 31, 

2005, then all current dietary risks will be mitigated. (EPA, 

2002) This suggests that altering the current label use of the 

compound might have a mitigating effect on dietary risks and 

thus may influence or reduce the outcome of the Dose-Response 

Data element. The Agency went further and characterized the 

possible mitigated dietary risks for fenamiphos. The 

indications are that the dietary (acute and chronic) exposures 

from eating commodities treated with fenamiphos would be below 

the Agency's level of concern for the entire U.S. population, 

including infants and children. In addition, the mitigated 

dietary (drinking water) exposures would not be of concern for 

surface and ground water sources in soils that are not 

extremely vulnerable. However, exposure to shallow ground 

water sources of drinking water associated with soils that are 

extremely vulnerable would still exceed the Agency's level of 

concern (EPA, 2002). The sole manufacturer of fenamiphos has 
since filed a notice to voluntarily cancel all registrations 

for products containing fenamiphos instead of developing 

additional data as part of the risk mitigation proposal by the 

EPA (EPA, 2002). 

However, the question remains valid. Would the registration 

status or label changes and possible resultant mitigated 

dietary risks have been sufficient to alter the determination 

of the overall fenamiphos potency distribution for the universe 

health effects (Toxicity 2 category)? Would this ultimately 

warrant that the contaminant be re-screened to the PCCL with 

updated data inputs that could possibly result in a fall from 

the draft universe CCL3? If the answer is no, then based on 

the toxicological data elements the Agency used for screening 

fenamiphos, and devoid of any other new input data, and/or 

until the tolerance reassessment process considers cumulative 

risks for the Organophosphate class of chemicals, fenamiphos 

would likely remain partitioned into the Category 2 toxicity 

for the screen to the PCCL. 

The occurrence data principle is described by the Agency for 

its screening purposes in the CCL 3 as essentially an 

occurrence factor assigned to a contaminant. This occurrence 

factor is derived from the cumulative of its quantitative and 

descriptive data elements that characterize a contaminants 

potential to occur in drinking water. These data elements are 

categorized in CCL 3 Chemicals: Screening to a PCCL (EPA, 2008 

b) and are as follows; 

* Finished Water - measures concentration and frequency of 

detections 

* Ambient Water - measures concentration and frequency of 

detections 

* Total Releases in the Environment - measures pounds per year 

and number of states 
* Pesticide Application Rates - measures pounds per year and 

number of states 

* Production volume - measures pounds per year 

Based on the changes to the registration status for fenamiphos, 

isn't it reasonable to assume that the potential of fenamiphos 

to occur in public water systems has drastically been reduced? 

The notice by the sole manufacturer to voluntarily cancel all 

registrations for products containing fenamiphos as of May 31, 

2007 (EPA, 2002) would certainly translate to an immediate 

effect on the criteria for current total pesticide application 

rates and production volumes. In addition, some of the data 

element inputs used in the determination of the occurrence 

factor that were initially used during the screening process 

would continue to trend toward a reduction over the short term 

as the product stocks of fenamiphos are depleted. This 

includes the remaining occurrence categories of finished water, 

ambient water, and total releases in the environment. For 

instance, the Agency uses the most up to date production data 

that is available and reported under the Chemical Update 

System/Inventory Update Rule (CUS/IUR) and lists this as their 

input value for initial screening purposes (EPA, 2008 b). If 

we substitute a current 2008 production rate of zero as input 

into the criteria screen for production data, wouldn't this 

then indicate that fenamiphos would possibly be a candidate to 

move out of the PCCL, and in fact move back into the Universe 

CCL? Likewise, as depletion of existing stocks of fenamiphos 

progresses, wouldn't this also lower the value over time for 

the Total Environmental Releases (lbs/year)? Some of the 

environmental release data used for fenamiphos in the PCCL 

screen came from the National Center for Food and Agricultural 

Policy (NCFAP). The most recent available version of this 

database reflects the last year of available data as of 1997 

(NCFAP, 2008). The Agency indicates that they used this 1997 

data as well as data reported from the 2002 Toxics Release 

Inventory (TRI) for evaluation of environmental release data 

category (EPA, 2008 b) in the determination of the occurrence 

factor. This occurrence factor determined for the screen to 

the PCCL doesn't accurately reflect fenamiphos' current 

registration and label use status. If the current occurrence 

data inputs were used for re-screening fenamiphos to the PCCL, 
it seems likely that fenamiphos would move from the PCCL back 

to the CCL Universe of some 26,000 unique substances. 

Although there are valid toxicological (Toxicity Category 2) 

and aquatic environmental concerns associated with fenamiphos, 

both the inclusionary principles of toxicological and 

occurrence data do not appear to be satisfied for this 

compound. Given its current label and registration status, it 

is hard to imagine that fenamiphos would be a candidate for the 

CCL 3 or carry a great degree of potential to occur in drinking 

water. 

References: 

(1) United States Environmental Protection Agency. (2008). 

Drinking Water Contaminant Candidate List 3--Draft [Federal 

Register: February 21, 2008 (Volume 73, Number 35)], [EPA-HQ- 

OW-2007-1189 FRL-8529-7], RIN 2040-AD99. Retrieved March 7, 

2008, from Federal Register Online via GPO Access 

[wais.access.gpo.gov]: 

http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket. 

access.gpo.gov-/2008/E8-3114.htm. 

(2) United States Environmental Protection Agency. (2008). Fact 

Sheet: Third Drinking Water Contaminant List (CCL3). EPA 815- 

F-08-001. Office of Water (4607M). February, 2008. Retrieved 

March 17, 2008), from EPA website via GPO Access 

[wais.access.gpo.gov]: 

http://www.epa.gov/OGWDW/ccl/pdfs/fs_ccl3.pdf 

(3) United States Environmental Protection Agency. (2008 a). 

Contaminant Candidate List 3 Chemicals: Identifying the 

Universe. EPA 815-R-08-002. Draft. February, 2008. Retrieved 

March 17, 2008), from EPA website via GPO Access 

[wais.access.gpo.gov]: 

http://www.epa.gov/OGWDW/ccl/pdfs/report_ccl3_chemicals_univer 

se.pdf 
(4) United States Environmental Protection Agency. (2008 b). 

Contaminant Candidate List 3 Chemicals: Screening to a PCCL. 

EPA 815-R-08-002. Draft. February, 2008. Retrieved March 17, 

2008), from EPA website via GPO Access [wais.access.gpo.gov]: 

http://www.epa.gov/safewater/ccl/pdfs/report_ccl3_chemicals_sc 

reening.pdf 

(5) Temple, Dr W.A. and Smith, Dr N.A. 1989. Organophosphorus 

Pesticides International Programme on Chemical Safety Poisons 

Information Monograph (Group Monograph) G001. Retrieved March 

29, 2008, from the IPCS INCHEM website 

http://www.inchem.org/documents/pims/chemical/pimg001.htm 

(6) Extension Toxicology Network. (2008). Pesticide Information 

Profiles. Retrieved March 17, 2008), from EXTOXNET Access 

[extoxnet.orst.edu]: http://extoxnet.orst.edu/pips/fenamiph.htm 

(7) United States Environmental Protection Agency. (2002). 

Interim Reregistration Eligibility Decision (IRED)-Fenamiphos. 

Prevention, Pesticides and Toxic Substances (7508C). EPA 738- 

R-02-004. Retrieved March 29, 2008, from Federal Register 

Online via GPO Access [wais.access.gpo.gov]: 

http://www.epa.gov/oppsrrd1/REDs/fenamiphos_ired.pdf 

(8) United States Environmental Protection Agency. (2002). 

Fenamiphos; Notice of Receipt of Request to Voluntarily Cancel 

All Product Registrations. [Federal Register: September 27, 

2002 (Volume 67, Number 188)] Retrieved March 29, 2008, from 

Federal Register Online via GPO Access [wais.access.gpo.gov]: 

http://www.epa.gov/EPA-PEST/2002/September/Day-27/p24648.htm 

(9) American Conference of Governmental Industrial Hygienists - 

TLVs and BEIs. (2002). Threshold Limit Values for Chemical 

Substances and Physical Agents and Biological Exposure Indices, 

p. 30. Retrieved March 29, 2008, via Access 

[wais.access.nlm.nih.gov]: 

http://toxnet.nlm.nih.gov/cgibin/sis/search/f?./temp/~Iy1iSo:1 
(10) The National Center for Food and Agricultural Policy 

(NCFAP). (2008). NCFAP Pesticide Use Database. Retrieved March 

29, 2008, via Access [ncsu.edu]: 

http://pestdata.ncsu.edu/ncfap/search.cfm 

CS Title: 0064 

Company/group/association name: 

Comment: 

I am a resident in a water service area which intends to use 

chloramine as a disinfectiant in my drinking water system. I 

understand that when monochloromine interacts with organic 

material many toxic byproducts are formed. Two of the most 

toxic byproducts of chloromine appear on your CCL 3, Hydrazine 

and N-Nitrosamines, specifically the most toxic, NDMA. Four 

other N- Nitrosamines, NDPA, NDEA, Nitrosodiphenylamine and 

NPYR also appear on the CCL3 list as likely disinfection 

byproducts. 

It was my understanding that NDMA has already been determined 

to be a 'probable human carcinogen" by the USEPA. It is also my 

understanding that Hydrazine is genotoxic. Little is known 

about the effect of these byproducts in the levels they are 

formed in the drinking water system. However, peer reviewed 

studies would indicate that these emerging byproducts are 

possibly 100's of times more toxic than those of chlorine. I am 

a stage 4 breast cancer survivor, so I am obviously concerned 

over the potential and unknown carcinogen effects this change 

in our drinking water may have, not only on my prognosis, but 

the prognosis of millions of other cancer survivors. Since I 

was diagnosed at the age of 34, with no family history or risk 

factors for the disease, I am convinced that environmental 

factors played a part in my contracting the disease. More 

studies need to be carried out on these Chloromine byproducts 

to determine their carcinogen effects before you move forward 

with the use of Chloromine in our water system. 

Water systems across the country are using or are intending to 

use chloramine as a disinfectant in order to meet EPA's Stage 2 

regulations regarding chlorine byproducts on the recommendation 

or suggestion of EPA. It is incumbent upon EPA then to study 

the byproducts of chloramine expeditiously in order to protect 
the public health from byproducts far worse than those of 

chlorine. I am asking not only for a study of these byproducts, 

but a moratorium on the use of chloramine until it's byproducts 

are studied and determined to be safe. 

Thank you, Tricia J. Coniglio, Camp Hill, PA 

CS Title: 0065 

Company/group/association name: 

Comment: 

Attached documents contain new information on perchlorate 

toxicity and contamination. 

[See PDF for Attachment] 

CS Title: 0066 

Company/group/association name: 

Comment: 

COMMENT 

Docket Title Drinking Water Contaminant Candidate List 3 

Docket ID EPA-HQ-OW-2007-1189 

Document ID EPA-HQ-OW-2007-1189-0001 

Jane Boisvert 

95 Holmes Rd. 

S. Burlington, VT 05403 

802-863-3331 

To Whom It May Concern: 

I am a resident in a water service area using or intending to 

use chloramine as a disinfectant in my drinking water system. I 

understand that when monochloramine interacts with organic 

material many toxic byproducts are formed. Two of the most 

toxic byproducts of chloramine appear on your CCL 3, Hydrazine 

and N- Nitrosamines, specifically the most toxic, NDMA. Four 

other N-Nitrosamines, NDPA, NDEA, Nitrosodiphenylamine and NPYR 
also appear on the CCL3 list as likely disinfection byproducts. 

It was my understanding that NDMA has already been determined 

to be a 'probable human carcinogen" by the USEPA. It is also my 

understanding that Hydrazine is genotoxic. Little is known 

about the effect of these byproducts in the levels they are 

formed in the drinking water system. However, peer reviewed 

studies would indicate that these emerging byproducts are 

possibly hundreds of times more toxic than those of chlorine. 

Water systems across the country are using or are intending to 

use chloramine as a disinfectant in order to meet EPA's Stage 2 

regulations regarding chlorine byproducts on the recommendation 

or suggestion of EPA. It is incumbent upon EPA then to study 

the byproducts of chloramine expeditiously in order to protect 

the public health from byproducts far worse than those of 

chlorine. I am asking not only for a study of these byproducts, 

but a moratorium on the use of chloramine until its byproducts 

are studied and determined to be safe. 

I have personally experienced health problems due to the use of 

chloramine in our water system and hope you will take action to 

stop the use of chloramine. 

Thank you. 

Jane Boisvert 

CS Title: 0067 

Company/group/association name: 

Comment: 

As a support group leader of non tuberculous mycobacteria in 

the NY and Metropolitan Area, as well as leading a national 

group on-line, I am representing close to 200 patients in their 

quest for a cure. This disease can be devistating, and removing 

our project would be catastrophic for some patients. 
Comment on Proposed EPA 

Drinking Water Contaminant Candidate List 3 

Docket: EPA-HQ-OW-2007-1189 

April 25, 2008 

Pursuant to the proposed list of contaminants on the Federal 

Register, I request that: i) Mycobacterium avium remain on the 

CCL and that ii) Mycobacterium avium be given the significantly 

higher score it merits. 

M. avium and related strains of mycobacteria (nontuberculous 

mycobacteria, or NTM) are known water contaminants that are 

currently being assessed relative to human morbidity and 

mortality. 

Environmental Source and Infection 

In April 2008, the Centers for Disease Control convened a 

meeting of leading experts to discuss priorities for better 

surveillance and understanding of this disease. NTM Info & 

Research (NTMir), the national not-for-profit organization for 

pulmonary NTM infection, is currently funding a pilot study to 

determine the connection between household water, which 

includes drinking water, and pulmonary NTM infection. Of five 

initial patients suffering from pulmonary NTM disease and their 

households surveyed thus far, four (or 80%) were determined to 

have lung infection identical to the strain in the water. At 

least 20 additional patient homes are currently being studied 

and compared to sputum. 

Epidemiology - Increasing Prevalence 

A recent study from Toronto, Ontario, provides concrete 

evidence that the prevalence of pulmonary NTM infections is 

much higher than previously understood. A pilot study is 

currently in process by NAIAD and Kaiser Permanente of Southern 
California to provide a snapshot of the epidemiology of 

pulmonary NTM in the United States. 

Health Effects 

As data is not currently collected by the CDC or any other 

agency, it is difficult to assess the mortality rates of 

pulmonary NTM in the United States until completion of the 

NAIAD/Kaiser Permanente study mentioned above. 

M. avium and other NTM cause pneumonia and other severe 

manifestations of illness frequently requiring hospitalization 

in excess of one week. Many, if not most NTM-related 

hospitalizations last more than 7 days. 

M. avium and other NTM infections can cause long term 

dysfunction or disability due to progressive and permanent loss 

of lung function. 

M. avium and other NTM's cause illness requires long-term 

physician intervention as initial treatment typically requires 

18-24 months of multi-antibiotic therapy, frequent CT scans, 

and frequent sputum testing. 

Aging Population at Greater Risk There appears to be an 

increase in pulmonary NTM infection in the immune competent 

population over age 60 with a majority being women. This is in 

addition to individuals with underlying vulnerability such as 

Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune 

compromised patients (HIV/AIDS, chemotherapy), 

I believe that removing M. avium from the CCL is not in the 

public's best interest and will have a negative impact on the 

U.S. population. Pulmonary NTM disease is being diagnosed with 

increasing frequency across the United States. I request that 

the EPA continue to monitor M. Avium in the water supply and 

give it a higher score. 
Thank you for your attention and consideration in this matter. 

Sincerely, 

Debbie Breslawsky 

breslaw1@gmail.com 

CS Title: 0068 

Company/group/association name: 

Comment: 

Comment on Proposed EPA 

Drinking Water Contaminant Candidate List 3 

Docket: EPA-HQ-OW-2007-1189 

April 29, 2008 

Pursuant to the proposed list of contaminants on the Federal 

Register, I request that: i) Mycobacterium avium remain on the 

CCL and that ii) Mycobacterium avium be given the significantly 

higher score it merits. 

M. avium and related strains of mycobacteria (nontuberculous 

mycobacteria, or NTM) are known water contaminants that are 

currently being assessed relative to human morbidity and 

mortality. 

Environmental Source and Infection In April 2008, the Centers 

for Disease Control convened a meeting of leading experts to 

discuss priorities for better surveillance and understanding of 

this disease. NTM Info & Research (NTMir), the national not- 

for-profit organization for pulmonary NTM infection, is 

currently funding a pilot study to determine the connection 

between household water, which includes drinking water, and 

pulmonary NTM infection. Of five initial patients suffering 

from pulmonary NTM disease and their households surveyed thus 

far, four (or 80%) were determined to have lung infection 

identical to the strain in the water. At least 20 additional 
patient homes are currently being studied and compared to 

sputum. 

Epidemiology - Increasing Prevalence A recent study from 

Toronto, Ontario, provides concrete evidence that the 

prevalence of pulmonary NTM infections is much higher than 

previously understood. A pilot study is currently in process by 

NAIAD and Kaiser Permanente of Southern California to provide a 

snapshot of the epidemiology of pulmonary NTM in the United 

States. 

Health Effects As data is not currently collected by the CDC or 

any other agency, it is difficult to assess the mortality rates 

of pulmonary NTM in the United States until completion of the 

NAIAD/Kaiser Permanente study mentioned above. 

M. avium and other NTM cause pneumonia and other severe 

manifestations of illness frequently requiring hospitalization 

in excess of one week. Many, if not most NTM-related 

hospitalizations last more than 7 days. 

M. avium and other NTM infections can cause long term 

dysfunction or disability due to progressive and permanent loss 

of lung function. 

M. avium and other NTM's cause illness requires long-term 

physician intervention as initial treatment typically requires 

18-24 months of multi-antibiotic therapy, frequent CT scans, 

and frequent sputum testing. 

Aging Population at Greater Risk There appears to be an 

increase in pulmonary NTM infection in the immune competent 

population over age 60 with a majority being women. This is in 

addition to individuals with underlying vulnerability such as 

Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune 

compromised patients (HIV/AIDS, chemotherapy), 
I believe that removing M. avium from the CCL is not in the 

public's best interest and will have a negative impact on the 

U.S. population. Pulmonary NTM disease is being diagnosed with 

increasing frequency across the United States. I request that 

the EPA continue to monitor M. Avium in the water supply and 

give it a higher score. 

Thank you for your attention and consideration in this matter. 

Sincerely, 

Andrea McMurrough 

(MAC/NTM patient) 

CS Title: 0069 

Company/group/association name: 

Comment: 

April 23, 2008 

Water Docket 

Environmental Protection Agency 

Mailcode: 2822T 

1200 Pennsylvania Avenue 

N.W. Washington D.C. 20460 

RE: Federal Register Docket - EPA-HQ-OW-2007-1189 

To Whom It May Concern: 

We are four law students attending New England School of Law 

and we write to you in support of adding perchlorate to the 

Safe Drinking Water Act (SDWA) contaminant list. 

The EPA Administrator is obligated to publish a maximum 

contaminant level goal and promulgate a national primary 
drinking water regulation for identified contaminants if the 

Administrator makes three findings[FN1: 42 USC §300g-1(b)(1) 

(A)]: 1) the contaminant is known to occur or there is a 

substantial likelihood that the contaminant will occur in 

public water systems with a frequency and at levels of public 

health concern[FN2: 42 USC §300g-1(b)(1)(A)(ii)]; 2) in the 

sole judgment of the Administrator, regulation of such 

contaminant presents a meaningful opportunity for health risk 

reduction for persons served by public water systems[FN3: 42 

USC §300g-1(b) (1)(A)(iii)]; and 3) the contaminant may have an 

adverse effect on the health of persons.[FN4: 42 USC §300g-1(b) 

(1)(A)(i)] 

This comment is organized around the three elements necessary 

for the Administrator to find that perchlorate is a 

contaminant, with a focus on the need for a national 

standardized maximum contaminant level. 

I. Perchlorate is Known to Occur at a Level of Public Health 

Concern 

It is well documented that perchlorate contamination is a 

dangerous and widespread occurrence, rising to the level of a 

significant public health concern. Contamination has been well 

documented in at least thirty-seven states and the District of 

Columbia.[FN5: Letter to James Inhofe, Anu Mittal, Government 

Accountability Office, September 16, 2005 at 1.] It has been 

estimated by some commentators that more than five hundred 

drinking water sources, serving approximately twenty million 

people, are affected by perchlorate contamination.[FN6: 

Exempting Department of Defense From Federal Hazardous Waste 

Laws : Resource Contamination as "Range Preservation"?, Caitlin 

Sislin, 32 ECGLQ 647, 653 (2005).] 

One government report cataloged 395 separate sites where 

perchlorate was found in the soil, groundwater, surface water, 

or drinking water.[FN7: Perchlorate: A System to Track Sampling 

and Cleanup Results is Needed, Government Accountability 

Office, May 2005] Several of these sites had levels of 

perchlorate contamination in their drinking water many times 
greater than EPA's Drinking Water Equivalent Level (DWEL) of 

24.5 parts per billion (ppb).[FN8: Id.] The City of Baldwin 

Park in California had a measured perchlorate level of 159 ppb 

in their drinking water, more than six times greater than EPA's 

DWEL; and the Atlantic Beach Water System in Duval County, 

Florida had a measured perchlorate level of 200 ppb, more than 

eight times the DWEL.[FN9: Id. at 33-34] In California alone, 

the Department of Health Services identified over 350 public 

drinking water sources that are contaminated with perchlorate. 

Further studies indicate that levels of contamination in 

California water wells range from 12 to 682,000 parts per 

billion.[FN10: 32 ECGLQ 647, 654-5 (2005)] 

The federal government itself is responsible for many of these 

contamination sites as at least forty Department of Defense 

facilities have perchlorate contaminated groundwater or surface 

water.[FN11: http://www.miltoxproj.org/laws.htm.] For example, 

the Longhorn Army Ammunition Plant in Harrison County, Texas 

was found to have 320,000 ppb, the Redstone Army Arsenal in 

Alabama with 220,000 ppb, the Naval Surface Warfare Center in 

Indian Head, Maryland with 276,000 ppb; the Edwards Air Force 

Base, Jet Propulsion Laboratory in Kern County, California with 

160,000 ppb; and the Army White Sands Missile Range near 

Alamogordo, New Mexico with 32,900 ppb.[FN12: 27 STENVLJ 43, FN 

573 (2008).] A recent federal government report stated that at 

least eight contaminated Department of Defense facilities are 

contaminated at a "significant" level.[FN13: Perchlorate: A 

System to Track Sampling and Cleanup Results is Needed, 

Government Accountability Office, May 2005 at 29-44; 27 STENVLJ 

43, FN 544 (2008)] 

While EPA has yet to issue a nationwide regulation for 

perchlorate in drinking water, the prevalence of perchlorate 

and the dangers of allowing it to persist in drinking water 

have not escaped the courts. Under both the Resource 

Conservation and Recovery Act (RCRA) and the Comprehensive 

Environmental Response, Compensation, and Liability Act 

(CERCLA) courts have had some ability to impose liability on 

those responsible parties for introducing perchlorate into the 

soil, groundwater, or drinking water.[FN14: 42 U.S.C. §690; 42 

U.S.C. §9601] For example, in Castic Lake Water Agency v. 

Whittaker Corp. the United States District Court for the 
Central District of California found that perchlorate was a 

hazardous waste under RCRA.[FN15: Castic Lake Water Agency v. 

Whittaker Corp., 272 F.Supp.2d 1053 (2003)] The court found 

that although perchlorate is not a "listed" hazardous waste, it 

is subject to RCRA as a "characteristic" hazardous waste 

because perchlorate demonstrates the characteristic of 

ignitability by being an "oxidizer," meaning that the chemical 

"cause[s] or enhance[s] the combustion of other 

materials."[FN16: Id.; 49 CFR 173.127] This classification as a 

characteristic waste allowed for the court to hold that not 

only does RCRA apply to perchlorate, but that CERCLA also 

applies by virtue of CERCLA being applicable to "hazardous 

substances" listed under various federal statutes, including 

RCRA. 

Although the courts have applied RCRA and CERCLA to perchlorate 

and EPA has issued other guidance standards, neither these 

decisions nor these policies are legally binding and are not a 

sufficient substitute for a national standard. A case such as 

Castic Lake merely allows for the application of certain 

federal statutes to perchlorate, the court did not state 

specifically when the federal statute should apply. Without 

legally binding regulations from EPA, it is unclear how much 

perchlorate is truly safe to drink. The federal government has 

cataloged several hundred perchlorate sites, yet there is no 

guidance as to whether any of these sites possess enough 

perchlorate to bring a federal suit and require a cleanup for 

the sake of our nation's drinking water. 

Massachusetts is a frontrunner in the regulation of perchlorate 

in the environment.[FN17: MassDeP, Addressing Perchlorate and 

other Emerging Contaminants in Massachusetts, available at 

http://www.mass.gov/dep/water/drinking/percfs77.htm] In July of 

2006, Massachusetts implemented the first standards in the 

nation for perchlorate in drinking water and waste site 

cleanup.[FN18: Id.] The Massachusetts drinking water standard 

is 2 parts per billion and the s-1/gw-1 standard is 0.1 parts 

per million.[FN19: Final Changes to the Massachusetts 

Contingency Plan 310 CMR 40.0000 available at 

http://mass.gov/dep/cleanup/laws/perchlorate-310CMR40-07282006. 

pdf.] These standards have been inserted into the Massachusetts 

Contingency Plan and are codified at 310 CMR 40.0000.[FN20: 
Id.] While the standards that are explained here are the most 

stringent because of the nature of exposure in drinking water 

and s-1/gw-1 locations, the complete set of standards that have 

been incorporated into the Massachusetts Contingency Plan are 

attached as Appendix A.[FN21: Id.] [See Appendix A in PDF] 

II. There is a Meaningful Opportunity to Reduce Health Risks 

The well established and significant public health risk of 

perchlorate, along with nonuniform standards among states, 

presents a meaningful opportunity for the Administrator to 

publish a maximum contaminant level goal and promulgate a 

national primary drinking water regulation for perchlorate. 

The statute is unambiguous in its mandate for the Administrator 

to establish national drinking water standards. The SDWA states 

that the Administrator "shall" publish such goals if the three 

factors outlined in this comment are found.[FN22: 42 USC 

§300g-1(b)(1)(A)] 

In Massachusetts v. EPA, the Supreme Court determined that EPA 

refused to comply with a clear statutory command and instead 

offered a "laundry list of reasons not to regulate."[FN23: 

Massachusetts v. EPA, 127 U.S. 1438, 1462 (2007).] The court 

held that EPA's actions were "arbitrary, capricious,...or 

otherwise not in accordance with law."[FN24: Id. at 1463] This 

decision centered on the Court's determination that EPA offered 

no reasoned explanation for its refusal to decide whether 

greenhouse gasses cause or contribute to climate change.[FN25: 

Id.] In the case of SDWA and perchlorate, there is similarly no 

reasoned explanation not to publish a maximum contaminant level 

goal and promulgate a national primary drinking water 

regulation for perchlorate. It is EPA's statutory mandate to 

regulate a contaminant that has adverse health effects and is 

known to occur at a frequency that gives rise to a public 

health concern. The time is ripe and a meaningful opportunity 

is presented for EPA to regulate perchlorate. 

III. Adverse Health Risks of Perchlorate 
Perchlorate is a compound that is both man-made and naturally 

occurring.[FN26: U.S. Food and Drug Administration, Perchlorate 

Questions and Answers, available at 

http://www.cfsan.fda.gov/~dms/clo4qa.html#effects, (updated 

February 7, 2008).] Ammonium perchlorate is used as the primary 

component in solid propellant for rockets, missiles, and 

fireworks.[FN27: USACHPPM, Perchlorate in Drinking Water, 

available at 

http://chppmwww.apgea.army.mil/documents/FACT/31-003-0502.pdf] 

Because of its short shelf life, ammonium perchlorate must 

periodically be replaced within the country's missile and 

rocket inventory. Since the 1950's this has resulted in large 

volumes of the compound being discarded.[FN28: Id.] This 

disposal program has led to contamination of groundwater 

sources, and therefore drinking water is the easiest way to 

come in contact with perchlorate.[FN29: Environmental 

Protection Agency, Perchlorate, available at http:// 

www.epa.gov/fedfac/documents/perchlorate.htm] 

Perchlorate presents a health risk because it interferes with 

the operation of the thyroid gland.[FN30: U.S. Food and Drug 

Administration, Perchlorate Questions and Answers, available at 

http://www.cfsan.fda.gov/~dms/clo4qa.html#effects, (updated 

February 7, 2008).] Because of this interference with thyroid 

function, it has been used medically to treat hyperthyroidism 

and iodine metabolism.[FN31: Id.] In adults, the thyroid 

controls metabolism, while in children it assists in 

development of the central nervous system.[FN32: Id.] 

Accordingly, pregnant woman and newborns are at significant 

health risk from exposure to perchlorate.[FN33: Id.] 

To classify the health risk that perchlorate poses to the 

population, the National Academy of Sciences conducted a study 

and reached a recommended reference dose of 0.7 micrograms per 

kilogram of body weight per day as the amount of percholrate 

that an individual could be exposed to daily without adverse 

effects.[FN34; Id.] In February 2005, EPA adopted this 

reference dose of 0.7 micrograms per kilogram of body weight 

per day.[FN35: Id.] This translates to 24.5 parts per billion 

based on two liters of drinking water consumption per day by 
adults.[FN36: Id.] 

With the current lack of EPA guidance in implementing legally 

binding federal standards, states have adopted a wide variety 

of drinking water standards. Listing perchlorate as a 

contaminant under the SDWA will resolve this ambiguity and 

ensure the nation's drinking water has the minimal amount of 

perchlorate that is safe for human consumption. 

IV. Conclusion 

Perchlorate is just one of many dangerous substances present in 

our nation's drinking water. For too long substances such as 

perchlorate have gone unregulated by EPA, and the public has 

been forced to suffer. Those fortunate enough to live in a 

state which regulates perchlorate, such as Massachusetts, 

should not be the only ones that are protected from being 

subjected to such a dangerous chemical in their drinking water. 

And conversely, residents in states that regulate perchlorate 

should not have to suffer from groundwater contamination from 

neighboring non-regulating states. The time is now to impose a 

national standard for the amount of perchlorate allowed in 

drinking water. 

Sincerely, 

Robert DeLong 

Marlee Furman 

Lane Goldberg 

Terry Oznick 

CS Title: 0070 

Company/group/association name: 

Comment: 
April 5, 2007 

Dear Representative Michele Kupersmith, 

In a recent phone call I mentioned the effects I have had from 

chloraminated water; they began in summer 2006. It was not 

until January 8th of 2007 that I became aware of Chloramine in 

our water and made the connection between my health issues and 

the water supply. 

On that day I ceased using tap water...completely. This caused 

immeasurable inconvenience and aggravation, not to mention 

excessive cost. My energy level returned in 2-3 days and in a 

week my symptoms had totally disappeared. This was all the 

proof I needed to know chloramine is harmful. An expensive 

whole house filtration system had to be installed in order to 

return to using tap water. It is expensive to maintain and, to 

this day, I continue to buy expensive spring water for drinking 

and cooking. 

I am gravely concerned about the long term effects of 

chloramine on the general population. This is a substance that 

has NEVER been studied, tested, or proven safe for human 

consumption. I am aware that there are no dermal, respiratory, 

or epidemiological studies on chloraminated water. 

Please get chloramine (chlorine + ammonia) out of our water, 

NOW. 

Respectfully, 

Elaine Greenfield 

The Canadian EPA has deemed Chloramine "toxic to the 
environment" (CEPA 1999) 

CS Title: 0071 

Company/group/association name: 

Comment: 

April 23, 2007 

Dear Jim Fay, 

In a recent email message I related to you how adversely I was 

affected by chloramine in our tap water, causing me to install 

a whole house filtration system, and, prior to that deal with 

the expense of bottled water, doctor's visits, laundry and 

showers out of town. 

Enclosed is only the first installment of my filtration system 

bill which will end up costing @ $2000. Added to this are other 

costs averaging @ $70 per month (doctors, bottled water, 

showers and laundry) 

As a tax payer in South Burlington, I really object to the fact 

that I have been forced into this situation by the Champlain 

Water District. I am paying a premium for potable water in 

addition to what I must pay the city of So. Burlington for 

water supplied by the CWD. (see enclosed bill) 

I firmly believe there should be some manner of compensation 

available to people negatively impacted by the water supply. 

Sincerely, 

Elaine Greenfield 

CS Title: 0072 

Company/group/association name: 

Comment: 
COMMENT 

Docket Title 

Drinking Water Contaminant Candidate List 3 

Docket ID 

EPA-HQ-OW-2007-1189 

Document ID 

EPA-HQ-OW-2007-1189-0001 

Name: Josephine M. Rakow, DO 

Address: P.O. Box 6, Camp Hill, PA 17001 

Phone: (717) 737-7643 

I am a resident in a water service area using or intending to 

use chloramine as a disinfectant in my drinking water system. I 

understand that when monochloramine interacts with organic 

material many toxic byproducts are formed. Two of the most 

toxic byproducts of chloramine appear on your CCL 3, Hydrazine 

and N-Nitrosamines, specifically the most toxic, NDMA. Four 

other N-Nitrosamines, NDPA, NDEA, Nitrosodiphenylamine and NPYR 

also appear on the CCL3 list as likely disinfection byproducts. 

It was my understanding that NDMA has already been determined 

to be a 'probable human carcinogen" by the USEPA. It is also my 

understanding that Hydrazine is genotoxic. Little is known 

about the effect of these byproducts in the levels they are 

formed in the drinking water system. However, peer reviewed 

studies would indicate that these emerging byproducts are 

possibly 100's of times more toxic than those of chlorine. 
Water systems across the country are using or are intending to 

use chloramine as a disinfectant in order to meet EPA's Stage 2 

regulations regarding chlorine byproducts on the recommendation 

or suggestion of EPA. It is incumbent upon EPA then to study 

the byproducts of chloramine expeditiously in order to protect 

the public health from byproducts far worse than those of 

chlorine. I am asking not only for a study of these byproducts, 

but a moratorium on the use of chloramine until it's byproducts 

are studied and determined to be safe. 

Thank you. 

CS Title: 0073 

Company/group/association name: 

Comment: 

I want the chemicals and pathogens on the below Candidate 

Contaminant List to be part of the standard contaminant list so 

that our own local water departments will receive the directive 

to monitor these additional contaminants on a regular basis 

Beyond Pesticides) EPA is seeking public comments on a proposed 

list of 104 possible drinking water contaminants that may need 

to be regulated in the future to ensure the continued 

protection of drinking water. Under the Safe Drinking Water 

Act, EPA includes on the draft Contaminant Candidate List (CCL) 

currently unregulated contaminants that are known or 

anticipated to occur in public water systems and which may 

require regulation. This draft CCL, which is the third such 

listing, lists 93 chemical contaminants or groups and 11 

microbes, and describes the process and basis for selecting 

these contaminants."EPA is casting a broader scientific net for 

potential regulation of chemicals and microbes in drinking 

water," said Assistant Administrator for Water Benjamin H. 

Grumbles. "EPA's proposed list of priority contaminants will 

advance sound science and public health by targeting research 

on certain chemicals and microbes and informing regulators on 

how best to reduce risk." 

The CCL process was established by the 1996 amendments to the 

Safe Drinking Water Act as a mechanism to determine if new 
regulations are needed to protect drinking water. Under this 

process EPA conducted extensive research into the occurrence 

and health effects of the listed contaminants before issuing 

new regulations or standards. 

In developing the draft CCL 3, the agency implemented a new 

approach for selecting contaminants which builds upon 

evaluations used for previous lists and is based on substantial 

expert input early in the process and recommendations from a 

larger number of different groups including stakeholders, the 

National Research Council and the National Drinking Water 

Advisory Council. 

The draft list includes chemicals used in commerce, pesticides, 

biological toxins, disinfection byproducts, and waterborne 

pathogens. The agency evaluated approximately 7,500 chemicals 

and microbes and selected 104 candidates for the final draft 

list based on their potential to pose health risks through 

drinking water exposure. The comment period is open for 90 days 

beginning the day of publication in the Federal Register, 

February 21, 2008 and ends May 21, 2008. 

The CCL has expanded to include roughly 40 pesticides and 

pesticide degradates, and includes acephate, captan, 

permethrin, and ziram. The first CCL listed only 60 

contaminants, which included less than 12 pesticides. 

Research has shown that over 200 contaminants are present in 

drinking water across the U.S., and more than half of these are 

unregulated (See Daily News of January 9, 2006 and March 3, 

2006). Exposure to these contaminants can cause serious adverse 

effects, including cancer, reproductive toxicity and birth 

defects. EPA has previously failed to enforce testing that 

would reveal the pollutants in tap water supplies and to set 

health-based limits for those found in tap water. EPA has also 

missed three mandatory Safety Drinking Water Act deadlines to 

set standards for unregulated contaminants. 

For more information on the CCL 3 and the list of contaminants 
visit: http://www.epa.gov/safewater/ccl/ccl3.html . For 

additional CCL 3 support documents and more detailed 

information on the contaminants, visit docket number EPA-HQ- 

OW-2007-1189. To submit a comment visit Regulation.gov and 

enter the above docket number. Comment period ends May 21, 

2008. 

EPA Contact: Dave Ryan, (202) 564-4355 / ryan.dave@epa.gov. 

CS Title: 0074 

Company/group/association name: 

Comment: 

#8 Buck Ridge Drive 

Wilmington, DE 19807 

Comment on Proposed EPA 

Drinking Water Contaminant Candidate List 3 

Docket: EPA-HQ-OW-2007-1189 

April 25, 2008 

As leader of a support group in Wilmington DE for men and women 

afflicted with non-tuberculosis mycobacteria pulmonary 

disease... and on behalf of that group... I am writing with the 

following request: 

Pursuant to the proposed list of contaminants on the Federal 

Register, I request that: 

i) Mycobacterium avium remain on the CCL and that 

ii) Mycobacterium avium be given the significantly higher score 

it merits. 

M. avium and related strains of mycobacteria (nontuberculous 
mycobacteria, or NTM) are known water contaminants that are 

currently being assessed relative to human morbidity and 

mortality. 

Environmental Source and Infection 

In April 2008, the Centers for Disease Control convened a 

meeting of leading experts to discuss priorities for better 

surveillance and understanding of this disease. NTM Info & 

Research (NTMir), the national not-for-profit organization for 

pulmonary NTM infection, is currently funding a pilot study 

[FNi: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] 

to determine the connection between household water, which 

includes drinking water, and pulmonary NTM infection. Of five 

initial patients suffering from pulmonary NTM disease and their 

households surveyed thus far, four (or 80%) were determined to 

have lung infection identical to the strain in the water.[FNii: 

http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 

20 additional patient homes are currently being studied and 

compared to sputum. 

Epidemiology - Increasing Prevalence 

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore 

P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- 

tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 

62:661-6.] provides concrete evidence that the prevalence of 

pulmonary NTM infections is much higher than previously 

understood. A pilot study is currently in process by NAIAD and 

Kaiser Permanente of Southern California to provide a snapshot 

of the epidemiology of pulmonary NTM in the United 

States.[FNiv: 

http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] 

Health Effects 

As data is not currently collected by the CDC or any other 

agency, it is difficult to assess the mortality rates of 
pulmonary NTM in the United States until completion of the 

NAIAD/Kaiser Permanente study mentioned above. 

M. avium and other NTM cause pneumonia and other severe 

manifestations of illness frequently requiring hospitalization 

in excess of one week. Many, if not most NTM-related 

hospitalizations last more than 7 days. 

M. avium and other NTM infections can cause long term 

dysfunction or disability due to progressive and permanent loss 

of lung function. 

M. avium and other NTM's cause illness requires long-term 

physician intervention as initial treatment typically requires 

18-24 months of multi-antibiotic therapy, frequent CT scans, 

and frequent sputum testing. 

Aging Population at Greater Risk 

There appears to be an increase in pulmonary NTM infection in 

the immune competent population over age 60 with a majority 

being women.[FNv: Official ATS/IDSA Statement: Diagnosis, 

Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. 

Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in 

addition to individuals with underlying vulnerability such as 

Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune 

compromised patients (HIV/AIDS, chemotherapy), 

I believe that removing M. avium from the CCL is not in the 

public's best interest and will have a negative impact on the 

U.S. population. Pulmonary NTM disease is being diagnosed with 

increasing frequency across the United States. We request that 

the EPA continue to monitor M. Avium in the water supply and 

give it a higher score. 

Thank you for your attention and consideration in this matter. 
Sincerely, 

Jolly Clarkson-Shorter 

CS Title: 0075 

Company/group/association name: 

Comment: 

Colorado State University 

College of Veterinary Medicine 

and Biomedical Sciences 

Department of Microbiology, Immunology and Pathology 

Fort Collins, Colorado 80523-1677 

Telephone: (970) 491-6136 

FAX: (970) 491-1815 

http://www.cvmbs.colostate.edu/microbiology/ 

Comment on Proposed EPA 

Drinking Water Contaminant Candidate List 3 

Docket: EPA-HQ-OW-2007-1189 

April 25, 2008 

Pursuant to the proposed list of contaminants on the Federal 

Register, I request that: 

i) Mycobacterium avium remain on the CCL and that 

ii) Mycobacterium avium be given the significantly higher score 

it merits. 
M. avium and related strains of mycobacteria (nontuberculous 

mycobacteria, or NTM) are known water contaminants that are 

currently being assessed relative to human morbidity and 

mortality. 

Environmental Source and Infection 

In April 2008, the Centers for Disease Control convened a 

meeting of leading experts to discuss priorities for better 

surveillance and understanding of this disease. NTM Info & 

Research (NTMir), the national not-for-profit organization for 

pulmonary NTM infection, is currently funding a pilot study 

[FNi: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] 

to determine the connection between household water, which 

includes drinking water, and pulmonary NTM infection. Of five 

initial patients suffering from pulmonary NTM disease and their 

households surveyed thus far, four (or 80%) were determined to 

have lung infection identical to the strain in the water.[FNii: 

http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 

20 additional patient homes are currently being studied and 

compared to sputum. 

Epidemiology - Increasing Prevalence 

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore 

P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- 

tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 

62:661-6.] provides concrete evidence that the prevalence of 

pulmonary NTM infections is much higher than previously 

understood. A pilot study is currently in process by NAIAD and 

Kaiser Permanente of Southern California to provide a snapshot 

of the epidemiology of pulmonary NTM in the United 

States.[FNiv: 

http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] 

Health Effects 

As data is not currently collected by the CDC or any other 
agency, it is difficult to assess the mortality rates of 

pulmonary NTM in the United States until completion of the 

NAIAD/Kaiser Permanente study mentioned above. 

M. avium and other NTM cause pneumonia and other severe 

manifestations of illness frequently requiring hospitalization 

in excess of one week. Many, if not most NTM-related 

hospitalizations last more than 7 days. 

M. avium and other NTM infections can cause long term 

dysfunction or disability due to progressive and permanent loss 

of lung function. 

M. avium and other NTM's cause illness requires long-term 

physician intervention as initial treatment typically requires 

18-24 months of multi-antibiotic therapy, frequent CT scans, 

and frequent sputum testing. 

Aging Population at Greater Risk 

There appears to be an increase in pulmonary NTM infection in 

the immune competent population over age 60 with a majority 

being women.[FNv: Official ATS/IDSA Statement: Diagnosis, 

Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. 

Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in 

addition to individuals with underlying vulnerability such as 

Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune 

compromised patients (HIV/AIDS, chemotherapy), 

I believe that removing M. avium from the CCL is not in the 

public's best interest and will have a negative impact on the 

U.S. population. Pulmonary NTM disease is being diagnosed with 

increasing frequency across the United States. We request that 

the EPA continue to monitor M. Avium in the water supply and 

give it a higher score. 

Thank you for your attention and consideration in this matter. 
Sincerely, 

Diane Ordway, PhD 

Assistant Professor 

Department of Microbiology, Immunology and Pathology 

Colorado State University 

CS Title: 0076 

Company/group/association name: 

Comment: 

Comment on Proposed EPA 

Drinking Water Contaminant Candidate List 3 

Docket: EPA-HQ-OW-2007-1189 

April 25, 2008 

Pursuant to the proposed list of contaminants on the Federal 

Register, I request that: 

i) Mycobacterium avium remain on the CCL and that 

ii) Mycobacterium avium be given the significantly higher score 

it merits. 

M. avium and related strains of mycobacteria (nontuberculous 

mycobacteria, or NTM) are known water contaminants that are 

currently being assessed relative to human morbidity and 

mortality. 

Environmental Source and Infection 

In April 2008, the Centers for Disease Control convened a 

meeting of leading experts to discuss priorities for better 
surveillance and understanding of this disease. NTM Info & 

Research (NTMir), the national not-for-profit organization for 

pulmonary NTM infection, is currently funding a pilot 

study[FNi] to determine the connection between household water, 

which includes drinking water, and pulmonary NTM infection. Of 

five initial patients suffering from pulmonary NTM disease and 

their households surveyed thus far, four (or 80%) were 

determined to have lung infection identical to the strain in 

the water.[FNii] At least 20 additional patient homes are 

currently being studied and compared to sputum. 

Epidemiology -Increasing Prevalence 

A recent study from Toronto, Ontario,[FNiii] provides concrete 

evidence that the prevalence of pulmonary NTM infections is 

much higher than previously understood. A pilot study is 

currently in process by NAIAD and Kaiser Permanente of Southern 

California to provide a snapshot of the epidemiology of 

pulmonary NTM in the United States.[FNiv] 

Health Effects 

As data is not currently collected by the CDC or any other 

agency, it is difficult to assess the mortality rates of 

pulmonary NTM in the United States until completion of the 

NAIAD/Kaiser Permanente study mentioned above. 

M. avium and other NTM cause pneumonia and other severe 

manifestations of illness frequently requiring hospitalization 

in excess of one week. Many, if not most NTM-related 

hospitalizations last more than 7 days. 

M. avium and other NTM infections can cause long term 

dysfunction or disability due to progressive and permanent loss 

of lung function. 

M. avium and other NTM's cause illness requires long-term 
physician intervention as initial treatment typically requires 

18-24 months of multi-antibiotic therapy, frequent CT scans, 

and frequent sputum testing. 

Aging Population at Greater Risk 

There appears to be an increase in pulmonary NTM infection in 

the immune competent population over age 60 with a majority 

being women.[FNv] This is in addition to individuals with 

underlying vulnerability such as Cystic Fibrosis, Alpha-1 

deficiency, bronchiectasis or immune compromised patients 

(HIV/AIDS, chemotherapy), 

I believe that removing M. avium from the CCL is not in the 

public's best interest and will have a negative impact on the 

U.S. population. Pulmonary NTM disease is being diagnosed with 

increasing frequency across the United States. I request that 

the EPA continue to monitor M. Avium in the water supply and 

give it a higher score. 

Thank you for your attention and consideration in this matter. 

I am a group leader with over 50 NTM patients primarily in the 

Dallas, Tx area. Most of us are patients of Dr. Richard Wallace 

at UT Health Center @ Tyler. I have led this support group for 

over 5 years. 

Sincerely, 

Amy Cherrnay 

2806 Lake Brook Ct 

Highland Village, TX 75077 972-318-8970 

CS Title: 0078 

Company/group/association name: 

Comment: 

Comment on Proposed EPA 

Drinking Water Contaminant Candidate List 3 
Docket: EPA-HQ-OW-2007-1189 

April 25, 2008 

Pursuant to the proposed list of contaminants on the Federal 

Register, I request that: 

i) Mycobacterium avium remain on the CCL and that 

ii) Mycobacterium avium be given the significantly higher score 

it merits. 

M. avium and related strains of mycobacteria (nontuberculous 

mycobacteria, or NTM) are known water contaminants that are 

currently being assessed relative to human morbidity and 

mortality. 

Environmental Source and Infection 

In April 2008, the Centers for Disease Control convened a 

meeting of leading experts to discuss priorities for better 

surveillance and understanding of this disease. NTM Info & 

Research (NTMir), the national not-for-profit organization for 

pulmonary NTM infection, is currently funding a pilot study 

[FNi: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] 

to determine the connection between household water, which 

includes drinking water, and pulmonary NTM infection. Of five 

initial patients suffering from pulmonary NTM disease and their 

households surveyed thus far, four (or 80%) were determined to 

have lung infection identical to the strain in the water.[FNii: 

http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 

20 additional patient homes are currently being studied and 

compared to sputum. 

Epidemiology - Increasing Prevalence 
A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore 

P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- 

tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 

62:661-6.] provides concrete evidence that the prevalence of 

pulmonary NTM infections is much higher than previously 

understood. A pilot study is currently in process by NAIAD and 

Kaiser Permanente of Southern California to provide a snapshot 

of the epidemiology of pulmonary NTM in the United 

States.[FNiv: 

http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] 

Health Effects 

As data is not currently collected by the CDC or any other 

agency, it is difficult to assess the mortality rates of 

pulmonary NTM in the United States until completion of the 

NAIAD/Kaiser Permanente study mentioned above. 

M. avium and other NTM cause pneumonia and other severe 

manifestations of illness frequently requiring hospitalization 

in excess of one week. Many, if not most NTM-related 

hospitalizations last more than 7 days. 

M. avium and other NTM infections can cause long term 

dysfunction or disability due to progressive and permanent loss 

of lung function. 

M. avium and other NTM caused illness requires long-term 

physician intervention as initial treatment typically requires 

18-24 months of multi-antibiotic therapy, frequent CT scans, 

and frequent sputum testing. My own case requires continuing 

treatment with 3-4 antibiotics, plus daily physical airway 

clearance using an electric vibrating vest. 

Aging Population at Greater Risk 
There appears to be an increase in pulmonary NTM infection in 

the immune competent population over age 60 with a majority 

being women.[FNv: Official ATS/IDSA Statement: Diagnosis, 

Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. 

Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in 

addition to individuals with underlying vulnerability such as 

Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune 

compromised patients (HIV/AIDS, chemotherapy), 

I believe that removing M. avium from the CCL is not in the 

public best interest and will have a negative impact on the 

U.S. population. Pulmonary NTM disease is being diagnosed with 

increasing frequency across the United States. We request that 

the EPA continue to monitor M. Avium in the water supply and 

give it a higher score. 

I represent a support group of eight other patients in 

Minnesota and western Wisconsin. 

Thank you for your attention and consideration in this matter. 

Sincerely, 

Jean Ratchye 

309 Ryan Ave. 

St. Paul MN 55102 

CS Title: 0079 

Company/group/association name: 

Comment: 

Comment on Proposed EPA 

Drinking Water Contaminant Candidate List 3 

Docket: EPA-HQ-OW-2007-1189 

April 25, 2008 
Pursuant to the proposed list of contaminants on the Federal 

Register, I request that: 

i) Mycobacterium avium remain on the CCL and that 

ii) Mycobacterium avium be given the significantly higher score 

it merits. 

M. avium and related strains of mycobacteria (nontuberculous 

mycobacteria, or NTM) are known water contaminants that are 

currently being assessed relative to human morbidity and 

mortality. 

Environmental Source and Infection 

In April 2008, the Centers for Disease Control convened a 

meeting of leading experts to discuss priorities for better 

surveillance and understanding of this disease. NTM Info & 

Research (NTMir), the national not-for-profit organization for 

pulmonary NTM infection, is currently funding a pilot study 

[FNi: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] 

to determine the connection between household water, which 

includes drinking water, and pulmonary NTM infection. Of five 

initial patients suffering from pulmonary NTM disease and their 

households surveyed thus far, four (or 80%) were determined to 

have lung infection identical to the strain in the water.[FNii: 

http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 

20 additional patient homes are currently being studied and 

compared to sputum. 

Epidemiology - Increasing Prevalence 

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore 

P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- 

tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 

62:661-6.] provides concrete evidence that the prevalence of 

pulmonary NTM infections is much higher than previously 
understood. A pilot study is currently in process by NAIAD and 

Kaiser Permanente of Southern California to provide a snapshot 

of the epidemiology of pulmonary NTM in the United 

States.[FNiv: 

http://www.ntminfo.org/default_aspx/p/article/id/16.aspx ] 

Health Effects 

As data is not currently collected by the CDC or any other 

agency, it is difficult to assess the mortality rates of 

pulmonary NTM in the United States until completion of the 

NAIAD/Kaiser Permanente study mentioned above. 

M. avium and other NTM cause pneumonia and other severe 

manifestations of illness frequently requiring hospitalization 

in excess of one week. Many, if not most NTM-related 

hospitalizations last more than 7 days. 

M. avium and other NTM infections can cause long term 

dysfunction or disability due to progressive and permanent loss 

of lung function. 

M. avium and other NTM's cause illness requires long-term 

physician intervention as initial treatment typically requires 

18-24 months of multi-antibiotic therapy, frequent CT scans, 

and frequent sputum testing. 

Aging Population at Greater Risk 

There appears to be an increase in pulmonary NTM infection in 

the immune competent population over age 60 with a majority 

being women.[FNv: Official ATS/IDSA Statement: Diagnosis, 

Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. 

Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in 

addition to individuals with underlying vulnerability such as 

Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune 

compromised patients (HIV/AIDS, chemotherapy), 
I believe that removing M. avium from the CCL is not in the 

public's best interest and will have a negative impact on the 

U.S. population. Pulmonary NTM disease is being diagnosed with 

increasing frequency across the United States. We request that 

the EPA continue to monitor M. Avium in the water supply and 

give it a higher score. 

Thank you for your attention and consideration in this matter. 

Sincerely, 

Carole LaMontagne 

Support Group Leader of New England States 

I am representing 26 ladies and 1 man that have NTM disease 

CS Title: 0080 

Company/group/association name: 

Comment: 

Comment on Proposed EPA 

Drinking Water Contaminant Candidate List 3 

Docket: EPA-HQ-OW-2007-1189 

April 25, 2008 

Pursuant to the proposed list of contaminants on the Federal 

Register, I request that: 

i) Mycobacterium avium remain on the CCL and that 

ii) Mycobacterium avium be given the significantly higher score 

it merits . 

M. avium and related strains of mycobacteria (nontuberculous 
mycobacteria, or NTM) are known water contaminants that are 

currently being assessed relative to human morbidity and 

mortality. 

Environmental Source and Infection 

In April 2008, the Centers for Disease Control convened a 

meeting of leading experts to discuss priorities for better 

surveillance and understanding of this disease. NTM Info & 

Research (NTMir), the national not-for-profit organization for 

pulmonary NTM infection, is currently funding a pilot study 

[FNi: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] 

to determine the connection between household water, which 

includes drinking water, and pulmonary NTM infection. Of five 

initial patients suffering from pulmonary NTM disease and their 

households surveyed thus far, four (or 80%) were determined to 

have lung infection identical to the strain in the water.[FNii: 

http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 

20 additional patient homes are currently being studied and 

compared to sputum. 

Epidemiology - Increasing Prevalence 

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore 

P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- 

tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 

62:661-6.] provides concrete evidence that the prevalence of 

pulmonary NTM infections is much higher than previously 

understood. A pilot study is currently in process by NAIAD and 

Kaiser Permanente of Southern California to provide a snapshot 

of the epidemiology of pulmonary NTM in the United 

States.[FNiv: 

http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] 

Health Effects 

As data is not currently collected by the CDC or any other 

agency, it is difficult to assess the mortality rates of 
pulmonary NTM in the United States until completion of the 

NAIAD/Kaiser Permanente study mentioned above. 

M. avium and other NTM cause pneumonia and other severe 

manifestations of illness frequently requiring hospitalization 

in excess of one week. Many, if not most NTM-related 

hospitalizations last more than 7 days. 

M. avium and other NTM infections can cause long term 

dysfunction or disability due to progressive and permanent loss 

of lung function. 

M. avium and other NTM's cause illness requires long-term 

physician intervention as initial treatment typically requires 

18-24 months of multi-antibiotic therapy, frequent CT scans, 

and frequent sputum testing. 

Aging Population at Greater Risk 

There appears to be an increase in pulmonary NTM infection in 

the immune competent population over age 60 with a majority 

being women.[FNv: Official ATS/IDSA Statement: Diagnosis, 

Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. 

Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in 

addition to individuals with underlying vulnerability such as 

Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune 

compromised patients (HIV/AIDS, chemotherapy), 

I believe that removing M. avium from the CCL is not in the 

public's best interest and will have a negative impact on the 

U.S. population. Pulmonary NTM disease is being diagnosed with 

increasing frequency across the United States. We request that 

the EPA continue to monitor M. Avium in the water supply and 

give it a higher score. 

Thank you for your attention and consideration in this matter. 
Sincerely, 

Deanne York, patient/East Texas Support Group Leader 

17335 Hidden Valley Lane 

Flint, TX 76752 

Home phone 903-561-6672 

Cell 713-417-6615 

dsyork1@sbcglobal.net 

PS. I am an NTM Support Group Leader from East Texas. I 

represent over 60 NTM patients. Most of those patients have 

MAC!!! MAI 

CS Title: 0083 

Company/group/association name: 

Comment: 

Please find attached a recent review publication on the risk 

assessment for human health associated to cyanotoxins exposure. 

E. Funari and E. Testai Human health risk assessment related to 

cyanotoxins exposure. Critical Rev. Toxicol., 38, 97-126 

(2008). [See PDF for Attachment] 

Hoping it could be useful to your evaluation 

Sincerely yours 

Emanuela Testai & Enzo Funari 

Dr. Emanuela Testai 

Istituto Superiore di Sanità 

Environment & Primary Prevention Dept. 

Mechanisms of Toxicity Unit 

Viale Regina Elena, 299 

00161 Roma (Italy) 

Tel. +39 06 49902920 

Fax +39 06 49387139 
E-mail: emanuela.testai@iss.it 

CS Title: 0084 

Company/group/association name: 

Comment: 

May 8, 2008 

Via www.regulations,gov 

Docket ID No. EPA-HQ-OW-2007-1189 

Water Docket 

U.S. Environmental Protection Agency 

Mail Code: 2822T 

1200 Pennsylvania Avenue, NW 

Washington. DC 20460 

Re: Dow AgroSciences Cormnents on EPA's Draft Drinking Water 

Contaminant Candidate List 3 

To whom it may concern: 

Dow AgroSciences LLC ("DAS") appreciates the opportunity to 

provide comments on the draft "Drinking Water Contaminant List 

3" released by EPA on February 21, 2008 (EPA-HQ-OW-2007-118, 

FRL-8529-7). As the primary manufacturer of the chemical 

tebufenozide (CASRN 112410-23-8), DAS recommends that EPA 

remove tebufenozide from the draft list for regulation as a 

contaminant under the Safe Drinking Water Act (SDWA). A 

rationale for this recommendation is provided below. 

1. Tebufenozide is a pesticide which is already adequately 

regulated by the U.S. EPA's Office of Pesticide Programs (OPP) 

under FIFRA and FEPCA. 

Tebufenozide was registered for use by the U.S. EPA's Office of 

Pesticide Programs under auspices of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) and Federal Food, Drug, 

and Cosmetic Act (FFDCA) as modified by the Food Quality 

Protection Act of 1996 after thorough evaluation of the 

potential environmental impacts and human safety associated 

with its use. Reports of more than 300 studies documenting the 

chemistry, environmental fate, toxicology and human safety of 

tebufenozide are on file with EPA's OPP and support the 

registered uses of the products as regulated under FIFRA and 

FEPCA. 

In addition to Tebufenozide Technical (EPA Reg. No. 62719-419), 

registered for manufacturing use, approved products for use by 

farmers and pest management specialists include Confirm[FN*: 

Trademark of Dow AgroSciences] 2F (EPA Reg. No. 62719-420), 

Confirm 70WSP (EPA Reg. No. 62719-434), and Mimic[FN*: 

Trademark of Dow AgroSciences] 2LV (EPA Reg. No. 62719-439). 

Tebufenozide-containing products are sold for use through 

professional pest management dealers and distributors, and they 

are not marketed for retail consumer use in home yards or 

gardens. Labeling and use of tebufenozide-containing products 

are highly regulated by U.S. EPA as well as state lead 

pesticide regulatory agencies. Precautions to prevent entry of 

tebufenozide to surface or ground waters are included on each 

product label: 

* Do not cultivate within 10 feet of aquatic areas so as to 

allow growth of a vegetative filter strip. 

* For terrestrial uses, do not apply directly to water or to 

areas where surface water is present or to intertidal areas 

below the mean high water mark, except under forest canopy when 

aerially applied to control forest pests. 

* Do not contaminate water when disposing of equipment 

washwaters and rinsate. 

* Do not apply when weather conditions favor drift or runoff 

from areas treated. 
DAS believes existing regulation of tebufenozide by EPA under 

FIFRA and FEPCA is adequate to protect the environment and 

human health, including drinking water, and does not believe 

additional regulation under SDWA is warranted. 

2. Tebufenozide is a pesticide product being promoted by EPA as 

a preferred alternative to existing products, and further 

regulation under the SDWA would be counterproductive to this 

aim. 

Tebufenozide was first registered for use as a pesticide by 

U.S. EPA during 1995 under its "reduced risk" program. This 

program expedites the approval of conventional pesticides that 

the Agency believes pose less risk to human health and the 

environment than existing alternatives. Subsequent to its 

initial classification and registration as a reduced risk 

product by EPA for use in walnuts during 1995, tebufenozide was 

classified as reduced risk and gained registration approval for 

uses including pecans (1998), leafy vegetables, brassica 

vegetables, fruiting vegetables, cranberry, forestry, 

ornamentals, berries, mint, pome fruit, cotton, turnip, canola 

(1999), tree nuts (2000), citrus fruits, grapes, and tuberous 

and corm vegetables (2004). 

In addition, tebufenozide received a Presidential Green 

Chemistry Challenge Award in 1998 from U.S. EPA. The aim of 

this program is to promote pollution prevention and industrial 

ecology as well as the principles of green chemistry in 

chemical design, manufacture and use. In conferring the award, 

EPA noted that tebufenozide (trade name Confirm) 

"...effectively and selectively controls important caterpillar 

pests in agriculture without posing significant risk to the 

applicator, the consumer, and the ecosystem. It will replace 

many older, less effective, more hazardous insecticides..." 

Both of these programs have promoted the use of tebufenozide as 

a reduced risk, green chemistry alternative and further 

regulation under the SDWA by the EPA Office of Water would be 

at odds with this clear intent of the Agency. 
3. Tebufenozide does not have an environmental fate profile 

that would make it a high priority for regulation in drinking 

water. 

Based on studies conducted according to EPA OPP guidelines 

(Dong et. al., 2000) and on file with the Agency, tebufenozide 

has a dissipation half-life in soil of 7 to 66 days under 

aerobic laboratory conditions and a half-life of 31 to 53 days 

in soil under field conditions. These degradation rates 

indicate that tebufenozide will not accumulate or persist in 

the soil environment. Moreover, tebufenozide has an average 

sorption coefficient (Koc) of 572, which indicates that it is 

not highly mobile. Given its rapid degradation in soil and 

favorable Koc, it is unlikely to enter surface or ground water 

environments via runoff or leaching. 

Tebufenozide has not been listed by the U.S. Geological 

Survey's National Water Quality Assessment Program or the U.S. 

Department of Agriculture's Pesticide Data Program as a 

priority ground or surface water contaminant for monitoring 

purposes. 

*Dong, L.; Hazelton, G.A.; Fernandes, J.M.; Lisk, D.C.; Long, 

l.W. (2000) "Contirm 2F and Contirm 70WSP Agricultural 

Insecticides - Reduced Risk Rationale - Citrus", Report 

OOR-1029, 134 pages (MRID 45141001). 

4. Tebufenozide does not have a toxicological profile that 

would that would make it a high priority for regulation in 

drinking water. Maximum contaminant levels (MCLs) under SDWA 

are established by the U.S. EPA for those "chemicals that are 

thought to pose the most serious risk." A review of the 

toxicological database for tebufenozide reveals and supports a 

low hazard toxicological profile and as such, there would 

appear to be little scientific basis for including tebufenozide 

as a candidate for MCL development. 
Tebufenozide is of low acute toxicity, with no mortality or 

significant clinical signs following doses as high as 5000 

mg/kg/day by oral and dermal routes of exposure. Tebufenozide 

represents a low hazard via inhalation as well. It is not a 

skin or eye irritant and is not associated with dermal 

sensitization. Tebufenozide is rapidly absorbed by the body and 

eliminated quickly, with limited tissue distribution and 

metabolism. It is not bioaccumulative. 

In studies using oral exposure in laboratory animals ranging 

from 28 to 52 weeks in duration, tebufenozide was generally 

well-tolerated at dose levels up to regulatory limit doses. 

There are established NOAELs and LOAELs for all short and long- 

term studies involving tebufenozide. Tebufenozide showed no 

indication of genotoxicity in a variety of in vitro and in vivo 

studies including gene mutation, clastogenicity, and 

unscheduled DNA synthesis. Metabolites of tebufenozide that 

have been evaluated also show no indication of genotoxic or 

mutagenic potential. In standard guideline-compliant 

oncogenicity studies, tebufenozide was devoid of carcinogenic 

potential and showed no signs reflective of chronic toxicity. 

Tebufenozide has been evaluated in two multigeneration 

reproduction studies and there is no indication that it poses a 

specific reproductive hazard. Similarly, it is not a specific 

developmental toxicant and is not teratogenic as evaluated in 

two species. In an assessment of neurotoxicity following single 

high doses, tebufenozide was devoid of findings indicative of 

neurotoxic potential. An acceptable daily intake (ADI) value of 

0.02 mg/kg bw/day has been proposed based upon an NOAEL 

(hematological effects) of 2 mg/kg bw/day obtained in a 52-week 

dog study. 

In summary, tebufenozide represents a low-hazard compound with 

no sentinel toxicological effects or critical endpoints that 

drive the need for establishment of an MCL in drinking water. 

5. Tebufenozide does not have a current or future use profile 

that would make it a high priority for regulation in drinking 

water. 
When introduced onto the market as a pesticide product in the 

mid-1990's, tebufenozide was initially widely used in fruit, 

vegetable, and row crop agriculture. As manufacturers including 

DAS have introduced newer insecticide products during the 

intervening years, many uses of tebufenozide have been replaced 

by these newer products. Thus, use of tebufenozide has declined 

significantly during the past several years, and more than 90% 

of product use is now associated with sugarcane agriculture in 

the Southern U.S. where it continued to have an excellent fit 

with integrated pest management programs. DAS anticipates that 

use of tebufenozide on a niche market basis will continue for 

the foreseeable future in U.S. agriculture but will not expand 

significantly as newer alternatives continue to be introduced. 

Thus, the volume of current and projected tebufenozide use in 

the U.S. would not seem to merit serious consideration for 

regulation under the SDWA as a priority contaminant. 

Kenneth D. Racke, Ph.D. 

Regulatory Manager - Insecticides 

U.S. Regulatory and Government Affairs 

CS Title: 0085 

Company/group/association name: 

Comment: 

On behalf of Breast Cancer Action and our 20,000 members, we 

urge you to adopt the Contaminant Candidate List (CCL 3) to 

ensure that drinking water is properly monitored for toxic 

chemicals. Breast Cancer Action is very concerned about the 

link between environmental exposures and breast cancer. Many of 

the contaminants on the CCL 3 are associated with breast cancer 

and other diseases, and should be properly monitored and 

regulated. 

We also want to ensure that perchlorate is federally regulated, as it is in California. 

Thank you for giving us the opportunity to comment on drinking 

water standards. 

Sincerely, 
Barbara A. Brenner 

Executive Director 

Breast Cancer Action 

CS Title: 0055 

Company/group/association name: 

Comment: 

I urge you to include the chemicals and pathogens on the 

Candidate Contaminant list as part of EPA's standard 

contaminant list. I believe this is essential for protectionof 

public health. This refers to Docket #EPA-HQ-OW-2007-1189-0001. 

CS Title: 0088 

Company/group/association name: 

Comment: 

Attached you will find comments from the Methanol Institute 

encouraging the Agency not to include methanol on the final 

Contaminant Candidate List 3. 

May 15, 2008 

Water Docket 

Environmental Protection Agency 

Mailcode: 2822T 

1200 Pennsylvania Avenue, N.W. 

Washington, D.C. 20460 

Docket ID No. EPA-HQ-OW-2007-1189 

Comments of the Methanol Institute Regarding Drinking Water 

Contaminant Candidate List 3 - Draft 

The Federal Register notice of February 21, 2008, published for 

public review and comments a draft list of contaminants that 

are currently not subject to any proposed or promulgated 

national primary drinking regulations, that are known or 

anticipated to occur in public water systems, and which may 
require regulation under the Safe Drinking Water Act. This 

notice included methanol as a candidate chemical for listing. 

We believe that methanol does not pose a risk to drinking water 

and would therefore not be an appropriate candidate for a 

national primary drinking water standard. 

The Methanol Institute serves as the trade association for the 

global methanol industry. Methanol is an essential chemical 

building block used to manufacture a wide range of products 

including building materials, plastics, adhesives, solvents, 

paints, textiles, refrigerants, windshield wash and anti- 

freeze, and fuels. In 2008, the U.S. is expected to consume 6.7 

million metric tons (or 2.2 billion gallons) of methanol. Our 

industry's commitment to product stewardship helps ensure that 

methanol is used in a safe and responsible manner. 

In considering whether to include methanol in the draft CCL 3 

listing, the Agencys own evaluation team assigned methanol to 

the "L?-L" model decision category. This means that the 

evaluation team found methanol to be close to the boundary for 

a List-Not List decision, and "leaned" towards listing. 

Clearly, the evaluation team itself questioned a listing for 

methanol, and in reviewing the "Attribute Score" for methanol 

we can see why methanol was on the boundary. 

Methanol was assigned a potency score of "3," on a "1" to "10" 

range indicating that low doses of methanol are not a 

significant concern for adverse health effects. In terms of 

severity, methanol scored a "6" on a nine point range as having 

health effects that may be "significant, irreversible, non- 

lethal conditions or disorders." In terms of severity, methanol 

was not considered a risk for developmental or reproductive 

effects, tumors or disorders likely leading to death, or death. 

These scores are based on a reference dose (U.S. EPA 1986), 

which is considered the richest supporting data set. 

The preliminary CCL3 suggests a severity grade of "6" for 

methanol toxicity, "significant, irreversible, nonlethal 

conditions or disorder". The data from the selected study (the 

basis for the EPA RfD) indicated altered organs weights and 
increased serum enzymes indicative of liver toxicity, but no 

liver pathology was present. Therefore, there is no indication 

from these data that the effects were irreversible. On the 

contrary, one would expect these effects to disappear following 

a recovery period without methanol exposure. Based on the data, 

a severity grade of "5" (significant reversible effects) is 

more appropriate. 

Methanol's consideration for listing is likely not based on 

these health effects attributes, but simply because methanol 

scores highly on the occurrence attributes. Methanol scored a 

"10" for both prevalence (how widespread the occurrence) and 

magnitude (quantity). In assessing occurrence, there were no 

findings of methanol in finished water systems or in ambient 

water, which form the top of the hierarchy for assessing actual 

occurrence in drinking water. Methanol is a high production 

chemical, which accounts for its high occurrence ranking, even 

if its has not actually been found in drinking water. For 

magnitude, methanol releases reported under the Toxics Release 

Inventory, must account for its "10" ranking. Again, since no 

methanol was identified in finished or ambient water, there are 

no median values, which are at the top of the hierarchy for 

measuring magnitude. Persistence and mobility make up the lower 

end of the magnitude hierarchy. Here methanol is identified as 

a chemical that "biodegrades fast," so it is not considered a 

persistent contaminant. Methanol is completely miscible in 

water. 

We can understand the apprehension the evaluation team may have 

had when considering to list methanol. It would appear that 

methanol was included in the draft list only because it is a 

high production volume chemical. The occurrence data does cite 

201,697,278 lbs/year in total releases according to the 2004 

TRI report, but when you examine the TRI report in detail, a 

different picture emerges. First, total TRI on-site and off- 

site reported "disposed or otherwise released" figures have 

consistently fallen for the past 15 years, with 178,319,830 

pounds reported in the 2006 TRI Report. Of this total, more 

than 83% are fugitive or point source air emissions and 

deposition to water bodies is not a factor. Only 0.022% of the 

total methanol is represented by "total off-site disposal or 

other releases." Further, the total quantity disposed of or 
otherwise released on-and off-site, represents just 0.07% of 

the total production-related waste managed for methanol, with 

the vast majority of methanol recycled or treated on-or off- 

site. By these metrics, there is only a minimal concern for 

methanol entering surface or ground-water resources. 

In 1999, the Methanol Institute commissioned a study by Malcolm 

Pirnie, Inc. entitled "Evaluation of the Fate and Transport of 

Methanol in the Environment" (available at www.methanol.org). 

The purpose of this report was to summarize the existing 

information through a literature review of over 100 reports, as 

well as the use of computer modeling, to determine the fate of 

methanol in the environment. The researchers also explored 

three conceptual release scenarios, including tank truck or 

rail car release, barge release, and release from underground 

storage tanks at a refueling facility. This study found: 

"The physical and chemical properties of methanol help to 

further define the fate and transport of this chemical in the 

various environmental media in the context of each of the 

conceptual release scenarios. The dominant mechanisms of 

methanol loss from subsurface soil and groundwater are expected 

to be biodegradation and advection (dispersion and diffusion) 

with little loss from adsorption on soils due to its high 

solubility and low retardation factor. In surface water, the 

infinite solubility of methanol will result in rapid wave-, 

wind-, and tide enhanced dilution to low concentrations (< 1%). 

Once concentrations have been diluted below toxic levels the 

dominant mechanism of methanol loss is expected to be 

biodegradation. Compared to other loss mechanisms identified, 

including volatilization and chemical degradation, 

biodegradation is expected to be the dominant process 

controlling the fate of methanol in the soil, groundwater, and 

surface water environments. In addition, the biodegradation of 

methanol can occur under both aerobic (oxygen present) and 

anaerobic (oxygen absent) conditions. 

Therefore, following any of the three conceptual release 

scenarios presented, methanol is not likely to persist in soil 

or water due to its rapid biodegradation. Methanol is miscible 

in water and consequently will dissolve quickly and be diluted 
to low concentrations in the event of a surface water spill. In 

groundwater, methanol concentrations are highly dependent on 

the nature and the magnitude of the release, but will likely 

fall to low concentrations once complete dissolution has 

occurred. In both surface and ground waters, methanol will 

likely be easily biodegraded under a wide range of possible 

water quality conditions." 

These findings are consistent with the EPA's Evaluation Team's 

notation the methanol "biodegrades fast," and is generally 

considered to be environmentally benign. Further, over 200 

wastewater treatment plants inject methanol into the treatment 

process for denitrification with no significant residual 

methanol in the effluent. With many of the nation's most 

sensitive estuaries being harmed by high nitrogen loading, 

methanol is playing an increasingly important role in helping 

to prevent and reverse the spread of "dead zones." 

The Malcolm Pirnie study also addressed human health effects 

finding: "Methanols properties and toxicity are well 

understood, an the ocular toxicity and metabolic acidosis that 

are effects of acute high doses of methanol are well-known. 

Methanol is neither mutagenic, nor carcinogenic. While methanol 

produces toxic effects on humans and animals, the current 

evidence suggests that these effects only occur at high doses." 

This report also focused on the potential use of methanol as a 

transportation fuel in comparison with gasoline and stated, "In 

conclusion, the fate and transport of methanol in the 

environment is well understood. Methanol spills to the soil, 

groundwater, and surface water will quickly biodegrade under 

both aerobic and anaerobic conditions and, consequently, 

methanol is not expected to persist. Methanol exhibits a lower 

toxicity to both humans and indigenous microbes then 

conventional gasoline. Therefore, based on this analysis, 

methanol appears to be a more environmentally benign fuel 

compared to conventional gasoline." 

In conclusion, we would encourage the Agency not to include 

methanol on the final Contaminant Candidate List 3. The 
Attribute Score for methanol - when explored in detail - would 

indicate that methanol has a low risk for human health impacts 

and that there is very little concern that methanol would 

impact finished water systems or ambient water. While methanol 

is an essential chemical for the U.S. economy, a detailed 

review of the Toxics Release Inventory demonstrates that 

methanol does not pose an environmental threat. Since the half- 

life for methanol in groundwater and surface water is just one 

to seven days, methanol is not a persistent contaminant. We 

appreciate this opportunity to provide our comments, and would 

be pleased to address any questions you may have regarding this 

statement. 

Sincerely, 

John Lynn 

President & CEO 

CS Title: 0089 

Company/group/association name: 

Comment: 

May 14, 2008 

Via E-Mail 

Water Docket 

U.S. Environmental Protection Agency 

Mail Code 2822T 

1200Pennsylvania Avenue, NW 

Washington, DC 20460 

Re:Docket No. EPA-HQ-OW-2007-1189 -- Drinking Water Contaminant 

Candidate List 3-Draft; 73 Fed. Reg. 9628 (Feb. 21, 2008) 

Dear Sir/Madam: 
The Olefins Panel (Panel) of the American Chemistry Council 

submits these comments, together with the appended technical 

document, on the U.S. Environmental Protection Agency's (EPA) 

February 21,2008, Federal Register notice on the draft third 

Contaminant Candidate List (CCL 3) under the Safe Drinking 

Water Act (SDWA). The Panel, which consists of companies[FN1: 

Panel member companies include Chevron Phillips Chemical 

Company, LP, The Dow Chemical Company, Eastman Chemical 

Company, Equistar Chemicals LP, ExxonMobil Chemical Company, 

Huntsman Corporation, INEOS Olefins & Polymers USA, NOVA 

Chemicals Inc., Shell Chemical Company, and Texas 

Petrochemicals, Inc.] that manufacture, use, or process 1,3- 

butadiene, one of the chemical contaminants included on the 

draft CCL 3, has a strong interest in the list and the approach 

that EPA utilized to develop it. 

As discussed in the appended comments, the Panel urges EPA not 

to include 1,3-butadiene on the final CCL 3 for the following 

reasons: 

* 1,3-butadiene is a highly volatile gas that is expected to 

partition predominantly to air, and thus is very unlikely to be 

found in drinking water. 

* In making CCL 3 decisions, EPA inappropriately used total TRI 

releases to determine l,3-butadiene's potential to occur in 

drinking water. 

* EPA should define 1,3-butadiene's potential to occur in 

drinking water based on its minimal surface water releases, 

which are the most relevant data for characterizing potential 

drinking water occurrence. 

The Panel appreciates the opportunity to submit these comments. 

For the reasons included in the attached comments and noted 

above, the Panel urges EPA not to include 1,3-butadiene on the 

final CCL 3. 

If you have any questions, please contact Dr. Elizabeth Moran, the Olefins Panel Manager, at 

Elizabeth_Moran@americanchemistry.com or (301) 924-2006. 
Sincerely, 

Sharon H. Kneiss 

Vice President, Products Division 

Attachments 

BEFORE THE U.S. ENVIRONMENTAL PROTECTION AGENCY 

COMMENTS OF THE OLEFINS PANEL OF THE AMERICAN CHEMISTRY COUNCIL 

ON 

DRINKING WATER CONTAMINANT CANDIDATE LIST 3-DRAFT 

Drinking Water Contaminant 

Candidate List 3-Draft 

73 Fed. Reg. 9628 (Feb. 21, 2008) 

Docket No. EPA-HQ-OW-2007-1189 

Elizabeth J. Moran, Ph.D. 

Manager, Olefins Panel 

Saeda A. Siam, Esquire 

Olefins Panel Counsel 

Of Counsel: 

Lynn L. Bergeson, Esquire 

Ira Dassa, Esquire 

Bergeson & Campbell, P.C. 

1203 Nineteenth Street, N.W. 

Suite 300 

Washington, D.C. 20036-2401 
AMERICAN CHEMISTRY COUNCIL 

1300 Wilson Boulevard 

Arlington, VA 22209 

May 14, 2008 

EXECUTIVE SUMMARY 

The Olefins Panel (Panel) of the American Chemistry Council 

submits these comments, together with the appended technical 

document, on the U.S. Environmental Protection Agency's (EPA) 

February 21, 2008, Federal Register notice on the draft third 

Contaminant Candidate List (CCL 3) under the Safe Drinking 

Water Act (SDWA). The Panel, which consists of companies that 

manufacture, use, or process 1,3-butadiene, one of the chemical 

contaminants included on the draft CCL 3, has a strong interest 

in the list and the approach that EPA utilized to develop it 

The Panel urges EPA not to include 1,3-butadiene on the final 

CCL 3 for the following reasons: 

* In making CCL 3 decisions, EPA must use the most relevant 

data for 1,3-butadiene. 

* 1,3-butadiene is a highly volatile gas that is expected to 

partition predominantly to air. 

* EPA should define 1,3-butadienes potential to occur in 

drinking water based on its minimal surface water releases, 

which are the most relevant data for characterizing potential 

drinking water occurrence. 

TABLE OF CONTENTS 
EXECUTIVE SUMMARY ..........................................i 

TABLE OF CONTENTS......................................... ii 

INTRODUCTION............................................... 1 

I. 1,3-BUTADIENE SHOULD NOT BE INCLUDED ON THE FINAL CCL 3. 2 

A. In Making CCL 3 Decisions, EPA Must Use the Most Relevant 

Data for 1,3-Butadiene..................................... 3 

B. 1,3-Butadiene Is a Highly Volatile Gas That Is Expected to 

Partition Predominantly to Air............................. 5 

C. EPA Should Define 1,3-Butadienes Potential to Occur in 

Drinking Water Based on Its Minimal Surface Water Releases, 

Which Are the Most Relevant Data for Characterizing Potential 

Drinking Water Occurrence.................................. 7 

CONCLUSION................................................. 8 

INTRODUCTION 

The Olefins Panel (Panel) of the American Chemistry Council 

submits these comments, together with the appended technical 

document, on the U.S. Environmental Protection Agency's (EPA) 

February 21, 2008, Federal Register notice on the draft third 

Contaminant Candidate List (CCL 3) under the Safe Drinking 

Water Act (SDWA).[FN1: 73 Fed. Reg. 9628 (Feb. 21, 2008).] The 

Panel, which consists of companies[FN2: Panel member companies 

include Chevron Phillips Chemical Company, LP, The Dow Chemical 

Company, Eastman Chemical Company, Equistar Chemicals LP, 

ExxonMobil Chemical Company, Huntsman Corporation, INEOS 

Olefins & Polymers USA, NOVA Chemicals Inc., Shell Chemical 

Company, and Texas Petrochemicals, Inc.] that manufacture, use, 

or process 1,3-butadiene, one of the chemical contaminants 

included on the draft CCL 3, has a strong interest in the list 

and the approach that EPA utilized to develop it 
Under Section 1412(b)(1)(B) of the SDWA, as amended, EPA is 

required to publish every five years "a list of contaminants 

which, at the time of publication, are not subject to any 

proposed or promulgated national primary drinking water 

regulation, which are known or anticipated to occur in public 

water systems, and which may require regulation under [the 

SDWA]."[FN3: 42 U.S.C. § 300g-1(b)(1)(B)(i)(I). For a 

contaminant to be regulated under the SDWA, EPA must make three 

findings: (1) the contaminant may have an adverse effect on the 

health of persons; (2) the contaminant is known to occur or 

there is a substantial likelihood that the contaminant will 

occur in public water systems with a frequency and at levels of 

public health concern; and (3) regulation presents a meaningful 

opportunity for health risk reduction for persons served by 

public water systems. Id. § 300g-1(b)(1)(A)(i)-(iii).] Congress 

made it clear that in selecting unregulated contaminants for 

this list, known as the CCL, EPA must "consider the [National 

Contaminant Occurrence Database (NCOD)] established under 

section [1445(g) of the SDWA]"[FN4: Id. § 300g-1(b)(1)(B)(i) 

(I).] and "select contaminants that present the greatest public 

health concern."[FN5: Id. § 300g-1(b)(1)(C).] Inclusion of a 

contaminant on the CCL means that the contaminant, at a later 

date, may become subject to an EPA determination to 

regulate.[FN6: Id. §§ 300g-1(b)(1)(B)(ii), (E).] Once listed, 

there is no procedure set forth in the SDWA, short of a 

determination not to regulate, for a contaminant's removal from 

the particular CCL on which it appears.[FN7: See 70 Fed. Reg. 

9071, 9073 (Feb. 24, 2005) (a regulatory determination not to 

regulate a particular contaminant serves to "remove that 

contaminant from the CCL"), available at 

http://www.epa.gov/fedrgstr/EPA- 

WATER/2005/February/Day-24/w3527.htm; but see 63 Fed. Reg. 

10273, 10275 (Mar. 2, 1998) (stating that EPA is "not precluded 

from modifying the CCL prior to the due date of the next CCL"), 

available at 

http://www.epa.gov/fedrgstr/EPA- 

WATER/1998/March/Day-02/w5313.htm.] 

I. 1,3-BUTADIENE SHOULD NOT BE INCLUDED ON THE FINAL CCL 3 
The Panel's comments focus entirely on EPA's inclusion of 1,3- 

butadiene on the draft CCL 3. For the reasons discussed more 

fully below, 1,3-butadiene does not warrant inclusion on the 

final CCL 3, and the Panel urges EPA to remove it from the 

list. 

EPA based 1,3-butadiene's "potential to occur in drinking 

water" on the total 2004 reported releases to the environment 

pursuant to the Toxics Release Inventory (TRI) program and the 

number of states in 2004 having those TRI-reported 

releases.[FN8: 73 Fed. Reg. at 9637, 9640.] Because, however, 

1,3-butadiene is a highly volatile gas and thus, as EPA itself 

recognizes, is expected to partition predominantly to the 

atmosphere, the Panel urges EPA instead to consider the minimal 

level of surface water releases in determining whether 1,3- 

butadiene should be listed. Such a consideration shows that 

1,3-butadiene is not "known or anticipated to occur in public 

water systems,"[FN9: 42 U.S.C. § 300g-1(b)(1)(B)(i)(I).] and 

that it does not present "a substantial likelihood [of 

occurrence] in public water systems..." such that it can be 

regulated under the SDWA.[FN10: Id. § 300g-1(b)(1)(A)(ii).] 

Likewise, these data support the conclusion that 1,3-butadiene 

cannot be considered to present one of "the greatest public 

health concern[s]" from drinking water exposure.[FN11: Id. § 

300g-1(b)(1)(C).] Consequently, 1,3-butadiene does not meet the 

statutory standard for inclusion on the CCL. 

A. In Making CCL 3 Decisions, EPA Must Use the Most Relevant 

Data for 1,3-Butadiene 

Under the screening approach that EPA used to narrow the 

universe of CCL 3 contaminants to a Preliminary CCL (PCCL), all 

chemical contaminants that were categorized in Toxicity 

Category 1, including 1,3-butadiene, "were captured [in the 

PCCL] regardless of their occurrence category."[FN12: 73 Fed. 

Reg. at 9638; EPA, Contaminant Candidate List 3 Chemicals: 

Screening to a PCCL, at 16, 19 (Feb. 2008 Draft), available at 

EPA-HQ-OW-2007-1189-0044.] In the subsequent classification 

process through which the 532 PCCL chemical contaminants were 

further evaluated, modeled, and narrowed to the draft CCL 3 on 

which EPA seeks comment, EPA sought to ensure, inter alia, a 
"meaningful basis for classification" as well as the 

"incorporati[on] [of] relevant data." As EPA explained, "[t]he 

classification process...must consider the potential for 

occurrence in water," and "[t]he most relevant data used for 

the classification process include health effects data that are 

appropriate for drinking water exposures, and occurrence data 

that indicate the nature and spatial extent of potential 

occurrence in drinking water."[FN13: EPA, Contaminant Candidate 

List 3 Chemicals: Classification of the PCCL to CCL, at 2 (Feb. 

2008 Draft) (classification of the PCCL to CCL), available at 

EPA-HQ-OW-2007-1189-0046. Of course, in implementing Section 

1412 of the SDWA, EPA is required to use "the best available, 

peer-reviewed science and supporting studies conducted in 

accordance with sound and objective scientific practices." 42 

U.S.C. § 300g-1(b)(3)(A).] 

As with most other chemical contaminants, EPA utilized the 

occurrence attributes of "prevalence" and "magnitude" to define 

1,3-butadiene's actual or potential occurrence in drinking 

water.[FN14: Classification of the PCCL to CCL at 18.] 

Importantly, 1,3-butadiene is not known to occur in drinking 

water, and indeed, neither the NCOD that EPA is required to 

consider in its development of the CCL nor any other source of 

finished water or ambient water occurrence data reflects any 

detections of 1,3-butadiene.[FN15: See EPA, Contaminant 

Information Sheets for the Draft CCL 3 Chemicals, at 12 (Feb. 

2008 Draft) (Information Sheets), available at EPA-HQ- 

OW-2007-1189-0042.] This fact should be taken into greater 

account in the CCL process. 

The process that EPA utilized treats chemicals known to occur in drinking water the same as 

those for which there is no evidence of occurrence. Regardless 

of how toxic a particular chemical may be, if it is not found 

or anticipated to be found in public water systems, then 

inclusion on the CCL is neither warranted nor legally 

appropriate. Thus, there needs to be a way to remove from 

consideration those chemicals with little or no potential to 

occur in drinking water. To the extent that EPA purported to do 

this, the use of TRI total environmental release data is 

inappropriate, as can be seen in the case of 1,3-butadiene. 

B. 1,3-Butadiene Is a Highly Volatile Gas That Is Expected to 

Partition Predominantly to Air 
EPA used the prevalence and magnitude attributes as the basis 

for evaluating 1,3-butadiene's potential to occur in public 

water systems, with magnitude corresponding to the total on- 

and off-site disposal or other releases of 1,3-butadiene (i.e., 

1,964,956 pounds) reported under the TRI for 2004, and 

prevalence corresponding to the number of states (34) with 

releases.[FN16: Id.] Reliance on TRI release data without 

considering 1,3-butadiene's physical properties and fate has 

led, however, to the erroneous conclusion that 1,3-butadiene 

might occur in drinking water.[FN17: In crafting the CCL 2, EPA 

explained that "[a] contaminant was considered to have the 

potential to occur [in drinking water] if, using the TRI, the 

release to surface water was in excess of 400,000 pounds per 

year and the physical-chemical properties indicated persistence 

and mobility of the contaminant." 69 Fed. Reg. 17406, 17409 

(Apr. 2, 2004) (emphasis added), available at 

http://www.epa.gov/fedrgstr/EPAWATER/ 

2004/April/Day-02/w7416.htm. For some contaminants, then, 

physical-chemical properties played a distinct role in the CCL 

2 process. In the CCL 3 process, EPA considered chemical and 

physical properties, but only in those cases where production 

data under the Toxic Substances Control Act Chemical Update 

System/Inventory Update Rule constituted the sole measure of 

occurrence. See 73 Fed. Reg. at 9640-41. Certainly for 1,3- 

butadiene, chemical and physical properties also must play a 

distinct role in determining whether inclusion on the CCL 3 is 

appropriate.] 

EPA, in contravention of its intent to incorporate "[t]he most 

relevant data," did not account for 1,3-butadiene's well-known 

physical properties.[FN18: The expert panel that EPA convened 

to provide input on EPAs approach to the draft CCL 3 

recommended that "the physical properties of each chemical, 

especially gases, should be analyzed to determine if model 

results would change if surface water release information was 

used instead of total release data." EPA, Chemical Expert Input 

and Review for the Third Contaminant Candidate List, at 8 (Feb. 

2008 Draft), available at EPA-HQ-OW-2007-1189-0038.] As EPA's 

most recent health assessment of the chemical states, 1,3- 

butadiene "is very slightly soluble in water" and "a highly 

volatile gas [that] is expected to partition predominantly to 
the atmosphere and then undergo rapid destruction by 

photoinitiated reactions."[FN19: EPA, Health Assessment of 1,3- 

Butadiene, at 2-1 (Oct. 2002) (IRIS Assessment), available at 

http://www.epa.gov/ncea/iris/supdocs/buta-sup.pdf; see also 

Agency for Toxic Substances and Disease Registry, Toxicological 

Profile for 1,3-Butadiene, at 59 (July 1992) (ATSDR Profile), 

available at http://www.atsdr.cdc.gov/toxprofiles/tp28.pdf.] 

Moreover, "[b]ased on its physical properties, rapid 

volatilization of 1,3-butadiene from either soil or water to 

[the] atmosphere is expected to dominate over all other 

potential environmental processes."[FN20: IRIS Assessment at 

2-1; ATSDR Profile at 59.] In sum, quantities of 1,3-butadiene 

that are released to air, which are the vast majority of the 

total environmental releases, do not end up in drinking water, 

and any quantities that are released to other media partition 

to the atmosphere.[FN21: According to the TRI Explorer Chemical 

Report for 2004, of the total quantity of 1,3-butadiene 

released to the environment, more than 96 percent was in the 

form of fugitive and point source air emissions. See TRI 

Explorer Chemical Report for 2004, available at 

http://www.epa.gov/triexplorer/.] The appended technical 

comments soundly demonstrate both that 1,3-butadiene partitions 

primarily to the air -- 99.99% is removed via atmospheric 

processes -- and that any 1,3-butadiene that is released to 

water will partition significantly into the air. In the 

unlikely event that any 1,3-butadiene remains in surface water 

entering a treatment facility, standard water treatment 

practices have been shown to remove it. 

C. EPA Should Define 1,3-Butadienes Potential to Occur in 

Drinking Water Based on Its Minimal Surface Water Releases, 

Which Are the Most Relevant Data for Characterizing Potential 

Drinking Water Occurrence 

In view of 1,3-butadiene's highly relevant physical properties, 

EPA should base its characterization of 1,3-butadiene's 

potential to occur in drinking water not on the total quantity 

released to the environment, but rather on the total quantity 

released to surface water. In 2004, this figure was a mere 493 

pounds encompassing only eight states.[FN22: Information Sheets 

at 12.] This figure decreased by more than 50 percent in 2005, 

to 236 pounds, and by more than 50 percent yet again in 2006, 
to 113 pounds.[FN23: See TRI Explorer Chemical Reports for 2005 

and 2006, available at http://www.epa.gov/triexplorer/.] This 

level of surface water release is quite minimal, and as noted 

above, any 1,3-butadiene so released rapidly volatilizes to the 

atmosphere.[FN24: As explained in the appended technical 

comments, any 1,3-butadiene that somehow finds its way into 

groundwater, which, given the chemicals volatility and sparing 

solubility in water, is likely to be an exceedingly small 

amount, would volatilize quickly or otherwise be removed during 

the drinking water treatment process.] 

Thus, 1,3-butadiene does not meet the statutory standard for 

CCL listing, as it is not known or anticipated to occur in 

public water systems, nor is there a substantial likelihood of 

it occurring in public water systems. 

CONCLUSION 

The Panel appreciates the opportunity to submit these comments. 

For the reasons noted above, the Panel urges EPA not to include 

1,3-butadiene on the final CCL 3. 

Technical Comments on the U.S. Environmental Protection 

Agency's Inclusion of 1,3-Butadiene in the Draft Third 

Contaminant Candidate List under the Safe Drinking Water Act 

The U.S. Environmental Protection Agency (EPA) has published a 

draft list of chemicals that are known or anticipated to be 

public water system contaminants that may require regulation 

under the Safe Drinking Water Act (SDWA) (Federal Register, 

2008). When issued in final, the list will become the third 

Contaminant Candidate List (CCL 3) issued since EPA published 

the SDWA Amendments in 1996. EPA has asked for comments on the 

draft CCL 3, which includes 1,3-butadiene (BD). 

The SDWA Amendments list three criteria used to identify 

chemicals requiring regulation: 
* The contaminant may have an adverse effect on the health of 

persons; 

* The contaminant is known to occur or there is a substantial 

likelihood that the contaminant will occur in public water 

systems with a frequency and at levels of public health 

concern; and 

* In the sole judgment of the Administrator, regulation of such 

contaminant presents a meaningful opportunity for health risk 

reduction for persons served by public water systems. 

Data presented in this document show that BD is very unlikely 

to be present in public water systems because of its physical 

properties and because manufacturing controls mitigate against 

its release into the environment. With regard to chemical fate, 

as measured by environmental models, the atmosphere is the 

primary modeling compartment to receive BD from its 

manufacture, In the air, specific fate processes result in BD's 

physical degradation. BD is rapidly degraded in air and has a 

calculated half-life that ranges from two to six hours. BD is 

not expected to be present in public drinking water based on 

physical processes that remove volatile substances used in 

water treatment facilities and on the outcome of modeling that 

considered these processes together with BD's physico-chemical 

properties. 

1,3-Butadiene Emissions from Manufacturing 

Total yearly emissions of BD are reported by industry to the 

EPA pursuant to the Emergency Planning and Community Right-to- 

Know Act. These data are made available to the public through 

the Toxics Release Inventory (TRI). The most recent data are 

from 2006, as reported in 2007, and listed in Table 1 (EPA, 

2008). These data are used in the following sections to 

estimate the partitioning behavior of BD in the environment and 

its potential partitioning to drinking water. 
The TRI data indicate that industrial emissions of BD declined 

by 69% during the years between 1988 and 2006 (the most recent 

reporting year), or from approximately 7.7 million pounds to 

2.4 million pounds per year (EPA, 2008). Although the total 

emission of BD from the 2006 TRI was reported as 2.4 million 

pounds per year, only 1.6 million pounds was actually released 

to the environment and was reported within the following 

compartments (Table 1): point source and fugitive losses to air 

(1.498 million pounds), underground injection (0.102 million 

pounds), soil landfill both on- and off-site (685 pounds), and 

loss to surface water (113 pounds). The remaining 0.8 million 

pounds are classified as "storage" and not considered as an 

environmental emission. 

Table 1. 2006 TRI data (pounds) for 1,3-butadiene reported to 

EPA and normalized to a yearly emission rate (kg/hr/yr). [see 

PDF] 

1,3-Butadiene Atmospheric Fate 

The atmosphere is the main environmental compartment of 

interest when considering fate processes that impact potential 

exposure to BD. BD is a gas and will partition to the air upon 

entering the environment even at reduced temperatures. Its 

behavior in the environment is largely explained by its vapor 

pressure, which has been reported as 856 mm Hg (1141 hPa) at 

-1.5 °C (Boublik et al., 1984) and 2110 mm Hg (2813 hPa) at 25 

°C (EPA, 2000). Although BD's water solubility has been 

reported as 735 mg/L at 25 °C (McAuliffe, 1966), suggesting 

that it has a degree of solubility, its Henry's Law constant 

(HLC), a measure of a chemical's volatilization rate from 

water, shows that BD will preferentially partition to air from 

solution. The HLC for BD is calculated as 20,699 Pa-m3/mole 

using the water solubility and vapor pressure data for 25 °C. 

The dissolution of BD from water as facilitated in a drinking 

water treatment plant is discussed below. 

BD that enters the environment will primarily partition to the 

atmosphere, which is the major manufacturing route of loss. 
Results from an environmental distribution model, EQC Level III 

(Canadian Environmental Modelling Centre, 2004; Mackay, 2001; 

Mackay et al., 1996), support this assessment. The EQC Level 

III model, which represents a steady state unit regional 

environment, is based on a number of default and user-selected 

parameters[FN1: EQC Level III fugacity model v2.02. Model input 

parameters from EPA (2000) for BD at 25 °C: molecular weight = 

54.09; water solubility = 735 g/m3; vapor pressure = 281,300 

Pa; log Kow = 1.99; melting point = -108.9 °C; air half-life 

(AOPWIN, v1.91) = 1.9 hours; water half-life (Mackay et al., 

2006) = 42 hours (within the range of suggested values); soil 

and sediment half-life (Mackay et al., 2006) = 168 hours 

(within the range of suggested values and comparable to the 

Biowin 4 Primary Survey Model). Emission rates used in the 

model to soil, air, and water compartments are based on 2006 

IUR data (Table 1).]. Using emission values from the 2006 IUR 

and physical-chemical and biological parameters from the EPI 

SuiteTM package of programs (EPA, 2000) and the Handbook of 

Physical-Chemical Properties and Environmental Fate for Organic 

Chemicals (Mackay et al., 2006), EQC predictions show the air 

compartment retaining 99.7% of the steady state mass of BD, 

with the remaining 0.3% residing in the water, soil, and 

sediment compartments. The mass balance calculation suggests 

that 97.32% of BD is reacted in the atmosphere. Another 2.67% 

is atmospherically advected from the defined unit environment 

(and will subsequently undergo atmospheric reaction outside the 

modelled system). Consequently, 99.99% of emitted BD is removed 

from the EQC model environment via atmospheric processes. 

In spite of its water solubility, wet deposition of BD from the 

air is not likely to play a significant role in its atmospheric 

fate, once again because of repartitioning to the air, i.e., 

net loss to the atmosphere. Additionally, partitioning to the 

air from aqueous solution for BD that may be entrained in 

process waters will also contribute to the net transfer to the 

atmosphere. 

In the air, BD participates in a range of chemical reactions 

that leads to its degradation and the production of stable 

reaction products. These reactions are mediated by a variety of 

reactive species, but the predominant route of degradation is 

photoxidation via hydroxyl radicals (OH-) (Atkinson, 1985; 
Atkinson, 1989). The rate at which an organic compound reacts 

with OH- is a direct measure of its atmospheric persistence 

(Meylan and Howard, 1993). Atkinson (1985), in a review of 

reported kinetic data for BD, recommends the following rate 

constant: 

k(BD) = 6.68 E-11 cm3 molecule-1 s-1 at 298 K (24.9 °C) 

Using an average concentration of 5 E5 OH- cm-3, the calculated 

atmospheric half-life for BD is 5.76 hours. Atkinson (1985) 

from a review of the literature reports that OH- concentrations 

in the lower troposphere have been estimated at less than or 

approximately equal to 5E6 molecules cm-3, and suggests the use 

of a daily average concentration of approximately 5E5 molecules 

cm-3 for the northern hemisphere, as reported by Crutzen 

(1982). 

EPA has developed a computer model that includes a calculation 

of the atmospheric oxidation potential (AOPWIN, v1.92, in EPA, 

2000) as a result of OH- attack. AOPWIN estimates the rate 

constant for the atmospheric, gas-phase reaction between 

photochemically produced OH- and organic chemicals. The rate 

constants estimated by the program are then used to calculate 

atmospheric half-lives for organic compounds based upon an 

average atmospheric OH- concentration of 1.5E6 molecule cm-3. 

AOPWIN uses the following rate constant: 

k(BD) = 6.66 E-11 cm3 molecule-1 s-1 at 25 °C (298.15 K) 

Since the reactions necessary for this degradative process only 

take place in the presence of sunlight, the model normalizes 

atmospheric half-lives to a 12-hour day. BD is calculated by 

this model to have an atmospheric half-life of 0.16 day (1.9 

hours) as a result of photolysis by OH- attack. 

Manufacturing processes result in air being the primary 

compartment to which BD will migrate upon release. The results 

of the two calculations, using the recommended rate constants 
cited by Atkinson and AOPWIN, show that the half-life for BD in 

air is relatively short, ranging from approximately 2 to 6 

hours, depending on OH- concentration. Because of its short air 

half-life, BD is not expected to be in air at sufficient 

concentrations to act as a potential source of contamination to 

drinking water. Additionally, concentrations of BD in surface 

water as a result of manufacturing processes will significantly 

dissipate to the air based on its relatively high HLC. 

1,3-Butadiene Environmental Partitioning 

As mentioned above, BD has a relatively high water solubility. 

Consequently, there are two relevant drinking water sources 

that may result in BD exposure. These include: surface water, 

with loadings from atmospheric deposition, soil runoff and 

direct water discharges; and groundwater, with loadings mainly 

from underground injection. 

Using the EQC Level III model, as described above with 2006 

emissions taken from Table 1, the role of surface water in the 

environmental fate and exposure of BD was explored. Model 

results suggest that 0.15% of the overall steady state mass is 

found in surface water. Subsequently, based on these US 

emission rates applied over the EQC unit area of 105 km2 (10% 

of which is water surface area and the remaining 90% is soil 

area), the resultant surface water concentration is 0.0015 

ng/L. Hence, based on these predictions, the amount of BD in 

surface water is negligible. 

Underground injection represents 6.4% (102,000 pounds) of the 

total environmental emissions of BD. The main drinking water 

concern is dissolution into groundwater. Exposure of 

groundwater to the atmosphere will result in BD depletion 

similar to that described for surface water. In most cases, 

groundwater will also be treated before consumption. During 

this process, aeration or air stripping of the groundwater will 

be important to BD mitigation. EPA has indicated that air 

stripping is one of the best-available technologies for 

removing volatile organic compounds (VOCs) from groundwater 

(Dyksen, 2005). To simulate BD volatilization resulting from 
aeration, the STP model (Clark et al., 1995) was used. This 

model is generally used to predict the fate of chemicals in 

sewage treatment facilities, consisting in part of an aeration 

tank. By defining the model system as a single aeration tank 

and using typical water treatment facility properties, this 

process can be examined. 

Aeration basins of water treatment facilities are usually 

between 3-5 m deep, 3-9 m wide, with a width:depth ratio of <=2 

for optimal mixing, and the length is governed by the desired 

water detention time, usually between 10-30 minutes (Dyksen, 

2005). The aeration rate for treatment is set between 

0.0008-0.012 m3 air/L of water. For a water flow rate of 226.8 

m3/h (upper range of typical values), aeration rates equate to 

1812722 m3/h, and tank volumes of 37.8-113.4 m3, for detention 

times of 10-30 minutes, respectively. Assuming an aeration tank 

depth of 5 m, the subsequent tank area based on this water flow 

rate of 226.8 m3/h would be 7.56-22.68 m2. The mass transfer 

coefficients (MTC) used for this analysis were 23.46 m/h for 

air-side and 0.01 m/h for water-side (Mackay and Yeun, 1983), 

which represent relatively conservative values (i.e., higher 

MTC values would result in greater volatilization). Based on 

these inputs, model results indicate that between 86.2-98.9% of 

BD would be removed by volatilization in the defined water 

treatment aeration tank. 

During the water treatment process, other implemented 

mitigation technologies would further decrease the amount of BD 

in water. The use of dissolved air flotation (DAF) units in the 

water clarification process can be another significant removal 

pathway for VOCs due to the introduction of air to the 

treatment water. Oxidation is yet another potential loss 

mechanism, especially in both the aeration and DAF processes. 

There also are sorption technologies applied that may help 

remove residual levels of BD that are aqueous dissolved. 

Consequently, after treatment it is unlikely that BD would be 

present in drinking water. 

Summary 
In summary, BD is unlikely to be present in drinking water. 

Emissions of BD from manufacturing facilities have decreased 

over the period 1988-2006. Modeling shows that the air is the 

primary environmental compartment to receive BD from 

manufacturing because of its physical properties. In air, 

atmospheric fate processes result in its rapid degradation, 

with an atmospheric half-life of two to six hours. Any BD 

released to surface or groundwater from manufacturing, or that 

enters surface or groundwater through run-off, will 

subsequently partition significantly to air based on its 

physical properties. In the unlikely event that any BD remains 

in water entering a drinking water treatment facility, standard 

water treatment processes will likely remove it. Since BD is 

unlikely to be present in drinking water, EPA should remove it 

from the draft CCL 3. 

References 

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reactions of the hydroxyl radical with organic compounds under 

atmospheric conditions. Chem. Rev. 85: 69-201. 

Atkinson R (1989). Kinetics and mechanisms of the gas-phase 

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Boublík T, Fried V and Hála E (1984). The Vapour Pressures of 

Pure Substances. Second Edition, pp. 972, Elsevier Science 

Publishers, New York, NY, USA. 

Canadian Environmental Modelling Centre (2004). Level III 

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http://www.trentu.ca/academic/aminss/envmodel/models/L3280new.h 

tml 

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model of organic chemical fate in a sewage treatment plant. 

Environ. Sci. Technol. 29: 1488-1494. 

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313-328. Ann Arbor Press Ann Arbor, MI, USA. 

Dyksen J (2005). Aeration and air stripping (Chapter 5). In: 

Water treatment plant design (4th ed.), Ed. EE Baruth. McGraw- 

Hill. pp. 25. 

Environmental Protection Agency (EPA) (2000). EPI SuiteTM, 

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DC, USA. 

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http://www.epa.gov/cgi-bin/broker?_SERVICE=oiaa&_PROGRAM= 

xp_tri.sasmacr.tristart.macro&VIEW=USCH&trilib=TRIQ0&TAB_RPT= 

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] EPA, Washington, DC, USA. 

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Agency. EPA-HQ-OW-2007-1189 FRL-8529-7. Drinking Water 

Contaminant Candidate List 3-Draft. Vol. 73, No. 35. Thursday, 

February 21, 2008. Notices. 

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Approach. Second Edition, pp. 1-261, Lewis Publishers, Boca 

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Evaluating the environmental fate of a variety of types of 
chemicals using the EQC model. Environ. Toxicol. Chem. 15: 

1627-1637. 

Mackay D, Shiu W, Ma K-C and Lee S (2006). Handbook of 

physical-chemical properties and environmental fate for organic 

chemicals, 2nd ed. CRC Press. 

Mackay D and Yeun A (1983). Mass transfer coefficient 

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Environ. Sci. Technol. 17: 211-217. 

McAuliffe C (1966). Solubility in water of paraffin, 

cycloparaffin, olefin, acetylene, cycloolefin, and aromatic 

hydrocarbons. J. Physical Chem. 70: 1267-1275. 

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atmospheric gas-phase reaction rate of organic compounds with 

hydroxyl radicals and ozone. Chemosphere 12: 2293-2299. 

CS Title: 0090 

Company/group/association name: 

Comment: 

Please refer to the accompanying attachment supporting my 

recommendation that members of the bacterial group, 

Mycobacterium avium Complex (MAC) be included in the "Drinking 

Water Contaminant Candidate List 3". 

Comments in Response to Publication of EPA-HQ-OW-2007-1189 FRL- 

8529-7 RIN 2040-AD99 

Drinking Water Contaminant Candidate List 3 - Draft 

AuthorJoseph O. Falkinham, III 

Department of Biological Sciences 

Virginia Tech 

Blacksburg, VA 24061-0406 
Phone (540) 231-5931 

FAX (540) 231-9307 

E-mailjofiii@vt.edu 

Note. The recommendation reflects the views of the author and 

does not represent the views of Virginia Tech. 

Recommendation 

Mycobacterium avium and Mycobacterium intracellulare (M. avium 

Complex, MAC) should be included in the drinking water 

Contaminant Candidate List 3. 

Justification for Recommendation 

(1) The prevalence and incidence of MAC disease in the United 

States and Canada is increasing. 

(2) The prevalence and incidence of MAC disease is particularly 

increasing among the elderly. MAC pulmonary disease is 

dramatically increasing amongst elderly individuals (> 60 

years). In as much as the proportion of elderly US citizens 

will continue to increase, the increase in MAC disease will 

continue to increase. 

(3) MAC disease has long-term adverse health, economic, and 

social effects on individuals, their families, and communities. 

(4) MAC are normal inhabitants of drinking water distribution 

systems that persist, grow, and form biofilms throughout 

drinking water systems. The majority of MAC cells reside in 

biofilms on pipe surfaces and are dislodged or released by 

water flow to enter household, hospital and building water 

systems. 
(5) Current methods for delivery of contaminant-free water 

actually select for the growth and persistence of MAC in 

drinking water distribution systems. 

(6) The presence of MAC in drinking water has been linked to 

infection and disease in persons exposed to that water. 

(7) Opportunities exist for reduction of health risks through 

imposition of water treatment measures. 

Details Relevant to Summary Comments 

(1) The Prevalence and Incidence of MAC Disease is Increasing 

Recent reports document a rising prevalence and incidence of 

disease and infection by M. avium complex bacteria (MAC) and 

other nontuberculous mycobacteria (NTM). The reports have 

analyzed three sets of data. First are reports of increased 

incidence of patients suffering from MAC or NTM disease (Marras 

and Daley, 2002). Second are reports of increases in the number 

of samples sent to mycobacteriology laboratories for culture 

and the increased number and frequency of patient specimens 

yielding MAC or NTM (Yates et al., 1997; Martin-Casabona et 

al., 2004; Lipsky et al., 1984; Gordin et al., 1990; Yajko et 

al., 1994; Stone et al., 1997; Wright et al., 1998; Marras et 

al., 2007). Third, is a report of the increase in skin 

sensitivity to mycobacterial antigens over three decades in the 

United States (Khan et al., 2007). All three measures reflect 

the increasing burden of exposure to MAC and NTM in the United 

States. 

Although infections caused by nontuberculous mycobacteria, 

including members of the M. avium complex (MAC) are not 

required to be reported, estimates of disease incidence in the 

United States have been published. Most estimates of infection 

and disease in the United States and Canada are outdated (1960 

- 1996) and range from 0.1 to 1.8 per 100,000 (reviewed in 

Marras and Daley, 2002). For example, in 1987, a study 
conducted by the CDC reported that the incidence of NTM disease 

was 1.8 per 100,000 and that for MAC alone was 1.1/100,000 for 

MAC (O'Brien et al., 1987). A more recent estimate of the 

prevalence of pulmonary NTM infection in Ontario (Marras et 

al., 2007) showed significant increases for MAC from 5.6 (1997) 

to 8.4 (2003)/100,000, M. xenopi (another waterborne pathogenic 

mycobacterium) from 2.6 (1997) to 4.2 (2003), and rapidly 

growing mycobacteria from 1.2 (1997) to 2.0 (2003). Because 

MAC and NTM disease is not reportable, it is likely that the 

estimates are low and the prevalence of MAC and NTM disease are 

considerably higher. 

Reports of increased frequency of MAC and NTM isolation from 

specimens submitted to reference mycobacteriology laboratories 

have come from England (Yates et al., 1997) and 14 European 

nations (Martin-Casabona et al., 2004). A recent study of the 

Public Health Laboratory Information System resulted in 

estimates of 3.5 and 3.7 MAC isolates (alone) per 100,000 in 

1993 and 1996, respectively. If total pathogenic NTM are 

included, the rates are 4.4 (1993) and 4.5 (1996). Another 

example of the increasing incidence of MAC and NTM in the 

United States (where MAC predominates) is evidence of the 

increased proportion of nontuberculous mycobacterial isolations 

amongst samples submitted to laboratories in the United States 

over the period 1984 to 1998. During this period of time there 

was no substantial change in the incidence of Mycobacterium 

tuberculosis infection or isolations. 

Reference Specimen NumberNTM (%) 

Lipsky et al. (1984) 58 1 (2 %) 

Gordin et al. (1990) 142 5 (4 %) 

Yajko et al. (1994) 30633 (11 %) 

Stone et al. (1997) 38796 (25 %) 

Wright et al. (1998) 1315638 (49 %) 

Finally, the incidence of positive skin sensitivity reactions 

to antigens prepared from Mycobacterium intracellulare, a 

member of the M. avium complex, over the period 1971-1972 and 

1999-2000 were compared (Khan et al., 2007). Unlike many other 
bacterial pathogens, skin sensitivity reactions to 

mycobacterial antigens can be used to detect infection. The 

prevalence of positive M. intracellulare antigen sensitivity 

reactions increased from 11.2 % to 16.6 % of the individuals 

tested (Khan et al., 2007). Thus, individuals in the United 

States are being exposed to MAC and NTM either through wider 

distribution (not just southeastern), higher numbers, or more 

frequently. 

Clearly, all three measures of MAC or NTM disease or exposure 

document the increasing prevalence of MAC and NTM in humans in 

the United States and elsewhere. 

(2) MAC Pulmonary Disease Incidence is Increasing Dramatically 

amongst the Elderly 

The prevalence and incidence of MAC pulmonary disease amongst 

elderly individuals has been increasing dramatically since it 

was first described (Albelda et al., 1985; Prince et al., 

1989). This new presentation of MAC pulmonary disease appears 

in elderly men and women who lack any of the classic risk 

factors for mycobacterial pulmonary disease (Prince et al., 

1989). The only common feature is that the infected 

individuals are elderly and low weight. 

Increases of MAC disease amongst the elderly, geriatric 

population have been noted in several published community-based 

studies, not at referral hospitals. In particular, increases 

have been documented in two geographically separated regions of 

the United States, Portland, Oregon (Reich and Johnson, 1991) 

and Chapel Hill, North Carolina (Kennedy and Weber, 1994). 

Similarly, increases amongst the elderly have been noted in 

Calgary, Alberta, Canada (Field et al., 2004) and Toronto, 

Ontario, Canada (Marras et al., 2007). Thus, the dramatic 

increase in MAC pulmonary disease is not restricted 

geographically, but occurs across the United States and Canada. 

One common feature of persons living in those areas in the 

united States and Canada is access to high quality treated 

drinking water; a normal habitat of MAC and NTM. 
In as much as all models of future U.S. population composition 

roject that the proportion of elderly will increase, it is 

logical to expect that the incidence and prevalence of MAC and 

NTM pulmonary disease will continue to increase. In fact, the 

increases will accelerate as the proportion of elderly amongst 

the US population increases. 

Other groups of individuals, whose incidence in the US 

population is expected to increase include patients that arte 

immunosuppressed as a consequence of transplantation or 

chemotherapy. Members share the common characteristic of 

reduced immune competence and greater susceptibility to 

infection. Both transplant (Simpson et al., 1982) and 

immunosuppressed patients (Skogberg et al., 1995) as well as 

those with malignancies (Claass et al., 1995) are more 

susceptible to MAC and NTM infection. Again, as is the case 

for the elderly, it is expected that the proportion of those 

individuals is expected to rise in the United States. 

(3) MAC Disease has Strong Adverse Health, Economic, and Social 

Effects on Individuals 

MAC and NTM pulmonary disease has severe adverse effects on 

persons with the disease. The list of salient clinical 

symptoms of MAC and NTM disease includes: 

Cough 

Malaise and Fatigue 

Fevers and Night Sweats 

Anorexia and Weight Loss (Prince et al., 1989; Field et al., 

2004) 

Thus, there can be no doubt that MAC and NTM disease 

dramatically reduce the quality of life for infected persons. 

Recommended MAC and NTM therapy involves multi-drug regimens 

(Field et al., 2004; Griffith et al., 2007). Guidelines from 
the American Thoracic Society and Infectious Disease Society of 

America recommend combinations of two, three, and four 

antibiotics (Griffith et al., 2007). It is well-established 

that treatment with each drug is accompanied with side-effects. 

Further, rather than simply adding side-effects, there are drug 

interactions that multiply the side-effects. In treatment of 

MAC and NTM disease, high failure rates of treatment are due to 

an inability to tolerate side-effects (Field et al., 2004). 

Long treatment durations are characteristic of treatment of MAC 

and NTM infections (Griffith et al., 2007). Relapses are 

common amongst MAC and NTM pulmonary patients, requiring 

hospitalization and additional medical attention. Both lead to 

severe economic hardships on MAC- or NTM-infected individuals 

that are beyond those caused by the symptoms that reduce energy 

levels and mobility. Multi-drug regimens are quite expensive, 

particularly because mycobacteria are not susceptible to 

antibiotics used to treat other bacteria infections. 

(4) MAC are Normal Inhabitants of Drinking Water Distribution 

Systems 

Members of the M. avium complex (MAC) as well as other 

nontuberculous mycobacteria (NTM) are normal inhabitants of the 

human environment. In addition to natural waters (Falkinham, 

et al., 1980) and soils (Brooks et al., 1984), MAC and other 

NTM are also normal inhabitants of drinking water distribution 

systems (Aronson et al., 1999; Covert et al., 1999; Falkinham 

et al., 2001). As the water distribution systems were located 

throughout the United States and employed different methods of 

water treatment and had different organic matter contents, it 

is likely that most, if not all, US drinking water systems 

carry a resident and persistent population of MAC and NTM. 

MAC and other NTM are not contaminants of drinking water 

distribution systems, but they grow in the distribution system. 

In fact, the further the distance the water sample is collected 

in a distribution system, the higher the numbers of MAC 

(Falkinham et al., 2001). 
In addition to water distribution systems MAC and NTM have been 

shown to increase in number in hospital hot water systems (du 

Moulin et al., 1988; Kusnetsov et al. 2003). What is troubling 

about this discovery is that hospitals are comprised primarily 

of persons more susceptible to infection as a consequence of 

their conditions leading to hospitalization. Further, the 

information on hospitals suggests that MAC and NTM, whose 

original source is the public or private water supply, can 

populate the water systems of buildings and homes. 

(5) Drinking Water Treatment and Practice Selects for MAC 

Growth and Persistence in Drinking Water Systems 

MAC are at least 100-times more resistant to chlorine, 

chloramine, chlorine dioxide and ozone than Escherichia coli, 

the standard for disinfection (Taylor et al., 2000). 

Consequently use of any disinfectant leads to killing of other 

microorganisms and the survival of MAC and other NTM. The 

hydrophobic cell envelope of MAC and other NTM leads to their 

preferential attachment to surfaces where they grow and form a 

biofilm. Thus, MAC and NTM are not washed out of a drinking 

water distribution system. Further, biofilm-grown MAC are 

significantly more resistant to disinfectants than are those 

grown and exposed in suspension (Steed and Falkinham, 2006). 

MAC can grow in drinking waters at assimilable organic carbon 

(AOC) concentrations as low as 50 μg/L; they are oligotrophic 

(Norton et al., 2004). 

The goal of water treatment is to reduce the number of 

pathogenic microorganisms and organic and inorganic chemicals 

in water. However, achieving those aims using chemical 

disinfection selects for MAC and NTM. Addition of disinfectant 

and reduction of AOC both select for MAC and NTM persistence 

and growth. In the absence of competitors, disinfectant- 

resistant, slowly growing MAC and NTM on the surfaces of pipes 

can utilize all the available nutrients for growth. As the 

mycobacteria grow cells are released into the water where they 

can colonize and grow in new habitats; for example hospitals, 

buildings, and households. 
A recent, troubling report indicates that disinfectant changes, 

to reduce the formation of trihalomethanes (Stage 1 

Disinfection-Byproducts Rule, January 1, 2002) may lead to 

increases in MAC and NTM in drinking water distribution 

systems. A change from chlorine to chloramine in the drinking 

water system of Pinellas County, Florida led to an increase in 

the frequency of isolation and number of MAC and NTM (Pryor et 

al., 2004). Thus, changes in water treatment to reduce 

chemical exposures, may select for increased MAC and NTM 

numbers. 

(6) The Presence of MAC in Drinking Water has been Linked to 

Disease in Persons Exposed to that Water. 

MAC in drinking water has been epidemiologically linked to 

disease in humans. Patients in a Boston AIDS outpatient clinic 

were infected with M. avium that shared the same DNA 

fingerprint pattern as M. avium isolates recovered from the 

water used to prepare coffee (von Reyn et al., 1994). More 

recently, the fingerprints of M. avium isolates recovered from 

the hot and cold water and biofilm in a bathroom showerhead in 

a condominium in New York were shown to be clonally related to 

the M. avium isolate recovered from a resident who used the 

shower regularly (Falkinham et al., 2008). The significance of 

the latter case lies in the fact that the resident was young, 

not immunodeficient, and had none of the classic risk factors 

for M. avium (Falkinham et al., 2008). 

(7) Opportunities Exist for Reduction of Health Risks Through 

Imposition of Water Treatment Measures. 

Although MAC and NTM are disinfection-resistant, they are as 

susceptible to ultraviolet light (UV) as are other 

microorganisms, such as Escherichia coli. Thus, UV- 

disinfection is a viable and alternative means for reducing 

numbers of MAC and NTM in drinking water. 

Numbers of MAC in drinking water systems are correlated with 
particulate matter (Falkinham et al., 2001). MAC and NTM are 

bound to particulates because of their very high cell surface 

hydrophobicity (Stormer and Falkinham, 1989; Bendinger et al., 

1993). If particulate matter is effectively removed from water 

entering and leaving treatment facilities, MAC and NTM numbers 

will be reduced. 

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Simpson, G. L, t. A. Raffin, and J. S. Remington. 1982. 

Association of prior nocardiosis and subsequent occurrence of 

nontuberculous Mycobacteriosis in a defined, immunosuppressed 

population. J. Infect. Dis. 146:211-219. 

Skogberg, K., P. Ruutu, P. Tukiainen, and V. V. Valtonen. 1995. 

Nontuberculous mycobacterial infection in HIV-negative patients 

receiving immunosuppressive therapy. Eur. J. Clin. Microbiol. 

Infect. Dis. 14:755-763. 

Steed, K. A. and J. O. Falkinham, III. 2006. Effect of growth 
in biofilms on chlorine susceptibility of Mycobacterium avium 

and Mycobacterium intracellulare. Appl. Environ. Microbiol. 

72:4007-4100. 

Stone, B. L., W. J. Burman, M. V. Hildred, E. A. Jarboe, R. R. 

Reves, and M. L. Wilson. 1997. The diagnostic yield of acid- 

fast bacillus smear-positive sputum specimens. J. Clin. 

Microbiol. 35:1030-1031. 

Stormer, R. S. and J. O. Falkinham, III. 1989. Differences in 

antimicrobial susceptibility of pigmented and unpigmented 

colonial variants of Mycobacterium avium. J. Clin. Microbiol. 

27:2459-2465. 

Taylor, R.H., J.O. Falkinham, III, C.D. Norton, and M.W. 

LeChevallier. 2000. Chlorine-, chloramine-, chlorine dioxide- 

and ozone-susceptibility of Mycobacterium avium. Appl. Environ. 

Microbiol. 66:1702-1705. 

von Reyn, C. F., J. N. Maslow, T. W. Barber, J. O. Falkinham, 

III, and R. D. Arbeit. 1994. Persistent colonisation of potable 

water as a source of Mycobacterium avium infection in AIDS. 

Lancet 343:1137-1141. 

Wright, P. W., R. J. Wallace, Jr., N. W. Wright, B. A. Brown, 

and D. E. Griffith. 1998. Sensitivity of fluorochrome 

microscopy for detection of Mycobacterium tuberculosis versus 

nontuberculous mycobacteria. J. Clin. Microbiol. 36:1046-1049. 

Yajko, D. M., P. S. Nassos, C. A. Sanders, J. J. Madej, and W. 

K. Hadley. 1994. High predicitve value of the acid-fast smear 

for Mycobacterium tuberculosis despite the high prevalence of 

Mycobacterium avium complex in respiratory specimens. Clin. 

Infect. Dis. 19:334-336. 

Yates, M. D., A. Pozniak, A. H. C. Uttley, R. Clarke, and J. M. 

Grange. 1997. Isolation of environmental mycobacteria from 
clinical specimens in south-east England: 1973-1993. Int. J. 

Tuberc. Lung Dis. 1:75-80. 

CS Title: 0091 

Company/group/association name: 

Comment: 

19 May 2008 

Water Docket, Environmental Protection Agency 

Mail code: 2822T, 1200 Pennsylvania Ave., NW. 

Washington, DC 20460 

USA 

Dear Sirs 

Subject: Comments on the US EPA Drinking Water Contaminant 

Candidate List 3 (CCL3) (Draft; Notice of February 21, 2008) 

Docket ID No.: EPA-HQ-OW-2007-1189 

The International Molybdenum Association submits the following 

comments to the above referenced notice published by the United 

States Environmental Agency at 73 Fed. Reg. 9628 (Feb. 21, 

2008). That notice relates to the US EPA's Drinking Water 

Contaminant Candidate List 3, which includes molybdenum as one 

of the ninety three chemicals or groups of chemicals listed. 

As set forth in the Federal Register notice, US EPA seeks to 

classify contaminants on the basis of available data to 

characterize the occurrence and adverse health risks that a 

contaminant may pose to consumers of a public water supply. The 

Federal Register notice identifies the US EPA Integrated Risk 

Information System (IRIS) as among the primary sources used in 

developing the draft CCL3. We wish to comment on one of the 

criteria the US EPA uses for retaining a chemical on the 

candidate list, namely, the potential to cause adverse effects 

in humans. 
For molybdenum we note that the potency score was based on a 

reference dose derived in the IRIS. In turn, the IRIS entry for 

molybdenum and derivation of the reference dose (0,005 

mg/kg/day) was derived using data for increased uric acid 

levels found by Koval'skiy et al. 1961. However, as noted by US 

EPA in IRIS, 2008, when referring to the study by Koval'skiy et 

al., the "increased copper excretion and elevated serum 

ceruloplasmin are not definitive adverse effects, and as 

presented here are associated with no frank adverse effects in 

a human population." 

The IRIS entry also refers to other documents which, 

importantly, do not support the finding that molybdenum 

increases uric acid levels. Instead, two cited studies found 

that 0,022 mg/kg/day molybdenum did not affect urinary acid 

excretion (Deosthale and Gopolan, 1974) and that uric acid was 

lower in blood with higher molybdenum exposure (US EPA, 1979). 

Nonetheless, the aforementioned reference dose in IRIS was 

still based on the Koval'skiy et al., 1961 study, with 

confidence in this value noted as 'medium'. 

The United States National Research Council (NRC) has noted 

many weaknesses in the Koval'skiy study and concluded that the 

involvement of molybdenum in the apparent adverse effects that 

were identified was "speculative" and insufficient to establish 

a cause-and-effect relationship (Vyskocil and Viau, 1999). A 

further relevant comment about the Koval'skiy et al., 1961 

study is with regard to the fact that it was retained by the 

European Chemicals Bureau as the basis for its R48[FN1: R48 

means Harmful: Danger of serious damage to health by prolonged 

exposure through inhalation and if swallowed.] classification 

of pure molybdenum trioxide in the EU in the late 1990's. This 

was subsequently challenged by IMOA, and the ECB Classification 

and Labelling Committee, at its 21-24 September 2004 meeting in 

Arona, Italy, agreed to withdraw the R48 classification, and 

documented this in its molybdenum trioxide entry in the 30th 

Adaptation to Technical Progress of EU Directive 67/548/EEC. 

Some primary concerns about the Koval'skiy study were the 

potential for cross-contamination of the analysed samples, the 

limited number of control subjects (5) compared with exposed 
persons (52), the criteria for the selection of subjects for 

blood and urine sampling. This cast substantial doubt on the 

role of molybdenum in the aetiology of the findings. IMOA and 

the ECB concluded that the study did not contribute to the 

understanding of the potential toxicity of ingested molybdenum. 

Its quality for NOAEL derivation was considered severely 

inadequate. 

Lastly, we wish to inform you that as part of industry's 

obligations under REACH (the new chemicals legislation in 

Europe) to provide proof of safe production, use and disposal 

of a substance, IMOA has very recently conducted a thorough 

review of the available literature on molybdenum Repeated Dose 

Toxicity. More than 55 articles (including animal and human 

studies) have been identified and assessed. Specifically, each 

study has been thoroughly reviewed and catergorised based on 

stringent criteria for reliability and relevancy, and IMOA has 

identified the available data that can be used for deriving a 

NOAEL for systemic effects after chronic oral exposure. This 

IMOA review concludes that the NOAEL should be an order of 

magnitude higher than the level derived in IRIS from in the 

Koval'skiy et al., 1961 study. The results of this review can 

be made available to the Agency once the IMOA internal review 

process is completed. 

Given the substantial concerns about the quality of the 

Koval'skiy et al., 1961 study, and the combined evidence from 

other human health studies, the basis for listing molybdenum on 

the draft CCL3 is weak. The scores for the occurrence of 

molybdenum in public water systems were also low for prevalence 

(9) and magnitude (8). On the other hand and as confirmed by 

several other studies, molybdenum is an essential trace element 

in the human body. IMOA considers that, in this context, 

molybdenum does not merit EPA prioritisation, and proposes that 

it not be assigned any further priority at this time. 

We thank you for this opportunity to submit our above comments, 

and remain at your disposal for further dialogue. 

Yours sincerely, 
Sandra Carey 

HSE Executive 

Kindly direct further correspondence to: 

sandracarey@imoa.info and Iregoli@imoa.info 

Tel: + 44 (0) 7778 813721 

References: 

Koval'skiy, G.A. et al., 1961. Changes of purine metabolism in 

man and animals under conditions of molybdenum biogeochemical 

provinces. Zh. Obshch.Biol. 22: 179-191 

Deosthale, Y.G. and C. Gopalan. 1974. The effect of molybdenum 

levels in sorghum (Sorghum vulgare Pers.) on uric acid and 

copper excretion in man. Br. J. Nutr. 31: 351-355. 

U.S. EPA. 1979. Human health effects of molybdenum in drinking 

water. Cincinnati, OH. EPA-600A-79-006. 

30th Adaptation to Technical Progress, EU Directive 67/548/EEC 

CS Title: 0092 

Company/group/association name: 

Comment: 

Docket ID No. EPA-HQ-OW-2007-1189 

Candidate Contaminant List- Cyanobacterial Toxins 

Submitted by Ian R. Falconer, Pharmacology, University of 

Adelaide, South Australia, 5005 and Cooperative Research Centre 

for Water Quality and Treatment. 

There are currently three cyanobacterial toxins listed, the 
peptide toxin(s) microcystin(s), and alkaloid toxins 

cylindrospermopsin and anatoxin-a. 

Microcystins 

The WHO issued a Provisional Guideline Value for microcystin-LR 

in 1998, and since that time 14 countries have issued similar 

guidelines. This value was derived from rodent No Observed 

Adverse Effect Level data, with standard safety factors. In 

2006 the International Agency for Research on Cancer (IARC) 

carried out a review of carcinogenicity data for microcystins, 

and resolved that microcystin-LR is a 'Possible Carcinogen 

(class 2B). This was based on an overall review of human 

epidemiology data, experimental carcinogenicity data and 

mechanistic data. The most significant element was the data for 

tumour promotion by microcystin. 

While there are substantial gaps in the data for human 

toxicology of microcystins, the frequency of occurrence in 

drinking water sources (including in the USA) and human and 

animal epidemiological data, make these compounds of concern to 

health. Their variability of removal in water treatment makes 

assessment of this contaminant essential under circumstances of 

cyanobacterial contamination of reservoirs. 

Attention also needs to be given to contamination of 

cyanobacterial health food products, which have been shown in 

many cases to contain microcystins. Appropriate analytical 

techniques and standards are available. 

I recommend that microcystins (in toxicity equivalents to 

microcystin-LR) be determined to be regulated contaminants, 

with applicable Maximum Contaminant Levels, in drinking water 

and 'algal' (cyanobacterial) food supplements. 

Cylindrospermopsin 
The compound came to attention in 1980 after about 150 children 

suffered hepatoenteritis following a water-bloom of 

Cylindrospermopsis raciborskii on the local drinking water 

reservoir. The toxin was subsequently isolated and 

characterized. Since that time it has also been identified as 

the most abundant cyanotoxin in the Brazilian dialysis 

poisoning in 1996, in which more than 50 patients died. There 

are adequate data for rodent toxicity and toxicology, in vitro 

mechanisms of cytotoxicity and genotoxicity, and limited data 

on teratogenicity and carcinogenicity of cylindrospermopsin. 

There is inadequate current data to resolve issues of 

carcinogenicity. Second species toxicology is absent, though in 

vitro studies of cell lines derived from different species and 

organs provide a similar pattern of toxicity. This cytotoxic 

and genotoxic alkaloid was referred to the WHO Chemical Safety 

Committee in 1998, and to the IARC in 2006. Both bodies 

resolved that there was insufficient data for resolution at 

that time. 

The toxin is widely distributed in natural and artificial water 

bodies, and there are appropriate analytical techniques and 

standards available. 

I recommend that this compound be retained on the candidate 

contaminant list. The National Toxicology Program as a matter 

of urgency should carry out studies of chronic toxicity and 

carcinogenicity. 

On the basis of the results of these studies, 

cylindrospermopsin should be evaluated for classification as a 

regulated contaminant. 

Anatoxin-a 

The toxicity, toxicology and mechanism of action of this 

neurotoxin are known. 

As far as I am aware there have been no substantiated human 
poisoning events with this toxin. Dogs appear to be vulnerable, 

with reports of rapid death following eating of cyanobacterial 

scum, or dogs licking their contaminated coats. The relatively 

high dose required for oral toxicity, together with no reported 

chronic low-dose effects, teratogenicity, or carcinogenicity, 

indicate that this alkaloid is unlikely to present a challenge 

to human health from drinking water. 

Consumption of cyanobacterial concentrates as health food 

supplements however may pose a risk if anatoxin-a producing 

species are used. 

I recommend that anatoxin-a be removed from on the Candidate 

Contaminant List. 

References 

Toxic Cyanobacteria in Water; a guide to their public health 

consequences, monitoring and management. Chorus, I and Bartram, 

J., E & FN Spon, on behalf of WHO, London 1999 

Cyanobacterial Toxins of Drinking Water Supplies; 

cylindrospermopsins and microcystins. Falconer, Ian R., CRC 

Press, Boca Raton, Fl. 2005 

Cyanobacterial Harmful Algal Blooms; state of the science and 

research needs. Hudnell, H.K., Adv. In Exp. Med. and Biol. 619, 

Springer 2008 

20 May 2008 

CS Title: 0095 

Company/group/association name: 

Comment: 

Comment on Proposed EPA 

Drinking Water Contaminant Candidate List 3 
Docket: EPA-HQ-OW-2007-1189 

April 25, 2008 

Pursuant to the proposed list of contaminants on the Federal 

Register, I request that: i) Mycobacterium avium remain on the 

CCL and that ii) Mycobacterium avium be given the significantly 

higher score it merits. 

M. avium and related strains of mycobacteria (nontuberculous 

mycobacteria, or NTM) are known water contaminants that are 

currently being assessed relative to human morbidity and 

mortality. 

Environmental Source and Infection 

In April 2008, the Centers for Disease Control convened a 

meeting of leading experts to discuss priorities for better 

surveillance and understanding of this disease. NTM Info & 

Research (NTMir), the national not-for-profit organization for 

pulmonary NTM infection, is currently funding a pilot study to 

determine the connection between household water, which 

includes drinking water, and pulmonary NTM infection. Of five 

initial patients suffering from pulmonary NTM disease and their 

households surveyed thus far, four (or 80%) were determined to 

have lung infection identical to the strain in the water. At 

least 20 additional patient homes are currently being studied 

and compared to sputum. 

Epidemiology - Increasing Prevalence 

A recent study from Toronto, Ontario, provides concrete 

evidence that the prevalence of pulmonary NTM infections is 

much higher than previously understood. A pilot study is 

currently in process by NAIAD and Kaiser Permanente of Southern 

California to provide a snapshot of the epidemiology of 

pulmonary NTM in the United States. 

Health Effects 

As data is not currently collected by the CDC or any other 
agency, it is difficult to assess the mortality rates of 

pulmonary NTM in the United States until completion of the 

NAIAD/Kaiser Permanente study mentioned above. 

M. avium and other NTM cause pneumonia and other severe 

manifestations of illness frequently requiring hospitalization 

in excess of one week. Many, if not most NTM-related 

hospitalizations last more than 7 days. 

M. avium and other NTM infections can cause long term 

dysfunction or disability due to progressive and permanent loss 

of lung function. 

M. avium and other NTM's cause illness requires long-term 

physician intervention as initial treatment typically requires 

18-24 months of multi-antibiotic therapy, frequent CT scans, 

and frequent sputum testing. 

Aging Population at Greater Risk 

There appears to be an increase in pulmonary NTM infection in 

the immune competent population over age 60 with a majority 

being women. This is in addition to individuals with underlying 

vulnerability such as Cystic Fibrosis, Alpha-1 deficiency, 

bronchiectasis or immune compromised patients (HIV/AIDS, 

chemotherapy), 

I believe that removing M. avium from the CCL is not in the 

public's best interest and will have a negative impact on the 

U.S. population. Pulmonary NTM disease is being diagnosed with 

increasing frequency across the United States. I request that 

the EPA continue to monitor M. Avium in the water supply and 

give it a higher score. 

Thank you for your attention and consideration in this matter. 

Sincerely, 

J. Davis 
CS Title: 0096 

Company/group/association name: 

Comment: 

Docket ID No. EPA-HQ-OW-2007-1189 

I am a member of Citizens Concerned About Chloramine, but these 

are my personal comments. 

I am concerned about the possible health effects of chloramine 

when it is used as a residual disinfectant in drinking water. 

(By "chloramine", I mean the three inorganic chloramines, 

namely, monochloramine, dichloramine, and trichloramine.) 

--- 

Chloramine is not on CCL 3: 

<http://www.epa.gov/OGWDW/ccl/ccl3.html#ccl3> nor is it on PCCL 

3 (see Appendix 2 of this document): 

<http://www.epa.gov/OGWDW/ccl/pdfs/report_ccl3_chemicals_screeni 

ng.pdf> Was chloramine on the list of 7,500 chemicals from 

which the PCCL 3 chemicals were selected? Does this list have a 

name? Is it available online? 

According to this document: 

<http://www.epa.gov/EPA-WATER/2006/October/Day-16/w17099.htm> 

the deadline for submitting nominations for the universe from 

which PCCL 3 was subsequently selected was 12-15-06. 

At a "stakeholders" meeting of 9-5-07 in San Francisco, which 

was initiated by Dennis Agatep, from Rep. Anna Eshoo's office, 

and facilitated by EPA's Jim Vreeland, EPA's Dr. Bruce Macler 

said that he was working on the CCL 3 list and that it was 

possible that chloramine would be on the list. Given the status 

of the 7,500-chemical list as of 9-5-07, was that still a 

possibility then? 
--- 

Hypothetically, is it possible that chloramine could ever 

appear on a Contaminant Candidate List in the future? Or, for 

example, is it the case that, by definition, chloramine cannot 

be a contaminant because it is a residual disinfectant? If so, 

is there a process -- analogous to the CCL process -- by which 

EPA determines when to study the possible health effects of 

residual disinfectants? 

CS Title: 0098 

Company/group/association name: 

Comment: 

Water Docket 

EPA-HQ-OW-2007-1189 

Environmental Protection Agency 

Mailcode: 2822T 

1200 Pennsylvania Ave., NW. 

Washington, DC 20460 

Re: Comment on Proposed EPA 

Drinking Water Contaminant Candidate List 3 

Docket: EPA-HQ-OW-2007-1189 

April 30, 2008 

Dear Sir or Madam, 

Pursuant to the proposed list of contaminants on the Federal 

Register, I respectfully request that: 

i) Mycobacterium avium remain on the CCL and that 

ii) Mycobacterium avium be given the significantly higher score 

it merits . 
M. avium and related strains of mycobacteria (nontuberculous 

mycobacteria, or NTM) are known water contaminants that cause 

significant lung disease and are associated with significant 

morbidity and mortality. 

Environmental Source and Infection 

In April 2008, the Centers for Disease Control convened a 

meeting of leading experts to discuss priorities for better 

surveillance and understanding of this disease. NTM Info & 

Research (NTMir), the national not-for-profit organization for 

pulmonary NTM infection, is currently funding a pilot study 

[FNi: http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] 

to determine the connection between household water, which 

includes drinking water, and pulmonary NTM infection. Of five 

initial patients suffering from pulmonary NTM disease and their 

households surveyed thus far, four (or 80%) were determined to 

have lung infection identical to the strain in the water.[FNii: 

http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least 

20 additional patient homes are currently being studied and 

compared to sputum. 

Epidemiology - Increasing Prevalence 

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore 

P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- 

tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 

62:661-6.] provides concrete evidence that the prevalence of 

pulmonary NTM infections is much higher than previously 

understood. A pilot study is currently in process by NAIAD and 

Kaiser Permanente of Southern California to provide a snapshot 

of the epidemiology of pulmonary NTM in the United 

States.[FNiv: 

http://www.ntminfo.org/default_aspx/p/article/id/16.aspx] 

Health Effects 
As data is not currently collected by the CDC or any other 

agency, it is difficult to assess the mortality rates of 

pulmonary NTM in the United States until completion of the 

NAIAD/Kaiser Permanente study mentioned above. 

M. avium and other NTM cause pneumonia and other severe 

manifestations of illness frequently requiring hospitalization 

in excess of one week. Many, if not most NTM-related 

hospitalizations last more than 7 days. 

M. avium and other NTM infections can cause long term 

dysfunction or disability due to progressive and permanent loss 

of lung function. 

M. avium and other NTM's cause illness requires long-term 

physician intervention as initial treatment typically requires 

18-24 months of multi-antibiotic therapy, frequent CT scans, 

and frequent sputum testing. 

Aging Population at Greater Risk 

There appears to be an increase in pulmonary NTM infection in 

the immune competent population over age 60 with a majority 

being women.[FNv: Official ATS/IDSA Statement: Diagnosis, 

Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. 

Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in 

addition to individuals with underlying vulnerability such as 

Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune 

compromised patients (HIV/AIDS, chemotherapy). 

I believe that removing M. avium from the CCL is not in the 

public's best interest and will have a negative impact on the 

U.S. population. Pulmonary NTM disease is being diagnosed with 

increasing frequency across the United States. I request that 

the EPA continue to monitor M. avium in the water supply and 

give it a higher score. 
Thank you for your attention and consideration in this matter. 

Sincerely, 

Ed Chan, MD 

Associate Professor of Medicine 

K720, Goodman Building 

National Jewish Medical and Research Center 

1400 Jackson St 

Denver, Colorado 80206 

Tel: 303-398-1491 

Fax: 303-398-1806 

e-mail: chane@njc.org 

CS Title: 0099 

Company/group/association name: 

Comment: 

April 29, 2008 

Water Docket EPA-HQ-OW-2007-1189 

Environmental Protection Agency 

1200 Pennsylvania Ave., NW Mailcode: 2822T 

Washington, DC 

Dear Gentlemen and Ladies: 

As an academic physician working in the field of mycobacterial 

lung infections for the last 35 years, I am immensely concerned 

with rapidly increasing numbers of cases due to the 

nontuberculous mycobacteria (NTM), especially M. avium Complex 

(MAC). 

Due to the absence of systematic surveillance, I cannot 

quantitate this epidemic. Suffice it to say, the number of new 

patients being seen by pulmonary and infectious disease 

specialists across the United States has by description of 
these specialists soared over the past two decades. 

Although both men and women are afflicted, recent trends 

suggest a rising proportion of the morbidity is seen among 

middle-aged women. 

MAC infection requires extended (18 to 24 months) therapy and 

frequently entails retreatment. Resectional surgery may be 

employed in the attempt to control the disease. 

Preliminary data suggest that MAC may be acquired from our 

potable water system. Current hygienic practices limit coliform 

contamination but do nothing to diminish NTM contamination. 

It is unthinkable that at this junction the EPA would drop M. 

avium from the list of drinking water contaminant candidate 

list. 

If/when the linkage between potable water contamination and 

this epidemic of MAC lung disease is established this will be a 

major blemish and embarrassment for the EPA. 

Sincerely 

Michael D. Iseman, MD 

Professor of Medicine 

Division of Mycobacterial and Respiratory Infections 

Department of Medicine 

University of Colorado Health Sciences Center 

CS Title: 0101 

Company/group/association name: 

Comment: 

This comment is related to the manner in which chemical 
mobility is ranked in the CCL classification procedure. 

Currently, in the CCL classification procedure, pH- independent 

physicochemical parameters are used to predict chemical 

mobility in water. The use of pH-dependent physicochemical 

parameters is more appropriate scientifically. For more 

information, refer to the document attached. 

May 20,2008 

Water Docket 

U.S. Environmental Protection Agency 

Mail Code 2822T 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460 

Dear Colleagues: 

I am writing to comment on Docket No. EPA-HQ-OW-2007-1189, the 

Drinking Water Contaminant Candidate List 3 - Draft as 

published in the Federal Register. Vol. 73, No. 35, February 

21, 2008. I suggest a change in the manner in which mobility is 

ranked in the CCL classification procedure. 

I have studied the procedures used by the U.S. Environmental 

Protection Agency to prepare the Drinking Water Contaminant 

Candidate List under advisement from the National Drinking 

Water Advisory Council (NDWAC). I commend you for using a well- 

conceived, science-based approach when considering the chemical 

and microbial candidates to be listed in CCL 3. However, there 

is one aspect of this procedure that I request that you 

reconsider, that being, the manner in which the mobility 

scoring hierarchy used to select chemicals for CCL 

classification was developed, realizing that mobility data 

comprise but one part of the complex process. 

I ask that you consider these aspects of the mobility scoring 
hierarchy applied in the CCL procedure: 

* pH-dependence of the physical properties used to determine 

chemical mobility is not expressly incorporated into the CCL 

classification process at present; 

* knowledge that drinking water commonly undergoes treatment at 

pH 7-8 and is distributed between pH 6-9 is important to 

determining the potential mobility of a chemical; and, 

* a "very high" category should be added to the mobility 

scoring hierarchy in addition to the "low," "medium," and 

"high" categories included in the CCL classification procedure. 

Currently, in the CCL classification procedure, pH-independent 

physicochemical parameters are used to predict chemical 

mobility in water (refer to Federal Register. Vol. 73, No. 35, 

February 21,2008, page 9641). The application of pH-dependent 

physicochemical parameters is more scientifically correct, 

especially because many microconstituents in water are 

ionizable. Converting the CCL mobility score ranking to 

reliance on pH-dependent parameters instead of pH-independent 

parameters is an application of the appropriate science. The 

effect of this change would be that more chemicals, 

particularly highly hydrophilic chemicals, would be more 

intensely scrutinized for their potential to be very highly 

mobile in the environment. 

In two publications, I have presented data to substantiate this 

position: 

* M.J.M. Wells. 2006. Log Dow: Key to Understanding and 

Regulating Wastewater-Derived Contaminants. Environ. Chern., 

3:439-449 

* M.J.M. Wells. 2007. Examination of the Mobility Scoring 

Hierarchy Used to Select Chemicals for the U.S. EPA Contaminant 
Candidate List Classification Procedure [CDROM pp. 86-98]. 

Proceedings of the Water Environment Federation 2007 Specialty 

Conference Series. Compounds of Emerging Concern: What Is on 

the Horizon? Providence, RI. 

It is not possible to upload these manuscripts to the Docket 

because they are copyrighted materials.. 

The character of the ionized chemical forms present in water 

impacts their mobility. The CCL procedure already recognizes 

that mobility is important to transport of chemicals in the 

aquatic environment based on physical properties of the 

contaminant. Please consider my suggestion that the pH- 

independent physical properties currently used in the CCL 

mobility scoring hierarchy are not chemically appropriate for 

microconstituents that are ionized at the pH of drinking water. 

If I can answer questions or supply additional information, 

please contact me. 

Sincerely, 

Martha J.M. Wells, Ph.D. 

Professor, Environmental Chemistry 

Center for the Management, Utilization, and 

Protection of Water Resources and 

Department of Chemistry 

Tennessee Technological University 

Box 5033 

Cookeville, TN 38505 

Phone: (931)372-6123 

FAX: (931)372-6346 

Email: mjmwells@tntech.edu 

CS Title: 0102 

Company/group/association name: 

Comment: 

Environmental Protection Agency 
Docket ID No. EPA-HQ-OW-2007-1189 

Comments submitted by Sierra Club, National Water Committee 

May 21, 2008 

Re: Drinking Water Contaminant Candidate List 3--Draft; Notice 

Federal Register: February 21, 2008 (Volume 73, Number 35)] 

[Page 9627-9654] 

Dear Sir or Madame: 

On behalf of the Sierra Club, please accept these comments on 

the Drinking Water Contaminant Candidate List 3. 

Thank you. 

Sincerely your, 

Debbie Neustadt, Chair 

National Water Committee, Sierra Club 

Part I. EXCLUSION OF HEALTH EFFECTS ON IMMUNOSUPPRESSED 

POPULATION IN PCCL (PRELIMINARY CONTAMINANT CANDIDATE LIST) 

SCREENING VIOLATES THE SDWA AND IS CONTRARY TO REASONABLE AND 

DILIGENT ACTION BY US EPA. 

According to US EPA, "SDWA refers to several categories of 

sensitive populations including the following: children and 

infants, elderly, pregnant women, and persons with a history of 

serious illness." (US EPA, 2008) However, EPA also states that 

"Health effects for individuals with marked immunosuppression 

(e.g., primary or acquired severe immunodeficiency, transplant 

recipients, individuals undergoing potent cytoreductive 
treatments) are not included in this health effects scoring." 

(US EPA, 2008) 

Individuals with marked immunosuppression qualify as "persons 

with a history of serious illness," a sensitive population 

referenced in the SDWA. So, in its screening of microbial 

contaminant candidates, EPA should have included health effects 

for individuals with marked immunosuppression. Failure to 

consider the health effects in this sensitive subpopulation 

violates the SDWA. . 

EPA justifies exclusion of the immunosuppressed subpopulation 

from the health effects screening by claiming that individuals 

with marked immunosuppression "often have a higher standard of 

ongoing health care and protection required" than children and 

infants, elderly, pregnant women, and persons with a history of 

serious illness, all of whom are included in the health effects 

screening. However, the SDWA requires EPA to consider health 

effects for sensitive persons and makes no provision for 

disregarding health effects for persons who may require a 

higher standard of ongoing health care and protection. 

Whatever immunosuppressed persons may require in terms of 

health care and protection, many of them receive no health 

care. According to Fleming et al. 2002, "Advances in HIV/AIDS 

treatment have substantially reduced AIDS related morbidity and 

mortality and extended the lives of many. New treatments, 

however, are not a cure and do not benefit all people with HIV. 

An estimated 42% to 59% of people living with HIV/AIDS are not 

in regular HIV care." Fleming concludes, "The proportion of 

[HIV] infected persons who know their status is increasing; 

three-quarters have been diagnosed, but a large proportion may 

not be in ongoing care." So US EPA's failure to consider the 

health effects of microbial contaminants on this sensitive 

population deprives the HIV/AIDs population of equitable 

consideration for protection from pathogens as provided by the 

SDWA. For the roughly 50% of those suffering HIV/AIDs 

infection and without regular HIV care, EPA's failure to 

consider enhancing prevention of infection leaves them without 

any protection at all. 
EPA is incorrect in its claim that "nearly all pathogens have 

very high health effect scores for the markedly 

immunosuppressed individuals; therefore there is little 

differentiation between pathogens based on health effects for 

the immunosuppressed subpopulation." Certain pathogens tend to 

plague certain sensitive populations and to pose elevated risks 

for severe illness and death to those populations. Some of the 

pathogens listed on the PCCL (preliminary contaminant 

candidates list) have plagued the HIV/AIDs population while 

others are not generally considered in the associated medical 

literature. So in failing to consider the association between 

certain of the pathogens and the HIV/AIDs population, EPA has 

failed to include an important factor which would have been 

useful in determining which pathogens pose a current or 

emerging health threat to the American public. 

Selkir et al., 1997, examined national multicause death 

certificates to ascertain the impact of HIV on mortality from 

opportunistic infection. For each opportunistic infection, the 

percentage of deaths with HIV infection reported as the 

underlying cause was calculated for toxoplasmosis, 

cryptosporidiosis/isosporiasis, and for nontuberculous 

mycobacteriosis. The data provided by Selkir indicates that 

these opportunistic infections are of critical concern to the 

HIV/AIDs population. We conclude that in failing to consider 

the health effects of the candidate pathogens on the HIV/AIDs 

population, EPA disregarded nearly all of the risk posed to the 

public by these pathogens. As HIV/AIDs patients become 

infected, antibiotic resistant strains of these pathogens will 

emerge. So, EPA should have considered which pathogens are 

known to be presently causing high death rates in the HIV/AIDs 

population because antibiotic strains of these pathogens are 

likely to emerge. Preventing infection of the HIV/AIDs 

population protects the lives of this sensitive subpopulation 

now and reduces the opportunity for the emergence of antibiotic 

resistance. 

The World Health Organization (WHO, 2008) has assessed the 

magnitude of the problem of antibiotic resistant Mycobacterium 

tuberculosis, estimating that about 489,139 cases emerged in 

2006, and the global proportion of resistance among all cases 
is 4.8%. Data indicated that HIV status and drug-resistant TB 

are related, "Despite the expansion of HIV testing and 

treatment globally, only seven countries were able to report 

drug resistance data disaggregated by HIV status. The two 

countries with the most robust data both showed a significant 

association between HIV and MDR-TB. Both of these countries are 

situated in the former Soviet Union where diagnostic networks 

for both TB and HIV are relatively well developed." 

In conclusion, we urge EPA to revisit the health effects 

screening so that HIV/AIDs population, women suffering breast 

cancer, kidney transplant survivors, and other immunosupressed 

indivuals will receive the consideration due them under the 

SDWA. 

Fleming PL, Wortley PM, Karon JM, DeCock KM. 2002. "HIV 

Prevalence in the United States, 2000", Abstract #11, Oral 

Abstract Session 5, 9th Conference on Retroviruses and 

Opportunistic Infections, 2002. 

Selik R. M. ; Karon J. M. ; Ward J. W. 1997. Effect of the 

human immunodeficiency virus epidemic on mortality from 

opportunistic infections in the United States in 1993., The 

Journal of infectious diseasesvol. 176(3), pp. 632-636 

US EPA. Office of Water. 2008. Contaminant Candidate List 3 

Microbes: PCCL to CCL Process Office of Water (4607M) EPA 815- 

R-08-007 February 2008 page 5-6 

WHO. 2008. Anti-Tuberculosis Drug. Resistance In The World. 

Fourth Global Report. 

PART II. INCLUSION OF THE CHOLERA PATHOGEN VIOLATES SDWA 

STATUATORY REQUIREMENTS FOR INCLUSION ON THE CCL. 

Under the SDWA, statutory requirement #2 requires that a 

candidate contaminant should be known or likely to occur in 
public water systems at a frequency and level of concern. The 

cholera pathogen does not meet this requirement. It is not 

reasonable for EPA to conclude that V. chloera is "known or 

likely to occur in public water systems at a frequency and 

level of concern" with the following facts in evidence: 

* A cholera epidemic has not occurred in the US in the last 

hundred years. 

* The CDC surveillance data from cases of laboratory-confirmed 

toxigenic Vibrio chloera between 1995 and 2000 showed 61 cases 

of cholera, non of them associated with U.S. drinking water. 

There were 61% of the cases picked up outside the U.S., 23% 

from undercooked seafood, 2% from a melon contaminated by a 

food handler, and 8% with no source identified (Steinberg et 

al.,) . No cases were traced to drinking water. 

* No epidemic of cholera occurred when thousands of Americans 

were literally awash in Gulf Coast waters in the wake of 

hurricanes Rita and Katrina. The CDC noted that, "No evidence 

suggests increased risk for cholera among Gulf Coast residents 

or consumers of Gulf Coast seafood after the hurricanes." 

(CDC 2006) 

Selection of the cholera pathogen also violates statutory 

requirement 3: Does regulation of the contaminant present a 

meaningful opportunity for health risk reduction for persons 

served by public water systems? The causative agent for 

cholera is killed by the same water treatment which kills E. 

coli and other common coliform bacteria. Public water systems 

are already monitored and treated for coliform bacteria. So 

there is no meaningful opportunity for health risk reduction 

for persons served by public water systems. 

Steinberg EB, Greene KD, Bopp CA, Cameron DN, Wells JG, Mintz 

ED. Cholera in the United States, 1995-2000: trends at the end 

of the milennium. J Infect Dis. 2001;184:799-802. 
CDC. 2006. Editorial note re: Two Cases of Toxigenic Vibrio 

cholerae O1 Infection After Hurricanes Katrina and Rita- 

Louisiana, October 2005 in JAMA. 2006;295:1118-1120. MMWR. 

2006;55:31 

PART III. INCLUSION OF Salmonella enterica, Shigella sonnei, 

and E. coli (0157) VIOLATES THE SDWA STATUTORY REQUIREMENTS FOR 

INCLUSION ON THE CCL. 

The SDWA Statutory Requirement 3 requires that the regulation 

of the contaminant present a meaningful opportunity for health 

risk reduction for persons served by public water systems. 

Enteric bacteria are already well-controlled in treated 

drinking water. Appearance of Salmonella, Shigella, or E. coli 

occurs when drinking water treatment breaks down or is 

interrupted, but not due to inadequacy of water treatment 

methodology. So, further regulation presents no opportunity for 

health risk reduction for persons served by public water 

systems. 

PART IV. SDWA REGULATION OF Naegleria. fowlerii WOULD BE 

INADEQUATE AND INEFFECTUAL. 

The deaths of children exposed to the pathogenic amoeba N. 

fowlerii in bathing water are tragic. N. fowlerii only lives 

in warm water so prohibiting the use of hot source water for 

drinking water could potentially prevent such deaths. These 

deaths through exposure to drinking water while bathing are 

extremely rare, however. The more common route of exposure and 

death associated with N. fowlerii is through recreational 

waters such as hot springs. The SDWA does not cover such 

recreational waters. We urge US EPA to utilize the CWA to 

issue additional guidance for recreational waters which are 

warm enough to harbor N. fowlerii. 

CS Title: 0103 

Company/group/association name: 

Comment: 

May 20, 2008 
Water Docket 

Environmental Protection Agency 

Mail code: 2822T, 1200 Pennsylvania Ave., NW. 

Washington, DC 20460 

USA 

Dear Sir or Madam: 

Subject: Comments on the US EPA Drinking Water Contaminant 

Candidate List 3 (CCL3) (Draft; Notice of February 21, 2008) 

Docket ID No.: EPA-HQ-OW-2007-1189 

Climax Molybdenum Company (Climax), a subsidiary of Freeport- 

McMoRan Copper and Gold Inc., presents the following comments 

on the draft Drinking Water Contaminant List 3 (CCL3) relative 

to the inclusion of molybdenum in the draft list. While there 

are multiple reasons that the inclusion of molybdenum in the 

CCL3 is not warranted, Climax believes that the primary reason 

is that the science behind the reference dose has significant 

issues that warrant revisiting. Specifically, the Koval'skiy 

study that was relied on by EPA in establishing a reference 

dose of 0.005 mg/Kg is almost 50 years old, has limited value 

under current scientific protocols, and the conclusions made by 

this study are not supported by more recent studies. 

Detailed Comments 

Climax has over the past 25 years maintained an ongoing 

assessment program of the environmental and human health 

effects of molybdenum. As part of this program and via our 

membership in the International Molybdenum Association (IMOA) 

extensive literature studies have been carried out to identify 

relevant articles and studies that will improve our 

understanding of the effects of molybdenum compounds on human 

health and the environment. 
IMOA is also submitting comments on the draft CCL3 list and 

Climax supports those comments and conclusions. Climax concurs 

with the IMOA submittal, specifically the following statements: 

"...IMOA has very recently conducted a thorough review of the 

available literature on molybdenum Repeated Dose Toxicity. More 

than 55 articles (including animal and human studies) have been 

identified and assessed. Specifically, each study has been 

thoroughly reviewed and catergorised based on stringent 

criteria for reliability and relevancy, and IMOA has identified 

the available data that can be used for deriving a NOAEL for 

systemic effects after chronic oral exposure. This IMOA review 

concludes that the NOAEL should be an order of magnitude higher 

than the level derived in IRIS from in the Koval'skiy et al., 

1961 study." Page 2 of the IMOA submittal; and 

"Given the substantial concerns about the quality of the 

Kowal'skiy et al., 1961 study, and the combined evidence from 

other human health studies, the basis for listing molybdenum on 

the draft CCL3 is weak. The scores for the occurrence of 

molybdenum in public water systems were also low for prevalence 

(9) and magnitude (8). On the other hand and as confirmed by 

several other studies, molybdenum is an essential trace element 

in the human body. IMOA considers that, in this context, 

molybdenum does not merit EPA prioritisation, and proposes that 

it not be assigned any further priority at this time." Page 2 

of IMOA submittal. 

One of IMOA's activities was to review and evaluate each 

molybdenum related technical study as to the quality of the 

study, either as a Q1, Q2, or Q3 level. Q1 studies meet 

currently accepted test designs, analytical protocols, are peer 

reviewed, and are considered of high quality. Q1 studies are 

fully acceptable for proper evaluation and interpretation of 

environmental and human health effects and would be appropriate 

for use in establishing regulatory limits. Q3 studies, on the 

other hand, are seriously flawed and are of very limited use 

for regulatory guidance or establishment of limits. The sole 

basis for EPA's establishment of a reference dose for 

molybdenum under the IRIS system, and that is referenced as 

support in listing Mo in the CCL3, is derived from the 
Koval'skiy (1961) study in Armenia. The IMOA expert panel 

concluded that this study is a Q3 study and of very limited 

value in establishing regulatory limits/guidelines. EPA and the 

Institute of Medicine both concluded that this study is of 

marginal value. 

Climax is also aware that the National Mining Association (NMA) 

has submitted comments that address a number of EPA and 

government sponsored studies that characterize molybdenum 

content of major drinking water supplies across the United 

States. Climax concurs with and supports the NMA comments. 

Climax Molybdenum Company appreciates your consideration of 

these comments and if there is any further information or 

clarification that might be required by EPA, please contact Mr. 

Kenneth Kloska, Director Environmental Services - Global 

Operations at 303-569-3221 x 1226. 

Sincerely, 

Kenneth Kloska 

Director Environmental Services - Global Operations 

Climax Molybdenum Company 

CS Title: 0104 

Company/group/association name: 

Comment: 

In the United States over 5,000,000 people are diagnosed each 

year with gastric illnesses, 1,000,000 are hospitalized, 40,000 

undergo surgery, and 6,500 die from ulcer related 

complications. Costs in the United States associated with 

gastric ulcer disease are estimated at five billion dollars per 

year. 

Recent evidence of the ability of the viable but non culturable 

form of H. pylori to resist disinfection along with the 

significant economic burden of diseases related to this 

organism warrant its inclusion in the regulatory process. 
Furthermore, when considering the burden of disease caused by a 

microorganism acute or chronic categorization should not be 

factored into the decision. The decision should be made as a 

function of risk to the consumer along with the feasibility of 

controlling such risk. 

May 19, 2008 

Water Docket 

EPA/DC EPA West, Room 3334 

1301 Constitution Ave. N.W. 

Washington, DC 

Re: Docket ID No. EPA-HQ-OW-2009-1189 

[Federal Register: February 21, 2008 (Volume 73, Number 35)] 

[Notices] 

[Page 9627-9654] 

Dear Sir or Madam: 

The following comments are offered in support of the inclusion 

of Helicobacter pylori (H. pylori) on the third Contaminant 

Candidate List. Recent evidence of the ability of the viable 

but non culturable form of H. pylori to resist disinfection 

along with the significant economic burden of diseases related 

to this organism warrant its inclusion in the regulatory 

process. Furthermore, when considering the burden of disease 

caused by a microorganism acute or chronic categorization 

should not be factored into the decision. The decision should 

be made as a function of risk to the consumer along with the 

feasibility of controlling such risk. 

INTRODUCTION 

Helicobacter pylori infection is the leading cause of gastric 
diseases including gastric inflammation, ulcers,[FN1: Gomes, B. 

C. & De Martinis, E. C. P. The significance of Helicobacter 

pylori in water, food and environmental samples. Food Control 

15, 397-403 (2004).] and some forms of stomach cancer [FN2: 

Dawsey, S. M., Mark, S. D., Taylor, P. R. & Limburg, P. J. 

Gastric cancer and H pylori. Gut 51, 457-458 (2002).]. Although 

estimates vary, it is believed that 50% of people in developed 

countries and 90% of people in developing nations have been 

infected by this pathogen [FN3: Rolle-Kampczyk, U. E. et al. 

Well water - one source of Helicobacter pylori colonization. 

International Journal of Hygiene and Environmental Health 207, 

363-368 (2004).]. 

In the United States over 5,000,000 people are diagnosed each 

year with gastric illnesses, 1,000,000 are hospitalized, 40,000 

undergo surgery, and 6,500 die from ulcer related complications 

[FN4: Degnan, A. J., Sonzogni, W. C. & Standridge, J. H. 

Development of a Plating Medium for Selection of Helicobacter 

pylori from Water Samples. Applied and Environmental 

Microbiology 69, 2914-2918 (2003).]. Costs in the United States 

associated with gastric ulcer disease are estimated at five 

billion dollars per year. Consequently, H. pylori infection is 

a significant public health problem worldwide including the 

United States. 

The difference in prevalence of gastric diseases in developed 

versus developing nations has led to the speculation that 

drinking water has an important role in exposure to H. pylori 

since developed nations tend to have better water supplies and 

sanitation. However, the relative significance of drinking 

water as a route of exposure compared to other routes has not 

been well defined. Hulten et al.[FN5: Hulten, K., Enroth, H., 

Nystrom, T. & Engstrand, L. Presence of Helicobacter species 

DNA in Swedish water. Journal of Applied Microbiology 85, 

282-286 (1998).] suggest that the success of H. pylori results 

from its ability to use multiple transmission routes. They also 

propose that the success of this bacterium might result from 

its efficiency in establishing an infection once inside a 

susceptible host. While the issue of host susceptibility is an 

area that should be pursued by clinical researchers, a clearer 

understanding of the microbial ecology of H. pylori is 

paramount to the control of this pathogen. 
Regulatory Context 

In 2000, a Federal Advisory Committee for the Microbial and 

Disinfectant/Disinfection By-Products Rules was convened under 

the United States Environmental Protection Agency (USEPA)'s 

required six year review process. The Committee recommended 

that the USEPA "evaluate available data and research on aspects 

of distribution systems that may create risks to public health" 

[FN6: USEPA. 83015-83024 (Federal Register, December 29, 

2000).]. That directive led to a series of expert workshops and 

panels aimed at understanding risks in drinking water including 

the establishment of a National Academy of Science Committee 

that produced the report: Drinking Water Distribution Systems: 

Assessing and Reducing Risks. The committee concluded that 

"distribution system ecology is poorly understood...there is 

very little information available about the types, activities, 

and distribution of microorganisms in distribution systems..." 

and to "more adequately assess risk, more information on the 

microbial ecology of distribution systems...is needed". 

In their 2008 report on Environmental and Workplace Health, 

Health Canada concluded "Further studies are needed to confirm 

that H. pylori are present in drinking water in a viable state 

and that they can be transmitted by this medium."[FN7: 

anonymous. (Health Canada, 2008).] Helicobacter pylori 

appropriately appears on USEPA's Contaminant Candidate List 

(CCL) [FN8: USEPA. 9071-9077 (February 24, 2005).]. 

Microorganisms are listed on the CCL if they have significant 

adverse health effects and have been found in drinking water. 

Both are true of this organism and recent publications 

regarding the microbial ecology and susceptibility to 

disinfectants warrants its consideration for regulation. 

Identification of H. pylori Infection 

The identification of Helicobacter pylori infection can be 

broadly divided into four categories [FN9: Mitchell, H. & 

Megraud, F. Epidemiology and diagnosis of Helicobacter pylori 
infection. Helicobacter 7, 8-16 (2002).]: 1) Microscopic 

identification of a biopsy sample that may include a step to 

culture the organisms and thereby increase the numbers of 

recovered organisms. 2) Stool antigen tests or serologic 

antibody tests. Antibodies are formed in response to an H. 

pylori infection. 3) The urea breath test for assessing urease 

(enzyme) activity of H. pylori. This is a non-invasive test in 

which the subject expels air after ingestion of a test solution 

containing radio-labeled urea. Helicobacter pylori's prolific 

production of urease is key to the liberation of ammonia needed 

to neutralize stomach acid and allow penetration of the mucus 

and epithelium layers of the gut. 4) Genetic methods for 

identifying the DNA of H. pylori. The DNA from a sample is 

amplified in the polymerase chain reaction (PCR) and compared 

to known DNA of H. pylori. Evolution of PCR methods in clinical 

settings is proceeding at a rapid pace. 

Reports in the literature conflict when defining the "gold 

standard". Published reports identify either biopsy from 

endoscopy [FN10: Agreus, L. & Talley, N. J. Dyspepsia: Current 

understanding and management. Annual Review of Medicine 49, 

475-493 (1998).] or the urea breath test [FN11: Pathak, C. M., 

Bhasin, D. K., Pramod, K. A. & Khanduja, K. L. C-14-urea breath 

test as a 'Gold Standard' for detection of Helicobacetr pylori 

infection. Medical Science Monitor 10, LE14-LE15 (2004).] as 

the "gold standard". However recent reports describe advantages 

of the stool antigen test as a non-invasive test appropriate 

for diagnosis in children [FN12: Gisbert, J. P. & Pajares, J. 

M. Stool antigen test for the diagnosis of Helicobacter pylori 

infection: a systematic review. Helicobacter 9, 347-368 

(2004).]. In addition to being non-invasive the stool antigen 

test does not require expensive equipment required for the 

breath test. Some clinicians prefer the stool antigen test for 

these reasons and are comfortable selecting one that has a high 

level of accuracy [FN13: Jacobshon, S. (October 12, 2008).]. 

For example, the Premier Platinum HpSA (Meridian, Cincinnati, 

OH) has 91% sensitivity and 93% specificity [FN14: Perry, S. et 

al. Gastroenteritis and transmission of Helicobacter pylori 

infection in households. Emerging Infectious Diseases 12, 

1701-1708 (2006).]. 

Occurrence of H. pylori in Source Waters and Drinking Water 
Perhaps the reason most epidemiologic studies have not included 

environmental samples is the difficulty in isolating H. pylori. 

Helicobacter pylori is microaerophilic, meaning it requires 

very low dissolved oxygen levels. When transferred from the gut 

to an oxygen-rich environment the organism converts from its 

bacillary (rod shaped) form to a coccoid (spherical) form 

[FN15: Benaissa, M. et al. Changes in Helicobacter pylori 

ultrastructure and antigens during conversion from the 

bacillary to the coccoid form. Infection and Immunity 64, 

2331-2335 (1996).; FN16: Shahamat, A. et al. Development of two 

PCR-based techniques for detecting helical and coccoid forms of 

Helicobacter pylori. Journal of Clinical Microbiology 42, 

3613-3619 (2004).]. The coccoid form of H. pylori represents a 

viable but non-culturable (VBNC) state. Adams et al.[FN17: 

Adams, B. L., Bates, T. C. & Oliver, J. D. Survival of 

Helicobacter pylori in a natural freshwater environment. 

Applied and Environmental Microbiology 69, 7462-7466 (2003).] 

have examined the relationship between culturability of H. 

pylori and its morphological state in laboratory strains. They 

were able to show for the first time that environmental 

isolates exist in all morphological forms (rod, U and cocci) as 

viable but non-culturable, and suggest that all forms could be 

infectious. Azevedo et al.[FN18: Azevedo, N. F., Pacheco, A. 

P., Keevil, C. W. & Vieira, M. J. Nutrient shock and incubation 

atmosphere influence recovery of culturable Helicobacter pylori 

from water. Appl Environ Microbiol 70, 490-3 (2004).] posited 

two reasons for the failure of culture techniques to reveal the 

presence of H. pylori in drinking water: either the organisms 

are in fact not there because they have not survived the 

disinfection procedure or the culture techniques are inadequate 

to recover the organism. Degnan et al.[FN4: Degnan, A. J., 

Sonzogni, W. C. & Standridge, J. H. Development of a Plating 

Medium for Selection of Helicobacter pylori from Water Samples. 

Applied and Environmental Microbiology 69, 2914-2918 (2003).] 

developed a selective media (HP agar) for culturing H. pylori 

that is based on inhibiting competing organisms found in 

natural waters. Unfortunately, the group has recently reported 

the failure to identify H. pylori in private wells in Wisconsin 

using this agar [FN19: Degnan, A. in Proceedings, AWWA WQTC 

(AWWA, Quebec City, Quebec, November 9, 2005).]. 
Since such extremely small concentrations of bacteria exist in 

drinking water samples a method is required that amplifies 

their existence. Polymerase chain reaction (PCR) is such a 

method and has greatly enhanced the identification of microbes 

in these environments. Recent advances in PCR [FN20: Bunn, J. 

E. G., MacKay, W. G., Thomas, J. E., Reid, D. C. & Weaver, L. 

T. Detection of Helicobacter pylori DNA in drinking water 

biofilms: implications for transmission in early life. Letters 

in Applied Microbiology 34, 450-454 (2002).; FN21: arbone, M. 

et al. Occurrence of Helicobacter pylori DNA in the coastal 

environment of southern Italy (Straits of Messina). Journal of 

Applied Microbiology 98, 768-774 (2005).] methods including 

quantitative-(Q)-PCR [FN22: Sen, K. (2007).; FN23: Nayak, A. K. 

& Bose, J. B. Detection of Helicobacter pylori in sewage and 

water using a new quantitative PCR method with SYBR (R) green. 

Journal of Applied Microbiology 103, 1931-1941 (2007).] have 

allowed for detection of H. pylori in water. Polymerase Chain 

Reaction has been used for the identification of H. pylori DNA 

in water sources in developed nations including the United 

States [FN24: Hegarty, J. P., Dowd, M. T. & Baker, K. H. 

Occurrence of Helicobacter pylori in surface water in the 

United States. Journal of Applied Microbiology 87, 697-701 

(1999).] England [FN25: Watson, C. L. et al. Detection of 

Helicobacter pylori by PCR but not culture in water and biofilm 

samples from drinking water distribution systems in England. 

Journal of Applied Microbiology 97, 690-698 (2004).], Germany 

[FN3: Rolle-Kampczyk, U. E. et al. Well water - one source of 

Helicobacter pylori colonization. International Journal of 

Hygiene and Environmental Health 207, 363-368 (2004).] and 

Sweden [FN5: Hulten, K., Enroth, H., Nystrom, T. & Engstrand, 

L. Presence of Helicobacter species DNA in Swedish water. 

Journal of Applied Microbiology 85, 282-286 (1998).]. In the 

British study H. pylori DNA was detected by PCR from drinking 

water and pipe biofilm samples. This confirmation of H. pylori 

in a municipal drinking water supply in a developed nation 

highlights the need to investigate the relationship between 

water system operations (i.e., disinfection practices) and H. 

pylori viability. 

Non-environmental routes of exposure have been reported by 

various researchers. Malaty et al. [FN26: Malaty, H. M. et al. 

Evidence from a nine-year birth cohort study in Japan of 

transmission pathways of Helicobacter pylori infection. Journal 
of Clinical Microbiology 38, 1971-1973 (2000).] showed that 

breastfeeding was protective against H. pylori infection in a 

study of infants, but Kitagawa et al. [FN27: Kitagawa, M. et 

al. Maternal transmission of Helicobacter pylori in the 

perinatal period. Journal of Obstetrics and Gynaecology 

Research 27, 225-230 (2001).] concluded that if a mother does 

not wash her nipples and hands prior to breastfeeding the 

infant might become infected. Sinha et al.[FN28: Sinha, S. K. 

et al. The incidence of Helicobacter pylori acquisition in 

children of a Canadian First Nations community and the 

potential for parent-to-child transmission. Helicobacter 9, 

59-68 (2004).] reported that passage from mother to child is 

associated with the practice of putting a pacifier in the 

mothers mouth before offering it to the child. Higher rates of 

infection with H. pylori have been associated with low 

socioeconomic status (SES) in several studies [FN29: Brown, L. 

M. et al. Helicobacter pylori infection in rural China: 

demographic, lifestyle and environmental factors. International 

Journal of Epidemiology 31, 638-646 (2002).; FN30: Glynn, M. K. 

et al. Seroincidence of Helicobacter pylori infection in a 

cohort of rural Bolivian children: Acquisition and analysis of 

possible risk factors. Clinical Infectious Diseases 35, 

1059-1065 (2002).; FN31: Mazari-Hiriart, M. et al. Longitudinal 

study of microbial diversity and seasonality in the Mexico City 

metropolitan area water supply system. Applied and 

Environmental Microbiology 71, 5129-5137 (2005).]. Low socio- 

economic status is frequently related to density of living 

conditions and access to safe water. Differences in rates among 

those in high-density living conditions have been explored in 

both high and low SES cohorts. Wallace et al. [FN32: Wallace, 

R. A., Schluter, P. J., Forgan-Smith, R., Wood, R. & Webb, P. 

A. Diagnosis of Helicobacter pylori infection in adults with 

intellectual disability. Journal of Clinical Microbiology 41, 

4700-4704 (2003).] compared the prevalence of H. pylori 

infection in institutionalized intellectually disabled adults 

to intellectually disabled adults who had never been 

institutionalized and reported twice the infection rate in the 

institutionalized subjects. The increased prevalence was 

attributed to high-density living conditions. A large 

prospective cohort study in Northern California implicated 

vomitus as the most significant route of exposure [FN14: Perry, 

S. et al. Gastroenteritis and transmission of Helicobacter 

pylori infection in households. Emerging Infectious Diseases 

12, 1701-1708 (2006).]. The risk of converting to H. pylori 
positive status (by stool or serology) was 4.8 times higher 

(adjusted odds ratio 95% CI: 1.4-17.1) if the infected 

household member had gastroenteritis. The adjusted odds ratio 

was 6.3 times higher (95% CI: 1.6-24.5) if exposure was to a 

household member who had gastroenteritis with vomiting compared 

to being in a household where inhabitants did not have 

gastroenteritis. The study included low income Hispanic members 

living in the south San Francisco Bay area. Many of these 

individuals reside in areas served by an predominantly 

unfiltered but disinfected water supply. None of these studies 

investigated drinking water as a route of exposure, or as a 

confounding variable. 

Only a few studies have attempted to attribute the prevalence 

of H. pylori infection to environmental exposures. A cross- 

sectional study in 13 villages from Linqu County, Shandong 

Province, China [FN29: Brown, L. M. et al. Helicobacter pylori 

infection in rural China: demographic, lifestyle and 

environmental factors. International Journal of Epidemiology 

31, 638-646 (2002).] included 3,288 adults ages 35-69. In this 

population 1,994 people (61.7%) were infected, 1,019 (31.6%) 

were uninfected, and the status of 275 (8.5%) could not be 

determined. Serostatus was used as the measure of H. pylori 

infection. Prevalence odds ratios were used to compare the odds 

of being exposed to a factor given the subject was seropositive 

to the odds of being exposed to a factor given that the subject 

was seronegative. Exposure was determined by a 15 minute 

interview in which neither the interviewer nor interviewee knew 

the serostatus of the subject. While this data collection 

process is subject to recall and reporting biases there is no 

reason to assume that the biases would be more pronounced in 

one group over the other. The investigators reported an 

association between seropositivity and low "village education 

level", being single, sharing a bed with more than 2 people, 

lack of hand-washing before eating, washing or bathing in a 

pond or ditch, and source of drinking water. The 13 villages 

were grouped into three categories referred to as "village 

education level" which was based on the average number of years 

of schooling village residents as a group had completed. High 

"village education" level was defined as 3.99-3.83 years (4 

villages), medium as 3.74 to 3.37 years (5 villages), and low 

3.27-2.32 years (4 villages). Even with these small differences 

a strong association was reported for "village education level" 
and seropositivity, but not on individual's education level and 

H. pylori infection. To their credit they point out that a 

limitation in the study is the homogeneity of the population. 

The investigators suggest that "village education level" may be 

a surrogate for cultural practices that may lead to exposure. 

An association between "village education level" and source of 

drinking water was alluded to but not fully described. No 

association was reported between H. pylori seropositivity and 

alcohol or tobacco use, raw fruit and vegetable intake, or 

individual social class measures. The investigators conclusion 

based on these data is that person-to-person contact is the 

most likely route for H. pylori infection in this population, 

but that waterborne exposure should be further investigated. 

Since the population excluded individuals less than 35 years 

old, transmission from parent to child could not be assessed. 

As pointed out in the study, serostatus provides no information 

regarding duration of the infection. The seropositive subjects 

in this study may have been infected since childhood. Like most 

of the epidemiologic studies to date, analyses in the Shandong 

study were performed at the individual subject level. 

Associations to factors were based on reported exposure to 

those factors by the individual for the individual. 

Environmental samples (including drinking water samples) were 

not collected. 

Only one group has reported analysis of both H. pylori 

infection and H. pylori in drinking water samples from a public 

water systems. The widely cited reports of Klein et al.[FN33: 

Klein, P. D., Graham, D. Y., Gaillour, A., Opekun, A. R. & 

Smith, E. O. Water Source as Risk Factor for Helicobacter- 

Pylori Infection in Peruvian Children. Lancet 337, 1503-1506 

(1991).] and Hulten et al.[FN34: Hulten, K. et al. Helicobacter 

pylori in the drinking water in Peru. Gastroenterology 110, 

1031-1035 (1996).] provide the most convincing evidence of 

drinking water as a route of exposure. They performed urea 

breath tests on 266 Peruvian children in families of low 

socioeconomic status and 141 Peruvian children of high economic 

status. All children were 2 months to 12 years old. The 

children lived in households that received either "municipal 

water" or water from "community wells". "Municipal water" was 

either delivered by water trucks to 55 gallon drums or 150 

gallon cisterns in front of homes in the first town (average 

annual income US$1,500), via pipes that fed taps spaced at 50 
meter intervals along the streets in the second town (average 

annual income US$1,500), piped from a river to internal 

plumbing in the third town (average annual income US$6,000), or 

"municipal water" delivered to three towns with an annual 

average income greater than US$15,000 [FN33: Klein, P. D., 

Graham, D. Y., Gaillour, A., Opekun, A. R. & Smith, E. O. Water 

Source as Risk Factor for Helicobacter-Pylori Infection in 

Peruvian Children. Lancet 337, 1503-1506 (1991).]. Prevalence 

of H. pylori infection was strongly correlated with the SES of 

the towns. Prevalence of infection was three times higher for 

children living in homes without internal plumbing. No 

information was provided regarding the treatment of the systems 

sources nor distribution system water quality. The more 

enlightening result was that of the high SES group split into 

those that received "municipal water" and those that received 

water from "community wells". "The unadjusted disease incidents 

[sic] was 37% for municipal water and 4% for community well 

water; the corresponding odds ratio was 11.4 (p=0.02)" [FN33: 

Klein, P. D., Graham, D. Y., Gaillour, A., Opekun, A. R. & 

Smith, E. O. Water Source as Risk Factor for Helicobacter- 

Pylori Infection in Peruvian Children. Lancet 337, 1503-1506 

(1991).]. The adjusted odds ratio (holding age and sex 

constant) was 12.8 times higher for "municipal water" then 

"well water"[FN33: Klein, P. D., Graham, D. Y., Gaillour, A., 

Opekun, A. R. & Smith, E. O. Water Source as Risk Factor for 

Helicobacter-Pylori Infection in Peruvian Children. Lancet 337, 

1503-1506 (1991).]. Five years after the epidemiologic study 

the group was able to test water samples that had been 

collected and frozen until development of PCR assays [FN34: 

Hulten, K. et al. Helicobacter pylori in the drinking water in 

Peru. Gastroenterology 110, 1031-1035 (1996).]. Twenty-four of 

the 34 water samples tested positive for H. pylori by PCR, all 

were from systems fed with "municipal water". Klein et 

al.[F[FN33: Klein, P. D., Graham, D. Y., Gaillour, A., Opekun, 

A. R. & Smith, E. O. Water Source as Risk Factor for 

Helicobacter- Pylori Infection in Peruvian Children. Lancet 

337, 1503-1506 (1991).] likened their findings to that of John 

Snows comparison of cholera incidence in those receiving water 

from the Southwark and Vauxhall Company versus the Lambeth 

Company. Two years later Hulten et al.[FN5: Hulten, K., Enroth, 

H., Nystrom, T. & Engstrand, L. Presence of Helicobacter 

species DNA in Swedish water. Journal of Applied Microbiology 

5, 282-286 (1998).] reported positive identification in 24 

private wells and 3 of 24 tap water samples from municipal 
supplies in Sweden using PCR methods. 

Glynn et al. [FN30: Glynn, M. K. et al. Seroincidence of 

Helicobacter pylori infection in a cohort of rural Bolivian 

children: Acquisition and analysis of possible risk factors. 

Clinical Infectious Diseases 35, 1059-1065 (2002).] considered 

drinking water quality in a prospective cohort study of 

Bolivian children. Although not randomized, some children were 

part of an ongoing project that supplied families with capped 

plastic water containers and the addition of a chlorine 

solution to be used in lieu of an open bucket traditionally 

used to store water. Of 188 children who were seronegative in 

the first survey, 44 (23%) were seropositive one year later. 

The investigators speculate that the plastic containers could 

become infected when cups were dipped into them. Lindkvist et 

al. [FN35: Lindkvist, P. et al. Helicobacter pylori infection 

in Ethiopian children: A cohort study. Scandinavian Journal of 

Infectious Diseases 31, 475-480 (1999).] reported higher 

seropositivity among children in Ethiopia whose families used a 

well (26/39 [67%]), compared to whose who used the public water 

system (18/39 [47%]). (Relative risk=1.41; 95% CI 0.94-2.10). 

This study would have been strengthened by clearer delineation 

between exposures. Perhaps some children utilized both sources. 

Conflicting results leave the significance of person-to-person 

contact, fecal-oral, gastro-oral, and waterborne routes 

unresolved. Thus 25 years after identification of H. pylori as 

the etiologic agent of gastric disease [FN36: Marshall, B. 

Unidentified Curved Bacilli on Gastric Epithelium in Active 

Chronic Gastritis. Lancet 1, 1273-1275 (1983).; FN37: Marshall, 

B. J. & Warren, J. R. Unidentified Curved Bacilli in the 

Stomach of Patients with Gastritis and Peptic-Ulceration. 

Lancet 1, 1311-1315 (1984).] there still exists a lack of 

consensus regarding transmission of this organism. Public 

health protection measures such as water quality regulations 

rely on occurrence data [FN38: USEPA. 27486 (Federal Register, 

June 29, 1989).]. To determine whether drinking water poses a 

risk of exposure to H. pylori the occurrence of the organism in 

source waters and drinking water must be known. An 

understanding of the microbial ecology (optimum growth 

conditions, including temperature, nutrient requirements, 

interactions with other organisms, and life cycle), are 
important. Next, the susceptibility of the organism to 

treatment and factors that reduce susceptibility to 

disinfection must be known. Once the microbial ecology and the 

effectiveness of treatment are understood, strategies for 

limiting exposure in drinking water (including treatment and 

operational strategies or regulations) can be applied. 

Susceptibility to Drinking Water Treatment 

The bacillary (spiral/rod) form of H. pylori is easily killed 

with chlorine and other disinfectants when dispersed in water, 

[FN39: Baker, K. H., Hegarty, J. P., Redmond, B., Reed, N. A. & 

Herson, D. S. Effect of oxidizing disinfectants (chlorine, 

monochloramine, and ozone) on Helicobacter pylori. Applied and 

Environmental Microbiology 68, 981-984 (2002).] but some 

morphological states are not as vulnerable. Moreno et al. 

[FN40: Moreno, Y. et al. Survival and viability of Helicobacter 

pylori after inoculation into chlorinated drinking water. Water 

Research 41, 3490-3496 (2007).] used culture methods and 

fluorescent in situ hybridization to identify viable but non 

culturable H. pylori, and Reverse Transciptase-PCR to evaluate 

the response of cells exposed to chlorine under laboratory 

conditions. Their results suggest that VBNC H. pylori can 

survive disinfection. 

CT is the measure of disinfectant effectiveness and is the 

acronym for disinfectant concentration (C) in milligrams per 

liter multiplied by contact time (T) in minutes. Johnson et al. 

[FN41: Johnson, C. H., Rice, E. W. & Reasoner, D. J. 

Inactivation of Helicobacter pylori by chlorination. Applied 

and Environmental Microbiology 63, 4969-4970 (1997).] 

determined CT values for H. pylori in chlorinated drinking 

water and compared them to CT values for E. coli. For freely 

dispersed bacteria the value of 0.12 mg*min/liter was 

calculated for 99% (2 log10) inactivation of H. pylori compared 

to a CT value of 0.045 mg*min/liter for 2 log10 inactivation of 

E. coli. Believing that the inactivation rates are actually 

closer the investigators attributed the discrepancy between the 

two rates to particulate matter in the H. pylori samples that 

protected the organisms from disinfection. The authors 

concluded that the H. pylori CT values would be higher if the 
organisms were not protected by particles or biofilms. 

Baker et al. also compared the disinfection of H. pylori to E. 

coli and found it to be more resistant to chlorine even though 

their samples were washed to remove particulate matter [FN39: 

Baker, K. H., Hegarty, J. P., Redmond, B., Reed, N. A. & 

Herson, D. S. Effect of oxidizing disinfectants (chlorine, 

monochloramine, and ozone) on Helicobacter pylori. Applied and 

Environmental Microbiology 68, 981-984 (2002).]. They found H. 

pylori to be more resistant to ozone than E. coli, but equally 

resistant to chloramine. As with most bacteria, the CT values 

for 2 log inactivation were highest for chloramine and lowest 

for ozone. CT values for chloramine were reported to be 9.5 

mg*min/liter. Similarly, these investigators include the caveat 

that disinfection CT values were based on dispersed cells. 

Although additional work needs to be done to more completely 

characterize the susceptibility of the coccoid form of H. 

pylori as well as biofilm and amoeba-associated bacteria to 

disinfectants. However, the literature is adequate to indicate 

that H. pylori should remain on CCL3, and be considered for 

future regulation to protect the health of drinking water 

consumers in the United States, it's territories and in Tribal 

lands. 

This letter is being submitted solely as my opinion and may not 

reflect the opinion of others, with whom I have current or past 

formal or informal affiliations including the National Academy 

of Sciences, the USEPA, the American Water Works Association, 

the Association of Metropolitan Water Agencies, public or 

private water systems, or the University of California, 

Berkeley. Please contact me if there are any questions on the 

information contained in this letter. I appreciate the 

opportunity to offer these comments. 

Sincerely, 

Charlotte D. Smith 

CS Title: 0105 
Company/group/association name: 

Comment: 

March 10, 2008 

US EPA 

Drinking Water Quality 

Ariel Rios Bldg 

1200 Pennsylvia Ave, N.W. 

Washington, D.C. 20460 

Dear Sirs: 

It has come to our attention that the drinking water provided 

by the muninucipalities of Philadelphia, PA and South Jersey 

are providing drinking water contaminated with trace amounts of 

prescription drugs. 

It may be time to require local water companies to remove these 

drugs and other organic compounds since they have the economies 

of scale and the incremental costs to consumers may be minimal. 

I have written to other appropriate authorities regarding this 

matter. 

Thank you for your consideration in this matter. 

Sincerely, 

Thomas C Jordan + family 

1110 Elena Court 

Sicklerville, NJ 08081 

RNC # (35-662502-6033 

CS Title: 0114 

Company/group/association name: 

Comment: 
THIS SHOULD BE CONSIDERED AS THIS WRITER INDICATES. THE REPORT 

IS SOUND. HEALTH IS IMPORTANT AND SHOULD BE THE PRIMARY REASON 

FOR ACTION. NOT LISTENING TO PROFITEERS. 

CS Title: 0115 

Company/group/association name: 

Comment: 

The USW is submitting its comments on drinking water standards 

under the Safe Drinking Water Act. USW is concerned with a 

particular chemical listed on the Contaminant Candidate List, 

PFOA (perfluorooctanoic acid), as well as another 

perfluorinated chemical, PFOS (perfluorooctane sulfonic acid). 

USW believes it is vital to regulate these chemicals through 

the Safe Drinking Water Act. 

Docket: EPA-HQ-OW-2007-1189 

Drinking Water Contaminant Candidate List 3 

May 21,2008 

Please see the enclosed comments regarding the Drinking Water 

Contaminant Candidate list submitted by the United Steel, Paper 

and Forestry, Rubber, Manufacturing, Energy, Allied-Industrial 

and Service Workers International Union AFL-CIO/CLC (USW). 

For further information regarding USW's comments please contact 

either Diane Heminway or Shawn Gilchrist at 412-562-2400. 

Diane Heminway 

Environmental Projects Coordinator 

USW Health, Safety and Environment Department 
Shawn Gilchrist 

Resource Technician 

USW SC Global Bargaining Department 

Docket: EPA-HQ-OW-2007-1189 

Drinking Water Contaminant Candidate List 3 

May 21,2008 

The United Steel, Paper and Forestry, Rubber, Manufacturing, 

Energy, AlliedIndustrial and Service Workers International 

Union AFl-CIO/ClC (USW) thanks EPA for giving us the 

opportunity to comment on drinking water standards under the 

Safe Drinking Water Act. The USW is North America's largest 

manufacturing union. We represent over 850,000 workers in the 

U.S. and Canada. 

The union is concerned with a particular chemical listed on the 

Contaminant Candidate List, PFOA (perfluorooctanoic acid), as 

well as another perfluorinated chemical, PFOS (perfluorooctane 

sulfonic acid). We are aware of EPA's decision to exclude PFOS 

from the draft CCl 3, and the agency's willingness to accept 

comments on that decision. 

EPA has long known of human health concerns of PFOS, and its 

unique ability to bind to proteins, unlike most persistent 

organic compounds, which accumulate in fatty tissue. Eight 

years ago, EPA acknowledged that: 

"PFOS accumulates to a high degree in humans and animals. It 

has an estimated half-life of 4 years in humans. It thus 

appears to combine Persistence, Bioaccumulation, and Toxicity 

properties to an extraordinary degree." 

In addition, citing a 3M rat study, EPA noted: 
"PFOS caused postnatal deaths (and other developmental effects) 

in offspring in a 2-generation reproductive effects rat study 

(NOAEL of O. 1 mg/kg/day and LOAEL of 0.4 mg/kg/day). At higher 

doses in this study, all progeny in the first generation died 

while at the LOAEL many of the progeny from the second 

generation died. It is very unusual to see such second 

generation effects." (Source: 

http://www.chernicalindustryarchives.org/search/pdfs/scotchgard 

/20000516_226-0629.pdf 

Further, PFOS has been of great interest to the Organisation 

for Economic Cooperation and Development (OECD) who, in 2006, 

made strong recommendations for industry and government to 

monitor the impact of PFOS. (Source: 

http://www.olis.oecd.org/olis/2007doc.nsf/LinkTo/NT00002AB6/$FI 

LE/JT03229256.PDF) 

While it is presently ubiquitous in the environment, the threat 

of exposure is likely to increase as consumers dispose of 

household products containing PFOS. In turn, it is reasonable 

to anticipate that PFOS will continue to accumulate in the 

environment, including in ground and surface water, aquatic 

biota and humans. Although PFOS is no longer being 

manufactured, its persistence, and bio-accumulative and toxic 

properties warrant careful monitoring and regulation. 

The EPA is well aware of the numerous studies documenting the 

exposures and dangers of PFOA. Although DuPont, currently the 

only major U.S. producer of PFOA, continues to claim that there 

is no proof that PFOA causes harm to human health, evidence to 

the contrary continues to mount, such as: 

* EPA's Science Advisory Board identifies PFOA as a "likely" 

human carcinogen. (Source: Washington Post; Compound in Teflon 

a "likely carcinogen;" Juliet Eilperin; June 29, 2005) 

* Researchers found PFOA and PFOS in the umbilical cord blood 

of children indicating that these chemicals cross the placenta 

between mother and child. (Source: Environmental Working 
Group/Commonweal, Body Burden Study- The Pollution in Newborns, 

Executive Summary; July 14, 2005) 

* The Centers for Disease Control and John Hopkins University 

have reported health impacts in newborn babies such as low 

birth weight and reduced head circumference. (Source: Possible 

Etiologies of PFAA-Induced Developmental Effects: Reflections 

from a Pediatric Perspective; Johns Hopkins University, 

Baltimore, MD; U.S. Centers for Disease Control and Prevention) 

* PFOA has been found in the breast milk of nursing mothers, 

and has been found in children between the ages of 2 and 12 at 

blood levels similar to those found in adults. (Source: Study 

conducted by Kathleen Arcaro of the University of Massachusetts 

Amherst-results are scheduled for publication in Environmental 

Science and Technology ( 

http://www.umass.edu/loop/talkingpoints/articles/74700.php); 

other breast milk studies reported in February and May 2007 

Issue of Environmental Health Perspectives) 

* A study by the National Institute for Occupational Safety and 

Health has shown that PFOA may prime the immune system to 

overreact to allergens in mice. (Source: Toxicological 

Sciences, DOI: 10.1093/toxsci/kfm053; From Issue 2609 of New 

Scientist magazine, page 14; June 25, 2007) 

* Researchers at the University of Pennsylvania School of 

Medicine found PFOA to be present in about 96 percent of the 

U.S. population, tending to accumulate within the body. 

(Source: Today's Sunbeam; DuPont reports PFOA testing; Randall 

Clark; May 07, 2008) 

* Exposure to PFOA may be associated with changes in liver and 

immune function, as well as higher cholesterol levels in 

children. In May 2008, the preliminary results of a study of 

PFOA's possible impacts on the health of nearly 70,000 

residents in the mid-Ohio Valley were released. The study 

examined the potential health impacts of PFOA released from 

DuPont's Washington Works plant south of Parkersburg, West 
Virginia. Previous studies of workers exposed to PFOA revealed 

elevated levels of kidney cancer, heart disease and diabetes. 

(Source: AScribe Newswire; Big Study of Teflon Chemical in 

People Suggests Harm to Immune System, Liver, Thyroid; May 13, 

2008; www.hsc.wvu.edu/som/cmed/ophp/grandRoundsWebcast.asp) 

USW represents 1,600 members at six DuPont facilities. We first 

became active in PFOA issues over three years ago. USW has 

tested the blood of some of our DuPont members and retirees at 

the Chambers Works facility in Pennsville, New Jersey and 

discovered exposure levels in some individuals to be hundreds 

of times higher than those found in the general public. 

Studies have shown that some workers exposed to perfluorinated 

chemicals (PFCs) are more prone to prostate and bladder cancer 

and experience higher than normal levels of cholesterol - a 

risk factor for heart attack and stroke. (Source: Minneapolis 

Star Tribune; Death rate up for 3M workers exposed to PFOA; Tom 

Meersman; March 5, 2008 

Numerous samples of surface water and drinking water supplies 

taken by the USW and others have revealed the presence of PFOA, 

PFOS and other PFCs. The PFCs being found in drinking water 

supplies are also found in the blood of the general population 

as reported by the Centers for Disease Control and Prevention. 

The agency found 11 polyfluoroalkyl compounds, including 

perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid 

(PFOA), and perfluorohexane sulfonic acid (PFHxS) in 1562 serum 

samples collected from a representative U.S. population 12 

years of age and older in the 1999-2000 National Health and 

Nutrition Examination Survey. (Source: Division of Laboratory 

Sciences, National Center for Environmental Health, Centers for 

Disease Control and Prevention, Abstract Received for review 

November 9, 2006, Revised manuscript received January 31, 2007, 

Accepted February 2,2007) 

USW believes that the EPA must determine nation-wide 

regulations to protect the public from further exposure to PFOA 

and PFOS. States, such as Minnesota, North Carolina and New 

Jersey have instituted their own standards or guidelines for 
one or both PFCs. For example, after finding widespread 

contamination of drinking water supplies in the state, the 

NJDEP set a safe drinking water guidance value of .04 parts per 

billion for PFOA. (Source: 

http://www.state.nj.us/dep/watersupply/pfoa.htm) 

PFOA makes its way into products and downstream industries 

further exacerbating the contamination of people and the 

environment. DuPont and other companies promised EPA they would 

reduce and eventually eliminate PFOA use and manufacture via 

the 2010/2015 PFOA Stewardship Program. Unfortunately, DuPont 

refuses to make public verifiable annual PFOA production 

amounts. Recent test results of wells conducted by DuPont near 

its Chambers Works, NJ facility show levels of PFOA that exceed 

the NJDEP guidance level. (Source: Today's Sunbeam; DuPont 

reports PFOA testing, Randall Clark; May 07,2008) 

The 2010/2015 PFOA Stewardship Program is voluntary. We have 

little faith this program will achieve its goals, nor will it 

assure the protection of public water supplies. USW believes 

voluntary promises are not a substitute for much needed 

regulation and accountability. Therefore, it is vital to 

regulate PFOA through the Safe Drinking Water Act. 

CS Title: 0116 

Company/group/association name: 

Comment: 

May 21, 2008 

Water Docket 

Docket ID No. EPA-HQ-OW-2007-1189 

U. S. Environmental Protection Agency 

Mail Code: 2822T 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460 

To Whom It May Concern: 
Thank you for the opportunity to provide comment on the draft 

third Contaminant Candidate List (CCL3) as published in the 

February 21, 2008 Federal Register. We have reviewed the 

proposed list and offer the comments found in the attachment. 

We hope EPA will carefully consider our comments and provide a 

final CCL3 that will lead to sound decisions in the regulatory 

development process. 

Sincerely, 

Mark S. Mayer, P.E. 

Natural Resources Administrator 

SD Drinking Water Program 

Attachment 

Attachment 

Comments on the third Contaminant Candidate List (CCL3) 

by South Dakota Department of Environment and Natural Resources 

(DENR) 

Overall, we support the proposed CCL3 process and EPA's efforts 

to increase public health protection. We do, however, offer the 

following comments noted below. 

Specific Comments: 

* Pharmaceuticals and Personal Care Products: Although this 

issue is not new, in light of the recent media attention, we 

feel it is important to develop the science necessary to make 

sound decisions when regulating these compounds. We also feel 

that scientific study focused in this area will assist us in 

answering questions in this area from consumers. We do not 
support efforts to regulate through legislation in lieu of a 

scientific based approach as outlined in the 1996 Safe Drinking 

Water Act amendments. Furthermore, we support efforts made to 

reduce these compounds from the source rather than add costly 

and complex treatment systems to address an issue that may more 

easily be impacted through proper handling and disposal. 

* Synergistic Effects: The current health effects information 

on Maximum Recommended Daily Doses is derived based on the 

effects of single compounds. We support efforts to look at the 

cumulative and synergistic effects of these compounds in 

addition to the current process. 

* CCL Process: South Dakota has limited staff resources to 

study issues related to development of standards for various 

drinking water contaminants. We therefore rely on the 

scientific studies conducted by EPA and other partners in 

developing standards and regulatory determinations. Recognizing 

that we all operate in a resource constrained environment, we 

feel the CCL process is an important step in regulatory 

determinations and should be used to prioritize those 

contaminants that pose the greatest risk to public health. 

CS Title: 0119 

Company/group/association name: 

Comment: 

METOLACHLOR TASK FORCE 

(Agan Chemical Manufacturers, Ltd., Drexel Chemical Co. and 

Sipcam Agro USA, Inc.) 

May 20, 2008 

Water Docket 

U.S. Environmental Protection Agency 

Mailcode: 2822T 

1200 Pennsylvania Avenue, N.W. 

Washington, D.C. 20460 
Dear Sir or Madam: 

SUBJECT: Docket ID No. EPA-HQ-OW-2007-1189 

The Metolachlor Task Force (EPA Company Number 75008) wishes to 

make the following comments on two metolachlor metabolites 

listed on your Draft Contaminant List 3, Federal Register, 

Volume 73, No. 35, page 9633, February 21, 2008. Specifically, 

these two are: 

Metolachlor ethanesulfonic acid (ESA) CASRN: 171118-09-5 

Metolachlor oxanilic acid (OA) CASRN: 152019-73-3 

The Health Effects Division has reviewed the following 

toxicology studies (each performed by Oak Ridge National 

Laboratories), and found them acceptable. These studies are 

Developmental Toxicity and Subchronic Oral Toxicity studies on 

the two metabolites. Results for each were: 

Developmental Rat for ESA, MRID No. 44931711: 

No signs of maternal or fetal toxicity 

No evidence of teratogenicity 

Maternal toxicity NOAEL is >= 1000 mg/kg/day 

Developmental Rat for OA, MRID No. 44929510: 

Maternal Toxicity NOEL = 100 mg/day 

No evidence of teratogenicity 

Maternal toxicity NOAEL is >= 1000 mg/kg/day 

Subchronic Oral Toxicity Rat (ESA), MRID No. 44931710: 

NOAEL is >= 20,000 ppm 

NOEL is >= 6,000 ppm 

Subchronic Oral Toxicity Rat (OA), MRID No. 44929509: 
NOAEL is >= 15,000 ppm 

Subchronic Oral Toxicity Dog (ESA), MRID No. 44931709: 

NOAEL is >= 1,000 mg/kd/day 

These toxicological results indicate that these two metolachlor 

metabolites are not teratogenic and are relatively non-toxic to 

rats and to the dog (ESA). 

Further, an additional study, MRID No. 44931716, a bile 

cannulation study with ESA, demonstrated that ESA was not 

absorbed. Therefore, there is no risk associated with ESA in 

this regard. 

The presence of these two metabolites in water is clearly an 

indication of the prior presence of metolachlor. We believe 

that it is misleading to list these without also indicating 

that these two metabolites are relatively non-toxic. The 

presence of these two metabolites in water does not constitute 

a toxicological concern and this should be clearly stated. 

Since there is no toxicological concern, it is not clear why, 

simply because they are present, they should be on the List. 

Our point is simply that the mere presence of these metabolites 

in water, which pose no toxicological concern, does not warrant 

inclusion on a list which implies "contaminants" of concern nor 

inclusion in regulations under the Safe Drinking Water Act. 

Sincerely, 

E. M. Bellet 

Technical Manager 

Metolachlor Task Force 

16160 Nall 

Stilwell, Kansas 66085 

CS Title: 0120 

Company/group/association name: 

Comment: 
Since the Contaminant Candidate List process began about 10 

years ago, none of the contaminants included on the two prior 

Contaminant Candidate Lists have been adopted by the United 

States Environmental Protection Agency (USEPA) as National 

Primary Drinking Water Regulations. The NJDEP is very concerned 

about this practice since many of the contaminants on the past 

Contaminant Candidate Lists, as well as many of the 

contaminants on the present CCL3, both occur widely in drinking 

water and have health effects of potential concern. The health 

effects data for many of these chemicals are extensive and 

complicated. For such chemicals, the risk assessment involves a 

large amount of time and effort. Most states have limited 

resources as far as risk assessment and cannot address all 

chemicals of concern in drinking water without assistance from 

USEPA. We urge USEPA to use its vast resources to address such 

chemicals by regulating when appropriate, rather than simply 

determining that every chemical evaluated does not need 

regulation. Our comments focus on four chemicals of concern to 

New Jersey: PFOA, 1,2,3-trichloropropane, MTBE, and 

perchlorate. 

May 21, 2008 

Water Docket 

Environmental Protection Agency 

Mail Code: 2822T 

1200 Pennsylvania Ave, NW 

Washington, DC 20460 

RE: Docket ID No. EPA-HQ-OW-2007-1189 

Drinking Water Contaminant Candidate List 3--Draft (Federal 

Register:February 21, 2008, Volume 73, Number 35, p. 9627-9654, 

DOCID:fr21fe08-134) 

To Whom It May Concern: 

In response to Federal Register notice of the February 21, 

2008, the New Jersey Department of Environmental Protection 
(NJDEP) is pleased to comment on the Draft Contaminant 

Candidate List 3 (CCL3). Our comments focus on four chemicals 

of concern to New Jersey: PFOA, 1,2,3-trichloropropane, MTBE, 

and perchlorate. 

General Comments 

Section 1412(b) (1) of the federal Safe Drinking Water Act 

(SDWA), as amended in 1996, requires USEPA to publish the 

Contaminant Candidate List every five years. The SDWA specifies 

that the list must include contaminants that are not subject to 

any proposed or promulgated National Primary Drinking Water 

Regulations, are known or anticipated to occur in public water 

systems (PWSs), and may require regulation under SDWA. The 1996 

SDWA Amendments also specify three criteria to determine 

whether a contaminant may require regulation: 1) the 

contaminant may have an adverse effect on the health of 

persons; 2) the contaminant is known to occur or there is a 

substantial likelihood that the contaminant will occur in 

public water systems with a frequency and at levels of public 

health concern; and 3) in the sole judgment of the 

Administrator, regulation of such contaminant presents a 

meaningful opportunity for health risk reduction for persons 

served by public water systems. 

Since the Contaminant Candidate List process began about 10 

years ago, none of the contaminants included on the two prior 

Contaminant Candidate Lists have been adopted by the United 

States Environmental Protection Agency (USEPA) as National 

Primary Drinking Water Regulations. The NJDEP is very concerned 

about this practice since many of the contaminants on the past 

Contaminant Candidate Lists, as well as many of the 

contaminants on the present CCL3, both occur widely in drinking 

water and have health effects of potential concern. The health 

effects data for many of these chemicals are extensive and 

complicated. For such chemicals, the risk assessment involves a 

large amount of time and effort. Most states have limited 

resources as far as risk assessment and cannot address all 

chemicals of concern in drinking water without assistance from 

USEPA. We urge USEPA to use its vast resources to address such 

chemicals by regulating when appropriate, rather than simply 
determining that every chemical evaluated does not need 

regulation. 

Specific Contaminants of Concern to New Jersey 

Perfluorooctanoic acid (PFOA) 

PFOA is a chemical of concern in drinking water, which NJDEP 

strongly urges USEPA to address, as discussed below. It is well 

known that drinking water has been contaminated by PFOA from 

point sources, such as the Ohio and West Virginia area 

contaminated by the DuPont Washington Works facility in 

Parkersburg, West Virginia and the several sites contaminated 

by 3M in Minnesota. However, it is also important to recognize 

that the lower levels of PFOA found in drinking water not 

impacted by a known point source may also result in health 

effects of concern. 

As discussed below, it appears that health-based drinking water 

concentrations developed using a very conservative approach 

involving application of standard uncertainty factors for 

Reference Dose development, as well as animal-to-human 

extrapolation based on blood levels instead of administered 

dose, do not protect against health effects in the human 

population. 

New Jersey Occurrence Information 

In 2006, NJDEP conducted a small statewide PFOA and 

perfluorooctane sulfonic acid (PFOS) occurrence study (NJDEP, 

2007a). Twenty-nine samples from twenty-three ground and 

surface water systems were collected in various areas 

throughout the state. STL Denver, the only laboratory certified 

by NJDEP for PFOA, conducted the analysis. The detection limit 

was 0.001 ug/L and the quantitation limit was 0.004 ug/L. 

Samples consisted of raw groundwater and surface waters, as 

well as samples of finished water. PFOA was found in raw and 

treated surface water, and raw and treated ground water from 
unconfined wells. 

The data from the occurrence study show levels of PFOA from 

0.003 ug/L, a level that is detected but not quantified to 

0.039 ug/L. PFOA was detected and quantified at 65% of the 23 

systems sampled. If the samples where PFOA was detected but was 

not quantifiable are included, PFOA was found in 78% of the 

systems sampled. 

NJDEP is continuing to sample at water systems where PFOA was 

detected. In this follow-up sampling, PFOA was detected at four 

water systems at or above 0.04 ug/L (the NJDEP health-based 

drinking water guidance level, discussed below). The highest 

concentration was measured at systems with no known point 

source of PFOA was 0.069 ug/L. 

Significance of Drinking Water Exposure to Human Body Burden 

Although these drinking water concentrations of PFOA are 

relatively low, they may contribute significantly to the body 

burden of PFOA in the general population (Post et al., 2007). 

The average blood concentration of PFOA in the general 

population is approximately 5 ug/L and the 90th percentile is 

9.4 ug/L (USEPA, 2005a). 

A study of a community whose drinking water was contaminated 

with PFOA showed that, on average, ingestion of water with a 

given PFOA concentration results in a blood concentration 100- 

fold higher (Emmett et al., 2006). Similar results are 

predicted by modeling done by Gray (2005) and Hinderliter and 

Jepson (2001). For example, ingestion of drinking water with 

0.03 ug/L PFOA would be expected to contribute about 3 ug/L to 

the blood concentration of PFOA. Therefore, the contribution to 

total human exposure of PFOA in drinking water at levels below 

0.1 ug/L may be significant. 

Toxicology and Risk Assessment 
New Jersey Health-based Drinking Water Guidance 

In 2007, NJDEP developed a health-based drinking water guidance 

for PFOA of 0.04 ug/L in response to a request from a New 

Jersey water supply with detections of up to 0.19 ug/L in its 

wells, located near a point source of PFOA (NJDEP, 2007b). 

The NJDEP health-based drinking water guidance is based on the 

endpoints identified by USEPA (2005a) in its draft PFOA risk 

assessment. Since the half life of PFOA is much longer in 

humans than in the experimental animals used in the studies, 

the risk assessment was based on blood levels of PFOA rather 

than administered doses of PFOA. This approach was recommended 

by the USEPA Science Advisory Board (USEPA, 2006a). Appropriate 

uncertainty factors and a Relative Source Contribution factor 

were applied to the blood levels in the animal studies at the 

NOAELs and LOAELs identified by USEPA to determine target human 

blood levels. A similar approach was used for the cancer 

endpoint to determine the blood level at the 10-6 risk level. 

The 100:1 blood/drinking water concentration factor observed by 

Emmett et al. (2006) was used to determine drinking water 

concentrations anticipated to result in the target blood 

levels. 

The most sensitive endpoints, resulting in a health-based 

drinking water concentration of 0.04 ug/L, were body weight and 

hematological changes in a chronic study of adult female rats. 

The drinking water concentrations based on endpoints from 

several other studies were very close to 0.04 ug/L (adult male 

rat - 0.08 ug/L, cynomolgus monkey - 0.05 ug/L, pregnant female 

rat - 0.07 ug/L, carcinogenicity in male rats at 10-6 risk 

level - 0.06 ug/L). 

The USEPA (2005a) draft risk assessment did not consider more 

recent studies, which reveal additional effects of PFOA of 

serious concern, as discussed below. 

Recent mouse developmental data 
The developmental data considered by USEPA (2005a) were from 

rat studies. The rat is not a good model for developmental 

effects of PFOA because the half-life of PFOA in female rats is 

very short (2-4 hours), so that steady state is never reached 

with daily dosing, and the fetus receives minimal exposure. In 

contrast, PFOA has a longer half-life in female mice, resulting 

in a higher steady state blood level and greater exposure to 

the fetus. Recent mouse developmental studies, reviewed by Lau 

et al. (2007), have revealed effects resulting from prenatal 

exposure including post-natal mortality, decreased birth 

weight, delayed post-natal growth and development, obesity at 

18 months of age, and inhibition of mammary gland development. 

Recent data on mechanism of liver carcinogenicity 

Very recent new data shed light on the relevance of the 

positive carcinogenicity studies in rats to PFOA's human 

carcinogenic potential, which has been a subject of ongoing 

controversy. 

PFOA was found to induce liver adenomas, Leydig cell adenomas, 

and pancreatic acinar cell tumors in male Sprague-Dawley rats 

and mammary cell fibroadenomas in female rats, although USEPA 

(2005a) questioned the significance of the mammary tumors 

compared to historical background incidences. USEPA (2005a) 

interpreted the liver, Leydig cell, and pancreatic acinar cell 

tumors as constituting a "tumor triad" known to be caused by a 

class of chemicals which are peroxisome proliferator-activated 

receptor-alpha (PPAR-a) agonists. USEPA (2005a) states that the 

relevance to humans of tumors caused by this group of chemicals 

is uncertain. Additionally, they state that there are no 

adequate human studies of PFOAs carcinogenic potential since 

the occupationally exposed cohorts are still quite young. Based 

upon this, USEPA (2005a) concluded that PFOA was best described 

as having "suggestive evidence of carcinogenicity, but not 

sufficient to assess human carcinogenic potential". 

The USEPA Science Advisory Board (2006a) disagreed with USEPA 
(2005a) as to the most appropriate descriptor for the 

carcinogenicity of PFOA. They concluded that the PFOA cancer 

data are consistent with the USEPA cancer guidelines descriptor 

"likely to be carcinogenic to humans" which applies to 

chemicals which have been shown to cause tumors in more than 

one species, sex, strain, site, or exposure route, regardless 

of the existence of evidence in humans. Most Science Advisory 

Board panel members felt that the animal data are much stronger 

than the type of data which would warrant a "suggestive" 

descriptor. This conclusion was based on the following: 1) 

existence of two positive cancer studies in animals for PFOA, 

2) data suggesting that PPAR-a activation may not be the sole 

mechanism of liver carcinogenesis (discussed above in regard to 

liver toxicity of PFOA), 3) disagreement about the 

appropriateness of comparison to historical controls rather 

than concurrent controls in evaluating the mammary tumor date, 

and 4) disagreement about the USEPA (2005a) assumptions about 

the mode of action for the Leydig cell and pancreatic acinar 

cell being related to PPAR-alpha agonist activity, and the 

USEPA comparison of mammary tumors to historical, rather than 

concurrent, controls. 

A new study (Tilton et al., 2008) suggests that PFOA promotes 

liver tumors in rainbow trout by a mechanism independent of 

PPAR-alpha and peroxisome proliferation. The rainbow trout has 

been used as a model for chemically induced liver cancer in 

humans for over 40 years, and, like humans, is insensitive to 

liver toxicity through peroxisome proliferation. PFOA was shown 

to enhance liver carcinogenesis post-initiation through an 

estrogenic mechanism independent of peroxisome proliferation, 

which may be relevant to human carcinogenic potential. 

Recent human birth weight and clinical effects at very low 

exposures 

Recent human data suggest effects in humans at blood levels of 

PFOA typical of the general population, orders of magnitude 

below effect levels seen in animal studies. 

Several studies associating PFOA blood levels in the general 
population with effects on birth weight and other fetal growth 

indicators (ponderal index, head circumference, and birth 

length) have been published (Apelberg et al., 2007; Fei et al. 

2007; Fei et al., 2008). The effects observed within the 

general population are of a very large magnitude. For example, 

in a study of 1400 Danish mothers and their infants (Fei et 

al., 2007), the largest decrease in mean birth weight, 126 g, 

was seen between the lowest quartile for PFOA in maternal blood 

(3.91 ug/L or below) and the second quartile (3.91-5.20 ug/L). 

The decrease in mean birth weight between the lowest quartile 

(less than 3.91 ug/L and the highest quartile (6.97 ug/L and 

above) was 175 g. No association between birth weight and PFOS 

blood levels was observed. 

Additionally, recent preliminary data from a study of 

approximately 70,000 Ohio and West Virginia residents exposed 

to PFOA in their drinking water at levels from 0.05 ug/L to 3 

ug/L or higher suggest an association between several clinical 

parameters and exposure to PFOA. Apparent effects are seen at 

blood levels orders of magnitude below the blood levels at 

which effects have been seen in animals (Frisbee, 2008). The 

effects involved include decreased C-reactive protein (an 

indicator of inflammation), decreased immunoglobulin G, 

increases in two liver enzymes (SGPT and SGOT), increased 

cholesterol in children, and effects on thyroxine levels. These 

effects are consistent with the known toxicity of PFOA from 

animal and/or human occupational studies, as reviewed by Lau et 

al. (2007), as PFOA is known to produce liver toxicity, 

suppress the immune system, and suppress inflammatory response 

in animal studies, and has been observed to increase thyroid 

hormone and cholesterol levels in occupational studies. 

In this study, the study population was divided into deciles 

based on PFOA blood levels, with about 6700 people in each 

group. The mean blood levels for each decile is shown below (S. 

Frisbee, personal communication): 

Decile Mean PFOA Blood Level (ug/L) 

1 5.65 

2 9.80 

3 13.47 
4 18.06 

5 24.28 

6 33.26 

7 47.44 

8 71.33 

9 124.11 

10 482.33 

The PFOA levels in the first decile and the second decile are 

almost identical to the mean and the 90th percentiles in the 

United States population. No threshold was apparent for a 

number of the observed effects in human populations, both for 

the birth weight study (Fei et al., 2007) and for clinical 

parameters (C-8 reactive protein, liver enzymes, and increased 

cholesterol in children), and effects appear to occur down to 

the lowest exposure groups, which are in the range of the mean 

concentration general population. 

Effects are seen well below the blood levels derived by 

applying conservative uncertainty factors to animal data by 

NJDEP (2007b); the blood level for the most sensitive effect 

thus derived was 18 ug/L. 

Recommendation 

As discussed above, it appears that health-based drinking water 

concentration for PFOA developed using a very conservative 

approach involving application of standard uncertainty factors 

for Reference Dose development, as well as animal-to-human 

extrapolation based on blood levels instead of administered 

dose, is not protective against health effects in the human population. 

Because humans appear to be so sensitive to PFOA's 

effects and PFOA appears to occur ubiquitously in drinking 

water, based on New Jersey and other data, it is important that 

exposure to PFOA through drinking water be appropriately 

limited through MCL development. 

1,2,3-Trichloropropane 
1,2,3-Trichloropropane (1,2,3-TCP) is a chemical of concern in 

drinking water, which NJDEP strongly urges USEPA to address. 

1,2,3-TCP is a potent genotoxic carcinogen which occurs in 

drinking water at levels resulting in significant cancer risk 

based on test results from New Jersey public and non-public 

water supplies. Currently, USEPA does not provide any 

information as to 1,2,3-TCP's carcinogenicity on its 2006 USEPA 

Office of Water Drinking Water Regulations and Health Advisory 

Table (USEPA, 2006b). Instead, it provides a Lifetime Health 

Advisory which results in a lifetime cancer risk of 4 x 10-3 to 

3 x 10-2, based on available slope factors. This information, 

which is not protective of public health, has been used by 

several states to develop drinking water and groundwater 

guidance for 1,2,3-TCP, as the basis for evaluating situations 

of drinking water and groundwater contamination, etc. 

Therefore, NJDEP strongly urges USEPA to provide appropriate 

public health protective information in its Drinking Water 

Regulations and Health Advisory Table and to develop an MCL for 

1,23-trichloropropane. 

Uses 

1,2,3-TCP is a known contaminant of nematocides and soil 

fumigants including D-D (NTP, 2005) (1,2-dichloropropane and 

1,3-dichloropropene [mixed isomers] ) and Telone (1,3- 

dichloropropene). Telone has been reported to contain up to 

0.17% 1,2,3-TCP by weight (WHO, 2003). This is thought to be 

the source of 1,2,3-TCP contamination of rural wells in New 

Jersey and other locations. When 1,2,3-TCP was detected in 

Galloway Township, Atlantic County, New Jersey, in 1999, three 

other chemicals were also found at the sampling sites: 

dibromochloropropane, 1,2-dichloropropane, and ethylene 

dibromide. The occurrence of 1,2,3-TCP is discussed in more 

detail. 

1,2,3-TCP was extensively used in the past as a solvent, 

cleaning and degreasing agent, and paint and varnish remover. 

It is used as intermediate in the synthesis of several organic 

compounds including polysulfone liquid polymers, 

dichloropropene, hexafluorpropylene, and polysulfides (NTP, 
2005). 

1,2,3-TCP is a byproduct produced in significant quantities in 

the manufacture of other chlorinated compounds, including 

epichlorohydrin. It is listed as a component which is present 

at greater than 0.01% (a reporting threshold) on the Right to 

Know lists of New Jersey, Pennsylvania, and Massachusettes, as 

well as the California Proposition 65 list. According to the 

SPI Epichlorohydrin Task Force, the majority of 1,2,3-TCP 

produced as a byproduct of epichlorohydrin production today is 

incinerated on-site (WHO, 2003). 1,2,3-TCP is also a byproduct 

of dichloropropene, propylene dichlorohydrin, dichlorohydrin, 

and glycerol (NTP, 2005). 

A polymer used as a coagulant in the treatment of potable water 

and wastewater is produced by reacting epichlorohydrin with 

dimethylamine. Epichlorohydrin is a known contaminant of these 

polymers, and is likely to be present in finished drinking 

water due to its use in the coatings of drinking water pipes 

(USEPA, 1985). Since 1,2,3-trichloropropane is a contaminant in 

epichlorohydrin, it might also be present in drinking water, 

especially since 1,2,3-trichloropropane is more stable in water 

than epichlorohydrin. 

An NSF International (2000) report prepared for Health Canada 

on impurities in drinking water treatment, 1,2,3-TCP was 

identified as a contaminant in an unidentified well drilling 

aid. However, the Action Level (target drinking water level 

based on health effects) used by Health Canada was 5 ug/L, 

which is much higher than the health based drinking water level 

or practical quantitation limit (see below). 

A health-based drinking water guidance of 0.005 ug/L was 

developed by NJDEP in 1999 based upon the 10-6 risk level and 

the slope factor of 7 (mg/kg/day)-1 in the USEPA HEAST (1995) 

tables. This slope factor was based on the combined incidence 

of benign and malignant tumors at various sites in rats. 

Standard exposure factors for body weight (70 kg) and drinking 

water ingestion (2 L/day) were used. The New Jersey Drinking 

Water Quality Institute is currently in the process of 
recommending a Maximum Contaminant Level (MCL) to NJDEP for 

1,2,3-TCP for possible standard setting. A more complete 

explanation of the risk assessment is presented below. 

Occurrence 

1,2,3-Trichloropropane has been found in both public water 

supplies (including in USEPA Unregulated Contaminant 

Monitoring) and private wells. As discussed above, it is known 

to be present in soil fumigants including D-D (mixed isomers of 

1,2-dichloropropane and 1,3-dichloropropene) and Telone (1,3- 

dichloropropene), and there are also other potential sources of 

contamination. Because the health-based drinking water 

concentration (at the10-6 risk level) for 1,2,3- 

trichloropropane is so low (see below), less sensitive 

analytical methods will miss occurrences at levels of concern, 

and reporting limits given by each state for the UCMR Round 1 

monitoring ranged from 0.5 ug/L to 5 ug/L. 

In 2005, NJDEP conducted a review of occurrence of 1,2,3- 

trichloropropane in New Jersey drinking waters. 1,2,3- 

Trichloropropane was detected at levels above the health-based 

drinking water guidance developed by NJDEP of 0.005 ug/L (see 

below) in 30 of the 2,640 private wells (1.1%) sampled during 

contaminated site investigations overseen by NJDEPs Site 

Remediation Program between 1999 and 2004. In addition, as part 

of NJDEPs Synthetic Organic Compound (SOC) Waiver Program 

sampling, 1,2,3-trichloropropane was detected at levels above 

the health-based drinking water guidance of 0.005 ug/L 

developed by NJDEP in 11 of approximately 260 community water 

systems (4%) sampled between 1999 and 2004. 

In unregulated contaminant monitoring in California from 1989 

through the 1990s, fewer than 20 sources reported detections, 

reflecting the less sensitive analytical methods available at 

that time, with a reporting limit of 0.5 μg/L. However, more 

recent monitoring in California with a more sensitive 

analytical method reported 1,2,3-trichloropropane detections in 

303 sources, at levels up to 57 μg/L. Of the 303 detections, 2 

were below 0.005 ug/L, 171 between 0.005 and 0.05 ug/L, 104 
between 0.05 and 0.5 ug/L, 20 between 0.5 and 5 ug/L, 4 between 

5 and 50 ug/L, and 1 above 50 ug/L. This dataset is not yet 

complete (CDPH, 2007). 

California Department of Public Health (CDPH, 2007) states on 

its fact sheet that the primary possible contaminating activity 

for 1,2,3-TCP in drinking water appears to be hazardous waste 

sites. No further justification is given for this statement. 

1,2,3-Trichloropropane is the main contaminant at a Superfund 

site, MacKenzie Chemical Works in Suffolk County, New York 

(ATSDR, 2004). ATSDR conducted an evaluation of this site in 

2004, and used New York's MCL of 5 ug/L to evaluate the 

significance of the contamination. (5 ug/L is New York's MCL 

for Principal Organic Contaminants, a generic number for 

organic contaminants when there is no information indicating 

that a lower value is warranted.) The cancer risk level at 5 

ug/L is about 10-3. Analytical methods used in this 

investigation were chosen with the belief that a detection 

limit below 5 ug/L was not needed. 

According to the ATSDR report on this site, concentrations of 

1,2,3-trichloropropane of up to 34,000 ug/L were detected in 

off-site groundwater, at 10,000 ug/L one block from the site, 

and above 100 ug/L more than 0.25 miles from the site. A well 

field is located about 0.5 miles downgradient from the site. No 

VOCs were detected in routine monitoring of a deep well in that 

well field that serves the local community. ATSDR concluded 

that "the site poses no public health hazard at the present 

because there are no known exposures to site-related 

contaminants." It is troubling that a drinking water benchmark 

of 5 ug/L, which is 1000 times above the public health 

protective concentration of 0.005 ug/L, was used by ATSDR and 

the state of New York to evaluate this highly contaminated 

site. This information was used to provide reassuring, but 

perhaps incorrect, conclusions to the local community that 

there is no exposure of concern to 1,2,3-trichloropropane. 

Additional test results posted on web sites reveal many other 

cases of drinking water and ground water contamination by 
1,2,3-trichloropropane at high levels, including a site in 

Dover Township, New Jersey where concentrations up to 210 ug/L 

in ground water were found (NJDHSS, 2001). 

Toxicology and Risk Assessment 

1,2,3-Trichloropropane is metabolically activated to a reactive 

intermediate and is a potent carcinogen. It is genotoxic in 

almost every system in which it was tested, and it caused a 

high incidence of tumors at multiple sites in male and female 

rats and mice in an NTP (1993) carcinogenicity bioassay. From 

the 1993 study, NTP concluded that there was clear evidence of 

carcinogenic activity in both sexes of both species. 

Additionally, it was reasonably anticipated to be a human 

carcinogen in the NTP Eleventh Report on Carcinogens (2005). 

Thus, the weight of evidence for carcinogenicity for 1,2,3- 

trichloropropane is much stronger than for many other chemicals 

which are treated as non-threshold carcinogens as a 

conservative default assumption. From this information, there 

is no doubt that the risk assessment for 1,2,3-trichloropropane 

should be based on a non-threshold low dose model, and that a 

risk assessment based on a Reference Dose is inappropriate for 

this chemical. 

Three slope factors have been developed for 1,2,3- 

trichloropropane using the data from the 1993 NTP study: an 

older USEPA HEAST (1995) slope factor which was based on 

classification as a probable human carcinogen (B2) and the 

linearized multistage model, and slope factors in the draft 

risk assessments developed by USEPA IRIS (2007) and the 

California EPA Public Health Goal program (2007) which both use 

time-to-tumor low dose modeling, but differ in choice of 

species and modeling details. The range of drinking water 

concentrations at the 10-6 risk level, based on the three slope 

factors available, is 0.0015 ug/L to 0.009 ug/L, assuming water 

consumption of 2 liters per day. 

A health-based drinking water guidance of 0.005 ug/L was 

developed by NJDEP in 1999 based upon the 10-6 risk level and 

the slope factor of 7 (mg/kg/day)-1 in the USEPA HEAST (1995) 
tables. This slope factor was based on the combined incidence 

of benign and malignant tumors at various sites in rats. 

Standard exposure factors for body weight (70 kg) and drinking 

water ingestion (2 L/day) were used. The New Jersey Drinking 

Water Quality Institute is currently in the process of 

developing a Maximum Contaminant Level recommendation to NJDEP 

for 1,2,3-TCP. 

Health Advisory information provided by USEPA Office of Water 

The 2006 USEPA Office of Water Drinking Water Regulations and 

Health Advisory Table (HA Table) does not indicate that 1,2,3- 

trichloropropane is a carcinogen and provides a Lifetime Health 

Advisory for this contaminant. As you know, the users of this 

table do not necessarily have any toxicology or risk assessment 

expertise, since it is a practical reference table intended to 

be used by persons directly addressing local public health 

issues, such as detection of drinking water contaminants 

without MCLs in public water supplies or private wells. 

Examples of users of the HA Table are county and local health 

officials or water purveyors. 

As discussed above, there is no doubt that the cancer risk 

assessment for 1,2,3-trichloropropane should be based on a non- 

threshold linear low dose model, and that a risk assessment 

based on a Reference Dose is inappropriate for this chemical. 

In spite of this, the IRIS entry for 1,2,3-TCP, fifteen years 

after the 1993 NTP study was published in final form, provides 

a Reference Dose for non-cancer effects of 0.006 mg/kg/day 

which was developed in 1989, prior to completion of the 1993 

NTP study. For carcinogenicity, the only entry is "no data, 

dated 11/1/1993." 

USEPA Office of Water does not provide Lifetime Health 

Advisories for known or probable human carcinogens (Groups A or 

B, using the older weight of evidence terminology). However, 

the HA Table does not even indicate that 1,2,3-trichloropropane 

is a carcinogen, and gives a Lifetime Health Advisory of 40 

ug/L, based on the IRIS Reference Dose of 0.006 mg/kg/day. The 

range of lifetime cancer risks at the Lifetime Health Advisory 
of 40 ug/L, using the slope factors currently being considered 

by USEPA and California EPA is 4 x 10-3 to 3 x 10-2 or 4 in 

1000 to 3 in 100. Thus, an unacceptably high level of cancer 

risk will result if the guidance provided in the table is used 

by local health officials to provide advice about 1,2,3- 

trichloropropane contamination of drinking water. Additionally, 

this guidance may be used as the basis to choose analytical 

methods which are not sensitive enough to detect levels of 

concern. 

Current USEPA Office of Water procedures do not allow 

information from final NTP studies, HEAST, NCEA, IRIS drafts, 

or other such reliable sources, to be posted on the HA Table, 

even if this information clearly demonstrates that the 

information provided on the HA Table is not protective of 

public health. USEPA Office of Water procedures do not allow 

for inclusion of any carcinogenicity information until the IRIS 

cancer assessment for this chemical is finalized, which will 

likely take years due to the number of time consuming reviews 

required by the IRIS process. 

Ironically, older versions of the Drinking Water Regulations 

and Health Advisory Table (e.g. 1996) listed 1,2,3- 

trichloropropane as a Group B2 (probable human) carcinogen and 

provided a drinking water concentrations based on cancer risk, 

based on the slope factor provided in the 1995 HEAST table. As 

discussed above, the HEAST slope factor was the basis for the 

drinking water guidance value of 0.005 ug/L developed by NJDEP 

in 1999. 

The Lifetime Health Advisory of 40 ug/L provided in the HA 

Table is widely used by states and other parts of USEPA as a 

health-based drinking water concentrations for 1,2,3- 

trichloropropane. Some examples follow: 

1) Situations where Lifetime Health Advisory from the HA Table 

has been routinely used by state and local environmental or 

public health officials in states with no listed guidance to 

assess the significance of detections in drinking water. It is 

obviously not possible to determine how many times that this 
has occurred, since this information is not normally posted on 

the Internet. 

2) Several states, including Arizona (42 ug/L), Florida (42 

ug/L), Minnesota (40 ug/L), New York (5 ug/L) Washington (21 

ug/L), and Wisconsin (50 ug/L) have drinking water standards or 

guidance concentrations at high risk levels, based on the 

USEPAs incorrect and outdated toxicity information (USEPA, 

2000; HSDB, 2008). 

3) Because the health-based drinking water concentration (at 

the 10-6 risk level) for 1,2,3-trichloropropane is so low, 

less sensitive analytical methods will miss occurrences at 

levels of concern, and reporting limits given by each state for 

the Unregulated Contaminant Monitoring Round 1 monitoring 

ranged from 0.5 ug/L to 5 ug/L. Additionally, the 2001 USEPA 

Office of Water reports "Occurrence of Unregulated Contaminants 

in Public Water Systems-A National Summary" (Table V.A.1) 

(USEPA, 2001a) and "Occurrence of Unregulated Contaminants in 

Public Water Systems-An Initial Assessment" (Tables A58 a, c) 

(USEPA, 2001b) incorrectly give 40 ug/L as the "MCL" for 1,2,3- 

trichloropropane, although it is currently not a regulated 

contaminant. 

Recommendations 

NJDEP strongly urges USEPA Office of Water to update its HA 

Table to provide appropriate public health protective drinking 

water guidance based on the carcinogenic effects of 1,2,3-TCP. 

NJDEP strongly urges USEPA Office of Water to develop an MCL 

for 1,2,3-TCP based on its occurence in drinking water and its 

carcinogenic effects. 

Methyl tertiary butyl ether (MTBE) 

MTBE is a chemical of concern in drinking water, which NJDEP 

strongly urges USEPA to address, as discussed below. MTBE was 

listed on CCL1 and CCL2, and both times a decision was made not 

to regulate this chemical. In addition, MTBE is included in the 
current CCL3. There is as much or more relevant toxicology data 

on MTBE than for many other regulated chemicals, and it is a 

contaminant which is commonly found in drinking water 

throughout the United States. At least 41 of 50 states have 

developed a drinking water or ground water standard or guidance 

for MTBE as shown on a map linked from the USEPA website ( 

http://www.epa.gov/swerust1/mtbe/mtbemap.pdf). MTBE is the most 

frequently detected volatile organic contaminant in data 

collected through New Jersey's Private Well Testing Act. Of the 

51,028 wells tested under the Private Well Testing Act, 38 

(0.01%) exceeded the New Jersey MCL of 70 ug/L and the highest 

concentration detected was 1550 ug/L. 

New Jersey was among the first states to develop an MCL for 

MTBE. The basis for New Jerseys MCL was published in 1994 

(NJDWQI, 1994), and it was adopted in 1996. 

There is controversy over the reporting and interpretation of 

the results of the only available chronic oral study for MTBE 

(Belpoggi et al.,1995; Belpoggi et al., 1998). In this study, 

rats were dosed with MTBE by gavage in olive oil. The New 

Jersey Drinking Water Quality Institute (1994) recognized the 

uncertainties regarding the carcinogenicity of MTBE, 

specifically by oral exposure, and classified MTBE as a 

possible human carcinogen (equivalent to USEPA Group C under 

the 1986 USEPA guidelines). This classification forms the basis 

for New Jerseys Drinking Water Health-based Maximum 

Contaminant Level (MCL) for MTBE. The Health-based MCL is based 

on a subchronic oral gavage study in rats (Robinson, 1990), and 

the endpoint of concern was increased relative kidney weight. 

An additional uncertainty factor of 10 was incorporated to 

account for possible carcinogenic effects, following USEPA's 

and New Jerseys approach for drinking water risk assessment of 

possible human carcinogens. Some states have followed New 

Jerseys approach, while other states have based their MTBE 

risk assessments on a cancer slope factor. 

A subchronic drinking water study for MTBE in rats was recently 

conducted (Bermudez et al., 2008) in order to set the doses for 

a two year drinking water study. This two year study is 

currently in progress, with the in-life phase expected to end 
in April 2009. The target date for the final report for this 

study is January 2010 (E. Bermudez, personal communication). 

The results of this study may answer some of the unresolved 

issues regarding the oral carcinogenicity of MTBE. 

Recommendation 

MTBE is a contaminant for which the states have a strong need 

for guidance from USEPA. It is recommended that USEPA evaluate 

the results of the current chronic oral drinking water study 

when it is complete, along with other toxicology information, 

and develop an MCL for MTBE. 

Perchlorate 

Perchlorate is a chemical of concern in drinking water, which 

NJDEP strongly urges USEPA to address, as discussed below. 

Perchlorate is a chemical with diverse uses in flares, 

fireworks, rocket fuel, and explosives. It is also found in 

fertilizers from certain geographic regions. Its widespread 

occurrence in drinking water has been well documented by 

others. 

After perchlorate was found in New Jersey drinking water as 

part of monitoring required by USEPA's Unregulated Contaminant 

Monitoring Rule, the New Jersey Drinking Water Quality 

Institute was asked by NJDEP to recommend a drinking water 

standard for perchlorate. NJDEP anticipates proposing a 

perchlorate MCL of 5 ug/L in the near future, as discussed 

below. 

The National Research Council (2004) recommended a Reference 

Dose for perchlorate based on a small, but detailed study by 

Greer et al. (2002), which measured the inhibition of iodine 

uptake by the thyroid and the levels of thyroid hormone in 

adults receiving doses of perchlorate. The No Observed Effect 

Level for inhibition of iodine uptake in this study was 0.007 

mg/kg/day. Iodine uptake is a full biological step away from a 
reduction in thyroxine or an increase in TSH, neither of which 

was observed even at the highest dose of perchlorate in this 

study. 

The Reference Dose of 0.0007 mg/kg/day incorporates an 

uncertainty factor of 10 to protect sensitive subpopulations 

including fetuses and infants. Additional uncertainty factors 

were not considered necessary since the observed effect was not 

in and of itself considered adverse. This conclusion was 

supported by other data indicating the absence of effects on 

thyroid hormone in newborns and pregnant women in areas with 

perchlorate in the drinking water. Additional data since then 

has confirmed this for both groups. This Reference Dose was 

adopted by USEPA IRIS in 2005. 

After reviewing the scientific literature the New Jersey 

Drinking Water Quality Institute concurred with National 

Research Councils Reference Dose (NJDWQI, 2005). From this 

Reference Dose, the Institute established a drinking water 

equivalent level of 24.5 micrograms of perchlorate per liter of 

water based on a 70 kilogram adult. 

The last step in developing a health-based drinking water 

concentration is to adjust the drinking water equivalent level 

to account for other sources of exposure, such as food. When 

little data is available on other exposures that may add to the 

exposure from water, the default assumption is that the 

drinking water contribution should be limited to 20% of the 

total. Application of a 20% Relative Source Contribution factor 

results in a health-based drinking water concentration of 5 

ug/L, which was recommended as the basis for New Jerseys MCL 

(NJDWQI, 2005). Based on their relative intakes of water and 

formula or breast milk, infants were considered to be 

protected. This is supported by the recent publication of Food 

and Drug Administration data on exposure to perchlorate in 

foods. 

Recommendation 
NJDEP strongly urges USEPA to develop an MCL for perchlorate 

based on its widespread occurrence, well characterized effects 

on thyroid function, and adequate information on the relative 

contributions of food and drinking water to perchlorate 

exposure. 

Other CCL3 Contaminants Addressed by NJDEP 

New Jersey has developed Health-based MCLs (equivalent to USEPA 

MCLGs) for formaldehyde, n-hexane, and ethylene glycol, and is 

currently in the process of developing analytical methods for 

these so that an MCL may be adopted. The basis for the 

formaldehyde and n-hexane Health-based MCLs is found on the New 

Jersey Drinking Water Quality Institute's website 

http://www.nj.gov/dep/watersupply/njdwqinstitute.htm. 

A recommendation has been made to revise the Health-based MCL 

for ethylene glycol from 290 ug/L to 10,000 ug/L, based on 

evaluation of more recent data on both renal toxicity and 

developmental effects. 

New Jersey promulgated an MCL for 1,1-dichloroethane in 1996. 

The New Jersey carcinogenicity classification, Reference Dose, 

and Health-based MCL for 1,1-dichloroethane, which were 

developed in 1994 and are found on the website given above, 

were recently reevaluated by the New Jersey Drinking Water 

Quality Institute. Based on reevaluation of the data relevant 

to carcinogenic effects and the current cancer risk assessment 

guidelines, it is recommended to classify 1,1-dichloroethane 

in New Jersey Carcinogenicity Category II, equivalent to Group 

C, under the previous (1986) USEPA guidance, and analogous to 

Suggestive Evidence of Carcinogenic Potential under the current 

(2005) guidance. USEPA IRIS does not provide a slope factor for 

1,1-dichloroethane. It was recommended that an additional 

uncertainty factor of 10 for potential carcinogenicity be 

incorporated into the Reference Dose. 

The current basis of the Reference Dose, kidney effects in cats 

exposed by inhalation, is a more sensitive endpoint than a 
newer rat oral subchronic study, and it was recommended to 

continue to use the current endpoint. It is recommended that 

the uncertainty factor of 5 currently used for small number of 

animals in the cat study be removed. The basis for the 

Reference Dose is already very conservative and health 

protective and the total uncertainty factor would exceed the 

maximum uncertainty factor of 10,000 used in Reference Dose 

development. 

Based on the above, the recommended Reference Dose is 0.0032 

mg/kg/day, which is a two-fold decrease from current Reference 

Dose of 0.0065 mg/kg/day. The recommended Health-based MCL is 

23 ug/L, also a two-fold decrease from the current value of 46 

ug/L. 

Conclusion 

We appreciate the opportunity to comment on the Draft 

Contaminant Candidate List 3. If you have any questions or 

require additional information, please contact Dr.Gloria Post 

of the NJDEP Division of Science, Research and Technology at 

(609) 292-8497 or gloria.post@dep.state.nj.us. 

Attachment 

[See PDF for Attachment] 

Sincerely, 

Judith Louis, Ph.D., Chief 

Bureau of Environmental Assessment 

Division of Science Research and Technology 

Barker Hamill, Assistant Director 

Water Supply Operations 

Division of Water Supply 

C: Eileen Murphy, NJDEP 
Michele Putnam, NJDEP 

Sandra Krietzman, NJDEP 

CS Title: 0122 

Company/group/association name: 

Comment: 

COMMENTS OF 3M COMPANY ON EPA'S INCLUSION OF PFOA ON THE THIRD 

CONTAMINANT CANDIDATE LIST (CCL 3) 

INTRODUCTION 

3M Company (3M) appreciates the opportunity to comment on the 

U.S. Environmental Protection Agency's (EPA) inclusion of 

perfluorooctanoic acid (PFOA) on the Draft Third Drinking Water 

Candidate Contaminant List (CCL 3). 73 Fed. Reg. 9628 (Feb. 21, 

2008). 3M supports the mission of the CCL process to protect 

our Nation's drinking water. As discussed below, however, 3M 

believes that in assessing PFOA for inclusion on the CCL 3, EPA 

should use more relevant information to characterize PFOA's 

potential human health effects and exposure levels. To ensure a 

clear and accurate record, it is important that EPA properly 

characterize PFOA health effects and exposure during the CCL 3 

process. 3M offers the following comments for EPA's 

consideration. 

DISCUSSION 

1. A More Relevant Study Should Be Used to Characterize the 

Potency and Severity of PFOA Health Effects 

According to the PFOA Contaminant Information Sheet[FN1: See 

EPA, Contaminant Information Sheets for the Draft CCL 3 

Chemicals (February 2008), Docket ID No. EPA-HQ- 

OW-2007-1189-0043, p. 151-52.], EPA used a 1 mg/kg/day LOAEL 

included in EPA's 2005 Draft Risk Assessment of PFOA[FN2: EPA, 

Draft Risk Assessment of the Potential Human Health Effects of 

Associated with Exposure to Perfluorooctanoic Acid and its 

Salts, Office of Pollution Prevention and Toxics, Risk 
Assessment Division (January 4, 2005). (Hereinafter "Draft Risk 

Assessment").] to characterize the potential for PFOA to cause 

adverse health effects. For the reasons explained below, 3M 

believes this LOAEL should not be used to characterize the 

potency and severity of PFOA health effects in laboratory 

animals. 

EPA's use of the 1 mg/kg/day LOAEL value reported in the Draft 

Risk Assessment fails to properly capture the nature and intent 

of that document. The Draft Risk Assessment reported multiple 

endpoints and did not purport to determine a particular 

"critical effect" and effect level for regulatory or formal 

listing purposes. In its review of the Draft Risk Assessment, 

the EPA Science Advisory Board (SAB) agreed with EPA's 

inclusion of multiple endpoints in the "current draft", and did 

not render an opinion as to appropriateness of any single value 

for use in characterizing PFOA health effects.[FN3: See EPA, 

SAB Review of EPA's Draft Risk Assessment of Potential Human 

Health Effects Associated with PFOA and its Salts (May 30, 

2006), EPA-SAB-06-006.] In fact, the Draft Risk Assessment 

calculated two margins of exposure (MOEs) for PFOA in adult 

animals -- one based on a LOAEL from a two-generation study of 

rats and another based on a LOAEL from a study of cynomolgus 

monkeys -- and did not render an opinion as to whether one was 

more appropriate than the other. (EPA also separately 

calculated MOEs for developmental effects). 

Studies based on primates are a better model than rats for 

human risk assessment in the case of PFOA. Notably, the only 

agency to establish a drinking water criterion for PFOA through 

rulemaking -- the Minnesota Department of Health -- based its 

interim Health Risk Level for PFOA on an effect level from the 

monkey study.[FN4: See 32 Minn. Reg. 374 (Aug. 27, 2007).] 

Primates are preferable to rats because PFOA is known to act, 

at least in part, through a mechanism of action in rodents that 

is much less operative in humans. 

EPA calculated margins of exposure from the monkey study in its 

Draft Risk Assessment, but has not derived a Reference Dose 

from the monkey study. EPA's risk assessment guidance calls for 

the use of a benchmark dose for determining the point of 
departure and Reference Dose when such a benchmark dose is 

available. In a published risk assessment for PFOA, 3M and co- 

authors (Butenhoff et al. 2004a) have calculated benchmark 

doses for endpoints in the monkey study (Butenhoff et al. 

2002). The benchmark dose for liver-weight-to-brain-weight 

ratio is 3.9 mg/kg/day. 3M believes this is a more relevant 

point of departure. 

Indeed, not only are rats less relevant for human risk 

assessment than non-human primates, but the particular point of 

departure used in the draft EPA risk assessment for the rat 

study is not appropriate. The 1 mg/kg/day point of departure 

chosen by EPA during the CCL 3 process is based on a reduction 

in male post-weaning body weight in the first-generation pups 

in a two-generation reproductive study in rats reported in York 

(2002) and Butenhoff et al. (2004b). Although the Draft Risk 

Assessment did base one of the MOE calculations on this effect, 

the Draft Risk Assessment itself acknowledges that the 

"significance of reduced body weight for human health is not 

clear." [FN5: Draft Risk Assessment at 96.] 3M agrees that the 

effects on male body weights in this study are not of clear 

significance for human health and therefore urges that EPA not 

use this effect to characterize PFOA health effects in the CCL 

3 process. 

2. A Default Relative Source Contribution Value of 20% Should 

Not Have Been Used in the Calculation of a PFOA Health 

Reference Level 

3M believes that the relative source contribution (RSC) value 

that EPA used to calculate the health reference level (HRL) for 

PFOA as part of the CCL 3 process does not follow EPA guidance. 

Although 3M recognizes that EPA used this HRL for CCL screening 

purposes only, we are concerned that EPA's calculation approach 

could influence future regulatory activity. Accordingly, EPA 

should follow the procedures for calculating HRL values 

provided in its own guidance. 

In Step Three of the CCL 3 process (Classification to the CCL), 

EPA used a default 20% (0.2) RSC value for PFOA.[FN6: See EPA, 
Draft: Contaminant Candidate List 3 Chemicals: Classification 

of the PCCL to CCL, EPA 815-R-08-004, February 2008 

(hereinafter "Classification to CCL") at p. 61.] The RSC is a 

factor used to describe the proportion of the total permissible 

dose that is derived from the ingestion of water, versus other 

exposure routes. EPA guidance on the derivation of water 

quality criteria, referenced in the CCL,[FN7: EPA, Methodology 

for deriving ambient water quality criteria for the protection 

of human health. Office of Water, EPA-822-B-00-004, October, 

2000, p. 1-7.] allows RSC values in the range of 0.2 to 0.8, 

with a default value of 0.2 applied in the absence of data 

supporting a different RSC. (20% relative source contribution 

used "unless there are data to suggest that the 20% is 

inappropriate)."[FN8: Classification to CCL at 61.] In fact, 

there are data which show that a 20% RSC for PFOA is 

inappropriate. As described below, a comparison of exposures in 

persons with and without known drinking water PFOA exposure 

shows that where there is drinking water exposure, it is the 

major source of exposure -- well above 20% of the total 

exposure. 

Background exposures in the general population, which generally 

does not have drinking water exposure, have been well 

documented in a number of studies published by both the Centers 

for Disease Control and Prevention (CDC) and 3M. 

* 3M's studies have used American Red Cross samples from adult 

blood donors. 3M has published data on Red Cross samples from a 

variety of geographic locations in the U.S., including 

Minneapolis-St. Paul donors (Olsen et al., 2003). The levels 

in this study are also consistent with levels in studies of 

children from twenty states, and with levels found in a 

separate study of the elderly (Olsen et al., 2004a and 2004b). 

* The 3M national study has been confirmed by published Centers 

for Disease Control data based on a statistically 

representative sample of the U.S. population. (Calafat et al., 

2007a). 

* 3M has also published a more recent study of levels of PFOA 
in Minneapolis-St. Paul blood donors, showing a decline in 

general population exposures (Olsen et al., 2007). CDCs data 

also show a decline in PFOA concentrations in the general 

population (Calafat, et al., 2007b). 

Data on persons known to be exposed to PFOA in drinking water 

are available from three sources: 1) a peer-reviewed University 

of Pennsylvania study of a community exposed to PFOA in 

drinking water in West Virginia (Emmett et al., 2006a, 2006b); 

2) recently published study of a German population exposed to 

PFOA in drinking water (Holzer, et al., 2008); and 3) exposure 

data on persons living in Washington County, Minnesota, 

presumably exposed to PFOA in municipal or private well water 

prior to the installation of treatment.[FN9: Blood sampled by 

attorneys (Taft, Stettinius & Hollister LLP) who are suing 3M 

in private litigation. Data available in EPA FYI Docket No. AR 

226.] Exposure data for both the general population and persons 

exposed through drinking water are summarized in Table 1, 

below. 

Table 1. Geometric Mean Serum/Plasma Concentrations of PFOA 

(ppb) [see PDF] 

Although we must assume that people who live in Oakdale were 

exposed via the consumption of Oakdale municipal drinking 

water, the number of samples is sufficient to demonstrate a 

marked difference between the serum concentrations in the 

Oakdale population with exposure through city water and the 

general population in the Minneapolis/St. Paul metropolitan 

area or the U.S. general population. These data show that 

background serum concentrations based on non-drinking water 

exposures (serum ranging from 2.2 to 5.2 ppb) account for 

between 6 and 14 % of the serum concentrations in persons 

exposed via drinking water (whose mean serum concentration is 

36.5 ppb). Thus, in persons exposed through drinking water, 

drinking water accounts for between 86 and 94% of 

exposures.[FN10: The proportion for the German population 

studied in Holzer et al. (2008) is similar - 75 to 88%.] 

The Oakdale blood data, while unpublished, are consistent with 
the published data on the West Virginia/Ohio population exposed 

to PFOA. In studying the association of drinking water 

concentrations with serum concentrations of PFOA in a 

population in West Virginia/Ohio, University of Pennsylvania 

researchers similarly found that drinking water was the major 

source of exposure. Emmett et al. (2006a, 2006b). This study 

concluded that serum PFOA concentrations "depended on the 

source of residential drinking water, and not potential air 

exposure," and that "[r]esidential water source was the primary 

determinant of serum (PFOA)." 

In that study, serum concentrations among 291 residents using 

Little Hocking, Ohio city water were, on average, 105 times the 

residential drinking water concentration. PFOA concentrations 

in Oakdale city well samples averaged 0.3 to 0.8 ppb between 

October 2005 and March 2006, before 3M provided treatment. 

Therefore, the reported 2005 geometric mean Oakdale serum PFOA 

concentration of 36.5 ppb is consistent with the relationship 

between drinking water and serum PFOA concentrations observed 

in the University of Pennsylvania study. 

Finally, in the German study (Holzer, et al., 2008), persons 

consuming municipal water currently containing 0.5 ppb PFOA in 

drinking water had serum levels elevated 4.5-8.3 times the 

reference population. The authors concluded that drinking water 

consumption is a significant predictor of serum levels. 

These facts provide strong, objective evidence that exposures 

from sources other than water are low and declining, and that 

the higher concentrations observed in the Oakdale population 

and the University of Pennsylvania study in West Virginia/Ohio, 

are most certainly due to the drinking water source. 

Based on these data, EPA guidance would lead to a RSC of 50-80% 

rather than the 20% based on a default assumption. 3M believes 

that because data are available showing that the default 20% 

RSC value is inappropriate for PFOA, EPA should not use the 

default value in the CCL 3 process or in other regulatory 

proceedings. 
3. An Inappropriate Measure Was Used to Classify PFOA Occurrence 

3M believes the information used to classify PFOA occurrence in 

Step Three of the CCL 3 process also is inappropriate. To 

define the magnitude aspect of PFOA's occurrence in drinking 

water, EPA used the highest public drinking water level 

reported for Little Hocking, OH (7.2 μg/l) cited in Emmett et 

al. (2006a). Because Emmett et al. does not contain prevalence 

data for PFOA, EPA described the prevalence of PFOA using data 

for "Select Minnesota Municipal Wells" as described in a 

February 27, 2006 presentation by the Minnesota Department of 

Health (MDH) to the Minnesota Senate Environment and Natural 

Resources Committee.[FN11: MDH (H. Goeden and J. Kelly), 

"Perfluorochemicals in Minnesota" (February 27, 2006), EPA 

Docket ID No. EPA-HQ-OW-2007-1189-0027.] In using Minnesota 

prevalence data and West Virginia magnitude data, EPA has 

derived a measure of occurrence for PFOA that does not actually 

exist in the environment, which creates an artificial and 

inaccurate impression of the extent of PFOAs occurrence in 

drinking water. 3M believes that it is more scientifically 

appropriate to use occurrence and magnitude data that actually 

occur simultaneously in the environment. 

In addition, 3M believes EPA's characterization of the MDH 

prevalence data used in deriving a measure of PFOA occurrence 

is somewhat misleading. As noted by EPA in the PFOA Contaminant 

Information Sheet, the MDH presentation indicates that 6 of 37, 

or 16.2%, of municipal wells sampled contained detectable 

levels of PFOA.[FN12: See Id. at slide 17.] However, MDH 

sampled 37 municipal wells in seven Minnesota communities 

(Cottage Grove, Hastings, Lake Elmo, St. Paul, North St. Paul, 

Woodbury and Oakdale) and all six wells with PFOA detections 

were located in a single community, Oakdale, which has known 

contamination. No PFOA was detected in the other six 

communities municipal wells. Thus, the positive occurrence 

data relied upon by EPA are linked to a single location, and 

therefore do not support the prevalence of PFOA in Minnesota 

suggested by the 16.2% figure. Indeed, the aggregate of 

Minnesota well samples, which includes data from non-community 

wells and private wells is only 8.2%, even with the bias 

introduced by the Oakdale data. Moreover, the 6 out of 37 wells 
with PFOA is an artificially high proportion, and not 

representative of more widespread prevalence because all wells 

sampled were in Washington County, which was chosen 

specifically because PFOA from waste sites was expected to be 

found in the drinking water. 

CONCLUSION 

As explained above, 3M believes that, in the process of 

assessing PFOA for inclusion on the CCL 3, EPA did not use the 

most relevant information to characterize PFOAs potential 

human health effects and exposure levels. A clear and accurate 

record of the CCL 3 process with respect to PFOA is important, 

in our view, particularly given that determinations made in the 

process may influence other regulatory or formal listing 

determinations. 3M hopes that EPA finds the foregoing comments 

useful in helping to ensure a clear and accurate CCL 3 record. 

References 

Amacher, D. E., Schomaker, S. J., Boldt, S. E., Mirsky, M. 

(2006) The relationship among microsomal enzyme induction, 

liver weight, and histological change in cynomolgus monkey 

toxicology studies. Food. Chem. Toxicol. 44, 528-537. 

Butenhoff, J., Costa, G., Elcombe, C., Farrar, D., Hansen, K., 

Iwai, H., Jung, R., Kennedy, G., Jr., Lieder, P., Olsen, G., 

Thomford, P. (2002) Toxicity of ammonium perfluorooctanoate in 

male cynomolgus monkeys after oral dosing for 6 months. 

Toxicol. Sci. 69:244-257. 

Butenhoff, J.L., Gaylor, D.W., Moore, J.A., Olsen, G.W., 

Rodricks, J., Mandel, J.H., Zobel, L.R. (2004 ) 

Characterization of risk for general population exposure to 

perfluorooctanoate. Reg. Toxicol. Pharmacol., 39:363-380. 

Calafat, AM., Kuklenyik, Z., Reidy, J. A, Caudill, S. P., 
Tully, J. S., Needham, L. L. (2007a) Serum concentrations of 11 

polyfluoroalkyl compounds in the U.S. population: data from the 

national health and nutrition examination survey (NHANES). 

Environ. Sci. Technol. 41, 22372242. 

Calafat, A.M., Wong, L-Y., Kuklenyik, Z., Reidy, J.A., Needham, 

L.L. (2007b) Polyfluoroalkyl Chemicals in the U.S. Population: 

Data from the National Health and Nutrition Examination Survey 

(NHANES) 2003-2004 and Comparisons with NHANES 1999-2000, Env. 

Health Persp. 115:1596-1602. 

Emmett, E. A., Shofer, F. S., Zhang, H., Freeman, D., Desai, 

C., Shaw, L. M. (2006a) Community exposure to 

perfluorooctanoate: relationships between serum concentrations 

and exposure sources. J .Occup. Environ. Med. 48:759-770. 

Emmett, E. A., Zhang, H., Shofer, F. S., Freeman, D., Rodway, 

N. V., Desai, C., Shaw, L. M. (2006b) Community exposure to 

perfluorooctanoate: relationships between serum levels and 

certain health parameters. J Occup Environ Med 48:771-779. 

EPA (2002), "Hepatocellular Hypertrophy." Health Effects 

Division Guidance Document # G2002.01, October 21, 2002. 

Holzer, J., Midasch, O., Rauchfuss, K., Kraft, M., Reupert, R., 

Angerer, J., Kleeschulte, P., Marschall, N., Wilhelm, M. (2008) 

Biomonitoring of Perfluorinated Compounds in Children and 

Adults Exposed to Perfluorooctanoate-Contaminated Drinking 

Water, Env. Health Persp. 116:651-657. 

Olsen, G. W., Church, T. R, Miller, J. P., Burris, l M., 

Hansen, K. J., Lundberg, J. K., Armitage, J. B., Herron, R. M., 

Medhdizadehkashi, Z., Nobiletti, J. B., O'Neill, E. M., Mandel, 

J. H., Zobel, L. R (2003) Perfluorooctanesulfonate and other 

fluorochemicals in the serum of American Red Cross adult blood 

donors. Environ. Health Perspect. 111, 1892-1901. 
Olsen, G.W., Church, T.R, Hansen, K.J., Burris, lM., Butenhoff, 

J.L., Mandel, J.H., and Zobel, L.R (2004a) Quantitative 

evaluation ofperfluorooctanesulfonate (PFOS) and other 

fluorochemicals in the serum of children," Journal of 

Childrens Health 2:53-76. 

Olsen, G.W., Church, T.R., Larson, E.B., van Belle, G., 

Lundberg, lK., Hansen, K.J., Burris, lM., Mandel, J.H., and 

Zobel, L.R. (2004b) Serum concentrations 

ofperfluorooctanesulfonate and other fluorochemicals in an 

elderly population from Seattle, Washington, Chemosphere 

54:1599-1611. 

Olsen, G. W., Mair, D. C., Reagen, W. K., Ellefson, M. E., 

Ehresman, D. l, Butenhoff, J. L., Zobel, L. R (2007) 

Preliminary evidence of a decline in perfluorooctanesulfonate 

(PFOS) and perfluorooctanoate (PFOA) concentrations in American 

Red Cross blood donors. Chemosphere 68, 105-111. 

York, R.G. (2002). Oral (gavage) two-generation (one litter per 

generation) reproduction study of ammonium perfluorooctanoate 

(APFO) in rats. Argus Research Laboratories, Inc. 

CS Title: 0123 

Company/group/association name: 

Comment: 

May 21,2008 

Via E-Mail 

Water Docket 

U.S. Environmental Protection Agency 

Mail Code 2822T 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460 

Re: Docket No. EPA-HQ-OW-2007-1189 -- Drinking Water 
Contaminant Candidate List 3-Draft; 73 Fed. Reg. 9628 (Feb. 21, 

2008) 

Dear Sir/Madam: 

The Ethylene Oxide/Ethylene Glycols Panel (Panel) of the 

American Chemistry Council submits these comments on the U.S. 

Environmental Protection Agency's (EPA) February 21, 2008, 

Federal Register notice on the draft third Contaminant 

Candidate List (CCL 3) under the Safe Drinking Water Act 

(SDWA). The Panel is comprised of companies that manufacture 

most of the ethylene oxide (EO) produced in the United States 

or use large amounts of EO, as well as the major domestic 

producers of ethylene glycol (EG). Because EO and EG are two of 

the chemical contaminants included on the draft CCL 3, the 

Panel has a strong interest in the list and the approach that 

EPA used to develop it. 

As discussed in the appended comments, the Panel urges EPA not 

to include EO and EG on the final CCL 3 for the following 

reasons: 

* EO should be removed from the final CCL 3 because: 

~ EPA must rely on the most relevant data for EO; 

~ EPA did not use the most relevant data in scoring EO's health 

effects; 

~ EPA erred in defining EO's potential to occur in drinking 

water based on total environmental releases rather than on 

surface water releases; and 

~ Inasmuch as EPA has not made its three models publicly 

available, the Panel has been deprived not only of an 

opportunity to verify the model results but also of an_adequate 
opportunity to comment on the models. 

* EG should not have moved from the Universe to the Preliminary 

CCL (PCCL) because: 

~ EPA should have categorized EG in Toxicity Category 5; 

~ EG is not known to occur in drinking water; and 

~ EPA erroneously used total environmental releases as the data 

element for characterizing EG's potential to occur in drinking 

water. 

* Even assuming EG's movement from the Universe to the PCCL was 

not erroneous, which it was, EG does not belong on the final 

CCL 3, or at the very least EPA must reconfigure and rerun its 

algorithms and models so that they are based on the level of 

EG's surface water releases, not the total environmental 

releases. 

~ EPA erred in defining EG's potential to occur in drinking 

water based on total environmental releases rather than on 

surface water releases, which are the most relevant data for 

characterizing potential drinking water occurrence; and 

~ Because EPA has not made its three models publicly available, 

the Panel has been deprived not only of an opportunity to 

verify the model results but also of an adequate opportunity to 

comment on the models. 

The Panel appreciates the opportunity to submit these comments. 

For the reasons noted above, the Panel urges EPA not to include 

EO and EG on the final CCL 3. 

If you have any questions, please contact me, at (703) 741-5607 
or via e-mail at Sarah_McLallen@americanchemistry.com. 

Sincerely, 

Sarah McLallen 

Manager, EO and EG Panels 

Attachment [See PDF for Attachment] 

BEFORE THE U.S. ENVIRONMENTAL PROTECTION AGENCY COMMENTS OF THE 

ETHYLENE OXIDE/ETHYLENE GLYCOLS PANEL OF THE AMERICAN CHEMISTRY 

COUNCIL ON DRINKING WATER CONTAMINANT CANDIDATE LIST 3-DRAFT 

Drinking Water Contaminant 

Candidate List 3-Draft 

73 Fed. Reg. 9628 (Feb. 21, 2008) 

Docket No. EPA-HQ-OW-2007-1189 

Sarah C.L. McLallen 

Manager, Ethylene Oxide/Ethylene Glycols Panel 

Theodore R. Waugh, Esquire 

Assistant General Counsel 

Of Counsel: 

Lynn L. Bergeson, Esquire 

Ira Dassa, Esquire 

Bergeson & Campbell, P.C. 

1203 Nineteenth Street, N.W. 

Suite 300 

Washington, D.C. 20036-2401 
AMERICAN CHEMISTRY COUNCIL 

1300 Wilson Boulevard 

Arlington, VA 22209 

May 21, 2008 

EXECUTIVE SUMMARY 

The Ethylene Oxide/Ethylene Glycols Panel (Panel) of the 

American Chemistry Council submits these comments on the U.S. 

Environmental Protection Agency's (EPA) February 21, 2008, 

Federal Register notice on the draft third Contaminant 

Candidate List (CCL 3) under the Safe Drinking Water Act 

(SDWA). The Panel is comprised of companies that manufacture 

most of the ethylene oxide (EO) produced in the United States 

or use large amounts of EO, as well as the major domestic 

producers of ethylene glycol (EG). Because EO and EG are two of 

the chemical contaminants included on the draft CCL 3, the 

Panel has a strong interest in the list and the approach that 

EPA used to develop it. 

The Panel urges EPA not to include EO and EG on the final CCL 3 

for the following reasons: 

* EO should be removed from the final CCL 3 because: 

~ EPA must rely on the most relevant data for EO; 

~ EPA did not use the most relevant data in scoring EO's health 

effects; 

~ EPA erred in defining EO's potential to occur in drinking 

water based on total environmental releases rather than on 

surface water releases; and 
~ Inasmuch as EPA has not made its three models publicly 

available, the Panel has been deprived not only of an 

opportunity to verify the model results but also of an adequate 

opportunity to comment on the models. 

* EG should not have moved from the Universe to the Preliminary 

CCL (PCCL) because: 

~ EPA should have categorized EG in Toxicity Category 5; 

~ EG is not known to occur in drinking water; and 

~ EPA erroneously used total environmental releases as the data 

element for characterizing EG's potential to occur in drinking 

water. 

* Even assuming EG's movement from the Universe to the PCCL was 

not erroneous, which it was, EG does not belong on the final 

CCL 3, or at the very least EPA must reconfigure and rerun its 

algorithms and models so that they are based on the level of 

EG's surface water releases, not the total environmental 

releases. 

~ EPA erred in defining EG's potential to occur in drinking 

water based on total environmental releases rather than on 

surface water releases, which are the most relevant data for 

characterizing potential drinking water occurrence; and 

~ Because EPA has not made its three models publicly available, 

the Panel has been deprived not only of an opportunity to 

verify the model results but also of an adequate opportunity to 

comment on the models. 

TABLE OF CONTENTS 
EXECUTIVE SUMMARY.....i 

TABLE OF CONTENTS.....iii 

INTRODUCTION.....1 

I. EO SHOULD NOT BE INCLUDED ON THE FINAL CCL 3.....2 

A. EO Should Be Removed from the Final CCL 3.....3 

1. EPA Must Rely on the Most Relevant Data for EO.....3 

2. EPA Did Not Use the Most Relevant Data in Scoring EO's 

Health Effects.....3 

3. EPA Erred in Defining EO's Potential to Occur in Drinking 

Water Based on Total Environmental Releases Rather Than on 

Surface Water Releases.....7 

a. EO Is Not Known to Occur in Drinking Water.....7 

b. EO Is a Gas That Easily Evaporates.....7 

c. EPA Should Define EO's Potential to Occur in Drinking Water 

Based on Surface Water Release Data, Which Are the Most 

Relevant Data for Characterizing Potential Drinking Water 

Occurrence.....10 

4. Inasmuch As EPA Has Not Made Its Three Models Publicly 

Available, the Panel Has Been Deprived Not Only of an 

Opportunity to Verify the Model Results But Also of an Adequate 

Opportunity to Comment on the Models.....11 
II. EG SHOULD NOT BE INCLUDED ON THE FINAL CCL 3.....12 

A. EG Should Not Have Moved from the Universe to the 

PCCL.....12 

1. EPA Should Have Categorized EG in Toxicity Category 5.....12 

2. EG Is Not Known to Occur in Drinking Water.....14 

3. EPA Erroneously Used Total Environmental Releases As the 

Data Element for Characterizing EG's Potential to Occur in 

Drinking Water.....14 

B. Even Assuming EG's Movement from the Universe to the PCCL 

Was Not Erroneous, Which It Was, EG Does Not Belong on the 

Final CCL 3, or at the Very Least EPA Must Reconfigure and 

Rerun Its Algorithms and Models So That They Are Based on the 

Level of EG's Surface Water Releases, Not the Total 

Environmental Releases.....16 

1. EPA Erred in Defining EG's Potential to Occur in Drinking 

Water Based on Total Environmental Releases Rather Than on 

Surface Water Releases, Which Are the Most Relevant Data for 

Characterizing Potential Drinking Water Occurrence.....16 

2. Because EPA Has Not Made Its Three Models Publicly 

Available, the Panel Has Been Deprived Not Only of an 

Opportunity to Verify the Model Results But Also of an Adequate 

Opportunity to Comment on the Models.....17 

CONCLUSION.....18 

INTRODUCTION 
The Ethylene Oxide/Ethylene Glycols Panel (Panel) of the 

American Chemistry Council submits these comments on the U.S. 

Environmental Protection Agency's (EPA) February 21, 2008, 

Federal Register notice on the draft third Contaminant 

Candidate List (CCL 3) under the Safe Drinking Water Act 

(SDWA).[FN1: 73 Fed. Reg. 9628 (Feb. 21, 2008).] The Panel is 

comprised of companies that manufacture most of the ethylene 

oxide (EO) produced in the United States or use large amounts 

of EO, as well as the major domestic producers of ethylene 

glycol (EG).[FN2: Panel member companies include: ARC; BASF 

Corporation; Bayer Corporation; Celanese Chemicals, on behalf 

of itself and Old World Industries; The Dow Chemical Company; 

Eastman Chemical Company; Equistar Chemicals LP; Honeywell; 

Huntsman Corporation; Sasol North America Inc.; Shell Chemical 

LP; and Sunoco, Inc.] Because EO and EG are two of the chemical 

contaminants included on the draft CCL 3, the Panel has a 

strong interest in the list and the approach that EPA used to 

develop it. 

Under Section 1412(b)(1)(B) of the SDWA, as amended, EPA is 

required to publish every five years "a list of contaminants 

which, at the time of publication, are not subject to any 

proposed or promulgated national primary drinking water 

regulation, which are known or anticipated to occur in public 

water systems, and which may require regulation under [the 

SDWA]."[FN3: 42 U.S.C. § 300g-1(b)(1)(B)(i)(I). For a 

contaminant to be regulated under the SDWA, EPA must make three 

findings: (1) the contaminant may have an adverse effect on the 

health of persons; (2) the contaminant is known to occur or 

there is a substantial likelihood that the contaminant will 

occur in public water systems with a frequency and at levels of 

public health concern; and (3) regulation presents a meaningful 

opportunity for health risk reduction for persons served by 

public water systems. Id. § 300g1( b)(1)(A)(i)-(iii).] Congress 

made it clear that in selecting unregulated contaminants for 

this list, known as the CCL, EPA must "consider the [National 

Contaminant Occurrence Database (NCOD)] established under 

section [1445(g) of the SDWA]"[FN4: Id. § 300g-1(b)(1)(B)(i) 

(I).] and "select contaminants that present the greatest public 

health concern."[FN5: Id. § 300g-1(b)(1)(C).] Inclusion of a 

contaminant on the CCL means that the contaminant, at a later 
date, may become subject to an EPA determination to 

regulate.[FN6: Id. §§ 300g-1(b)(1)(B)(ii), (E).] Once listed, 

there is no procedure set forth in the SDWA, short of a 

determination not to regulate, for a contaminant's removal from 

the particular CCL on which it appears.[FN7: See 70 Fed. Reg. 

9071, 9073 (Feb. 24, 2005) (a determination not to regulate a 

particular contaminant serves to "remove that contaminant from 

the CCL"); but see 63 Fed. Reg. 10273, 10275 (Mar. 2, 1998) 

(stating that EPA is "not precluded from modifying the CCL 

prior to the due date of the next CCL").] 

I. EO SHOULD NOT BE INCLUDED ON THE FINAL CCL 3 

For the reasons discussed more fully below, EO should not be 

included on the final CCL 3, and the Panel urges EPA to remove 

it from the list. 

A. EO Should Be Removed from the Final CCL 3 

1. EPA Must Rely on the Most Relevant Data for EO 

In the classification step through which the 532 Preliminary 

CCL (PCCL) chemical contaminants were further evaluated, 

modeled, and narrowed to the draft CCL 3 on which EPA seeks 

comment, EPA stated that it sought to ensure, inter alia, a 

"meaningful basis for classification" as well as the 

"incorporati[on] [of] relevant data."[FN8: EPA, Contaminant 

Candidate List 3 Chemicals: Classification of the PCCL to CCL, 

at 2 (Feb. 2008 Draft), available at EPA-HQ-OW-2007-1189-0046.] 

EPA stated that "[t]he classification process ... must consider 

the potential for occurrence in water," and "[t]he most 

relevant data used for the classification process include 

health effects data that are appropriate for drinking water 

exposures, and occurrence data that indicate the nature and 

spatial extent of potential occurrence in drinking water."[FN9: 

Id. In implementing Section 1412 of the SDWA, EPA is required 

to use "the best available, peer-reviewed science and 

supporting studies conducted in accordance with sound and 

objective scientific practices." 42 U.S.C. § 300g-1(b)(3)(A).] 
2. EPA Did Not Use the Most Relevant Data in Scoring EO's 

Health Effects 

EPA used the attributes of "potency" and "severity" to evaluate 

health effects of the chemicals it reviewed.[FN10: 

Classification of the PCCL to CCL at 5.] EPA gave EO a score of 

6 for potency and 8 for severity; EPA stated that the key 

health effects data element upon which it relied for this 

scoring was the California Office of Environmental Health 

Hazard Assessment's (OEHHA) oral slope factor of 0.31 mg/kg- 

day-1.[FN11: See EPA, Contaminant Information Sheets for the 

Draft CCL 3 Chemicals, at 85 (Feb. 2008 Draft) (Information 

Sheets), available at EPA-HQ-OW-2007-1189-0042.] 

The most recent OEHHA Toxicity Criteria Database indicates that 

the oral slope factor for EO is identical to the inhalation 

slope factor for EO.[FN12: See OEHHA, "OEHHA Toxicity Criteria 

Database," at 2 (Jan. 25, 2008), available at 

http://www.oehha.ca.gov/risk/pdf/TCDB012508cas.pdf.] This 

single unit risk number is based on an analysis conducted by 

EPA in 1985, which was reevaluated by OEHHA in 1987 as part of 

California's Toxic Air Contaminant (TAC) Program.[FN13: See 

OEHHA, Toxic Air Contaminant Report for Ethylene Oxide, Part B 

- Health Effects of Ethylene Oxide, at 60-64 (revised Aug. 31, 

1987), available at 

http://www.arb.ca.gov/toxics/id/summary/ethylenoxideb.pdf; 

OEHHA, Air Toxics Hot Spots Program Risk Assessment Guidelines, 

Technical Support Document for Describing Available Cancer 

Potency Factors, at 293, 303-304 (Dec. 2002) (OEHHA Cancer 

Potency Factors), available at 

http://www.oehha.ca.gov/air/hot_spots/pdf/TSDNov2002.pdf.] This 

slope factor is based on excess mononuclear cell leukemias 

(MCL) observed by Snellings, et al. in female F344 rats exposed 

to EO by inhalation.[FN14: Snellings, W., Weil, C., and 

Maronpot, R. (1984). A two-year inhalation study of the 

carcinogenic potential of ethylene oxide in Fischer 344 rats. 

Toxicol. Appl. Pharm. 75:105-117.] 

More recent evaluations by EPA's Office of Research and 
Development (ORD)[FN15: EPA, Evaluation of the Carcinogenicity 

of Ethylene Oxide (Aug. 2006 External Review Draft), available 

at 

http://cfpub.epa.gov/ncea/cfm/iris/recordisplay.cfm?deid=157664 

.] and by Health Canada[FN16: Health Canada, Canadian 

Environmental Protection Act, 1999, Priority Substances List 

Assessment Report, Ethylene Oxide (2001), available at 

http://www.ec.gc.ca/substances/ese/eng/psap/final/ethyleneoxide 

.cfm.] of the unit risk for the various tumors induced in 

animal bioassays with EO have confirmed that the highest unit 

risk is associated with excess MCL tumors reported by 

Snellings, et al. in female rats. As part of the development of 

the Reregistration Eligibility Decision for EO, EPA's Office of 

Prevention, Pesticides, and Toxic Substances (OPPTS) prepared a 

summary of the unit risk numbers for all of the tumors from 

animal bioassays that have been derived by ORD and Health 

Canada.[FN17: EPA, "Ethylene Oxide (ETO): Selection of Interim 

Unit Risk Estimates in Rodents; PC Code 042301, DP Barcode: 

D316656" (May 15, 2007) (EO Unit Risk Memorandum), available at 

EPA-HQ-OPP-2005-0203-0098.] 

Although the MCL tumors in female rats yield the largest unit 

risk estimates, OPPTS concluded that it would not be 

appropriate to utilize numbers for these tumors because "this 

tumor type is unique to F344 rats and does not have a human 

counterpart. Additionally, the cell of origin is not known, nor 

is it known if the tumor is hematopoietic in origin. MCL in 

F344 rats arise spontaneously, primarily in older 

animals."[FN18: Id. at 3.] This conclusion by OPPTS is 

consistent with a broad range of scientific opinion that such 

tumors have dubious relevance to humans.[FN19: Swaen, G.J.W. 

and P. Van Heerde (1987). Tumors of the hematopoeitic system. 

In Pathology of tumors in laboratory animals. Vol 1. Tumors of 

the Rats (Ed., Turusov VS). Lyon, France: International Agency 

for Research on Cancer; Stefanski, S.A., M.R. Elwell, P.C. 

Stronmberg (1990). Spleen, lymph nodes, and thymus. In: 

Pathology of the Fischer rat. (Ed: Boorman G.A., et al.). San 

Diego, CA: Academic Press; Ward, J.M., S. Rehm, C.W. Reynolds 

(1990). Pathology of tumors in laboratory animals. Tumors of 

the rat. Tumors of the haematopoietic system. IARC Sci Pub. 

125-57; Caldwell, D.J. (1999). Review of mononuclear cell 

leukemia in F-344 rat bioassays and its significance to human 

cancer risk: A case study using alkyl phthalates. Reg. Toxicol. 
Pharmacol. 30:45-53; Walker, V.E., K.Y. Wu, P.B. Upton, A. 

Ranasinghe, N. Scheller, M.H. Cho, J.S. Vergnes, T.R. Skopek, 

J.A. Swenberg (2000). Biomarkers of exposure and effect as 

indicators of potential carcinogenic risk arising from in vivo 

metabolism of ethylene to ethylene oxide. Carcinogenesis 

21(9):1661-1669.] 

Instead of using the MCL tumors, OPPTS concluded that the most 

appropriate tumor types to use to estimate human risk based on 

the available animal bioassays are the lung adenomas/carcinomas 

observed in male B6C3F1 mice and brain tumors in male F344 

rats.[FN20: EO Unit Risk Memorandum at 3.] In the older 

analysis from 1987, the California Department of Health 

Services discussed these other tumor types,[FN21: OEHHA Cancer 

Potency Factors at 299, 301.] but elected instead to use "data 

from the most sensitive sex, site and species, the female rat 

mononuclear cell leukemia."[FN22: Id. at 303.] Nevertheless, it 

is not scientifically defensible for EPA to disregard the broad 

scientific consensus that has emerged in subsequent years that 

MCL tumors in the F344 rat are not relevant to humans. 

The Panel recognizes that EPA may have selected the OEHHA oral 

slope factor for EPA's CCL 3 analysis because it purports to be 

an oral unit risk factor and because it is also expressed in 

units that are appropriate for potential oral consumption. 

Nevertheless, this number is based on the same inhalation 

bioassays as the subsequent assessments by ORD, Health Canada, 

and OPPTS. EPA cannot justify use of an earlier assessment 

based on the same data that no longer reflects the best 

available science. For the current CCL 3 analysis, EPA should 

use the unit risk numbers that have been derived by ORD for the 

lung adenomas/carcinomas observed in male B6C3F1 mice and brain 

tumors in male F344 rats, after correcting these numbers to a 

slope factor that is appropriate for an oral route of 

administration. 

3. EPA Erred in Defining EO's Potential to Occur in Drinking 

Water Based on Total Environmental Releases Rather Than on 

Surface Water Releases 
a. EO Is Not Known to Occur in Drinking Water 

EPA utilized the occurrence attributes of "prevalence" and 

"magnitude" to define EO's actual or potential occurrence in 

drinking water.[FN23: Classification of the PCCL to CCL at 18.] 

Importantly, however, EO is not known to occur in drinking 

water, and indeed, neither the NCOD that EPA is required to 

consider in its development of the CCL, nor any other source of 

finished water or ambient water occurrence data, reflects any 

detections of EO.[FN24: See Information Sheets at 86 (showing 

no entries under Finished Water Occurrence Data or Ambient 

Water Occurrence Data).] 

b. EO Is a Gas That Easily Evaporates 

EPA relied on the "prevalence" and "magnitude" attributes as 

the basis for evaluating EO's potential to occur in public 

water systems, with magnitude corresponding to the total on- 

and off-site disposal or other releases of EO (i.e., 374,110 

pounds) reported under the Toxics Release Inventory (TRI) for 

2004, and prevalence corresponding to the number of states (38) 

with releases.[FN25: Id; see also 73 Fed. Reg. at 9637, 9640.] 

Reliance on TRI release data without considering EO's physical 

properties and environmental fate has led, however, to the 

erroneous conclusion that EO might occur in drinking water. 

EPA stated in drafting the previous CCL (i.e., CCL 2) that "[a] 

contaminant was considered to have the potential to occur [in 

drinking water] if, using the TRI, the release to surface water 

was in excess of 400,000 pounds per year and the physical- 

chemical properties indicated persistence and mobility of the 

contaminant."[FN26: 69 Fed. Reg. 17406, 17409 (Apr. 2, 2004) 

(emphasis added).] For some contaminants, then, physical- 

chemical properties played a distinct role in the CCL 2 

process. In the CCL 3 process, EPA considered physical and 

chemical properties, but only in those cases where production 

data under the Toxic Substances Control Act Chemical Update 

System/Inventory Update Rule constituted the sole measure of 

occurrence.[FN27: See 73 Fed. Reg. at 9640-41. In those 

instances, EPA used "persistence-mobility" as a surrogate 
measure for magnitude.] EPA should also consider the physical 

and chemical properties of those substances for which TRI 

release data served as the basis for occurrence attribute 

scoring, particularly given that the expert panel convened by 

EPA to provide input on EPA's approach to the draft CCL 3 

stated that "[TRI] release data, as well as the physical 

properties of each chemical, especially gases, should be 

analyzed to determine if model results would change if surface 

water release information was used instead of total release 

data."[FN28: EPA, Chemical Expert Input and Review for the 

Third Contaminant Candidate List, at 8 (emphasis added) (Feb. 

2008 Draft), available at EPA-HQ-OW-2007-1189-0038.] 

In contravention of its intent to incorporate "[t]he most 

relevant data" and in spite of the expert panel's 

recommendation, EPA inexplicably did not account for EO's well- 

known physical properties. Not only is EO a gas, it is one that 

"evaporates very easily."[FN29: Agency for Toxic Substances and 

Disease Registry, Toxicological Profile for Ethylene Oxide (EO 

Toxicological Profile), at 2 (Dec. 1990), available at 

http://www.atsdr.cdc.gov/toxprofiles/tp137.html; see also 

Ethylene Oxide Product Stewardship Guidance Manual, at 34 (May 

2007) ("Because of its volatility, EO has a tendency to 

evaporate from water or soil to the air.").] As the Agency for 

Toxic Substances and Disease Registry (ATSDR) has pointed out, 

"[a]lthough [EO] dissolves in water in any proportion, it ... 

has the tendency to escape (volatilize) due in part to its high 

vapor pressure. Conway et al. (1983) reported that about 95% of 

[EO] mixed with water volatilizes within 4 hours ...."[FN30: EO 

Toxicology Profile at 60; see also World Health Organization 

(WHO), Concise International Chemical Assessment Document 54 - 

Ethylene Oxide, at 8 (2003) (CICAD 54), available at 

http://www.who.int/ipcs/publications/cicad/en/cicad54.pdf.] 

ATSDR therefore states in the Public Health Statement portion 

of the EO Toxicological Profile that any EO released to water 

"will either break down or be destroyed ... within a few 

days."[FN31: EO Toxicology Profile at 2; see also Product 

Stewardship Guidance Manual at 35 ("EO will biodegrade in 

aerobic systems such as rivers [and] lakes").] 

Moreover, it is significant that of the total quantity of EO 

released to the environment in both 2005 and 2006, almost 88 
percent was in the form of fugitive and point source air 

emissions.[FN32: See TRI Explorer Chemical Reports for 2005 and 

2006, available at http://www.epa.gov/triexplorer/. In 2004, 

air releases of EO amounted to more than 89 percent of the 

total quantity released to the environment. See TRI Explorer 

Chemical Report for 2004.] As WHO states, "release of [EO] to 

the atmosphere is unlikely to result in transfer to other 

environmental compartments in significant quantities," and "[a] 

lthough water solubility suggests that washout from the 

atmosphere by precipitation could be important, volatilization 

from the water is too rapid to suggest this to be a significant 

fate process."[FN33: CICAD 54, at 7.] 

In sum, quantities of EO that are released to water volatilize, 

and quantities that are released to air, which are the vast 

majority of the total environmental releases, do not end up in 

drinking water. 

c. EPA Should Define EO's Potential to Occur in Drinking Water 

Based on Surface Water Release Data, Which Are the Most 

Relevant Data for Characterizing Potential Drinking Water 

Occurrence 

In view of EO's highly relevant physical properties, EPA should 

base its characterization of EO's potential to occur in 

drinking water not on the total quantity released to the 

environment, but rather on the total quantity released to 

surface water. The latter figure constitutes the "most relevant 

data [for indicating] the nature and spatial extent of 

potential occurrence in drinking water."[FN34: Classification 

of the PCCL to CCL at 2.] 

In 2004, the level of EO surface water releases was 4,761 

pounds encompassing only four states,[FN35: Information Sheets 

at 86.] and in 2006, the latest year for which TRI data are 

available, the figure was considerably lower, 1,010 

pounds.[FN36: See TRI Explorer Chemical Report for 2006, 

available at http://www.epa.gov/triexplorer/.] Moreover, as 

indicated above, quantities of EO that are released to water 

will either break down or be destroyed such that no EO should 
be present in drinking water. 

Thus, EO does not meet the statutory standard for CCL listing, 

as it is not known or anticipated to occur in public water 

systems, nor is there a substantial likelihood of it occurring 

in public water systems. 

4. Inasmuch As EPA Has Not Made Its Three Models Publicly 

Available, the Panel Has Been Deprived Not Only of an 

Opportunity to Verify the Model Results But Also of an Adequate 

Opportunity to Comment on the Models 

For the reasons explained above, EO should not be included on 

the CCL 3. In addition, EPA has not made publicly available, 

either in the regulatory docket or elsewhere, the three 

classification models that it used to select contaminants from 

the PCCL for the CCL. As a result, neither the Panel nor any 

other interested stakeholder is able either to verify the model 

results or to comment adequately on the models themselves. For 

this reason, EPA at the very least must reconfigure and rerun 

the models so that they are based on the most relevant data for 

EO - an appropriately determined oral slope factor, EO's 

physical-chemical properties, and the amount of surface water 

releases -- before making a determination on whether EO should 

be included on the final CCL 3. 

II. EG SHOULD NOT BE INCLUDED ON THE FINAL CCL 3 

For the reasons discussed more fully below, EG also should not 

be included on the final CCL 3, and the Panel urges EPA to 

remove it from the list as well. 

A. EG Should Not Have Moved from the Universe to the PCCL 

1. EPA Should Have Categorized EG in Toxicity Category 5 
During the screening step, EPA categorized EG in Toxicity 

Category (TC) 4, the second lowest of the five toxicity 

categories.[FN37: See EPA, Contaminant Candidate List 3 

Chemicals: Screening to a PCCL, at 29 (Feb. 2008 Draft), 

available at EPA-HQ-OW-2007-1189-0044.] EPA relied on the World 

Health Organization's (WHO) Tolerable Daily Intake (TDI) value 

of 0.05 mg/kg-day and partitioned this value into TC 4.[FN38: 

Id. at 7-8 (Exhibit 4), 29.] EPA, however, failed to 

acknowledge that the WHO's TDI value, which is derived from a 

study by Gaunt, et al. (1974) and is "based on a benchmark dose 

of 49 mg/kg body weight per day calculated for non-neoplastic 

renal effects in animals and an uncertainty factor of 1000," 

is, according to WHO, "uncertain, owing primarily to lack of 

information on progression of renal lesions in the most 

sensitive animal model."[FN39: WHO, Concise International 

Chemical Assessment Document 45 - Ethylene Glycol: Human Health 

Aspects, at 5 (2002), available at 

http://www.who.int/ipcs/publications/cicad/en/cicad45.pdf.] The 

Panel has presented and published over 20 studies in the last 

10 years on EG's mode of action. Table 1 (appended as 

Attachment 1) provides a listing of these research projects on 

metabolism and clearance with pharmacokinetic and 

pharmacodynamic data that support a reduction in uncertainty 

factors for purposes of EG risk assessment, and the appended 

technical comments (appended as Attachment 2) discuss in detail 

why the Gaunt study is unreliable. [See PDF for Attachments] 

Based on the Panel's studies, the appended technical comments, 

and WHO's self- acknowledged "uncertainty" concerning the TDI 

value, EG is properly categorized in TC 5. 

Moreover, EPA relied on the 0.05 mg/kg-day TDI value as a 

reference dose (RfD)-equivalent in the Universe-to-PCCL 

screening step, yet in the PCCL-to-CCL classification step, EPA 

relied on the Integrated Risk Information System (IRIS) oral 

RfD of 2 mg/kg-day.[FN40: See Information Sheets at 83. The 

IRIS oral RfD is based on the DePass, et al. (1986) study.] The 

basis for this divergence is not explained, and the Panel 

believes it is not supportable, particularly when, in the case 

of EG, it yields a perverse result. Inasmuch as the 

classification step involves "a more detailed evaluation of ... 

health effects" data,[FN41: 73 Fed. Reg. at 9631.] EPA should 

have relied on the IRIS oral RfD in the screening step as well. 

Exhibit 4 in the PCCL Screening Document reveals that an oral 
RfD of 2 mg/kg-day, which is greater than 0.1 mg/kg-day, puts 

EG in TC 5, not TC 4.[FN42: See PCCL Screening Document at 8.] 

2. EG Is Not Known to Occur in Drinking Water 

EG is not known to occur in drinking water, and indeed, neither 

the NCOD that EPA is required to consider in its development of 

the CCL, nor any other source of finished water or ambient 

water occurrence data, reflects any detections of EG in 

water.[FN43: See Information Sheets at 84 (showing no entries 

under Finished Water Occurrence Data or Ambient Water 

Occurrence Data).] 

3. EPA Erroneously Used Total Environmental Releases As the 

Data Element for Characterizing EG's Potential to Occur in 

Drinking Water 

In the penultimate stage of the Universe-to-PCCL screening 

process, EPA erroneously used the total environmental releases 

from the TRI for 2004 -- 10,076,483 pounds -- to define EG's 

potential to occur in drinking water.[FN44: Id. According to 

the TRI Explorer, total environmental releases of EG in 2004 

equaled 8,648,773 pounds, not 10,076,483 pounds. See TRI 

Explorer Chemical Report for 2004.] Particularly given the 

absence of any water detections of EG, EPA should have focused 

instead on the level of surface water releases of EG (i.e., 

576,990 pounds in 2004). 

EPA indicated that it "chose to use the pounds released per 

year into the environment for screening because the mass 

applied to the environment was more directly related to a 

potential concentration in water than the number of States 

where a chemical is released or applied."[FN45: 73 Fed. Reg. at 

9637; see also PCCL Screening Document at 14 ("EPA chose to use 

the data on the pounds per year released to the environment for 

screening rather than the number of states with releases.").] 

Nowhere, though, did EPA explain why the level of total 

environmental releases, or even the number of states with 

releases, is more directly related to a potential concentration 
in water than the level of surface water releases. Surface 

water release data, precisely because they are specific to 

waterbodies, are far more relevant to potential drinking water 

occurrence than total environmental release data, whether the 

latter is expressed in pounds per year or the number of states 

with releases. 

Proper reliance on surface water releases -- 576,990 pounds -- 

together with EG's proper toxicity categorization -- TC 5 -- 

means that EG, according to Exhibit 11 in the PCCL Screening 

Document, should stay in the Universe and should not move to 

the PCCL.[FN46: See PCCL Screening Document at 18. Even if EG 

falls into TC 4, which it does not, it remains in the Universe 

and does not move to the PCCL with a surface water release 

level of less than 1,000,000 pounds per year.] Furthermore, in 

the 2006 TRI, the level of EG surface water releases decreased 

by almost 15%, to 494,440 pounds. According to Exhibit 11, this 

level, too, should not result in EG moving from the Universe to 

the PCCL. 

Finally, should EPA nevertheless use total environmental 

releases rather than surface water releases for purposes of the 

screening step, EPA should consider the fact that according to 

the TRI Explorer, total environmental releases of EG in 2004 

equaled 8,648,773 pounds, not 10,076,483 pounds.[FN47: See TRI 

Explorer Chemical Report for 2004. Total environmental release 

levels for 2006 and 2005 were lower, equaling 7,543,760 and 

7,320,942 pounds, respectively. See TRI Explorer Chemical 

Reports for 2006 and 2005.] This level of releases places EG in 

the 1M - <10M occurrence column on Exhibit 11. As a TC 5 

chemical, EG falls into the shaded area on the exhibit, meaning 

that EG should stay in the Universe and should not move to the 

PCCL. 

B. Even Assuming EG's Movement from the Universe to the PCCL 

Was Not Erroneous, Which It Was, EG Does Not Belong on the 

Final CCL 3, or at the Very Least EPA Must Reconfigure and 

Rerun Its Algorithms and Models So That They Are Based on the 

Level of EG's Surface Water Releases, Not the Total 

Environmental Releases 
1. EPA Erred in Defining EG's Potential to Occur in Drinking 

Water Based on Total Environmental Releases Rather Than on 

Surface Water Releases, Which Are the Most Relevant Data for 

Characterizing Potential Drinking Water Occurrence 

EPA utilized the occurrence attributes of prevalence and 

magnitude to define EG's actual or potential occurrence in 

drinking water. As discussed above, there are no data showing 

that EG is known to occur in drinking water. The prevalence and 

magnitude attributes thus served as the basis for evaluating 

EG's potential to occur in public water systems, with magnitude 

corresponding to the total on- and off-site disposal or other 

releases of EG (i.e., 10,076,483 pounds) reported under the 

2004 TRI, and prevalence corresponding to the number of states 

(49) with releases.[FN48: Information Sheets at 84. As noted 

above, supra n.44, total environmental releases of EG in 2004 

actually equaled 8,648,773 pounds.] 

In contravention of its intent to incorporate "[t]he most 

relevant data" and in spite of the expert panel's 

recommendation, discussed in Section I.A.3.b above, that the 

physical properties of chemicals should be analyzed, EPA did 

not take into account that EG "degrades rapidly in all 

environmental media," including water and soil, and "does not 

bioaccumulate."[FN49: ATSDR, Draft Toxicological Profile for 

Ethylene Glycol, at 183 (Sept. 2007), available at 

http://www.atsdr.cdc.gov/toxprofiles/tp96.pdf.] Considering 

this and the fact that EG is not known to occur in drinking 

water, EPA should have based its characterization of EG's 

potential to occur not on the total quantity released to the 

environment, but rather on the total quantity released to 

surface water. This figure constitutes the "most relevant data 

[for indicating] the nature and spatial extent of potential 

occurrence in drinking water."[FN50: Classification of the PCCL 

to CCL at 2.] 

2. Because EPA Has Not Made Its Three Models Publicly 

Available, the Panel Has Been Deprived Not Only of an 

Opportunity to Verify the Model Results But Also of an Adequate 

Opportunity to Comment on the Models 
For the reasons explained above, EG should not be included on 

the CCL 3. In addition, EPA has not made publicly available, 

either in the regulatory docket or elsewhere, the three 

classification models that it used to select contaminants from 

the PCCL for the CCL. As a result, neither the Panel nor any 

other interested stakeholder is in a position either to verify 

the model results for EG or to comment adequately on the models 

themselves. For this reason, EPA at the very least must 

reconfigure and rerun the models so that they are based on the 

most relevant data for EG -- its physical-chemical properties 

and the amount of surface water releases -- before making a 

determination on whether EG should be included on the final CCL 

3. 

CONCLUSION 

The Panel appreciates the opportunity to submit these comments. 

For the reasons stated above, the Panel urges EPA not to 

include EO and EG on the final CCL 3. 

CS Title: 0126 

Company/group/association name: 

Comment: 

If a profiteer tells you there is nothing wrong with the water, 

you still have to investigate further since that is their money 

talking. The money and profits is what concerns them. They dont 

want to clean up anything they dont have to. And what they are 

getting away with is horrible. I believe dirty water filled 

with drugs is out there. I have seen many studies showing that 

so I think taxpayers who fund epa should have this agency do 

the job for them, not for money grubber profiteers. The whole 

couintry, our children, our parents, needs the safe practice o 

fnot polluting our water with drugs. We cannot focus on 

profiteers needing money. The level of protection needs to be 

higher, not lower. 

CS Title: 0127 

Company/group/association name: 

Comment: 
May 21, 2008 

Via E-Mail 

Water Docket 

U.S. Environmental Protection Agency 

Mail Code 2822T 

1200 Pennsylvania Avenue, N.W. 

Washington, D.C. 20460 

Re: Docket No. EPA-HQ-OW-2007-1189 -- Drinking Water 

Contaminant Candidate List 3-Draft; 73 Fed. Reg. 9628 (Feb. 21, 

2008) 

Dear Sir/Madam: 

The N-Methyl-2-Pyrrolidone Producers Group, Inc. (NMP Producers 

Group or Group) submits these comments on the U.S. 

Environmental Protection Agency's (EPA) February 21, 2008, 

Federal Register notice on the draft third Contaminant 

Candidate List (CCL 3) under the Safe Drinking Water Act 

(SDWA). The NMP Producers Group members include the domestic 

producers of NMP.[FN1: Members of the NMP Producers Group are: 

BASF Corporation, International Specialty Products, Inc., and 

LyondellBasell Industries.] Because NMP is one of the chemical 

contaminants included on the draft CCL 3, the Group has a 

strong interest in the list and the approach that EPA used to 

develop it. 

The Group urges EPA not to include NMP on the final CCL 3. 

Based on EPA's own criteria, NMP should not have moved from the 

universe of potential CCL candidates (Universe) to the 

Preliminary CCL (PCCL). Moreover, EPA did not use the best 

available data in scoring NMP's health effects. 
EPA Should Have Categorized NMP in Toxicity Category 5 and Not 

Moved NMP from the Universe to the PCCL 

EPA states that it used a "multi-step process, based on 

available data, to characterize occurrence and adverse health 

risks a contaminant may pose to consumers of public water 

systems for inclusion on the [CCL]."[FN2: EPA, Contaminant 

Candidate List 3 Chemicals: Screening to a PCCL, at 1 (Feb. 

2008 Draft), available at EPA-HQ-OW-2007-1189-0044 (Screening 

to a PCCL).] These steps included building a universe of 

potential drinking water contaminants for consideration 

(Universe), using "straightforward screening criteria" to 

narrow the Universe to the PCCL, and "using a structured 

classification approach (e.g., a classification model) as a 

tool, along with expert judgment, to develop a proposed CCL 

from the PCCL."[FN3: Id.] 

During the Universe-to-PCCL screening step, EPA partitioned 

chemicals into one of five toxicity categories (TC). EPA states 

that it "selected ranges of toxicity values for each toxicity 

category that differed based upon the type of data 

element."[FN4: 73 Fed. Reg. at 9636.] The data element types 

included reference doses (RfD) and their equivalents (e.g., 

tolerable daily intakes (TDI) from the World Health 

Organization (WHO)), no observed adverse effect levels, lowest 

observed adverse effect levels (LOAEL), maximum recommended 

daily doses, and lethal dose 50 (LD50) levels.[FN5: See 

Screening to a PCCL at 2-8 (showing how Exhibit 4 indicates 

"how the Universe dose-response data elements partition into 

their toxicity categories for screening").] 

During the Universe-to-PCCL screening step, EPA categorized NMP 

in TC 4, the second lowest of the five toxicity 

categories.[FN6: Id. at 3, 31.] EPA relied on a 120 milligrams 

per kilograms per day (mg/kg/day) LOAEL and partitioned this 

value into TC 4.[FN7: Id. at 7-8 (Exhibit 4), 31.] Based on 

this toxicity categorization and NMP's environmental release 

data, EPA moved NMP from the Universe to the PCCL.[FN8: Id. at 

18 (Exhibit 11).] 
Once on the PCCL, EPA undertook the PCCL-to-CCL classification 

step, in which it used the attributes of "potency" and 

"severity" to evaluate NMP's health effects.[FN9: EPA, 

Contaminant Candidate List 3 Chemicals: Classification of the 

PCCL to CCL, at 5 (Feb. 2008 Draft) (Classification of the PCCL 

to CCL), available at EPA-HQ-OW-2007-1189-0046.] In assessing 

NMP's health effects during this more detailed step, EPA relied 

not on the 120 mg/kg/day LOAEL, but on the WHO's TDI value of 

0.6 mg/kg-day.[FN10: EPA, Contaminant Information Sheets for 

the Draft CCL 3 Chemicals, at 135 (Feb. 2008 Draft) 

(Information Sheets), available at EPA-HQ-OW-2007-1189-0042.] 

NMP received a score of 3 for potency and 5 for severity based 

on the TDI value. In view of these scores and NMP's 

environmental release data, EPA selected NMP for inclusion on 

the draft CCL 3. 

EPA stated that the PCCL-to-CCL classification step involves "a 

more detailed evaluation of ... health effects" data. EPA 

further stated that during the classification step, EPA sought 

to ensure, inter alia, a "meaningful basis for classification" 

as well as the "incorporati[on] [of] relevant data."[FN11: 

Classification of the PCCL to CCL at 2.] There is no rational 

basis for EPA to rely upon the TDI during its more detailed 

evaluation, but not to rely upon that same value during the 

Universe-to-PCCL screening step. Given EPA's criteria for 

determining which chemicals move from the Universe to the PCCL, 

NMP should not have moved to the PCCL based on a 0.6 TDI -- 

which, as an RfD-equivalent value, falls within TC 5 -- in 

combination with its environmental release data.[FN12: See 

Screening to a PCCL at 8 (Exhibit 4), 18 (Exhibit 11).] 

EPA Must Be Transparent and Rely on the Best Available Data for 

NMP 

EPA's guidelines under the Information Quality Act (IQA)[FN13: 

Congress enacted the IQA to ensure the consistency and quality 

of information disseminated by federal agencies. The statute 

required the Office of Management and Budget (OMB) to develop 

federal government-wide guidelines that "provide policy and 

procedural guidance to Federal agencies for ensuring and 
maximizing the quality, objectivity, utility, and integrity of 

information (including statistical information) disseminated by 

Federal agencies," and called upon individual agencies to issue 

their own guidelines "ensuring and maximizing the quality, 

objectivity, utility, and integrity of information (including 

statistical information) disseminated by the agency." 44 U.S.C. 

§ 3516, note. OMB issued the final version of the government- 

wide IQA guidelines in early 2002, see 67 Fed. Reg. 8452 (Feb. 

22, 2002), and EPA issued its IQA guidelines later that year. 

See EPA, Guidelines for Ensuring and Maximizing the Quality, 

Objectivity, Utility, and Integrity, of Information 

Disseminated by the Environmental Protection Agency (Oct. 2002) 

(IQA Guidelines), available at 

http://www.epa.gov/quality/informationguidelines/documents/EPA_ 

InfoQualityGuidelines.pdf.] affirm that "EPA is dedicated to 

the collection, generation, and dissemination of high quality 

information."[FN14: IQA Guidelines at 10, 21.] 

Consistency with its IQA Guidelines requires EPA to ensure 

transparency and disclose fully all the data that it relies 

upon in making regulatory decisions, such as NMP's inclusion on 

the PCCL or draft CCL 3. Even though, for the reasons discussed 

above, EPA should not rely upon the 120 mg/kg/day LOAEL in 

determining whether NMP moves from the Universe to the PCCL, it 

is difficult for the Group to determine what study EPA relied 

upon in using a 120 mg/kg/day LOAEL for purposes of the 

Universe-to- PCCL screening step. A review of information made 

available publicly regarding the values upon which EPA relied 

during the CCL 3 process indicates that the 120 mg/kg/day LOAEL 

was derived from a National Technical Information Service 

(NTIS) document and that the critical effect was "endocrine -- 

changes in spleen weight."[FN15: Information Sheets at 135.] 

EPA does not reference the particular study, however, and it is 

unclear which study EPA is relying upon. The Group urges EPA to 

ensure transparency and clearly identify the study upon which 

EPA determined that NMP should move from the Universe to the 

PCCL. 

Moreover, EPA did not use the best available data in scoring 

NMP's health effects for purposes of the classification step. 

In implementing SDWA Section 1412, EPA is required to use "the 

best available, peer-reviewed science and supporting studies 
conducted in accordance with sound and objective scientific 

practices."[FN16: 42 U.S.C. § 300g-1(b)(3)(A).] EPA, acting as 

the Organization for Economic Cooperation and Development 

(OECD) sponsor country for NMP, presented NMP at the Screening 

Information Data Set (SIDS) Initial Assessment Meeting (SIAM) 

24 held in Paris, France in 2007. A copy of the most recent 

draft version SIDS Initial Assessment Report (SIAR) is 

appended. The studies identified as critical studies in the 

SIAR represent the best available data available for NMP and 

should be used by EPA in scoring NMP's health effects. 

The Group appreciates the opportunity to submit these comments. 

For the reasons discussed above, NMP should not be included on 

the final CCL 3. [ See PDF for attachment.] 

Sincerely, 

Patrick L. Gibson, Chair 

NMP Producers Group, Inc. 

Attachment 

cc: NMP Producers Group, Inc. (w/attachment) (via e-mail) 

CS Title: 0129 

Company/group/association name: 

Comment: 

May 21, 2008 

Via Electronic Submission 

Water Docket 

U.S. Environmental Protection Agency 

Mailcode: 2822T 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460 
Re: Comments on Drinking Water Contaminant Candidate List 3- 

Draft Docket ID No. EPA-HQ-OW-2007-1189; Chemical Abstract 

Services Registry Number (CASRN) 7440-62-2 

The Vanadium Producers and Reclaimers Association (VPRA) 

welcomes the opportunity to provide these comments concerning 

the U.S. Environmental Protection Agency's (EPA) draft 

Contaminant Candidate List (CCL 3),[FN1: 73 FED. REG. 9628 

(Feb. 21, 2008).] specifically with respect to the EPA's 

recommendations with respect to elemental vanadium (CASRN 

7440-62-2).[FN2: Id. at 9633, Exh. 2.] The VPRA is a not-for- 

profit corporation whose members are engaged in the production 

and reclamation of vanadium in the United States, primarily in 

the metals and materials manufacturing and chemical industries. 

The VPRA recommends that vanadium be removed from further 

consideration for CCL 3 listing under the Safe Drinking Water 

Act (SDWA) for the following reasons: EPA's health effects data 

show only minor effects that do not support listing elemental 

vanadium as a contaminant; EPA's occurrence data show elemental 

vanadium as present well below the levels identified by the 

MRL, RfD, and chronic LOAEL values that the EPA selected for 

analysis; and the data set on which EPA relies is weak and is 

not focused specifically on elemental vanadium-the substance 

EPA has listed in the draft CCL 3-thus undercutting the basis 

for listing. EPA's apparent assumption that the toxicity of 

vanadium compounds is due merely to their vanadium content is 

not supportable. As explained in VPRA's comments, available 

chemical, physical and toxicological data demonstrate that 

vanadium compounds differ significantly from one another. 

I. Summary of EPA's Findings for Vanadium 

To develop the draft CCL 3 that is the subject of this comment 

period, EPA initially evaluated a broad universe of 

approximately 7,500 potential chemical and microbial 

contaminants, and applied screening criteria to pare that 

universe down to 560 substances for further study (the 

"preliminary CCL", or PCCL).[FN3: See generally U.S. EPA Office 

of Water, Contaminant Candidate List 3 Chemicals: Screening to 
a PCCL (Draft), EPA 815-R-08-003 (Feb. 2008) (hereinafter "PCCL 

Screening Document").] EPA then selected 104 substances (93 

chemicals, including vanadium, and 13 microbials) from the PCCL 

to comprise this draft CCL 3 using a highly complex series of 

classification algorithms, explained in some detail.[FN4: 

Contaminant Candidate List 3 Chemicals: Classification of the 

PCCL to CCL, Office of Water 4607M, EPA 815-R-08-004, Feb. 

2008-Draft, www.eap.gpv/safewater (hereinafter "PCCL to CCL 

Screening Document").] 

EPA is proposing to designate vanadium as a Toxicity Category 3 

chemical, with Toxicity Category 1 being the category of most 

concern and Toxicity Category 5 being reserved for substances 

of low concern.[FN5: PCCL Screening Document, Appx. 22, at 35.] 

Toxicity Category 3 is also referenced in EPA background 

documents as the most common toxicity categorization, or the 

"central tendency grouping";[FN6: Contaminant Candidate List 3 

Chemicals: Screening to a PCCL, Office of Water (4607M), EPA 

815-R-08-003, Feb. 2008-Draft, at p. 3.] it is also the first 

EPA Category grouping in which any toxicological effects (no 

matter how small) are observed, and does not in itself serve as 

a basis alone to go forward with a CCL 3 listing. This 

designation appears to be based on the "attribute scores" that 

the EPA has assigned vanadium to evaluate its health effects 

and occurrence in drinking water.[FN7: See PCCL Screening 

Document, Vanadium Contaminant Information Sheet, p. 188 

("Attribute Scores" summary table at the top of the page).] 

EPA's proposed conclusions with respect to vanadium may be 

summarized as follows: 

[EPAs proposed conclusions with respect to vanadium may be summarized as follows:] 

* Low doses of vanadium are not of significant concern for adverse health effects. 

* The critical effects selected for vanadium for consideration 

are slight effects that are reversible or of minimal 

toxicological significance.[FN8: See PCCL to CCL Screening 

Document, Exh. A-3.] In this study, other parameters that were 

unaffected at all exposure levels include weight gain, organ 

weights, and liver function.[FN9: See, e.g., Agency for Toxic 

Substances and Disease Registry, Toxicological Profile for 

Vanadium and Compounds (July 1992) (hereinafter "ATSDR 1992 
Profile"). The toxicology profile is available at 

http://www.atsdr.cdc.gov/mrls/index.html.] 

* The occurrence ranking for vanadium implies that it has a 

relatively high prevalence, although the summary of the 

database findings that EPA provides in the public record does 

not appear to support such a determination.[FN10: PCCL 

Screening Document, Vanadium Contaminant Information Sheet, at 

188.] 

* EPA's prevalence ranking of "10" for vanadium (the highest 

prevalence factor possible) makes little sense given that 

elemental vanadium is virtually insoluble in water.[FN11: See, 

e.g., ATSDR 1992 Profile, at Table 3-2.] EPA's background 

information notes a water solubility for vanadium of 8,000 

mg/L.[FN12: PCCL Screening Document, Vanadium Contaminant 

Information Sheet, at 188.] This is not accurate. As explained 

further in Section III below, it is very unlikely for vanadium 

to be present in drinking water systems at a level that 

warrants listing on the CCL 3. 

* A distinct but corollary concept is EPA's proposed 

identification of vanadium as "assume persistent", based on 

uncited data that is not provided in the public record for a 

specific vanadium compound.[FN13: PCCL Screening Document, 

Vanadium Contaminant Information Sheet, at 188.] It is not 

appropriate for EPA to use relative persistence[FN14: See, 

e.g., 63 FED. REG. 53,417, 53,421 (Oct. 5, 1998) (one must also 

evaluate a substance's tendency to bioaccumulate). In this 

regard, a review of the relevant scientific literature tends to 

indicate that vanadium's bioavailability is very low, usually 

found to be less than 1% of an administered dose, and most 

ingested vanadium is excreted unabsorbed. See, e.g., Harris, 

W.R., Friedman, S.B., and Silberman, D. (1984) J. INORG. 

BIOCHEM. 20, 157-69; Patterson, B.W. et al. (1986) AM. J. 

PHYSIOL. 251, R325-32.] alone as a criterion for evaluating the 

environmental effects of a naturally occurring element such as 

vanadium. Also, in this regard, EPA's note "biodegrades 

sometimes" is confusing and inconsistent with EPA's proposed, 

unqualified finding of persistence. For these reasons, the VPRA 

requests that the reference be deleted. 
* EPA's complex classification algorithm process has resulted 

in a determination of "L?", indicating that the agency believes 

that vanadium is on the boundary of a decision to include or 

not include on the final CCL. In addition, the expert 

disagreement with the proposed "L?" decision favors not listing 

vanadium on the CCL 3.[FN15: PCCL to CCL Screening Document, 

Appx. F (Chemicals Reviewed by the EPA Evaluation Team: Summary 

of Results), at F-4.] 

II. The Health Effects Data Used Do Not Support the Proposed 

Listing for Elemental Vanadium. 

EPA chose to rely on the Agency for Toxic Substances and 

Disease Registry's (ATSDR's) Minimum Risk Level (MRL) of 0.003 

mg/kg/day rather than the RfD value of 0.007 mg/kg/day listed 

under the Health Effects Data for the Risk Assessment 

Information System (RAIS) database maintained by the Department 

of Energy. While EPA maintains that, in general, an MRL is 

"roughly equivalent to the RfD,"[FN16: Id.] this is not true 

for vanadium and EPA's modeling results. EPA's use of the MRL 

has a direct and overly conservative effect on the outcome of 

EPA's modeling, and has resulted in an inflated potency rating 

for vanadium.[FN17: Id. at Appx. A, Exh. A.1, and Potency 

Scoring Table, Exh. A-2] ATSDR states that "[i]t is important 

to note that MRLs are not intended to define clean up or action 

levels for ATSDR or other Agencies" (emphasis in 

original).[FN18: See Footnote 9, supra, available at 

http://www.atsdr.cdc.gov/mrls/.] EPA has not sufficiently 

articulated for the record why it used the MRL value instead of 

the RfD in this case. Because both of these values exist, the 

use of the MRL in this case fundamentally undermines the degree 

of confidence associated with the already borderline "L?" 

decision. 

A more serious flaw in EPA's use of the MRL is the 

inconsistency of the database noted for the health effects 

information. EPA lists the Registry of Toxic Effects of 

Chemical Substances (RTECS) Lowest Oral Chronic Effect Level 

(LOAEL) of 960 mg/kg/day, but this dataset is not considered in 
EPA's assessment.[FN19: See PCCL to CCL Screening Document, 

Vanadium Contaminant Information Sheet, at 187. The 

corresponding ATSDR toxicology profile is available at 

http://www.atsdr.cdc.gov/mrls/index.html. The corresponding 

RAISHE database can be viewed at http://rais.ornl.gov/.] The 

RTECS value for a LOAEL for chronic exposure indicates a very 

low toxicity and is not consistent with either the MRL or RfD 

values noted. Use of this alternative dataset would yield an 

RfD that would be markedly higher than the one EPA employs. 

Both the RfD and RTECS LOAEL are found in EPA's summary tables 

for vanadium.[FN20: PCCL Screening Document, Vanadium 

Contaminant Information Sheet, at 187.] Furthermore, the RTECS 

LOAEL is for chronic toxicity and is consistent with the EPA's 

assessments for drinking water. Use of the RTECS value also 

would result in a potency score for vanadium significantly 

ower than the value of "6" employed in the EPA's modeling 

approach.[FN21: See Footnote 17, supra.] 

Another basis to forego further consideration of elemental 

vanadium in this process is that none of the data relied upon 

by the EPA are studies on the health effects of elemental 

vanadium, which is the substance identified for proposed 

listing by CASRN 7440-62-2. EPA's apparent assumption that the 

toxicity of vanadium compounds is due merely to their vanadium 

content is not supportable. "The toxicity of vanadium depends 

on its physico-chemical state; particularly on its valence 

state and solubility."[FN22: Dennis M. Opresko, Ph.D., Toxicity 

Summary for Vanadium and Vanadium Compounds (Dec. 1991), at 1, 

available at http://risk.lsd.ornl.gov/rap_hp.shtml.] It is not 

scientifically sound to assess the risks of elemental vanadium 

by grouping all vanadium compounds together. 

The wide disparity of the data reflects the limitations in the 

dataset EPA used in its assessment. Examples of the data EPA 

has inappropriately used in this listing proposal include: 

* The study used to establish the critical health effect to be 

regulated is a study of sodium metavanadate that showed mild 

histological changes in a few tissues while other parameters 

measured (including weight gain, organ weights, and liver 

function) were unaffected at all doses tested. 
* Data on vanadium pentoxide were listed in the tables of EPA's 

draft background documents.[FN23: See PCCL Screening Document, 

Vanadium Pentoxide Contaminant Information Sheet, at 1057-58.] 

These data should not be used as the basis for the proposed 

listing for elemental vanadium; the Contaminant Information 

Sheets and other listings in the background tables related to 

vanadium pentoxide should be deleted, as this specific vanadium 

compound is not being proposed for listing. 

In addition, the reference to vanadium pentoxide as a teratogen 

is directly contradicted by the ATSDR toxicology profile. The 

ATSDR concluded under developmental effects that minor skeletal 

abnormalities (including supernumary ribs and delayed skeletal 

ossification) have been noted in the offspring of animals that 

have been injected with vanadium.[FN24: See ATSDR 1992 Profile, 

at 28.] Compounds causing only such minor effects are not 

classified as teratogens, and the ATSDR did not do so. 

Moreover, the ATSDR 1992 Profile clearly states the relevance 

of these findings is not known.[FN25: Id.] Furthermore, EPA's 

reliance on injection as the route of exposure is not 

appropriate for assessing potential effects from ingestion, and 

this exposure pathway is not appropriate for developmental 

studies. In particular, the reference to the University of 

Maryland's (UMD's) "Partial List of Acute Toxins" should be 

deleted because it is not for elemental vanadium, it does not 

specify a teratogenic effect, and it is not supported by the 

ATSDR assessment.[FN26: PCCL Screening Document, Vanadium 

Pentoxide Contaminant Information Sheet, at 1057.] 

The use of studies examining other compounds and inapplicable 

exposure pathways necessarily undercuts any reasonable basis 

for establishing the effects of elemental vanadium through oral 

ingestion of drinking water. Indeed, EPA has so indicated in 

its technical support documents to this rule.[FN27: See, e.g., 

PCCL to CCL Screening Document, at 2, n. 12 ("The most relevant 

data used for the classification process include health effects 

data that are appropriate for drinking water exposures, and 

occurrence data that indicate the nature and spatial extent of 

potential occurrence in drinking water.").] 
In summary, the health effects data used to propose this 

listing form an inadequate public record for listing elemental 

vanadium on the CCL 3. 

III. The Occurrence Data Used Do Not Support the Proposed 

Listing for Elemental Vanadium. 

EPA's assignment for vanadium of the highest prevalence factor 

("10") makes little sense given that, as the ATSDR 1992 Profile 

(on which EPA relies) indicates, elemental vanadium is 

virtually insoluble in water.[FN28: See ATSDR 1992 Profile at 

Table 3-2.] ATSDR's conclusion on this point is consistent with 

other scientific data sources,[FN29: See, e.g., CRC HANDBOOK OF 

CHEMISTRY AND PHYSICS, 37th Ed., at 618-19.] contradicts 

plainly EPA's uncited water solubility value of 8,000 

mg/L,[FN30: See PCCL Screening Document, Vanadium Contaminant 

Information Sheet, at 188.] and makes it exceedingly unlikely 

that vanadium could persist in drinking water systems at the 

levels suggested by the EPA Evaluation Team's documents. For 

these reasons the VPRA requests that EPA revise its prevalence 

factor findings to be consistent with the ATSDR 1992 Profile's 

data on solubility. 

Moreover, EPA fails to articulate its reasoning associated with 

the information presented in its summary of the NIRS data on 

vanadium.[FN31: Id.] The NIRS data represents relatively old 

(1985) monitoring results in which vanadium was detected; at 

that time, only 146 of the 989 public water systems (PWSs) were 

sampled. The median detection value of 7.3 μg/L indicates a low 

level of concern, well below the MRL and RfD values[FN32: The 

use of the median is consistent with EPA's statement that "[t] 

he median was selected [for use] over mean because it typically 

is a more stable estimate of central tendency in environmental 

occurrence data." PCCL to CCL Screening Document, at 20.] based 

on the VPRA's use of EPA's default assumptions for determining 

Drinking Water Level of Comparison (DWLOC) values.[FN33: See 

U.S. EPA Office of Pesticide Programs, Standard Operating 

Procedure (SOP) for Incorporating Screening-Level Estimates of 

Drinking Water Exposure into Aggregate Risk Assessments, Public 

Comment Draft (Sept. 1, 2000), at 10.] Using the median of 7.3 
μg/L from the NIRS reported data, the following exposure values 

were derived: 

Adult males: 7.3 μg/L (10-3 μg/mg(2 L/day) / 70 kg bw = 2.09 x 

10 -4 mg/kg bw/day 

Adult females: 7.3 μg/L (10-3 μg/mg(2 L/day) / 60 kg bw = 2.43 

x 10 -4 mg/kg bw/day 

Infants/children: 7.3 μg/L (10-3 μg/mg(2 L/day) / 10 kg bw = 

7.3 x 10 -4 mg/kg bw/day 

These results show potential exposures to be well below the no 

significant risk levels established by the MRL and RfD values 

based on the NIRS data. VPRA respectfully submits that 

additional considerations such as these are reasonable and 

appropriate in the case of substances such as elemental 

vanadium, that are naturally occurring and that are recognized 

as nutritionally important in the human diet.[FN34: Vanadium is 

a beneficial trace element that is unavoidably present at low 

levels (micrograms or less) in most plant and animal tissues. 

In rats, chicks and goats, a variety of inconsistent deficiency 

symptoms have been seen under conditions of synthetic diets 

with all vanadium excluded. Such signs include reduced growth, 

poor bone development, impaired reproductive capacity and, in 

chicks, poor feather development. See generally Nielsen, F.H. 

(1995) MET. IONS BIOL. SYST. 31, 543-73; Nechay, B.R. et al. 

(1986) FASEB J. 45, 123-132; Whitney, E.N., Cataldo, C.B., and 

Rolfes, S.R. (2002) Understanding normal and clinical 

nutrition, 6th ed., Wadsworth/Thomas Learning, Stamford, CT 

USA.] These data do not justify going forward with a listing 

for vanadium on the CCL 3, because they do not adequately 

establish that there is a substantial likelihood that vanadium 

occurs in public water systems with a frequency and at levels 

of public health concern. 

IV. Conclusion and Request for Relief 
In conclusion, VPRA is asking EPA to decide not to list 

elemental vanadium on the CCL 3 list. A CCL listing depends in 

no small measure, on having a high degree of confidence that 

the data relied upon for the listing (1) are clear and easily 

understood by the regulated community; (2) are generated from 

data on the chemical substance that is the subject of the 

listing; and (3) represent the same or similar exposure 

pathways as the pathway EPA seeks to eventually regulate. The 

weak data set underpinning EPA's proposed findings for 

elemental vanadium does not allow EPA to meet these elements. 

Vanadium at the levels of detection reported in the NIRS survey 

possesses a low risk for human health impacts. EPA's modeling 

conclusion squarely reflects the questionable nature of going 

forward with a listing. For these reasons, the record in this 

rulemaking has not sufficiently established the factual basis 

by which to determine that vanadium "may require regulation 

under [the SDWA]."[FN35: 42 U.S.C. § 300g-1(b)(1)(B)(i)(I).] 

* * * 

The VPRA appreciates this opportunity to provide its comments, 

and would be pleased to address any questions the EPA may have 

concerning these comments. Questions may be directed to John 

Hilbert, President of the VPRA, at (202) 842-0219. 

Respectfully submitted, 

John W. Hilbert III, President 

The Vanadium Producers and Reclaimers Association 

900 Second Street, N.E. 

Suite 201 

Washington, D.C. 20002 

Tel: (202) 842-3204 

Fax: (202) 842-0439 

Of Counsel: 

Martha E. Marrapese, Esq. 

Jason E. Yearout, Esq. 

Keller and Heckman LLP 
1001 G Street, N.W. 

Suite 500 West 

Washington, DC 20001 

CS Title: 0133 

Company/group/association name: 

Comment: 

21 May 2008 

Water Docket, Environmental Protection Agency 

Mail code: 2822T, 1200 Pennsylvania Ave., NW. 

Washington, DC 20460 

USA 

Subject: Comments on the US EPA Drinking Water Contaminant 

Candidate List 3 (CCL3) (Draft; Notice of February 21, 2008) 

Docket ID No.: EPA-HQ-OW-2007-1189 

Dear Sir or Madam: 

I am writing on behalf of the North American Metals Council 

("NAMC") to express the Council's views on the listing of 

molybdenum on EPA's Drinking Water Contaminant Candidate List 3 

(CCL3). NAMC is an unincorporated not-for-profit group of North 

American-based metals-producing and metals-using associations 

and companies.[FN1: A more complete description of NAMC can be 

found on its website at http://www.namc.org.] One of NAMC's 

prime objectives is to ensure that sound science is used in 

regulatory decision-making for metals. Toward that end, we wish 

to comment on the application to molybdenum of one of the 

criteria EPA uses for evaluating whether a chemical should be 

added to (or remain on) the Contaminant Candidate List, namely, 

the potential to cause adverse effects in humans. 

NAMC does not believe EPA has made use of all of the available 

scientific information in proposing to include molybdenum on 

CCL3. In particular, we note that the potency score for 

molybdenum was based on a reference dose (0.005 mg/kg/day) that 
was derived using data for increased uric acid levels from a 

study published by Koval'skiy et al. (1961) almost half a 

century ago and that EPA itself characterizes as having only a 

"medium" level of confidence. Other more recent (and better 

conducted) studies do not support the finding that molybdenum 

increases uric acid levels (Deosthale and Gopolan, 1974 and US 

EPA, 1979), even when ingested at higher dosage levels. That 

being the case, it is not appropriate to use 0.005 mg/kg/day as 

the reference dose to derive a human health effects potency 

score for molybdenum. 

The International Molybdenum Association (IMOA) has very 

recently conducted a thorough review of the available 

literature on molybdenum Repeated Dose Toxicity. The results of 

this review and an assessment of the need for additional data 

should be undertaken before a final decision regarding the 

inclusion of molybdenum on CCL3 is made. 

We thank you for this opportunity to submit comments on CCL3, 

and we would be prepared to discuss the issue further if that 

would be helpful. 

Yours sincerely, 

William J. Adams, Ph.D. 

Chairman, NAMC 

Kindly direct further correspondence to: 

William.adams@riotinto.com 

Tel: + 1 801 558 0222 

References: 

Koval'skiy, G.A. et al., 1961. Changes of purine metabolism in 

man and animals under conditions of molybdenum biogeochemical 

provinces. Zh. Obshch.Biol. 22: 179-191 
Deosthale, Y.G. and C. Gopalan. 1974. The effect of molybdenum 

levels in sorghum (Sorghum vulgare Pers.) on uric acid and 

copper excretion in man. Br. J. Nutr. 31: 351-355. 

U.S. EPA. 1979. Human health effects of molybdenum in drinking 

water. Cincinnati, OH. EPA-600A-79-006. 

CS Title: 0063 

Company/group/association name: 

Comment: 

The EPA online draft of the Contaminant Candidate List 3 gives 

a short description of each of the candidate contaminants. The 

description on perchlorates while not inaccurate gives the 

impression that the majority of the perchlorate contaminant in 

the United States is from manufacture for aerospace use. 

Research found the following interesting facts. Chilean nitrate 

has been imported into the United States since early 20th 

century. In 2001 the U.S. imported 88,150 metric tons of 

Chilean nitrate according to the Foreign Trade division, U.S. 

Census Bureau. Perchlorates make up 3.64% +/- 0.34 of Chilean 

Nitrates. That makes approximately 3,209 metric tons of 

perchlorates distributed on U.S. fields in one year by one 

product alone. This averages out to approximately 0.3 ounces 

per acre of every crop land acre of the U.S. or 1.36 pounds of 

pure perchlorate per acre since Chilean nitrates have been 

imported. This does not account for the other fertilizer 

components that contain perchlorates, the fact that the U.S. 

imports less Chilean nitrates in recent years than in the past, 

nor the fact that some fields would have much more and some 

less. The percentages of other fertilizer components that are 

also high in perchlorates include langbenite: 1.86%, dihydrogen 

ammonium phosphate: 0.46%, and potash (murate): 0.36%. It is 

recommended that EPA revise their description of perchlorates 

and not emphasize the manufacture of solid rocket propellant as 

heavily, and continue to search for true sources of this 

contaminant. Otherwise, perchlorates will continue to be a real 

threat to Americans by way of contaminated water and 

foodstuffs. 

CS Title: 0086 
Company/group/association name: 

Comment: 

USEPA Drinking Water Contaminant Candidate List and Regulatory 

Determinations 

Submitted by: Joseph Cotruvo, Joseph Cotruvo & Associates, LLC 

Richard Bull, MoBull Consulting 

James Crook, Reuse Consultant 

Margaret Whittaker, ToxServices, LLC 

We are providing the attached information and dossiers to the 

record of the CCL3 process for your consideration. These 

documents were prepared as part of the WateReuse Foundation's 

funded Project 06-004: Identifying Health Effects Concerns of 

the Water Reuse Industry and Prioritizing Research Needs for 

Nomination of Chemicals for Research to Appropriate Health 

Agencies . They were prepared by the research team that 

consisted of Joseph Cotruvo PI, Richard Bull, Margaret 

Whittaker and staff of ToxServices and James Crook. The 

comments and views detailed herein may not necessarily reflect 

the views of the WateReuse Foundation, its officers, directors, 

employees, affiliates, or agents. These draft documents and 

their concepts were reviewed by an invited interdisciplinary 

expert committee that met on April 22-23, 2008, and they will 

form the basis for expanded documents that will ultimately 

become the deliverables for the project. 

Although the title of the project refers to concerns of the 

water reuse industry, the information contained therein is 

relevant to public water supplies in general, and in 

particular, those whose source waters are recipients of treated 

upstream discharges, therefore these comments are highly 

pertinent to the CCL3 decision process. Some of them amply 

demonstrate the intimate linkage between wastewater treatment 

and upstream discharges, and the quality of treated drinking 

water as determined by the technologies that are employed. 

The information provided includes a compilation of water 
quality data associated with standard and advanced waste 

treatment processes and it identifies monitored chemicals that 

are either removed or not well removed by these unit processes. 

For example, the data demonstrate that membrane processes and 

particularly reverse osmosis remove virtually all organic (and 

inorganic) chemicals of potential concern to very low usually 

not detectable levels, (except e.g., low molecular weight 

nitrosamines derived from interactions between chloramines 

disinfectants and wastewater components, for which, if present, 

other technologies are required). They demonstrate that well 

designed advanced waste treatment aimed at planned indirect 

potable reuse produces product water that is higher quality 

than surface sources that are receiving waters and sources of 

unplanned potable reuse. 

The proposed CCL3 contains numerous chemicals that are either 

chemically reactive (e.g., oxirane, methyl-, not toxic (e.g., 

N-methyl-2-pyrrolidone), unlikely to be found widely in 

national drinking waters (e.g.,RDX ), more likely to be found 

in foods (e.g., methanol), unstable in the water process system 

(e.g., cumene hydroperoxide, and toluene diisocyanate) 

indicating that the selection and screening process requires 

significant reconsideration. 

However it is notable by the absence of disinfection by- 

products, except for 5 N-nitrosamines. We find this to be 

remarkable and baffling considering that disinfection by- 

products are virtually unique to drinking water supplies and 

they may result in almost universal exposures to consumers 

based upon the type of disinfection and treatment system being 

utilized in their water supply. The dossiers include 

substantial information on disinfection by-products that have 

not received sufficient investigation with regard to risk. One 

(DBP-1) is a general review of the chemistry of major drinking 

water disinfectants and identifies several categories of by- 

products that have a high probability of being relatively toxic 

compounds. These include compounds that have been identified 

and others that have a high potential to be present. They 

include: N-chlorinated amines and other N-chloroorganic 

nitrogen compounds, haloquinones, other nitrosamines and 

halonitriles, haloaldehydes, halopropanones. The additional DBP 

dossiers provide more specific information on the categories of 
substances and identify specific research that is needed to 

allow risk assessments to be conducted on the chemicals. The 

latter is important to help EPA develop research strategies to 

prepare for decisions to be made in future CCL determinations. 

The several Pharmaceuticals documents provide assessments of 

the pharmaceuticals that have been reported in drinking waters 

and source water and conclude that most of them are of little 

or no concern for public health because their MOEs relative to 

their lowest therapeutic doses (assumed to be LOAELs for most 

pharmaceuticals) are very large. However, they also point out 

that certain types of pharmaceuticals cannot be assessed in 

that way because of their modes of action. Some are genotoxic 

carcinogens (e.g. chemotherapeutic agents). Others, like the 

statins ,are potential hazards to sensitive populations that 

are not considered in their therapeutic uses in older 

populations. Because there are many statins prescribed and they 

are developmental toxicants, their cumulative risk during 

gestation and early postnatal development should be assessed. 

In addition there are several different mechanisms represented 

among antilipidemic drugs that could well lead to synergistic 

effects on the developing fetus. Similarly, antihypertensives 

are generally considered to be developmental toxicants and act 

by a large number of different mechanisms of action. 

Importantly, we also conclude that many pharmaceuticals of high 

current use are not among the reported measured chemicals in 

drinking water and that analytical methods development is 

needed and a nationally organized survey should be carried out 

that is representative not only of the volume of these drugs 

that are used, but also takes into account the very large 

differences in the effective doses of pharmaceuticals. The 

lowest therapeutic dose is a rational and easily identified 

reference to levels of these compounds that are biologically 

active and which could be minimally harmful (i.e., LOAELs). For 

many drugs, the frequency of adverse effects associated with 

these doses in humans is known, providing a much better 

benchmark for estimating safe doses than the pre-clinical 

animal studies. The national survey should also consider the 

metabolism of these drugs, focusing primarily on metabolites 

that are pharmacologically and toxicologically active. 
Nanoparticles as a group are subjects of interest, although 

there is a meager amount of research on ingestion toxicology. 

On the other hand it is likely that many of them are removed by 

environmental transport, aggregation and coagulation and 

sedimentation, and certainly by membrane processes. 

We would like to have the opportunity to meet with appropriate 

persons and offices in EPA to provide elaborations and to 

discuss the occurrence and exposure and toxicology research 

that is need to address the issues that we have identified. 

Attachments 

DBP-1 Disinfection as a Source of Diverse By-Products of 

Potential Health Concern 

DBP-2 Nitrosamines 

DBP-3 Developmental Neurotoxic Effects of Bromate 

DBP-4 Halonitriles 

DBP-5 Haloaldehydes 

DBP-6 Halopropanones 

DBP-7 Organic N-Chloramines 

DBP-8 Halofuranones, haloquinones, and related compounds [See 

PDF for Attachments] 

Pharm 2- Cumulative Risk from Pharmaceuticals with Common Modes 

of Action: Statins 
Pharm 3- Synergisms Among Pharmaceuticals and Other Water 

Contaminants that Have Different Modes of Action, but Affect 

the Same Physiological Systems: Antilipidemic Drugs, 

Phthalates, PFOAs & Disinfectant By-products 

Pharm 4- Synergisms among Pharmaceuticals with Different Modes 

of Action that Affect the Same Physiological Functions: Anti- 

Hypertensive Drugs 

Pharm 5- Bioavailability of Organic Iodine in Contrast Media 

Pharm 6- Genotoxic Carcinogens 

Pharm 8- Survey of Pharmaceuticals in Wastewaters and Drinking 

Waters that is Representative of Important Classes [See PDF for 

Attachments] 

Summary from 38 Data Sets from Wastewater Treatment Facilities 

Nanotechnology [See PDF for Attachments] 

CS Title: 0093 

Company/group/association name: 

Comment: 

May 19, 2008 

Water Docket 

U.S. Environmental Protection Agency 

Ariel Rios Building, Mail Code 2822T 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20460 

Re: Docket ID No. EPA-HQ-OW-2007-1189 Drinking Water 

Contaminant Candidate List 3-Draft 

(73 Fed. Reg. 9628, February 21, 2008) 

Ladies and Gentlemen: 

The Pharmaceutical Research and Manufacturers of America 
(PhRMA) is pleased to submit these comments on the U.S. 

Environmental Protection Agency's (EPA) Drinking Water 

Contaminant Candidate List 3 (CCL3). EPA has published the 

methodology that it used to identify the candidate chemicals 

for CCL3 (73 Fed. Reg. 9628, February 21, 2008) (Notice). The 

Notice makes available for public review and comment the 

results and recommendations of EPA's evaluation of potential 

drinking water contaminants that should be investigated further 

for addition to the primary drinking water regulations. PhRMA 

has carefully reviewed the Notice and is pleased to offer these 

comments on the CCL3 and EPA's methodology for identifying 

candidate chemicals. 

PhRMA represents the country's leading research-based 

pharmaceutical and biotechnology companies, which are devoted 

to inventing medicines that allow patients to lead longer, 

happier, healthier and more productive lives. Investing over 

$30 billion annually in discovering and developing new 

medicines, PhRMA companies are leading the way in the search 

for cures. PhRMA member companies are continuously developing 

new products and optimizing their production processes. Because 

active pharmaceutical ingredients (API) are a class of 

chemicals that has been evaluated for inclusion in the CCL3, 

EPAs evaluation process for determination of which APIs are 

included on the proposed CCL3 is of considerable importance to 

PhRMA. 

EPA has requested comments on the methodology that it used to 

develop the draft CCL3 and on its decisions to identify 

chemicals in specific contaminant classes, including 

pharmaceuticals, in the draft CCL3 (73 Fed. Reg. 9651-53). The 

Agency also requests any additional data and studies that 

support its proposed listings and that may support adding 

chemicals to the draft list. 

PhRMA is specifically responding to EPA's request for comments 

in the following sections of the Notice: 

EPA's methodology for identifying candidate contaminants has a 

strong scientific foundation and has been rigorously applied. 
EPA has responded to recommendations from the National Research 

Council (NRC) and National Drinking Water Advisory Council 

(NDWAC) by developing and implementing a multi-step process to 

identify candidate contaminants for addition to the National 

drinking water standards. This methodology incorporates both 

public input and expert review at several points in the process 

to identify a broad universe of candidate contaminants and then 

evaluate the potential frequency of occurrence in drinking 

water supplies and the potential health effects of each such 

contaminant to develop candidates for further evaluation for 

potential drinking water criteria. 

The EPA methodology evaluates contaminant health effects, 

occurrence (prevalence), and environmental fate to identify 

specific contaminants of concern. All of these factors are 

essential elements of a science-based assessment procedure and 

PhRMA supports EPA's implementation of these in the CCL3 

methodology. 

The inclusion of the public in the methodology considerably 

strengthens the identification of contaminants of concern. The 

opportunity for the public to offer suggestions and 

recommendations for the list allows both the general public and 

regulated entities (e.g., states, cities, water suppliers) to 

provide EPA with specific drinking water concerns that should 

be considered in the selection of contaminants for detailed 

study. 

External expert panels, which EPA has used in preparing the 

draft list, are an invaluable and indeed necessary component of 

developing such a list. External experts, including academic 

and corporate researchers, bring to the evaluation process 

considerable knowledge of specific contaminants that complement 

EPA's data collection effort. In the case of APIs, the 

pharmaceutical industry researchers have knowledge of the human 

health effects, potency, occurrence, and environmental fate of 

specific chemicals that may not be available in EPA's data 

sources and its is essential that this information be included 

in the evaluation process. PhRMA strongly supports the use of 
external experts in the contaminant listing process. 

The CCL3 methodology, as described in the Notice and supporting 

documents, has a strong scientific foundation and has been 

rigorously applied by EPA to develop the candidate list of 

drinking water contaminants. PhRMA strongly supports EPA's 

methodology and how it has applied it to develop the draft 

CCL3. 

EPA's conclusion that only one active pharmaceutical ingredient 

deserves listing on the draft CCL3 is supported by recent 

scientific publications. 

EPA's CCL3 methodology evaluated 287 active pharmaceutical 

ingredients (API) as candidate CCL3 contaminants (the 

universe). Approximately 10% of these APIs were included on the 

preliminary CCL. The Agency concluded that only one API, 

nitroglycerin, should be proposed for inclusion on the CCL3 (73 

Fed. Reg. 9652). 

A 2008 research paper that is not included in EPA's 

contaminants database supports the conclusion of the draft CCL3 

that few APIs are likely to be present in drinking water at 

potentially significant concentrations.[FN1: Focazio MJ, et al, 

"A national reconnaissance for pharmaceuticals and other 

organic wastewater contaminants in the United States-II) 

Untreated drinking water sources," Sci Total Environ (2008), 

doi:10.1016/j.scitotenv.2008.02.021] This paper presents a 

summary of U.S. Geological Survey (USGS) reconnaissance 

sampling of 74 untreated surface and ground drinking water 

sources and analysis of the samples for sub-microgram/litre 

(μg/L) concentrations of emerging contaminants, including 36 

APIs. USGS analyzed source samples for thirty-six (36) APIs 

(including prescription pharmaceuticals and antibiotics) and 

sixty percent (22) of the APIs were never detected at the sub- 

μg/L target detection limits. Only one API, carbamazepine, was 

detected in more than 8.1 percent (21.6 percent) of the source 

samples analyzed by the USGS. 
A 2005 paper published results of a study that evaluated human 

health risk from pharmaceuticals in surface waters. The study 

evaluated 26 APIs and used PhRMA's PhATE model to predict 

surface water concentrations, which were then used to evaluate 

human health risk due to drinking water exposure and fish 

consumption. The model predictions of surface water 

concentrations were compared to USGS surface water data for the 

same APIs and were shown to be conservative - i.e., the model 

predictions were higher than the measured concentrations. Based 

on the acceptable daily intakes of each API, the study 

concluded that the drinking water risk from the 26 APIs that 

were evaluated was very low.[FN2: Schwab, B.W., et al, "Human 

pharmaceuticals in US surface waters: A human health risk 

assessment," Regulatory Toxicology and Pharmacology, 42 (2005), 

296-312/] EPA's CCL3 methodology has come to the same 

conclusion. 

While there is considerable public concern regarding the 

presence of pharmaceutical compounds in public water supplies, 

there is a significant amount of data that supports the 

conclusions of EPA's draft CCL3 list - that APIs in drinking 

water are typically not present at concentrations that merit 

detailed evaluation for the potential development of drinking 

water standards. 

Summary 

PhRMA supports the methodology that EPA has developed and 

implemented to create the draft CCL3. Data collected and 

evaluated by EPA regarding APIs in public water supply source 

water are supported by the technical literature and demonstrate 

that there is no current scientific basis for adding more APIs 

to the CCL3. PhRMA continues to actively develop new 

methodologies to evaluate the presence, fate and potential 

human health effects of APIs in surface and ground waters and 

will continue to share this information with EPA. 

We appreciate the opportunity to offer these comments. If you 

have any questions about PhRMA's comments, please contact me. 
Sincerely, 

Michael Garvin, Pharm.D. 

Assistant Vice President, Science and Regulatory Affairs 

CS Title: 0094 

Company/group/association name: 

Comment: 

May 20, 2008 

TO: Docket ID No. EPA-HQ-OW-2007-1189 

FROM: Paul S. Berger, Ph.D. 

SUBJECT: Comments on the Drinking Water Contaminant Candidate 

List 3-Draft (73 FR 9628, 21 February 2008) 

I have the following three comments in response to the draft 

CCL3. 

Comment 1: Please include adenoviruses, enteroviruses, and the 

Mycobacterium avium complex on CCL3. 

I urge EPA to include the adenoviruses, enteroviruses, and the 

Mycobacterium avium complex (MAC) on CCL3. These PCCL 

pathogens were on the CCL1 and CCL2, and research to control 

these pathogens in drinking water is ongoing. It would be a 

shame if, after EPA and other groups had funded and conducted 

much of the needed research, EPA were to reverse its position 

and not make a regulatory decision regarding these pathogens. 

The exclusion of pathogens from a previous CCL without a 

regulatory decision on them seemingly represents both a waste 

of research money and a disruption of an orderly regulation 

development process. 
In addition, my sense is that little or no additional research 

is needed for EPA to make a regulatory decision on Salmonella 

enterica, Shigella sonnei, Vibrio cholerae, and the hepatitis A 

virus, all of which are listed in the draft CCL3. I believe 

sufficient data are already available in the published 

literature to make a reasoned decision on these four pathogens. 

Thus, I believe EPA resources for pathogens could be made 

available to continue needed research on the adenoviruses, 

enteroviruses, MAC, and perhaps several other pathogens on the 

PCCL that EPA did not include on the draft CCL3. 

Comment 2: The number of chemicals on the draft CCL3 relative 

to the number of pathogens is disproportionate. 

The CCL2 included 42 chemicals and chemical groups. In the 

draft CCL3, this number has dramatically increased to 93, more 

than double. In marked contrast, the number of microbes has 

only increased from 9 on CCL2 to 11 (or 12 if the cyanotoxins 

are included). This stance suggests that a wildly 

disproportionate increase in EPA resources will be going to 

chemicals, compared to, and at the expense of, pathogens. What 

is the scientific justification for this resource allocation 

disparity? What is EPA's basis for claiming that every one of 

the 93 chemical and chemical groups listed in the draft CCL3 is 

more likely to pose a public health risk than the adenoviruses, 

enteroviruses, Mycobacterium avium complex, and other PCCL 

pathogens that were not selected? 

Comment 3: I support inclusion of cyanotoxins on the CCL3. 

I strongly support EPA's decision to include the cyanotoxins on 

CCL3. 

CS Title: 0106 

Company/group/association name: 

Comment: 
May 20,2008 

Mr. Benjamin H. Grumbles 

Assistant Administrator 

U.S. Environmental Protection Agency 

Ariel Rios Building 

1200 Pennsylvania Avenue, N.W. 

Washington, D.C. 20460 

Dear Administrator Grumbles: 

I received your April 11, 2008, letter outlining the 

Environmental Protection Agency's interest and current actions 

regarding pharmaceuticals in our ambient and treated waters. 

We, too, are attentive to ensuring that our public water 

systems continue to provide safe drinking water for all 

consumers. Although our agency has received few inquiries from 

Arkansas consumers, this issue has generated many media 

inquires. 

As you are aware, the results of monitoring programs examining 

the prevalence of pharmaceuticals and personal care products in 

water have been available for a number of years. It appears 

evident from these results that waters located downstream from 

a sewer discharge or from a livestock operation will likely 

contain some traces of these contaminants at the parts per 

billion, parts per trillion, or even lower levels. 

The Arkansas Department of Health is currently reviewing the 

feasibility and resources needed to initiate a public water 

systems pharmaceuticals or personal care product monitoring 

program. Currently, the Department does analysis for most of 

the regulated and unregulated contaminants outlined in the 

National Primary Drinking Water Regulations or attains the 

results from certified private laboratories for those 

contaminants for which we do not analyze. All of those data are 

contained within the federal Safe Drinking Water Information 

System (SDWIS) and are reported by our Department to the EPA on 

a quarterly basis. 
In order to best determine the feasibility of implementing a 

program, the question of paramount importance is whether a 

chemical or a group of chemicals constitutes a health concern. 

If so, at what level does that concern begin and how can the 

level of exposure be reduced. A greater perspective of the 

types of chemicals present in wastewater and in ambient waters, 

the concentrations of the chemicals, the degree of removal of 

the chemicals by both wastewater and drinking water treatment 

processes, and the degree of natural degradation over time and 

distance in ambient waters are questions that deserve greater 

research. Additional data is also needed on the total body dose 

of these contaminants from other media, food, and air, as well 

as from our environmental exposure, including what we wear, 

where we work, and how we live our lives. Because these 

contaminants have multiple origins and involve multiple methods 

of exposure, the answers to these questions should not fall on 

any individual agency, but requires a coordinated national 

effort to harness the resources of federal, state, and local 

partners. 

Such an effort should include: 

* Improved data gathering to determine the prevalence and 

concentration of chemicals in the environment. 

* Expanded research on the health effects from trace levels of 

chemicals. 

* Improved communication with the public on the conclusions 

from the health effects research. 

* Expanded programs to reduce the amount of waste going into 

the environment including better programs for proper disposal 

and take back of pharmaceuticals, and better treatment of 

wastewater before its discharge. 
* Enhanced awareness and education efforts among physicians, 

pharmacists, and veterinarians. 

* Greater emphasis on the importance of source water 

protection. 

* Partnerships with generators of chemicals, including 

pharmaceutical companies, on responsible stewardship programs. 

Your letter illuminated that the EPA considered 287 

pharmaceuticals and personal care products for possible 

inclusion in the Contaminant Candidate List 3 (CCL3) for public 

water systems; however, only one chemical was included in the 

Draft CCL3. The reason given for this decision was your 

conclusion that "most of these chemicals occurred at very low 

levels compared to the best available human health effects 

date." Such a conclusion seems to imply that the EPA does not 

believe the presence of pharmaceuticals and personal care 

products in drinking water at the levels detected constitutes a 

public health concern based on currently available information. 

If that implication is correct, then it would be helpful to 

Arkansas for EPA to assist our state in communicating that 

conclusion to the public and to the media. If that implication 

is not correct, then it is reasonable to reevaluate the Draft 

CCL3 and to explore modifying that draft to include more of 

these chemicals as contaminants. 

I stand ready to assist you in any way that I can. I am pleased 

that you have requested our input in this all-important matter 

and look forward to more dialogue on this topic as appropriate. 

Sincerely, 

Paul Halverson, DrPH, FACHE 

Director and State Health Officer 

CS Title: 0107 

Company/group/association name: 

Comment: 
May 21, 2008 

Water Docket 

U.S. Environmental Protection Agency (2822T) 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460 

Re: Comments of the Pesticide Policy Coalition on EPA's 

"Drinking Water Contaminant Candidate List 3 - Draft; Notice." 

72 FR 9627. February 21, 2008. 

Docket No. EPA-HQ-OW-2007-1189. 

Dear Docket Manager: 

The Pesticide Policy Coalition ("PPC" or the "Coalition") is 

pleased to submit comments to the U.S. Environmental Protection 

Agency ("EPA" or the "Agency") in response to the publication 

of the Agency's Draft Drinking Water Contaminant Candidate List 

3 ("Draft CCL3") [EPA-HQ-OW-2007-1189 FRL-8529-7]. 

PPC represents a membership of food, agriculture, pest 

management and related organizations that support transparent, 

fair and science-based regulation of pest management. PPC 

members include: nationwide and regional farm, commodity, 

specialty crop, and silviculture organizations; cooperatives, 

food processors and marketers; pesticide manufacturers, 

formulators and distributors; pest- and vector-control 

operators; research organizations; and other interested 

parties. PPC serves as a forum for the review, discussion, 

development and advocacy of pest management policies and issues 

important to its members. 

PPC recognizes that § 1412(b)(1) of the 1996 Safe Drinking 

Water Act Amendments ("SDWA") requires that EPA publish an 

updated list every five years of contaminants that are 
* not subject to any proposed or promulgated national primary 

drinking water regulations, 

* are known or anticipated to occur in public water systems, 

and 

* may require regulation under the SDWA if 

(a) the contaminant may have an adverse effect on the health of 

persons; 

(b) the contaminant is known to occur or there is a substantial 

likelihood that the contaminant will occur in public water 

systems with a frequency and at levels of public health 

concern; and 

(c) if, in the sole judgment of the Administrator, regulation 

of such contaminant presents a meaningful opportunity for 

health risk reduction for persons served by public water 

systems. 

EPA must evaluate candidate substances from several sources, 

including those registered as pesticides under the Federal 

Insecticide, Fungicide, and Rodenticide Act ("FIFRA"). EPA has 

finalized previous CCLs in 2002 and 2007, in which seven 

pesticides and two degradates were identified but not chosen 

for regulation. 

The Coalition understands the CCL3 was compiled through a 

complex, multi-step process recommended by the National Academy 

of Sciences' National Research Council and developed by the 

Agency. EPA used an "adaptive management approach" to create a 

broadly defined universe of 7,500 chemical and biological 

drinking water contaminants from 284 data sources that, upon 

assessment with screening criteria for potential to occur in 

public water systems and potential for public health concern, 
was reduced to a preliminary CCL ("PCCL") of most significant 

candidates. A final draft CCL3 of 93 chemicals or chemical 

groups and 11 microbiological contaminants was produced by EPA 

from the PCCL with structured classification models and expert 

judgment for chemicals that may occur in public water systems 

and cause adverse health effects. EPA also included on the CCL3 

contaminants nominated by the public during the public comment 

period. Among these are 42 pesticides and pesticide degradates. 

PPC supports the use of a transparent, objective, and 

scientifically robust selection mechanism for this and future 

CCLs. The Coalition recognizes the iterative process EPA used 

to develop the draft CCL3 goes a long way towards achieving 

these goals. However, PPC wishes to make the following 

observations and suggestions: 

(1) The SDWA §1412(b)(1)(C) directs the Agency to select 

"contaminants for consideration ... that present the greatest 

public health concern." In the process of narrowing the 

universe of 7,500 unregulated chemicals down to the 93 most 

notable on this draft list, EPA selected nearly half to be 

pesticides or pesticide degradates. Such a selection bias is 

inconsistent with the toxicological knowledge and use controls 

posed by FIFRA, and with the extremely low levels of pesticides 

detected in either polished or ambient drinking water ("The 

likelihood of pesticide concentrations exceeding a human-health 

benchmark in a public-supply well or domestic well is low..." 

"pesticide concentrations exceeded one or more human-health 

benchmark in about 10% of [ambient] agricultural streams, 7 

percent of urban streams, and in 1% of mixed-land-use streams." 

USGS, Pesticides in the Nation's Streams and Ground Water, 

1992-2001). EPA has not clearly demonstrated in the process 

used to derive the draft CCL3 that these 42 pesticides and 

degradates represent a proportional share (42/93) of "those 

contaminants that pose the greatest public health concern..." 

The proportional share of pesticides and pesticide degradates 

on the list should also reflect the Agency's experience with 

previous CCLs, where none of the selected pesticides and 

degradates were ultimately deemed appropriate for regulation. 

(2) Of the pesticides listed in the draft CCL3, three are no 
longer in registered pesticide products. Ethion (CAS 563-12-2) 

products were all cancelled in 2003, and all use of existing 

stocks was prohibited after 12/31/2004 (67 FR 13327; 

3/22/2002). All ethion tolerances have been revoked, effective 

10/1/2008 (69 FR 43918; 7/23/2004). For fenamiphos (CAS 

22224-922), voluntary cancellation of the final remaining uses 

was published 4/23/2008; (73 FR 21942). Nitrofen (CAS 

1836-75-5) has not been marketed since 1980. All product 

registrations were cancelled in 1984, and all tolerances were 

revoked in 1985 (50 FR 37850; 9/18/1985). 

(3) The PPC understands that data collected under the 

Unregulated Contaminant Monitoring Rule ("UCMR", [40 CFR 

§141.40]) are an important source of occurrence information for 

the CCL process. The UCMR requires all large public water 

systems and a subset of small systems to monitor for an 

identified list of unregulated contaminants, including several 

pesticides and pesticide degradates, and report occurrence data 

to EPA. The first UCMR of 30 chemicals was finalized in 1999, 

and in January 2007 EPA published a second list, "UCMR 2" (72 

FR 367; 1/4/2007), of 25 additional chemicals to be monitored 

using five different analytical methods. From the UCMR, EPA 

collects data to evaluate and prioritize what action the agency 

will take on contaminants included in the CCL. However, as part 

of EPA's narrowing of the PCCL to this draft CCL3, EPA simply 

swept all of the UCMR 2 chemicals into the draft CCL3, even 

though the UCMR 2 monitoring wont be completed for several 

years. The PPC believes it would be more prudent for EPA to let 

public water systems actually collect the required UCMR 2 

occurrence data instead of assuming the results, as the Agency 

has done. Undoubtedly, the UCMR 2 data can be appropriately 

used in the CCL4 list that will be required in the future. 

(4) The PPC acknowledges that the EPA applied structured 

classification models to evaluate and identify drinking water 

priority contaminants. Decisions to include chemicals on the 

final draft CCL3 generally were made using model results and 

best available data to identify contaminants that may occur in 

public water systems where they may cause adverse health 

effects. More than a third of the chemicals were selected in 

this way - high certainty data from finished or ambient water 

monitoring and a potency/90th percentile concentration ratio of 
= 10. However, the balance of the CCL3 compounds were selected 

on the basis of less rigorous selection data, including the use 

of surrogates for many important parameters (e.g., pounds sold 

per year in place of prevalence, or persistence and mobility in 

place of potential magnitude). Of this less rigorous group, 

pesticides and degradation products were selected from EPA's 

Office of Pesticide Programs' (OPP) registration and re- 

registration database of modeled surface and/or ground water 

data. When possible, EPA obtained ambient water values from the 

USGS National Water Quality Assessment Program (NAWQA), UCMR 

monitoring, USDA Pesticide Data Program, and numerous other 

sources. However, EPA selected the highest reported 

concentration as the occurrence value used in screening. 

Pesticides on the CCL3 were selected from a "medium certainty 

bin," characterized by the Agency as needing further occurrence 

and/or health effects research. The PPC agrees with this 

"medium certainty" determination, but urges EPA to limit its 

CCL3 selection to those with high certainty, high quality data. 

(5) From the CCL3, EPA is to make a regulatory determination on 

five of the 93 chemicals and 11 microbiological contaminants 

that, if regulated, would present the most meaningful 

opportunity for improvement of water quality and public health. 

From our perspective, there are more essential choices among 

the CCL3 candidates than the pesticides identified in the draft 

list. The listed pesticides are part of an arsenal of crop 

production tools that are subject to more than 200 toxicology 

and ecological tests before they are licensed by EPA to control 

pests in orchards, grain fields, forests, highway road sides, 

homes, home lawns, gardens, and city parks. All aspects of 

their sale and use are strictly regulated by FIFRA, and water 

quality standards already exist or are being developed for 

many. New products are continually entering the marketplace, 

bringing lower use rates and improved environmental 

characteristics to this arsenal of products. Furthermore, the 

strong emphasis on mixtures for synergistic effectiveness, new 

containers that promote proper use, and education promoting 

protection of streams, wells and aquifer recharge areas, all 

are paying dividends. 

PPC appreciates the opportunity to comment on this proposal. If 

you have any questions or comments regarding this submission, 
please feel free to contact us. 

Sincerely, 

Beau Greenwood, Acting Chair 

Pesticide Policy Coalition 

Telephone: 202-296-1585 

CS Title: 0108 

Company/group/association name: 

Comment: 

May 21, 2008 

Water Docket 

U.S. Environmental Protection Agency 

Mail Code 4607 M 

1200 Pennsylvania Ave. NW 

Washington, DC 20360-0001 

Re: Comments on Drinking Water Contaminant Candidate List 3 - 

Draft Notice; Docket ID EPA-HQ-OW-2007-1189 

Dear Water Docket: 

The Association of Metropolitan Water Agencies (AMWA) 

appreciates the opportunity to comment on the draft Contaminant 

Candidate List 3 (CCL 3) (73 FR 9628). As directors and CEOs of 

the largest publicly owned drinking water systems in the United 

States serving more than 127 million Americans, AMWA strongly 

supports the scientific and data-driven CCL process. As 

required by the 1996 Amendments to the Safe Drinking Water Act, 

the CCL process identifies potential contaminants, gathers 

needed information to determine if a national regulation is 

needed, and presents a formal evaluation and determination on 

whether to regulate a given contaminant. 
AMWA believes that EPA should focus the CCL in a way that will 

best utilize its scarce resources and optimize its resource 

budget. In fact, we suggest that EPA reduce the number of 

substances included in each CCL to help this effort. 

The Office of Ground Water and Drinking Water (OGWDW) relies on 

the Office of Research and Development (ORD) to perform the 

research needed to support its mission. ORD needs to clearly 

identify how it intends to support the CCL process by working 

with OGWDW to prioritize research on listed contaminants. ORD 

should detail its projects related to CCL research in its 

multi-year plan. In addition, EPA should use the CCL as an 

opportunity to communicate the progress and results of research 

on CCL contaminants and AMWA encourages EPA to note in the 

final CCL how this will be accomplished. 

The attached comments provide AMWA's views on various aspects 

of the development of CCL 3 and recommendations for the CCL 

process in general. AMWA appreciates the opportunity to comment 

on the draft CCL 3. Please contact Erica Brown, Director of 

Regulatory Affairs, at 202-331-2820 if you have any questions. 

Sincerely, 

Diane VanDe Hei 

Executive Director 

Association of Metropolitan Water Agencies Comments On the 

Drinking Water Contaminant Candidate List 3; Draft Notice 73 

Federal Register 9628, February 21, 2008 

1. EPA requested comment on various aspects of the development 

of CCL 3. In response to this request, AMWA provides the 

following comments and recommendations: 

a. AMWA supports EPA's efforts to provide a transparent, data- 

driven CCL process. In previous letters to the agency, AMWA has 
supported the recommendations of the National Drinking Water 

Advisory Council (NDWAC, 2004) as well as the National Academy 

of Science/National Research Council report, Classifying 

Drinking Water Contaminants for Regulatory Consideration 

(NAS/NRC, 2001) and encouraged the agency to employ a process 

that is transparent and reproducible. 

AMWA commends EPA for including experts throughout the CCL 

process by hosting various workshops to identify screening 

criteria, evaluate data sources, assess the data training set 

of the chemical contaminants and review the CCL prior to its 

publication. AMWA encourages the agency to continue to improve 

the transparency in the final CCL 3 notice and in future 

endeavors by clearly documenting when and how EPA experts or 

authorities outside of the agency were consulted and by making 

their assessments public. If this information is currently 

available in the docket documents, it is not easily identified. 

b. AMWA encourages EPA to continue to promote a transparent 

process using expert judgment to ensure that the classification 

process or algorithm is repeatable. In the Federal Register 

notice, there is one place where AMWA suggests EPA could be 

more transparent in explaining how expert judgment was used to 

develop the draft CCL. For example, on 73 FR 9651, one of the 

microbial expert panels recommended that EPA remove microbial 

contaminants from the list if they are inactivated by 

conventional treatment. It's not apparent in the FR notice how 

EPA addressed this recommendation. 

AMWA thanks EPA for the opportunity to participate in the CCL 

process by identifying experts who could provide valuable 

information to improve the process in these key areas. EPA 

should continue to leverage the expertise of subject matter 

experts and stakeholders to help identify emerging contaminants 

and the latest peer reviewed literature. AMWA would like to 

continue to support the Agency in this process by providing 

assistance or by identifying experts who could inform the 

process in these key areas. 

c. EPA should focus the CCL list in a way that will best 
utilize its scarce resources and optimize its resource budget. 

In past comment letters, AMWA has asked EPA to more clearly 

inform the public how the agency intends to use the CCL to 

prioritize drinking water research in order to make regulatory 

decisions about contaminants on the list. 

AMWA has several ideas for how this could be accomplished: 

EPA should provide a synopsis of the data required for each 

contaminant listed that identifies the information that is 

still needed to make a regulatory determination. The 

contaminant information sheets available in the docket 

currently show whether data that would likely be used to make a 

regulatory determination (e.g., RfD, concentrations in ambient 

water or finished water) were available for the screening, but 

this information is not easily accessed across all contaminants 

listed, nor is it prioritized in any way. 

This synopsis envisioned could be used to prioritize research 

needs and information for the Office of Research and 

Development (ORD) multiyear plan. A clear presentation of these 

data gaps could also help other research organizations such as 

AwwaRF and universities to more easily identify key areas to 

focus needed research. 

Given limited resources, the development of a synopsis would 

benefit the process by improving its transparency and also by 

helping the agency to prioritize the CCL based on information 

required to make a regulatory decision, or based on achievable 

goals for obtaining missing data, or both. 

d. EPA should remove Legionella and Viruses from CCL 3 since 

these microbials already have MCLGs and treatment techniques 

under the Surface Water Treatment Rule. Since these 

contaminants already have MCLGs, it seems that EPA should be 

reviewing these regulations as part of the 6-Year Review 

process and not considering them as "new" contaminants for 

potential regulation under the CCL. 
e. EPA should reduce the number of substances on the CCL to 

better focus its resources. The SDWA states that the 

Administrator shall regulate contaminants that will provide a 

"meaningful opportunity for health risk reduction for persons 

served by public water systems" (Sec. 1412 (b)(1)(A)(iii)). It 

is unclear how the agency intends to focus its efforts on 

prioritizing research and data gathering on a list of over 100 

contaminants in order to ultimately make regulatory decisions. 

AMWA therefore recommends that EPA keep the list at a more 

manageable level and list only those chemical contaminants that 

the agency currently believes are the largest potential threat 

to public health. AMWA suggests listing only those chemicals 

(36 in all) that came out of screening process in the high 

certainty bin, with consideration of those chemicals nominated 

by the public that had additional data provided to the agency 

that could be used in the data screening process. With regard 

to the medium certainty bin, EPA can retain those chemicals on 

the PCCL and prioritize them over other PCCL contaminants given 

their attribute scores. 

With respect to the microbes on the CCL, AMWA agrees with the 

use of waterborne disease outbreak data, health effects and 

occurrence in the scoring protocols for ranking pathogens on 

the PCCL. 

f. ORD's Multi-year Plan Should Correlate To CCL Needs. OGWDW 

relies on the Office of Research and Development (ORD) to 

perform the research needed to support its mission. Listing 

contaminants on the CCL should enable all offices in EPA 

responsible for supporting regulatory determinations with the 

ability to focus precious research dollars on those chemical 

and microbial contaminants that are a potential health risk to 

drinking water consumers. 

ORD needs to clearly identify how it intends to support the CCL 

process by working with OGWDW to prioritize research on CCL 

contaminants. ORD should detail its projects related to CCL 

research in its multi-year plan. 
The CCL process is a mechanism that has been created to help 

the Agency effectively determine which contaminants to 

regulate. AMWA supports the process and believes Congress 

intended for it to help determine future drinking water 

regulations. AMWA therefore encourages EPA to work to integrate 

this process into its regulatory and research programs as it 

believes Congress intended. 

g. EPA should use the CCL as an opportunity to clearly 

communicate the progress and results of research on CCL 

contaminants. AMWA suggests EPA include the status of research 

on CCL contaminants that have been on the list since 1997 in 

the final CCL3 and future list proposals. This information 

could be included in the synopsis of research gaps. Including 

this information in future CCL documentation would speak to the 

issue of transparency by informing the public about research 

that has been completed up to this point. Such information 

would also help EPA make future decisions about whether to list 

contaminants on the CCL and could help guide other experts in 

deciding where to focus their research efforts. 

h. EPA's should use the OPPT HPV chemicals in the CCL analysis 

based on drinking water related data. AMWA agrees that 

including chemicals from EPA's Office of Pollution Prevention & 

Toxics (OPPT) High Production Volume (HPV) list in the universe 

is important. However, inclusion of these chemicals on the PCCL 

or CCL should be based on a drinking water occurrence or 

exposure component. OGWDW should work with OPPT to ensure that 

its screening protocol for HPV chemicals includes a drinking 

water exposure component and use this information to inform 

future CCLs. 

i. EPA should continue to leverage the connection between the 

CCL and UCMR. AMWA thanks EPA for specifying the connection 

between the CCL and Unregulated Contaminant Monitoring rule 

(UCMR) in the CCL proposal. AMWA is pleased to see the 

explanation of how information from certain UCMR 2 monitoring 

will be used in the finalization of CCL 3 and the development 

of future CCLs. AMWA encourages EPA to improve correlation of 
CCL and UCMR wherever possible by using the UCMR to gather 

occurrence data for contaminants on the CCL with the highest 

potential public health threat and largest data gaps for 

occurrence. 

For example, many of the testing methods for microbial 

contaminants require highly specific media (serological and/or 

molecular) and technical expertise. Outsourced testing would be 

required for many utilities if these contaminants were listed 

on a future UCMR. Similarly, testing for the more explosive, 

radioactive or toxic chemicals on the draft list would require 

specialized facilities, instrumentation and expertise to run 

(e.g., strontium, perchlorate, nitroglycerin). 

EPA must keep these issues in mind as it considers CCL 

contaminants in the development of the next UCMR. 

2. EPA also requested comments on how pharmaceuticals were 

considered in the CCL3 process. AMWA urges EPA and the Food and 

Drug Administration to address whether the presence of trace 

amounts of pharmaceuticals results in short-term or long-term 

effects on human health and how such chemicals affect the 

environment. 

In addition, EPA should continue to work to improve source 

water quality through education as well as using existing 

regulatory authority to establish water quality standards and 

protect source waters from animal feeding and production 

operations and other nonpoint sources of pollution. 

AMWA believes the federal government should take the lead in 

developing a national program to provide consumers with an easy 

way to dispose of unused prescriptions. Likewise, EPA should 

work with other federal agencies, such as the Drug Enforcement 

Agency to revise guidelines that currently encourage consumers 

to flush certain unused prescriptions down the sewer system. 

Federal regulations should remove barriers that prevent 

hospitals and other medical facilities from disposing unused 

medicines and medical substances in an environmentally 
responsible manner. 

CS Title: 0110 

Company/group/association name: 

Comment: 

Docket: EPA-HQ-OW-2007-1189 

Drinking Water Contaminant Candidate List 3 

May 21, 2008 

The NJ Environmental Federation (NJEF) thanks EPA for giving us 

the opportunity to comment on drinking water standards under 

the Safe Drinking Water Act. The NJ Environmental Federation 

has 100,000 members and 100 member groups, and is the NJ 

chapter of Clean Water Action. 

NJEF is concerned with a particular chemical listed on the 

Contaminant Candidate List, PFOA (perfluorooctanoic acid), as 

well as another perfluorinated chemical, PFOS (perfluorooctane 

sulfonic acid). We are aware of EPA's decision to exclude PFOS 

from the draft CCL 3, and the agency's willingness to accept 

comments on that decision. 

EPA has long known of human health concerns of PFOS, and its 

unique ability to bind to proteins, unlike most persistent 

organic compounds, which accumulate in fatty tissue. Eight 

years ago, EPA acknowledged that: 

"PFOS accumulates to a high degree in humans and animals. It 

has an estimated half-life of 4 years in humans. It thus 

appears to combine Persistence, Bioaccumulation, and Toxicity 

properties to an extraordinary degree." 

In addition, citing a 3M rat study, EPA noted: 

"PFOS caused postnatal deaths (and other developmental effects) 
in offspring in a 2-generation reproductive effects rat study 

(NOAEL of 0.1 mg/kg/day and LOAEL of 0.4 mg/kg/day). At higher 

doses in this study, all progeny in the first generation died 

while at the LOAEL many of the progeny from the second 

generation died. It is very unusual to see such second 

generation effects." (Source: 

http://www.chemicalindustryarchives.org/search/pdfs/ 

scotchgard/20000516_226-0629.pdf 

Further, PFOS has been of great interest to the Organisation 

for Economic Co-operation and Development (OECD) who, in 2006, 

made strong recommendations for industry and government to 

monitor the impact of PFOS. (Source: 

http://www.olis.oecd.org/olis/2007doc.nsf/LinkTo/NT00002AB6/$FI 

LE/JT03229256.PDF) 

While it is presently ubiquitous in the environment, the threat 

of exposure is likely to increase as consumers dispose of 

household products containing PFOS. In turn, it is reasonable 

to anticipate that PFOS will continue to accumulate in the 

environment, including in ground and surface water, aquatic 

biota and humans. Although PFOS is no longer being 

manufactured, its persistence, and bio-accumulative and toxic 

properties warrant careful monitoring and regulation. 

The EPA is well aware of the numerous studies documenting the 

exposures and dangers of PFOA. Although DuPont, currently the 

only major U.S. producer of PFOA, continues to claim that there 

is no proof that PFOA causes harm to human health, evidence to 

the contrary continues to mount, such as: 

* EPA's Science Advisory Board identifies PFOA as a "likely" 

human carcinogen. (Source: Washington Post; Compound in Teflon 

a "likely carcinogen;" Juliet Eilperin; June 29, 2005) 

* Researchers found PFOA and PFOS in the umbilical cord blood 

of children indicating that these chemicals cross the placenta 

between mother and child. (Source: Environmental Working 

Group/Commonweal, Body Burden Study- The Pollution in Newborns, 
Executive Summary; July 14, 2005) 

* The Centers for Disease Control and John Hopkins University 

have reported health impacts in newborn babies such as low 

birth weight and reduced head circumference. (Source: Possible 

Etiologies of PFAA-Induced Developmental Effects: Reflections 

from a Pediatric Perspective; Johns Hopkins University, 

Baltimore, MD; U.S. Centers for Disease Control and Prevention) 

* PFOA has been found in the breast milk of nursing mothers, 

and has been found in children between the ages of 2 and 12 at 

blood levels similar to those found in adults. (Source: Study 

conducted by Kathleen Arcaro of the University of Massachusetts 

Amherst-results are scheduled for publication in Environmental 

Science and Technology ( 

http://www.umass.edu/loop/talkingpoints/articles/74700.php); 

other breast milk studies reported in February and May 2007 

Issue of Environmental Health Perspectives) 

* A study by the National Institute for Occupational Safety and 

Health has shown that PFOA may prime the immune system to 

overreact to allergens in mice. (Source: Toxicological 

Sciences, DOI: 10.1093/toxsci/kfm053; From Issue 2609 of New 

Scientist magazine, page 14; June 25, 2007) 

* Researchers at the University of Pennsylvania School of 

Medicine found PFOA to be present in about 96 percent of the 

U.S. population, tending to accumulate within the body. 

(Source: Today's Sunbeam; DuPont reports PFOA testing; Randall 

Clark; May 07, 2008) 

* Exposure to PFOA may be associated with changes in liver and 

immune function, as well as higher cholesterol levels in 

children. In May 2008, the preliminary results of a study of 

PFOA's possible impacts on the health of nearly 70,000 

residents in the mid-Ohio Valley were released. The study 

examined the potential health impacts of PFOA released from 

DuPont's Washington Works plant south of Parkersburg, West 

Virginia. Previous studies of workers exposed to PFOA revealed 
elevated levels of kidney cancer, heart disease and diabetes. 

(Source: AScribe Newswire; Big Study of Teflon Chemical in 

People Suggests Harm to Immune System, Liver, Thyroid; May 13, 

2008; www.hsc.wvu.edu/som/cmed/ophp/grandRoundsWebcast.asp) 

The NJ Environmental Federation first became active in PFOA 

issues over three years ago, when PFOA was detected in the 

public water supply wells in Penns Grove and Carneys Point in 

NJ, some of which exceeded the interim NJ DEP guidance for PFOA 

of .04 ppb. United Steel Workers has tested the blood of some 

of their DuPont members and retirees at the Chambers Works 

facility in Pennsville, New Jersey and discovered exposure 

levels in some individuals to be hundreds of times higher than 

those found in the general public. 

Studies have shown that some workers exposed to perfluorinated 

chemicals (PFCs) are more prone to prostate and bladder cancer 

and experience higher than normal levels of cholesterol - a 

risk factor for heart attack and stroke. (Source: Minneapolis 

Star Tribune; Death rate up for 3M workers exposed to PFOA; Tom 

Meersman; March 5, 2008 

Numerous samples of surface water and drinking water supplies 

taken by the USW and others have revealed the presence of PFOA, 

PFOS and other PFCs. The PFCs being found in drinking water 

supplies are also found in the blood of the general population 

as reported by the Centers for Disease Control and Prevention. 

The agency found 11 polyfluoroalkyl compounds, including 

perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid 

(PFOA), and perfluorohexane sulfonic acid (PFHxS) in 1562 serum 

samples collected from a representative U.S. population 12 

years of age and older in the 1999-2000 National Health and 

Nutrition Examination Survey. (Source: Division of Laboratory 

Sciences, National Center for Environmental Health, Centers for 

Disease Control and Prevention, Abstract Received for review 

November 9, 2006, Revised manuscript received January 31, 2007, 

Accepted February 2, 2007) 

NJEF believes that the EPA must determine nation-wide 

regulations to protect the public from further exposure to PFOA 
and PFOS. States, such as Minnesota, North Carolina and New 

Jersey have instituted their own standards or guidelines for 

one or both PFCs. For example, after finding widespread 

contamination of drinking water supplies in the state, the 

NJDEP set a safe drinking water guidance value of .04 parts per 

billion for PFOA. (Source: 

http://www.state.nj.us/dep/watersupply/pfoa.htm) 

PFOA makes its way into products and downstream industries 

further exacerbating the contamination of people and the 

environment. DuPont and other companies promised EPA they 

would reduce and eventually eliminate PFOA use and manufacture 

via the 2010/2015 PFOA Stewardship Program. Unfortunately, 

DuPont refuses to make public verifiable annual PFOA production 

amounts. Recent test results of wells conducted by DuPont near 

its Chambers Works, NJ facility show levels of PFOA that exceed 

the NJDEP guidance level. (Source: Today's Sunbeam; DuPont 

reports PFOA testing; Randall Clark; May 07, 2008) 

The 2010/2015 PFOA Stewardship Program is voluntary. We have 

little faith this program will achieve its goals, nor will it 

assure the protection of public water supplies. NJEF believes 

voluntary promises are not a substitute for much needed 

regulation and accountability. Therefore, it is vital to 

regulate PFOA through the Clean Water Act. 

Submitted by 

Jane Nogaki, Vice Chair 

NJ Environmental Federation 

223 Park Avenue 

Marlton, NJ 08053 

CS Title: 0112 

Company/group/association name: 

Comment: 

May 21, 2008 

Via Electronic Mail 
Water Docket 

U.S. Environmental Protection Agency 

Mailcode: 2822T 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460 

RE: Docket ID No. EPA-HQ-OW-2007-1189 

Dear Sir or Madam: 

The National Mining Association (NMA) submits these comments in 

response to the U.S. Environmental Protection Agency's request 

for comments on Drinking Water Contaminant Candidate List 3 

(CCL3)-Draft. 73 Fed. Reg. 9628 (Feb. 21, 2008). 

NMA is a trade association representing producers of most of 

America's coal, metals, and industrial and agricultural 

minerals. Its membership also includes manufacturers of mining 

and mineral processing machinery and supplies, transporters, 

financial and engineering firms, and other businesses related 

to mining. NMA has a strong interest in any regulatory decision 

that would lead to establishing a primary drinking water 

standard for any contaminant occurring in drinking water to the 

extent NMA member companies provide water supply services to 

mining and mineral processing facilities and their associated 

communities. In addition, NMA members may also be affected by 

the impact of establishing a drinking water standard for 

constituents that are regulated in other federal and state 

regulatory programs, particularly in the areas of groundwater 

standards, waste management and site remediation, costs that 

should be considered when making such determinations. 

General Comments: 

We reviewed EPA's draft listing methodology, including the 

health effects data and occurrence data contained in the 

February 2008 Contaminant Information Sheets for the PCCL 

Chemicals Considered for CCL 3. We focused on certain metal 

parameters, which are molybdenum, cobalt, vanadium, strontium 
and germanium, and assessed the toxicological and occurrence 

data available at this time for these parameters. Based on this 

review, we do not believe that sufficient support is available 

for these parameters to remain on a final list of contaminants 

that would be subject to any proposed or promulgated national 

primary drinking water regulations under the Safe Drinking 

Water Act. There is insufficient information available to 

conclude that these parameters are either a concern for 

drinking water or a national concern for which federal 

regulation is appropriate or supportable. Each parameter is 

discussed below. 

Specific Comments: 

Molybdenum 

Molybdenum (Mo) is an essential trace mineral, and a cofactor 

for enzymes xanthine oxidase, aldehyde oxidase and sulfide 

oxidase that are needed for a variety of metabolic processes. 

Levels of Mo in national Public Water System ("PWS") finished 

water samples reported in the National Inorganics and 

Radionuclides Survey ("NIRS") ranged from 0 to 180 μg/L, 

although as discussed below the highest reported value of 180 

μg/L may be an anomaly. 

Average US daily intakes of Mo range from 76 to 350 μg 

(Schroeder et al. 1970, Tsongas et al. 1980, Pennington and 

Jones 1987). The Tolerable Upper Limit (UL) for Mo is 2.0 

mg/day (IOM 2000). EPA established a reference dose (RfD) of 

0.005 mg/kg-day for Mo based on a cross-sectional 

epidemiological study conducted almost 50 years ago in Armenia 

(Koval'skiy et al. 1961). 

Molybdenum compounds appear to have low toxicity in humans and 

are generally considered not to be a serious environmental 

contaminant in terms of human health (IOM 2000, Jarrell et al. 

1980). There are limited human toxicity data for Mo; most data 

pertain to animals, especially ruminants. The biological basis 

for toxicity in ruminants (production of thiomolybdates) is not 
relevant for humans. Several important beneficial roles of Mo, 

such as the absorption and retention of fluorine, may 

indirectly reduce dental caries and osteoporosis. 

A screening level review conducted by an EPA contractor in 

August 2003 did not identify any critical new studies on which 

to base a new risk assessment. However, there are several 

studies by Mertz (1976) and Turnlund et al. (1995-2007) that 

could be useful in re-evaluating the potential risks of dietary 

Mo. For example, Turnland reports on the interrelated roles of 

copper and Mo metabolism and on the physiological adaptations 

to Mo intake, such as lower tissue storage and greater urinary 

excretion during high Mo intake, which help prevent Mo 

deficiency and toxicity. Summarized below are key points 

regarding the listing of Mo on CCL 3. 

Occurrence data in finished water samples - It is unknown how 

representative the NIRS occurrence data are of actual national 

PWS Mo concentrations. NIRS concentrations ranged from 6 to 180 

μg/L, with a median value of 10 μg/L. However, USGS (1964) 

reported that Mo concentrations in finished drinking water 

samples from the 100 largest U.S. cities ranged from 0 to 68 

μg/L, with a median value of 1.4 μg/L. Greathouse and Craun 

(1979) reported Mo concentrations in tap water ranged from 1.1 

to 52.7 μg/L, with a mean concentration of 8 μg/L. The 

Environmental Working Group, a non-profit health advocacy 

organization, tested Mo concentrations in tap water supplied by 

PWS between 1998 and 2003. The highest detected level was 76 

μg/L, which is less than half the highest value of 180 μg/L 

reported in NIRS. Based on concentrations measured in finished 

drinking water in these other reports, and the 90% and 99% 

detect values of 30 and 110 μg/L, respectively, in the 

occurrence data, the high value of 180 μg/L may be an anomaly 

and the NIRS overestimated Mo concentrations in national PWS. 

Risk assessment or available data to conduct a risk assessment 

- The EPA established a reference dose (RfD) of 0.005 mg/kg-day 

for molybdenum (Mo) based on a cross-sectional epidemiological 

study in Armenia (Koval'skiy et al. 1961). Mo content in soil 

and plants in the village of Ankava was 38 and 190 times, 

respectively, that of the smaller adjoining settlement that 
served as the control. The average intakes of Mo in Ankava 

residents were in the range of 10-15 mg/day (corresponding to 

an intake of 0.14-0.21 mg/kg-day for a 70 kg adult). Whereas, 

Mo levels were relatively high in Ankava, copper levels were 

quite low. Compared with the adjoining settlement, results from 

medical exams demonstrated an increased prevalence of gout-like 

symptoms along with hyperuricemia (elevated serum uric acid) 

that increased with increasing residency time in the region. 

Based on these results, a Mo intake of 0.14 mg/kg/day was 

designated as a lowest observed adverse effect level ("LOAEL"). 

EPA applied an uncertainty factor ("UF") of 3 for sensitive 

individuals instead of 10 because of the moderately large study 

size (300 villagers from Ankava and 100 villagers from the 

adjoining settlement) and a factor of 10 because of the absence 

of a no-effect level in the study. The oral RfD of 0.005 mg/kg- 

day was derived by dividing the LOAEL of 0.14 mg/kg/day by a UF 

of 30. EPA could have applied a higher UF to account for the 

lack of reproductive and developmental toxicity, but did not 

because the RfD is already only slightly above the Effective 

Safe and Daily Intake (ESSADI) established for Mo, an essential 

trace mineral, by the U.S. Food & Drug Administration. A lower 

RfD value could result in insufficient intake to meet minimal 

nutritional requirements. 

The Koval'skiy study, selected as the principal study for the 

derivation of the RfD, is subject to several limitations. As a 

cross-sectional study, only prevalence, rather than incidence, 

of gout-like symptoms can be determined. The absence of 

information on the temporal relationship between exposure and 

health outcomes in a cross-sectional study substantially 

weakens the strength of evidence for a causal relationship. It 

is also possible that an unmeasured covariate may contribute to 

the increased prevalence of gout-like symptoms among residents 

of the Ankava community. Gout can develop as co-morbidity of 

other diseases, including obesity, alcohol, diabetes, 

hypertension, renal disorders, lead toxicity and hereditary 

factors. In the absence of detailed information on the presence 

of other essential trace elements in the diets of the study 

subjects, the possible contribution of metal imbalance is 

difficult to assess. 

One of the weaknesses in the Koval'skiy study identified by the 
National Research Council (1977) was the significantly 

decreased mean serum copper levels in residents presenting with 

elevated uric acid levels and gout-like symptoms and the 

elevated mean copper levels of the controls (compared with 

normal baseline levels). The Nuclear Regulatory Commission 

(NRC) interpreted this finding to suggest external 

contamination of the control samples during the assay procedure 

(NRC 1977). Urinary copper levels were also elevated in the 

controls, suggesting similar procedural contamination (NRC 

1977). Standard analytical methods for collecting samples for 

metal analyses (for example, use of acid-washed polypropylene 

and other laboratory materials) were likely not followed in the 

early Armenian study and could explain the higher than expected 

copper levels in the controls. However, it would not explain 

the low copper levels in the residents. 

Koval'skiy reported a positive correlation between serum uric 

acid levels and serum Mo and xanthine oxidase (a Mo-containing 

enzyme) levels. The strength of this correlation is 

questionable because of limitations in the analytical methods 

used to determine Mo tissue concentrations. (Serum Mo is 

difficult to measure, especially in 1961, and does not 

accurately reflect serum Mo status due to temporal dietary 

fluctuations.) More recent studies in humans, such as those 

onducted by Deosthale and Goplan (1974) and Chappell et al. 

(1979) that were reviewed by EPA in IRIS do not support the 

finding of increased serum uric acid levels in response to 

dietary Mo intake at levels lower than those in the Kovalskiy 

study. Deosthale and Goplan (1974) reported no change in uric 

acid excretion at intakes up to 1.5 mg/day and Chappell et al. 

(1979) reported a decrease in serum uric acid concentrations at 

intakes of greater than 0.49 mg/day (based on 70 kg adult). 

These studies, along with that conducted by Turnlund and Keyes 

(2000), which was not included in IRIS, identified levels of 

dietary Mo intake that were not associated with adverse health 

effects. 

In summary, the current RfD for Mo of .005 mg/kg-day or 350 

μg/day (based on a 70 kg adult) is notably lower than the value 

of 1500 μg/day that produced no adverse health effects 

(Deosthale and Goplan 1974, Turnlund and Keyes 2000) and the UL 

of 2,000 μg/day (IOM 2000). Therefore, the RfD warrants further 
evaluation. The need for additional research is supported by 

the National Academies' National Research Council (1977) and 

Institute of Medicine (2000). The National Research Council 

concluded that the involvements of Mo in the induction of 

adverse health effects are speculative, especially considering 

the small size of the control group (n=5) compared with the 

Ankava group (n=52), and a cause-andeffect relationship between 

Mo and these putative adverse effects needs to be established. 

The Institute of Medicine (2000) also concluded that because of 

the deficiencies in the Kovalskiy study, inadequate data exist 

to identify a causal association between excess Mo intake in 

normal, apparently healthy individuals and any adverse health 

outcomes. The current RfD relies heavily on an epidemiological 

study conducted over 50 years ago by Koval'skiy et al. (1961), 

which, because of its cross-sectional design, is insufficient 

to establish causality. As such, Mo should be removed from the 

CCL 3 until more reliable information is available that 

supports the toxicity of molybdenum to humans and that explains 

the influence of low dietary copper concentrations and other 

potential metals imbalances. 

Cobalt 

There are several important toxicological concerns with the 

available data that would need to be addressed before cobalt 

could be listed on the CCL 3. The current RAIS does not include 

a toxicity profile for cobalt, so the principal and supporting 

studies to support the RAIS RfD value of 0.02 mg/kg/day is 

unknown. Most toxicological studies are inhalation and not oral 

exposure studies. There is very little oral human exposure data 

available. 

ATSDR established a minimal risk level (MRL) based primarily on 

one 40-year old study involving 6 subjects administered a 

single dose. RIVM derived a TDI, which is one order of 

magnitude lower than the ATSDR MRL, based on patients with 

alcoholism who chronically consumed excessive amounts of beer 

containing cobalt sulfate. Although these studies were cited in 

the 1992 ATSDR Toxicological Profile for Cobalt, ATSDR did not 

consider them when deriving its MRL in 2004. Although IARC and 

NTP have classified cobalt for its carcinogenic potential based 
on non-oral routes of exposure, EPA has not. It is debatable 

whether reversible changes in hematological parameters 

constitute a critical health effect. Cobalt was detected in 

only 3 out of 989 sites (0.3%) and even the maximum 

concentration detected (10.6 μg/L) is 1 order of magnitude 

lower than the calculated DWS/MCLG of 140 μg/L using the RAIS 

RfD. Based on these low concentrations and the limited number 

of detections, we believe that cobalt does not qualify for 

inclusion on the CCL 3. 

Vanadium 

We have concerns that the vanadium level for purposes of a CCL 

3 listing is too low, and a protective level of vanadium in 

drinking water may be one order of magnitude higher than that 

estimated by EPA. The occurrence data indicate that 

concentrations of vanadium detected in 15% of PWS samples 

ranged from 3.1 to 70.4 μg/L (median 7.3, 90% 23, 99% 45). 

These values are within the range of a hypothetically- 

calculated DWS/MCGL using either the RAIS RfD or ATSDR MRL, and 

hence could support consideration of the CCL 3 listing of 

vanadium. However, in the contaminant information sheet, EPA 

did not include the IOM 2000 findings in which a UL of 0.026 

mg/kg/day was determined to be the highest level of daily 

nutrient intake that is likely to pose no risk of adverse 

health effects. In support of a more conservative NOAEL of 5 

ppm, ATSDR cites other studies that reported adverse 

developmental, cardiovascular, and gastrointestinal effects at 

doses greater than 5 ppm; however, IOM (2000) evaluated these 

reports to be inconsistent and did not consider them when 

deriving the UL. Hence, based on the IOM report findings, the 

level of vanadium in drinking water that is protective of human 

health may be one order of magnitude higher than that estimated 

by RAIS/EPA and ATSDR. Additional support for a higher vanadium 

standard includes the RTECS LOAEL value of 960 mg/kg/day, which 

EPA did include in the contaminant information sheet for 

vanadium, and that is 125 times the LOAEL value of the IOM 

(2000) report. 

For the purpose of assessing the available health guidelines, 

the table below is provided comparing the RAIS RfD, ATSDR MRL, 
and IOM UL and their respective DWS/MCGLs. 

Table 1 [see PDF] 

Based upon the RTECS value, vanadium should be excluded from 

the CCL 3 until such time that additional information is 

available on the health effects of this parameter. 

Strontium 

We have questions about the risk factor used by EPA to 

calculate the RfD. EPA calculated the RfD by using the NOAEL 

value of 190 mg Sr/kg/day reported in the Storey (1961) study 

and a UF of 300 (factor of 10 for extrapolating from lab 

animals to humans; factor of 10 for an incomplete database and 

to account for uncertainties in using data for SrCO3 to 

estimate risk for other Sr salts; and a factor of 3, instead of 

10, because the study was performed in young animals which are 

a sensitive subpopulation). However, ATSDR calculated a MRL of 

2 mg/kg/day using the same NOAEL value of 190 mg/kg/day and a 

UF of 30 and modifying factor of 3. It is questionable whether 

the UF of 300 used by EPA was warranted considering other 

compounds for which there is an incomplete database or numerous 

chemical states and an additional factor of 10 is not applied. 

The NOAEL value of 525 mg/kg/day reported in the more recent, 

better designed study by Marie et al. (1985) would result in a 

RfD of 1.75 mg/kg/day, which is consistent with the ATSDR MRL 

of 2 mg/kg/day. 

Germanium 

The occurrence data indicate that germanium was detected in 

only 0.4% (4 out of 989) of PWS samples and measured 

concentrations ranged from 26 to 230 μg/L (median 220, 90% 220, 

99% 230). Based on an oral-chronic LOAEL value of 0.318 

mg/kg/day, the hypothetically-calculated DWS/MCGL would be 

2,226 μg/L, which is 10-fold higher than the median or highest 

concentration detected in the PWS samples. Based on the very 
low prevalence of germanium detected in PWS samples and the 

relatively low toxicity of germanium based on human data, the 

CCL 3 listing is unsubstantiated and the additional burdens and 

costs associated with monitoring and reporting are not 

warranted. 

(Source - Obara et al., 1991. Germanium Poisoning: Clinical 

Symptoms and Renal Damage Caused by Long-Term Intake of 

Germanium. Japanese Journal of Medicine, 30:1, 67-72) 

If you have any additional questions regarding the National 

Mining Associations comments, please feel free to contact me 

at kbennett@nma.org. 

Sincerely, 

Karen Bennett 

Vice President, Environmental Affairs 

National Mining Association 

CS Title: 0113 

Company/group/association name: 

Comment: 

May 21, 2008 

Water Docket 

Environmental Protection Agency 

Mailcode: 2822T 

1200 Pennsylvania Ave., NW 

Washington, DC 20460 

Re: Docket ID No. EPA-HQ-OW-2007-1189 

Drinking Water Contaminant Candidate List 3- Draft 

To Whom It May Concern: 
The State-FIFRA Issues Research and Evaluation Group (SFIREG) 

Water Quality-Pesticide Disposal Working Committee (WQPD-WC) 

would like to thank the EPA Office of Groundwater and Drinking 

Water (OGWDW) for the opportunity to comment on the release of 

Contaminant Candidate List 3 (CCL3). The WQPD-WC has reviewed 

the CCL3 and asks that that the Agency consider the following 

comments as the CCL3 process is finalized. 

The WQPD-WC within the SFIREG is comprised of 10-12 individuals 

that seek to represent state agencies on pesticides and water 

quality technical information needs and regulatory matters. The 

WQPD-WC works primarily with the EPA-Office of Pesticide 

Programs, but the EPA's Office of Groundwater and Drinking 

Water (OGWDW) has shown continued interest in working with 

SFIREG on issues related to pesticides and water quality. On 

May 5, 2008, OGWDW representatives attended a WQPD-WC meeting 

to further explore water quality themes of interest to both 

parties. The WQPD-WC would like to thank the OGWDW for this 

interest and for soliciting input from the state lead agencies 

(SLAs) in the completion of the current and future CCL efforts. 

Many SLAs have a wealth of data on ambient and targeted water 

monitoring for pesticides that could serve positively in the 

development of CCLs and subsequent regulatory determinations. 

In addition, data held by SLAs will aid the OGWDW in 

identifying priority analytes for the unregulated contaminant 

monitoring rule and subsequent data collection efforts, 

therein. 

Although many registered pesticides may pose a potential threat 

to public and private water supplies and to ambient water 

quality, there are very few pesticide active ingredients or 

degradates, for which OGWDW has adopted either primary drinking 

water regulations or developed health advisory values that 

represent currently used compounds. For the many states that 

lack an infrastructure to readily develop standards for 

pesticides in drinking water or risk-based guidance values, 

communicating potential risks or making a risk management 

decision is all that more difficult. Therefore, the WQPD-WC is 

very encouraged to see that of the 93 chemical contaminants 

included in the draft CCL3, 35 are pesticide active ingredients 
or pesticide degradates, many of which have already received 

much scrutiny from the WQPD-WC and SLAs with regard to 

potential impacts on ambient or potable water supplies. 

Understanding that the OGWDW has a history in CCL1 and CCL2 of 

including pesticide active ingredients in the final CCL, the 

WQPD-WC encourages the OGWDW to include as many pesticide 

active ingredients as possible in the final CCL3 list. As 

mentioned, regulatory levels for pesticides in drinking water 

are sparse. Including pesticide active ingredients or 

degradates in the final list will greatly benefit state lead 

agencies charged with pesticide regulation due to the fact that 

by including such compounds, OGWDW proceeds with a regulatory 

determination that either no regulation is needed or that 

primary drinking water regulation is needed. This process 

ultimately provides SLAs with valuable information on risk 

management since regulatory determinations typically lead OGWDW 

to develop either a primary standard (Maximum Contaminant 

Level), Health Advisory values (e.g., Lifetime-HAs) or 

preliminary reference levels such as Health Reference Levels 

(HRLs), any of which can be used to aid in the interpretation 

of monitoring data with respect to potential human health risk. 

Lastly, to further aid SLAs, the SFIREG WQPD-WC requests that 

OGWDW work with SFIREG to facilitate access to HRLs developed 

for CCL3 compounds that are considered for the regulatory 

determination process, and also encourages the OGWDW to 

consider developing pesticide HRL values or other drinking 

water risk assessment advice outside of the CCL process. 

Thank you for your consideration of these comments. The WQPD-WC 

looks forward to working further with the OGWDW. 

Sincerely, 

Jeff Comstock 

SFIREG- WQPD-WC 

Agrichemical Management Section 

Vermont Agency of Agriculture 
Davis H. Daiker 

SFIREG- WQPD-WC 

Administrator- Scientific Evaluation Section 

Florida Department of Agriculture and Consumer Service 

Cc: Mr. Dave Frederickson, SIFREG 

Mr. Jack Peterson, WQ&PD-WC 

Mr. Joe Zachmann, SFIREG 

Ms. Maureen Serafini, AAPCO 

Mr. Dan Helfgott, OPP 

Dr. Debbie Edwards, OPP 

CS Title: 0118 

Company/group/association name: 

Comment: 

May 20, 2008 

Re: Drinking Water Contaminant Candidate List.3 - Draft 

(EPA-HQ-OW-2007-1189) 

To Whom It May Concern: 

I am writing in support of the regulation of perfluorooctanoic 

acid (PFOA) under the Safe Drinking Water Act. 

Minnesota is one of seven states with widespread contamination 

of Perfluorochemicals (PFC), including PFOA. In 2005, PFOA was 

first detected in the community of Oakdale, Minnesota. It has 

since been detected in seven additional metropolitan 

communities located near or on the Mississippi River and former 

industrial waste disposal sites used by the manufacturing 

company 3M. 

PFOA is a very stable, man-made chemical that the human body is 

unable to break down, and if exposure is constant, the 

chemicals are likely to persist in humans' bodies. The long 

term potential health risks of PFOA have been documented by a 
growing body of scientific research that shows PFOA causes 

liver cancer, testicular cancer and may cause other types of 

cancer such as breast cancer, as well as, birth defects, 

weakened immune system and Altered Hormone System Function. In 

2006, the EPA Science Advisory Board classified PFO as a likely 

human carcinogen, A recent industry funded study, showed that 

3M employees exposed to PFOA died of stroke and prostate cancer 

at higher rates than other workers at the company's Chemolite 

plant in Cottage Grove, Minnesota. 

As the state senator who represents many people who have been 

exposed to PFOA and other perflourochemicals, I urge federal 

regulation of PFOA. Without such regulation, it is incumbent on 

states to try to set guidelines for exposure. While Minnesota 

has such a guideline for exposure to PFOA, it is a higher rate 

than other states. This, in effect, leaves Minnesotans to 

question whether the Minnesota Department of Health has set 

appropriate levels of exposure. 

For the safety of the thousands of people around the country 

whose drinking water has been contaminated with PFOA, I 

strongly urge the EPA to increase regulation of PFOA through 

the Safe Drinking Water Act. 

Sincerely, 

Katie Sieben 

Minnesota State Senator 

CS Title: 0124 

Company/group/association name: 

Comment: 

NRDC Comments on the Draft Drinking Water Contaminant Candidate 

List 3 

Docket Number: EPA-HQ-OW-2007-1189 

May 21, 2008 

Pursuant to the Safe Drinking Water Act Amendments of 1996 
(SDWA), the U.S. Environmental Protection Agency (EPA) is 

required to publish, every five years, a list of unregulated 

contaminants that are known or anticipated to occur in public 

water systems and may require regulation under the SDWA. The 

Agency then must make a decision about whether or not to 

regulate at least five of the contaminants on the list. 

EPA is on the third round of this process and has published a 

list of candidate contaminants, called the CCL3. The draft list 

contains 104 contaminants: 11 microbiological contaminants and 

93 chemical contaminants. EPA culled this list down from a 

universe of over 7000 contaminants. NRDC submits the following 

comments on EPAs Draft CCL3. 

I. SUMMARY 

NRDC requests that EPA take the following actions concerning 

the Draft CCL3: 

* Delete the pesticide nitrofen (CAS # 1836-75-5) from the 

Draft CCL3. The available information on use, release and 

potential environmental occurrence of this chemical does not 

support its inclusion in the CCL3. 

* Regulate perchlorate (CAS # 7790-98-9) in drinking water 

pursuant to the Safe Drinking Water Act (SDWA). NRDC agrees 

with the inclusion of perchlorate in the CCL3 and supports the 

promulgation of a fully heath-protective Maximum Contaminant 

Level (MCL) for perchlorate. 

* Regulate perfluorooctanoic acid (PFOA, CAS # 335-67-1) in 

drinking water pursuant to the Safe Drinking Water Act (SDWA). 

This chemical is a known endocrine disruptor and drinking water 

contaminant, and is appropriately included in the Draft CCL3. 

* Add the following chemicals to the CCL3: 
o Alkylphenol polyethoxylates (APEs): 

* Alkylphenol mono- to tri-oxylates (CAS # 68555-24-8) 

* Nonylphenol (NP) (CAS # 25154-52-3) 

* Nonylphenol ethoxylate (NPE) (CAS # 9016-45-9) 

* Octylphenol ethoxylate (OPE) (CAS # 9036-19-5) 

[This commenter recommends that EPA add the following chemicals to the CCL3:]o Antibiotics: 

* Amoxicillin (CAS # 26787-78-0) 

* Bacitracin zinc (CAS # 1405-89-6) 

* Linezolid (CAS # 165800-03-3) 

* Methicillin (CAS # 61-32-5) 

* Oxacillin (CAS # 66-79-5) 

* Penicillin (multiple CAS #s) 

* Spiramycin (CAS # 8025-81-8) 

* Tylosin (CAS # 1401-69-0) 

* Vancomycin (CAS # 1404-90-6) 

* Virginiamycin (CAS # 11006-76-1) 

[This commenter recommends that EPA add the following chemicals to the CCL3:] o Bisphenol A (BPA) (CAS # 80-05-7) 

[This commenter recommends that EPA add the following chemicals to the CCL3:] o Microbials: 

* Mycobacterium Avium Complex (MAC) 

[This commenter recommends that EPA add the following chemicals to the CCL3:] o Pesticides: 

* Aldicarb (CAS # 116-06-3) 

* Azinphos-methyl (CAS # 86-50-0) 

* Carbaryl (CAS # 63-25-2) 

* Chlorpyrifos (CAS # 2921-88-2) 

* Dichlorvos (DDVP) (CAS # 62-73-7) 

* Dicofol (CAS # 115-32-2) 

* Endosulfan (CAS # 115-29-7) 

[This commenter recommends that EPA add the following chemicals to the CCL3:] * Linuron (CAS # 330-55-2) 

[This commenter recommends that EPA add the following chemicals to the CCL3:] * Phosmet (CAS # 732-11-6) 

* Trichlorfon (CAS # 52-68-6) 

* Triclocarban (CAS # 101-20-2) 

* Triclosan (CAS # 3380-34-5) 
[This commenter recommends that EPA add the following chemicals to the CCL3:] o Phthalates: 

* Benzyl butyl phthalate (BzBP) (CAS # 85-68-7) 

* Di-isononyl phthalate (DiNP) (CAS # 28553-12-0) 

* Di-n-octyl phthalate (DnOP) (CAS # 117-84-0) 

* Dibutyl phthalate (DBP) (CAS # 84-74-2) 

* Dicyclohexyl phthalate (DCHP) (CAS # 84-61-7) 

* Diethyl phthalate (DEP) (CAS # 84-66-2) 

* Dimethyl phthalate (DMP) (CAS # 131-11-3) 

[This commenter recommends that EPA add the following chemicals to the CCL3:] o Reproductive hormones: 

* Equilenin (CAS # 517-09-9) 

* Equilin (CAS # 474-86-2) 

* 17a-Ethynyl estradiol (CAS # 57-63-6) 

* 17 a -Estradiol (CAS # 57-91-0 70) 

* 17ß-Estradiol (CAS # 50-28-2) 

* Estriol (CAS # 50-27-1) 

* Estrone (CAS # 53-16-7) 

* Mestranol (CAS # 72-33-3) 

* 19-Norethisterone (CAS # 68-22-4) 

* Progesterone (CAS # 57-83-0) 

* Testosterone (CAS # 58-22-0) 

II. DETAILED COMMENTS 

The CCL3 contains contaminants that need not be listed at this 

time. 

EPA listed nitrofen (CAS # 1836-75-5) as one of the chemical 

contaminants on the draft CCL3. However, NRDC does not believe 

that nitrofen needs to be included on the list. Nitrofen does 

not appear to pose a threat of contamination to drinking water 

supplies due to the lack of significant sources of nitrofen 

releases to the environment and to its rapid biodegradation in 

the aquatic environment. Nitrofen is no longer sold or 

manufactured in the United States[FN1: National Library of 

Medicine. Hazardous Substances Data Base. 

http://toxnet.nlm.nih.gov/cgibin/sis/htmlgen?HSDB.] and all EPA 

registrations for nitrofen products were cancelled in 

1983.[FN2: U.S. Environmental Protection Agency (U.S. EPA). 
1998. Status of Pesticides in Registration, Reregistration, and 

Special Review (aka Rainbow Report.http:// 

www.epa.gov/oppfead1/international/piclist.htm.] Nitrofen in 

water biodegrades relatively quickly, with about 99% 

biodegradation occurring within 50 days.[FN3: Spectrum 

Laboratories. Chemical Fact Sheet: CAS # 1836755. 

http://www.speclab.com/compound/c1836755.htm] A search of the 

EPA Superfund Information Systems database found no hazardous 

waste sites proposed, listed, or deleted from the National 

Priorities List where nitrofen was a contaminant of 

concern.[FN4: U.S. EPA. Superfund Information Systems. 

http://cfpub.epa.gov/supercpad/cursites/srchsites.cfm.] The 

HazDat database of the Agency for Toxic Substances and Disease 

Registry (ATSDR), which contains information on the release of 

hazardous substances from Superfund sites or from emergency 

events, did not contain listings of any sites where nitrofen 

was detected.[FN5: Agency for Toxic Substances and Disease 

Registry (ATSDR). Hazardous Substance Release and Health 

Effects Database (HazDat). 

http://www.atsdr.cdc.gov/Hazdat.html] A search of the EPA 

STORET database back to 1980 found data for only 75 

environmental samples of any kind analyzed for nitrofen. All of 

these were water samples from Dade County in the state of 

Florida taken between 1997 and 1999. No nitrofen was detected 

in any of the samples.[FN6: U.S. EPA. STORET. 

http://www.epa.gov/storet/dbtop.html] 

The EPA Toxics Release Inventory contains reports of nitrofen 

disposal and other releases for only three years since 

reporting began in 1988: 505 pounds were released into the air 

from the Custom Alloy Corporation facility in High Bridge, NJ 

in both 2000 and 2001, and 25,300 pounds were disposed of in 

RCRA Subtitle C (hazardous waste) landfills from a Chemical 

Waste Management facility in Kettleman City, CA.[FN7: U.S. EPA. 

Toxics Release Inventory. http://www.epa.gov/triexplorer.] As 

such, nitrofen releases appear to be very limited in both time 

and geographic location. 

Currently, the lack of sources of nitrofen releases to the 

environment suggests that exposure among the U.S. population is 

through consumption of imported vegetables treated with 

nitrofen,[FN8: National Library of Medicine. Hazardous 
Substances Data Base. http://toxnet.nlm.nih.gov/cgi-bin/ 

sis/htmlgen?HSDB.] and not through drinking water. Therefore, 

EPA should prioritize other, more troubling, chemicals to be 

listed on the CCL3 and considered for regulation. 

EPA must regulate some of the chemicals listed on the CCL3 

Perchlorate. NRDC agrees with the inclusion of perchlorate (CAS 

# 7790-98-9 ) in the CCL3 and supports the promulgation of a 

fully health-protective Maximum Contaminant Level (MCL) for 

perchlorate in drinking water that is protective of sensitive 

subpopulations such as pregnant women, fetuses, infants and 

children. Perchlorate is known to interfere with the normal 

function of the thyroid gland. The thyroid gland produces a 

hormone that is necessary for regulation of many body functions 

including heart rate, metabolism, energy, mood, cognitive 

function, and growth and development. Iodide is a necessary 

ingredient of the thyroid hormone thyroxine (T4). Normally, 

iodide is transported into the thyroid gland by the 

sodiumiodide symporter (NIS). Once in the gland, iodide is 

bound to thyroglobulin. Perchlorate blocks the NIS and prevents 

uptake of iodide into the gland. 

Thyroid hormone deficiency is associated with 

neurodevelopmental deficits While there may be other toxic 

actions and target organs for perchlorate toxicity, it is a 

scientific certainty that the thyroid is a critical target 

organ, and inhibition of iodine uptake is a critical mechanism 

of toxicity. Furthermore, it is well established that thyroid 

hormones are critically important for normal growth and 

development of the central nervous system, and therefore that 

gestation and infancy are periods of vulnerability to 

perturbations in normal thyroid hormone activity. Adequate 

levels of thyroid hormone are necessary for correct migration 

of cortical neurons during brain formation (1st trimester), 

neuronal proliferation during cerebellar formation (2nd 

trimester), microtubule formation, and myelin deposition 

(postnatal).[FN9: Glinoer D. Potential consequences of maternal 

hypothyroidism on the offspring: Evidence and implications. 

Horm Res 55:109-114, 2001.] Since the need for adequate thyroid 

hormone begins early in development, often before a mother may 
know that she is pregnant, treatment with iodide supplements 

may be too late to rescue early thryroid-dependent 

developmental processes. 

In infants with early-life or prenatal onset of hypothyroidism, 

a condition where the thyroid does not produce adequate levels 

of thyroid hormone, researchers have recorded lasting effects 

in selective memory and attention deficits, language, hearing, 

and vestibular function [FN10: Rovet JF. Congenital 

hypothyroidism: an analysis of persisting deficits and 

associated factors. Neuropsychol Dev Cogn C Child Neuropsychol. 

2002 Sep;8(3):150-62. Review.]. Congenital hypothyroidism in 

infants is not uncommon, occurring in one out of every 

3,500-5,000 children in North America. Surveys in pregnant 

women in the U.S. have reported that 2.5 percent of pregnant 

women have borderline or subclinical hypothyroidism (thyroid 

stimulating hormone (TSH) concentrations above 6 mU/l), and 

about 1 percent are estimated to have frank hypothyroidism. 

Since there are over 4 million babies born annually, this 

represents 40,000 infants born to mothers with frank 

hypothyroidism. A 1999 study by Dr. James Haddow, medical 

director, Foundation for Blood Research, showed that children 

born to mothers with untreated hypothyroidism during pregnancy 

score lower on IQ tests than children of healthy mothers.[FN11: 

Haddow JE, Palomaki GE, Allan WC, Williams JR, Knight GJ, 

Gagnon J, O'Heir CE, Mitchell ML, Hermos RJ, Waisbren SE, Faix 

JD, Klein RZ. N Engl J Med. 1999 Maternal thyroid deficiency 

during pregnancy and subsequent neuropsychological development 

of the child. Aug 19;341(8):549-55. Comment in: N Engl J Med. 

1999 Aug 19;341(8):601-2. N Engl J Med. 1999 Dec 

23;341(26):2015-6; discussion 2017. N Engl J Med. 1999 Dec 

23;341(26):2015; discussion 2017. N Engl J Med. 1999 Dec 

23;341(26):2016-7. N Engl J Med. 1999 Dec 23;341(26):2016; 

discussion 2017.] Of the 62 women in Dr. Haddow's study, only 

14 were diagnosed and receiving treatment for hypothyroidism 

before their pregnancies. Of those with untreated 

hypothyroidism, their children's IQ scores averaged 7 points 

below the children of mother's with normal thyroid hormone 

levels, and 19 percent had IQ scores below 85. Children who 

have an I.Q. less than 85 are more likely to have difficulties 

in school, and may be less successful in their careers and 

interpersonal relationships. In a later study researchers 

reported that pregnant women with borderline or more severe 
hypothyroidism (TSH levels 6mU/L or greater) have an almost 

four-times greater risk for miscarriage during the second 

trimester.[FN12: Allan WC, Haddow JE, Palomaki GE, Williams JR, 

Mitchell ML, Hermos RJ, Faix JD, Klein RZ. Maternal thyroid 

deficiency and pregnancy complications: implications for 

population screening. J Med Screen. 2000;7(3):127-30.] This 

study suggests that 6 out of every 100 late term miscarriages 

may be attributable to thyroid deficiency during pregnancy. 

The World Health Organization recognizes iodine deficiency as 

the most common preventable cause of mental retardation in the 

world. Without adequate maternal iodine intake, both the fetus 

and mother are hypothyroid. Without appropriate diagnosis and 

treatment with iodide supplements the child may suffer abnormal 

neurodevelopment, in extreme cases leading to cretinism with 

mental retardation, deaf-mutism and spasticity. The World 

Health Organization estimated in 1990 that 20 million people 

worldwide had some degree of brain damage due to iodine 

deficiency experienced in fetal life. Although iodine 

deficiency is less common in the United States, the CDC 

biomonitoring data found that among women of childbearing age, 

15% have low urine iodine concentrations (below 5 ug/dl) 

indicative of iodine deficiency. These women would be expected 

to be most vulnerable to the toxic effects of perchlorate 

during pregnancy. CDC reported that iodide deficiency was most 

common in women living below the poverty level, and people in 

the Southern U.S. 

Because perchlorate crosses the placenta, it has the potential 

to directly affect the fetus, and may induce hypothyroidism in 

the fetus and newborn, in addition to its indirect fetal 

effects through interference with maternal thyroid 

activity.[FN13: Clewell RA, Merrill EA, Yu KO, Mahle DA, 

Sterner TR, Mattie DR, Robinson PJ, Fisher JW, Gearhart JM. 

Predicting fetal perchlorate dose and inhibition of iodide 

kinetics during gestation: a physiologicallybased 

pharmacokinetic analysis of perchlorate and iodide kinetics in 

the rat. Toxicol Sci. 2003 Jun;73(2):235-55.] A 2005 study 

reported that perchlorate was detected in all 38 samples of 

breast milk from women living in 18 states across the U.S. 

Perchlorate was also detected in all but one of the 47 store 

milk samples from 11 states. Although the study had a limited 
number of samples, it did report that the breast milk with the 

highest perchlorate levels (above 10 ug/L) also had the lowest 

iodide content.[FN14: Kirk AB, Martinelango PK, Tian K, Dutta 

A, Smith EE, Dasgupta PK. Perchlorate and iodide in dairy and 

breast milk. Environ Sci Technol. 2005 Apr 1;39(7):2011-7] 

These data suggest that perchlorate contamination in breast 

milk may lower the iodide content, thereby creating a double 

jeopardy for the breastfeeding infant, robbing its food source 

of necessary iodide while also dosing it with perchlorate. Most 

concerning, these researchers reported that in the breast milk 

samples the average concentration of perchlorate was five times 

higher than in store milk, raising concern that the healthiest 

source of food for newborns is in need of regulatory 

protection. 

Several studies have demonstrated exposure and measurable 

effects of perchlorate exposure in children and adults: 

* Blount et al. (2006a). This study found detectable 

perchlorate levels in all urine samples from 2,820 individuals 

studied as part of the National Health and Nutrition 

Examination Survey (NHANES) in 2001 and 2002. Researchers found 

a median perchlorate level of 3.6 ug/l (3.38 ug/g creatinine) 

and a 95th percentile level of 14 ug/l (12.7 ug/g creatinine). 

The estimated doses corresponding to the urinary levels of 

perchlorate were below the EPA Reference Dose (RfD).[FN15: 

Blount BC, Valentin-Blasini L, Osterloh JD, Mauldin JP, Pirkle 

JL. Perchlorate Exposure of the U.S. Population, 2001-2002. J 

Expo Sci Environ Epidemiol. 2007 Jul;17(4):400-7.] 

* Blount et al. (2006b). This study involved a portion of the 

study cohort described in Blount 2006a, cited above. The 

researchers studied the relationship between low-level 

perchlorate exposure as indicated by perchlorate concentrations 

in urine and serum levels of total thyroxine (T4) and thyroid 

stimulating hormone (TSH) in 2,299 men and women aged 12 and 

older. The study found that higher perchlorate levels were 

significantly correlated with lower levels of T4 and higher 

levels of TSH in women with low urinary iodine (<100 

ug/l).[FN16: Blount BC, Pirkle JL, Osterloh JD, Valentin- 

Blasini L, Caldwell KL. Urinary perchlorate and thyroid hormone 
levels in adolescent and adult men and women living in the 

United States. Environ Health Perspect. 2006 

Dec;114(12):1865-71.] 

* Brechner et al, 2000. Authors report an association between 

perchloratecontaminated drinking water in Yuma, Arizona and 

abnormal thyroid function in newborns. Their data suggest that 

even low-level perchlorate may increase risk of thyroid 

disruption in newborns.[FN17: Brechner RJ, Parkhurst GD, Humble 

WO, Brown MB, Herman WH. Ammonium perchlorate contamination of 

Colorado River drinking water is associated with abnormal 

thyroid function in newborns in Arizona. J Occup Environ Med. 

2000 Aug;42(8):777-82.] 

* Schwartz 2001. An unpublished study reported that perchlorate 

contaminated drinking water in a Southern California community 

is associated with thyroid disruption in newborns in a dose- 

dependent manner, with measurable effects at contamination 

levels of 3 to over 13 ug/L. 

The Blount et al. 2006a and 2006b studies cited above were 

published after EPA issued its 24.5 ppb Drinking Water 

Equivalent Level (DWEL) for perchlorate. Taken together, these 

studies provide key evidence about perchlorate interference 

with thyroid hormones at levels below the EPA Reference Dose 

(RfD) and demonstrate the inadequacy of the 24.5 ppb DWEL that 

was calculated based on the RfD. 

EPA drinking water monitoring data show that widespread 

contamination may be exposing millions of people to perchlorate 

throughout the country. EPA's Unregulated Contaminant 

Monitoring Rule (UCMR) required all large public water systems 

(serving a population of over 10,000 people) and a sample of 

smaller systems to monitor for perchlorate for a period of 

three years beginning in 2001. Public water systems (PWS) in 26 

states and two U.S. territories had reported perchlorate 

detections as of the January 2005 UCMR data release.[FN18: U.S. 

EPA. Unregulated Contaminant Monitoring Rule, [January 2005 

data release]. http://www.epa.gov/safewater/ucmr/index.html] 

Concentrations in the samples that tested positive for 
perchlorate ranged from 4.0 ppb (the minimum reporting level or 

MRL) to 420.0 ppb, with an average of 10.0 ppb. Of the 32,877 

samples analyzed nationally, 614, or 1.9 percent, contained 

perchlorate at or above the MRL. A total of 153 of the 3,722 

PWS tested, or 4.1 percent, detected perchlorate in their 

water. These systems served a population of 12.6 million, or 

7.0 percent of the population served by all the PWS monitored. 

California and Arizona had the largest populations served by 

systems that detected perchlorate, with 5.3 million and 2.7 

million, respectively. 

Some perchlorate detections in PWS seem to correspond closely 

with the locations of known perchlorate releases, particularly 

in some sites in California and Arizona, while in other states 

there is no apparent connection. Unidentified releases may play 

a role, but since perchlorate contamination can travel long 

distances in groundwater and surface water, geographic 

proximity to a release site is not always necessary for a water 

source to become contaminated. EPA had listed 109 sites of 

known perchlorate releases in 29 states as of December 10, 

2004.[FN19: U.S. EPA. Known Perchlorate Releases in the U. S. - 

December 10, 2004. 

http://www.epa.gov/fedfac/pdf/detection_with_dates_12_10_04.pdf 

] 

Other agencies have collected perchlorate occurrence data that 

demonstrate that perchlorate is even more widespread than the 

UCMR database indicates. NRDC has reviewed the following data 

sources: 

* Arizona: The Arizona Departments of Environmental Quality 

(ADEQ) and Water Resources (ADWR) conducted a study of 

perchlorate contamination in water between May and August, 

2004, after two earlier studies by ADEQ and the City of Phoenix 

documented numerous occurrences of perchlorate in ground and 

surface waters in 1999 and 2000. Researchers analyzed a total 

of 41 surface water samples, 35 groundwater samples, and 12 

samples from underground recharge facilities supplied by 

Colorado River water. The sampling points included both 

drinking and non-drinking water sources.[FN20: Arizona 

Department of Environmental Quality (ADEQ)., Perchlorate in 
Arizona: Occurrence Study of 2004 (revised). 

http://www.azdeq.gov/function/about/perch.html.] 

* California: The California Department of Health Services 

(DHS) began tracking perchlorate occurrence in drinking water 

wells in 1997, and has required PWS to test for it since 1999. 

The data produced by the early well tests have been entered 

together with more recent drinking water monitoring data in a 

database maintained by the DHS Drinking Water Program. Although 

the database reporting limit is 4 ppb, it contains results for 

some samples with perchlorate levels as low as 1 ppb. As of 

April 2005, the database contained perchlorate sampling results 

for 1,231 PWS with active water sources. It also contained 

perchlorate results for 34 agricultural and monitoring sites 

belonging to 17 systems.[FN21: California Department of Health 

Services (DHS). California Drinking Water Data [database on 

CD], April 2005.] 

* Massachusetts: The Massachusetts Department of Environmental 

Protection (DEP) promulgated an emergency regulation in 

February 2004 that required all community and non-transient, 

non-community (NTNC) water systems to test for perchlorate at 

each entry point. Groundwater systems were required to monitor 

in April and September, 2004. Surface water systems had to test 

in March 2004 and quarterly during the remainder of 2004. The 

DEP database contains results as low as 0.19 ppb, but 

concentrations below 1 ppb were below the limit of 

quantitation. The concentrations reported for these positive 

samples are usually laboratory estimates.[FN22: Personal 

communication from D. Guterman, Massachusetts DEP, April 5, 

2005.] The DEP database contained monitoring results for 706 

PWS as of March 2005.[FN23: Massachusetts Department of 

Environmental Protection. Perchlorate monitoring results [data 

provided by Drinking Water Program], March 2005.] 

* Texas: In 2002 Texas Tech University (TTU) Water Resources 

Center initiated a two-phase study of perchlorate contamination 

in the High Plains area of western Texas for the Texas 

Commission on Environmental Quality. In 2003 the second phase 

of the investigation extended the initial nine-county study 

area to encompass 54 counties. A total of 560 PWS wells, 29 
U.S. Geological Survey (USGS) wells, 99 High Plains Water 

District (HPWD) wells and 76 private wells were sampled.[FN24: 

W.A. Jackson et al., Distribution and Potential Sources of 

Perchlorate in the High Plains Region of Texas: Final Report, 

Texas Tech University Water Resources Center, prepared for 

Texas Commission on Environmental Quality, 2004., 

http://www.waterresources.ttu.edu/research.htm.] 

* U.S. Government Accountability Office (GAO): In May 2005 GAO 

published a report on perchlorate contamination and actions 

taken to address this problem in the U.S. This report listed 

perchlorate release sites and perchlorate detections in public 

water systems and private wells.[FN25: U.S. Government 

Accountability Office (GAO), Perchlorate: A System to Track 

Sampling and Cleanup Results Is Needed, 2005, GAO-05-462. 

http://www.gao.gov] 

A review of these data sources conducted by NRDC in 2005 found 

reports of of 5,369 public water systems sampled, of which 402 

(7.5 percent) detected perchlorate in their water. The highest 

concentrations were reported by systems in Massachusetts and 

Puerto Rico, where the highest levels found were 1,300 and 420 

ppb, respectively. Water systems in California, the state with 

the most affected systems, had concentrations ranging from 1.0 

to 130 ppb, with an average of 9.2 ppb in positive samples 

The occurrence, exposure and health effects data discussed 

above support the establishment of a Maximum Contaminant Level 

(MCL) for perchlorate. Unlike the existing DWEL, which fails to 

take into account the demonstrated effects of perchlorate 

exposure at low doses, the MCL should be protective of 

sensitive subpopulations such as pregnant women, fetuses, 

infants and children. In developing the MCL, EPA must consider 

factors such as body weight and routes and patterns of 

exposure, and include an appropriate margin of safety. 

Perfluorooctanoic acid. We are pleased that the Agency included 

perfluorooctanoic acid or PFOA (CAS # 335-67-1) on the draft 

CCL3. Because of the toxicity and widespread exposure to PFOA, 

we believe that the time is ripe for EPA to regulate PFOA 
within this cycle, as required by the SDWA. 

The adverse health effects associated with exposure to PFOA are 

well documented. PFOA binds to serum proteins in blood and acts 

as an endocrine disruptor (lowering testosterone concentrations 

while increasing estradiol levels) and developmental toxicant, 

as found in some animal studies on rats.[FN26: Jensen AA, 

Leffers H. Emerging endocrine disrupters: perfluoroalkylated 

substances. Int J Androl. 2008 Apr;31(2):161-9.] A study of 

fish hepatocytes has confirmed the estrogenic properties of 

PFOA found in rat studies.[FN27: Liu C, Du Y, Zhou B. 

Evaluation of estrogenic activities and mechanism of action of 

perfluorinated chemicals determined by vitellogenin induction 

in primary cultured tilapia hepatocytes. Aquat Toxicol. 2007 

Dec 30;85(4):267-77.] 

A study in female mice found that PFOA decreased IgM antibody 

synthesis.[FN28: Dewitt JC, Copeland CB, Strynar MJ, Luebke 

RW. Perfluorooctanoic Acid-Induced Immunomodulation in Adult 

C57BL/6J or C57BL/6N Female Mice. Environ Health Perspect. 2008 

May;116(5):644-50] PFOA has also been found to cause liver 

damage in mice, which is characterized by multifocal 

coagulation, liquefaction necrosis, hepatocytomegaly, 

acidophilic cytoplasm and other cellular changes.[FN29: Son HY, 

Kim SH, Shin HI, Bae HI, Yang JH. Perfluorooctanoic acid- 

induced hepatic toxicity following 21-day oral exposure in 

mice. Arch Toxicol. 2008 Apr;82(4):239-46.; FN30: Wolf DC, 

Moore T, Abbott BD, Rosen MB, Das KP, Zehr RD, Lindstrom AB, 

Strynar MJ, Lau C. Comparative Hepatic Effects of 

Perfluorooctanoic Acid and WY 14,643 in PPAR-{alpha} Knockout 

and Wild-type Mice. Toxicol Pathol. 2008 May 8.] This compound 

also causes liver, testis and pancreatic tumors in rats.[FN31: 

Kennedy GL Jr, Butenhoff JL, Olsen GW, O'Connor JC, Seacat AM, 

Perkins RG, Biegel LB, Murphy SR, Farrar DG. The toxicology of 

perfluorooctanoate. Crit Rev Toxicol. 2004 Jul- 

Aug;34(4):351-84.] PFOA causes changes in gene expression 

affecting inflammation, cell cycle regulation, and metabolic 

processes.[FN32: Rosen MB, Abbott BD, Wolf DC, Corton JC, Wood 

CR, Schmid JE, Das KP, Zehr RD, Blair ET, Lau C. Gene Profiling 

in the Livers of Wild-Type and PPAR{alpha}-Null Mice Exposed to 

Perfluorooctanoic Acid (PFOA). Toxicol Pathol. 2008 May 8.; 

FN33: Wei Y, Chan LL, Wang D, Zhang H, Wang J, Dai J. Proteomic 
analysis of hepatic protein profiles in rare minnow 

(Gobiocypris rarus) exposed to perfluorooctanoic acid. J 

Proteome Res. 2008 Apr;7(4):1729-39.] Neurotoxic effects have 

also been found in mice exposed neonatally to PFOA.[FN34: 

Johansson N, Fredriksson A, Eriksson P. Neonatal exposure to 

perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid 

(PFOA) causes neurobehavioural defects in adult mice. 

Neurotoxicology. 2008 Jan;29(1):160-9.] 

Studies have indicated effects on humans as well. A study of 

newborn children in Maryland found an association between PFOA 

concentrations in cord serum and infants' birth weight and 

size.[FN35: Apelberg BJ, Witter FR, Herbstman JB, Calafat AM, 

Halden RU, Needham LL, Goldman LR. Cord serum concentrations of 

perfluorooctane sulfonate (PFOS) and perfluorooctanoate (PFOA) 

in relation to weight and size at birth. Environ Health 

Perspect. 2007 Nov;115(11):1670-6.] In a study of 454 workers 

occupationally exposed to PFOA, higher levels of serum PFOA 

were associated with increased total cholesterol, decreased 

total bilirubin and increased serum aspartate aminotransferase, 

providing evidence of PFOA effects on the human liver.[FN36: 

Sakr CJ, Leonard RC, Kreckmann KH, Slade MD, Cullen MR. 

Longitudinal study of serum lipids and liver enzymes in workers 

with occupational exposure to ammonium perfluorooctanoate. J 

Occup Environ Med. 2007 Aug;49(8):872-9.] 

In addition to these health effects, concerns about the 

occurrence and bioaccumulation of PFOA in the general 

population have existed since the 1990s.[FN37: U.S. 

Environmental Protection Agency. Basic Information on PFOA. 

http://www.epa.gov/oppt/pfoa/pubs/pfoainfo.htm] Wastewater 

treatment plants (WWTP) are an important source of PFOA 

contamination in surface water,[FN38: Sinclair E, Kannan K. 

Mass loading and fate of perfluoroalkyl surfactants in 

wastewater treatment plants. Environ Sci Technol. 2006 Mar 

1;40(5):1408-14.] which degrades drinking water sources. As a 

result, drinking water is an important pathway of PFOA 

exposure. 

Elevated concentrations of PFOA have been found near facilities 

that use perfluorinated compounds or process wastewater 
containing these chemicals. For example, PFOA concentrations of 

253 to 1150 ng/L were detected in the Conasauga River in 

Georgia. The study location was downstream of a wastewater land 

application site in Dalton, GA home to a large carpet 

manufacturing facility that is a source of fluorinated 

chemicals. Meanwhile, PFOA levels in streams and ponds in the 

Dalton area ranged from 49.9 to 299 ng/L.[FN39: Konwick BJ, 

Tomy GT, Ismail N, Peterson JT, Fauver RJ, Higginbotham D, Fisk 

AT. Concentrations and Patterns of Perfluoroalkyl Acids in 

Georgia, USA Surface Waters Near and Distant to a Major Use 

Source. Environ Toxicol Chem. 2008 Apr 17:1.] 

It has been estimated that the daily exposure of Americans to 

PFOA ranges from 1 to 130 ng/kg(bw)/day, the greater portion of 

which is due to oral exposure through food and drinking 

water.[FN40: Trudel D, Horowitz L, Wormuth M, Scheringer M, 

Cousins IT, Hungerbühler K. Estimating consumer exposure to 

PFOS and PFOA. Risk Anal. 2008 Apr;28(2):251-69.] A study near 

a fluoropolymer production facility determined that exposure 

through drinking water, rather than inhalation exposure, was 

the determinant factor in serum PFOA levels.[FN41: Emmett EA, 

Shofer FS, Zhang H, Freeman D, Desai C, Shaw LM. Community 

exposure to perfluorooctanoate: relationships between serum 

concentrations and exposure sources. J Occup Environ Med. 2006 

Aug;48(8):759-70.] A similar German study also concluded that 

drinking water is a key exposure pathway near PFOA-contaminated 

sites. In this study, researchers analyzed blood PFOA levels in 

a study population of 691 individuals aged 6 to 69 years who 

lived near an agricultural area contaminated by the application 

of soil conditioner mixed with industrial waste. This 

population was exposed to PFOA through contaminated drinking 

water at concentrations of 500-640 ng/L The study found average 

PFOA levels in blood of 24.6 ug/L (children 5-6 years), 26.7 

ug/L (mothers 23-49 years), and 28.5 ug/L (men 18-69 years). 

These values are 4.5 to 8.3 times higher than concentrations 

detected in a control population. PFOA concentrations were 

significantly related to tap water consumption at home.[FN42: 

Hölzer J, Midasch O, Rauchfuss K, Kraft M, Reupert R, Angerer 

J, Kleeschulte P, Marschall N, Wilhelm M. Biomonitoring of 

perfluorinated compounds in children and adults exposed to 

perfluorooctanoatecontaminated drinking water. Environ Health 

Perspect. 2008 May;116(5):651-7.] 
The 2003-2004 National Health and Nutrition Examination Survey 

(NHANES) found PFOA levels in 99.7% of the samples of human 

blood serum collected from the 2,094 study participants. The 

geometric mean PFOA concentration was 3.9 ug/L (95% confidence 

interval: 3.6 - 4.3 ug/L). This study population was 

representative of the general U.S. population above 12 years of 

age.[FN43: Calafat AM, Wong LY, Kuklenyik Z, Reidy JA, Needham 

LL. Polyfluoroalkyl chemicals in the U.S. population: data from 

the National Health and Nutrition Examination Survey (NHANES) 

2003-2004 and comparisons with NHANES 1999-2000. Environ Health 

Perspect. 2007 Nov;115(11):1596-602.] In addition, a study of 

299 newborn children born in Baltimore, MD, determined that 

PFOA was present in 100% of the cord serum samples. The 

geometric mean concentration was 1.6 ng/mL.[FN44: Apelberg BJ, 

Goldman LR, Calafat AM, Herbstman JB, Kuklenyik Z, Heidler J, 

Needham LL, Halden RU, Witter FR. Determinants of fetal 

exposure to polyfluoroalkyl compounds in Baltimore, Maryland. 

Environ Sci Technol. 2007 Jun 1;41(11):3891-7] 

PFOA is persistent both in the environment and in the human 

body. In a study of retired perfluorochemical workers, the 

arithmetic and geometric mean elimination half-life of PFOA in 

blood serum was found to be 3.8 years, respectively, indicating 

a long persistence in the organism.[FN45: Olsen GW, Burris JM, 

Ehresman DJ, Froehlich JW, Seacat AM, Butenhoff JL, Zobel LR. 

Half-life of serum elimination of 

perfluorooctanesulfonate,perfluorohexanesulfonate, and 

perfluorooctanoate in retired fluorochemical production 

workers. Environ Health Perspect. 2007 Sep;115(9):1298-305.] 

Given the adverse health effects associated with exposure to 

PFOA, as well as the widespread PFOA contamination in the 

environment, EPA must determine to regulate levels of this 

chemical in drinking water, which will meaningfully reduce 

health risks for those served by public water systems. 

EPA has not included some contaminants on the CCL3 that should 

be listed 
Despite the appearances of having a comprehensive process for 

creating the CCL3 - by first looking at the universe of 

contaminants and then culling that list down - EPA failed to 

include some important categories of contaminants that are 

posing significant risk of adverse health effects in drinking 

water. 

Alkylphenol polyethoxylates (APEs). These compounds include: 

* Alkylphenol mono- to tri-oxylates (CAS # 68555-24-8) 

* Nonylphenol (NP) (CAS # 25154-52-3) 

* Nonylphenol ethoxylate (NPE) (CAS # 9016-45-9) 

* Octylphenol (OP) (CAS # 27193-28-8) 

* Octylphenol ethoxylate (OPE) (CAS # 9036-19-5) 

An estimated 450,000,000 pounds of alkylphenol polyethoxylates 

(APEs) are produced annually in the United States, and about 

half that amount is estimated to be released to wastewater. 

Alkylphenols were first reported to be estrogenic in the 1930s. 

In 1991, publication of the effects of nonylphenol on cultured 

human breast cancer cells led to health concerns. Estrogenic 

effects have also been shown in the mouse. Estrogenic effects 

are present at tissue concentrations of 0.1 μM for octylphenol 

and 1 μM for nonylphenol. A recombinant yeast screen using the 

human estrogen receptor has shown similar results.[FN46: Ying 

GG, Williams B, Kookana R. Environmental fate of alkylphenols 

and alkylphenol ethoxylates--a review. Environ Int. 2002 

Jul;28(3):215-26.] 

Alkylphenol polyethoxylates do not break down effectively in 

sewage treatment plants or in the environment. Instead they 

degrade to alkylphenols and alkylphenol ethoxylates, which 

persist for longer. Nonylphenol and its ethoxylates, and other 

alkylphenols, have been detected in wastewater and in 

waterways.[FN47: Gatidou G, Thomaidis NS, Stasinakis AS, Lekkas 

TD. Simultaneous determination of the endocrine disrupting 

compounds nonylphenol, nonylphenol ethoxylates, triclosan and 

bisphenol A in wastewater and sewage sludge by gas 

chromatography-mass spectrometry. J Chromatogr A. 2006 Oct 27.] 
Antibiotics. In March 2008, the Associated Press released a 

report on finding pharmaceuticals in drinking water that 

garnered considerable press across the country, despite EPA 

being cognizant of this problem for at least a decade. 

Currently, there are no pharmaceuticals listed on any of the 

CCLs. In light of the widespread presence of these chemicals in 

our drinking water, EPA must act now and include a subset of 

the chemicals on the CCL3. 

Widespread exposure to antibiotics is contributing to the 

growth of bacterial resistance, and this problem is of grave 

concern. In the past several decades almost every bacteria that 

can cause infections in humans has developed resistance to at 

least one antibiotic, and some are resistant to multiple 

antibiotics. The Centers for Disease Control and Prevention 

(CDC) have identified antibiotic resistance as one of the most 

pressing public health problems to face our nation.[FN48: 

Centers for Disease Control and Prevention (CDC). Campaign to 

Prevent Antimicrobial Resistance in Healthcare Settings. 

http://www.cdc.gov/drugresistance/healthcare/problem.htm] 

Infections caused by bacteria with resistance to at least one 

antibiotic have been estimated to kill over 60,000 hospitalized 

patients each year.[FN49: Health Care Without Harm. Antibiotic 

Resistance and Agricultural Overuse of Antibiotics, 2005. 

http://www.noharm.org/details.cfm?ID=938&type=document] 

Antibiotic resistance is caused by a number of factors 

including repeated and improper use of antibiotics in both 

humans and animals. Scientists also agree that exposure to low 

levels of antibiotics actually promotes bacterial resistance by 

exerting selective pressure for genes that promote resistance. 

Antibiotics are found in wastewater because the body does not 

completely metabolize all drugs, so both the metabolized and 

unmetabolized drug are excreted by humans into wastewater. For 

example, when amoxicillin is ingested, 60-75% of the antibiotic 

is excreted unchanged into the urine. This antibiotic, now in 

the environment, may encounter other bacteria and promote 

resistance. It is unknown how much of an impact current low 

levels of antibiotics in drinking water are having on the 

problem of bacterial resistance. However, the potential has 

been recognized for many years.[FN50: USA Today, in an 11/8/00 
news article stated, "Experts fear that even low levels of 

antibiotics fouling the nations water supply may help create 

super-bugs: micro organisms that have evolved to survive an 

antibiotics lethal assault."] 

Massive quantities of antibiotics are used in agriculture both 

to treat infections and as food additives to promote growth and 

to compensate for conditions that contribute to infection. 

Animals raised in Concentrated Animal Feeding Operations 

(CAFOs) are at increased risk for infection due to close 

confinement and stress. In fact, it has been estimated that 70% 

of the antibiotics used in the U.S. are for animal 

husbandry.[FN51: Mellon et al. Hogging It: Estimates of 

Antimicrobial Abuse in Livestock. Union of Concerned 

Scientists: Cambridge MA. 2000.] Improper use and overuse of 

antibiotics in livestock and poultry can cause resistance in 

strains of bacteria that can infect humans. Furthermore, half 

of the antibiotics used in livestock are in the same classes of 

drugs that are used in humans. As a result the U.S. Institute 

of Medicine (IOM) and the World Health Organization (WHO) both 

stated that the widespread use of antibiotics in agriculture is 

contributing to antibiotic resistance in humans.[FN52: Quotes 

from the Healthcare Without Harm factsheet. Antibiotic 

Resistance and Agricultural Overuse of Antibiotics. 2005. 

http://www.noharm.org/us/food/issue U.S. Institute of 

Medicine/National Academy of Science: "Clearly, a decrease in 

antimicrobial use in human medicine alone will have little 

effect on the current [antibiotic-resistant] situation. 

Substantial efforts must be made to decrease inappropriate 

overuse in animals and agriculture as well." World Health 

Organization: "There is clear evidence of the human health 

consequences due to resistant organisms resulting from non- 

human usage of antimicrobials. These consequences include 

infections that would not have otherwise occurred, increased 

frequency of treatment failures (in some cases death) and 

increased severity of infections."] 

Large animal feeding operations generate a large amount of 

waste that can potentially contaminate groundwater and 

waterways contributing to antibiotic resistance and 

contamination of waterways with steroid hormones.[FN53: 

Gilchrist MJ, Greko C, Wallinga DB, Beran GW, Riley DG, Thorne 
PS. The potential role of concentrated animal feeding 

operations in infectious disease epidemics and antibiotic 

resistance. Environ Health Perspect. 2007 Feb;115(2):313-6. 

Wallinga D, Mellon M, Roach S. Antibiotic use in swine farms in 

Alberta. Can Vet J. 2006 Dec;47(12):1153; author reply 1153-4. 

Wallinga D. Public health advocate. Prev Vet Med. 2006 Feb 

24;73(2-3):221-8. Epub 2005 Oct 28.] As occurs in humans, some 

portion of the antibiotics administered to livestock will pass 

unchanged through their bodies and will be excreted in their 

waste. It has been estimated that between 25-75% of antibiotics 

are excreted unchanged in feces and can persist in the soil 

after land application.[FN54: Chee-Sanford, J.C., et al. 

Occurrence and Diversity of Tetracycline Resistance Genes in 

Lagoons and Groundwater Underlying Two Swine Production 

Facilities. Applied and Environmental Microbiology, April 2001. 

Vol. 6 no. 4, pp. 1494-1502.] Manure is applied in large 

quantities as fertilizer in farm fields. In addition to 

potentially contaminating the food supply with antibiotic 

resistant bacteria, antibiotics in manure can persist in soil 

and promote the development of more antibiotic resistant 

bacteria. Animal waste and its associated contaminants can 

enter waterways through groundwater contamination, overflow of 

waste lagoons into surface water or by over-application of 

manure as fertilizer in farm fields. A recently published study 

found evidence of fecal contamination and increased levels of 

antibiotic resistant bacteria downstream of a swine 

concentrated feeding operation.[FN55: Sapkota AR, et al. 

Antibiotic-resistant enterococci and fecal indicators in 

surface water and groundwater impacted by a concentrated Swine 

feeding operation. Environ Health Perspect. 2007 

Jul;115(7):1040-5.] Other studies have found antibiotic 

resistance in groundwater underlying a swine waste 

lagoon.[FN56: Chee-Sanford, J.C., et al. Occurrence and 

Diversity of Tetracycline Resistance Genes in Lagoons and 

Groundwater Underlying Two Swine Production Facilities. Applied 

and Environmental Microbiology, April 2001. Vol. 6 no. 4, pp. 

1494-1502.] 

As such, antibiotics that are used both for human medical needs 

and in large-scale agriculture operations at low levels in 

animal feed to promote animal growth must be included on the 

CCL3 and must be regulated. These antibiotics include 

bacitracin zinc, spiramycin, tylosin, and virginiamycin. 
Notably, these antibiotics were all banned for agricultural use 

in the European Union in 1998. 

Infections among hospital patients (nosocomial infections) from 

enterococci bacteria are very common. Such infections that 

result in human disease can be fatal, particularly those caused 

by strains of vancomycin-resistant enterococci (VRE). During 

2004, VRE caused about one of every three infections in 

hospital intensivecare units, according to the Centers CDC. As 

of 2007, the U.S. had reported seven cases of vancomycin- 

resistant Staphylococcus aureus (VRSA) infection. Therefore, 

vancomycin must be included on the CCL3. 

Beta-lactam antibiotics are a broad class of antibiotics which 

include penicillin derivatives, cephalosporins, monobactams, 

carbapenems and Beta-lactamase inhibitors. Methicillin, a form 

of penicillin, had been relied upon as an common effective 

treatment for Staphylococcus aureus infections but now many 

strains of S. aureus bacteria are resistant to methicillin. 

These are now called MRSA, or 'methicillin-resistant 

Staphylococcus aureus'. Unfortunately, MRSA is actually 

resistant to much of the entire class of penicillin-like 

antibiotics called beta-lactams. Therefore, EPA must include 

penicillin, amoxicillin, oxacillin and methicillin on the CCL3. 

Linezolid resistance in Staphylococcus aureus was reported in 

2003. Community-acquired MRSA (CA-MRSA) has now emerged as an 

epidemic that is responsible for rapidly progressive, fatal 

diseases including necrotizing pneumonia, severe sepsis and 

necrotizing fasciitis. Outbreaks of CA-MRSA infections have 

been reported in correctional facilities, among athletic teams, 

among military recruits, in newborn nurseries, and among active 

homosexual men. Therefore, linezolid must be included on the 

CCL3. 

Bisphenol A (BPA). Bisphenol A (4,4'-(1-Methylethylidene) 

bisphenol or 4,4'-Isopropylidenediphenol), (CASRN 80-05-7), is 

a monomer used as the building block of polycarbonate plastics 

and other plastics including epoxy resins. BPA is found in a 

wide variety of everyday consumer products, such as the coating 
of food and drink packaging, dental sealants, baby bottles, 

water bottles, microwave ovenware and eating utensils. As these 

products age, the polycarbonate polymer breaks down, releasing 

the BPA monomer. BPA is produced at over one million pounds per 

year and is frequently found in the environment. BPA releases 

to the environment in the U.S. totaled 1.4 million pounds in 

2006, including 3,410 pounds released directly to water and 

108,805 pounds released to the air.[FN57: U.S. EPA, Toxics 

Release Inventory, http://www.epa.gov/triexplorer.] 

A number of recent studies have revealed that early life 

exposures to low-doses of BPA result in adverse effects later 

in life. The developing fetus is especially vulnerable. 

Although many of these studies were done in laboratory animals, 

the exposures occurred at concentrations currently found in the 

human population.[FN58: Calafat AM, Ye X, Wong LY, Reidy JA, 

Needham LL. Exposure of the U.S. population to bisphenol A and 

4-tertiary-octylphenol: 2003-2004. Environ Health Perspect. 

2008 Jan;116(1):39-44.] 

* In rats, in utero exposure to BPA causes long-term effects on 

development of mammary tissue, causing preneoplastic lesions, 

increased susceptibility to cancer and increased sensitivity to 

a chemical known to cause breast cancer.[FN59: Durando M, Kass 

L, Piva J, Sonnenschein C, Soto AM, Luque EH, Muñoz-de-Toro M. 

Prenatal Bisphenol A Exposure Induces Preneoplastic Lesions in 

the Mammary Gland in Wistar Rats. Environ Health Perspect, 2007 

Jan;115(1):80-6.; FN60: Murray TJ, Maffini, MV, Ucci AA, 

Sonnenschein C and Soto AM. Induction of mammary gland ductal 

hyperplasias and carcinoma in situ following fetal bisphenol A 

exposure. Reprod Toxicol, 2007 Apr-May;23(3):383-90.] 

* Perinatal exposure to low levels of BPA causes precancerous 

prostate lesions (prostatic intraepithelial neoplasia) in rats. 

The effect appears to result from the failure in exposed 

animals of a gene to become hypermethylated as the rats 

age.[FN61: Ho SM, Tang WY, Belmonte de Frausto J, and Prins GS. 

Developmental exposure to estradiol and bisphenol A increases 

susceptibility to prostate carcinogenesis and epigenetically 

regulates phosphodiesterase type 4 variant 4. Cancer Res. 

66(11):5624-32 (2006).] 
* Experiments with mice reveal that chronic adult exposure to 

BPA causes insulin resistance, a common problem in humans that 

can lead to Type II diabetes and heart disease.[FN62: Alonso- 

Magdalena P, Morimoto S, Ripoll C, Fuentes E and Nadal A. The 

estrogenic effect of bisphenol A disrupts pancreatic beta-cell 

function in vivo and induces insulin resistance. Environ Health 

Perspect.114(1):106-12 (2006).] 

* BPA has been shown to cause aneuploidy in mouse oocytes. 

Meiotic aneuploidy is the most common cause of miscarriage in 

women.[FN63: Hunt PA, Koehler KE, Susiarjo M, Hodges CA, Ilagan 

A, Voigt RC, Thomas S, Thomas BF, and Hassold TJ. Bisphenol A 

exposure causes meiotic aneuploidy in the female mouse. Curr 

Biol. 13(7):546-53 (2003).] 

* In a small prospective study, researchers in Japan found 

women with a history of repeated spontaneous miscarriages had 

higher levels of BPA. The researchers found evidence of 

aneuploidy in several of the miscarried fetuses in concordance 

with previous studies showing BPA causes meiotic 

aneuploidy.[FN64: Sugiura-Ogasawara M, Ozaki Y, Sonta S, Makino 

T and Suzumori K. Exposure to bisphenol A is associated with 

recurrent miscarriage. Hum Reprod. 20(8):2325-9 (2005).] 

* BPA lowers sperm count in adult rats even at extremely low 

levels.[FN65: Sakaue, M, S Ohsako, R Ishimura, S Kurosawa, M 

Kurohmaru, Y Hayashi, Y Aoki, J Yonemoto and C Tohyama. 

Bisphenol-A Affects Spermatogenesis in the Adult Rat Even at a 

Low Dose. J Occup Health 43:185-190 (2001).] 

Recently, a group of 38 scientists issued a consensus statement 

expressing their concern that current levels of BPA exposure 

were contributing to the human health conditions of 

neurobehavioral problems, obesity, infertility and reproductive 

cancers.[FN66: vom Saal FS, Akingbemi BT, Belcher SM, Birnbaum 

LS, Crain DA, Eriksen M, Farabollini F, Guillette LJ Jr, Hauser 

R, Heindel JJ, Ho SM, Hunt PA, Iguchi T, Jobling S, Kanno J, 

Keri RA, Knudsen KE, Laufer H, LeBlanc GA, Marcus M, McLachlan 
JA, Myers JP, Nadal A, Newbold RR, Olea N, Prins GS, Richter 

CA, Rubin BS, Sonnenschein C, Soto AM, Talsness CE, Vandenbergh 

JG, Vandenberg LN, Walser-Kuntz DR, Watson CS, Welshons WV, 

Wetherill Y, Zoeller RT. Chapel Hill bisphenol A expert panel 

consensus statement: integration of mechanisms, effects in 

animals and potential to impact human health at current levels 

of exposure. Reprod Toxicol. 2007 Aug-Sep;24(2):131-8] In 

addition, the U.S. National Toxicology Program has issued a 

draft report expressing "some concern" that BPA could cause 

neurobehavioral abnormalities, early onset puberty, and 

reproductive cancers, especially in fetuses, infants and 

children who are exposed.[FN67: Draft NTP brief on Bisphenol A. 

Released April 14, 2008. 

http://cerhr.niehs.nih.gov/chemicals/bisphenol/BPADraftBriefVF_ 

04_14_08.pdf] 

BPA is a water contaminant. A study in Germany found BPA in 

surface water (0.0005 to 0.41 ug/L), in sewage effluents (0.018 

to 0.702 ug/L), in sediments (0.01 to 0.19 mg/kg) and in sewage 

sludge (0.004 to 1.363mg/kg dw).[FN68: Fromme H, Kuchler T, 

Otto T, Pilz K, Muller J, and Wenzel A. Occurrence of 

phthalates and bisphenol A and F in the environment. Water Res. 

36(6):1429-38 (2002).] Cousins et al. (2002) reviewed 

previously published monitoring data for the United States and 

found a median reported water concentration of 0.5 ug/l (below 

the detection limit of the studies) and a 90th percentile of 

4.4 ug/l. The same study also suggested a half-life for BPA of 

4.5 days in surface water, indicating that BPA can be 

transported hundreds of kilometers in rivers before levels fall 

below detection limits.[FN69: Cousins IT, Staples CA, Klecka 

GM, Mackay1 D. Multimedia assessment of the environmental fate 

of bisphenol A. Human and Ecological Risk Assessment 2002 

8(5):1107-1135.] 

Microbials. Mycobacterium Avium Complex (MAC) causes lung 

infections in immunocompromised individuals.[FN70: Centers for 

Disease Control, Mycobacterium avium Complex. 

http://www.cdc.gov/ncidod/dbmd/diseaseinfo/mycobacteriumavium_t 

.htm] Mycobacteria are able to survive and grow in aquatic 

environments due to their protective outer coating, which also 

makes them resistant to chlorine treatment of water. 

Environmental sources are thought to be the main route of 
transmission of these pathogens. These bacteria are widely 

present in water sources and can also be found in biofilms that 

form on the inside of water pipes.[FN71: U.S. EPA, 

Mycobacteria: Drinking Water Fact Sheet, EPA-822-F-02-002. 

http://www.epa.gov.] 

About 20 to 30 percent of people with AIDS become infected with 

MAC. Although adults usually do not get MAC disease until their 

T-cell count drops below 50, children can get it earlier. 

People with disseminated MAC disease develop fever, night 

sweats, weight loss, abdominal pain, tiredness, and diarrhea. 

EPA researchers estimate that approximately 1500 individuals 

with advanced AIDS ingest tap water with detectable 

concentrations of MAC organisms each day.[FN72: Rice G, Wright 

JM, Boutin B, Swartout J, Rodgers P, Niemuth N, Broder M. 

Estimating the frequency of tap-water exposures to 

Mycobacterium avium complex in the U.S. population with 

advanced AIDS. J Toxicol Environ Health A. 2005 Jun 

11-25;68(11-12):1033-47.] A related species typically 

considered MAC, Mycobacterium avium intracellulare, has been 

listed in Contaminant Candidate Lists (CCLs) 1 and 2. MAC 

should be included again in CCL3. The health effects and 

demonstrated occurrence in drinking water of MAC support the 

establishment of an MCL for this microbial contaminant. 

Pesticides. Aldicarb (CAS # 116-06-3) is an N-methyl carbamate 

insecticide that causes reversible red blood cell and plasma 

cholinesterase inhibition. This pesticide is classified as 

Toxicity Category 1 because of its high toxicity through all 

routes of exposure (oral, dermal and inhalation). Symptoms of 

acute aldicarb exposure observed in animal studies include 

decreased motor activity, lacrimation, tremors, salivation, 

pinpoint pupils, and decreased grip strength. A rat study by 

EPA/ORD demonstrated that young animals are more susceptible to 

aldicarb-induced brain cholinesterase inhibition than 

adults.[FN73: U.S. EPA, Aldicarb, HED Revised Preliminary Human 

Health Risk Assessment for the Reregistration Eligibility 

Decision Document (RED). May 12, 2006.] Although it is 

generally believed that acute high level exposure to aldicarb 

will not cause chronic health effects, one case study by 

Grendon et al. (1994) in Washington State documented long-term 

health problems in men and sheep resulting from a single 
poisoning incident.[FN74: Grendon J, Frost F, Baum L. Chronic 

health effects among sheep and humans surviving an aldicarb 

poisoning incident. Vet Hum Toxicol. 1994 Jun;36(3):218-23.] 

EPA has not assessed the risks of chronic exposure to aldicarb 

in its 2006 Revised Human Health Risk Assessment (HRA). The 

Agency reasoned that since cholinesterase inhibition due to 

aldicarb exposure is reversed in less than 24 hours, such an 

assessment is unnecessary and chronic exposure can be treated 

as a series of acute exposures.[FN75: U.S. EPA 2006, supra.] 

However, EPA mentioned in the Revised HRA that effects such as 

pale kidneys and hydroceles in the oviducts occurred in dams in 

a developmental study, symptoms that suggest chronic damage not 

seen in acute single-exposure cases. In addition, some studies 

suggest that chronic exposure to aldicarb may have longer-term 

effects on the immune and nervous systems. Fiore et al (2006) 

analyzed immune function in two groups of women, one exposed to 

aldicarb at environmental concentrations in groundwater at 

levels below 61 ppb (23 subjects), and an unexposed group (27 

subjects). No women in either group had known reasons for 

immune problems. The researchers found a significant 

association between aldicarb exposure and abnormalities in T- 

cell subset ratios.[FN76: Fiore MC, Anderson HA, Hong R, 

Golubjatnikov R, Seiser JE, Nordstrom D, Hanrahan L, Belluck D. 

Chronic exposure to aldicarb-contaminated groundwater and human 

immune function. Environ Res. 1986 Dec;41(2):633-45.] Hajoui et 

al. (1992) also found changes in the percentages of certain T- 

cell subsets after subchronic, but not chronic exposure.[FN77: 

Hajoui O, Flipo D, Mansour S, Fournier M, Krzystyniak K. 

Immunotoxicity of subchronic versus chronic exposure to 

aldicarb in mice. Int J Immunopharmacol. 1992 

Oct;14(7):1203-11.] The results of a rat study by Smulders et 

al. (2003) suggest that exposure to carbamates such as aldicarb 

may also lead to chronic changes in the nervous system 

resulting from the inhibition of neuronal nicotinic 

acetylcholine receptors.[FN78: Smulders CJ, Bueters TJ, Van 

Kleef RG, Vijverberg HP. Selective effects of carbamate 

pesticides on rat neuronal nicotinic acetylcholine receptors 

and rat brain acetylcholinesterase. Toxicol Appl Pharmacol. 

2003 Dec 1;193(2):139-46.] A similar study of the carbamates 

fenoxycarb, carbaryl, and S-ethyl N,N-dipropylthiocarbamate 

(EPTC), which have the same mechanism of action, showed that 

increasing the pesticide dose or the length of exposure reduced 
the rate of reversal of acetylcholine receptor 

inhibition.[FN79: Smulders CJ, Van Kleef RG, de Groot A, Gotti 

C, Vijverberg HP. A noncompetitive, sequential mechanism for 

inhibition of rat alpha4beta2 neuronal nicotinic acetylcholine 

receptors by carbamate pesticides. Toxicol Sci. 2004 

Nov;82(1):219-27.] Therefore, two mechanisms, cholinesterase 

inhibition and acetylcholine receptor inhibition may lead to 

chronic neurotoxicity from exposure to carbamate pesticides 

such as aldicarb. This raises concerns about chronic low-level 

exposure such as may result from aldicarb contamination of 

drinking water. 

EPA placed aldicarb under Special Review in 1984 due to 

concerns about groundwater contamination.[FN80: U.S. EPA, 49 FR 

28320, 1984, and 53 FR 24630, 1988.] Aldicarb degradation in 

groundwater is slow. This chemical is persistent and mobile in 

soil, and degrades in the environment to aldicarb sulfoxide and 

aldicarb sulfone, both of which are cholinesterase inhibitors. 

In 1991 EPA established MCLs of 0.003 ppb for aldicarb, 0.004 

ppb for aldicarb sulfoxide and 0.002 ppb for aldicarb sulfone, 

but these MCLs never went into effect. Instead, EPA issued a 7 

ppb health advisory for each of the aldicarb species and for 

combined aldicarb residues. 

EPA based its drinking water risk assessment in the HRA on the 

highest aldicarb concentrations in groundwater found in eight 

regions where aldicarb was used. The concentrations ranged from 

0 to 24 ppb. The region with no aldicarb detections was removed 

from the analysis. Surface water concentrations, on the other 

hand, were derived from models for lack of sufficient 

monitoring data. 

Acute dietary exposure estimates from food alone exceeded the 

level of concern for children 1 to 2 years old (159% of the 

acute Population Adjusted Dose, or aPAD), and children 3 to 5 

years old (129% aPAD), so that any additional exposures from 

drinking water would increase these risks of concern. The 

highest exposure from groundwater calculated for the regions 

where this pesticide was detected was 945% aPAD for the 95th 

percentile of the most exposed population sub-group. For the 

general U.S. population and other sub-groups, exposure ranged 
from 20% aPAD to 393% aPAD.[FN81: U.S. EPA, 2006, supra.] 

It is clear from EPA's own analysis that aldicarb is a water 

contaminant that poses health risks of concern at levels found 

in food and drinking water. Given that food exposure alone 

exceeds levels of concern for children, drinking water exposure 

creates an additional unacceptable risk. EPA must move to 

establish a protective MCL for aldicarb. 

Azinphos-methyl (CAS # 86-50-0) is an organophosphate pesticide 

classified as toxicity category 1 for oral exposure. Exposure 

to azinphos-methyl causes plasma, red blood cell and brain 

cholinesterase inhibition, with symptoms including headache, 

nausea, vomiting, dizziness, anxiety, muscle tremors and 

weakness. Studies by Souza et al. (2004, 2005) found that 

azinphos-methyl affected human placental enzymatic activity, 

which may have adverse consequences for fetal 

development.[FN82: Souza MS, Magnarelli de Potas G, Pechen de 

D'Angelo AM. Organophosphorous and organochlorine pesticides 

affect human placental phosphoinositides metabolism and PI-4 

kinase activity. J Biochem Mol Toxicol. 2004;18(1):30-6.; FN83: 

Souza MS, Magnarelli GG, Rovedatti MG, Cruz SS, De D'Angelo AM. 

Prenatal exposure to pesticides: analysis of human placental 

acetylcholinesterase, glutathione S-transferase and catalase as 

biomarkers of effect. Biomarkers. 2005 Sep-Oct;10(5):376-89.] 

Exposure to organophosphate pesticides (OPs) such as azinphos- 

methyl has been associated with lower performance on 

neurobehavioral tests in exposed adults.[FN84: Rothlein J, 

Rohlman D, Lasarev M, Phillips J, Muniz J, McCauley L. 

Organophosphate pesticide exposure and neurobehavioral 

performance in agricultural and non-agricultural Hispanic 

workers. Environ Health Perspect. 2006 May;114(5):691-6.] 

Children are more vulnerable than adults to the neurotoxic 

effects of OPs and may suffer developmental effects from low- 

level chronic exposures.[FN85: Rohlman DS, Arcury TA, Quandt 

SA, Lasarev M, Rothlein J, Travers R, Tamulinas A, Scherer J, 

Early J, Marin A, Phillips J, McCauley L. Neurobehavioral 

performance in preschool children from agricultural and non- 

agricultural communities in Oregon and North Carolina. 

Neurotoxicology. 2005 Aug;26(4):589-98.] 
Azinphos-methyl has a high potential to pollute surface waters 

due to runoff and spray drift.[FN86: U.S. EPA, Interim 

Reregistration Eligibility Decision for Azinphos-Methyl, Case 

No. 0235. October 30, 2001.; FN87: Dabrowski JM, Bennett ER, 

Bollen A, Schulz R. Mitigation of azinphos-methyl in a 

vegetated stream: comparison of runoff- and spray-drift. 

Chemosphere. 2006 Jan;62(2):204-12.] Data on environmental 

concentrations of azinphos-methyl in the United States are 

limited, but studies in South Africa suggest that under certain 

conditions azinphos-methyl may also reach high concentrations 

(>40 ppb) in groundwater.[FN88: Loewy RM, Carvajal LG, Novelli 

M, de D'Angelo AM. Effect of pesticide use in fruit production 

orchards on shallow ground water. J Environ Sci Health B. 2003 

May;38(3):317-25.; FN89: Loewy RM, Carvajal LG, Novelli M, 

Pechen de D'Angelo AM. Azinphos methyl residues in shallow 

groundwater from the fruit production region of northern 

Patagonia, Argentina. J Environ Sci Health B. 

2006;41(6):869-81.] 

EPA indicated in its drinking water assessment in the Interim 

Reregistration Eligibility Decision (IRED) document for 

azinphos-methyl that the estimated environmental concentration 

(EEC) of this pesticide in surface water is 16 ppb at typical 

application rates in peaches. This concentration is over three 

times the acute drinking water level of comparison (DWLOC) 

[FN90: The drinking water level of concern (DWLOC) is the 

amount of allowable risk left for exposure through drinking 

water, after considering the contribution from food to the 

total allowable dietary risk. The DWLOC is compared with the 

drinking water estimated environmental concentration (EEC) to 

determine whether drinking water exposure risks are of 

concern.] the agency calculated for infants less than a year 

old (5 ppb), and over twice the DWLOC for children 1-6 years (6 

ppb). The highest annual mean concentrations in surface water 

according to monitoring data and EPA models ranged from 0.27 

ppb to 7.2 ppb. The latter concentration exceeds the chronic 

DWLOC the agency calculated for infants less than a year old (7 

ppb). 

While EPA argued in the IRED that the phase-out of azinphos - 

methyl use on peaches will eliminate drinking water risks of 

concern, EPA is still allowing the use of azinphos-methyl on 
apples (the most frequently treated crop) at application rates 

equal to or higher than those for peaches (1.0-1.5 lb ai/A per 

application, 4.5 lb ai/A per year maximum on apples vs. 1.125 

lbs ai/A per application, 4.5 lbs ai/A per year maximum on 

peaches). Furthermore, the total amount of azinphos-methyl used 

on apples (890,000 lb active ingredient) is over seven times 

the amount used on peaches (120,000 lb). Therefore, the EPA 

assessment indicates that azinphos-methyl poses a risk to 

drinking water supplies. While EPA has issued a four-year 

limited registration for azinphos-methyl use on apples and 

seven other crops, the Agency has stated that these 

registrations may be extended, thus creating the need to 

regulate azinphosmethyl as a drinking water contaminant. 

Carbaryl (CAS # 63-25-2) is an N-methyl carbamate pesticide 

that acts as a neurotoxic acetylcholinesterase inhibitor and a 

"likely" carcinogen according to the Office of Pesticide 

Programs Cancer Assessment Review Committee. The systemic 

effects of carbaryl include headache, dizziness, weakness, 

shaking, nausea, stomach cramps, diarrhea, and sweating. 

Effects may also include loss of appetite, weakness, weight 

loss, and general malaise. Carbaryl is particularly toxic to 

the developing nervous system of fetuses, infants, and young 

children. Exposure to elevated levels of carbaryl may cause 

developmental neurotoxicity and "significant changes in some of 

the morphometric measurements of the brain".[FN91: Brenda 

Tarplee, U.S. EPA Health Effects Division, Carbaryl 

Reassessment Report of the FQPA Safety Factor Committee, 

Memorandum, December 13, 1999, Tox Review No. 013891.; FN92: 

Brenda Tarplee, U.S. EPA Health Effects Division, Carbaryl - 

2nd Reassessment Report of the FQPA Safety Factor Committee, 

Memorandum, April 30, 2001, Tox Review No. 014553.] 

Approximately 3.9 million pounds of carbaryl active ingredient 

are used annually in the U.S. When EPA issued its Revised Risk 

Assessment for carbaryl in 2003, its water assessment did not 

consider non-agricultural sources of carbaryl, which constitute 

a total of 40% of carbaryl use by weight, and which are the 

dominant sources of carbaryl pollution in surface water. 

Despite ignoring non-agricultural uses, the carbaryl health 

risk assessment in the Interim Reregistration Eligibility 

Decision (IRED) found that acute surface water risks presuming 
maximum label application rates exceeded the drinking water 

level of concern (DWLOC) for children and the general 

population when combined with estimated food exposures.[FN93: 

U.S. EPA, Interim Reregistration Eligibility Decision for 

Carbaryl, Case No. 0080. Revised October 22, 2004.] 

U.S. Geological Survey National Water-Quality Assessment (USGS 

NAWQA) monitoring data presented in the carbaryl assessment 

demonstrated that streams draining urban areas had both higher 

concentrations of carbaryl and more frequent detections, when 

compared with streams draining agricultural or mixed land use 

areas. It is clear that contamination of water is predominantly 

from non-agriculture uses of carbaryl, and that by not 

considering these uses, the Agency dramatically underestimated 

the amount of carbaryl in drinking water (Estimated 

Environmental Concentration, or EEC), which is likely to be 

two-times higher than EPA estimates. Twenty-one (21) percent of 

surface water samples in the NAWQA database contained 

detectable levels of carbaryl. 

EPA discussed in its IRED the limitations of existing 

monitoring data: 

"Carbaryl is fairly mobile, but is not likely to persist or 

accumulate in the environment. As such, it is difficult for 

monitoring studies to detect peak concentrations that can 

occur. EPA determined that currently available monitoring 

studies for carbaryl are limited in this regard, and did not 

use them to define peak values for carbaryl." 

As a result of these data limitations, EPA used models to 

estimate drinking water EECs for currently registered uses in 

the carbaryl IRED. The Agency reported that the acute drinking 

water EECs ranged from 23 to 410 ppb for acute exposure, and 

from 1.3 to 23 ppb for chronic exposure, which exceeded the 

acute DWLOC for children 1-2 years old (7.4 ppb) and for the 

general population (200 ppb). This is especially concerning, 

given that these calculations are likely to underestimate risk 

by excluding non-agricultural uses of carbaryl, which comprise 

40% of total carbaryl used. Therefore, it is likely that actual 
EECs are even higher, possibly 40% higher, than what the 

Agency calculates. The high toxicity of carbaryl, coupled with 

the high exceedances of acceptable levels in drinking water, 

make this level of risk to infants and children unacceptably 

high. 

Given the limitations in the monitoring data that the Agency 

has acknowledged, and the fact that the highest EEC estimated 

by EPA models was 55 times the acute DWLOC for children 1 to 2 

years old, it is clear that carbaryl presents risks of concern 

from drinking water exposure and should be regulated as a 

drinking water contaminant by establishing an MCL. 

Chlorpyrifos (CAS # 2921-88-2) is an organophosphate pesticide 

used at approximately 21-24 million pounds active ingredient 

(a.i.) annually in the United States. Most chlorpyrifos is used 

in agriculture on crops such as corn and cotton, but other uses 

include golf courses, road medians, food processing plants, 

manufacturing plants, ship holds, railroad boxcars, and non- 

structural wood treatments. Chlorpyrifos is applied aerially, 

by chemigation, groundboom, hand wand, airblast sprayer, and 

other methods.[FN94: U.S. EPA, Interim Reregistration 

Eligibility Decision for Chlorpyrifos. 2002.] 

With chlorpyrifos and other developmental neurotoxic chemicals, 

risk to the fetus, infant, and child comes primarily from the 

timing of exposure. Even a very small dose, for even a short 

duration, during a developmental period of vulnerability will 

result in permanent neural dysfunction. There is no 

demonstrated reliable threshold of safety for this highly toxic 

chemical, as indicated in the IRED, where a no-effect level 

could not be determined for developmental neurotoxicity. 

However, there is demonstrated evidence of neuropathology and 

increased vulnerability of fetuses when exposed to chlorpyrifos 

[FN95: Makris S, Raffaele K, Sette W, Seed J. A retrospective 

analysis of twelve developmental neurotoxicity studies 

submitted to the USEPA Office of Prevention, Pesticides, and 

Toxic Substances (OPPTS). Draft November 12, 1998.]. EPA has 

acknowledged this susceptibility in the chlorpyrifos Human 

Health Risk Assessment: 
"In conclusion, the weight of the evidence raises concern for 

an increase in both the sensitivity and susceptibility of the 

fetus or young animal to adverse biochemical, morphological, or 

behavioral alterations from chlorpyrifos treatment during brain 

development. With respect to cholinesterase inhibition, an 

increase in sensitivity of the young compared to adults was 

seen all along the dose response curve, even at relatively low 

doses." [FN96: U.S. EPA. Human Health Risk Assessment: 

Chlorpyrifos. 2000.] 

Although EPA said in the IRED that the drinking water risk is 

below the level of concern, the Agency noted that there have 

been cases of high levels of drinking water well contamination 

associated with localized applications of chlorpyrifos as a 

subterranean termiticide. This was addressed, EPA said, by 

eliminating all termiticidal uses. However, despite EPAs 

assertions that only termiticidal use leads to water 

contamination problems, USGS and others have found 

contamination of ground and surface water with chlorpyrifos and 

its metabolites, and EPAs own modeling shows that it is likely 

that in certain areas of heavy use, chlorpyrifos (and its 

metabolites) present significant water risks. There is no 

evidence that the water risks of chlorpyrifos and its 

metabolites are limited to termiticidal use. 

There is extensive evidence of the potential of chlorpyrifos to 

contaminate surface and groundwater. Combined USGS data for 

state, local, national, and multi-state studies that measured 

chlorpyrifos concentrations in surface water detected the 

pesticide at 7 of 108 (6%) sites sampled.[FN97: Larson, Steven 

J., Capel, Paul D., and Majewski, M.S., 1997, Pesticides in 

Surface Waters: Distribution, Trends, and Governing Factors. 

Chelsea, MI: Ann Arbor Press, 373 p. 19.] Chlorpyrifos has 

medium runoff potential due to its relatively low water 

solubility, 2 mg/L [FN98: Becker, R.L., Herzfeld, D., Ostlie, 

K.R., and Stamm-Katovich, E.J., 1989, Pesticides: Surface 

runoff. leaching, and exposure concerns, University of 

Minnesota, Minnesota Extension Service Publication AG-BU-3911, 

32 p.; FN99: Goss, DW. Screening procedure for soil and 

pesticides relative to potential water quality impacts: Weed 

Technol. 1992 6:701-8.]. A chlorpyrifos flux as a percentage of 
use of 0.15 has been measured in the Minnesota River.[FN100: 

Larson et al, 1997, supra.] Chlorpyrifos is also used in non- 

agricultural settings and can drift or runoff directly into 

surface water bodies in areas of high population density. 

Data from the Mid-Continent Pesticide Study [FN101: Burkart MR, 

Kolpin DW. Hydrologic and land-use factors associated with 

herbicides and nitrate in near-surface aquifers. J. Environ. 

Qual. 1993 22(4):646-56.] show that chlorpyrifos was present in 

the ground water in 4.2% of the wells sampled.[FN102: Barbas, 

JE, Resek, EA. 1996, Pesticides in Ground Water: Distribution, 

Trends, and Governing Factors. Chelsea, MI: Ann Arbor Press, 

588 p., at p. 98-9] Chlorpyrifos has been detected in 0.6% of 

wells sampled, according to the U.S. EPA's Pesticides in Ground 

Water Database.[FN103: Barbas & Resek, supra, at p. 167] Long 

(1989) detected chlorpyrifos in the ground water of 30% of 56 

sites examined beneath pesticide mixing and loading facilities 

in Illinois.[FN104: Long, T., 1989, Groundwater contamination 

in the vicinity of agrichemical mixing and loading facilities, 

in Illinois Agricultural Pesticides Conference: Proceedings: 

University of Illinois, College of Agricultural Consumer and 

Environmental Services, Urbana-Champaign, Ill., pp. 139-149; 

Barbas & Resek at 327.] The maximum concentration detected was 

0.5 ppb. 

Water monitoring sample sites are not necessarily correlated 

with chlorpyrifos use sites, and in particular, may miss sites 

where multiple fields are treated with chlorpyrifos resulting 

in pooled runoff into a common water source. In fact, the IRED 

states, "it is not clear that they [monitoring data] represent 

the most vulnerable groundwater where chlorpyrifos is used most 

intensively" (IRED p.18). Monitoring of surface water is likely 

to be subject to the same problem. Levels of chlorpyrifos in 

pooled runoff sites are likely to be many times higher than 

single field sites. Similarly, data collection is not timed to 

correspond with worst-case scenarios, such as closely following 

chlorpyrifos applications, or following large storm runoff 

events, and thus most often misses these highly toxic 

environmental exposures. 

Using the PRZM/EXAMS screening model, EPA estimated that 90-day 
average and peak chlorpyrifos concentrations were 6.7 and 40 

ppb respectively. Meanwhile, acute DWLOCs for infants less than 

a year old, children 1-6 years and females 13 to 50 years 

ranged from 0.9 to 9 ppb. Chronic DWLOCs for these population 

groups ranged from 0.2 to 0.72 ppb. EPA's modeling estimates 

therefore show that chlorpyrifos exposure in drinking water has 

the potential to expose vulnerable groups of the population to 

unacceptable levels of this chemical. 

Dichlorvos (CAS # 62-73-7), or DDVP, is an organophosphate 

insecticide widely used in agriculture. Like other 

organophosphates, dichlorvos is an acetylcholinesterase 

inhibitor. DDVP exposure may cause symptoms such as nausea, 

vomiting, dizziness, muscle spasms, and seizures. According to 

a 2000 EPA Cancer Assessment review, there is suggestive 

evidence that dichlorvos may cause cancer.[FN105: U.S. EPA, 

Dichlorvos (DDVP) - Report of the Cancer Assessment Review 

Committee. 2000.] The National Toxicology Program has stated 

that there is "clear evidence" of carcinogenic activity of 

dichlorvos in a mice study.[FN106: National Toxicology Program. 

NTP Toxicology and Carcinogenesis Studies of Dichlorvos (CAS 

No. 62-73-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). 

National Toxicology Program Technical Report Series 

1989;342:1-208] One study has linked dichlorvos exposure to 

leukemia in children under 15.[FN107: Leiss JK, Savitz DA. Home 

pesticide use and childhood cancer: a case-control study. Am J 

Public Health. 1995; 85:249-52] Another study has also found an 

association between dichlorvos exposure and leukemia in adult 

men.[FN108: Brown LM, Blair A, Gibson R, et al. Pesticide 

exposures and other agricultural risk factors for leukemia 

among men in Iowa and Minnesota. Cancer Res. 

1990;50(20):6585-91] Furthermore, EPA has determined that 

"dichlorvos has been shown to be a direct acting mutagen by 

common in vitro bacterial genetic toxicity assays and in vitro 

mammalian test systems."[FN109: U.S. EPA. HED Preliminary Risk 

Assessment for Dichlorvos. October 11, 2000.] 

Dichlorvos is soluble in water and may enter surface waters in 

runoff. However, no data on its occurrence in surface waters 

has been collected; there is also little data on dichlorvos in 

groundwater. Two other pesticides, naled and trichlorfon, 

degrade to dichlorvos in the environment and represent 
additional inputs of dichlorvos to water. However, monitoring 

data on these two pesticides is also very limited. 

Given the lack of monitoring data, EPA used IR-PCA PRZM/EXAMS 

models to calculate estimated drinking water concentrations 

(EDWCs) of dichlorvos in surface water. The models produced 

estimates that were below the EPA level of concern.[FN110: U.S. 

EPA. Interim Reregistration Eligibility Decision for Dichlorvos 

(DDVP), 2006.] However, the complete lack of monitoring data 

raises questions about whether an exclusive reliance on 

modeling results is appropriate for a neurotoxic and 

potentially carcinogenic pesticide such as dichlorvos. EPA 

should collect data monitoring data for dichlorvos by requiring 

such data from the registrants or commissioning its own studies 

to better assess drinking water risks and set an MCL if 

necessary. 

Dicofol (CAS # 115-32-2) is an organochlorine pesticide used in 

agriculture, primarily on cotton and citrus crops. 

Approximately 860,000 pounds of active ingredient are used 

every year. Animal studies have found that dicofol causes 

toxicity in the liver, adrenal glands, kidneys, thyroid, 

reproductive organs, heart and stomach. Liver and thyroid 

effects occurred at relatively low doses (100 ppm and 10 ppm, 

respectively). Dicofol is a possible human carcinogen.[FN111: 

U.S. EPA. Reregistration Eligibility Decision, Dicofol, 1998.] 

Dicofol has shown endocrine disruptor activity in vivo and in 

vitro.[FN112: Hoekstra PF, Burnison BK, Garrison AW, Neheli T, 

Muir DC. Estrogenic activity of dicofol with the human estrogen 

receptor: Isomer- and enantiomer-specific implications. 

Chemosphere. 2006 Jun;64(1):174-7. Epub 2005 Dec 7.; FN113: 

Thibaut R, Porte C. Effects of endocrine disrupters on sex 

steroid synthesis and metabolism pathways in fish. J Steroid 

Biochem Mol Biol. 2004 Dec;92(5):485-94. Epub 2004 Dec 21.; 

FN114: Ishihara A, Sawatsubashi S, Yamauchi K. Endocrine 

disrupting chemicals: interference of thyroid hormone binding 

to transthyretins and to thyroid hormone receptors. Mol Cell 

Endocrinol. 2003 Jan 31;199(1-2):105-17.] This chemical has 

been shown to interfere with blastocyst implantation in 

rats.[FN115: Jadaramkunti UC, Kaliwal BB. Possible mechanisms 

for the anti-implantation action of dicofol in albino rats. J 

Basic Clin Physiol Pharmacol. 2001;12(3):217-26.] 
EPA used its SCI-GROW model to estimate dicofol concentrations 

in groundwater and calculated a 90-day average peak 

concentration of 0.069 ppb. An overall mean surface water 

concentration of 0.5 ppb was estimated with the PRZM-EXAMS 

model. Both concentrations were below the Drinking Water Levels 

of Comparison (DWLOCs) for children and the general U.S. 

population for both acute and chronic exposure. However, there 

are some important shortcomings in EPA's assessment of dicofol 

exposure and risk. 

The first problem with the assessment is related to the way EPA 

calculated the Reference Dose (RfD). EPA is supposed to apply 

an additional safety factor of 10x to the RfD calculation to 

protect infants and children, who may have increased 

susceptibility to health effects from chemical exposures 

compared to adults. The Agency reduced the FQPA safety factor 

of 10x to 3x based on the lack of increased pre-natal or post- 

natal susceptibility to dicofol in developmental toxicity 

studies. However, EPA stated that a developmental neurotoxicity 

study was necessary because dicofol produced neurotoxicity in 

rats and such a study might identify an endpoint for dietary 

risk. Despite lacking such a study, EPA improperly reduced the 

safety factor to 3x. If the 10x factor had been applied as 

mandated by the Food Quality Protection Act, a more protective 

acute RfD of 0.015 mg/kg day-1 would have been chosen instead 

of the 0.05 mg/kg day-1 dose EPA used in its assessment. Had 

EPA applied the 10x safety factor, dicofol exposure from food 

alone would have exceeded the acute RfD and the EPA level of 

concern for all population groups (see Table 1). This would 

have resulted in a DWLOC of zero (0), so that any drinking 

water exposure would have been of concern. 

Table 1. Comparison of acute dietary exposure values from food 

at the 99.9th percentile [see PDF] 

The unwarranted reduction of the FQPA safety factor also 

affected the outcome of the chronic dietary exposure 

assessment. As shown in Table 2, if the 10x factor had been 

applied, chronic exposures from food alone for infants and 
children 1 to 6 years old would have exceeded the level of 

concern. Therefore, any drinking water exposure would have been 

of concern as well. 

Table 2. Chronic dietary food exposure and risk estimate from 

Dicofol (in food alone) [see PDF] 

Another shortcoming in the EPA assessment is that the Agency 

relied on models to estimate environmental concentrations in 

surface and groundwater, but did not have a robust set of 

monitoring data. EPA should require the collection of surface 

and groundwater monitoring data in areas where dicofol is 

applied. The Agency should use these data to corroborate its 

exposure estimates and make a regulatory determination for 

dicofol under the SDWA. 

Endosulfan (CAS # 115-29-7) is an organochlorine insecticide 

and acaricide. Technical grade endosulfan is made of both alpha 

and beta stereoisomers whose toxicity is manifested through 

blockage of inhibitory GABA (gamma amino butyric acid) gated 

chloride channels, resulting in over-stimulation of the central 

nervous system. Endosulfan is a recognized neurotoxin [FN116: 

Lakshmana MK, Raju TR. 1994. Endosulfan induces small but 

significant changes in the levels of noradrenaline, dopamine, 

and serotonin in the developing rat brain and deficits. 

Toxicology, 91(2): 139- 150.] and endocrine disruptor [FN117: 

Willey JB, Krone PH. 2001. Effects of endosulfan and 

nonylphenol on the primordial germ cell population in pre- 

larval zebrafish embryos. Aquat Toxicol, 54(1-2): 113-123], 

making even extremely low-dose exposures of very great concern, 

especially to vulnerable populations such as children and 

fetuses. 

Endosulfan is similar in its acute oral toxicity to the related 

insecticides aldrin and dieldrin, except that it is slightly 

more toxic than these substances in female laboratory 

animals.[FN118: OSHA comments from the January 19, 1989 Final 

Rule on Air Contaminants Project extracted from 54 FR 2332 et. 

seq.] Inhalation of endosulfan dust by humans has been 

associated with slight nausea, confusion, excitement, flushing, 
and dry mouth [FN119: State of California: Department of 

Industrial Relations/Ex. 1-8]. Nine employees who had been 

working with 50-percent water-wettable endosulfan powder for 

only a few days had convulsions [FN120: Association of American 

Pesticide Control Officials, Inc. 1969, as cited in ACGIH 

1986/Ex. 1-3, p. 230]. 

Endosulfan is a significant endocrine disruptor and 

reproductive toxicant. This pesticide increases the rate of 

testosterone breakdown and excretion.[FN121: Wilson V, LeBlanc 

GA. Endosulfan elevates testosterone biotransformation and 

clearance in CD-1 mice. Toxicol Appl Pharmacol 148:158-168, 

1998.] In immature rats, endosulfan causes significant dose- 

related decreases in sperm counts, and causes sperm deformities 

at low exposure levels.[FN122: Sinha N, Narayan R, Saxena DK. 

Effect of endosulfan on the testis of growing rats. Bulletin 

Environ Contamination Toxicol 58:79-86, 1997. Sinha N, Narayan 

R, Shanker R, Saxena DK. Endosulfan-induced biochemical changes 

in the testis of rats. Veterinary and Human Toxicol 37:547-549, 

1995.] In fish, endosulfan elevates levels of thyroxine and 

suppresses levels of triiodothyronine, probably by inhibiting 

the conversion of thyroxine to T3.[FN123: Sinha N, Lal B, 

Singh TP. Pesticides induced changes in circulating thyroid 

hormones in the freshwater catfish clarias batrachus. 

Comparative Biochem Physiol 100C: 107-110, 1991.] The 

developing brain is potentially most severely affected by this 

pesticide via altered levels of critical neurotransmitters such 

as dopamine, noradrenaline and serotonin; the altered 

neurotransmitter levels are associated with deficits in 

learning and memory.[FN124: Lakshmana MK, Raju TR. Endosulfan 

induces small but significant changes in the levels of 

noradrenaline, dopamine and serotonin in the developing rat 

brain and deficits in the operant learning performance. 

Toxicology 91:139-150, 1994.] 

The EPA estimates that 1.4 million pounds of endosulfan are 

applied annually to U.S. crops. According to the EFED risk 

assessment for the RED on endosulfan, monitoring data show 

widespread contamination of surface water. EPA modeled surface 

water contamination and calculated acute estimated 

environmental concentrations ranging from 4.49 ppb to 23.86 

ppb. Chronic EECs ranged from 0.53 ppb to 1.5 ppb. The acute 
and chronic EEC for endosulfan in groundwater was 0.012 ppb. 

EPA concluded in the RED that "residues of endosulfan in 

drinking water are of concern" for acute exposure for infants 

less than one year old and for children 1-6 years old. EPA 

determined that exposure from food alone created risks of 

concern for children 1 to 6 years old and set a DWLOC of zero 

(0) ppb for this population.[FN125: U.S. EPA, Reregistration 

Eligibility Decision for Endosulfan. 2002.] 

EPA proposed mitigation measures to address risks from 

endosulfan contamination of drinking water (110-foot setbacks 

for ground applications, 3-foot vegetative buffers, and 

reductions in application rates). However, the implementation 

of required mitigation measures to reduce pesticide risks is 

rarely monitored or enforced. Given the risk indicated in the 

drinking water exposure assessment, EPA should require more 

widespread monitoring for endosulfan and take regulatory action 

to establish an MCL for endosulfan. 

Linuron (CAS # 330-55-2) is an urea-based herbicide used 

primarily on soybeans (79 percent of usage). It has been shown 

to cause non-malignant testicular and liver tumors in 

animals.[FN126: Extension Toxicology Network (EXTOXNET), 

Pesticide Information Profiles. June 1996. 

http://extoxnet.orst.edu/pips/linuron.htm.] Investigation of 

the testicular tumors revealed that this herbicide acts by 

blocking the function of male androgens. In animals, at 

relatively low doses, linuron is a recognized anti-androgen. 

This chemical has been shown in laboratory studies to decrease 

male sex organ weights, cause testicular atrophy, delay 

puberty, and increase estrogen levels in males.[FN127: Cook JC, 

Mullin LS, Frame SR, Biegel LB. Investigation of a mechanism 

for Leydig cell tumorigenesis by linuron in rats. Toxicol Appl 

Pharmacol 119:195-204, 1993.; FN128: Gray LE Jr, Wolf C, 

Lambright C, Mann P, Price M, Cooper RL, Ostby J. 

Administration of potentially antiandrogenic pesticides 

(procymidone, linuron, iprodione, chlozolinate, p,p'-DDE, and 

ketoconazole) and toxic substances (dibutyl- and diethylhexyl 

phthalate, PCB 169, and ethane dimethane sulphonate) during 

sexual differentiation produces diverse profiles of 

reproductive malformations in the male rat. Toxicol Ind Health. 

1999 Jan-Mar;15(1-2):94-118.] 
About 400,000 pounds of linuron are used in U.S. agriculture 

each year. This herbicide persists for 1-5 months in soil, and 

has been shown to run off of fields into surface and 

groundwater supplies. EPA concluded in its Reregistration 

Eligibility Decision (RED) that linuron exceeded the Levels of 

Concern (LOC) for groundwater quality. EPA also expressed 

"moderate concerns" for drinking water supply systems relying 

on surface water sources.[FN129: U.S. EPA. Reregistration 

Eligibility Decision for Linuron, 1995.] 

Several factors in EPA's drinking water exposure assessment 

raise concerns about groundwater contamination. In the 

groundwater portion of the assessment, data were present for 

only four states: Georgia, Missouri, Virginia, and Wisconsin. 

In Georgia linuron was found in groundwater in concentrations 

up to 5 ppb. EPA later cast doubt on the reliability of the 

data and removed it from consideration in the final RED, basing 

its decision on new information received from the State of 

Georgia. 

Valid groundwater detections in Missouri (up to 1.9 ppb), 

Virginia (up to 1.31 ppb in 4 of 8 wells) and Wisconsin (up to 

2.7 ppb) may seriously underestimate linuron levels throughout 

the country because these three states are not among the 16-20 

states where linuron is most heavily used. The sixteen states 

listed on page 3 of EPA's Overview of Linuron Risk Assessment 

appear to account for well over 80% of linuron use in the 

United States, [FN130: U.S. EPA., Overview of Linuron Risk 

Assessment. 2002. 

http://www.epa.gov/oppsrrd1/reregistration/linuron/linuron_over 

view_5-31-02.PDF.] so the complete absence of any data on 

groundwater in any of these states is a critical data gap. The 

USGS has also reported on areas where linuron is most heavily 

used on a per-acre basis. The USGS maps indicate that Indiana, 

Ohio, Michigan, Delaware, and Maryland are heavy use 

states.[FN131: U.S. Geological Survey (USGS). 1992 Pesticide 

Use Maps. 

http://ca.water.usgs.gov/pnsp/pesticide_use_maps/show_map.php?y 

ear=92&map=m1993] These states are not among the ones from 

which groundwater data are available. Strangely, only one of 
these (Michigan) is listed by EPA as among heavy use states. 

Casting further doubt on EPA's estimates of the risks of 

linuron in drinking water sources is the fact that the model 

used for surface water assessment was not tested against any 

data whatsoever. The exposure estimates (18 ppb) for infants 

and children exceed EPA's chronic DWLOC (6 ppb) by three-fold. 

This result is of particular concern in light of the serious 

flaws in the drinking water risk assessment that conspire to 

underestimate the actual risk. EPA admits that "residues of 

linuron and its metabolites in drinking water may represent a 

chronic human health risk..." 

Since linuron is not regulated under the Safe Drinking Water 

Act (SDWA), water supply systems are not required to sample or 

analyze for it. This is a particular problem because EPA admits 

that drinking water treatment is unlikely to remove linuron and 

its degradates. The Agency must move rapidly to collect more 

data on linuron in water and must make a high priority of 

regulating linuron under the SDWA. 

Phosmet (CAS # 732-11-6) is an organophosphate pesticide used 

primarily on apples, peaches, walnuts, almonds and pears. 

Approximately 1.25 million pounds of active ingredient are 

applied every year. Phosmet is a neurotoxicant that causes red 

blood cell, plasma, serum and brain cholinesterase inhibition. 

It also shows mutagenic activity.[FN132: Vlckova V, Miadokova 

E, Podstavkova S, Vlcek D. Mutagenic activity of phosmet, the 

active component of the organophosphorus insecticide Decemtione 

EK 20 in Salmonella and Saccharomyces assays. Mutat Res. 1993 

Jul;302(3):153-6.; FN133: Hasegawa R, Cabral R, Hoshiya T, 

Hakoi K, Ogiso T, Boonyaphiphat P, Shirai T, Ito N. 

Carcinogenic potential of some pesticides in a medium-term 

multi-organ bioassay in rats. Int J Cancer. 1993 May 

28;54(3):489-93. Erratum in: Int J Cancer 1993 Sep 

30;55(3):528.] Phosmet interferes with human placental 

enzymatic activity, which may affect fetal development.[FN134: 

Souza MS, Magnarelli GG, Rovedatti MG, Cruz SS, De D'Angelo AM. 

Prenatal exposure to pesticides: analysis of human placental 

acetylcholinesterase, glutathione S-transferase and catalase as 

biomarkers of effect. Biomarkers. 2005 Sep-Oct;10(5):376-89] 
EPA has stated in its Interim Reregistration Eligibility 

Decision (IRED) for phosmet that there is "suggestive evidence 

of carcinogenicity" based on increased incidence of liver 

adenomas and carcinomas in male mice, and of mammary gland 

tumors in females.[FN135: U.S. EPA, Interim Reregistration 

Eligibility Decision for Phosmet, Case No. 0242. October 30, 

2001.] 

Phosmet is mobile in runoff and has the potential to 

contaminate drinking water sources. EPA has done a drinking 

water risk assessment for phosmet as part of the pesticide 

reregistration process. The EPA IRED used modeling estimates to 

assess phosmet exposure through drinking water due to the 

limited amount of monitoring data available. Estimated 

environmental concentrations ranged from 0.4 to 140 ppb. While 

EPA concluded that drinking water exposure through surface and 

groundwater was not of concern, there are several flaws in the 

EPA analysis that undermine that conclusion, as explained 

below. The IRED drinking water assessment should not be relied 

upon to decide whether to regulate phosmet under the SDWA 

EPA determines whether the drinking water risks of a pesticide 

are of concern as part of its dietary risk assessment for that 

chemical. For drinking water risk to remain below the Agency's 

level of concern, the sum of food and drinking water exposures 

must be less than the Population Adjusted Dose (PAD).[FN136: 

The PAD is a term that expresses the dietary risk of a 

chemical, and reflects the Reference Dose, either acute or 

chronic, that has been adjusted to account for the FQPA safety 

factor (i.e., RfD/FQPA safety factor). A risk estimate that is 

less than 100% of the acute or chronic PAD does not exceed the 

Agencys risk concern.] The IRED risk summary for phosmet 

indicates that dietary risk, acute and chronic, is below the 

Agencys level of concern. However, the Agency had initially 

determined that acute dietary exposures were of great concern 

for infants and children, with up to 2000% of the acute 

Reference Dose (aRfD) consumed [FN137: Swartz, C., U.S. EPA. 

Phosmet. HED review of the Gowan Co. probabilistic (Monte 

Carlo) acute dietary exposure risk assessment. July 30, 1999 ]. 

Such an exceedance in exposure from food alone means that any 

additional exposure from drinking water would create additional 

unacceptable risks. 
The assessment of food exposure was subsequently revised using 

a newly submitted acute neurotoxicity study by the registrant 

[FN138: Phosmet: Acute neurotoxicity study. (GD Cappon, lead 

investigator; Gowan Co., Yuma, AZ, sponsor). MRID No. 44673301. 

WIL Research Labs, Ashland OH. Oct 8, 1998.], reviewed by the 

Agency in February 1999,[FN139: Raffaele K. 1999. Phosmet: 

Acute neurotoxicity study. U.S. EPA. DER of study MRID 

44673301. Obtained by FOIA #RIN 0593-02, to Jennifer Sass, Jan. 

16, 2002] and by the hazard identification assessment review 

committee (HIARC) in July, 1999.[FN140: Taylor LL. 1999. 

Phosmet: Revised report of the hazard identification assessment 

review committee on phosmet. HED Doc No. 013604. August 4, 

1999.] This new acute neurotoxicity study in rats was used to 

raise the No Observable Adverse Effects Level (NOAEL) to 4.5 

mg/kg/day, from the 1.1 value that had been used, based on a 

chronic toxicity study in rats. The result was a four-fold 

change, which also resulted in an increase in the PAD. The 

HIARC executive summary of the study states that "no effects of 

treatment were seen in the 3.0 or 4.5 mg/kg group", which is in 

agreement with the registrants conclusions. However, the study 

DER [FN141: Raffaele K. 1999. Phosmet: Acute neurotoxicity 

study. U.S. EPA. DER of study MRID 44673301. Obtained by FOIA 

#RIN 0593-02, to Jennifer Sass, Jan. 16, 2002. Discussion and 

conclusions, p. 13-14] finds some critical problems with this 

study: 

* "Extremely high variability was noted in the data from the 

motor activity testing, raising questions about the sensitivity 

of the procedures used in this study. For example, an increase 

in subsession activity approaching 300% above control levels 

was not found to be statistically significantly different from 

controls." 

* "There was also some large variability in some of the blood 

cholinesterase measurements (especially for the red blood 

cells), such that decreases of 25% were not statistically 

significant. Again, it is possible that true differences caused 

by exposure to phosmet might be obscured by the high 

variability of the measure." In fact, the DER states that "the 

smallest statistically significant change detected in blood 
measures was 40% (DER p. 10) 

* "no information is available regarding the dose response 

curves for cholinesterase inhibition or behavioral effects. 

This is especially relevant since similar levels of inhibition 

(60-75%) were seen in brain and red blood cell cholinesterase 

at the high dose, with brain inhibition persisting throughout 

the study." 

NRDC suggests that this study is not sufficient to establish a 

NOAEL, since the variability in cholinesterase inhibition was 

so great that the study design did not provide any statistical 

power to detect treatment effects. Therefore, the increase in 

the PAD that made it possible for food and drinking water 

exposures to remain below the level of concern was not 

scientifically supported. 

Notwithstanding EPA's previous determination that phosmet in 

drinking water does not pose risks of concern (which, as noted 

above, was based on a flawed study), phosmet should be 

regulated as a water contaminant under the SDWA and an MCL 

should be established. 

Trichlorfon (CAS # 52-68-6) is an organophosphate insecticide 

with agricultural non-food and feed crop uses (e.g. 

agricultural non-cultivated areas, ornamental trees, etc.), as 

well as indoor and outdoor residential use. Usage volume data 

for these registered uses is not available.[FN142: U.S. EPA. 

Reregistration Eligibility Decision for Trichlorfon, List A, 

Case 0104. 1997.] 

Like the other organphosphates, trichlorfon is a neurotoxicant 

and cholinesterase inhibitor. Trichlorfon exposure is 

associated with kidney, lung and gastrointestinal abnormalities 

in animal studies. Anemia has also been reported, as well as 

benign pheochromocytomas. A statistically significant increase 

in mononuclear cell leukemia was also observed. Incidences of 

alveolar/bronchiolar adenomas, renal tubular adenomas and 

alveolar/bronchiolar carcinomas, while not statistically 
significant, occurred with frequencies "well outside of the 

historical control range for all three tumor types."[FN143: 

U.S. EPA, 1997, supra.] While EPA decided to classify 

trichlorfon in Group E for carcinogenicity arguing that the 

statistically significant increases in tumors in the studies 

were seen in the lower but not the higher doses, we argue that 

the evidence remains suggestive given that separate studies 

found significant increases in the same types of tumors. 

In the studies analyzed by EPA during the reregistration 

process, trichlorfon also showed developmental toxicity in 

animals (decreased fetal body weight, delayed or reduced 

ossification) and mutagenic activity in an in vitro cytogenetic 

study in mammalian cells. 

Trichlorfon is highly mobile in soil, but EPA did not assess 

its groundwater contamination potential during the 

reregistration process for lack of appropriate data. 

Trichlorfon can enter surface waters in ground spray and 

runoff. Well samples from Georgia in the EPA Pesticides in 

Ground Water Database showed trichlorfon detections in 12 of 

179 wells with concentration up to 10 ppb. EPA did not consider 

these samples useful, citing analytical uncertainties. 

Trichlorfon has a half-life in soil of 1 to 27 days, depending 

on soil type, which increases its potential to contaminate 

surface waters. However, the trichlorfon RED does not address 

drinking water risks. Despite the cancellation of feed and food 

crop uses, trichlorfon still has registered agricultural and 

residential outdoor uses that pose a risk of surface and 

possibly groundwater contamination. The scarcity of monitoring 

data on environmental concentrations should not lead to an 

assumption of negligible risk. The known toxicity of 

trichlorfon, its mobility and extended half-life in soil all 

make it a likely water contaminant in high use areas. EPA 

should require the collection of monitoring data for these 

areas to enable the Agency to assess water contamination risks 

and make a regulatory decision concerning trichlorfon. 

Triclocarban (Urea, N-(4-chlorophenyl)-N'-(3,4-dichlorophenyl) 
3,4,4'-Trichlorocarbanilide), CAS # 101-20-2, an antimicrobial 

pesticide also known as TCC, is a possible endocrine disruptor 

that has been widely detected in effluent from wastewater 

treatment plants (WWTPs) in the United States. TCC has also 

been frequently detected in environmental water samples. An 

animal study indicates that triclocarban exposure enhanced the 

effects of testosterone both in vitro and in vivo in male 

rats.[FN144: Chen J, Ahn KC, Gee NA, Ahmed MI, Duleba AJ, Zhao 

L, Gee SJ, Hammock BD, Lasley BL. Triclocarban enhances 

testosterone action: a new type of endocrine disruptor? 

Endocrinology. 2008 Mar;149(3):1173-9.] 

The half-life of TCC in sediment is 540 days. One study 

predicted the magnitude and frequency of TCC contamination 

nationwide based on experimental and modeling data to be 1150 

ng/L and 60%, respectively; much higher than previously 

recognized by EPA (240 ng/L, 30%).[FN145: Halden RU, Paull DH. 

Co-occurrence of triclocarban and triclosan in U.S. water 

resources. Environ Sci Technol. 2005 Mar 15;39(6):1420-6.] 

Another study in the Greater Baltimore area found an average 

TCC level of 6.75 ug/L in wastewater samples, while river water 

samples had concentrations of up to 5.6 ug/L.[FN146: Halden RU, 

Paull DH. Analysis of triclocarban in aquatic samples by liquid 

chromatography electrospray ionization mass spectrometry. 

Environ Sci Technol. 2004 Sep 15;38(18):4849-55.] These 

concentrations are higher than the Predicted Environmental 

Concentrations (PEC) calculated by the TCC Consortium in a 

report submitted to EPA in 2003 as part of the High Production 

Volume Chemical program, which estimated PECs from 0.0013 to 

0.050 μg/L.[FN147: TCC Consortium. High Production Volume (HPV) 

Chemical Challenge Program Data Availability and Screening 

Level Assessment for Triclocarban. 2002. 

http://www.epa.gov/chemrtk/pubs/summaries/tricloca/c14186.pdf] 

The actual measurements from the Greater Baltimore area study 

also exceed the TCC Consortiums Predicted No Effect 

Concentration of 0.146 μg/L.[FN148: TCC Consortium. High 

Production Volume (HPV) Chemical Challenge Program Data 

Availability and Screening Level Assessment for Triclocarban. 

2002. 

http://www.epa.gov/chemrtk/pubs/summaries/tricloca/c14186.pdf] 

A study of a 684 million liter per day typical activated sludge 
WWTP found a concentration of 6.1 ± 2.0 ug/L in the influent 

and 0.17 ± 0.03 ug/L in the effluent. Approximately 127 ± 6 g/d 

exited the plant in the effluent, a clear indication that 

conventional wastewater treatment may leave considerable levels 

of TCC in the water.[FN149: Heidler J, Sapkota A, Halden RU. 

Partitioning, persistence, and accumulation in digested sludge 

of the topical antiseptic triclocarban during wastewater 

treatment. Environ Sci Technol. 2006 Jun 1;40(11):3634-9.] 

Because of this, TCC concentrations tend to be higher 

downstream of WWTPs.[FN150: Sapkota A, Heidler J, Halden RU. 

Detection of triclocarban and two co-contaminating 

chlorocarbanilides in US aquatic environments using isotope 

dilution liquid chromatography tandem mass spectrometry. 

Environ Res. 2007 Jan;103(1):21-9.] The most important sources 

of triclocarban to the aquatic environment were estimated to be 

activated sludge treatment plants (contributing 39-67%), 

followed by trickling filters (31-54%), combined sewer 

overflows (2-7%) and sanitary sewer overflows (<0.2%).[FN151: 

Halden RU, Paull DH. Co-occurrence of triclocarban and 

triclosan in U.S. water resources. Environ Sci Technol. 2005 

Mar 15;39(6):1420-6.] 

Given these data, triclocarban should be added to the CCL3. 

Triclosan (5-chloro-2-(2,4-dichlorophenoxy)-phenol) (CAS # 

3380-34-5), is a broad spectrum antimicrobial pesticide that is 

widely used in personal care products such as soaps, 

toothpastes, cosmetics, skin creams and deodorants; kitchen 

accessories such as cutting boards and utensils; and in 

textiles such as sportswear, shoes and carpets. 

Triclosan is produced at over one million pounds per year. The 

chemical structure of triclosan is similar to other endocrine 

disrupting compounds and potential breakdown products of 

triclosan include dioxins.[FN152: Latch DE, Packer JL, Stender 

BL, VanOverbeke J, Arnold WA, and McNeill K. Aqueous 

photochemistry of triclosan: formation of 2,4-dichlorophenol, 

2,8-dichlorodibenzo-p-dioxin, and oligomerization products. 

Environ Toxicol Chem. 24(3):517-25 (2005).] 
Recently, low levels of triclosan were found to interfere with 

the metamorphosis of frogs. Exposure to as little as 0.15 

micrograms/l triclosan caused an earlier metamorphosis than 

normal, with effects on the tadpole brain and tail.[FN153: 

Veldhoen N, Skirrow RC, Osachoff H, Wigmore H, Clapson DJ, 

Gunderson MP, Van Aggelen G, and Helbing CC. The bactericidal 

agent triclosan modulates thyroid hormone-associated gene 

expression and disrupts postembryonic anuran development. Aquat 

Toxicol. 80(3):217-27 (2006).] Triclosan activates the human 

pregnane X receptor (hPXR), which is involved in the enzymatic 

metabolism of steroids and xenobiotics.[FN154: Jacobs MN, Nolan 

GT, Hood SR. Lignans, bacteriocides and organochlorine 

compounds activate the human pregnane X receptor (PXR). Toxicol 

Appl Pharmacol. 2005 Dec 1;209(2):123-33.] 

Triclosan has been found in wastewater treatment effluent and 

drinking water sources.[FN155: Greyshock AE, Vikesland PJ. 

Triclosan reactivity in chloraminated waters. Environ Sci 

Technol. 2006 Apr 15;40(8):2615-22.] Triclosan was detected in 

Louisiana sewage treatment plant effluent at 10-21 ng/l.[FN156: 

Boyd GR, Reemtsma H, Grimm DA, Mitra S. Pharmaceuticals and 

personal care products (PPCPs) in surface and treated waters of 

Louisiana, USA and Ontario, Canada. Sci Total Environ. 2003 Jul 

20;311(1-3):135-49.] Boyd (2004) reported triclosan 

concentrations of ND - 29 ng/l in two stormwater canals in New 

Orleans.[FN157: Boyd GR, Palmeri JM, Zhang S, Grimm DA. 

Pharmaceuticals and personal care products (PPCPs) and 

endocrine disrupting chemicals (EDCs) in stormwater canals and 

Bayou St. John in New Orleans, Louisiana, USA. Sci Total 

Environ. 2004 Oct 15;333(1-3):137-48.] Triclosan has also been 

detected in raw and finished drinking water samples from 

Southern California.[FN158: Loraine GA and Pettigrove ME. 

Seasonal variations in concentrations of pharmaceuticals and 

personal care products in drinking water and reclaimed 

wastewater in southern California. Environ Sci Technol. 

40(3):687-95 (2006).] 

Phthalates. Phthalates are endocrine disruptors that have been 

found to cause developmental and reproductive abnormalities in 

animal studies.[FN159: Centers for Disease Control and 

Prevention. Third National Report on Human Exposure to 

Environmental Chemicals. Atlanta (GA): CDC, 2005.] Furthermore, 
studies have found an association between phthalate metabolite 

concentrations and obesity, insulin resistance and thyroid 

hormone levels in humans.[FN160: Meeker JD, Calafat AM, Hauser 

R. Di(2-ethylhexyl) phthalate metabolites may alter thyroid 

hormone levels in men. Environ Health Perspect. 2007 

Jul;115(7):1029-34.] Stahlhut et al. (2007) analyzed urinary 

concentrations of seven phthalate metabolites in 1,443 adult 

men and found a statistically significant positive association 

between concentrations of the metabolites MBzP, MEHHP, MEOHP 

and MEP and abdominal obesity. Concentrations of MBP, MBzP and 

MEP were positively and significantly associated with insulin 

resistance.[FN161: Stahlhut RW, van Wijngaarden E, Dye TD, Cook 

S, Swan SH. Concentrations of urinary phthalate metabolites are 

associated with increased waist circumference and insulin 

resistance in adult U.S. males. Environ Health Perspect. 2007 

Jun;115(6):876-82.] In a different study, baby boys exposed to 

the phthalates, DMP, DEP or BBP, in their mothers breast milk 

were found to have hormonal disturbances at 3 months of 

age.[FN162: Main KM, Mortensen GK, Kaleva MM, Boisen KA, 

Damgaard IN, Chellakooty M, Schmidt IM, Suomi AM, Virtanen HE, 

Petersen DV, Andersson AM, Toppari J, Skakkebaek NE. Human 

breast milk contamination with phthalates and alterations of 

endogenous reproductive hormones in infants three months of 

age. Environ Health Perspect. 2006 Feb;114(2):270-6.] Studies 

have found that di-isononyl phthalate (DiNP) is an anti- 

androgenic endocrine disruptor with developmental and 

reproductive toxicity. Exposures in pregnant rats have been 

shown to adversely affect development of the male reproductive 

tract. Adverse effects include a cluster of outcomes that has 

been called "phthalate syndrome" and includes underdeveloped or 

absent reproductive organs, retained nipples, cryptorchidism, 

decreased anogenital distance (AGD), hypospadias, and decreased 

or abnormal sperm. DINP does not bind to the androgen receptor 

and these effects are likely mediated through interference with 

testosterone synthesis.[FN163: Gray LE Jr, Wilson VS, Stoker T, 

Lambright C, Furr J, Noriega N, Howdeshell K, Ankley GT, and 

Guillette L. Adverse effects of environmental antiandrogens and 

androgens on reproductive development in mammals. Int J Androl. 

29(1):96-108 (2006).; FN164: Gray LE Jr, Ostby J, Furr J, Price 

M, Veeramachaneni DN, and Parks L. Perinatal exposure to the 

phthalates DEHP, BBP, and DINP, but not DEP, DMP, or DOTP, 

alters sexual differentiation of the male rat. Toxicol 

Sci.58(2):350-65 (2000).] 
Phthalates enter the environment as a result of releases from 

industrial facilities that manufacture or use these compounds, 

from waste disposal sites, through the use of phthalate- 

containing products by consumers and through discharge of 

municipal wastewaters containing phthalates. Phthalates have 

been found in numerous hazardous waste sites: diethyl phthalate 

(DEP) has been identified at 348 sites, dibutyl phthalate (DBP) 

at 602 sites, dimethyl phthalate (DMP) at 167 sites, benzyl 

butyl phthalate (BzBP) at 413 sites, dicyclohexyl phthalate 

(DCHP) at one site, and di-n-octyl phthalate (DnOP) at 433 

sites, among other phthalates.[FN165: Agency for Toxic 

Substances and Disease Registry (ATSDR). Hazardous Substance 

Release and Health Effects Database (HazDat). 

http://www.atsdr.cdc.gov/Hazdat.html] 

Phthalates have been detected in environmental water samples 

across the United States, which raises concerns about drinking 

water as a route of exposure. The following data were found in 

a search for stream water samples analyzed for phthalates in 

the EPA STORET database. Results are for the period January 

2000 through May 2008:[FN166: U.S. EPA. STORET. 

http://www.epa.gov/storet/] 

* Benzyl butyl phthalate (BzBP) was present in 167 of 677 

stream water samples analyzed for this chemical, with a maximum 

concentration of 3.6 ug/L. 

* Di-isononyl phthalate (DiNP) - No data available.[FN167: The 

Institute for Health and Consumer Protection (IHCP) of the 

Europen Chemicals Bureau estimated a half life in surface water 

for DINP of 50 days. According to the IHCP, 7 percent of the 

DINP in the influent in sewage treatment plants will be 

released in the effluent. See European Commission Joint 

Research Centre, Institute for Health and Consumer Protection, 

1,2-Benzenedicarboxylic acid,Di-C8-10-Branched Alkyl Esters, 

C9-Rich and Di-"Isononyl" Phthalate (DINP), CAS Nos: 68515-48-0 

and 28553-12-0, EINECS Nos: 271-090-9 and 249-079-5, Summary 

Risk Assessment Report, 2003. 

http://ecb.jrc.it/DOCUMENTS/Existing- 

Chemicals/RISK_ASSESSMENT/SUMMARY/dinpsum046.pdf. Given the 
widespread use and high production volumes of DINP, these 

releases could pose risks for water quality.] 

* Di-n-octyl phthalate (DnOP) was found in 42 (8%) of 497 

stream water samples, with a maximum concentration of 0.85 

ug/L. 

* Dibutyl phthalate (DBP) was found in 221 (34%) of 659 stream 

water samples for that period, with a maximum concentration of 

7.4 ug/L. 

* Diethyl phthalate (DEP) was detected in 264 (35%) of the 748 

stream water samples analyzed. The maximum concentration found 

was 10.14 ug/L. DEP levels were >= 1 ug/L in 79 (11%) of the 

samples tested. 

* Dimethyl phthalate (DMP) was present in 49 (7%) of 678 stream 

water samples, with a maximum of 3.2 ug/L. 

Phthalates are ubiquitous in the U.S. population. Although 

significant exposure can occur due to consumer products, the 

contribution of drinking water to overall exposure deserves to 

be examined. The NHANES measured the concentrations of 12 

phthalate metabolites in the urine of over 2,500 children and 

adults. The highest average concentration was 163 ug/g 

creatinine for MEP, a metabolite of the plasticizer diethyl 

phthalate (see Table 3). The Centers for Disease Control and 

Prevention (CDC) did not report what percentage of samples had 

detectable concentrations of each of the metabolites, but nine 

of the metabolites were found in the urine of at least half of 

the individuals.[FN168: Centers for Disease Control and 

Prevention. Third National Report on Human Exposure to 

Environmental Chemicals. Atlanta (GA): CDC, 2005.] 

Table 3. CDC report of phthalate concentrations in urine; 

NHANES 1999 - 2000 and 2001 - 2002 [see PDF] 
Table 4. Frequency of detection of phthalate metabolites in 

human urine samples, United States [see PDF. Note that 

footnotes 169-174 are associated with this table] 

Therefore, the following phthalate compounds should be added to 

the CCL 3: 

* Benzyl butyl phthalate (BzBP) (CAS # 85-68-7) 

* Di-isononyl phthalate (DiNP) (CAS # 28553-12-0) 

* Di-n-octyl phthalate (DnOP) (CAS # 117-84-0) 

* Dibutyl phthalate (DBP) (CAS # 84-74-2) 

* Dicyclohexyl phthalate (DCHP) (CAS # 84-61-7) 

* Diethyl phthalate (DEP) (CAS # 84-66-2) 

* Dimethyl phthalate (DMP) (CAS # 131-11-3) 

Reproductive hormones. The U.S. Geological Survey (USGS) 

conducted a study of 139 streams in 30 states that found 

widespread presence of estrogenic compounds, ovulation 

inhibitors and other reproductive hormones in surface water 

near urbanized and agricultural areas (see Table 5).[FN175: 

Kolpin DW, Furlong ET, Meyer MT, Thurman EM, Zaugg SD, Barber 

LB, Buxton HT. Pharmaceuticals, hormones, and other organic 

wastewater contaminants in U.S. streams, 1999-2000: a national 

reconnaissance. Environ Sci Technol. 2002 Mar 

15;36(6):1202-11.] 

While each of these compounds is generally found at low 

concentrations, the potential effects on human health of 

mixtures of these compounds are unknown. Based on the 

individual effects of these chemicals, possible risks include 

defects of the reproductive system in individuals exposed 

during critical stages of development (e.g. testosterone) 

[FN176: Hotchkiss AK, Lambright CS, Ostby JS, Parks-Saldutti L, 

Vandenbergh JG, Gray LE Jr. Prenatal testosterone exposure 

permanently masculinizes anogenital distance, nipple 

development, and reproductive tract morphology in female 

Sprague-Dawley rats. Toxicol Sci. 2007 Apr;96(2):335-45.], 

decreased fertility (ovulation inhibitors such as mestranol, 

19-norethisterone), and increased risk of breast cancer (e.g. 

equilenin, equilin)[FN177: Ding S, Shapiro R, Geacintov NE, 
Broyde S. Equilenin-derived DNA adducts to cytosine in DNA 

duplexes: structures and thermodynamics. Biochemistry. 2005 Nov 

8;44(44):14565-76.], among others. 

Table 5. Concentrations of reproductive hormones in U.S. 

streams (USGS, 2002)[see PDF] 

Wastewater treatment plants (WWTPs), the likely sources of most 

of these chemicals, do not treat sewage for these pollutants. 

Furthermore, drinking water treatment plants do not generally 

test or treat water for these contaminants, so the frequency of 

occurrence of these chemicals in treated drinking water and the 

degree of human exposure are not known. Additional monitoring 

of water sources and drinking water are necessary to determine 

the full extent of the contamination, to assess risks to human 

health, and to determine acceptable levls of exposure and 

appropriate regulatory action. Therefore, equilenin, equilin, 

17a-ethynyl estradiol, 17 a - estradiol, 17ß-estradiol, 

estriol, estrone, mestranol, 19-norethisterone, progesterone 

and testosterone should be added to the CCL3. 

III. RECOMMENDATIONS 

We urge EPA to add the contaminants recommended above by NRDC 

to the CCL3. These contaminants meet EPA's criteria to be 

listed in CCL3. Their health effects, use patterns and known or 

likely environmental occurrence in drinking water sources 

should make them candidates for regulation under the SDWA. 

Furthermore, NRDC also recommends that EPA delete the pesticide 

nitrofen (CAS # 1836-75-5) from the Draft CCL3. The available 

information on this chemical does not support its inclusion in 

the CCL3. 

NRDC agrees with the inclusion of perchlorate and 

perfluorooctanoic acid (PFOA) in the Draft CCL3 and requests 

that EPA act promptly to regulate these endocrine disruptors in 

drinking water pursuant to the Safe Drinking Water Act (SDWA). 
Finally, we recommend that the Agency act to promptly assess 

the risks associated with other contaminants nominated to the 

CCL3 and take appropriate regulatory action under the SDWA to 

establish Maximum Contaminant Levels (MCLs) as necessary. 

Respectfully submitted, 

/s/ 

Mae Wu 

Staff Attorney 

Health and Environment Program 

CS Title: 0128 

Company/group/association name: 

Comment: 

Regarding: Drinking Water Contaminant Candidate List 3-Draft; 

Docket EPA-HQ-OW-2007-1189 FRL-08529--7 

The Environmental Working Group (EWG) is a non-profit public 

health and environmental research and advocacy organization 

based in Washington, DC. EWG research addresses toxic 

industrial chemicals that pollute the environment and may be 

present in everyday consumer products. With the attached 

letter, we provide detailed comments and recommendations to the 

EPA regarding its draft Drinking Water Contaminant Candidate 

List 3 (CCL3), especially highlighting the urgent need for the 

inclusion of pharmaceuticals and perfluorochemicals (PFCs) on 

the final CCL3, and the promulgation of drinking water 

standards for these wide-spread pollutants that pose health 

risks to millions of Americans. 

May 21, 2008 

Water Docket (2822T) 

Environmental Protection Agency 
1200 Pennsylvania Ave., NW. 

Washington, DC 20460 

Regarding: Drinking Water Contaminant Candidate List 3-Draft; 

Docket EPA-HQ-OW-2007-1189 FRL-08529--7 

To Whom It May Concern: 

The Environmental Working Group (EWG) is a non-profit public 

health and environmental research and advocacy organization 

based in Washington, DC. EWG research addresses toxic 

industrial chemicals that pollute the environment and may be 

present in everyday consumer products. With this letter, we 

provide detailed comments and recommendations to the EPA 

regarding its draft Drinking Water Contaminant Candidate List 3 

(CCL3), especially highlighting the urgent need for the 

inclusion of pharmaceuticals and perfluorochemicals (PFCs) on 

the final CCL3, and the promulgation of drinking water 

standards for these wide-spread pollutants that pose health 

risks to millions of Americans. 

EWG analysis of water utilities' tap water test results shows 

that nationwide, water contaminated with 260 chemicals, 

including 166 industrial pollutants, such as plasticizers, 

solvents, pharmaceutical production ingredients, and 

propellants, are served to 210,528,000 people in 42 states (EWG 

2005b). Fifty six percent of those people drink water with one 

or more industrial contaminants present at levels above non- 

enforceable EPA guidelines. In fact, more than 140 of the 

chemical contaminants detected in tap water are unregulated, 

without an enforceable, health-based limit in tap water. Due to 

the lack of federal oversight and the absence of monitoring and 

health standards, vulnerable populations, especially pregnant 

women and children, are not protected from this multitude of 

toxic chemicals in drinking water. 

As highlighted by the recent national investigation by the 

Associated Press (Mendoza 2008), in addition to industrial 

chemicals, a wide range of pharmaceuticals that include 
antibiotics, sex hormones, and drugs used to treat epilepsy and 

depression, contaminate drinking water supplies of at least 41 

million Americans. With every refreshing glass of water, 

millions of Americans are also drinking low-level mixtures of 

highly potent pharmaceuticals. The health effect of this 

cocktail of chemicals and drugs has not been studied, but there 

are many reasons to be concerned about risks for infants and 

others who are vulnerable. Pharmaceuticals, hormones, 

pesticides, and anti-microbial ingredients from personal care 

products contaminate many streams around the entire United 

States (Kolpin 2002). Chemical pollution of ambient waters 

contributes to the load of chemicals in tap water. EPA needs to 

show leadership and act with utmost dedication to protecting 

public health by mandating monitoring and setting enforceable 

health standards for these hazardous contaminants. 

We especially urge the EPA to include perfluorinated compounds 

on the final CCL3 list. PFCs are persistent, long-lasting 

industrial chemicals that have been utilized in a variety of 

manufacturing applications such as production of non-stick 

Teflon cookware, stain-proof Scotchgard products, grease- 

resistant food packaging and other types of paper materials, as 

well as carpets, water-proof textiles, and fire-fighting foam. 

In addition to the major fluorochemical producers (DuPont and 

3M in the United States), many secondary manufacturers have 

used PFCs for decades in their products. Industrial wastewater 

discharges and air emissions of PFCs from businesses that 

produce stain-and grease-resistant paper, carpets, textiles, 

and furniture likely contributed to the PFC pollution of 

drinking water supplies across the country. Due to their 

extraordinary stability, PFCs last in the environment for 

thousands of years. PFCs accumulate in bodies of both wildlife 

and humans, recirculating through groundwater, lakes, rivers, 

and oceans, and coming back to people with water, food, air and 

dust. As a result of decades of environmental discharges of 

PFCs, these toxic chemicals are now found in many areas of the 

country, in many bodies of water, and in bodies of more than 

98% of all Americans (Calafat, Kuklenyik 2007; Calafat, Wong 

2007). At least 11 different states have documented drinking or 

ambient water contamination with PFCs and a national survey is 

critically needed to reveal the full extent of PFC water 

contamination. 
PFCs such as perfluorooctanoic acid (PFOA), perfluorooctane 

sulfonic acid (PFOS) and related chemicals, bioaccumulate and 

remain in blood, liver, and other tissues for years. This 

persistence in the human body distinguishes PFCs from other 

contaminants and significantly elevates the level of health 

concern, making monitoring and the establishment of tap water 

standards critical for PFC compounds. Contamination of drinking 

water with PFCs creates a constant source of exposure and has 

been associated with some of the highest blood levels of these 

toxic compounds ever measured. Some residents of communities in 

Ohio and West Virginia drinking PFOA contaminated tap water had 

blood levels of PFOA 250 times the national average. These 

individuals experienced PFOA exposures equivalent to 

occupational levels and in amounts associated with serious 

adverse health effects, as demonstrated by initial data 

obtained in a major ongoing epidemiological study in the region 

(West Virginia University School of Medicine 2008). It is thus 

reasonable to feel concerned that other communities in other 

states drinking PFOA contaminated water would face similarly 

elevated exposures and health problems. 

PFCs have a broad spectrum of adverse health effects. PFOA 

exposure has been associated with impaired fetal and neonatal 

development, changes in reproductive and thyroid hormones, 

compromised immune and liver function, increased blood 

cholesterol levels, and potential predisposition to chronic 

diseases later in life. Gestational period, newborn babies and 

young children are the most sensitive developmental stages that 

should be especially protected from PFC contaminants in 

drinking water. During pregnancy, PFCs move to the body of the 

fetus through the placenta (Apelberg, Goldman 2007; Inoue 2004; 

Midasch 2007; Tittlemier 2004); a newborn child also gets a 

large dose of PFCs with breast milk (Arcaro 2008; Karrman 2007; 

Kuklenyik 2004; So 2006; Tao 2008; Volkel 2007). Tap water 

standards for PFOA and other PFC will go a long way in 

protecting the health of this vulnerable population from 

adverse effects both in early development and in later life. 

The Safe Drinking Water Act (SDWA) requires EPA to publish an 

updated list every five years which details currently 

unregulated drinking water contaminants that may pose human 
health risks. From this list, EPA must make determinations on 

whether to establish tap water standards for at least five 

contaminants with a national primary drinking water regulation. 

EPA originally considered three candidate perfluorochemicals 

for inclusion into the Contaminant Candidate List 3: PFOA, a 

processing aid for manufacturing of Teflon non-stick and water- 

resistant chemicals, PFOS, the primary ingredient in the 

furniture stain-proofing coating Scotchgard that was phased out 

in 2000, and perfluorobutanoic acid (PFBA), a replacement 

chemical that manufacturers are increasingly using instead of 

longer-chain PFCs. 

Of the three PFCs nominated for CCL3, only PFOA was included in 

the current draft of CCL3. While we support the EPA decision to 

place PFOA on the list, we urge the agency to add other 

perfluorochemicals including, but not limited to PFOS and PFBA, 

as potential water contaminants that ought to be regulated 

under the Safe Drinking Water Act. Given the widespread use of 

PFCs in industrial applications and consumer goods ranging from 

food packaging to carpets and textiles, as well as detection of 

multiple PFCs in bodies of 98% of Americans, PFC contamination 

of drinking water requires thorough scrutiny in order to meet 

current scientific and regulatory standards for safety. 

Specifically, we urge EPA to: 

* List a full range of perfluorochemicals on the CCL3, 

including, but not limited to, PFOA, PFOS, PFBA, and other PFCs 

that have been found in the environment and in people and that 

are likely to contaminate both finished and ambient water 

sources; 

* Establish regulatory standards for PFOA in drinking water; 

* Include in the final CCL3 a broader list of contaminants 

found by water utilities in tap water, especially focusing on 

antibiotics and other pharmaceuticals. 
Details and our rationale for these recommendations are 

provided below. 

1. List a full range of perfluorochemicals on the CCL3, 

including PFOA, PFOS, PFBA, and other PFCs found in the 

environment and in people. 

We support the EPA decision to place PFOA on the Draft Drinking 

Water Contaminant Candidate List 3. However, we disagree with 

the Agency's decision to exclude PFOS and PFBA from 

consideration as hazardous water contaminants. The stability of 

PFCs in the environment makes these chemicals distinct from 

many other classes of chemical water pollutants that have been 

previously regulated by the EPA (Conder 2008). Biomonitoring 

studies carried out by the Center for Disease Control found 

PFOS, PFOA, perfluorohexane sulfonic acid (PFHxS) and 

perfluorononanoic acid (PFNA) in more than 98% of 2,094 people 

tested. For some of these chemicals, children younger than 12 

years of age have higher levels than adults (Olsen, Church 

2004). PFCs enter human bodies from different sources, such as 

food, chemical-laden dust and water (Emmett 2006; Frisbee 

2008). Various PFCs have been detected in finished and/or 

ambient water sampled in various locations in 11 states (Table 

below). PFOA has been found in tested water samples from all of 

these 11 states, PFOS has been found in 7 states, and PFBA 

appears poised to become an emergent water contaminant (MDH 

2008). 

We urge the Agency to add PFOS and PFBA to the CCL3. Even 

though production of PFOS has been banned by the EPA (US EPA 

2002), this persistent and bioaccumulative compound is still 

present in many water sources in the US (MDH 2008). PFOS 

negatively affects early development in animals and humans 

(Apelberg, Witter 2007; Lau 2004); it interferes with the 

function of the nervous system and causes neurobehavioural 

defects (Johansson 2008), kills immune cells and weakens body's 

capacity to resist infection (Keil 2008; Peden-Adams 2008), and 

affects thyroid hormones that are critical for normal growth 

and maturation in children (Lau 2003; Luebker 2005). 

Considering how common is PFOS contamination of water sources, 

we believe EPA needs to set a regulatory standard to protect 
the health of people, especially young children, from PFOS. 

In the absence of EPA guidance, states need to carry out their 

wn risk assessments and set water contamination levels for 

PFCs. For example, the Minnesota Department of Health issued 

advisory guidelines of 1.0 μg/L for PFBA and set the limits for 

other PFCs chemicals in drinking water as well (MDH 2008). The 

presence of PFBA and other PFCs in groundwater at the 

fluorochemical manufacturing sites points to the potential of 

these replacement PFC chemicals to become new, emergent water 

contaminants whose health consequences will be directly tested 

on people exposed through drinking water. Now that the human 

health effects of PFC contamination in drinking water are 

becoming widely known from the C8 (PFOA) Health Project (West 

Virginia University School of Medicine 2008), it is imperative 

to protect vulnerable populations from future exposures to 

PFCs. 

EPA needs to assess cumulative risks associated with multiple 

PFCs in finished and ambient water sources for children and 

other vulnerable populations. New data are constantly coming to 

light that demonstrate the extent of water contamination with 

PFCs (Fuchs 2008; Fuquay 2008; Hawthorne 2008; Konwick 2008; 

United Steelworkers Union 2006). Already, drinking and ambient 

water in 11 states is contaminated with PFCs and the full scope 

of this problem might be even larger since businesses using 

fluorochemical products are found all around the country. This 

gap in our knowledge should be filled with a national survey of 

PFCs in water and a full range of PFCs should be included in 

the Unregulated Contaminant Monitoring Program. 

In summary, we urge the EPA to list perfluorochemicals on the 

final CCL3, including, but not limited to, PFOA, PFOS and PFBA, 

and other PFCs that are commonly detected in people and the 

environment, so that the agency can mitigate the human health 

risks posed by these chemicals. 

2. Establish regulatory standards for PFOA in drinking water. 
We support the EPA in including PFOA on the Contaminant 

Candidate List 3 and we urge the agency to take the next, 

urgently needed step for public health protection by issuing 

national regulatory standards for PFOA levels in drinking 

water. In order to help the individual states that look to EPA 

for guidance and protect the health of all Americans, the 

agency should proceed with this step immediately, even while 

the data on other PFC water contaminants are collected. 

Unquestionably, PFOA meets all the criteria for a contaminant 

that requires regulation by the EPA. Together with other PFCs, 

PFOA is now found in bodies of 98% of Americans (Calafat, Wong 

2007); often, children younger than 6 years of age have higher 

PFOA levels compared to adults (Emmett 2006; Olsen, Church 

2004). PFOA can cross the placenta and transfer from the 

mothers body to the fetus (Apelberg, Goldman 2007; Inoue 2004; 

Midasch 2007; Tittlemier 2004). PFOA contaminates the milk of 

breast-feeding mothers (Karrman 2007; Kuklenyik 2004; So 2006; 

Tao 2008; Volkel 2007). Once ingested with food or water, PFOA 

accumulates in the human body to 100-fold greater levels and 

persists for many years (Emmett 2006; Olsen, Burris 2007). This 

means that trace levels of PFOA in tap water can produce much 

higher long term exposures in people. For example, drinking 

water from the Little Hocking water system in Ohio was 

contaminated with PFOA at about 3.5 parts per billion (ppb), 

but some individuals drinking this water, who had no other 

unique exposures to PFOA, had blood levels of PFOA as high as 

1,000 ppb (Emmett 2006). 

As demonstrated by numerous studies in people and in animals, 

PFOA has an adverse effect on many health parameters, such as 

fetal and neonatal development (Lau 2004), immune function 

(DeWitt 2008; Yang 2002), reproductive and thyroid hormones 

(Lau 2007), liver function (Frisbee 2008; Son 2007), and blood 

levels of cholesterol and other lipids (Frisbee 2008; Olsen and 

Zobel 2007; Sakr, Kreckmann 2007; Sakr, Leonard 2007). In two 

studies of newborn babies, higher PFOA levels correlated with 

smaller weight and size at birth (Apelberg, Witter 2007; Fei 

2007, 2008). PFOA exposure increases predisposition to obesity, 

heart disease, diabetes, and stroke (European Congress on 

Obesity 2008; Leonard 2007; Lundin 2007). PFOA causes liver, 

pancreatic, testicular, and mammary cancer in animals (Sibinski 
1987). In epidemiological studies, PFOA has been shown to 

increase the risk of various cancers, especially prostate 

cancer, as well as liver, kidney, and bladder cancers (Leonard 

2007; Lundin 2007; Olsen, Burlew 2004). 

Despite extensive denial of PFOA health effects by the chemical 

industry, toxic effects of this chemical have been revealed by 

the chilling initial results from the C8 Health Project (West 

Virginia University School of Medicine 2008), a major 

epidemiological survey of residents in Ohio and West Virginia 

whose drinking water supply has been contaminated by PFOA. 

Sixty nine thousand people have been enrolled in the project, 

making it by far the largest study ever of PFC health effects 

in people (Frisbee 2008). The health effects observed in the 

study population are strong indicators of health problems that 

might be caused by PFOA in average Americans. Toxic effects 

from PFOA were observed in study participants with blood levels 

of the chemical equal to those found in the more highly exposed 

individuals in the US population. It is reasonable to expect 

that people in other states with contaminated drinking water 

may reach the same levels of exposure associated with 

significant adverse health effects in this study. As reported 

by the scientific team from the West Virginia University: 

* Higher levels of PFOA in people correlate with lower levels 

of liver-produced Creactive protein that helps the body fight 

bacteria, viruses, and other pathogens. 

* PFOA exposure is associated with higher serum levels of two 

enzymes that can indicate liver damage; the same findings as 

have been found in occupational studies (Olsen and Zobel 2007; 

Sakr, Kreckmann 2007). These two findings indicate powerful 

liver toxicity of PFOA. 

* Elevated PFOA levels in children are associated with high 

cholesterol levels, predisposing children to future weight 

problems and accompanying risk of heart disease. 

* PFOA-exposed people have abnormal levels of thyroid hormones. 
The multitude of PFOA health effects is especially worrisome 

because both PFOA and other PFCs are known to occur in public 

water systems with a frequency and at levels of public health 

concern. PFOA has been detected in public water supplies in 

many localities in West Virginia and Ohio (Emmett 2006; WVDEP 

2005), 78% of drinking water systems tested by the New Jersey 

Department of Environmental Protection (NJDEP 2007), and in 

multiple townships in Washington County, Minnesota (MDH 2008). 

Additionally, drinking water supplies in some localities in 

Georgia may potentially be contaminated with PFOA (United 

Steelworkers Union 2006), where surface waters have been shown 

to be polluted with high levels of various PFCs (Konwick 2008). 

Other affected states include North Carolina (NCDENP 2008a), 

where groundwater contamination with PFOA in the vicinity of 

DuPont's Fayetteville Works plant doubled between 2006 and 2007 

(Fuquay 2008), Alabama, where the Tennessee River is 

contaminated with PFOA and PFOS emitted by the 3M 

fluorochemical plant (Decatur) (Hansen 2002), Illinois, where 

both PFOA and PFOS have been detected in Chicago drinking water 

supply (Hawthorne 2008) as well as New York and Virginia (Clean 

Water Action Alliance of Minnesota 2008). All of these data are 

presented in the Table below: 

[Table 1 - see PDF] 

All together, various PFCs have been detected in finished 

and/or ambient water sampled in various locations in 11 states. 

PFOA has been found in tested water samples from all of these 

11 states; PFOS has been found in 7 states. Most worrisome, 

groundwater levels of PFBA, a replacement chemical for some of 

the older PFC applications, appear to be on the rise (MDH 

2008). 

Without federal health standards for PFOA, individual states 

are forced to set their own standards so as to protect their 

citizens. For example, PFOA standards or risk-based levels have 

been established by North Carolina (2 μg/L) (NCDENP 2008b), 

Minnesota (0.5 μg/L) (MDH 2007) and New Jersey (0.04 μg/L) 

(NJDEP 2007). The 2006 consent order between EPA and DuPont 
required the company to offer alternative drinking water source 

or treatment for both public and private water users living 

near the Washington Works plant in Parkersburg, West Virginia 

whenever PFOA levels in their drinking water exceed 0.5 μg/L 

(US EPA 2006). 

When confronted with such regulatory patchwork and the lack of 

guidance from the EPA, many states do not know how best to 

proceed, leaving the health of Americans at jeopardy (Hawthorne 

2008; Sohn 2008). Many other states do not have the resources 

or expertise to establish and enforce drinking water standards 

for PFCs. Most states and the people who live in them depend on 

the EPA to protect them from drinking water contaminants. A 

failure to act will leave the residents in those states 

drinking tap water contaminated with highly toxic and 

persistent PFC pollutants for many years to come. 

EPA regulation of PFOA and other PFCs that are commonly 

detected in people and the environment presents a meaningful 

opportunity for reduction of health risk due to these 

industrial chemical pollutants in drinking water. We urge the 

EPA to take much-needed action on PFOA and set a health- 

protective standard for PFOA in drinking water that will rely 

on the best available science and safeguard the health of 

millions of people. 

3. Include in the final CCL3 a broader list of contaminants 

found by water utilities in tap water, especially focusing on 

antibiotics and other pharmaceuticals. 

Pharmaceutical residues contaminate drinking water supplies 

when people take various prescribed and over the counter 

medications. While their bodies absorb and metabolize some of 

the chemicals, the rest is flushed out of the body and down the 

drain. Drinking water treatment plants are not designed to 

remove these residues, and the Associated Press (AP) National 

Investigative Team uncovered data showing these same chemicals 

in treated tap water and water supplies in 24 major 

metropolitan areas around the US (Mendoza 2008). Together with 

earlier publications by the US Geological Survey that 
identified pharmaceuticals and personal care product chemicals 

in waters bodies and streams around the United States (Kolpin 

2002), the results of the AP investigation point to the 

potential health dangers presented by pharmaceuticals in 

drinking water. 

All of the pharmaceuticals reported in drinking water supplies 

are unregulated in treated tap water-any level is legal. So 

far, the federal agencies have failed to set standards for 

pharmaceuticals which are generally exempted by the FDA from 

any environmental assessment (FDA 2008). Moreover, the EPA has 

not even required water utilities to test for these chemicals. 

Drug residues in tap water join hundreds of other synthetic 

chemicals Americans are exposed to daily, as contaminants in 

food, water, and air, or in common consumer products. EWG found 

an average of 200 industrial chemicals, pesticides and other 

pollutants in umbilical cord blood from 10 babies born in the 

U.S., indicating that our exposures to toxic chemicals begin in 

the womb, when risks are greatest (EWG 2005a). EWG analysis 

shows that of the top 200 drugs commonly prescribed in the 

U.S., 13 percent are known to have serious side effects at 

levels less than 100 parts-per-billion (ppb) in human blood, 

with some causing potential health risks in the parts-per- 

trillion range. These levels are dangerously close to the ones 

found in drinking and ambient water sources (Kolpin 2002; 

Mendoza 2008). 

We now call on the EPA to take swift action by setting 

standards for antibiotics and pharmaceuticals in tap water that 

will protect the health of all Americans, especially children. 

By the very nature of their design, pharmaceuticals can have 

effects on human body even at low doses. We urge the EPA to 

include in the final CCL3 a broad range of pharmaceutical 

resides and other contaminants found in tap water. This action 

will serve as the first, much needed step for ensuring the 

long-term health of our tap water - and the people who drink 

it. 

In conclusion, presence of pharmaceuticals and 

perfluorochemicals in all states where water samples have been 

tested for these compounds, and their effects on the 
environment and on human health makes these chemicals very 

important candidates for federal regulation under the Safe 

Drinking Water Act. Federal drinking water policies and 

regulations should be set to ensure that vulnerable 

populations, including pregnant women and children, are 

protected from chemical contaminants in drinking water. 

Ingestion of drugs and PFCs with drinking water presents a 

significant hazard for human health, especially during 

sensitive times in life, such as in utero. Most states do not 

have the resources to establish or enforce drinking water 

standards, and people in these states depend on strong 

protections from the EPA. Regulation of these pollutants will 

assure equitable and uniform protection for the health of all 

Americans. Thus, we urge the EPA to follow up on the draft CCL3 

by setting regulatory standards for both pharmaceuticals and 

PFCs in drinking water. 

Sincerely, 

Olga V. Naidenko, Ph.D. 

Senior Scientist 

Environmental Working Group 

1436 U street NW Suite 100 

Washington, DC 20009 

202-939-9157 

olga@ewg.org 

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[accessed December 28 2007]. 

Volkel W, Genzel-Boroviczeny O, Demmelmair H, Gebauer C, 

Koletzko B, Twardella D, et al. 2008. Perfluorooctane 

sulphonate (PFOS) and perfluorooctanoic acid (PFOA) in human 

breast milk: Results of a pilot study. Int J Hyg Environ 

Health: in press. 

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Health Project: WVU Data Housing Website. Available: 

http://www.hsc.wvu.edu/som/cmed/c8/ [accessed May 12 2008]. 
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Protection: Groundwater Investigation Steering Team (GIST). 

Available: www.ewg.org/files/WVDEP_GIST.pdf [accessed May 20 

2008]. 

Yang Q, Abedi-Valugerdi M, Xie Y, Zhao XY, Moller G, Nelson BD, 

et al. 2002. Potent suppression of the adaptive immune response 

in mice upon dietary exposure to the potent peroxisome 

proliferator, perfluorooctanoic acid. Int Immunopharmacol 

2(2-3): 389-97. 

CS Title: 0130 

Company/group/association name: 

Comment: 

May 21, 2008 

U.S. Environmental Protection Agency 

EPA Docket Center, Water Docket 

Mailcode: 2822T 

1200 Pennsylvania Ave., NW 

Washington, D.C. 20460 

Re: Comments On the Drinking Water Contaminant Candidate List 3 

-- Draft; Docket Number EPA-HQ-OW-2007-1189 

These comments are submitted by Waterkeeper Alliance 

("Waterkeeper") in response to the third Drinking Water 

Contaminant Candidate List ("CCL 3"). 

Waterkeeper Alliance, Inc. is a non-profit organization 

representing the interests of 177 member watershed groups. Each 

of these groups, and their members, has an express mission to 

preserve and protect local waterbodies for aesthetic, 

recreational, and other purposes.[FN1: The following 

Waterkeeper Alliance member programs have expressed their 

concurrence with these comments: Altamaha Riverkeeper, GA; 

Altamaha Coastkeeper, GA; Apalachicola Riverkeeper, FL; 
Assateague Coastkeeper, MD; California Coastkeeper Alliance, 

CA; Casco Baykeeper, ME; Columbia Riverkeeper, OR; Cook 

Inletkeeper, AK; French Broad Riverkeeper, NC; Kansas 

Riverkeeper, KS; Galveston Baykeeper, TX; Long Island 

Soundkeeper, CT; Lower Neuse Riverkeeper and Neuse River 

Foundation, NC; Milwaukee Riverkeeper, WI; Mobile Baykeeper, 

AL; Nantucket Soundkeeper, MA; NY/NJ Baykeeper, NY and NJ; 

Pamlico-Tar Riverkeeper, NC; Patuxent Riverkeeper, MD; Potomac 

Riverkeeper, DC; Raritan Riverkeeper, NJ; Russian Riverkeeper, 

CA; San Diego Coastkeeper, CA; Saranac Riverkeeper, NY; 

Sehanandoah Riverkeeper, VA; South Riverkeeper, MD; St. Johns 

Riverkeeper, FL; Tualatin Riverkeeper, WA; West/Rhode 

Riverkeeper, MD; West Virginia Headwaters Waterkeeper, WV; 

Western Lake Erie Waterkeeper, OH; Youghiogheny Riverkeeper, 

PA.] 

Waterkeeper is exceedingly concerned with the state of our 

nation's drinking waters. It believes that the Safe Drinking 

Water Act ("SDWA") can provide needed protections to the public 

by regulating the variety and amount of contaminants found in 

public water supplies. However, to provide these protections, 

United States Environmental Protection Agency ("EPA") must 

comprehensively address the pollution of America's drinking 

water sources. To do so, and to meet the objectives of the 

SDWA, EPA must consider all potential adverse effects of 

aqueous contaminants to the public; it should account for these 

hazards by controlling their occurrence, creating 

accountability; and it should promote the security of our 

public water systems. 

The CCL 3 list provides some essential contaminants for 

regulation. Yet, EPA must go further to protect public health 

and welfare. One way for EPA to do so is to follow the enclosed 

suggestions for improving the list. Specifically, EPA should 

categorically include, or, at a minimum, individually list, 

pharmaceuticals and personal care products, including endocrine 

disrupting compounds, in the final National Primary Drinking 

Water Regulations ("NPDWR"). 

I. BACKGROUND: THE SAFE DRINKING WATER ACT 
The Safe Drinking Water Act requires EPA to promulgate national 

drinking water regulations for public water systems.[FN2: 42 

USC § 300g-1.] EPA must issue regulations for each contaminant 

that may have any adverse effect on health and that is known or 

anticipated to occur in such systems.[FN3: 42 USC § 300g-1(b).] 

In creating the regulations, EPA goes through a number of 

steps. 

EPA first lists a number of unregulated contaminants for 

analysis and possible addition to the NPDWA. This list, the 

CCL, must be published for public comment by EPA at least once 

every five years.[FN4: 42 USC § 300g-1(b)(1)(B)(ii).] The 

overarching listing criteria are: 

1. That the contaminant is known to occur or there is a 

substantial likelihood that the contaminant will occur in 

public water systems with a frequency and at levels of public 

health concern; 

2. That the contaminant may have an adverse effect on the 

health of persons; and 

3. ...regulation of such contaminant presents a meaningful 

opportunity for health risk reduction for persons served by 

public water systems.[FN5: 42 USC § 300g-1(b)(1)(A).] 

After EPA identifies drinking water contaminants, it must 

determine whether the contaminant is likely to be present at 

hazardous levels in public water, and, if so, it establishes 

the contaminant's maximum contaminant level goals ("MCLG"), the 

ideal maximum level at which the contaminant can be in the 

water without causing a risk to health.[FN6: 42 USC § 300g-1(b) 

(3). See US EPA, Safe Drinking Water Act, at 

www.epa.gov/safewater/sdwa (May 6, 2008).] Finally, EPA 

performs a cost-benefit analysis to set contaminant standards, 

the maximum contaminant level ("MCL") that can feasibly be 

implemented under the SDWA.[FN7: Id.] 
MCLG are to be set "at the level at which no known or 

anticipated adverse effects on the health of persons occur and 

which allows an adequate margin of safety."[FN8: 42 USC § 

300g-1(b)(4)(A).] The resultant MCL should be set as close to 

the MCLGs "as is feasible."[FN9: 42 USC § 300g-1(b)(4)(B).] In 

determining "feasibility," the Administrator may weigh both the 

"quantifiable and nonquantifiable costs and benefits" of 

setting particular levels.[FN10: 42 USC §§ 300g-1(b)(3)(C), 

(4).] If EPA determines that the benefits would not outweigh 

the costs, the MCL is to be set to "maximize health risk 

reduction benefits at a cost that justifies the 

benefits."[FN11: 42 USC § 300g-1(b)(7).] 

The resulting SDWA regulations should be both comprehensive and 

protective. This point was reinforced in 1996 when President 

Clinton revised the act to provide new regulatory flexibility 

to the EPA by repealing the maximum number of contaminants to 

be regulated per year.[FN12: See Pub. L. 104-182, 110 Stat. 

1615.] The 1996 amendments further modified EPA's requirements 

under the SDWA to include the treatment of source water.[FN13: 

Id.] The resultant regulatory scheme places a proactive 

requirement on EPA to ensure protection to public water and 

human health. 

II. DETAILED COMMENTS 

A. EPA SHOULD ENSURE THAT THE CONTAMINANTS LISTED IN CCL 3 

SUFFICIENTLY PROTECT THE PUBLIC AGAINST ADVERSE HEALTH IMPACTS 

FROM INADEQUATE DRINKING WATER REGULATIONS. 

1. EPA Should Again Revise The Candidate Selection Process To 

Include Greater Public Participation. 

Congress requires public participation opportunities be 

included in the SDWA listing process.[FN14: 42 USC § 300g-1.] 

In 1996, Congress recognized that "safe drinking water is 

essential to the protection of public health,"[FN15: Pub. L. 

104-182, Sec. 3 (1).] and, therefore, that "procedures for 
assessing the health effects of contaminants establishing 

drinking water standards should be revised to provide greater 

opportunity for public education and participation."[FN16: Pub. 

L. 104-182, Sec. 3 (6).] The opportunities available with CCL 3 

show EPA's recognition of this mandate. However, to ensure 

protection of the public health and public interest, EPA must 

go further. 

In creating CCL 3, EPA amended its previous classification 

approach.[FN17: See Drinking Water Contaminant Candidate List 3 

- Draft, 73 Fed. Reg. 9627, 9631 (2008).] EPA's purported 

intent in making this change is to "increase transparency and 

reproducibility of the CCL decision process," and to increase 

public participation opportunities.[FN18: Id.] The result was a 

tiered process in which EPA first identified a broad universe 

of potential drinking water contaminants, then narrowed the 

list through a variety of screening processes, and, finally, 

solicited public review on considered contaminants. While it is 

somewhat understandable that EPA does not wish to review 

comments at every stage of CCL creation, it is not 

understandable, nor is it acceptable, to restrict public 

comment to an extremely limited number of these potentially 

dangerous contaminants. 

Under this new tiered approach, EPA reduced the potential 

contaminant list from over 7,500 contaminants to less than 200 

without any intermediate public comment periods.[FN19: Id.] As 

a result, the new approach actually decreases transparency in 

the regulatory process. We would suggest EPA involve the public 

much earlier in the selection process so that the public may: 

(1) assess the contaminants EPA is focusing on and (2) suggest 

further alternate contaminants for EPA to consider as it goes 

forward in the process[FN20: We recognize that EPA requested 

the public submit chemical and microbial contaminant 

nominations for CCL 3. 71 FR 60704 (2006). Riverkeeper 

participated in this process. However, EPA should open at least 

one more comment period with the purpose of identifying further 

contaminants for regulation.]. 

A more inclusive selection process might have remedied a 

glaring deficiency in CCL 3: the noticeable absence of 
pharmaceuticals and personal care products ("PPCPs"), including 

endocrine disrupting compounds. The 1996 amendments to the SDWA 

gave EPA immense power to regulate large numbers of 

contaminants[FN21: See Pub. L. 104-182, 110 Stat. 1615.], but 

EPA is not effectively using that power. As section B shows, a 

wide range of PPCPs must be regulated under the NPDWR; 

otherwise, the Agency simply cannot claim to be adequately 

protecting human health. 

2. Pathogens 

Each listed pathogen causes extremely adverse health effects in 

humans in relatively small concentrations. Therefore, every 

pathogen listed should be regulated as a contaminant under the 

SDWA. 

3. Chemical Contaminants 

Every chemical contaminant listed causes extremely adverse 

health effects in humans and should be regulated under the 

SDWA. 

a. Pesticides 

Waterkeeper applauds EPA's choice to include a number of 

pesticides in the CCL 3 listing. As EPA has noted, some 

pesticides, "such as the organophosphates and carbamates, 

affect the nervous system. Others may irritate the skin or 

eyes. Some pesticides may be carcinogens."[FN22: EPA, 

Pesticides: Health and Safety, at: 

www.epa.gov/pesticides/health/human.htm (May 15, 2008).] In 

fact, since pesticides "[b]y their nature [are] substances that 

in many cases are designed to kill pests, [they] can pose risks 

to humans and to the environment."[FN23: EPA, Reducing 

Pesticide Risk. Pesticides: Health and Safety, at: 

http://www.epa.gov/pesticides/health/reducing.htm (May 15, 

2008).] 
For example, listed pesticide Tebufenozide is known to cause 

human health effects including (but not limited to) 

reproductive effects, developmental toxicity, toxicity to the 

nervous system, and carcinogenicity.[FN24: See 61 Fed. Reg. 

60628, 60629 (1996).] 

We believe that all of the listed pesticides should be 

regulated as contaminants under the SDWA. However, the list is 

still missing a number of especially hazardous pesticides. 

Therefore, as a necessary protective measure, EPA should 

continue adding pesticides to this list. 

b. Pharmaceuticals and Personal Care Products 

Waterkeeper agrees with EPA that there are concerns regarding 

the presence of pharmaceuticals in the water supply.[FN25: See 

73 Fed. Reg. at 9652.] What Waterkeeper does not agree with is 

EPA's use of the word "potential" in describing this 

problem.[FN26: Id] Detailed below are numerous studies 

addressing the ongoing problems and hazards associated with 

pharmaceuticals in public drinking water supplies. Of 

particular importance is a recent study by the Associated Press 

addressing the fact that marked amounts of pharmaceuticals were 

found in at least 50 percent of the municipal water sources of 

the 50 cities tested.[FN27: See, Prescription drugs found in 

drinking water across U.S, Associated Press, April 4, 2008 at 

www.cnn.com/2008/HEALTH/03/10/pharma.water1 (May 15, 2008).] 

Further, Waterkeeper is unsure how EPA was able to go from 

originally considering 287 pharmaceutical contaminants to 

listing only one pharmaceutical, nitroglycerin, in the CCL 

3.[FN28: See 73 Fed. Reg. at 9652.] With so much information 

available regarding the hazardous results of elevated 

pharmaceutical levels in public drinking water, including 

source water, more pharmaceuticals should be listed for 

regulation. Waterkeeper hopes that the following section proves 

helpful to the EPA in identifying and listing a greater number 

of PPCPs for regulation. 
EPA's CCL 3 process produced enough evidence to show that the 

listed contaminants: 

1. Are prevalent in public water systems; 

2. Have an adverse effect on the health of persons; and 

3. That regulation of such contaminants would provide 

noticeable health risk reductions. 

Therefore, these contaminants must be regulated under the SDWA 

B. THE CONTAMINANT CANDIDATE LIST IS MISSING A NUMBER OF 

EXCEPTIONALLY HAZARDOUS DRINKING WATER POLLUTANTS. 

We appreciate that EPA must take a number of issues into 

account in determining which contaminants to list under CCL 3 

and, ultimately, the NPDWRs. However, there are a number of 

notable hazardous contaminants that were not publicly addressed 

in the past three listing processes, and which must be 

regulated in order to protect US drinking water supplies. An 

important category of contaminants that must be regulated is 

PPCPs. 

1. EPA Must Regulate Pharmaceuticals and Personal Care Product 

Levels in Public Water. 

PPCPs are scientifically shown to degrade drinking water 

quality and adversely affect human health.[FN29: See, e.g., Dr. 

Jennifer Sass, Senior Scientist NRDC, Statement before the 

Committee on Environment and Public Works Subcommittee on 

Transportation Safety, Infrastructure Security and Water 

Quality (April 15, 2008) ("Pharmaceuticals and personal care 

products (PPCPs) include human and veterinary drugs, both 

prescription and over-the-counter, medical agents such as 
chemotherapeutic drugs and x-ray contrast media, antibiotics, 

anti-inflammatories, blood pressure and cholesterol lowering 

medications, psychotropic drugs, oral contraceptives, anti- 

seizure medications, fragrances, sunscreens, 'antibacterial' 

soaps, lotions, shampoos, and creams.").] An investigation by 

the Associated Press revealed that pharmaceutical residues were 

detected in the drinking water supplies serving 41 million 

Americans.[FN30: See Jeff Donn, et al., AP Probe Finds Drugs in 

Drinking Water, Associated Press, March 9, 2008, at 

www.msnbc.msn.com/id/23503485/] 

Endocrine disrupting compounds ("EDCs") are included in PPCPs. 

EDCs are substances that directly or indirectly affect the 

body's ability to regulate homeostasis, growth, and 

reproduction. Endocrine disrupting compounds may influence the 

synthesis, transport, or metabolism of hormones in the body. 

Endocrine disrupting compounds may be medical substances like 

ethinyl estradiol, the active ingredient used in hormonal birth 

control, or they can include metals, pesticides, plasticizers, 

toxins such as polychlorinated biphenyls (PCBs), and naturally 

occurring phytoestrogens. 

PPCPs enter the environment in a number of ways including: 

waste from human or animal excretion, improper disposal such as 

flushing down a toilet, runoff from animal feeding operations, 

or leaching from municipal landfills.[FN31: Id.] As PPCPs are 

only partially metabolized by humans and other animals, they 

remain largely unchanged in urine and feces.[FN32: See 

Daughton, PPCPs as Environmental Pollutants, U.S. Environmental 

Protection Agency: Office of Research and Development (2004).] 

Human PPCPs, including hospital wastes, are often disposed of 

through sewage treatment systems or in landfills, ultimately 

being released into the environment.[FN33: Id.] Currently, 

wastewater treatment plants are not designed to remove PPCPs 

from the wastestream. This inadequacy results in PPCP- 

contaminated liquid effluent either being discharged to a 

eceiving waterbody or injected to groundwater, putting both 

surface water and aquifers at risk. Overflow, bypass, upsets, 

and system failures at wastewater treatment facilities also 

allow PPCP-contaminated waste to enter receiving waterbodies. 
Further, contamination can occur when treatment sludge 

(biosolids), containing pharmaceuticals attached to solid 

particles, are land applied. 

The research, manufacturing, and sale of PPCPs may also lead to 

environmental contamination. Pharmaceuticals in any stage of 

clinical testing are subject to release into the 

environment.[FN34: See Daughton. and Ternes, Special report: 

pharmaceuticals and personal care products in the environment: 

agents of subtle change?, Environmental Health Perspectives at 

107 (1999).] Drug surpluses, treated and untreated 

pharmaceutical waste, and pharmaceutical byproducts from 

manufacturing and research facilities, pharmacies, physicians, 

and humanitarian efforts are often expelled into sewer systems, 

ultimately ending up at wastewater treatment plants which allow 

the contaminants to travel, untreated, into receiving 

waterbodies. 

Pharmaceuticals are also used heavily in agriculture. Confined 

animal feeding operations ("CAFOs") often utilize antibiotics 

for both infection control and enhanced growth, while hormones 

are used to control reproductive cycles and to speed 

growth.[FN35: See, e.g., Song, et al., Determination of 

Amprolium, Carbadox, Monensin, and Tylosin in Surface Water by 

Liquid Chromatography / Tandem Mass Spectrometry, Rapid 

Communications in Mass Spectrometry 21: 1944-1950 (2007).] Like 

humans, animals do not completely metabolize pharmaceuticals, 

and their waste contains measurable levels of pharmaceutical 

compounds. Animal agricultural waste, and its associated 

contaminants, can enter the drinking water supply in a variety 

of ways. For example, much of the more than 110 million tons of 

swine waste produced in the United States each year[FN36: See 

Environmental Defense, Animal Waste Summary (1997) at 

www.hogwatch.org/maps/index (June 15, 2004).] is disposed of 

through direct land application, contaminating soil and 

groundwater resources.[FN37: See Daughton, PPCPs as 

Environmental Pollutants, U.S. Environmental Protection Agency: 

Office of Research and Development (2004); Chapin, et al. 

Airborn Mutlidrug-Resistant Bacteria Isolated from a 

Concentrated Swine Feeding Operation. Environmental Health 

Perspectives 113: 137-142 (2005)] Further, land application 

frequently results in manure-laden runoff, which introduces 
pharmaceuticals to receiving waterbodies. Contamination can 

also occur as a result of leaking manure storage facilities and 

improper disposal of euthanized or medicated carcasses. With no 

primary waste treatment required for animal wastes and without 

PPCP regulation, virtually all excreted PPCP compounds are 

flowing unfettered into drinking water sources. 

Aquaculture also uses many antibiotics and other anti- 

infectives and anesthetics. The close proximity of aquaculture 

facilities, medicated feed, and waste to natural aquatic 

ecosystems increases the probability that pharmaceuticals will 

enter the environment.[FN38: See Daughton. and Ternes, Special 

report: pharmaceuticals and personal care products in the 

environment: agents of subtle change?, Environmental Health 

Perspectives at 107 (1999).] 

From the outset, PPCPs represent a large regulatory category, 

but, in advancing a workable regulatory schedule, this category 

can be reduced through a few simple steps. First, PPCPs can 

easily be broken into two categories: pharmaceuticals and 

endocrine disrupters. Pharmaceuticals can then be further 

divided into therapeutic pharmaceuticals and non-therapeutic 

pharmaceuticals. Non-therapeutic pharmaceuticals refer to drugs 

administered at sub-therapeutic levels or for purposes other 

than their original design, as often seen in industrial 

agriculture. From this categorization, EPA can further narrow 

the regulatory category by analyzing which pharmaceuticals 

cause the greatest threat to water quality and the feasibility 

of limiting the use of these contaminants and treatment 

options. 

As discussed above, EPA engages in a three step process to 

determine whether and at what contaminant level to regulate a 

pollutant. As the following PPCPs have been proven to: 

1. Be prevalent in public water systems; 

2. Have an adverse effect on the health of persons; and 
3. Regulation of such contaminants would provide noticeable 

health risk reductions. 

They must be regulated, thereby reducing the health risks they 

pose to public health, drinking water, and the environment. 

a. Proposed Therapeutic Pharmaceuticals Meet Listing Standards 

i. Identifying and Prioritizing Drinking Water Problems: Best 

Available Science Dictates the Listing of Therapeutic 

Pharmaceuticals 

1. Therapeutic Pharmaceuticals are prevalent in public water 

systems. 

The domestic use of PPCPs is on par, in terms of quantity, with 

agrichemicals.[FN39: See, Daughton, C.G. and T.A. Ternes. 

Special report: pharmaceuticals and personal care products in 

the environment: agents of subtle change? Environmental Health 

Perspectives. 107. 1999.] The prevalent use of PPCPs makes them 

ubiquitous in the environment - they can be found in the 

rivers, lakes, and coastal waters of any place humans live or 

even visit.[FN40: Id.] PPCPs have been detected in wastewater 

effluents, surface waters, groundwater, and drinking water 

supplies around the world.[FN41: See, e.g., Westerhoff,et al., 

Fate of endocrine-disrupter, pharmaceutical, and personal care 

product chemicals during simulated drinking water treatment 

processes, Environmental Science and Technology at 39(17) 

(2005).] 

About 100 PPCPs have been detected in European and U.S. surface 

waters in the parts per trillion (ppt) to parts per billion 

(ppb) range.[FN42: See Hemminger, Damning the flow of drugs 

into drinking water, Environmental Health Perspectives at 

113(10) (2005).] An Environmental Working Group analysis shows 

that of the top 200 drugs in the U.S., thirteen percent list 

serious side effects at levels less than 100 parts-per-billion 
(ppb) in human blood, with some causing potential health risks 

in the parts-per-trillion range.[FN43: Environmental Working 

Group. Pharmaceuticals Pollute U.S. Tap Water (2008) at 

http://www.ewg.org/node/26128 (May 15, 2008).] However, despite 

the fact that "[t]he drug residues in tap water join hundreds 

of other synthetic chemicals Americans are exposed to daily," 

such as contaminants in food, water, air, and common consumer 

products, there continue to be no standards for these, or any, 

pharmaceuticals and there are no requirements that utilities 

test for these contaminants.[FN44: Id.] 

The United States Geological Survey ("USGS") conducted a study 

of pharmaceuticals, hormones, and other organic wastewater 

contaminants in 139 U.S. streams in1999 and 2000.[FN45: See 

Buxton and Kolpin, Pharmaceuticals, Hormones, and Other Organic 

Wastewater Contaminants in U.S. Streams, United States 

Geological Survey: Toxic Substances Hydrology Program, Fact 

Sheet FS-027-02 (2002).] They analyzed stream water for 95 

different organic compounds routinely found in residential, 

industrial, and agrichemical wastewaters. They found human and 

veterinary drugs, including antibiotics and natural and 

synthetic hormones, detergent metabolites, plasticizers, 

insecticides, and fire retardants in waters downstream of 

animal production facilities and heavily urbanized areas. 

Eighty-two contaminants were detected at least once and one or 

more organic wastewater contaminants were detected in 80 

percent of the streams sampled.[FN46: See Kolpin, et al., 

Pharmaceuticals, hormones, and other organic wastewater 

contaminants in U.S. streams, 1999-2000: A national 

reconnaissance, Environmental Science and Technology at 36(6) 

(2002).] Mixtures of contaminants were common in 75 percent of 

the sampled streams had more than one, 50 percent had seven or 

more, and 34 percent had ten or more contaminants 

present.[FN47: Id.] 

In March 2008, the Associated Press ("AP") released the results 

of an investigation into pharmaceutical contamination of U.S. 

drinking water supplies, finding that at least 41 million 

Americans are exposed to drugs such as pain relievers, 

antibiotics, anticonvulsants, mood stabilizers, and sex 

hormones through their drinking water.[FN48: 48 See Associated 

Press, Prescription drugs found in drinking water across U.S., 
April 4, 2008, at www.cnn.com/2008/HEALTH/03/10/pharma.water1 

(May 15, 2008).] The AP National Investigative Team reviewed 

hundreds of scientific reports; analyzed federal drinking water 

databases; visited environmental study sites and treatment 

plants; surveyed the nation's largest 50 cities, a dozen major 

water providers, and small water providers in all 50 states; 

and interviewed more than 230 officials, academics, and 

scientists. Besides identifying pharmaceuticals in drinking 

water supplies, the team also determined that 34 of the major 

water providers do not conduct any testing for these 

substances, and that those communities that do test do not 

share the results with the public. As detection methods are 

developed and improved these numbers will most likely only 

rise, especially since thousands of distinct PPCPs are 

available commercially and thousands of tons per year are 

used.[FN49: See, e.g., Daughton, PPCPs as Environmental 

Pollutants, U.S. Environmental Protection Agency: Office of 

Research and Development (2004).] 

Even EPA's own science details the ominous quantity of 

pharmaceuticals being released into drinking water: "[i]n 

addition to antibiotics and steroids, over 100 individual 

[Pharmaceuticals and Personal Care Products] have been 

identified (as of 2007) in environmental samples and drinking 

water."[FN50: US EPA, Pharmaceuticals and Personal Care 

Products at www.epa.gov/ppcp/faq.html (May 6, 2008).] It goes 

on to detail the major sources of PPCPs released into the 

environment. Of the six primary sources listed, two, veterinary 

drug use and agribusiness, fall within the CAFO category.[FN51: 

Id.] This representation shows the cogent link between the 

necessity for regulation of the PPCPs used in CAFOs and the 

reduction of pharmaceutical amounts in public waters. 

2. Therapeutic Pharmaceuticals in public water have an adverse 

effect on health and regulation of such contaminants would 

provide health risk reductions. 

The health risks associated with allowing pharmaceuticals to 

remain in public drinking water are clear. Pharmaceuticals make 

up a category of contaminants that, by their nature, affect the 

human body. Since pharmaceuticals began being prescribed in 
mass quantities for therapeutic use, physicians and the Food 

and Drug Administration ("FDA") have repeatedly stated that 

such pharmaceuticals are only to be taken by the person to 

which they were prescribed. While such pharmaceuticals are 

frequently life-saving for that person, they can be life- 

threatening for someone who does not possess a similar 

affliction. Such adverse effects become heightened if those 

pharmaceuticals are taken with liquor or paired with other 

pharmaceuticals. However, by not regulating pharmaceutical 

concentrations in the public drinking water, EPA is allowing 

the American public to unwittingly dosing itself with 

pharmaceuticals not prescribed to them. 

Even at very low levels of exposure, PPCPs have the potential, 

at the cellular level, to effect humans, and wildlife.[FN52: 

See Goodman, Sedatives and sex hormones in our water supply 

Democracy Now!, April 4, 2008 at 

www.alternet.org/water/80505/?page=1 (For many PPCPs, the 

specific modes of action and interaction with other substances 

are not fully understood.); Daughton, PPCPs as Environmental 

Pollutants, U.S. Environmental Protection Agency: Office of 

Research and Development (2004) (Eco-toxicity data is available 

for less than one percent of human pharmaceuticals.).] This is 

largely because PPCPs are bioreactive by design, leading to an 

intended physical or psychological response in the body. PPCPs 

bioreactive designs may cause a number of unintended reactions, 

and their hazards to public health are particularly strong, 

especially where the pathway of interactions is unknown.[FN53: 

See Daughton, PPCPs as Environmental Pollutants, U.S. 

Environmental Protection Agency: Office of Research and 

Development (2004).] Therefore, the effects on non-target 

species are unpredictable and potentially volatile.[FN54: Id.] 

Further, some PPCPs are proven to bioaccumulate, build up, in 

the body over time.[FN55: Bioaccumulation is "[t]he 

accumulation of a substance, such as a toxic chemical, in 

various tissues of a living organism. Bioaccumulation takes 

place within an organism when the rate of intake of a substance 

is greater than the rate of excretion or metabolic 

transformation of that substance." Bioaccumulation, The 

American Heritage Science Dictionary, Houghton Mifflin Company 

(2008) at 
http://dictionary.reference.com/browse/Bioaccumulation (May 13, 

2008).] This can cause both acute and chronic problems such as 

toxicity and carcinogenesis, as well as antibiotic resistance, 

neurobehavioral changes, and genetic and reproductive mutation. 

Recently, the Center for Disease Control identified antibiotic 

resistance as one of the most pressing public health problems 

to face our nation. It has implemented a campaign to halt 

antimicrobial resistance in healthcare settings, but such 

program will be ineffective without concerted removal of 

pharmaceuticals from drinking water.[FN56: See Center for 

Disease Control at 

www.cdc.gov/drugresistance/healthcare/problem.htm (May 15, 

2008).] 

Mutation of aquatic organisms is of extreme concern as these 

mutations signify "canaries in a coal mine" regarding impacts 

of excess pharmaceutical intake on human beings. For example, a 

study in a 1994 issue of Chemistry and Ecology linked 

production of vitellogenin, an egg protein usually only found 

in females, by male carp and trout to exposure of sewage 

effluent containing the active ingredient in birth control 

pills.[FN57: See Hemminger, Damning the flow of drugs into 

drinking water, Environmental Health Perspectives at 113 

(2005).] 

The improper and uncontrollable intake of pharmaceuticals 

through drinking water is hazardous to the public by, among 

other things, causing antibiotic resistance, overdose, sickness 

and possibly death.[FN58: See Jay Cohen, Overdose: The Case 

Against Drug Companies at 

http://www.lauralee.com/news/overdose2.htm (May 19, 2008) 

("Aggressive marketing, slanting research, unethical publishing 

of results, pressuring medical centers, intimidating 

researchers, influencing physicians, limiting information, 

manipulating the FDA, marketing drugs with inaccurate safety 

information and inappropriate doses -- all of these have 

created an environment in which medication development has 

become, in Dr. Angell's fitting term, a 'race to the bottom 

(72).'").] Therefore, reasonability and science dictate that 

regulation of these contaminants would reduce health risks. 
ii. Cost-Benefit Analysis 

EPA is not in the appropriate stage to determine whether 

pharmaceutical contaminants are too costly to regulate under 

National Drinking Water Regulations.[FN59: 42 USC § 300g-1(b) 

(1).] That determination should be made after the contaminant 

has been adopted for regulation and at the time that MCL limits 

are being finalized.[FN60: Id.] At the current stage, EPA 

should only be considering the likelihood that pharmaceuticals 

will occur in the public water system, the adverse health 

effects caused by these contaminants, and the health risk 

reductions that will come from regulating.[FN61: Id.] As 

detailed above, each of these benchmarks have been evidenced, 

and PPCPs should be considered for regulation. 

However, even if it is appropriate for EPA to perform cost- 

benefit analyses at this stage, the benefits of regulation 

greatly outweigh the associated costs. Under the SDWA, in 

determining a regulated contaminant's MCL, the Administrator 

should analyze seven issues: 

1. Quantifiable and nonquantifiable health risk reduction 

benefits for which there is a factual basis in the rulemaking 

record to conclude that such benefits are likely to occur as 

the result of treatment... 

2. Quantifiable and nonquantifiable health risk reduction 

benefits for which there is a factual basis in the rulemaking 

record to conclude that such benefits are likely to occur from 

reductions in co-occuring contaminants... 

3. Quantifiable and nonquantifiable costs for which there is a 

factual basis in the rulemaking record to conclude that such 

costs are likely to occur solely as a result of compliance with 

the maximum contaminant level... 
4. The incremental costs and benefits associated with each 

alternative maximum contaminant level considered... 

5. The effects of the contaminant on the general populations 

and on groups within the general population such as infants, 

children, pregnant women, the elderly, individuals with a 

history of serious illness, or other subpopulations that are 

identified as likely to be at greater risk of adverse health 

effects due to exposure to contaminants in drinking water than 

the general population... 

6. Any increased health risks that may occur as a result of 

compliance... 

7. Other relevant factors, including the quality and extent of 

the information, the uncertainties in the analysis supporting 

subclauses (I) through (IV), and factors with respect to the 

degree and nature of the risk.[FN62: 42 USC § 300g-1(b)(3)(C).] 

These factors can be broken down into two categories: benefits 

of regulation and costs. 

As detailed above, the human health and welfare benefits of 

regulating PPCPs are innumerable. The threat to human health 

caused by the ingestion of unprescribed pharmaceuticals through 

drinking water will be most apparent in infants, children, and 

pregnant women. Children and pregnant women are the most 

sensitive populations to drugs and the exposure to these 

contaminants may cause miscarriages, developmental 

abnormalities, and other life altering adverse effects.[FN63: 

See, e.g., Montenegro, et. al., Assessment of How Pregnancy 

Modifies Plasma Lead and Plasma/Whole Blood Lead Ratio in ALAD 

1-1 Genotype Women, Basic & Clinical Pharmacology & Toxicology 

102: 347-351 (2008).] For example, the Environmental Working 

Group "found an average of 200 industrial chemicals, pesticides 

and other pollutants in umbilical cord blood from 10 babies 

born in the U.S., indicating that our exposures to toxic 

chemicals begin in the womb, when risks are greatest."[FN64: 

Environmental Working Group, Pharmaceuticals Pollute U.S. Tap 
Water at: www.ewg.org/node/26128 (May 15, 2008).] 

As the 1996 SDWA amendments highlight, American have the right 

to know what pharmaceuticals are contained in their drinking 

water.[FN65: See Pub. L. 104-182, 110 Stat. 1615.] If 

regulated, such crucial information on PPCP content would be 

available in the annual consumer confidence reports. However, 

since the consumer confidence reports only contain information 

on regulated contaminants, such regulation is necessary for the 

public to protect itself against adverse health affects as a 

result of drinking medicated water. 

The costs of controlling pharmaceutical pollution are found in 

source control (dischargers) and treatment (drinking water 

suppliers). Industrial dischargers include pharmaceutical 

research and manufacturing companies, medical service providers 

such as hospitals and mortuaries, and privately owned 

wastewater treatment plans. Municipal dischargers include 

publicly owned treatment works. 

EPA does not appear to quantify the costs of removing PPCPs 

from public waters, and there are few other sources that 

directly address this issue.[FN66: See Daughton and Ternes, 

Special report: pharmaceuticals and personal care products in 

the environment: agents of subtle change?, Environmental Health 

Perspectives. at 107 (1999).] However, if EPA is using the cost 

burden as a crutch for claiming that PPCPs cannot be regulated, 

it must provide adequate data to illustrate this conclusion. 

Without such essential information, EPA cannot reject PPCP 

regulation under the premise of cost constraints. 

Based on this analysis, PPCP regulations must be implemented. 

b. Proposed Non-therapeutic Pharmaceuticals Meet Listing 

Standards 

i. Identifying and Prioritizing Drinking Water Problems: Best 

Available Science Dictates the Listing of Non-therapeutic 
Pharmaceuticals 

1. Non-Therapeutic Pharmaceuticals are prevalent in public 

water systems. 

Therapeutic and non-therapeutic pharmaceuticals are often the 

same drugs, with the same active and inert ingredients. 

However, the rampant use of pharmaceuticals for nontherapeutic 

means in confined animal feeding operations ("CAFOs") is 

threatening surface and groundwater supplies across the United 

States. Non-therapeutic pharmaceutical use is the 

administration of drugs to animals to treat or prevent the 

spread of illnesses or to prevent death.[FN67: Non-therapeutic 

pharmaceutical use is the standard application of hormones, 

steroids, and antibiotics to livestock and poultry feed for no 

discernable, non-preventative medical reason.] For example, 

CAFOs often utilize antibiotics to prevent infections due to 

crowded and stressful conditions and to enhance growth. 

Hormones are used to control reproductive cycles for 

convenience and to speed growth and production. 

An estimated 70 percent of all the antibiotics used in the US 

are used for animal husbandry.[FN68: See Mellon et al., Hogging 

It: Estimates of Antimicrobial Abuse in Livestock, Union of 

Concerned Scientists (2000); Antibiotic Resistance and 

Agricultural Overuse of Antibiotics, fact sheet, Health Care 

Without Harm, at 

www.noharm.org/details.cfm?ID=938&type=document (May 15, 

2008).] In fact, "[i]n the United States, hormone supplements 

are used in the production of approximately 90 percent of the 

beef cattle."[FN69: Balter, Scientific Cross-Claims Fly in 

Continuing Beef War, Science 284:1453-1455 (1999).] Also, "[a]n 

estimated 10.3 million pounds of antibiotics are used annually 

in U.S. swine production for nontherapeutic purposes."[FN70: 

Sapkota, et al. Antibiotic-Resistant Enterococci and Fecal 

Indicators in Surface Water and Groundwater Impacted by a 

Concentrated Swine Feeding Operation, Environmental Health 

Perspectives 115:1040-1045 (2007).] 

It is essential for EPA to generate a control mechanism against 
this excess use of pharmaceuticals; however, in the meantime, 

regulating under the SDWA ensures some protections are afforded 

to human health and drinking water against these powerful 

pollutants. Non-therapeutic pharmaceuticals are clearly a 

category that can be regulated, and that, in being regulated, 

will greatly improve water quality and potability. 

Types of non-therapeutic pharmaceuticals that could be 

regulated include, but are not limited to: 

1. Tetracycline, 

2. Erythromycin, 

3. Lincomycin, 

4. Virginiamycin, 

5. Ampicillin, and 

6. Bacitracin. 

Land application of PPCP-contaminated manure can pollute soil 

resources and ultimately groundwater.[FN71: See Daughton at 

PPCPs as Environmental Pollutants.] Manure-laden runoff and 

leaking manure storage facilities also introduce waste to 

receiving waterbodies. Further, improper disposal of carcasses 

also allows PPCPs to enter the environment. Since livestock at 

CAFO facilities are perpetually narcotized with non-therapeutic 

pharmaceuticals and since animals, like humans, do not 

completely metabolize pharmaceuticals, there is no question 

that pharmaceutical byproducts are released in factory farm 

animal waste, and that such byproducts reach public waters. 

2. Non- Therapeutic Pharmaceuticals in public water have an 
adverse effect on health and regulation of such contaminants 

would provide health risk reductions. 

The health risks associated with non-therapeutic 

pharmaceuticals are comparable to the health risks of 

therapeutic pharmaceuticals. This is because many of the 

pharmaceuticals are the same. However, because of their 

superfluous use, the impacts of non-therapeutic pharmaceuticals 

on water quality and public health are more poignant. 

A plentitude of studies address the impacts of the steroids, 

antibiotics, and hormones commonly used in CAFO operations on 

health and water quality. For example, USGS conducted an entire 

series of reports on the contaminants found in animal 

wastes.[FN72: Dr. Robert Hirsch, Associate Director for Water 

USGS, Statement before the Committee on Environment and Public 

Works Subcommittee on Transportation Safety, Infrastructure 

Security and Water Quality, April 15 (2008) ( Studies found at 

http://toxics.usgs.gov/bib/bib-Emerging.html).] These reports 

range in topic, but several address the movement of antibiotics 

from animal, to waste, to land application.[FN73: See, e.g., 

Barnes et. al., Water-quality data for pharmaceuticals, 

hormones, and other organic wastewater contaminants in U.S. 

streams, 1999-2000, U.S. Geological Survey Open-File Report 

02-94 (2002) at http://toxics.usgs.gov/pubs/OFR-02-94/; Buxton 

and Kolpin, Pharmaceuticals, hormones, and other organic 

wastewater contaminants in U.S. streams, U.S. Geological Survey 

Fact Sheet FS-027-02, 2 (2002) at 

http://toxics.usgs.gov/pubs/FS-027-02/; Kinney et. al, Presence 

and distribution of wastewater-derived pharmaceuticals in soil 

irrigated with reclaimed water, Environmental Toxicology and 

Chemistry, 25, 317-326 (2006) at 

http://pubs.acs.org/cgibin/abstract.cgi/esthag/2008/42/i06/abs/ 

es702304c.html; Kinney et. al., Survey of organic wastewater 

contaminants in biosolids destined for land application, 

Environmental Science & Technology, 40, 7207-7215 (2006) at 

http://www.setacjournals.org/perlserv/?request=get-abstract& 

doi=10.1897%2F05-187R.1; Kinney et al., Bioaccumulation of 

pharmaceuticals and other anthropogenic waste indicators in 

earthworms from agricultural soil amended with biosolid or 

swine manure, Environmental Science and Technology, 42 (6), 

1863-1870 (2008) at http://pubs.acs.org/cgi-bin/ 
abstract.cgi/esthag/2006/40/i23/abs/es0603406.html.] 

The Pew Commission on Industrial Farm Animal Production, a non- 

partisan organization, conducted a comprehensive impact study 

regarding the impacts of CAFOs on the environment and water 

quality. Pew researchers determined "unlike human use of 

antibiotics, non-therapeutic uses in animals typically do not 

require a prescription."[FN74: Putting Meat on the Table: 

Industrial Farm Animal Production in America, PEW Commission on 

Industrial Farm Animal Production at 66 (2008) at 

www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Industr 

ial_Agriculture/PCIFAP_FINAL.pdf (May 12, 2008).] Further, it 

was determined that pharmaceutical use by farmers was regularly 

"not in accordance with approved labeling."[FN75: Id.] For 

example, farmers were found to be administering drugs "for a 

species not listed on the label; for an indication, disease, or 

other condition not on the label; or by a route of 

administration not on the label."[FN76: Id.] 

As a result of their findings, the Commission concluded its 

report by recommending a number of necessary procedural changes 

industrialized factory farms should make in order to improve 

neighboring health and environmental quality. Two 

recommendations of particular interest are: 

1. Restrict the use of antimicrobials in food animal production 

to reduce the risk of antimicrobial resistance to medically 

important antibiotics[FN77: An analysis of the antibiotic 

resistance hazards of antimicrobials use in food animal 

production are discussed in the "cost-benefit analysis" section 

below.], and 

2. Increase veterinary oversight of all antimicrobial use in 

food animal production to prevent overuse and misuse of 

antimicrobials.[FN78: Putting Meat on the Table: Industrial 

Farm Animal Production in America, at 61,66.] 

These recommendations illustrate that the unregulated and 

inappropriate uses of the pharmaceuticals are one of the ways 
in which excess quantities of pharmaceuticals are poisoning our 

drinking waters, and they demonstrate that best available 

science dictates the listing of non-therapeutic 

pharmaceuticals. 

Available reports clearly prove that the pharmaceutical- 

contaminated waste produced by animal feeding operations are 

polluting waterways and, as detailed below, contributing to 

antibiotic resistant pathogens. Such concerns plainly impact 

water quality and risk human health. Therefore, EPA must 

regulate a number of non-therapeutic steroids, hormones, and 

antibiotics under the SDWA. To do otherwise will be a violation 

of the Congressional mandate to establish enforceable criteria 

and procedures which will assure healthy and safe drinking 

water.[FN79: See 42 USC §§ 300f to 300j-26.] 

ii. Cost-Benefit Analysis 

The regulation of non-therapeutic pharmaceuticals has many of 

the same costs and benefits as the regulation of therapeutic 

pharmaceuticals; however, the benefit of regulating non- 

therapeutic pharmaceuticals is even more pronounced. 

Many of the pharmaceuticals that CAFOs use non-therapeutically 

are the same as those being used therapeutically in humans. 

This results in two main problems. The first problem is the 

shear volume of pharmaceuticals being released into the water. 

Since some pharmaceuticals are being used for both therapeutic 

and non-therapeutic purposes, higher quantities of these 

pharmaceuticals are put into circulation, and, therefore, 

higher quantities are being excreted into the water. 

The second problem is antibiotic resistance. "Antibiotics are 

the leading treatment method for bacterial infectious diseases, 

which remain the most common cause of worldwide death."[FN80: 

Isolation of Antibiotic-Resistant Bacteria from the Air Plume 

Downwind of a Swine Confined or Concentrated Animal Feeding 

Operation, Environmental Health Perspectives 114: 1032-1037 at 

032 (2006), citing McGeer, Agricultural Antibiotics and 
Resistance in Human Pathogens: Villian or Scapegoat?, Can Med. 

Assoc J 159: 1119-1120 (1998).] "It is widely accepted that 

antibiotic-resistant pathogens make clinical treatment more 

difficult."[FN81: Id] Because "some classes of antibiotics that 

are used to treat life-threatening infections in humans, such 

as penicillins and tetracyclines, are allowed in animal feeds 

to promote growth,"[FN82: Putting Meat on the Table: Industrial 

Farm Animal Production in America, at 15.] an increased number 

of antibiotic resistant pathogens are forming, leaving human 

populations unprotected. Studies show that: 

Antimicrobial-resistant bacteria have been found both in and 

downwind of IFAP [Industrial Farm Animal Production] facilities 

(e.g., swine) but not upwind.[FN83: Id., citing Gibbs et al. 

(2004).] Several groups have reviewed the association between 

the use of lowlevel antimicrobials in food animal production 

and the development of antimicrobial resistance in humans[FN84: 

Id., citing Teuber (2001); Harris et al. (2002)]; FN85: Id. at 

16.] 

Those groups have found a correlative relationship. 

For example, in 2001 Chee-Sanford et al. found that "the 

movement of resistant bacteria and resistance determinants from 

swine CAFOs into the environment can be extensive." On thing 

that the group found was, "a high occurance of tetracycline 

resistance determinants in groundwater wells located close to 

swine lagoons."[FN86: Id., citing Sapkota et al at 1044.] And, 

in 2007, 

Sapkota et al. found "antibiotic resistant Enterococcus ssp. 

...in a drinking water well located 400 m down gradient from 

the facility."[FN87: Id.] 

As stated by the U.S. Institute of Medicine/National Academy of 

Science, "[c]learly, a decrease in antimicrobial use in human 

medicine alone will have little effect on the current 

[antibiotic-resistant] situation. Substantial efforts must be 

made to decrease inappropriate overuse in animals and 
agriculture as well."[FN88: Antibiotic Resistance and 

Agricultural Overuse of Antibiotics, Healthcare Without Harm 

factsheet, Novermber 8, 2005 at www.noharm.org/us/food/issue.] 

The World Health Organization ("WHO") also expressed its 

concern when it stated "[t]here is clear evidence of the human 

health consequences due to resistant organisms resulting from 

non-human usage of antimicrobials."[FN89: Id.] The Center for 

Disease Control estimated that 2 million people contract 

resistant infections annually, and, of those, 90,000 die.[FN90: 

Putting Meat on the Table: Industrial Farm Animal Production in 

America, at 15.] Further, "A decade ago the Institute of 

Medicine estimated that antimicrobial resistance costs the 

United States between $4 and $5 billion annually, and these 

costs are certainly higher now."[FN91: Id.] 

In Denmark, which in 1998 banned the use of antibiotics in food 

animal production for non-therapeutic purposes, it was found 

that 

the termination of antimicrobial growth promoters in Denmark 

has dramatically reduced the food animal reservoir of 

enterocicci resistant to these growth promoters, and therefore 

reduces a reservoir of genetic determinants (resistance genes) 

that encode antimicrobial resistance to several clinically 

important antimicrobial agents in humans.' The report also 

determined that the overall health of the animals (mainly 

swine) was not affected and the cost to producers was not 

significant.[FN92: Id. at 61, quoting WHO 2002 report] 

While the Safe Drinking Water Act may not be the appropriate 

location to ban the use of non-therapeutic pharmaceuticals, EPA 

can use it to ensure against further antimicrobial resistance 

by removing the contaminants from the water. The benefits of 

these regulations are clear. 

Much like the pesticide use, the use of non-therapeutic 

antibiotics is unnecessary and can be easily regulated. Based 

on this analysis, regulations must be implemented. 
c. Proposed Endocrine Disrupting Compounds Meet Listing 

Standards 

i. Identifying and Prioritizing Drinking Water Problems: Best 

Available Science Dictates the Listing of Endocrine Disrupting 

Compounds 

1. Endocrine Disrupting Compounds are prevalent in public water 

systems. 

In 1996, Congress mandated that EPA address endocrine 

disrupting compounds ("EDCs") in drinking water.[FN93: In 1996, 

the Food Quality Protection Act (FQPA) required EPA to develop 

a screening program to ascertain which substances may have 

estrogenic (or other endocrine) effects on humans. P.L. 

104-170. The Safe Drinking Water Act extended this mandate to 

include substances that may be found in sources of drinking 

water. 42 USC § 300g-1.] Twelve years later the Endocrine 

Disruptor Screening Program has failed to even start testing 

chemical contaminants and EPA has yet to implement necessary 

regulations. These compounds have long been identified as 

posing a threat to health and water quality, and EPA is 

severely delinquent in its response. 

Types of EDCs that could be regulated include, but are not 

limited to, estrogens, androgens and progesterones. Each of 

these have been reported to appear in significant 

concentrations around fields fertilized with poultry 

litter[FN94: See Finley-Moore, et al., 17ß-Estradiol and 

Testosterone in Soil and Runoff from Grasslands Amended with 

Broiler Litter, J Environ Qual 29: 1604-1611 (2000); Nichols, 

et al. Runoff of Estrogen Hormone 17ß-estradiol from Poultry 

Litter Applied to Pasture. J Environ Qual 26: 1002-1006 

(1997).] and in ponds below cattle holding facilities.[FN95: 

See Irwin, et al. Vitellogenin Induction in Painted Turtle, 

Chrysemys picta, as a Biomarker of Exposure to Environmental 

Levels of Estradiol, Aquat Toxicol 55: 49-60 (2001); Orlando, 

et al. Endocrine- Disrupting Effects of Cattle Feedlot Effluent 

on an Aquatic Sentinel Species, the Fathead Minnow, 
Environmental Health Perspectives 112:353-358 (2004).] 

2. Endocrine Disrupting Compounds in public water have an 

adverse effect on health and regulation of such contaminants 

would provide health risk reductions. 

EDCs are substances that directly and indirectly affect the 

body's ability to regulate homeostasis, growth, and 

reproduction. EDCs may influence the synthesis, transport, or 

metabolism of hormones in the body. EDCs are medical substances 

like ethinyl estradiol, the active ingredient used in hormonal 

birth control, but also include metals, pesticides, 

plasticizers, toxins such as polychlorinated biphenyls (PCBs), 

and naturally occurring phytoestrogens from plants like soy. 

"Endocrine disruption is one adverse health effect of concern 

because it may occur as a result of exposure to very low levels 

of hormonally active chemicals,"[FN96: Dr. Robert Hirsch, 

Associate Director for Water USGS, Statement before the 

Committee on Environment and Public Works Subcommittee on 

Transportation Safety, Infrastructure Security and Water 

Quality, April 15, 2008.] and it can be caused by any one of 

the number of unnecessarily endocrine disrupting hormones being 

injected daily into factory raised animals. For example, beef 

cattle CAFOs frequently use the anabolic steroid androgen 

mimic, trebolone acetate, to promote the growth of muscle. 

During degradation this steroid creates a product that is both 

stable in water and highly capable of binding to androgen 

receptors in fish.[FN97: See Durhan EJ, et al., Identification 

of metabolites of trebolone acetate in androgenic runoff from a 

beef feedlot, Environental Health Perspectives, 114 Suppl 

1:65-8 (2006); See also, Hotchkiss, et al., Fifteen years after 

"Wingspread" - Environmental Endocrine Disruptors and human and 

wildlife health: Where are we today and where we need to go, 

Toxicological Science Advance Access published Feb 16, 2008.] 

Exposure to this compound causes the masculinization of female 

fish and results in reduced fertility at even low 

concentrations.[FN98: Id.] The result in fish is an indication 

of the results that can be felt in humans. 
ii. Cost-Benefit Analysis 

The regulation of EDCs has many of the same costs and benefits 

as the regulation of therapeutic and non-therapeutic 

pharmaceuticals; however, Congress pointedly mandated the 

regulation of EDCs. 

Additionally, children and pregnant women are particularly 

sensitive to EDC exposure. This is known because of the 

predictive signs of toxicity and abnormality displayed in 

effected wildlife. All vertebrates, including fish, amphibians, 

reptiles, birds, and mammals including humans, are 

fundamentally similar during early embryonic development.[FN99: 

Natural Resources Defense Council, Endocrine Disruptors (2008) 

at http://www.nrdc.org/health/effects/qendoc.asp#children\ (May 

15, 2008).] Since EDCs affect the development of the body's 

vital organs and hormone system, developing fetuses, infants, 

and children are more vulnerable to exposure. Additionally, 

parents' exposure to certain EDCs may produce unexpected and 

tragic effects in their children, even decades after the 

exposure occurs. 

Based on this analysis, EDC regulations must be implemented. 

2. EPA Can Include These Contaminants In the Currently Proposed 

Regulations 

Under the SDWA, "[t]he Administrator may make a determinations 

to regulate a contaminant that does not appear on a list under 

clause (i) if the determination to regulate is made pursuant to 

subclause (II)."[FN100: 42 USC § 300g-1(b)(1)(B)(ii)(III).] 

Under this language, EPA may chose to list a contaminant for 

regulation even if that contaminant was not proposed for public 

comment if the contaminant is determined to: 

1. Have an adverse effect on the health of persons; 
2. Occur or there is a substantial likelihood that the 

contaminant will occur in public water systems with frequency 

and at levels of public health concern; and 

3. Regulation of such contaminant presents a meaningful 

opportunity for health risk reduction for persons served by 

public water systems.[FN101: 42 USC § 300g-1(b)(1)(A); See 42 

USC §§ 300g-1(b)(1)(B)(ii)(II),(III).] 

As we have shown above, PPCPs, including EDCs, meet these three 

points and, thus, should be regulated in the current listing 

process. 

If EPA does not include PPCPs in this provision, it should 

promulgate an interim national primary drinking water 

regulation to address this "urgent threat" to public 

health.[FN102: 42 USC § 300g-1(b)(1)(D).] As the AP 

investigation, USGS studies, and other studies show, PPCPs in 

water present an urgent and growing threat to public water, 

and, as such, they should not continue being unregulated when 

such a feasible alternative exists. 

III. CONCLUSION 

The public has a right, in both knowledge and action, to clean 

drinking water. A valuable step for EPA to take in ensuring 

drinking water purity is to include pharmaceutical and personal 

care products discharged by municipal wastewater treatment 

plants and by industry, including confined animal feeding 

operations, in the NPDWR. At a bare minimum, PPCPs should be 

included in the unregulated contaminant monitoring rule to 

require public water systems to monitor for their presence in 

our drinking water and to identify in the consumer confidence 

reports the levels found in drinking water. With every glass of 

water we draw from our taps and bottle of water we open, we are 

unwittingly dosing ourselves with chronic levels of everything 

from Percocet to hormonal birth control to pesticides. EPA must 

act before another five years goes by. 
Thank you for your time and consideration. 

Hannah Connor 

Staff Attorney 

Janelle Robbins 

Staff Scientist 

Waterkeeper Alliance 

50 South Buckhout Street 

Suite 302 

Irvington, New York 10533 

t. 914.674.0622 

f. 914.674.4560 

hconnor@waterkeeper.org 

jrobbins@waterkeeper.org 

CS Title: 0131 

Company/group/association name: 

Comment: 

Julie E. Macedo 

Phone: 415.983.1590 

Julie.macedo@pillsburylaw.com 

May 21,2008 

U.S. Environmental Protection Agency 

Via www.regulations.gov 

Docket ID No. EPA-HQ-OW-2007-1189 

Re: City of Rialto's Comments on EPA's Draft Drinking Water 

Contaminant Candidate List 3 
Dear Gentlepersons: 

Rialto appreciates the opportunity to provide comments on the 

draft "Drinking Water Contaminant Candidate List 3" ("CCL") 

released by the EPA on or about February 21, 2008. Rialto 

supports the listing of perchlorate on the CCL, and the 

ultimate regulation of perchlorate as a contaminant under the 

Safe Drinking Water Act. 

No National Standard for Perchlorate Currently Exists 

In July 2006, Massachusetts became the first state in the 

country to promulgate a drinking water standard for perchlorate 

of 2 parts per billion (see Massachusetts Department of 

Environmental Protection website at 

http://www.mass.gov/dep/water/drinkinglpercfs77.htm, a copy of 

which is enclosed for your convenience). Effective October 18, 

2007, California adopted a maximum contaminant level (MCL) of 6 

micrograms per liter (see California Department of Public 

Health website at 

http://www.cdph.ca.gov/certlic/drinkingwater/Pages/Perchlorate. 

aspx, a copy of which is enclosed for your convenience.) [See 

PDF for Attachments.]These regulations were promulgated after 

careful consideration of the potential adverse health effects 

perchlorate can have when ingested.[FNl: The California 

Governor's Office, the California Environmental Protection 

Agency and the Office of Environmental Health Hazard Assessment 

("OEHHA") prepared the "Public Health Goal for Perchlorate in 

Drinking Water" in March 2004, which is publicly available 

through the OEHHA website and is incorporated herein by 

reference.] No national standard for perchlorate currently 

exists. 

A National Standard for Perchlorate Is Necessary 

The listing of perchlorate on the CCL is necessary as a step 

closer to a national standard for perchlorate. Perchlorate is 

found in fireworks, military munitions and other manufacturing 
processes, and the City of Rialto has spent more than four 

years trying to force the parties responsible for the 

perchlorate contamination in Rialto to remove the perchlorate 

and provide an alternative source of uncontaminated drinking 

water. The contamination in Rialto is a result of more than 60 

years of manufacturing of munitions, including those contracted 

for by the United States Department of Defense for World War 

II, fireworks and other explosive devices. There are likely 

hundreds of other sites around the country that are affected by 

perchlorate, and inclusion on the CCL would result in further 

study, investigation, and ultimately, clean up. 

While California's adoption of an MCL for perchlorate is a step 

in the right direction, a remediation plan for the Rialto- 

Colton Basin (Rialto's source of its groundwater) has not yet 

been developed. The parties responsible for the contamination 

have significant financial assets which have been used to delay 

and oppose any ultimate adjudication of their liability. Public 

interest groups, such as Environment California and Center for 

Community Action and Environmental Justice were involved in 

providing public comment in an administrative proceeding 

against three suspected dischargers of perchlorate, but were 

forced to terminate their involvement due to the heavy 

financial burden. Listing of perchlorate on the CCL would 

result in further public comment, study of the health effects 

of perchlorate, and investigation into additional sites, 

probably many of which have not been used for decades. Under 

federal and state environmental laws, responsible parties must 

pay to remove and remediate the contamination their 

manufacturing operations caused. The lapse in time and current 

lack of regulation makes it easy for. the contamination to go 

unnoticed and the responsible parties to evade prosecution. 

Many of the sites across the country in which perchlorate is 

likely to be found are former industrial and/or military sites, 

which are often in disadvantaged neighborhoods. Placing the 

financial burden of providing clean, safe drinking water on the 

ratepayers rather than the parties responsible for the 

contamination is a fundamental injustice. In order to address 

this injustice, a national regulatory standard for perchlorate 

is needed. 

Very truly yours, 
Julie E. Macedo, 

Attorneys for City of Rialto, Rialto Utility Authority 

Attachments 

CS Title: 0132 

Company/group/association name: 

Comment: 

RE: Comments for EPA Drinking Water contaminant Candidate List 

3 - Draft 

Thank you for accepting comments for the Drinking Water 

contaminant Candidate List 3 draft list. The City of Peoria, 

Arizona is a growing suburban city in the Phoenix metropolitan 

area. Peoria is active in a variety of water quality committees 

and organizations, including Arizona Water and Pollution 

Control (AWPCA), the Western Coalition of Arid States 

(WESTCAS), the Water Systems Coordinating Council (WSCC), 

Environmental Laboratory Advisory Committee (ELAC) and Multi- 

agency Laboratory Association (MALA). The City participates in 

these groups to be actively involved in promoting and 

developing scientifically sound laws, regulations and policies 

that protect public health and the environment on a Federal, 

State and Regional level. 

The City of Peoria supports the use of sound scientific 

testing, yielding results which are accurate, reproducible and 

have appropriate quality control requirements consistent with 

current EPA methods. Therefore, any contaminant where 

methodology has not been rigorously tested to meet these 

requirements can yield inaccurate and invalid results. The City 

is concerned about pharmaceuticals, personal care products and 

Naegleria fowleri. 

Personal care products and pharmaceuticals have received a 

great deal of press recently and have elevated the public's 

concern. However, these contaminants do not have EPA 
promulgated methods for testing. Therefore, it is prudent to 

provide additional funding to ensure appropriate methods are 

developed which yield reliable, reproducible results. Upon 

promulgation of acceptable scientifically valid methods, 

utilities would be able to test various water supplies to 

evaluate the prevalence of these analytes using data that would 

be comparable and be assured that appropriate Quality Control 

standards were applied. The City suggests that additional 

funding be provided to continue developing testing 

methodologies appropriate for these analytes. 

Naegleria fowleri should be removed from the CCL 3 list. There 

is currently no promulgated method for identification of the 

organism in a water matrix. The organism's presence is 

typically only discovered post mortem. Due to two deaths in 

Arizona, staff members from the Arizona Department of 

Environmental Quality, Maricopa County Environmental Services, 

the University of Arizona and various Arizona water providers 

(including the City of Peoria) developed a coalition to study 

Naegleria fowleri. 

After several years of testing, County and State regulators 

requested that a Naegleria fowleri Proposed Operational 

Practices be developed. The draft document includes maintaining 

chlorine residual within the distribution system and cleaning 

wells and reservoirs on a routine basis. It also includes 

screening for viable organisms by plating the sample and 

observing the plate for the formation of amoebic plaques. Any 

plaque formation would trigger analysis of the plaque utilizing 

real time polymerase chain reaction methodology to evaluate the 

type of organism present. 

At this time, the City suggests removing Naegleria fowleri from 

the contaminant list and funding additional research to 

evaluate the proposed Operational Practices outlined above and 

to determine appropriate quality control to allow data to be 

confidently compared. 

CS Title: 0134 

Company/group/association name: 

Comment: 
May 16, 2008 

Water Docket 

U.S . Environmental Protection Agency 

Mail Code: 2822T 

1200 Pennsylvania Ave., NW. 

Washington, DC 20460 

Re: Docket ID No. EPA-HQ-OW-2007-1189, Draft CCL3 

To Whom It May Concern: 

Riverkeeper is a nonprofit, member-supported environmental 

organization dedicated to protecting the ecological integrity 

of the Hudson River, its tributaries, and the 2,000-square-mile 

New York City watershed, which provides unfiltered drinking 

water to more than 9 million consumers. As a signatory to the 

1997 Watershed Memorandum of Agreement, Riverkeeper has a 

demonstrated interest in protecting the New York City watershed 

and its stakeholders from contaminants entering surface water 

supplies. Accordingly, we submit the following comments on 

EPA's Draft Contaminant Candidate List 3 (CCL3). 

Research History Documents. Presence of Organic Wastewater 

Contaminants and Sodium Chloride in Drinking Water Supplies 

In 2000, a USGS-sponsored survey of organic wastewater 

contaminants (OWCs) in U.S. streams included eleven sampling 

sites in the Croton watershed, which is part of the unfiltered 

New York City drinking water supply watershed. All except one 

of the sampled stream sites contained detectable levels of 

seven steroid and hormone compounds; eight streams contained 

detectable levels of six selected antibiotic compounds and all 

eleven streams contained detectable levels of ten other 

selected human pharmaceutical compounds.[FN1: See D. KOLPIN, ET 

AL., WATER-QUALITY DATA FOR PHARMACEUTICALS, HORMONES, AND 

OTHER ORGANIC WASTEWATER CONTAMINANTS IN U.S. STREAMS, 
1999-2000 (2002), USGS Open-File Report 02-94, available at 

http://toxics.usgs.gov/pubs/OFR-02-94/.] 

In June 2006, the New York State Department of Health (NYSDOH) 

released its Pharmaceutical Project Report (Attachment I), 

which consistently detected pharmaceuticals in the effluent of 

four surface water-discharging wastewater treatment plants in 

the New York City watershed. [See PDF for Attachment] NYSDOH 

also detected pharmaceuticals in several New York City drinking 

water reservoir samples. 

In December 2006, Riverkeeper submitted comments regarding the 

nomination process for EPA's CCL3. Because concentrations of 

any OWCs in water resources may be toxic to humans and aquatic 

life, and because the drinking water resources for nine million 

New Yorkers are contaminated with detectible concentrations of 

OWCs, our comments included the nomination of all 50 OWCs USGS 

found in U.S. streams (Attachment II). [See PDF for Attachment] 

In addition, because the long-term deposition of millions of 

tons of salt (sodium chloride) on impervious road surfaces has 

resulted in roadside habitat degradation, wildlife kills, 

drinking water quality impacts, and corrosion of automobiles 

and infrastructure, we also nominated sodium and chloride to 

the CCL3. 

In February 2008, EPA released the Draft CCL3, which included 

93 chemical compounds and 11 microbiological contaminants. The 

list included only one pharmaceutical compound (nitroglycerin) 

despite the aforementioned studies that detected 

pharmaceuticals in public drinking water supplies. 

In March 2008, the Associated Press (AP) released the results 

of an independent study that detected a "vast array of 

pharmaceuticals...in the drinking water supplies of at least 41 

million Americans."[FN2: See Jeff Donn, NYC: Traces of 

Sedatives in NYC Water, ASSOC. PRESS, March 9, 2008.] The 

study included samples of New York City's drinking water. 

In April 2008, the U.S. Senate convened a hearing to address 
EPA's failure to require monitoring for pharmaceuticals in 

public drinking water supplies.[FN3: See Martha Mendoza, 

Senators Rip EPA Over Lack of Knowledge on Drugs in Drinking 

Water, MERCURY NEWS, April 15, 2008, available at 

http://www.mercurynews.com/healthandscience/ci_8935134.] 

Although EPA claimed to be "very concerned...[and] taking this 

very seriously,"[FN4: See id.] these claims are belied by the 

agency's abject failure to include any pharmaceuticals other 

than nitroglycerin on the Draft CCL3. Instead, EPA is merely 

"seeking additional data and information on the concentrations 

of pharmaceuticals in finished or ambient water..."[FN5: See 

Drinking Water Contaminant Candidate List 3 -- Draft, 73 Fed. 

Reg. 9,652 (Feb. 21, 2008).] 

The Draft CCL3 Should Promote the Precautionary Principle and 

Include Organic Wastewater Contaminants and Sodium Chloride 

EPA's application of its complex methodology for evaluating and 

listing contaminants appears to be shortsighted. Although these 

contaminants are currently found in low concentrations, the 

cumulative effects of ingesting them daily pose a potentially 

significant threat to human health and the environment. 

Requiring a preexisting, significant cause-and-effect 

relationship between existing pharmaceutical concentrations in 

water supplies and existing environmental or human health 

impacts ignores known risks and dangerously delays additional 

study and, if needed, corrective action. This is the same type 

of bureaucratic inertia and circular logic that drove the bald 

eagle (Haliaeetus leucocephalus) to the brink of extinction 

when DDT was approved for widespread use despite its known 

toxicity in the environment. 

Many studies have documented impacts to aquatic organisms when 

exposed to human pharmaceuticals, such as sex reversal in male 

American alligators[FN6: See B. LANCE AND M. BOGART, TAMOXIFEN 

SEX REVERSES ALLIGATOR EMBRYOS (1991), Cellular and Molecular 

Life Sciences, Vol. 47, No. 3, 263-266, available at 

http://www.springerlink.com/content/w644821311911312.] and wild 

fish populations,[FN7: See Karen A. KIDD, ET AL., Collapse of a 

Fish Population After Exposure to a Synthetic Estrogen, 104 

PROC. NAT'L ACAD. SCI. 8897-8901 (May 22, 2007), available at 
http://www.pnas.org/cgi/content/abstract/104/21/8897.] 

resulting in a collapse of the latter. Researchers also have 

documented the occurrence of a synthetic human hormone, ethinyl 

estradiol, in surface waters at concentrations more than ten 

times higher than the LD50 for at least one fish species.[FN8: 

B. HALLING-SORENSEN, B., ET AL., OCCURRENCE, FATE AND EFFECTS 

OF PHARMACEUTICAL SUBSTANCES IN THE ENVIRONMENT - A REVIEW 

(1998), Chemosphere 36(2):357-393, Cited In: National Oceanic 

and Atmospheric Administration, National Centers for Coastal 

Ocean Science, Pharmaceuticals in the Environment,Information 

for Assessing Risk, available at 

http://www.chbr.noaa.gov/peiar/detail.aspx?substanceid=146.] 

However, such studies typically focus on the effect of a single 

pharmaceutical in isolation; few have examined the synergistic 

effects of pharmaceuticals in combination or their metabolites. 

Despite these and other studies over the past two decades, EPA 

has steadfastly refused to regulate or even require monitoring 

of pharmaceuticals that are known to have deleterious effects 

on aquatic organisms. 

Rather than reactively list pharmaceuticals after their 

existing concentrations in water supplies are known to risk or 

have already impacted aquatic life and human health, EPA should 

act in accordance with the precautionary principle and 

proactively list all detected surface water pharmaceuticals 

before they cause health impacts. Contaminants should be 

removed from the list only after sound science has demonstrated 

that their concentrations occur at levels clearly demonstrated 

to be below health risk thresholds. 

For the foregoing reasons, Riverkeeper incorporates by 

reference our December 11, 2006 comments on contaminant 

nominations to the CCL3 process (Attachment II) and we re- 

nominate all previously nominated OWCs, sodium and chloride for 

inclusion on the final CCL3. [See PDF for Attachment] We also 

urge EPA to re-examine its approach to identify and evaluate 

contaminants for inclusion on the CCL3 so that consumers of 

public water supplies are safeguarded against unnecessary 

ingestion of many potentially harmful pharmaceuticals. 

Sincerely, 
William Wegner 

Staff Scientist 

Attachment 

CS Title: 0135 

Company/group/association name: 

Comment: 

May 26, 2008 

CCL3 Comments 

Environmental Protection Agency 

Mail Code: 4607M 

1200 Pennsylvania Ave., NW 

Washington, D.C. 20460 

Re: Drinking Water Contaminant Candidate List 3 

EPA-HQ-OW-2007-1189 

The American Society for Microbiology (ASM) is submitting 

comments on the proposed microbial contaminants listed in the 

draft CCL 3 document. The following comments were developed by 

the ASM Public and Scientific Affairs Board Committee on 

Environmental Microbiology. 

The ASM is the largest single life science society with more 

than 42,000 members, including scientists in academic, 

industrial, clinical, and government institutions, working in 

areas related to basic and applied research, the prevention and 

treatment of infectious diseases, laboratory and diagnostic 

medicine, the environment, and water and food safety. 

In providing nominations for CCL 3 in 2006, the ASM strongly 

encouraged the EPA to develop and implement a systematic 

strategy and set of criteria to identify and review all 
potential CCL organisms. Further, the ASM recommended that in 

evaluating CCL organisms, the EPA should use a formal decision- 

making process that reflects both the objectives of the CCL and 

the Safe Drinking Water Act. 

The ASM noted that a comprehensive strategy and set of 

evaluation criteria could lead to inclusion of additional 

organisms of concern, for example, E. coli O157:H7 and various 

campylobacteria that did not meet CCL criteria. The ASM 

applauds the EPA for including these organisms as candidate 

contaminants, and for including its nominated candidate, 

Naegleria fowleri. 

However, the ASM notes a number of concerns about the draft 

list. In particular, the use of the details regarding 

waterborne outbreaks and endemic diseases appear minimal and 

not to have been adequately incorporated or considered. 

Further, there appears not to have been adequate scrutiny of 

scientific papers addressing the occurrence of some of the 

candidate contaminants. 

Vibrio cholerae occurs on the list as does Entamoeba 

histolytica, presumably due to recorded outbreaks. These 

outbreaks were limited to the Marshall Islands and a prison, 

respectively, and appear inappropriate for justifying inclusion 

of either organism on CCL 3. Cholera is not endemic in the 

mainland U.S., and the reported E. histolytica cases appear 

related to sexual transmission and not waterborne. The listing 

of these two organisms, along with Salmonella enterica and 

Shigella sonnei, raises questions about the extent to which CCL 

3 is oriented to future and current needs and serving public 

health by addressing and placing appropriate weight on disease 

outbreaks. 

The ASM is also concerned that the CCL 3 pathogen list does not 

have a strong science-based justification. The data on 

occurrence in water is very poor for all pathogens, and thus 

surrogates or other published work are needed. The EPA should 

examine endemic levels of disease for all enteric pathogens 

reported to HHS and CDC. A high endemic disease rate suggests 
that pathogens are being excreted in sewage, and thus 

occurrence is probably higher than for Vibrio cholerae, which 

when detected is in marine or saline environment and most often 

lacks virulence factors. 

The ASM is pleased to have this opportunity to provide comments 

on the draft CCL 3 list, and hopes that its comments and 

recommendations are of assistance. 

Sincerely, 

Ruth Berkelman, M.D. 

Chair, Public and Scientific Affairs Board 

Gary King, Ph.D. 

Chair, Committee on Environmental Microbiology 

CS Title: 0136 

Company/group/association name: 

Comment: 

May 21, 2008 

Via Mail : 

Docket ID No. EPA-HQ-OW-2007-1189 

Water Docket 

U.S. Environmental Protection Agency 

Mail Code: 2822T 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460 

RE: E.I. duPont de Nemours and Company Comments on EPA's Draft 

Drinking Water Contaminant List 3 

To whom it may concern: 
E.I. duPont de Nemours and Company ("DuPont") appreciates the 

opportunity to provide comments on the draft "Drinking Water 

Contaminant List 3" released by EPA on February 21, 2008 (EPA- 

HQ-OW-2007-118, FRL-8529-7). As the primary manufacturer of the 

chemical diuron (CAS 330-54-1), DuPont recommends that EPA 

remove diuron from the draft list for regulation as a 

contaminant under the Safe Drinking Water Act. DuPont will 

provide rationale for this recommendation based on current 

labeled use practices that reduced the risk of occurrence 

compared to the environmental release data reported for 2004 

from the Toxic Release Inventory and the National Pesticide Use 

Database, developed by the National Center for Food and 

Agricultural Policy used for this draft determination. Due to 

the risk mitigation reqirements now required on all registrants 

labeling diuron end-use products from the September 30, 2003, 

EPA Reregistration Eligibility Decision for diuron, the current 

risk of occurrence is dramatically reduced from what the above 

2004 data would conclude. These risk mitigation requirements 

include: 

* Reduction of application rates and increased retreatment 

intervals between applications in numerous crops 

* Elimination of aerial applications with some specific 

exceptions 

* Implementation via labeling of best management practices to 

reduce spray drift 

DuPont will submit a more detailed rationale to support this 

recommendation in the proceeding weeks that will include more 

discussion of the above current reduced risk of occurrence and 

other pertinent information. 

Sincerely, 
Richard J. Ambrose 

US Product Registration Manager 

DuPont Crop Protection 

CS Title: 0137 

Company/group/association name: 

Comment: 

May 21, 2008 

Water Docket 

U.S. Environmental Protection Agency 

Mailcode: 2822T 

1200 Pennsylvania Avenue, NW 

Washington, D.C. 20460 

RE: Docket ID # EPA-HQ-OW-2007-1189 

Gentlemen: 

The Pennsylvania Coal Association is the principle trade 

organization of Pennsylvania's bituminous coal producers. PCA 

represents both large and small companies, partnerships and 

individuals that produce over 75% of the bituminous coal 

annually mined in Pennsylvania. Our members produce bituminous 

coal by surface (open pit and auger) methods and by underground 

mining methods. Also, they operate coal preparation plants and 

engage in other coal mining activities for which they are 

required to meet water quality standards. 

Our members would like to express their opposition to the 

addition of molybdenum (MO) as a parameter on a final list of 

contaminants that would be subject to proposed or promulgated 

national primary drinking water regulations under the Safe 

Drinking Water Act. MO is not a carcinogen (per your agency; 

nor is it listed in your "National Recommended Water Quality 

Criteria, 2006," as a toxic or non-priority pollutant. 
It is our understanding that, at least in Pennsylvania, the MO 

standard is being proposed because of a discharge permitting 

event for one (1) discharge in western Pennsylvania by a non- 

coal mining company, for which Pennsylvania DEP believed it was 

possible to amend the MO limit under current regulations. It is 

illogical and unnecessary to add nontoxic criteria for which 

there is no known technology for treatment to reduce its 

incidence to levels that may be required by both the Federal 

and state proposals. 

We also would add our support for comments submitted by the 

National Mining Association (NMA), in which it concluded that 

there is insufficient data to conclude that cobalt, vanadium, 

strontium and germanium should, together with MO, be included 

on a final list of contaminants subject to primary drinking 

water regulations. 

Thank you for considering PCA's comments. 

Sincerely, 



George Ellis, President 

Pennsylvania Coal Association 

GE:sg 

CS Title: 0138 

Company/group/association name: 

Comment: 

NRDC Addendum to Comments 

on the Draft Drinking Water Contaminant Candidate List 3 

Docket Number: EPA-HQ-OW-2007-1189 

May 21, 2008 

Pursuant to the Safe Drinking Water Act Amendments of 1996 
(SDWA), the U.S. Environmental Protection Agency (EPA) is 

required to publish, every five years, a list of unregulated 

contaminants that are known or anticipated to occur in public 

water systems and may require regulation under the SDWA. The 

Agency then must make a decision about whether or not to 

regulate at least five of the contaminants on the list. EPA is 

on the third round of this process and has published a list of 

candidate contaminants, called the CCL3. The Natural Resources 

Defense Council (NRDC) submits the following additional 

comments to those submitted previously by NRDC on EPA's Draft 

CCL3. 

These additional comments pertain specifically to cyanotoxins, 

chemical contaminants whose occurrence in drinking water is 

likely to increase as a result of projected climate change 

impacts on natural systems. 

I. SUMMARY 

NRDC additionally requests that EPA take the following actions 

concerning the Draft CCL3: 

* Include cyanotoxins (no CAS # listed) in the CCL3. These 

chemicals are known to cause serious and occasionally fatal 

human liver, digestive, neurological, and skin diseases. 

Monitoring for these chemicals in water sources and drinking 

water is needed to fully assess their risks to human health and 

determine whether regulation is necessary. 

* Address Vibrio cholerae, a microbial pathogen, in drinking 

water pursuant to the Safe Drinking Water Act (SDWA). This 

bacterium is known to cause outbreaks of cholera, an acute 

diarrheal illness caused by intestinal infection with the 

bacterium Vibrio cholerae, with serious and occasionally fatal 

human consequences. Monitoring for this pathogen in water 

sources and drinking water is needed to fully assess their 

risks to human health and determine whether regulation is 

necessary. 
II. DETAILED COMMENTS 

EPA must regulate cyanotoxins, which are among the chemicals 

listed on the CCL3. 

Cyanotoxins (3). NRDC urges EPA to include cyanotoxins (no CAS 

# listed) in the CCL3, in particular because these chemicals 

are produced by cyanobacterial species whose blooms are likely 

to expand further as a result of climate change. Climate change 

is a "potent catalyst" for the expansion of harmful 

cyanobacterial algal blooms in aquatic ecosystems [FN1: Paerl 

HW, Huisman J. 2008. Blooms like it hot. Science 320:57-58 (4 

April 2008).]. Rising water temperatures and increasingly 

frequent extreme rainfall events can contribute to the growth 

of these blooms, which are caused primarily by inflows of 

nutrient-rich runoff, among cyanobacterial algae species. 

Alternating periods of drought and deluge, which are also 

associated with climate change, promote cyanobacterial blooms 

in a number of freshwater lakes. Warming water temperatures, 

increasingly frequent extreme rainfall events, and alternating 

periods of drought and deluge -each of which can favor the 

growth of cyanobacteria - are consistent with the climate 

changes projected across much of the U.S. in the coming 

decades.[FN2: Intergovernmental Panel on Climate Change (IPCC). 

2007. Climate Change 2007: The Physical Science Basis. 

Contribution of Working Group I to the Fourth Assessment Report 

of the Intergovernmental Panel on Climate Change [Solomon S, 

Qin D, Manning M, Chen Z, Marquis M, Averyt KB, Tignor M, 

Miller HL (eds.)]. Cambridge University Press, Cambridge, 

United Kingdom and New York, NY, USA.; FN3: Confalonieri U, 

Menne B, Akhtar R, Ebi KL, Hauengue M, Kovats RS, Revich B, 

Woodward A. 2007. Human health (Chapter 8). Climate Change 

2007: Impacts, Adaptation and Vulnerability. Contribution of 

Working Group II to the Fourth Assessment Report of the 

Intergovernmental Panel on Climate Change, Parry ML, Canziani 

OF, Palutikof JP, van der Linden PJ, Hanson CE, Eds. Cambridge 

University Press, Cambridge, UK.] Ingestion of cyanotoxin- 

contaminated water can cause serious human illnesses, including 

neurological, liver, digestive, and skin diseases, as well as 

tumor promotion.[FN4: U.S. Centers for Disease Control and 

Prevention (US CDC). 2008. Environmental hazards and health 
Effects - Facts about cyanobacteria and cyanobacterial harmful 

algal blooms. Accessed May 21, 2008, available at: 

http://www.cdc.gov/hab/cyanobacteria/facts.htm#cyanotoxins.; 

FN5: Paerl and Huisman (2008).] An increase in occurrences of 

the cyanobacteria Microcystis in the Great Lakes in recent 

years, and associated exposures to the cyanotoxin microcystin 

in drinking water, has caused considerable concern[FN6: 

National Centers for Coastal Ocean Science, National Oceanic 

and Atmospheric Administration (NOAA), Silver Spring, MD. 2004. 

"Examine Environmental Regulation of Toxin Production by 

Cyanobacteria Capable of Disrupting Ecosystems and Endangering 

Drinking Water Supplies," available at: 

http://www8.nos.noaa.gov/nccos/npe/projectdetail.aspx?id= 

385&fy=2004.]. Preliminary studies have documented the presence 

of microcystins in the Great Lakes, at times exceeding the 

recommended limit of 1 μg/L established by the World Health 

Organization for drinking water supplies.[FN7: Ibid.] This 

argues for the inclusion of cyanotoxins on the CCL3 list and 

for monitoring the distribution and concentration of these 

substances such as microcystin which have "demonstrated the 

potential to jeopardize human health and drinking water 

quality."[FN8: National Oceanic and Atmospheric Administration 

(NOAA). 2008. "Harmful Algal Blooms and Hypoxia in the Great 

Lakes Region," available at: 

http://www.cop.noaa.gov/stressors/extremeevents/hab/habhrca/GL_ 

fact_09-06.pdf.] 

Vibrio cholerae. NRDC urges EPA to include Vibrio cholerae in 

the CCL3, in particular because the occurrence of this 

microbial pathogen is likely to expand further as a result of 

climate change.[FN9: Confalonieri et al. (2007).] Rising water 

temperatures and increased climate variability, which can 

result in higher stream flow rates, are projected to occur as 

climate change continues and "could favor conditions that 

increase the occurrence of V. cholerae in Chesapeake 

Bay."[FN10: Louis VR, Russek-Cohen E, Choopun N, Rivera ING, 

Gangle B, Jiang SC, Rubin A, Patz JA, Huq A, Colwell RR. 2003. 

Predictability of Vibrio cholerae in Chesapeake Bay. Appl 

Environ Microbiol 69(5):2773-2785.] The adverse health effects 

of cholera outbreaks can be devastating, with an estimated one 

in 20 infected persons developing "severe disease characterized 

by profuse watery diarrhea, vomiting, and leg cramps"[FN11: 

U.S. Centers for Disease Control and Prevention (US CDC). 2008. 
Cholera. Accessed May 21, 2008, available at: 

http://www.cdc.gov/nczved/dfbmd/disease_listing/cholera_gi.html 

.] which, without treatment, can prove rapidly fatal. Vibrio 

cholerae is a natural inhabitant of aquatic environments, and 

there is concern that as environmental changes associated with 

climate change continue, natural populations of V. cholerae may 

serve as a "precursor for new pathogenic or epidemic 

strains"[FN12: Louis et al. (2003).] when ingested via 

inadequately treated drinking water or contaminated shellfish. 

Cholera cases from domestic source exposures continue to be 

reported in the U.S.,[FN13: U.S. Centers for Disease Control 

and Prevention (US CDC). 2008. "Cholera and Other Vibrio 

Illness Surveillance System (COVIS)," available at: 

http://www.cdc.gov/nationalsurveillance/cholera_vibrio_surveill 

ance.html.] mostly from contaminated seafood, yet concerns 

about potential drinking water exposures under a changing 

climate argue for enhanced monitoring for these pathogens in 

water sources, to fully assess the risks they pose to human 

health. 

III. RECOMMENDATIONS 

We urge EPA to add cyanotoxins to the CCL3. These contaminants 

meet EPA's criteria to be listed in CCL3. Their health effects 

are known and they are likely to occur in drinking water 

sources. Their occurrence is also likely to expand as climate 

change continues, which makes it appropriate to include them in 

the CCL3. 

We also urge EPA to add Vibrio cholerae to the CCL3. This 

microbial pathogen meets EPA's criteria to be listed in CCL3. 

The adverse health effects of exposures to Vibrio cholerae are 

known and they are likely to occur in drinking water sources. 

Their occurrence is also likely to expand as climate change 

continues, which makes it appropriate to include this pathogen 

in the CCL3. 

Finally, we recommend that the Agency act to promptly assess 

the risks associated with these and the other contaminants 

nominated to the CCL3 and take appropriate regulatory action 
under the SDWA to establish Maximum Contaminant Levels 

(MCLs) as necessary. 

Respectfully submitted, 

/s/ 

Kim Knowlton, Dr.P.H. 

Scientist, Global Warming and Health Science Fellow 

Health and Environment Program 

Natural Resources Defense Council 

CS Title: 0140 

Company/group/association name: 

Comment: 

May 21, 2008 

Water Docket, U. S. Environmental Protection Agency 

Mail Code: 2822T 

1200 Pennsylvania Avenue NW 

Washington, DC 20460 

Re: Docket ID No. EPA-HQ-OW-2007-1l89 

[Federal Register: February 21, 2008 (Volume 73, Number 35)] 

[Notices] 

[Page 9627-9654] 

Dear USEPA: 

I am writing on behalf of Gelman Sciences, Inc., d/b/a Pall 

Life Sciences (PLS), in response to USEPA's request for public 

comments regarding the inclusion of the chemical 1,4-dioxane on 

the draft third Contaminant Candidate List (CCL3). PLS does not 

believe it would be appropriate or necessary to include 1,4- 

dioxane on the final CCL3 or to develop a "Maximum Contaminant 

Level" (MCL) for this compound given the potential for it to 
pose a public health concern and its potential to occur in 

public water systems. 

USEPA is currently updating the 1,4-dioxane Integrated Risk 

Information System (IRIS) risk assessment. The updated 

assessment is expected to provide more scientifically 

defensible toxicity values since they will have been developed 

using a larger body of toxicological studies and using updated 

approaches. Based on USEPA's IRIS Track system, the assessment 

is expected to be final by March 13, 2009. We urge you not to 

include 1,4-dioxane on the CCL3 list until this assessment can 

be updated to be consistent with the most recent federal 

guidance and the results of the ongoing IRIS assessment are 

available for consideration. Should USEPA identify 1,4-dioxane 

for MCL development, the updated toxicity values should be used 

rather than the older values referenced in the current 

documentation regarding why 1,4-dioxane was included on the 

draft CCL3 list. 

We are also providing additional information regarding the 

prevalence of 1,4-dioxane in public water supplies that USEPA 

may not be aware of. Michigan's Department of Environmental 

Quality (MDEQ) conducted a vulnerability assessment of its 

public drinking water supplies in 2004 regarding 1,4-dioxane. 

The MDEQ sampled approximately 50 public water supplies in 

Michigan, 25 of which were selected randomly. The remaining 25 

were targeted based on previous detections of chemicals 

commonly associated with 1,4-dioxane (primarily other 

chlorinated solvents). The results of this targeted survey are 

attached [See PDF for attachments]. Only one operating public 

water supply had detectable levels of 1,4-dioxane present in 

its water, between 3 and 5 parts per billion (ppb). The Ann 

Arbor Montgomery Well referenced in the attached summary as 

having 3 ppb of 1,4- dioxane, was taken out of service in April 

2001 and, therefore, was not in operation when sampled. Based 

in part on the results of this assessment, the MDEQ decided 

that not to promulgate an MCL for 1,4-dioxane under the State's 

version of the Safe Drinking Water Act. USEPA may contact Brock 

Howard from the MDEQ if additional information regarding 

Michigan's vulnerability assessment is desired. ((517) 

335-4101); HOWARDB1@michigan.gov). 
Given the pending IRIS reassessment and the available evidence 

that 1,4-dioxane is not a prevalent contaminant in public 

drinking water supplies, we suggest that it would be 

inappropriate and unnecessary to develop a MCL for 1,4-dioxane 

at this time. Thank you for your consideration of these 

comments. 

Very truly yours, 

ZAUSMER, KAUFMAN, AUGUST, 

CALDWELL & TAYLER, P.C. 

Michael L. Caldwell 

MLC:hlr 

Enclosures 

cc: Farsad Fotouhi, PLS 

CS Title: 0141 

Company/group/association name: 

Comment: 

May 21, 2008 

Docket ID No. EPA-HQ-OW-2007-1189 

Environmental Protection Agency 

Mail Code : 2822T 

1200 Pennsylvania Ave., NW. 

Washington, DC 20460 

Re : Contaminant Candidate List 3 (CCL3) 

To Whom it May Concern: 

In response to the notice in the Federal Register of February 
21, 2008 (Volume 73, Number 35) I am offering comments on the 

draft third Contaminant Candidate List (CCL3). In December 

2006, we provided the US Environmental Protection Agency (EPA) 

our nominations to the CCL3 "universe" as solicited in the 

publication in the Federal Register Vol. 71, Number 199, 

October 16, 2006. Our approach for nominating compounds to the 

universe was to identify groups of chemicals that pose a 

concern for water supplies from an exposure and/or health 

perspective. 

Subsequent to providing our comment letter we were 

nominated by the Association State Drinking Water 

Administrators (ASDWA) to serve on an expert panel convened by 

US EPA. The panel reviewed the methodology applied to select 

the CCL3 from the universe of potential contaminants. EPA has 

greatly improved its methodology compared to other CCLs and we 

commend EPA for this effort. 

The groups of compounds that we identified in our December 2006 

letter (attached) to be in the universe were disinfection by- 

products (DBPs), oxygenates, pharmaceuticals and personal care 

products (PPCPs), herbicides and solvent stabilizers. [See PDF 

for Attachment] We are pleased to see that representatives from 

these groups were present in the CCL3 and that several of the 

specific contaminants we described including but not limited to 

1,4- dioxane, alachor ethanesulfonic acid, and methyl tertiary- 

butyl ether (MTBE) are listed. 

Although the CCL3 list only has one PPCP listed, we are aware 

that the EPA is sensitive to the public demand for more work to 

understand the fate and transport of these chemicals. We think 

including more PPCPs on the CCL3 is not justified based on the 

information at this time, although more information is needed 

to evaluate their importance as a drinking water issue. We 

think EPA should continue to move forward with the CCL3 as 

proposed. If new information becomes available that changes the 

results from use of your evaluation methodology, then this 

information should be used in creating CCL4. 

If you would like any more information please feel free to 

contact either Lloyd Wilson Ph.D., of my staff or me at 
518-402-7650. 

Sincerely, 

Victor E. Pisani 

Director 

Bureau of Water Supply Protection 

cc: N. Kim, Ph.D. 

R. Svenson, P.E. 

J. Dunn, P.E. 

L. Wilson, Ph.D 

D. Luttinger, Ph.D. 

J. Storm, Ph .D. 

S. Stoner, DEC 

CS Title: 0142 

Company/group/association name: 

Comment: 

May 20, 2008 

Water Docket, US Environmental Protection Agency, 

Mailcode: 2822T, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460. 

RE: Docket In No. EPA-HQ-OW-2007-1189-Drinking Water 

Contaminant Candidate List 3--Draft 

To The Docket: 

The Massachusetts Department of Environmental Protection 

(MassDEP) is responding to the opportunity for comment on the 

Drinking Water Contaminant Candidate List (CCL) 3 published 

February 21, 2008 in the Federal Register (FR Volume 73, Number 

35, Page 9627-9654). The chemicals listed in the final list are 

not presently regulated in drinking water and have been 
identified as potential candidates for regulation in public 

water supplies under the Safe Drinking Water Act. 

Given the objectives of the CCL and the large number of 

presently unregulated chemicals, EPA is to be commended for 

developing a comprehensive and ordered approach for identifying 

these chemicals. 

Several chemicals on the CCL 3 list have been of interest to 

our Drinking Water Program for some time: MTBE, perchlorate, 

RDX, 1,4-dioxane and NDMA. More recently, we, like many others, 

have been paying attention to newly developing information on 

PFOA. We would welcome federal guidance on them and look 

forward to having access to additional data that will be 

generated as part of a national reconnaissance study which 

could be used to support and update the current regulatory 

standards. 

Closely linked to the MTBE issue, but notably missing from the 

CCL 3 list are two other compounds: tertiary butyl alcohol 

(TBA, CAS No. 75650) and tertiary-amyl methyl ether (TAME, CAS 

No. 994058). TBA is a breakdown product of MTBE in groundwater. 

Both TBA and TAME have also been used as gasoline octane 

enhancers. We have found both associated with MTBE at many 

gasoline release sites in Massachusetts. In the absence of 

federal guidance on these two compounds, Massachusetts has 

identified drinking water guidelines for use in the state. 

MassDEP has devoted significant resources to address issues 

associated with contaminants of emerging concern, with special 

emphasis on pharmaceuticals/personal care prodncts (PPCP) and 

endocrine disrupting chemicals (EDC). With the recent 

scientific and popular interest in understanding the potential 

effects of these classes of compounds to the environment, 

including the potential for contaminating source water and 

drinking water, MassDEP recommends that PPCPs and EDCs be 

included in this round. 

Nitrogen-containing disinfection by-products are another class 
of emerging, unregulated contaminants that should be part of 

the CCL; for example, haloacetonitriles and halogenated nitro- 

methanes[FN1: Zwiener, C. et al. 2007, Water, Env. Sci. 

Technol., 41(2) 363-372; and Muellner, M.G. et al., 2007, Env. 

Sci. Technol., 41(2) 645-651.]. 

We feel that it is important also to comment on the CCL process 

in the wider context of the US EPA's efforts to address 

chemicals in drinking water. MassDEP finds fault with EPA for 

devoting resources to the generation of the CCL 3 list which 

could otherwise have been used more profitably to address those 

chemicals already known to be problematic. The CCL exercise 

leads to a need to derive guidance and possibly standards for 

more chemicals. This process has taken place during a time when 

the agency and administration have shown to the public that it 

cannot complete the work in producing guidance it already has 

in hand. 

The identification of several high-profile chemicals through 

the the CCL process merely validates what many of the states 

have collectively been telling EPA for years: these chemicals 

have contaminated water in the states, and the states need both 

toxicological guidance and standards for these chemicals in 

order to limit exposures, provide goals for remediation and to 

protect public health. EPA's failures to provide timely 

guidance have been putting public health at unnecessary risk. 

For example, states have been advising EPA at many annual 

meetings of the Federal State Toxicology and Risk Assessment 

Committee (FSTRAC) of their needs for federal guidance on MTBE 

and perchlorate; beginning significantly well prior to the 

completion of the CCL 2 list (2005) which listed both of these 

chemicals. Both are also on the CCL 3 list. 

Once it was recognized that MTBE presence was widespread in 

groundwater at least 8-10 years ago, states urged EPA to issue 

toxicological guidance to help them deal with this issue. EPA 

chose to issue a hybrid piece of guidance termed the MTBE 

"Drinking Water Health Advisory" which many state government 

toxicologists and public health specialists view as not truly 
addressing the need for health-based guidance. While EPA has 

continued to work on the toxicology of this chemical internally 

in the intervening years, they have failed to share their 

interpretations of the underlying toxicology of this compound 

with states even after direct requests to do so. To do so would 

have provided state toxicologists with insight into the 

thinking of EPA's many excellent scientists who have been 

working on this compound, enabling state staffs at a minimum to 

issue their own guidance based on some of the best science and 

interpretations available. 

Perchlorate is another example of EPA's inability to put forth 

timely guidance in response to state's needs for such 

information. California was the first to recognize and inform 

EPA of the scope of perchlorate problems in its state in the 

l990s. Once Massachusetts recognized that it had perchlorate 

contamination problems, it too pressed EPA for timely guidance. 

EPA undertook early comprehensive reviews of the toxicology of 

this compound (2002) well in advance of the appearance of 

perchlorate on the CCL list. EPA's assessment then went through 

a lengthy review process culminating in the publication of an 

oral reference dose 20-fold less stringent than the Agency 

originally proposed in 2002. This value has not been critically 

accepted by the states, including ours.[FN2: Ginsberg G, Rice 

D. 2005. Environ Health Perspect 113(9):1117-9.] EPA has also 

notably not yet developed a drinking water standard for 

perchlorate. 

In the absence of federal action to expeditiously identify and 

promulgate national drinking water standards for perchlorate 

and MTBE over the last at least 6-8 years, MassDEP has 

established a Massachusetts Maximum Contaminant Level (MMCL) 

for perchlorate and a MassDEP Office of Research and Standards 

Guideline (ORSG) for MTBE. 

To many of those charged with protecting public health through 

drinking water regulation, EPA and the administration have 

demonstrated an institutional problem generating timely 

drinking water guidance and standards. This problem is not 

limited to the drinking water area, as EPA has also been 

embarassingly slow to process guidance for inhalation 
exposures; most notably and recently with tetrachloroethylene. 

This serious shortcoming of the process needs to be addressed 

before a program such as the CCL 3 can be effective. 

Thank you for the opportunity to comment. 

Sincerely yours, 

Michael S. Hutcheson, PhD, MPH 

Head, Air and Water Toxics Section 

Office of Research and Standards 

CS Title: 0145 

Company/group/association name: 

Comment: 

May 21, 2008 

Water Docket 

Docket ID No. EPA-HQ-OW-2007-1189 

Environmental Protection Agency 

Mail Code: 2822 T 

1200 Pennsylvania Ave., NW. 

Washington, DC 20460 

To Whom It May Concern: 

In response to the draft notice in the Federal Register of 

February 21, 2008 (Volume 73, Number 35), the California 

Department of Public Health would like to officer comments on 

the Drinking Water Contaminant Candidate List 3 (CCL3). 

* Need to Consider Synergistic Effects: California believes the 

current process has serious limitations because contaminants 

are typically, considered individually and not in mixtures. The 

health effects information from the Food and Drug 

Administration database on Maximum Recommended Daily Doses 

(MRDD) is derived based on the effects of single compounds. 

When in actuality, the compounds exist as mixtures in the 

environment. EPA should endeavor to address the cumulative-and 

synergistic effects of these compounds as well. As there may be 
synergistic effects, and resources are limited to properly 

evaluate the infinite numbers of contaminant combinations that 

are possible, there is a need to minimize the number of 

contaminants and their concentrations in water supplies through 

a source water assessment approach. 

* Comments on Pharmaceuticals and Personal Care Products: It is 

appropriate to add pharmaceuticals and personal care products 

(PPCPs) to the current and future CCL lists only as enough 

information becomes available to warrant consideration of these 

chemicals for possible regulation. We collectively need to 

avoid the "knee-jerk" reaction of calling for regulation of 

specific chemicals in response to media attention and instead, 

should continue to resolve that regulations be based on sound 

science. We urge EPA to continue to carefully evaluate 

available health effect information on contaminants of concern. 

Pharmaceuticals, in particular, have a voluminous amount of 

data on health effects available as a result of FDA 

requirements associated with the use of these compounds. As a 

goal, it would be ideal to have none of these contaminants in 

the drinking water but practicaliy, this is impossible. Thus, 

we should be guided by the premise that, if there is no 

observable health effect at levels found in drinking water 

(with an adequate margin of safety), then EPA should not set a 

standard. Resources could be better spent trying to prevent or 

minimize the amount of PPCPs that get into water sources in the 

first place. 

Nonetheless, public and legislative concern over 

pharmaceuticals and personal care products is not going away. 

EPA and the drinking water community need to get out ahead of 

the issue to avoid mandates from Congress prescribing a 

specific regulatory schedule. EPA should carefully review the 

data already evaluated in the CCL3 process and any new data 

reported in response to the February 21, 2008 Federal Register 

Notice to identify any contaminants in this group that could 

provide a meaningful opportunity for health risk reduction. If 

there is insufficient data on any of the PPCPs to warrant their 

inclusion on the CCL3, EPA needs to identify these as 

candidates for additional study and include them in a future 

Unregulated Contaminant Monitoring Regulation. 

California would also like to emphasize the importance of EPA 

carrying out studies on the possible health effects, if any, of 
low concentration of the pharmaceuticals that are being 

detected in water sources. We know a lot about therapeutic 

levels from FDA, but the levels are generally significantly 

higher than the levels that are seen in water sources. 

The presence of pharmaceuticals in drinking water supplies is 

an indication that protection of water supplies needs more 

attention, as does public education about the proper disposal 

of drugs. 

- Comments on Specific Contaminantsfor CCL4 (and beyond): 

* Contaminants Warranting Further Analysis - Highly Prescribed 

Drugs : Water reuse is becoming an increasingly important tool 

as water systems stretch their water resources to meet growing 

demand. California wants to make sure EPA considers the most 

highly prescribed drugs and over the counter sales leaders for 

future health effects and occurrence study. We do not have 

sufficient information about these contaminants to 

categorically recommend that they appear on CCL3, but ask that 

EPA consider developing occurrence data for these contaminants 

through a future Unregulated 

Contaminant Monitoring Regulation. 

~ ACE inhibitors such as Lisinopril, Enalipril 

~ Anti-anxiety such as Aprazolam, Lorazepam, Diazepam 

~ Antiarrythmics such as Digoxin 

~ Antibiotics such as Amoxicillin, erythromycin 

~ Anticoagulants such as Clopidogrel, warfarin 

~ Anticonvulsants such as Gabapentin, carbamazepine, primidone 

~ Antidepressants such as sertraline, Escitalopram, fluoxetine, meta 

~ Antihistamines such as pheniramine, bromopheniramine, 

chloropheniramine, clemastine, doxylamine, diphenylhydramine, 

triprolidine 

~ Antihypertensives such as clonidine 
~ Antiosteoporietics such as alandronate, risedronate 

~ Antiulcer drugs such as esomeprazole, lansoprazole, pantoprazole 

~ Bronchodilators such as albuterol, salmeterol 

~ Corticosteroids such Prednisone, fluticasone proprionate, mometasone 

furoate,triamcinolone 

~ Decongestants such as oxmetazoline, pseudoephredrine, 

xylometazoline, phenyipropylamine 

~ Antiulcer (H-2 receptor antagonists) such as Ranatidine, cimetidine, 

famotidine, nizatidine 

~ Expectorants such as guaifenesi n 

~ Glucocorticiods such as hydrocortisone 

~ Antifungals such as haloprogin, miconazole, clotrimazole, 

butaconazole, tioconazole, terbinafine 

~ Antismoking aids such as nicotine, continine 

* Contaminants Warranting Further Analysis--Genotoxic Compounds: 

 Genotoxic carcinogens, pharmaceuticals that are used for 

patients who, without the treatment would die, but are 

considered carcinogenic. While providing a benefit, they 

obviously may pose a health risk. These compounds should be 

considered for further examination. 

~ Flutamide 

~ Methotrexate 

~ Carboplatin 

~ Ifosfamide 

~ Megestrol 

~ Cyclophosphamide 

~ Bleomycin Al 
~ Topotecan 

~ Cisplatin 

~ Mitomycin 

~ Fluorouracil 

~ Docetaxel 

~ Mephalan 

~ Cyclosporine 

~ Procarbazine HCI 

~ Mercaptopurine 

~ Busulfan 

~ Epirubicin 

Thank you for your consideration of these comments . Please 

contact me at (916) 449-5577 if we may provide additional 

information or if any clarification of these comments are 

needed . 

Sincerely, 

Gary Yamam to, Assistant Chief 

Division of Drinking Water 

and Environmental Management 

cc: Rufus B. Howell, Chief 

California Department of Public Health 

Division of Drinking Water and Environmental Management 

Leah Walker 

California Department of Public Health 

Division of Drinking Water and Environmental Management 

Carl Lischeske 

California Department of Public Health 
Division of Drinking Water and Environmental Management 

Cindy Forbes 

California Department of Public Healt h 

Division of Drinking Water and Environmental Management 

 

CS Title: 0100 

Company/group/association name: 

Comment: 

May 21, 2008 

U.S. Environmental Protection Agency 

Docket ID No. EPA-HQ-OW-2007-1189 

Office of Groundwater and Drinking Water (OGWDW) 

Mail code: 2822T 

1200 Pennsylvania Ave. NW 

Washington, DC 20460 

RE: Drinking Water Contaminant Candidate List 3--Draft 

Dear Docket: 

Enclosed are the comments of the American Water Works 

Association (AWWA) on the draft Contaminant Candidate List 3 

(CCL3) as published in the February 21st Federal Register. The 

Contaminant Candidate List is the starting point and the 

foundation for the Environmental Protection Agency's (EPA's) 

drinking water standard-setting process. AWWA appreciates the 

opportunity to comment on this critical starting point of the 

standard-setting process, and we have several significant 

comments that we feel should be addressed in the final CCL3. 

If you have any questions about these comments, please feel 

free to contact me or Alan Roberson in our Washington Office. 

Yours Sincerely, 
Thomas W. Curtis 

Deputy Executive Director 

cc: 

Ben Grumbles-USEPA OW 

George Gray-USEPA ORD 

Audrey Levine-USEPA ORD 

Brian Mannix-USEPA OPEI 

Cynthia Dougherty-USEPA OGWDW 

Alan Roberson 

COMMENTS BY THE AMERICAN WATER WORKS ASSOCIATION ON THE DRAFT 

DRINKING WATER CONTAMINANT CANDIDATE LIST 3 (CCL3) 

Executive Summary 

The American Water Works Association (AWWA) is providing 

detailed comments on the draft CCL3 as published in the 

February 21st 2008 Federal Register (73 FR 9628). The following 

overview summarizes the central issues we address in our 

comments: 

* AWWA and the Environmental Protection Agency (EPA) 

should continue to rely on a science-driven CCL process to 

identify potential candidates for new drinking water 

regulations; 

* AWWA commends EPA for the substantial effort and 

increased scientific rigor applied to developing the draft 

CCL3; 

* AWWA also commends EPA for its implementation of the 

contaminant nominations process and for its involvement with 

stakeholders, but both processes need significant improvements. 
AWWA recommends increased stakeholder engagement for future 

CCLs. 

AWWA recommends the following: 

* In the final CCL3, EPA should clearly state the purpose 

of the CCL, and develop criteria for evaluating the 

effectiveness of future CCLs in meeting the drinking water 

program's goals; 

* EPA must critically assess the suitability of the 

current CCL process for identifying potential regulatory needs 

for Disinfection By-Products (DBPs); 

* The Agency should develop an integrated research agenda 

for CCL3 and other drinking water issues in a timely manner, 

beginning with an examination of the health effects data and 

identification of significant gaps in health effects data; 

* The number of contaminants on the final CCL3 should be 

commensurate with what can be supported with EPA's drinking 

water research program; and 

* EPA should work with states, water and wastewater 

utilities, the agricultural community, and the chemical and 

manufacturing industries to minimize source water 

contamination. 

AWWA independently developed processes for screening and 

prioritizing chemical contaminants and for listing priority 

microbial contaminants. For chemical contaminants, this process 

used space diagrams to visually summarize a large quantity of 

diverse data. For microbial contaminants, based on our process, 

AWWA recommends the addition of human enteroviruses, 

Mycobacterium avium, and rotavirus to the final CCL3. AWWA also 

recommends the removal of Entamoeba histolytica, Heliobacter 

pylori, Naegleria fowleri, Salmonella spp., Shigella spp., and 
Vibrio cholerae from the final CCL3. 

AWWA would like to work with EPA to integrate our approaches 

into the approach used by EPA, and believes that our approach 

increase transparency and ensures that data quality is 

appropriately considered in the development of the final CCL3. 

Introduction 

The American Water Works Association (AWWA) is an 

international, nonprofit, scientific and educational society 

dedicated to the improvement of drinking water quality and 

supply. Founded in 1881, the Association is the largest 

organization of water supply professionals in the world. Our 

60,000 plus members represent the full spectrum of the drinking 

water community: treatment plant operators and managers, 

environmental advocates, engineers, scientists, academicians, 

and others who hold a genuine interest in water supply and 

public health. Our membership includes more than 4,700 

utilities that supply roughly 80 percent of the nation's 

drinking water. 

AWWA appreciates the opportunity to comment on the draft CCL3 

as published in the February 21st 2008 Federal Register (73 FR 

9628). The CCL is the foundation for the standard-setting 

process mandated in the 1996 Safe Drinking Water Act (SDWA) 

Amendments. A robust, science-drive regulatory development 

process is the best means for protecting public health while at 

the same time, ensuring responsible and appropriate allocation 

of public resources. 

I. General Comments 

Science-Driven Process 

AWWA and the Environmental Protection Agency (EPA) should 

continue to rely on a science-driven CCL process to identify 
potential candidates for new drinking water regulations. 

Section 1412(b)(1)(A) of the 1996 Safe Drinking Water Act 

(SDWA) lists three criteria for listing of contaminants for 

consideration for potential national drinking water 

regulations: 

1. The contaminant may have an adverse health effect; 

2. The contaminant occurs, or is likely to occur, at a level 

and frequency of public health concern; 

3. A national regulation provides a meaningful opportunity for 

health risk reduction. 

This past two CCL processes can be summarized as follows: 

* In 1998, EPA listed 60 contaminants on the first CCL (CCL1), 

and in 2003, determined, based on the above criteria, that 9 of 

these contaminants did not need to be regulated (EPA, 1998, 

2003); 

* In 2005, EPA listed the 51 remaining CCL1 contaminants on the 

second CCL (CCL2), and in 2007, proposed not regulating 11 of 

these contaminants based on the same criteria (EPA, 2005, 

2007). For example, five CCL1 contaminants were undetected in 

the first Unregulated Contaminant Monitoring Rule (UCMR1), 

which included monitoring by over 3,300 public water systems 

(Roberson, 2005). 

The best available, peer-reviewed science must remain the 

foundation for the development of national drinking water 

regulations. As clearly articulated in the above SDWA criteria, 

occurrence of a particular contaminant in water does not, in 

and of itself, justify national regulation. This becomes 

increasingly important to recognize as continuously improving 

analytical technology leads to ever lower detection limits and 

consequently, greater numbers of contaminants being found. 
National drinking water regulations should not be driven by the 

"contaminant du jour." 

Endocrine disruptors and pharmaceuticals have both gotten 

increased levels of publicity over the past few years. Based on 

the mandates in the Food Quality Protection Act (FQPA) and the 

SDWA, EPA is in the process implementing the Endocrine 

Disruptor Screening Program (EDSP) to screen and test potential 

endocrine disruptors. Admittedly, it has taken several years to 

systematically organize the screening and testing processes, 

and to develop appropriate analytical methods. But the 

analytical methods issues have been resolved, and AWWA believes 

that EPA should be allowed to complete the implementation of 

the EDSP, and then take the appropriate regulatory actions. 

AWWA does not have any additional occurrence data on 

pharmaceuticals as requested in the February 21st Federal 

Register. Again, AWWA believes that EPA should be allowed to 

look at pharmaceuticals with the same scientific rigor as any 

other potential CCL contaminant. In fact, EPA included 287 

pharmaceuticals in the CCL Universe (p. 9652). Again, improved 

analytical methods should not be the driver for national 

drinking water regulations. In April 15th testimony to the 

Senate Subcommittee on Transportation Safety, Infrastructure 

Security, and Water Quality, Dr. Shane Snyder of the Southern 

Nevada Water Authority, a national leader in research on trace 

contaminants in water, stated "If our study had been 

constrained to find these compounds at parts-per-billion levels 

instead of delving into the parts-per-trillion range, none of 

them -not a single one- would have been found." 

The public health significance of contaminant occurrence data, 

and thus any potential needs for regulatory controls, cannot be 

ascertained without the scientific context of health effects 

information. The SDWA's contaminant listing criteria recognizes 

this need for integration of occurrence and health effects 

information. Dr. Snyder's testimony addressed this in a 

rhetorical question, "Are we going to make decisions based upon 

our ability to find contaminants, or based on protection of 

public health?" To date, health effects research has not been 

able to keep pace with rapid advances in detection 
capabilities. Clearly, more research is needed before 

sciencebased decisions on many trace contaminants can be made. 

More detailed comments on drinking water research needs and 

implementation of that research follow. 

Increased Scientific Rigor 

AWWA commends EPA for the substantial effort and increased 

scientific rigor applied to developing the draft CCL3. CCL1 was 

developed through an expert process, using the best available 

data to meet a statutory deadline. CCL2 simply carried over the 

remaining CCL1 contaminants after the first 9 regulatory 

determinations were made in 2003. The draft CCL3 represents an 

overhaul of the approach, an unprecedented effort from EPA to 

access and evaluate a vast amount of data on potential drinking 

water contaminants, and a reproducible and largely transparent 

process amenable to continuous improvement through adaptive 

management. This initiative followed upon recommendations from 

the National Research Council (NRC) and the National Drinking 

Water Advisory Council (NDWAC), from whom EPA solicited 

guidance. AWWA applauds EPA for soliciting such outside expert 

opinion, and for stepping up to the arduous task of 

implementing these recommendations. The result has been a more 

rigorous scientific approach for CCL3 with capacity for further 

refinement as needed. AWWA believes that inclusion of 

additional expert review panels in the draft CCL3 development 

process was a critical element of the approach and commends EPA 

for incorporating a portion of their input. 

AWWA recognizes and appreciates the magnitude of EPA's effort 

in developing the draft CCL3, including the considerable work 

involved in providing transparency to the overall process. AWWA 

has identified a few areas in these comments where additional 

transparency is needed. The first case would seem to involve 

minimal effort on the Agency's part by adding of a second row 

to the attribute score summary table found at the top right of 

chemical dossier pages. This new row would characterize the 

data tier level associated with the particular data element on 

which each attribute score was based. Additional comments 

concerning issues of transparency are included in the sections 

below on nominations (access to dossiers), on background 
documentation in the docket, and on DBPs. 

Nominations 

AWWA commends EPA for its past nominations process, but 

significant improvements are necessary for future nominations. 

AWWA nominated 21 chemicals and 13 pathogens in December 2006. 

Given the short comment period (60-days) and the limited 

available data at that time, it is not surprising that most of 

AWWA's nominations did not end up on the draft CCL3. As stated 

in the draft CCL Federal Register notice, most of the nominated 

contaminants (152 out of 172) were already under Agency 

consideration. The support document, Summary of Nominations for 

the Third Contaminant Candidate List provides considerable 

information about nominations but it's not always clear why 

particular contaminants did or did not advance to the PCCL or 

the draft CCL3. AWWA recommends that this document be enhanced 

to clarify the specific data-basis for the decisions to list or 

not list all of the nominations. 

Nominations are a central component of stakeholder 

participation in CCL development. In our 2006 nominations, AWWA 

recommended "...the nomination process should occur in tandem 

with, or preferably after, the publications of future draft 

CCLs so that the nomination process would allow AWWA and other 

drinking water stakeholders to make nominations for 

contaminants that may have been missed for one reason or 

another by the EPA process". Based on our analysis of the draft 

CCL3 and the associated documentation, AWWA now recommends that 

the nominations occur between the future Preliminary 

Contaminant Candidate Lists (PCCLs) and the future draft CCLs, 

as long as the PCCL dossiers are made publicly available as 

discussed below. This timing allows the nominated contaminants 

to go through the same screening/scoring processes as every 

other PCCL contaminant that is considered to be listed on 

future draft CCLs. EPA would have difficulties in comparing 

nominated candidates to the future draft CCLs after the 

screening/scoring is completed. 

AWWA's second major issue with the 2006 nominations could be 
solved with the release of the Preliminary Contaminant 

Candidate List (PCCL) dossiers to the public as part of the 

request for nominations for future CCLs. This release would 

serve three purposes: 

1. The dossiers could assist in increasing the scientific rigor 

of the nominations. 

2. Due to a longer timeframe between the nominations and the 

draft CCL, the PCCL itself and the dossiers could then be 

assessed with some rigor to better understand the health 

effects and occurrence data used in the PCCL/CCL process. 

3. The PCCL can then be used as one of the tools to develop 

research priorities, both at a national level with EPA, CDC, 

USGS, AwwARF, and others, and at the local level 

though utility research. 

Stakeholder Involvement 

AWWA commends EPA for its past stakeholder efforts and 

recommends increased stakeholder engagement for future CCLs. 

AWWA members participated in both the NRC and NDWAC efforts. 

EPA and other drinking water stakeholders participated in the 

AWWA CCL workshop in Scituate in the summer of 2005. Some AWWA 

members also participated in EPA's expert review panels; 

however, these expert panels were not typically open to the 

public so some elements of the CCL3 development process remain 

obscure to stakeholders. Experts participating in these review 

panels were under strict instructions to not talk about the 

proceedings. 

AWWA recommends that EPA consider additional options for both 

increased transparency to stakeholders and stakeholder 

engagement in future CCLs. The CCL docket is an example where 

the Agency's current approach to publishing dockets on 

www.regulations.gov. does not contribute to transparency. The 

CCL3 docket is limited to a number of static documents that are 
supposed to be read in their entirety (several hundred pages) 

within the 90-day comment period. Reading these static 

documents does not explain what key decisions and post-hoc 

analyses actually shaped the decision-making process on whether 

to list or not list. The documents present the underlying data 

in formats that are not searchable, not easily understood, and 

are unusable for future analyses by the public, certainly 

within the brief comment period. 

The proposed Integrated Risk Information System (IRIS) Dialogue 

Group provides a good model for how an expanded stakeholder 

effort could work. Whether this would be a "formal" EPA body, 

either as a subcommittee of the NDWAC or Board of Scientific 

Counselors (BOSC) or otherwise, or more of an informal body, is 

less important than there being an open pathway for ongoing 

dialogue between EPA and the "customers" of the CCL (utilities, 

consulting engineers, state regulatory agencies, academics, 

environmental advocates, etc.). 

This approach would remedy the "stop-and-start" characteristic 

of past CCL stakeholder involvement, affording better 

opportunities to identify and share available data and 

expertise on specific contaminants. As recommended by the 

NDWAC, CCL development, and stakeholder involvement should be 

an ongoing process, not a once-every-five-year event. AWWA 

recommends that EPA dedicate a portion of its website towards 

access to the CCL, the underlying data and database, and 

progress reports in resolving data gaps. 

AWWA has begun planning an informal stakeholder effort for late 

2008 to begin discussions on incentives/disincentives for 

emerging contaminant monitoring. The potential impacts to 

future utility monitoring from the recent story on 

pharmaceuticals in drinking water by the Associated Press and 

other media outlets is not clear at this time. Some utilities 

are focusing their efforts on better public affairs and risk 

communications, while others are concerned about conducting any 

monitoring at all due to the potential to be asked for that 

data in the future and any other associated 

reporting/notification issues. This is a conundrum that is not 

easily solved, and AWWA is planning a short series of 
conference calls with a limited number of stakeholders from 

utilities, environmental advocates, pharmaceutical 

manufacturers, and state regulators to identify the major 

issues with monitoring for emerging contaminants. What should 

be done about those major issues may required broader and more 

significant stakeholder effort over a few years. 

Purpose of the CCL 

AWWA recommends that EPA clearly state the purpose of the CCL 

in the final CCL3. AWWA's understands that the CCL serves 

multiple roles, being the starting point or foundation for the 

process for developing drinking water regulations as well as a 

mechanism to help prioritize research needs. It is important 

for the drinking water community that EPA clearly articulate 

its central objectives in the final CCL3. Because of the 

inextricable dependency of the CCL process on research data, 

which has become more transparent through the data mining 

activities underpinning the current effort, identification of 

research needs is clearly a natural outgrowth of the CCL 

process. 

The current ambiguity about research prioritization leads AWWA 

to wonder if the focus of the CCL process has changed since 

CCL1. While the mandate of the CCL remains the same, 

implementation of the process appears to have shifted toward 

regulatory determinations. Such a shift is acceptable as long 

as it is clearly articulated in the final CCL3, and it appears 

that developing the overall research agenda is now a lower 

priority for the draft CCL3. 

Criteria for Success for Future CCLs 

AWWA recommends that EPA develop criteria for evaluating the 

effectiveness of future CCLs in meeting the drinking water 

program's goals. EPA's ongoing work on developing performance 

indicators for two drinking water regulations (Arsenic and the 

Long-Term 2 Enhanced Surface Water Treatment Rule [LT2ESWTR]) 

is a small step in the right direction. More work is needed to 
develop performance indicators for the entire SDWA regulatory 

program and future CCLs should be included in this effort. 

AWWA suggests the following categories and considerations for 

CCL success measures: 

1. Systematic process 

2. Process allows EPA to make timely regulatory determinations 

3. Public health protection achieved with meaningful risk 

reduction 

4. Consumer confidence in public drinking water systems 

5. Has any retrospective study been conducted to assess the 

relative risk reduction (lives saved, cancer endpoints avoided, 

etc.) achieved by existing drinking water regulations? 

6. Has there been a retrospective study comparing projected and 

realized cost/benefits for existing drinking water regulations? 

7. Could such studies be extended to the CCL? 

8. Do supplementary data need to support such assessment need 

to be considered early on in the regulatory development 

process, and be embedded in the regulation itself? 

Disinfection By-Products (DBPs) 

AWWA recommends that EPA critically assess the suitability of 

the current CCL process for identifying potential regulatory 

needs for Disinfection By-Products (DBPs). DBPs clearly have 
the potential for significant exposure, as disinfection is 

required by all surface water systems (serving 191 million 

people) and by a significant portion of groundwater systems 

(serving over 89 million people). With respect to the wide 

range of known unregulated DBPs, the draft CCL3 includes only 4 

nitrosamines (one of the listed nitrosamines has not been 

identified as a DBP), and even excludes 2 of the nitrosamines 

that are required to be monitored under the 2007 second 

Unregulated Contaminant Monitoring Rule (UCMR2). Further 

comments on the relationship between the CCL and UCMR processes 

follow in the research section below. 

Some DBPs have been recognized for a long time already. Several 

new DBPs have been identified more recently by researchers such 

as Stuart Krasner of Metropolitan Water District of Southern 

California (MWDSC), Susan Richardson of EPA, and others. The 

list is expected to grow further with increased research focus 

and improved analytical methods. 

Many classes of unregulated halogenated DBPs that commonly 

occur are not represented in the CCL3. These include 

haloacetaldehydes (di-and tri-), halopicrins (mono-, di-, and 

tri-), halofuranones (MX and analogues), brominated 

trihaloacetic acids, and haloacetonitriles (di-and tri-). It is 

difficult to follow the logic for inclusion/exclusion of these 

contaminants in the universe or PCCL. The Federal Register 

notice states that DBPs and treatment additives were 

automatically added to the universe based on a default 

occurrence assumption and moved to the PCCL even if limited 

health or occurrence data were available. However, while the 

CCL3 "universe" included a number of the above-listed 

compounds, it skipped many others, and only one of these DBPs 

(chloropicrin) moved to the PCCL. It's very difficult to 

evaluate the CCL process with respect to the appropriateness of 

listing outcomes for DBPs because data gaps for contaminants 

that do not pass from the universe to the PCCL are not 

documented. This also presents a lost opportunity for 

identifying research needs. 

Does this indicate a gap in the process? The CCL process, as 

derived from the recommendations of the NRC and the NDWAC, does 
not appear, in AWWA's opinion, to be able to accommodate the 

evaluation of unregulated DBPs. Would significant modifications 

to the existing process make sense, or is a different process 

(an alternate regulatory pathway) needed for this contaminant 

class? 

Under the current framework, when research "happens", DBPs will 

come into the universe and pass to the PCCL, and CCL, if the 

data so indicate. The problem with this scenario is the 

apparent disconnect between research and the listing process. 

There seems to be a considerable amount of research planned, or 

in place, according to the multi-year research plan. But no 

reference is made to these efforts, or how they dovetail with 

the CCL process. 

The relationship of the six year review cycle to this question 

needs clarification. Bromoform was excluded from the universe 

because of its implicit coverage by review of the Stage 2 DBP 

rule. Is EPA assuming that the existing DBP regulations (i.e., 

TTHM and HAA5 MCLs and Total Organic Carbon (TOC) removal 

requirements) control all halogenated DBPs? The validity of 

such an assumption has not been addressed. 

AWWA recommends that a research plan be developed as soon as 

possible to evaluate whether or not EPA's current regulatory 

approach is adequate for DBPs. More research is needed to 

assess the adequacy of the current regulations with respect to 

halogenated DBPs. The Agency needs to more clearly trace the 

ecision making process employed for DBPs in the current CCL. 

AWWA is concerned that EPA appears to be "done" with re- 

evaluating or refining its regulatory approach towards DBPs and 

recommends that a research plan be developed as soon as 

possible to answer the question "Is the current regulatory 

approach for DBPs adequate?" At this time, AWWA is NOT 

recommending revisions to the DBP regulations, and we want to 

make that point perfectly clear. However, AWWA believes that 

more research is needed in a timely manner to answer the 

question on the adequacy of the current DBP regulatory approach 

The appropriate research should be identified, prioritized, and 

then implemented, given the increasing body of knowledge on 

DBPs and their unique status among drinking water contaminants. 
Drinking Water Research and the CCL 

AWWA recommends that EPA develop an integrated research agenda 

for CCL3 and other drinking water issues, beginning with an 

examination of the health effects data and identification of 

significant gaps in health effects data. AWWA makes the 

following recommendations for drinking water research, with 

further details below: 

* The number of contaminants on the final CCL3 should be 

commensurate with what can be appropriately supported by EPA's 

drinking water research budget; 

* The drinking water research budget should be increased to a 

level equivalent to the air pollution health effects research 

budget (in the range of $60 million/year); 

* The research of EPA's National Laboratories should be re- 

prioritized to reflect the research needs of the CCL; 

* A table of the research needs (analytical methods, 

occurrence, health effects, treatment) should be included in 

the final CCL3 and that table should be the starting point for 

developing an overall drinking water research program; 

* The linkages between the CCL and UCMR need to be clearly 

articulated in the final CCL3. 

Number of Contaminants 

AWWA recommends that the number of contaminants on the final 

CCL3 be commensurate with what can be supported with EPA's 

drinking water research program. If EPA's research program can 

only conduct the necessary research on 30 contaminants, then 
the final CCL3 should include only 30 contaminants. AWWA 

recommends that EPA link the number of contaminants on the 

final CCL3 with the appropriate resources being devoted to CCL 

research. 

Inclusion of more contaminants on the final CCL3 than be 

effectively researched and evaluated dilutes the research and 

monitoring efforts of the entire drinking water community. For 

example, progressive utilities that want to monitor for 

emerging contaminants or contaminants that might be regulated 

in the future are stuck with a large list that cannot be 

monitored. Consulting engineers that are master-planning future 

treatment facilities want to allow flexibility for future 

treatment processes for future contaminants, but again, the 

list is too large and too complex to allow for such 

flexibility. 

For example, if the final CCL3 contains a table (as detailed 

later in these comments) categorizing each contaminant's 

research needs among analytical methods, occurrence, health 

effects, or treatment, this information could then be extended 

to a cost estimate for the necessary research. 

For example, assume that each contaminant could be placed in 

the following categories based on the amount of research needs: 

* Limited-assume $2 million of research is needed 

* Moderate-assume $5 million of research is needed 

* Significant-assume $10 million of research is needed. 

Assuming an equal split of research needs (1/3 limited, 1/3 

moderate, 1/3 significant) across the 104 draft CCL3 

contaminants yields a total CCL3 research cost approaching $600 

million. This would take over 20 years to complete assuming 

EPA's current drinking water research budget at $50 million per 
year, with half (which may or may not be close to the actually 

percentage) of that drinking water research budget directed 

towards the CCL. This does not match up with the five year 

cycles for the CCLs and subsequent regulatory determinations. 

Analyzing a research budget can be challenging, and in 

particular, attempting to distinguish what is in support of a 

specific area of research (CCLs, DBPs, perchlorate, arsenic, 

etc.). AWWA is currently conducting a retrospective analysis of 

EPA's arsenic and DBP research plans to determine how much of 

the identified research was completed and used in the final 

regulations. This project may provide some limited insight into 

future planning, but clearly, better information about the 

impacts of research on the regulatory development process is 

needed. 

Drinking Water Research Budget 

AWWA recommends that the drinking water research budget be 

increased to a level equivalent to the air pollution health 

effects research budget (in the range of $60 million per year). 

AWWA supports a dedicated research authorization to support 

EPA's regulatory development process through the CCL and 

regulatory determinations. 

Outside reviewers have also recognized the need for increased 

research funding to meet the needs of the CCL. In late 2005, 

EPA's Board of Scientific Counselors (BOSC) completed a review 

of the Office of Research and Development's (ORD's) drinking 

water research program. This report made several important 

recommendations, and recommendation #5 addressed the CCL 

research needs: 

"The CCL process is challenging, given the potential for large 

numbers of contaminants. Additional research ultimately will be 

needed by ORD to respond adequately to this mandate. ORD is 

strongly encouraged to aggressively pursue partnering with 

other agencies and nongovernmental organizations (NGOs) to 

ensure that the CCL needs are addressed adequately". 
Drinking Water Research Priorities 

AWWA recommends that the research of EPA's National 

Laboratories be re-prioritized to reflect the research needs of 

the draft CCL3. Minimizing the uncertainties in the health 

effects data of the CCL3 contaminants should be a top priority 

of these National Laboratories. Additionally, these National 

Laboratories should develop a carefully managed plan to 

evaluate the occurrence of contaminants in source waters. This 

program should include the improvement of sampling methods, the 

development of new analytical methods, and statistical methods 

to appropriately analyze the occurrence data. The development 

of occurrence data should be not be solely at the expense of 

water utilities through the Unregulated Contaminant Monitoring 

Rule (UCMR). 

Table of Research Needs and Drinking Water Research Program 

AWWA recommends that research needs be identified and 

documented in the CCL process. The potential areas of research 

needs include health effects, analytical methods, occurrence 

and treatment studies. Research is needed in all of these areas 

at every stage of the CCL process as shown below: 

Universe ---> PCCL -> CCL--> MCL 

As the process stands, inputs for research are typically 

addressed between the CCL and MCL development process. This is 

one of the last steps in developing a regulation and includes 

research and data needs for appropriate cost/benefit analyses 

as mandated by SDWA. However, the process of moving compounds 

from the universe to the PCCL and from the PCCL to the CCL also 

provides unique opportunities to identify data and research 

gaps and needs. 

AWWA recommends that EPA take advantage of these opportunities 
in a more deliberate and formal approach. For example, in the 

present scheme, compounds that are not ranked high because of 

data gaps can be filtered back to the universe or otherwise 

never make it to the CCL. These compounds should be further 

considered as potential future research needs and these needs 

should be captured in a formal document made available to 

stakeholders and the public. This information is vital to 

advancing research before each subsequent CCL is published. 

By better identifying research needs earlier in the process, 

EPA is likely to generate more interest and receive more input 

from the research community. Currently, EPA does not have a 

formal process to make these data gaps well known. Therefore, 

the research community is not as aware as they could be of 

research needs at the various points of the regulatory 

development process. A focused effort with effective leadership 

can improve implementation of research for future CCL 

development. 

One example would be the use of surrogate data (such as 

production or environmental release information) to list a 

compound on the CCL. The use of surrogates is an opportunity 

for EPA to publicize the research needs for compounds that have 

no actual environmental measurements. Another example would be 

the case in which a compound drops from the process because of 

a lack of data. This should be identified and documented as a 

research need to give the research community the opportunity to 

investigate these topics. 

AWWA recommends that a table or other summary of research needs 

be developed for the final CCL3, similar to the research needs 

table in the final CCL1. A table or other summary of research 

needs would be helpful to the overall CCL development process. 

Listing of specific compounds or classes of compounds would 

allow the research community to investigate areas which EPA 

sees as research needs. 

For example, in CCL1, compounds that were listed included 

associated research needs such as analytical methods research, 

occurrence research, health effects research, and treatment 
research. AWWA suggests that the same categories of research 

needs formerly categorized on CCL1 be readopted for subsequent 

CCLs. Furthermore, AWWA suggests these research need categories 

not be limited to the compounds on the final CCL but should 

include compounds and associated research needs as identified 

in the process of moving compounds through Universe/PCCL/CCL 

(as stated above). AWWA recommends that EPA more clearly 

identify and document research needs for compounds in the CCL 

process. This includes both compounds on CCL3 as well as 

compounds in the universe, and especially in the PCCL, which 

failed to move further through the process due to missing 

required data. 

Such a table or summary of research needs should be included in 

the formal release of CCLrelated documents. This type of 

research summary would not only provide information for the 

wider research community but it would also allow public water 

systems to better prioritize their capital and operating 

budgets to address potential issues on the regulatory/research 

agenda. 

Linkages Between CCL and the Unregulated Contaminant Monitoring 

Rule (UCMR) 

The UCMR is a key mechanism to: 1) advance research/data gaps 

for contaminant occurrence identified through Universe/PCCL/CCL 

and 2) develop and refine research plans (i.e., results can be 

used to revise hypotheses about occurrence of contaminants and 

contaminant groups, which can then be used as feedback to 

overall research planning). 

AWWA recommends EPA clarify where the UCMR fits into the 

regulatory process and how it can benefit the research needs of 

the scientific community as well as future CCLs. It is not 

clear how EPA connects the UCMR with the CCL process. Are data 

from UCMR used to support the CCL or is the CCL process used to 

determine which unregulated contaminants should be added to 

future rounds of the UCMR, or both? 
For example, UCMR2 requires monitoring for 6 nitrosamines, but 

the draft CCL3 only lists 4 of the 6. What happened to the 

other 2? Logically, if utilities are required to monitor for a 

class of compounds (with an approximate cost of $15 million), 

then all 6 of the UCMR2 nitrosamines should be on the final 

CCL3 

Source Water Protection 

AWWA recommends that EPA work with states, water and wastewater 

utilities, the agricultural community, and the chemical and 

manufacturing industries to minimize source water 

contamination. Source water protection is an important issue 

for drinking water utilities. Public water suppliers must treat 

surface waters in order to deliver potable water that meets 

drinking water standards and protects public health. Protecting 

public health includes treating for high levels of nitrite and 

nitrate, removing algal biomass, reducing algal toxins, and 

addressing operational challenges that stem from many 

industrial and agricultural operations. 

AWWA supports a dedicated authorization in the Research Title 

of the Agriculture Reauthorization bill for collaborative 

research between the drinking water sector and the agriculture 

industry on ways to limit contaminants from entering water 

supplies. 

II. Specific Comments on CCL3 Chemical Contaminants 

Reviewing the significant amount of documentation for 

Universe/PCCL/CCL processes and the dossiers for each of the 93 

chemical contaminants was challenging, given the short comment 

period. Given the five-year CCL cycle, AWWA and its technical 

experts knew of the need for data for informed internal 

deliberations prior to the scheduled publication of the draft 

CCL3 in early 2008. So in 2007, in order to be better prepared 

for this publication, AWWA contracted with Missouri University 

of Science and Technology, with Dr. Craig Adams as the 

principal investigator. This project was to build upon the 
occurrence-toxicity space diagram concept by using a variety of 

public data sources (Rosen and Roberson, 2007). 

The purpose of the risk analysis conducted by Missouri 

University of Science and Technology, Rosen, and Roberson was 

to provide a tool with which to screen against the CCL3 list to 

identify oversights, omissions, or unwarranted inclusions with 

respect to chemical contaminants. The process did not have the 

advantage of having early access to the EPA's chemical dossiers 

nor some of the data included in the dossiers. A relatively 

large number of contaminants were initially analyzed, and this 

approach produced a completely transparent result for each 

chemical in the database, specifically showing the data 

sources, normalization, and data quality estimates. 

Visually-useful occurrence-toxicity space diagrams, as well as 

averaged normalized risk indices, using both high quality only, 

and all data, were initially generated. Initially, two diagonal 

dashed lines were generated to aid in this visual analysis. The 

first diagonal line connected the highest toxicity score (10) 

with the highest occurrence score (10), while the second line 

connected 5/5. The logic was to develop three areas for each 

contaminant: 

1. List-to the right and/or above the 10/10 line 

2. Possibly list-between the 10/10 line and the 5/5 line 

3. Do not list-to the left and/or below the 5/5 line. 

After the initial graphing, the project team decided to "kink" 

the 10/10 line so that contaminants with high occurrence but 

relatively low toxicity would fall into the "possibly list" 

area. 

Again, give the short comment period, AWWA technical experts 

decided that the occurrence and toxicity data contained within 
the dossiers for the draft CCL3 also be entered into the AWWA 

database, using EPA's normalization factors. This approach 

combined the EPA data in the space diagrams with the data that 

was found prior to the publication of the draft CCL3. This 

allows a simple visual comparison of the different data and 

different combinations of occurrence-toxicity. The charts for 

the 93 chemical contaminants are enclosed separately from these 

comments. 

The analysis provided a useful tool for examining proposed CCL3 

compounds by AWWA's CCL Technical Advisory Workgroup (TAW), but 

did not result in any significant recommended changes to EPA's 

CCL3 list. In all cases, the project occurrence-toxicity data 

was either at a higher level than, or bracketed by, the EPA 

occurrence-toxicity data. In other words, the project data did 

not contradict any of the EPA data, 

Another observation from this project was that there was much 

more variability in the occurrence data as opposed to the 

health effects data. This observation points to the need for 

improved analytical methods research that could then be used by 

a wide variety of laboratories to develop sounds estimates of 

national occurrence, where occurrence data is needed. 

Currently, it is proposed that, due to the incompleteness in 

data sets used and the potential implications or 

misinterpretation of ranked chemical lists for a larger number 

of chemicals, the technical results of the project on the 

larger database will only be written up in a master's thesis. A 

related drinking water policy paper will be published in 2009 

that will summarize the process used in the projects and the 

resultant drinking water policy implications. 

A question remains as to whether all PCCL compounds 

(approximately 500) should be entered into the database. This 

would require additional resources and additional time that is 

not available during the short comment period. The key question 

is what would be the purpose of this additional work, and 

specifically, what would be the application of the resulting 

data and/or database either or both internally (to AWWA) or 
externally. 

Treatability 

Inclusion of treatability considerations in the CCL3 criteria 

is problematic for a specific chemical agent due to the plant- 

to-plant and temporal within plant variability in treatment 

processes, temporal and spatial variability in physical, 

chemical and biological parameters in source waters and 

sediments (onto which agents may partition), and other factors. 

For example, two plants using the same powdered activated 

carbon may achieve nearly no removal versus complete removal of 

a specific chemical agent depending on water characteristics 

(e.g., natural organic matter concentration, temperature, pH, 

etc) and carbon dosage. Similarly, oxidative removal or 

transformation of a chemical may be significantly affected by 

these same water characteristics. Additionally, removal by 

filtration of a chemical agent may vary from negligible to 

complete depending on many varying factors such as use of 

filtration aids, pH, total turbidity and biological activity on 

filters. 

Therefore, AWWA suggests the most appropriate assumption for 

chemical contaminants is to assume no net removal through a 

water treatment plant with respect to the CCL process. This is 

a different assumption that for microbial contaminants as 

detailed later in these comments as disinfection is a 

regulatory requirement, but we believe this is appropriate for 

chemical contaminants. 

Use of Release/Production Data 

The use of release data as a surrogate measure for occurrence 

data in the magnitude and prevalence scores is a key decision 

in the CCL3 process. AWWA was surprised that release/production 

data or modeled concentrations were used for the majority of 

the chemical contaminants, as opposed to actual concentrations 

in drinking water sources or in treated drinking water. The 

lack of concentration data points to the need for increased 
research for new analytical methods that could be used on a 

widespread basis, as opposed to methods that can only be used 

by research laboratories. These new methods would then be used 

to develop sound estimates of national occurrence. Development 

of national occurrence distributions appears to be a critical 

research need for many contaminants. 

A key component for assessing risk to the public for a chemical 

or biological contaminant is their exposure to the agent 

including both magnitude (i.e., concentration) and prevalence. 

Concentrations are relevant especially in relation to 

references doses for the agent. Prevalence, however, can be 

impacted by either or both temporal or spatial variations, and 

thus, the total mass loading consumed by a given individual. 

Ideally, both magnitude and prevalence should be assessed in a 

statistically-sound manner using measured samples in raw and 

treated waters. However, in most cases as mentioned previously, 

measured values are not available and surrogates are used 

including either application rate data or production data. 

Key and significant problems are involved in the use of mass 

application or production data that make its use potentially 

highly misleading. For example, a contaminant concentration is 

dependent on the volume of water into which the agent is 

discharged and, therefore, dependent on factors such as the 

area of application, size of watersheds, and amount of rainfall 

or snowmelt in a watershed. Furthermore, the mass of a 

discharged or applied agent that is transported into a water 

supply is highly dependent on the chemical's properties and the 

local soil or water characteristics (including linear and non- 

linear partition coefficients, hydrolysis rates, biodegradation 

rates, etc.). Use of known parameters such as octanol-water 

partition coefficients can often lead to highly misleading 

results and may significantly under-or over-estimate the amount 

of an agent ending up in a watershed. 

While the AWWA recognizes the dilemma regarding a lack of 

sufficient magnitude and prevalence data, we strongly recommend 

that application or production data only be used with great 

caution. At a minimum, state-by-state application data should 

be the largest spatial areas considered, with a watershed-to- 
watershed approach being more optimal. Furthermore, because of 

the near impossibility of predicting the amount of an agent 

that will be transported to and remain in the aqueous phase in 

a drinking water source, we advocate that ideally a magnitude 

score for an agent in a watershed be based on its application 

rate relative to the volume of source water within the 

watershed. AWWA also recommends that the prevalence score be 

estimated based on the number of watersheds, and the relative 

populations served by the watershed, into which the agent is 

applied. 

The EPA should consider collaboration with other state and 

federal agencies (e.g., USGS, FDA, and USDA) in conducting this 

analysis. Use of a Graphical Information System (GIS) approach 

containing application data and hydrological data is 

appropriate. 

III. Specific Comments on CCL3 Microbial Contaminants Summary 

AWWA commends EPA for embracing many of the NRC and NDWAC 

recommendations in the development of a more rigorous 

scientific approach for identifying and evaluating microbial 

contaminants included on the draft CCL3 than was used for the 

CCL1 or CCL2. AWWA presents an alternative ("streamlined" 

decision tree) approach for evaluating PCCL contaminants that 

more explicitly, consistently, and transparently uses expert 

judgment and appropriate data to identify those pathogens whose 

potential regulation are more likely to lead to improvements in 

public health than the EPA process. The integrated and 

transparent use of focused expert input in the CCL process is 

clear from the language of SDWA and was supported by NRC and 

NDWAC reports. Based on the results of our alternative 

approach, which we recommend EPA use in developing the final 

CCL3, AWWA specifically recommends the addition of human 

enteroviruses, Mycobacterium avium, and rotavirus to the final 

CCL3. AWWA also recommends the removal of Entamoeba 

histolytica, Helicobacter pylori, Naegleria fowleri, Salmonella 

spp., Shigella spp., and Vibrio cholerae from the draft CCL3. 

Lastly, AWWA supports the inclusion of draft CCL3 microbial 

contaminants Campylobacter-like organisms, human caliciviruses, 

Hepatitis A, Legionella pneumophila, and toxigenic E. coli on 
the final CCL3. The details, results, and comparison of AWWA's 

approach with EPA's are provided in the comments below and in 

the Appendices. 

Documenting Expert Judgment for CCL3 Microbial Contaminants 

AWWA commends EPA for adopting and implementing the NRC 

paradigm (i.e., universe to preliminary CCL (PCCL) to CCL), 

which was subsequently supported by the NDWAC CCL Work Group, 

to develop the draft CCL3 for microbial contaminants. However, 

the agency needs to better define the process to describe all 

the interim steps that will be required to actually implement 

the CCL process-especially the integration of experts, 

particularly external experts. The majority of AWWA comments 

and critique of EPA's approach to develop the draft CCL3 focus 

on the third step of the CCL process (the "Classification 

Process") whereby PCCL contaminants are evaluated using a 

combination of health effect and occurrence attributes to 

obtain a composite score. As recommended by NDWAC (2004), this 

key step should also include "Evaluation" and "Expert Review" 

defined, respectively, as follows: "...After implementing the 

classification process, the prioritized list of contaminants 

would be evaluated by experts, including a review of the 

quality of information...The CCL classification process and 

draft CCL list would undergo a critical Expert Review by EPA 

and by outside experts before the CCL is proposed." However, it 

is not clear whether the purpose and results of any of the 

three expert workshops support or fulfill the Evaluation and 

Expert review components of the third step of the CCL process. 

AWWA recommends that EPA provide a document in the docket that 

identifies all of the internal and external experts used to 

develop the draft CCL3 and their expertise, how they were 

selected, their affiliation and expertise, and results of the 

deliberations-especially concerning the scoring and re-scoring 

of PCCL pathogens-to facilitate transparency of expert input 

into the CCL3 process for microbial contaminants. Although it 

is not clear from either the NRC (2001) report or NDWAC (2004) 

report what the actual role of experts will be or how the 

experts' input will be specifically captured, tested, or 

employed, clearly expert judgment and input continues to form a 
critical and integral part of the CCL3 process- particularly 

for microbial contaminants. Regarding the scoring process in 

general, AWWA notes that the March 2007 experts stated the 

following: "Perhaps there is an issue regarding the measure of 

reproducibility for scoring (i.e., could similar scores be 

reproduced with other experts or is there too much flexibility 

in scoring and professional judgment?). The group recommends 

that another group scoring should occur to determine scoring 

variability." Consistent with previous related comments, it is 

not clear whether the final scores provide in the Federal 

Register notice for the draft CCL3 were scored more than once 

and by more than one group of internal or external experts. 

AWWA agrees that the role of experts in the CCL process should 

continue in all phases of identifying, screening, and 

evaluating pathogens from the microbial universe to the PCCL 

and then to CCL. It remains unclear, however, exactly who were 

the selected experts (necessary information to determine the 

appropriate expertise of each of these experts), how the 

experts were chosen, by whom, what input was provided by these 

experts, and how such input was used (or modified or not used) 

as part of the CCL3 process. 

The draft CCL3 states that EPA convened a total of three 

workshops to review, discuss, and comment on the microorganism 

considered and selected for the draft CCL3 and notes that "The 

Agency's considerations of these and other recommendations are 

discussed in the Microbial Expert Review support document [EPA, 

2008b]." However, that document only identifies the six experts 

(including infectious disease microbiologists) and their 

selection process for the third expert workgroup that met on 

March 20-21, 2007, in addition to providing a summary of that 

group's deliberations, findings, and recommendations (EPA 

2008b). While the draft CCL3 discusses the importance and 

summarizes the key contributions of these other two expert 

panels to the CCL3 microbial process, whether the experts were 

internal, external, or a combination (or even their numbers) 

and how they were identified is not discussed. There is also no 

documentation of the deliberations of either group in the 

supporting docket. As stated in the Federal Register notice for 

the draft CCL3 (EPA, 2008): 

In December 2005, a group of expert microbiologists reviewed 
and commented on the universe of human pathogens and the 

screening criteria used to develop the PCCL. This panel agreed 

that focusing on human pathogens is a reasonable and pragmatic 

way to identify potential drinking water contaminants. While 

the panel suggested that animal pathogens may develop the 

ability to infect humans, they noted that these emerging 

contaminants should not be listed on the CCL based on the 

theoretical potential to become zoonotic pathogens. They also 

identified additional criteria and methods to apply those 

criteria to the Microbial Universe, which EPA incorporated into 

the CCL process. In June 2006, a panel of experts met for three 

days to review EPA's implementation of recommendations by NRC 

and NDWAC to select microbes for the CCL. EPA implemented the 

NDWAC recommendation to develop a process that paralleled the 

chemical process yet still accounted for the different types of 

data and information that are uniquely available for microbial 

contaminants. Panel members agreed that health effects and 

occurrence of microbes importance. The panel recommended that 

EPA use a decision tree approach for microbes rather than the 

classification approach suggested by NRC and NDWAC. The panel 

further recommended that the Agency consider a different 

selection process than the one used for chemical contaminants, 

related to the different information available for microbes. 

Based on this recommendation, the Agency evaluated options to 

consolidate the potency and severity attributes for microbes 

into a single health effect attribute, developed a waterborne 

disease outbreak protocol, and considered occurrence as a 

single attribute...The panel also recommended that the Agency 

consider drinking water treatment and removing microbes from 

further consideration if conventional drinking water treatment 

protects public health [emphasis added]. 

The two previous expert workshops clearly played a key role in 

the CCL3 microbial identification and selection process. 

Therefore, EPA should have provided a document in the docket 

that identifies the experts and how they were selected, and 

that summarizes the workshops in order to facilitate 

transparency in the CCL3 process for microbial contaminants. 

March 2007 Expert Workshop for CCL3 Microbial Contaminants 
The goal of the March 2007 workshop was to obtain expert input 

on the approach EPA is using to establish the microbial CCL3, 

focusing on providing comments on the draft list of 

microorganisms, the screening process, and scoring protocols 

used to establish the list (EPA, 2008a,b). Notably, two of the 

EPA experts-Kellogg Schwab and Rebecca Hoffman-were members of 

the AWWA microbial workgroup (see more below) that helped 

develop the proposed PCCL scoring approach and these comments. 

To facilitate this review, EPA provided the panel with 

background materials and staff presentations. Panel members 

also scored all PCCL pathogens independently using the EPA 

process, commented on specific pathogens considered for the 

draft CCL 3, and commented on the data and processes EPA used 

to identify the microbial contaminants. Many of the findings 

and recommendations of that expert workshop summary-including 

those that were apparently ignored and were not mentioned in 

the Federal Register notice for the draft CCL3-are discussed 

throughout these comments. 

AWWA Expert Microbial Workgroup 

In early 2008, AWWA formed an independent group of expert 

microbiologists (AWWA microbial workgroup) to independently 

assess EPA's process for evaluating (scoring) and selecting 

PCCL microbial contaminants included on the draft CCL3, as well 

as develop and use an alternative ("streamlined" decision tree) 

approach for evaluating PCCL contaminants. AWWA believes that 

the alternative process (i.e., the AWWA approach) more 

explicitly, consistently, and transparently uses expert 

judgment and appropriate data to identify those pathogens whose 

potential regulation are more likely to lead to improvements in 

public health than the EPA process. The AWWA microbial group 

met twice and includes the following experts: Ms. Rebecca 

Hoffman (Wisconsin State Laboratory of Hygiene, University of 

Wisconsin, Madison); Ms. Marilyn Marshall (Quality Assurance 

Officer, University of Arizona); Dr. Paul Rochelle (Interim 

Microbiology Unit Manager, Metropolitan Water District of 

Southern California Water Quality Laboratory); Dr. Kellogg 

Schwab (Director-Johns Hopkins Center for Water and Health, 

Johns Hopkins Bloomberg School of Public Health); and Dr. Donna 

Wolk (Clinical Director, Microbiology and Molecular 

Diagnostics, University of Arizona). The microbial workgroup 
also helped prepare these comments. Note, these comments focus 

on critiques of EPA's process for developing and finalizing the 

draft CCL3 and specific microorganisms included or excluded on 

the CCL3; therefore, no attempt was made by the microbial 

workgroup to systematically provide statements of support for 

the draft CCL3 or the CCL process in general. 

Critique of EPA Approach 

AWWA's evaluation of EPA's approach identified several broad 

methodological critiques as well as specific critiques for 

scoring waterborne disease outbreaks, occurrence, and health 

effects for individual PCCL contaminants. 

General Methodological Weaknesses 

AWWA recommends that EPA provide and document the results of an 

explicit and transparent expert post-scoring 

reality/confirmation check of draft CCL3 pathogens, preferably 

conducted by outside experts. AWWA's chief concern of EPA's 

list of pathogens on the draft CCL3 is the apparent lack of any 

sort of "post-scoring reality/confirmation check" by outside 

experts. This check is needed to confirm the appropriateness of 

the scoring of individual PCCL contaminants and whether the 

inclusion of a pathogen on the CCL3 would fulfill the core SDWA 

criteria regarding the regulation of individual CCL 

contaminants, such as the new regulation would constitute a 

meaningful opportunity for health risk reduction. The 2007 

workshop experts cautioned that EPA was not being proactive 

regarding new and potential pathogens and advised that only 

including pathogens that have been fully researched may take 

resources needed to research pathogens for which waterborne 

infection routes are suggested but unable to be proven since 

reliable and sensitive analytical methods do not exist. 

Therefore, the EPA experts recommended and were themselves a 

part of a post-scoring consensus vote of the highest ranked 

PCCL pathogens to assess whether or not the pathogens are those 

most appropriate to focus EPA's limited resources (EPA, 2008b). 

However, many of these expert opinions (e.g., Helicobacter 

pylori) were not only dismissed but were never mentioned in the 
Federal Register notice for the draft CCL3 (EPA, 2008a). 

AWWA recommends that EPA provide transparent support and 

justification for all of the March 2007 scores that were 

changed in an apparently "back door" and closed process that 

circumvented the expert scoring process. AWWA is concerned that 

EPA appears to have modified their own expert-based PCCL 

scoring process in a non-transparent manner by changing 13 

scores after the March 2007 expert scoring workshop (summarized 

in Table A-1; Appendix). [See PDF for Appendix] Several of 

these scoring revisions resulted in the inclusion of a pathogen 

(e.g., Helicobacter pylori) on the draft CCL3 while other 

changes and kept a pathogen off the draft CCL3 (e.g., human 

enteroviruses). 

AWWA recommends that treatability should be included in 

evaluating PCCL contaminants for potential inclusion on the CCL 

since treatability will be part of the regulatory 

determination-at least as part of any sort of post-scoring 

reality/confirmation checks by expert assessment of individual 

pathogens. AWWA's technical experts were surprised to find 

Vibrio cholera included on the CCL3. Typhoid and cholera were 

essentially eliminated in the U.S. in the early 1900s through 

the nationwide adoption of conventional treatment (filtration 

and disinfection). The absence of consideration of treatability 

in the CCL process could result in listing on many organisms 

for which existing treatment already removes or inactivates the 

pathogens (e.g., as evidenced by a lack of WBDOs in the U.S.) 

and thereby does not focus CCL3 pathogens to those whose 

regulation may result in meaningful reductions in public health 

risk for those served by public water systems. EPA's rationale 

for not considering treatment was the high number of untreated 

ground water systems, despite the recent Ground Water Rule 

[EPA, 2006b], and existing Surface Water Treatment Rule (SWTR) 

for surface water systems. 

AWWA recommends that all materials used in the identification, 

evaluation, and selection process for the CCL3, with the 

exception of those that are clearly proprietary, should be 

publicly available in the docket. Further, EPA should rely 

whenever possible on peer reviewed literature for CCL purposes. 
It is not sufficiently clear (i.e., transparent) from the 

February 2008 Federal Register notice for the draft CCL3 or 

supporting documents in the docket how data on pathogens were 

identified and organized, and the role of expert judgment as 

part of this process. Indeed, the March 2007 experts (EPA, 

2008b) commented that "...it appears that the draft fact sheets 

may not adequately represent the available and updated 

information for each contaminant; a number of data omissions 

were pointed out." Further, the 2007 workshop experts 

recommended that quality assurance activities be incorporated 

into the process including an overall plan to assess the 

quality of the data collection, data, entry, and interpretation 

of available literature (data quality). 

With a few notable exceptions (e.g., Legionella pneumophila), 

AWWA recommends that the CCL3 list the target pathogenic 

microorganism belonging to a specific genus (e.g., Shigella 

spp.) and provide a typical species of concern (e.g., Shigella 

sonnei). AWWA believes that listing CCL contaminants to detail 

both the genus and species is often inappropriate for CCL 

purposes; for example, documented outbreaks and occurrence 

often do not differentiate between species. EPA (2008a) alludes 

to the fact that there are taxonomic issues that relate to the 

width of the pathogen groups that they are assessing for CCL 

purposes. However, after discussing this in a general way, the 

draft CCL3 notice indicates that EPA selected a single species 

within the genus and then listed it accordingly. 

AWWA recommends that the CCL3 listing for E. coli expand beyond 

O157:H7 and include other waterborne, toxigenic E. coli of 

public health significance (e.g., other enterohemorrhagic 

serotypes of E. coli, enterotoxigenic E. coli; Hunter, 2003) in 

the U.S. and other developed nations. 

Furthermore, the taxonomy of Campylobacter should be expanded 

to include Campylobacter- like organisms such as Arcobacter, 

which was not distinguished from Campylobacter in the 

literature (e.g., Snelling et al., 2006; Vandamme et al., 1991) 

until relatively recently but was evaluated separately by both 

EPA (2008a) and then the outside experts in March 2007 (EPA, 

2008b). 
Waterborne Disease Outbreak Assessment Issues 

EPA's reliance on the current Centers for Disease Control and 

Prevention (CDC's)/Morbidity and Mortality Weekly Review (MMWR) 

definition as constituting a documented waterborne disease 

outbreak (WBDO) is inappropriate; EPA should have developed 

their own working definition of an outbreak that is appropriate 

for CCL purposes. The March 2007 workshop experts recommended 

that EPA develop a means of scoring the magnitude of WBDOs and 

noted that an outbreak affecting 1-2 individuals (per CDC's 

definition of a WBDO below) received the same score as 

outbreaks affecting thousands of persons. There is no 

incorporation of this recommendation listed in the description 

of scoring protocols for the draft CCL3 and EPA's scoring 

approach for WBDOs does not account for the magnitude of the 

outbreak. AWWA's approach incorporates both the frequency of 

outbreaks and the number of individuals affected. 

"CDC definition: A waterborne disease outbreak is an incident 

in which 1) two or more persons experience a similar illness 

after consumption or use of water intended for drinking and 2) 

epidemiologic evidence implicates the water as the source of 

illness. The stipulation that at least two persons be ill is 

waived for single cases of laboratoryconfirmed primary amebic 

meningoencephalitis. Second, epidemiologic evidence must 

implicate water as the probable source of the illness." 

AWWA recommends that EPA rely whenever possible on peer 

reviewed literature when evaluating outbreak data (e.g., 

drinking water supply suspected as source of Naegleria, Cabral 

et al., 2003). Moreover, the NDWAC report (2004) recommended 

that "EPA should generate and include, along with the actual 

values or the attribute scores that are generated, descriptive 

"tags" that provide additional data quality information that 

may be used by experts reviewing the data, attribute scores..." 

The Federal Register (EPA, 2008a) notice for the draft CCL3 

notes the following on p. 9629: "In developing the draft CCL 3, 

the Agency consider the best available data and information for 

unregulated contaminants." 
AWWA recommends the use of outbreak data tied to the 

implementation of the SDWA and its amendments. It is 

inappropriate to consider outbreaks occurring anywhere before 

1974 (i.e., prior to implementation of SDWA). AWWA advocates 

the use of outbreaks taking place on or after 1980 in the U.S. 

because of limited data availability and time constraints 

associated with providing comments on the draft CCL3. 

AWWA recommends that outbreaks should be defined for CCL 

purposes as those occurring in developed nations exclusively. 

EPA's inclusion and consideration of outbreak information from 

undeveloped countries, despite often vastly different laws, 

regulations, and practices concerning drinking water treatment, 

distorts the scoring and is inappropriate for regulations 

intended to be applied in the U.S. Further, data from U.S. 

territories should be carefully screened for usefulness (e.g., 

Vibrio in Marshall Islands, 2000). 

AWWA recommends that serological data associated with a WBDO 

must be linked with occurrence data in water (e.g., what is the 

linkage between actual waterborne microorganism and a concrete 

marker of exposure?). The sole use of serological data to 

determine waterborne outbreaks is hampered by the difficulty in 

determining the relationship between seropositivity and 

clinical disease (NRC, 2004). For example, the use of serology 

to detect immunoglobulin G (IgG) antibody to norovirus has been 

established (Anderson et al., 2001). However, diagnosis by IgG 

antibody to norovirus requires collection of an acute and 

convalescent serum sample with the first serum sample drawn 

within 5 days of symptom onset. Often, there is a lag time of 

several days after an outbreak is recognized before clinical 

specimens are collected to test for a viral etiology. In 

addition, it is possible for asymptomatic infection to occur 

with norovirus infection, making it more difficult to know if 

an individual is shedding the virus. Therefore, immunoglobulin 

A (IgA) testing may be the only method for the late detection 

of a norovirus infection as IgA antibody peaks earlier than IgG 

but for a shorter duration of time. However, the kinetics of 

IgA response to norovirus infection are still largely unknown. 

Consequently, it is not possible to determine precisely when 

viral shedding would most likely occur solely on the basis of 
the IgA titer. Thus, serologic data alone cannot be used to 

determine the cause of a norovirus outbreak. These issues would 

be similar for serological determination of WBDOs caused by 

other microorganisms. 

AWWA recommends that outbreaks should be defined for drinking 

water and their sources, not recreational waters such as 

swimming pools, hot tubs, etc., unless the source specifically 

serves as a designated source of drinking water. The SDWA 

Amendments of 1996 state that the focus of the CCL should be on 

public water systems. A sampling of the swimming pool outbreaks 

listed in CDC's MMWR (CDC, 2000, 2002, 2004) is illustrative: 

California, 1999, Apartment complex pool, 23 persons ill-The 

health department conducted a physical inspection of the pool 

and examined pool maintenance records. No water testing was 

performed by the health department, nor were pool maintenance 

records available for the dates immediately after the day of 

exposure.... However, swimmers reported that on the day in 

question, the pool was overcrowded and that toddlers were 

swimming in the pool. 

Florida, 2000, apartment complex pool, 3 persons ill-Inadequate 

water quality and low chlorine levels were documented in an 

outbreak at an apartment complex. Fecal material had been 

visible in the pool at the apartment complex. 

Nebraska 2000, 225 persons ill-Fecal accidents had occurred 

before the outbreak. Review of the pool maintenance logs 

revealed a 2-day period when the baby pool had not been 

chlorinated. 

Georgia 2002, 3 children ill-Records on water treatment for the 

pool were not available. 

Minnesota, 2002, 52 persons ill-An investigation revealed that 

in the 2 weeks before the outbreak, the chlorine feeder had 

been out of service, and the chlorine had been administered by 
hand. The flow meters had not been working, and the rate-of- 

flow meter readings were not monitored or documented. The 

filter sand bed was later discovered to be missing 8 of the 

required 18 vertical inches of sand. 

Each of these MMWR-documented outbreaks was triggered by fecal 

accidents, failure to maintain proper disinfection practices, 

or a combination of these two factors. AWWA feels it is 

inappropriate to consider WBDOs of this nature for CCL 

purposes. 

Occurrence Scoring Issues 

Using the rationale described above for outbreaks, for CCL 

purposes, AWWA strongly objects EPA's (1) use of pathogen 

occurrence data obtained in U.S. territories and undeveloped 

countries; (2) linking pathogen occurrence to the local 

residents' serological positivity; (3) assigning pathogen 

occurrence scores based on reports in non peer-reviewed 

literature (reports of Naegleria occurrence in ground water by 

Gerba et al., 2007 that is not peer reviewed); and (4) using 

occurrence data that was derived from water sources strictly 

used for recreational purposes. 

AWWA recommends that molecular methods should be assigned a 

lower weight (score) until there are standard practices in 

place to ensure that all molecular laboratories perform their 

testing in properly engineered laboratory space and apply 

strict contamination measures to their processes. Until that 

time, molecular testing for pathogen occurrence may be more 

prone to false positives results than culture methods, and 

therefore, should not receive equal weight. AWWA disagrees with 

EPA's protocol of assigning equal occurrence scores to 

pathogens regardless of the method used to measure their 

occurrence (i.e., molecular-vs. culture-based detection 

methods). 

In comments regarding occurrence, the draft CCL 3 (EPA, 2008a; 

p. 9646) states "This attribute does not characterize the 
extent to which a pathogen's occurrence poses a public health 

threat from drinking water exposure. Because viability and 

infectivity cannot be determined by noncultural methods, the 

public health significance of non cultural detections is 

unknown." Given this statement, which AWWA agrees with, AWWA 

asks the agency to provide the justification and address the 

appropriateness for scoring molecular-and culture-based 

occurrence information the same. This recommendation is 

supported by NDWAC (2004): "The Work Group noted a related key 

consideration in the CCL process should be that, in general, 

false negatives should be avoided when going from the Universe 

to the PCCL and false positives should be avoided when going 

from the PCCL to the CCL [emphasis added]." 

AWWA recommends that EPA carefully scrutinize occurrence 

information and assign higher scores to organisms for which 

multiple, independent laboratories have produced multiple peer- 

reviewed publications documenting the pathogen's occurrence. By 

equally weighting scores for microorganisms that have been 

repeatedly detected but only by a single laboratory, the 

potential bias introduced by laboratory contamination incidents 

is minimized and the waterborne disease-causing potential 

reflected by the pathogen's frequent presence may be more 

accurately assessed. 

Health Effects Scoring Issues 

AWWA agrees with the agency's decision to not consider severely 

immunocompromised populations (e.g., primary or acquired severe 

immunodeficiency, transplant recipients) in their health 

effects scoring. Each year, increasing numbers of U.S. 

residents become immunocompromised due to organ transplants, 

cancer therapy and HIV, etc. Combined with the opposing ends of 

the age spectrum, very young and very old, the numbers of 

immunocompromised persons increases each year. Although such 

populations are definitely sensitive subpopulations, such 

immunosuppressed individuals usually have a higher standard of 

ongoing health care and protection than the other sensitive 

populations (e.g., elderly, pregnant women). Moreover, nearly 

all pathogens would result in high health effect scores for 

severely immunocompromised, which would devalue the scoring 
process for this key attribute. There are advantages as well as 

limitations to EPA's approach of separately scoring health 

effects in the general population as well in several sensitive 

subpopulations, then combining scores for the general 

population and the highest scored subpopulation. The same can 

be said for approaches that use sub-strata or normalization to 

try to balance the effects of healthy and immunocompromised 

hosts. Advantages of separate scoring include the realistic 

assessment of the raw numbers of human hosts at risk for 

disease caused by each of the organisms. This perspective 

allows for a focus on the overall cost-benefit of research and 

regulations that may result from the final CCL3 list. In 

contrast, the ethical impact of minimizing the small numbers of 

immunocompromised hosts in comparison to immune competent hosts 

may warrant discussion and further expert review from a human 

ethics perspective. An alternate approach may be to assess 

health effects based on the most vulnerable populations and 

quality of life issues. While there is no universal approach, 

it is important to note that the AWWA approach (described 

below) attempted to determine the "most common" health outcome 

for each of five sub-criteria in the general population or non- 

severely immunocompromised populations. 

AWWA recommends that health effects scores should be determined 

primarily through the consensus of practicing infectious 

disease specialists, rather than environmental microbiologists. 

This is consistent with the recommendation by the 2007 workshop 

experts that practicing infectious disease specialists 

determine scores for health effects rather than (they presumed) 

environmental microbiologists. Given previous comments 

regarding the agency's lack of providing consistent information 

on which experts comprised the various expert groups that 

helped identify, evaluate, and list the microorganisms on the 

draft CCL3 (or summaries of their deliberations, conclusions, 

and recommendations), it is not clear whether the health 

effects scores for PCCL contaminants were evaluated by a 

sufficient number of infectious disease microbiologists outside 

of the March 2007 expert workshop. 

AWWA reiterates its recommendation that EPA provide and 

document the results of an explicit and transparent expert 

post-scoring reality/confirmation check of draft CCL3 
pathogens, preferably conducted by outside experts. It is 

disconcerting that EPA appears to have modified their scoring 

process for Helicobacter pylori and revised several other PCCL 

pathogens health effect scores following the March 2007 expert 

workshop (EPA, 2008b) in a non-transparent manner. This 

resulted in a dramatically higher ranking of an organism than 

was originally obtained by the expert scoring process. H. 

pylori was initially scored relatively low by the outside 

experts brought in by EPA in March 2007 (EPA, 2008b). The 

normalized health effects sum based on the EPA experts scoring 

was 2.1, resulting in an overall total score of 5.1 (normalized 

health effect score = 2.1 + occurrence = 3) and ranking H. 

pylori 21 out of 29 PCCL pathogens. In March 2007, the EPA 

experts scored each of the individual health effects categories 

(general population, children, elderly, pregnant women, and 

chronic disease) as 3, indicating that the illness requires 

physician intervention. However, the EPA subsequently gave H. 

pylori a normalized health effects score of 5.0, resulting in 

an overall score of 8.0 and ranking the organism 6 out of 

29-thus it was included on the draft CCL3. The EPA's scoring of 

health effects categories differed from the experts' scoring in 

two areas: the general population and the elderly. EPA scored 

both of these groups as 7, indicating that the organism causes 

significant mortality whereas the EPA experts scored both 

groups as 3 (as stated above). Because the normalized health 

effects sum is obtained by adding the general population score 

to the highest sensitive group score, increasing both of these 

scores to the maximum (7) will obviously have a large impact on 

the overall score. How does EPA support and rationalize a 

combined score of 8.0 for H. pylori when the expert panel 

assigned it a score of 5.1? This elevation in score made the 

difference between exclusion and inclusion on the draft CCL3 

for H. pylori. 

As noted previously, a total of 13 scores were changed by EPA 

after the expert scoring workshop (summarized in Table A-1; 

Appendix). [See PDF for Appendix] As described in the Federal 

Register notice (p. 9649), EPA chose to list the 11 highest 

ranked pathogens (Exhibit 18) and cites a number of "natural 

breakpoints," ultimately using a breakpoint of 7.1. Examination 

of the scores assigned by the March 2007 microbial experts and 

assembled highest to lowest in Table A-1 shows that the 

"natural breakpoints" occur at 5.9 or at 4.5. Furthermore, a 
number of the revisions of the expert review scores-namely 

those for rotavirus, Arcobacter butzleri, human enteroviruses, 

human adenoviruses, and Plesiomonas shigelloides-moved them out 

of the lower range of listed pathogens and into the group of 

unlisted microorganisms. These scoring changes altered the top 

11 pathogens that were included on draft CCL3. EPA appears to 

have subjectively manipulated the scoring process to ensure 

that H. pylori would be listed on CCL3, despite the fact that a 

strict application of EPA's process, and review by an 

independent panel of experts (as recommended by NRC and NDWAC), 

did not support its placement on the draft CCL3. Similarly, 

this manipulation relegated rotaviruses and enteroviruses to 

below the threshold score despite the EPA expert panel's 

recommendation (EPA, 2008b) that they be included on the CCL3. 

Further, at least one member of the March 2007 expert panel has 

raised this issue in comments submitted to the docket (Docket 

ID: EPA-HQ-OW-2007-1189). This individual stated the following: 

"This was not a trivial exercise and we had some difficulties 

with some agents that were included in the final list...It is my 

opinion that although we may have included some organisms where 

there was not uniform agreement, we did not exclude any 

organisms that we felt were appropriate for this. For that 

reason, I take exception at the inclusion of Helicobacter 

pylori and Entamoeba histolytica and the exclusion of 

Enterovirus and Rotavirus. The classification scores listed in 

Exhibit 17 do not reflect the opinion of the Expert Panel. If 

the currently published list of candidate agents is to be 

retained, then justification for the variance from the panel's 

recommendations, particularly for inclusion of H. pylori and 

exclusion of Enterovirus, needs to be justified using the 

stated selection criteria" 

AWWA Approach 

AWWA evaluated EPA's PCCL to CCL scoring process and revised it 

somewhat to address several of the perceived shortcomings of 

EPA's approach. Note, the AWWA microbial workgroup evaluated a 

total of 22 of 29 PCCL contaminants. The remaining seven 
pathogens were not individually evaluated due to their low EPA 

and EPA expert scores, which AWWA more-or-less agrees with, 

while Arcobacter was not evaluated due to taxonomy concerns 

that were discussed in the preceding section. (See Table A-1 in 

the Appendix for a full listing of EPA and EPA expert scores 

for all 29 PCCL pathogens.) [See PDF for Appendix] The AWWA 

scoring approach is essentially a streamlined, decision tree 

version of the EPA approach in that the organisms are ranked 

according to published accounts of causing waterborne disease 

outbreaks, occurrence in water, and health effects. However, a 

number of important distinctions from the EPA process have been 

made and are described below. 

Waterborne Disease Outbreaks (WBDOs) 

The AWWA process for WBDO scoring follows a decision tree 

format (see Figure A-1; Appendix) and poses a series of 

questions designed to most accurately categorize the 

information available on WBDOs in the U.S. that are attributed 

to PCCL pathogens. [See PDF for Appendix] In AWWA's process, 

waterborne disease outbreaks were considered only when cited in 

peer-reviewed literature or CDC's Morbidity and Mortality 

Weekly Reports (MMWR). AWWA feels it is inappropriate to cite 

non-peer reviewed literature such as conference proceedings 

papers (e.g., Gerba et al., 2007) as supporting documentation. 

Additionally, outbreak data with only serological association 

of waterborne disease were not considered because the sole use 

of serological data to determine waterborne outbreaks is 

hampered by the difficulty in determining the relationship 

between seropositivity and clinical disease as outlined above. 

If the PCCL pathogen could not be linked to a WBDO using this 

approach, the organism received a score of 0 and WBDO scoring 

was complete. (Again, EPA scoring for WBDOs always results in a 

score of at least 1, even if the pathogen has never resulted in 

a documented WBDO in any country.) If one or more WBDOs were 

attributed to the pathogen, the outbreak was evaluated further 

to determine a score from 1-5. 

In EPA's approach, pathogens responsible for WBDOs in 

developing countries were assigned a WBDO score, albeit lower 

than when the outbreaks occurred in the U.S. or the developed 
world. AWWA feels it is inappropriate to assign any score to 

outbreaks that have occurred in countries where sound water 

treatment and sanitation practices have not been widely 

implemented. Therefore, the AWWA approach only considered 

outbreak data from the U.S. and other developed countries. 

Outbreaks in U.S. territories (i.e. Vibrio outbreaks in 

Northern Mariana Islands 1994; Marshall Islands 2000; reported 

in CDC MMWR 2002) and those in the developing world were not 

considered because access to fresh, high quality finished 

drinking water in the majority of these locations is limited at 

best. If the WBDO did not occur in the U.S. or another 

developed country, then the pathogen received a score of 0 and 

WBDO scoring was complete for that pathogen. 

The intended use of the water responsible for an outbreak 

occurring in the U.S. and other developed countries was also 

considered. AWWA's approach scores only outbreaks in water 

intended for use as drinking water or serving as a drinking 

water source. Waterborne disease outbreaks in water explicitly 

used for recreational purposes were excluded from 

consideration. For example, consider the report of a 2001 

Cryptosporidium outbreak infecting 358 patrons of a waterpark 

in Illinios. This outbreak was attributed to feces from an 

infected patron; furthermore, ...this waterpark's records 

indicate that one fecal or vomit accident every 1-2 days was 

usual in 2001. (CDC MMWR 2004). Further, a CDC report 

attributing a Naegleria outbreak to infection via mudhole 

exposure (CDC MMWR, 2002) was excluded from consideration. 

Again, if the WBDO occurred in water that was not intended for 

human consumption, the pathogen received a score of 0 and WBDO 

scoring was complete. 

Subsequent questions incorporate the frequency and magnitude of 

the outbreaks. In agreement with the EPA approach, the AWWA 

process assigned a higher score to organisms responsible for 

more frequent outbreaks, although AWWA's approach scores <5 or 

>=5 outbreaks. Additionally the AWWA approach considered the 

magnitude of outbreak giving higher scores to outbreaks 

affecting greater numbers of persons (<100, 101-500, >500 

cases). A maximum outbreak score of 5 was assigned based on the 

decision tree endpoint. 
Occurrence in Water 

Similar to data used to determine waterborne disease outbreak 

scores, the data used to score occurrence in water (see Figure 

A-2; Appendix) were derived from peer-reviewed literature and 

included only reports from inside the U.S. or other developed 

counties. [See PDF for Appendix] Furthermore, occurrence 

reports were only considered if the organism(s) was present in 

water targeted for human consumption. The AWWA approach further 

differentiates pathogen occurrence in treated drinking water 

from occurrence in untreated drinking water. This was 

accomplished by taking into account that many pathogenic 

microorganisms are easily controlled with basic disinfection. 

For example, in order to control for viruses and pathogenic 

bacteria, the Ground Water Rule (GWR; EPA, 2006b) set treatment 

technique requirements because it was not feasible to monitor 

for viruses (or pathogenic bacteria) in all sources of drinking 

water obtained from ground water. Under the GWR, if systems 

detect total coliforms in the distribution system, they are 

required to monitor for a more specific fecal indicator (E. 

coli or enterococcus). Therefore, ground water systems and 

states are already monitoring for possible contamination that 

may suggest microbial contamination. These systems are then 

required to disinfect. Thus, between existing drinking water 

regulations and the GWR, there is good reason to believe that 

untreated surface and ground water systems that are at risk 

are, or soon will be, disinfecting. For these reasons, AWWA 

believes pathogens-especially bacteria-that are known to be 

easily inactivated using conventional disinfection should not 

be prioritized as highly as those which are not as sensitive to 

disinfection processes for CCL purposes. Subsequent steps in 

the scoring process discriminate frequency of detection (i.e. 

was there a single report by a single research group or 

multiple reports by multiple research groups); however, the 

scores of organisms in which there were multiple reports from 

only a single research laboratory were decremented by one 

point. The AWWA approach also assigns higher scores to 

pathogens when organisms have been cultured directly from the 

water source as opposed to molecular detection because 

molecular methods may be more prone to false positives. Scores 
were assigned accordingly with a range of 0-5 (e.g., Legionella 

pneumophila received an occurrence score of 5 while Hepatitis A 

received a score of 2; see Appendix). [See PDF for Appendix] 

Health Effects Scoring 

Health effects were scored on a scale of 1-5 as outlined in the 

decision tree template (see Figure A-3; Appendix). [See PDF for 

Appendix] For each microorganism the most common health outcome 

for the general population and non-severely immunocompromised 

sensitive subpopulations (e.g., children, pregnant women, 

elderly and chronically ill individuals) was determined. A 

single health effects score was developed for the microbe under 

evaluation. If death was the most common health outcome the 

health effect score was 5. If death was not a common health 

outcome, AWWA experts subsequently scored 5 subcriteria to 

obtain a consensus-based overall health effect score. These 

subcriteria included the following: 

1. Require medical attention to get better 

a. Self limiting (i.e., low score) 

b. Medical treatment (i.e., high score) 

2. Severity (any one of the four severity outcomes listed below 

receiving a high [i.e., bad] score results in an overall high 

score for this sub criteria) 

a. Hospitalization 

b. Doctor visit 

c. Duration 

d.Intensity 

3. Infectious dose (ID) 

a. High ID (i.e., low score) 

b. Low ID (i.e., high score) 

4. Secondary spread 

a. Low (i.e., low score) 

b. High (i.e., high score) 

5. Sequellae 

a. low (i.e., low score) 

b. High (i.e., high score) 

It is important to note that selection criteria focused on 

attempting to determine the "most common" health outcome for 
each of the sub criteria. For most microorganisms, a small 

percentage of the exposed population, even within a 

subpopulation, can have more significant health outcomes than 

the majority of the exposed population. While this effect was 

acknowledged, scoring was still assigned on consensus following 

determination of the most common outcome without overly 

weighting exceptional cases. It was also determined that 

because the population and subpopulations under consideration 

are within the U.S., all individuals are well nourished and do 

not have chronic microbial infections (commonly observed in 

developing nations) that could exacerbate a microbial 

infection. 

Score Summary 

The scores from the WBDO (0-5), occurrence (0-5), and health 

effects (1-5) decision trees were compiled and the organisms 

were ranked from highest to lowest scores. Unlike the EPA 

process, the AWWA approach included both WBDO and occurrence 

scores provided the occurrence report was distinct from that of 

the outbreak report. While they are related, they are not the 

same and do not provide the same information. Outbreaks are 

directly related to public health concerns while occurrence 

data provides an indication of the continued presence of the 

organism in water and therefore the potential of the organism 

to cause future waterborne disease. The intent of the AWWA 

expert group was to ensure that outbreaks and occurrence were 

not "double-counted"; that is, the group intended to avoid 

using a single report to score both outbreak and document 

pathogen occurrence. AWWA also believes it is appropriate to 

score both outbreak and occurrence given that these pieces of 

information are likely to be underestimated for a variety of 

reasons, including the fact that many outbreaks are either not 

reported or the causative agent is not identified (NRC, 2004). 

Additionally, outbreak and occurrence data may be limited due 

to the lack of reliable and sensitive detection methods. 

The final step in the AWWA approach relied on expert opinion. 

AWWA's microbiology workgroup independently evaluated the list 

of scored microbes, as was done by the external experts at the 

March 2007 workshop (EPA, 2008b), and voted to include or not 
include the pathogens on the draft CCL3 (see Table A-2; 

Appendix). [See PDF for Appendix] These expert opinions were 

based largely on whether a pathogen is known or likely to occur 

in public water systems with a frequency that poses a public 

health threat, the likelihood of the microorganism to withstand 

conventional treatment (filtration and disinfection), and 

whether or not there would be a meaningful opportunity to 

improve public health if this microorganism was regulated. The 

evaluation also included an uncertainty assessment to account 

for organisms that have documented adverse health effects but 

have limited occurrence information, perhaps due to lack of 

detection methodologies, although they are anticipated to occur 

in water. In addition, the AWWA microbiologists-including a 

practicing expert in clinical infectious disease microbiology- 

considered whether or not additional regulations would be 

appropriate given the knowledge of each organism's 

susceptibility to conventional water treatment. AWWA believes 

that listing some microbes that are widely (and in some cases, 

even historically) known to be sensitive to chlorination will 

misdirect EPA resources and limit the evaluation of more robust 

pathogens that are known or anticipated to occur in drinking 

water and have adverse health effects but for which data may be 

limited due to the lack of health effects information and the 

availability of sensitive and reliable analytical methods from 

which occurrence and outbreak information may be determined. 

As discussed above, in March of 2007, EPA invited experts in 

the field of microbiology to review and critique their process 

for identifying organisms to be listed on CCL3. The expert 

reviewers were asked to answer the following question: "Does 

the CCL3 represent pathogens that have the most potential to 

occur in PWSs and cause health effects?" Based on the summaries 

provided in the Federal Register notice (EPA, 2008a), the 

summary of the microbial expert meeting (EPA, 2008b), and as 

noted above, AWWA believes that many of the comments and 

recommendations provided by that expert review panel were not 

sufficiently implemented or addressed nor integrated into EPA's 

CCL approach, especially for the PCCL to CCL step. 

Comparison of Results of EPA's and AWWA's Approach for 

Evaluating PCCL Pathogens 
The EPA used a list of 1,415 human pathogens (bacteria, 

viruses, protozoa, helminths, and fungi) compiled by Taylor et 

al. (2001) as the starting point for populating the microbial 

universe, as recommended by NDWAC (2004). Based on a review of 

the literature, EPA added six fungi and reovirus to the 

microbial universe. In response to EPA's request for 

nominations, additional organisms were added (Methylobacterium 

spp. and Mimivirus) bringing the microbial universe to 1,425 

organisms. 

A variety of screening criteria were then used to exclude 

pathogens whose biological properties are incompatible with 

water transmission by ingestion, inhalation or dermal contact, 

and those pathogens that are typically transmitted by sources 

other than drinking water (e.g., exclusively vector- borne 

microbes and pathogens transmitted solely by respiratory 

secretions). This screening process resulted in exclusion of 

97.8% of the microbial universe and 29 pathogens moving to the 

PCCL. AWWA recognizes EPA's efforts in building a comprehensive 

microbial universe and supports the use of pragmatic screening 

criteria to define the PCCL. 

EPA then used a scoring system based on WBDOs, occurrence in 

water, and adverse health effects to score and rank the PCCL 

microbes and determine the draft CCL3. As noted above, the 

higher of the WBDO score or the occurrence score was added to 

the normalized health effects score to produce a composite 

pathogen score (maximum = 10 on EPA scale). EPA (2008a) notes 

that there were a few "natural" breakpoints in the 29 pathogen 

scores with the top 11 forming the highest ranked group of 

pathogens (score >7.1; see Table 1). AWWA does not prescribe an 

a priori fixed number of contaminants on the CCL but is 

concerned that too many contaminants render the list 

impractical and ineffective for its stated purposes. 

Consequently, natural or arbitrarily assigned breakpoints are 

necessary to pragmatically prioritize the contaminants that 

pass through to the final CCL. The maximum score of a pathogen 

using AWWA's approach was 15.0, so the breakpoint was somewhat 

arbitrarily assigned at half of the highest score of 14.5 

(7.25). 
As summarized in Table 1 below, using a breakpoint of 7.1, 

EPA's draft CCL3 includes 11 pathogens while the EPA experts 

scoring of PCCL pathogens using EPA's approach includes 12 

pathogens. The AWWA scoring approach resulted in 11 pathogens 

as the top ranked list, prior to the post-scoring 

reality/confirmation check that is an integral part of the AWWA 

process. 

Table 1 Comparison Between EPA, EPA Experts, and AWWA's Process 

for Ranking PCCL Pathogens (rank is in parentheses after each 

organism) [see PDF] 

Discussion of Controversial Microorganisms 

The sections that follow provide detailed discussions of nine 

"controversial microorganisms" from the PCCL for which the AWWA 

process-to include the results of the post-scoring 

reality/confirmation voting by the five AWWA microbial 

workgroup experts-results in a different list of pathogens for 

inclusion on the final CCL3 than that of EPA's draft CCL3. 

These pathogens include the following: (human) enteroviruses, 

Entamoeba histolytica, Helicobacter pylori, Mycobacterium 

avium, Naegleria fowleri, rotavirus, Salmonella sp., Shigella 

sp., and Vibrio sp. The Appendix (see Table A-2) provides a 

color-coded, side-by-side comparison of PCCL pathogen scores by 

EPA (i.e., the draft CCL3), the March 2007 EPA experts, and 

using the AWWA approach. [See PDF for Appendix] The completed 

decision trees for all pathogens in alphabetical order are 

enclosed separately from these comments. 

Furthermore, these comments do not include discussion of PCCL 

pathogens for which there is agreement between the draft CCL3 

and the AWWA approach for their inclusion (e.g., Legionella 

pneumophila) or exclusion (e.g., Hepatitis E) on the 

CCL3-despite variances in their respective scores and overall 

rankings. Note, although the EPA experts scores using the EPA 

approach resulted in recommending adenovirus for inclusion on 

the CCL3 (see Tables 1, A-1, and A-2), it is not discussed 

because AWWA agrees with EPA that it should not be included on 

the CCL3. 
On AWWA Prioritized List but not on EPA draft CCL3 

Enterovirus 

Enteroviruses are common human viruses associated with various 

clinical syndromes, ranging from minor febrile illness to 

severe, potentially fatal conditions (e.g., aseptic meningitis, 

paralysis, myocarditis, and neonatal enteroviral sepsis). 

Although most cases are asymptomatic, enteroviruses are the 

most common cause of meningitis in the U.S. (principally 

echoviruses and coxsackieviruses) with an estimated 

30,000-50,000 hospitalizations each year (Khetsuriani et al, 

2002; Kim et al 2001; Khetsuriani 2003). There are an estimated 

10-15 million symptomatic enterovirus infections each year in 

the U.S. Viruses belonging to the enterovirus group have been 

responsible for at least one waterborne disease outbreak in the 

developed world (Hafliger et al., 2000) and have been detected 

in U.S. source waters and treated drinking water (Borchardt et 

al., 2003; Keswick et al., 1984; Lieberman, et al., 2002; 

Vivier et al., 2004). A variety of group B and group A 

coxsackieviruses and echoviruses were identified by molecular 

methods in municipal well water (Borchardt et al., 2004). 

AWWA's approach scored enteroviruses as 7.5, making it 11th out 

of the 29 PCCL organisms, and above the cut-off score of 7.25 

for inclusion on the CCL. The EPA expert panel scored 

enteroviruses at 7.9, placing it 6th on the list, above the 

"natural" breakpoint of 7.0, and the EPA experts post-scoring 

vote was unanimous for inclusion of enteroviruses on the CCL3. 

However, EPA's final score was reduced to 6.6, ranking this 

group of viruses at position 13 and excluding them from draft 

CCL3. If EPA did use any sort of post-scoring 

reality/confirmation check to downgrade the enterovirus score 

such that it was excluded from the final CCL, the rationale for 

the reality/confirmation check needs to be fully explained. 

Mycobacterium avium 

Mycobacterium avium complex organisms are opportunistic 
pathogens that cause pulmonary disease and are capable of 

disseminating through the body and leading to debilitating and 

lifethreatening infection. The incidence rates of pulmonary 

mycobacteriosis appear to be increasing in the U.S. and in the 

developed world (Salama et al., 2003). EPA researchers Hilborn 

and Ghio (2008) conducted a review of peer-reviewed literature 

related to mycobacteria and drinking water and presented their 

findings at the 2008 Emerging Infectious Disease Conference. 

They concluded that there is clear evidence that drinking water 

is a source of pulmonary environmental mycobacteriosis; however 

the etiologic fraction of the disease attributable to drinking 

water is unknown. 

In the U.S., current disinfection practices appear to be 

efficient for inactivation of most of the microorganisms on the 

draft CCL3 with the possible exception of Mycobacterium avium. 

Because M. avium is more resistant to most disinfectants than 

other waterborne bacteria (Gerba et al., 2003; Taylor et al., 

2000), it is reasonable to assume that these biofilm-associated 

organisms (Torvinen et al., 2007; Vaerewijck et al., 2005) may 

continue to pose risks to treated water supplies as the nidus 

of bacteria would continue to exist in the water distribution 

system (Hilborn et al., 2006). In addition, the degree of M. 

avium resistance to disinfection remains uncertain. M. avium 

cells grown in low nutrient conditions have been show to be 10- 

fold more resistant than bacteriologic culture medium-grown M. 

avium cells (Torvinen et al., 2007). Furthermore, resistance to 

disinfection has been shown to be directly related to growth 

rate, with slower growing strains showing greatest resistance. 

Notably, in addition to its high overall score and ranking (7th 

of 11 top scoring pathogens, the AWWA experts voted unanimously 

for its inclusion in the post-scoring voting. Moreover, EPA's 

own microbial expert panel voted 4 to 2 in favor of its 

inclusion on the draft CCL3 despite not quite making the 7.1 

cut-off value for inclusion (EPA, 2008b). AWWA believes M. 

avium to be a pathogen whose inclusion on the CCL3, as it was 

on the CCL1 and CCL2, could bring about increased research to 

resolve important questions related to water treatment 

resistance, risks, and whether its regulation in drinking water 

would result in public health benefits. 
Rotaviruses 

A variety of rotaviruses are widespread throughout the animal 

kingdom, but the majority of human strains belong to G 

serotypes 1-4. Rotavirus infection is the most common cause of 

diarrhea in children worldwide, occurring primarily in winter 

epidemics with a high level of person-to-person transmission. 

Rotaviruses are excreted in very large quantities in the feces 

of infected subjects, so they are present in relatively high 

concentrations in wastewater and environmental water (Abad et 

al., 1998; Ansari et al., 1991; Dubois et al., 1997). 

Rotaviruses have been detected by molecular methods in treated 

drinking water (Gratacap-Cavallier et al., 2000) and non- 

disinfected well water (Borchardt et al., 2004), and 13.8% of 

groundwater samples were positive in a large survey 

(Abbaszadegan et al., 1999). They are relatively resistant to 

environmental stresses and conventional drinking water 

treatment may not completely remove or inactivate them. 

Consequently, drinking water may play a role in the 

transmission of these viruses but further study is warranted. 

Therefore, it is appropriate that rotaviruses are included on 

the CCL. AWWA's process scored rotavirus as 8.5, placing it 9th 

out of the 29 PCCL organisms. The EPA expert panel scored 

rotavirus at 7.2, placing it 10th on their list, above the 

"natural breakpoint" of 7.0. However, EPA's final score was 

reduced to 6.5, which means rotavirus is excluded from the 

draft CCL3. In post-scoring voting, EPA's expert panel was 

split (50/50) on whether rotaviruses should be on the CCL3. 

This uncertainty over its placement is reflected in the 

relatively low ranking by both the AWWA process and the EPA 

expert panel although both groups of experts placed it on the 

list. If EPA did use any sort of post-scoring 

reality/confirmation check to downgrade the rotavirus score 

such that it was excluded from the draft CCL3, the rationale 

for the reality/confirmation check needs to be fully explained. 

On EPA draft CCL3 but not on AWWA List 

Entamoeba histolytica 
Entamoeba histolyica is very common in developing countries, 

but rare in the U.S. Waterborne disease outbreaks are not 

anticipated in the U.S. and although still reportable in most 

states, amoebiasis was dropped from the list of nationally 

notifiable diseases in 1994 (Keene, 2006). While one report, 

the Morbidity and Mortality Weekly Surveillance Report (MMWR, 

2006) reference of the Palau outbreak in 2002 has been 

reported, this occurrence did not occur in the 

U.S. and the outbreak was reported from a stream that was not a 

drinking water source. Thus, this report is not a valid 

reference for CCL purposes. In another MMWR (2006)-reported 

outbreak cited by EPA, the source of the outbreak was a well in 

a community water source in which stool samples were found to 

contain not only E. histolytica, but some also contained 

Campylobacter jejuni and Giardia sp. These results suggest that 

it would be impossible to determine which of the diarrheal 

agents actually caused the outbreak because all reports of 

pathogens were derived from stool specimens. Moreover, E. 

histolytica was not found in the well water, and because of the 

mixed infections, there was no clear proof of E. histolytica 

being the primary cause of the human symptoms (MMWR, 2006). The 

AWWA approach scores E. histolytica low in outbreak and 

occurrence and results it being ranked near the bottom of the 

evaluated PCCL pathogens; thus, AWWA believes that it is 

inappropriate to include E. histolytica on the CCL3. 

Helicobacter pylori 

Although Helicobacter pylori remains one of the most common 

worldwide human infections and is associated with a number of 

important upper gastrointestinal conditions, including chronic 

gastritis, peptic ulcer disease, and gastric malignancy, its 

prevalence is closely tied to socioeconomic conditions and is 

more common in developing countries than in the U.S. and other 

developed countries (Chey and Wong, 2007). In some individuals, 

H. pylori causes acute gastric ulcers and can lead to gastric 

cancer, although the route of transmission into susceptible 

hosts remains largely unknown (Bellack et al., 2006; Brown, 

2000). It is an emerging pathogen whose impact on human health 
has only recently begun to be elucidated. Fecal-oral and 

personto- person contact have been proposed as possible routes 

of exposure to this pathogen; however, contaminated drinking 

water may also be a source (e.g., McDaniels et al., 2005; 

Reavis, 2005). In this regard, survival of H. pylori in 

different types of waters and biofilms (Park et al., 2001) in 

drinking water systems have been reported as possible 

reservoirs of this organism. However, attempts to culture H. 

pylori cells from environmental water samples continue to be 

largely unsuccessful and discussions on whether this fastidious 

microorganism can exist in an infectious state are 

controversial. 

As discussed previously, EPA appears to have modified the PCCL 

scoring process in a nontransparent manner that resulted in H. 

pylori receiving a dramatically higher ranking than was 

originally obtained by the expert scoring process as documented 

in EPA (2008a) and resulted in its inclusion on the draft CCL3. 

Also, at least one member of the March 2007 expert panel 

questioned the changes in expert scores by EPA and noted that 

the discussions of H. pylori in the draft CCL3 do not reflect 

the consensus opinion of the EPA expert panel. The Federal 

Register notice for the draft CCL3 (EPA, 2008a) states: 

"Given the slow development of adverse health effects due to 

infection by H. pylori, it is more difficult to link 

contamination of drinking water and show a waterborne disease 

outbreak. Therefore, given the long timeframe of cancer and 

ulcer development (as opposed to the commonly acute 

gastrointestinal illness of nearly all the other pathogens on 

the PCCL) as well as the ongoing nature of the research, EPA 

used peer-reviewed scientific papers to score the health 

effects of H. pylori." 

This implies that EPA rationalizes inclusion of H. pylori on 

the draft CCL3 based solely on the potential for causing 

gastric cancer. AWWA does not minimize the significance and 

impact of such a potentially devastating disease but questions 

the validity of its inclusion based on this single dramatic 

health effect, and contrary to the EPA's scoring process and in 

opposition to the EPA's expert panel and the lack of evidence 
for drinking water as a route of transmission. For these 

reasons, and because H. pylori was not ranked sufficiently high 

by consistent application of the AWWA scoring process and the 

post-scoring reality/confirmation check process, AWWA does not 

believes that it is inappropriate to include it on the CCL3. 

Naegleria fowleri 

Primary amebic meningoencephalitis (PAM) associated with 

exposure to Naegleria fowleri is an uncommon condition with a 

high mortality rate and is indeed a serious infection; however, 

since the organism is sensitive to chlorine at 1 ppm 

(DeJonckheere and van de Voorde, 1976), AWWA believes that this 

organism is not a viable candidate for inclusion on the final 

CCL3 list due to its ease of treatability and rareness of PAM 

associated with exposure in contaminated water. . 

The Arizona cases involving two children have been suggested by 

molecular analysis to be "associated" with a domestic water 

source but it is important to note that the water source had 

been stagnant and open to outside contamination. Molecular 

analysis revealed that 17/19 samples, collected from bathroom, 

kitchen pipes and sink traps were found to contain Naegleria 

DNA by nested PCR analysis; however, there was no assessment of 

viability. The domestic water was supplied from a private water 

company and disinfection did not occur at the time of the 

incidents. Therefore, the exposure scenario associated with 

this "outbreak" is not one of a chlorinated water system 

(Marciano-Cabral et al., 2003). Because N. fowleri is an 

organism that can be found in U.S. soils and thus in standing 

water, this outbreak report should not be considered conclusive 

for evidence of contamination in the treated drinking water 

supply. Although a small number of PAM-related deaths have been 

reported from contaminated recreational waters in the U.S., 

none have been reported from treated water supplies. Each of 

these cases involved bathing or swimming in warm freshwater and 

therefore should not receive focus from the drinking water 

regulations (Schuster and Visvesvara, 2003). A recent report 

(Gerba et al. 2007) describes the widespread occurrence of N. 

fowleri in well water, and reports some resistance to chlorine; 

however, this report was not peer reviewed and has not since 
been substantiated by other investigators. 

A catastrophic outcome for a very small number of individuals 

should not be the sole driver behind placing an organism on the 

CCL. While it is acknowledged that N. fowleri occurs in 

untreated and recreational waters and can cause death, there is 

no strong (and corroborated) evidence that treated drinking 

water is a significant mode of transmission. Thus, the AWWA 

approach resulted in N. fowleri scoring below the cut-off of 

7.25. Although the EPA experts ranked N. fowleri high at their 

workshop in March 2007, they subsequently identified some 

concerns with this ranking, stating that (EPA, 2008b) "although 

Naegleria fowleri received a high score, it may not be 

appropriate to include it on the CCL due to its rarity in the 

environment." 

On EPA Draft CCL3 and AWWA List but Excluded from AWWA List 

because of Post-Score Reality/Confirmation Check 

Salmonella spp., Shigella spp. 

Despite the fact that these bacteria pathogens continue to 

cause WBDOs (e.g., 124 cases of salmonellosis in June 1999 in 

Missouri due to a community well that had inadequate chlorine 

levels, MMWR, 2006; and the March 2008 salmonellosis outbreak 

in the City of Alamosa, Colorado), these outbreaks are 

uniformly attributed to breaches in water treatment or untoward 

weather events. Both microorganisms are sensitive to chlorine 

and do not pose a risk when conventional drinking water 

treatment is applied. Because regulations governing 

chlorination of surface and ground water public water systems 

are already in place, AWWA believes it is not prudent to use 

existing regulatory resources to enforce the SWTR and GWR than 

to potentially create new regulations through the CCL process, 

which would be specific to these organisms. 

Vibrio sp. 
No outbreaks have been reported in U.S. drinking water 

supplies. Foodborne (mostly seafood) and foreign travel is 

responsible for the burden of V. cholera cases in U.S. 

(Steinberg et al., 2001). One outbreak reported by CDC (MMWR) 

in 2004 originated in Alaska and was the result of raw oysters 

consumption from harvests in Alaskan waters. The MMWR (2006) 

reports disease resulting from exposure to Vibrio as a result 

of wading in flood water of Hurricane Katrina. In another 

report, non-01 V. cholerae was isolated from surface waters in 

Western Colorado; however, none of these environmental isolates 

have ever been associated with human disease (Rhodes et al. 

1986). Because this vegetative bacterium is widely (even 

"historically"; NRC, 2004) known to be sensitive to 

chlorination and does not pose a risk when drinking water is 

properly disinfected, similar to Salmonella and Shigella spp. 

above, AWWA does not feel it is appropriate to include V. 

cholerae on the CCL3. 

Recommendations for CCL3 Contaminants 

Based on the results of our alternative approach, which we 

recommend EPA use in developing the final CCL3, AWWA 

specifically recommends the addition of human enteroviruses, 

Mycobacterium avium, and rotaviruses to the final CCL3. AWWA 

also recommends the removal of Entamoeba histolytica, 

Helicobacter pylori, Naegleria fowleri, Salmonella spp., 

Shigella spp., and Vibrio cholerae from the draft CCL3. Lastly, 

AWWA supports the inclusion of draft CCL3 microbial 

contaminants Campylobacter-like organisms, human caliciviruses, 

Hepatitis A, Legionella pneumophila, and toxigenic E. coli 

on the final CCL3. 

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Marciano-Cabral, F., M.A. Cabral, and L.G.A. LaPat-Polasko. 

2003. Identification of Naegleria fowleri in domestic water 

Sources by nested PCR. Appl. Environ. Microbiol. 

69(10):5864-5869. 

McDaniels, A.E., L.Wymer, C. Rankin, and R. Haugland. 2005. 

Evaluation of quantitative real time PCR for the measurement of 

Helicobacter pylori at low concentrations in drinking water. 

Water Res. 39:4808-4816. 
MMWR (Morbidity and Mortality Weekly) Surveillance Summaries. 

2000. May 26, 2000/49 (SS04):1-35. 

MMWR Surveillance Summaries. 2002. November 22, 2002/51 

(SS08):1-28. 

MMWR Surveillance Summaries. 2004. October 22, 2004/53 

(SS08):23-25. 

MMWR Surveillance Summaries. 2006. December 22, 2006/55 

(SS12):31-58. 

NDWAC (National Drinking Water Advisory Council). 2004. 

"National Drinking Water Advisory Council Report on the CCL 

Classification Process to the U.S. Environmental Protection 

Agency." 

NRC (National Research Council). 2001. "Classifying Drinking 

Water Contaminants for Regulatory Consideration." Washington, 

DC: National Academy Press. 

NRC 2004. "Indicators for Waterborne Pathogens" Washington DC: 

National Academies Press. 

Park, S.R., W.G. MacKay, and D.C. Reid. 2001. Helicobacter sp. 

recovered from drinking water biofilm sampled from a water 

distribution system. Water Res. 35(6):1624-1626. 

Reavis, C. 2005. Rural health alert: Helicobacter pylori in 

well water. J. Amer. Acad. Nurse Pract. 17(7):283-289. 

Roberson, J.A. 2005. Triggers behind the regulatory development 

triad. Journal AWWA. 97(3):66-73. 
Rosen, J.S. and Roberson, J.A. 2007. A simplified approach to 

developing future contaminant candidate lists. Journal AWWA 

99(3):66-72. 

Rhodes, J.B., H.L. Smith Jr., and J.E. Ogg. 1986. Isolation of 

non-O1 Vibrio cholerae serovars from surface waters in western 

Colorado. Appl. Environ. Microbiol. 51(6):1216-1219. 

Salama, C., M. Policar, and M. Venkataraman. 2003. Isolated 

pulmonary Mycobacterium avium complex infection in patients 

with Human Immunodeficiency Virus infection: Case reports and 

literature review. Clin. Inf. Dis. (epub) 37:e35-e40. 

Schuster, F.L., and G.S. Visvesvara. 2004. Free-living amoebae 

as opportunistic and nonopportunistic pathogens of humans and 

animals. Int. J. Parasitol. 34(9):1001-1027. 

Snelling, W.J., M. Matsuda, J.E. Moore, and J.S. Dooley. 2006. 

Under the microscope: Arcobacter. Lett. Appl. Microbiol. 

42(1):7-14. 

Steinberg, E.B., K.D. Greene, C.A. Bopp, D.N. Cameron, J.G. 

Wells, and E.D. Mintz. 2001. Cholera in the United States, 

1995-2000: Trends at the end of the twentieth century. J. 

Infect. Dis. 184(6):799-802. 

Taylor, R. H., J. O. Falkinham, C. D. Norton, and M. W. 

LeChevallier. 2000. Chlorine, chloramine, chlorine dioxide, and 

ozone susceptibility of Mycobacterium avium. Appl. Env. 

Microbiol. 66:1702-1755 

Taylor, L. H., S. M. Latham, and M. E. Woolhouse. 2001. Risk 

factors for human disease emergence Philosophical Transactions 

of the Royal Society of London B. Vol. 356, pp. 983-989. 
Torvinen, E., M.J. Lehtola, P.J. Martikainen, and I.T. 

Miettinen. 2007. Survival of Mycobacterium avium in drinking 

water biofilms as affected by water flow velocity, availability 

of phosphorus, and temperature. Appl. Env. Microbiol. 

73(19):6201-6207. 

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Portaels. 2005. Mycobacteria in drinking water distribution 

systems: Ecology and significance for human health. FEMS 

Microbiol. Rev. 29:9111934. 

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Tytgat, and J. De Ley. 1991. Revision of Campylobacter, 

Helicobacter, and Wolinella taxonomy: Emendation of generic 

descriptions and proposal of Arcobacter gen. nov. Int. J. Syst. 

Bacteriol. 41(1):88-103. 

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Candidate List." Fed. Reg. 63:40:10273-10287. 

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Priority Contaminants on the Drinking Water Contaminant 

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Ground Water Rule; Final Rule." Fed. Reg. 71:65573-65660. 

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Regarding Contaminants on the Second Drinking Water Contaminant 

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Reg. 72:83:24016-24058. 
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3-Draft; Notice", Fed. Reg. 73:9628-9654. 

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Third Contaminant Candidate List." EPA 815-R-08-0010. 

See APPENDIX 

[See PDF for Appendix] 

CS Title: 0146 

Company/group/association name: 

Comment: 

Maryland Department of the Environment 

1800 Washington Boulevard Baltimore MD 21230 

410-537-3000 1-800-633-6101 

Martin O'Malley 

Governor 

Anthony G. Brown 

Lieutenant Governor 

Shari T. Wilson 

Secretary 

Robert M. Summers, Ph.D. 

Deputy Secretary 

Mr. Benjamin H. Grumbles 

Assistant Administrator 

U.S. Environmental Protection Agency Office of Water (4101M) 

1200 Pennsylvania Avenue, N.W. 

Washington, D.C. 20460 

Dear Mr. Grumbles: 

Thank you for your letters to John Colmers, Secretary of the 

Maryland Department of Health and Mental Hygiene, and me 

regarding pharmaceuticals in water and drinking water systems. 

The Maryland Department of the Environment (MDE) appreciates 

your interest in this matter. 
We agree with the Environmental Protection Agency's (EPA's) 

concern regarding the need to clarify the uncertainty of the 

effects of trace levels of pharmaceuticals in our water 

supplies. The States have limited resources to develop the 

potential effects for both public health and aquatic life and 

we look forward to EPA taking a strong leadership role in this 

area. 

Currently the department has undertaken a limited number of 

activities related to the areas of pharmaceutical research and 

prevention. In 2007, we prepared a summary of documented 

endocrine disruptor occurrences in Maryland which identified 

data for a small number of pharmaceuticals and personal care 

products (PPCPs), including Roxarsone, used in poultry feed, 

and Triclosan and Triclocarban used as antimicrobials in soaps. 

We also participated in several stakeholder groups. The 

Potomac Drinking Water Source Water Protection Partnership is 

investigating emerging contaminants broadly and supporting 

national-level studies such as those by EPA and the U.S. 

Geological Survey. The Maryland Chapter of the Hospitals for a 

Healthy Environment (H2E) provides assistance and networking 

initiatives to promote environmental sustainability in 

healthcare and is addressing pharmaceutical waste disposal. We 

maintain a presence in the EPA Region 3 PHARMS group, which is 

exploring best management practices for the handling of 

pharmaceuticals. The EPA's website about PPCPs has been useful 

to this committee, and MDE will share with EPA any outreach 

materials that we develop. 

You requested comments on EPA's selection of contaminants for 

the draft Contaminant Candidate List (CCL). We understand the 

difficulty of this task of narrowing down the many potential 

contaminants that exist in the environment and offer these 

comments in hopes that they may be appropriate for the 

screening process. The Maximum Recommended Daily Dose (MRDD), 

used to indicate a potential for adverse effect, is determined 

from clinical trials involving daily treatments over 3-12 

months. The MRDDs may not reflect the risks associated with 

long-term, very low-dose exposures to sensitive human 

populations and aquatic organisms. Applying a 10-fold 

uncertainty factor to MRDDs, as is done to derive long-term 

reference doses from acute or subchronic toxicity data, may be 

justifiable. Factors such as persistence and bioaccumulations 
may be used to adjust toxicity and occurrence rankings to the 

extent this type of information is available. 

The potential for endocrine disruption is also important, since 

we already understand the importance of low-dose exposures for 

these compounds. Because the number of pharmaceutical 

candidates is so large and the available research is limited, 

it may be reasonable and consistent with the CCL goals to limit 

the focus to a smaller number of compounds that represent major 

classes of pharmaceuticals and show evidence of occurrence in 

the aquatic environment in studies by the U.S. Geological 

Survey and others. Because many of the same pharmaceuticals 

are used in regions of the U.S., it might be possible to divide 

the work of testing, assigning different compounds to different 

locations, e.g., assigning agents A thru E to 10 states, agents 

F thru L to 10 other states, etc. 

We look forward to continuing our partnership with EPA and the 

transfer of knowledge on pharmaceuticals in the environment. 

Thank you again for your letter. If you would like further 

information, please contact me or Mr. Jay Sakai, Director of 

Water Management Administration at (410) 537-3512 or by e-mail 

at jsakai@mde.state.md.us. 

Sincerely, 

Shari T. Wilson 

Secretary 

cc: John M. Colmers, Secretary, Maryland Department of 

Health and Mental Hygiene 

Dr. Phil Heard, Science Service Administration 

Jay Sakai, Director, Water Management Administration 

STW/cj 

CS Title: 0147 

Company/group/association name: 

Comment: 

Lindon Park Neighborhood Association 
May 20, 2008 

Mr. David Ryan 

USEPA Headquarters 

Ariel Rios Building 

1200 Pennsylvania Avenue, N.W. 

Mail Code: 1703A 

Washington, DC 20460 

Re:Public Comment on Possible Drinking Water Contaminants 

Dear Mr. Ryan; 

The Lindon Park Neighborhood Association (LPNA) is the US EPA 

Technical Assistance Grant (TAG) recipient for the Motorola 

52nd Street (M52) Superfund Site in Phoenix, AZ. Our Superfund 

site is one of the larger and more complicated sites in the 

country and involves both Superfund CVOC contaminants and jet 

fuel commingled with Superfund CVOCs. The site is divided into 

three operable units (OU1, OU2, and OU3). EPA has the lead at 

OU3, where there is no interim or final remedy yet. The Arizona 

Department of Environmental Quality has the project management 

and community involvement lead at OU1 and OU2, which both have 

interim remedies in place. 

We became aware of the proposed 104 additions to the drinking 

water contaminants list through the sharing of information by 

community members involved with sites in other parts of the 

country. The TAG immediately recognized the potential 

importance of these additions and shared this information with 

our EPA contacts. LPNA has also included this topic for 

discussion at our last two TAG meetings on March 6 and April 

29, 2008 as well as distributing printouts of the CCL3 

information. 

A query of a database containing some of the M52 Superfund site 

sampling data found contaminants presented in the EPA CCL3. In 

particular the following contaminants are present in the 

Motorola 52nd Superfund site groundwater at varying levels: 

Bromomethane; 1,4-Dioxane; Chloromethane; Methyl Tert-butyl 

Ether; 1,1,1,2-Tetrachloroethane; 1,1-Dichloroethane; and 

Perchlorate. 

The Linden Park Neighborhood Association supports the addition 
of these contaminants as well as the others on the CCL3 to the 

draft list and supports establishment of MCLs for these 

contaminants. 

If these contaminants are added to the Drinking Water list and 

MCLs are established, there are two ways our Superfund site may 

be impacted: (1) when the final remedy is selected those 

contaminants would have to be added to the remedy ARARs 

(Applicable or Relevant and Appropriate Requirements), and (2) 

there may be an impact to the requirement to discharge the 

treated groundwater to the Salt River Project canal at Operable 

Unit 2 (OU2). There may be additional impacts when an interim 

and final remedy are selected for OU3 at our site. 

EPA has indicated that there are proposed, but not yet 

established, MCLs for those contaminants, and the ADEQ Drinking 

Water Program Unit Manager, Tony Bode, is not aware of any MCLs 

being established yet. Since Arizona protects its aquifers to 

Drinking Water Standards, the groundwater might be in violation 

for these contaminants once MCLs are established. 

We encourage the addition of the contaminants on the CCL3 to 

the regulated drinking water standards and hope that MCLs will 

be established soon. Setting MCLs as quickly as possible is 

crucial to reducing risk and protecting public health. 

Obviously the impact of these contaminant candidate additions 

with the establishment of MCLs goes well beyond the treatment 

at drinking water facilities and may be relevant at many, if 

not most, Federal and State Superfund sites in Arizona and 

perhaps throughout the country. 

Thank you for this opportunity to comment on the proposed 

additions to the draft Contaminant Candidate List. 

Sincerely, 

Mary I. Moore 

Vice President, Lindon Park Neighborhood Association 

TAG Project Manager, Motorola 52nd Street Superfund Site 

4839 East Brill Street 

Phoenix, AZ 85008 

CS Title: 0148 

Company/group/association name: 
Comment: 

SubjectRe: Docket W-98-02, Perchlorate andthe UCM list 

Government should include in water test for the contaminant... 

perchlorate be subject to "unregulated contaminant monitoring 

in public water systems" 

CS Title: 0149 

Company/group/association name: 

Comment: 

SubjectRe: Docket W-98-02, Perchlorate and the UCM list 

Hello. Let's do whatever we can to keep our water safe. Herma 

CS Title: 0150 

Company/group/association name: 

Comment: 

May 8, 2008 

Benjamin H. Grumbles, Assistant Administrator 

Office of Water 

United States Environmental Protection Agency 

Washington, DC 20460 

Dear Mr. Grumbles: 

Thank you for your letter of March 28, 2008, regarding the 

issue of pharmaceuticals in water and drinking water. I 

appreciate the attention you are focusing on this topic and 

look forward to working with the Environmental Protection 

Agency (EPA) as we all move forward to address the potential 

public health issues associated with this topic. 

As you know, the issue of pharmaceuticals and personal care 

products (PPCPs) in the environment is not new. As our 

analytical abilities have improved, PPCPs have been detected in 

many water bodies across the country. While we can find these 
products almost every place we look, our understanding of the 

potential effects these contaminants can have on public health 

and aquatic life remains uncertain. I hope EPA can help improve 

our understanding of the health and environmental effects 

of these contaminants by conducting further research and health 

risk studies in these areas. 

Public health practice is focused on the prevention of human 

health problems, and inasmuch as humans need a healthy 

environment in which to flourish, I appreciate your attention 

to the stewardship and pollution prevention aspects of this 

issue. I urge your strong support of efforts to keep PPCPs out 

of the environment in the first place. Two important aspects of 

such prevention efforts would include enhanced research into 

wastewater treatment technologies and more effective and widely 

available pharmaceutical take-back programs. 

In the enclosure to this letter, I have provided additional 

specific information regarding the efforts in Washington State 

to address PPCPs in the environment. I have also included 

suggestions on some efforts EPA could take to provide the 

needed national leadership on this complex and challenging 

issue. [See PDF for Attachments] 

Again, I appreciate your attention on this important matter and 

look forward to working with EPA to address the many 

significant issues involved. If you have any follow-up 

questions on our activities and issues in Washington State, 

please contact Gregg Grunenfelder, Assistant Secretary of our 

Division of Environmental Health, at 360-236-3050. 

Sincerely, 

Mary C. Selecky Secretary 

Enclosures 

cc: Sarah Neiderer, Association of State & Territorial Health 

Officials 

Jay Manning, Department of Ecology 
Gregg Grunenfelder, Department of Health 

Pharmaceuticals and Personal Care Products 

Washington State Perspectives 

May 6, 2008 

Monitoring Efforts for PPCPs in the Environment 

In Washington State, monitoring for PPCPs has been very 

limited. The only state monitoring effort undertaken to-date 

was conducted by the Washington State Department of Ecology in 

2003-04. The enclosed report presents the full findings from 

that monitoring effort: Results of a Screening Analysis for 

Pharmaceuticals in Wastewater Treatment Plant Effluents, Wells, 

and Creeks in the Sequim-Dungeness Area, November 2004. The 

study involved analysis for 24 PPCPs in tertiary wastewater 

treatment plant effluents and nearby wells and creeks in 

northwestern Washington. The treated effluents were ultimately 

used in re-use programs and conventional land application. A 

total of 16 compounds were detected in one or both effluents. 

Only caffeine, nicotine, and the diabetes drug Metformin 

(tentatively identified) were consistently detected in well and 

creek samples. 

Recommended Focus for Future Monitoring Efforts 

Future monitoring efforts for PPCPs should focus on the 

presence and fate of PPCPs in leachate, biosolids, and other 

byproducts of our solid waste and liquid water treatment 

systems. Given the state of our analytical monitoring 

techniques, more general monitoring will simply reconfirm what 

we already know - PPCPs are widely present in our environment. 

We suggest that a more responsible use of the limited federal 

resources that may be available for expanded monitoring efforts 

should be more focused in areas that will help inform future 

actions to address the pollution prevention aspects of this 

issue. 
Need for More Research 

Greater support for continued research is needed in the areas 

of wastewater treatment and water reclamation technologies to 

address the removal of PPCPs in effluent. Identifying efficient 

and effective ways to treat for these contaminants in 

wastewater, while at the same time not interfering with the 

treatment effectiveness to control known health threats such as 

microbial pathogens, is an essential action needing support 

from EPA. 

In addition, more research is needed to better understanding 

the health and environmental risks associated with the very low 

levels of PPCPs found in our environment. While our analytical 

techniques to detect these compounds in minute quantities have 

improved greatly, our understanding of the human and 

environmental impacts of these low levels of contamination is 

lagging - especially for endocrine disrupting compounds. To 

address this issue responsibly, greater understanding of the 

effects low level concentrations of these compounds have on 

aquatic life and human health is needed. 

Consideration of PPCPs in EPA's Drinking Water Regulatory 

Efforts 

PPCPs should receive priority consideration for both occurrence 

and health effects review as the next Contaminant Candidate 

List (CCL) is developed for potential future drinking water 

contaminant regulations. In future CCL efforts EPA needs to go 

beyond evaluation of determining acute and chronic toxicity and 

address the potential impacts associated with endocrine 

disruption. Future regulatory consideration should be based 

upon a process of comprehensive and sound scientific review. 

National Policy Direction on the Disposal of Unwanted 

Pharmaceuticals Needs to be Refocused 

Current national guidelines call for direct disposal of unused 
drugs into the solid waste stream. This seems to be an ill- 

advised long-term strategy because leachate from many landfills 

is often sent to the same wastewater treatment systems that 

receive residential wastewater. This disposal route may merely 

delay the continued pollution of surface water and ground 

water. 

A more effective and convenient way to safely and dispose of 

collect unwanted drugs is needed. In addition to protecting our 

nation's waters, another reason to establish more effective 

drug collection programs is to help prevent unintentional 

poisonings. In 2005, Washington State had 923 poisoning deaths. 

More than 90 percent of those deaths were associated with drug 

overdoses. Nationally and in Washington, prescription opiate 

overdose deaths have fueled a significant increase in poisoning 

deaths. The increase in deaths mirrors the increase in the 

volume of opiates prescribed. It is essential that at the 

national and state level we do everything we can to efficiently 

and effectively collect and dispose of unwanted medicines. 

Here in Washington, we do have a pilot pharmaceutical take-back 

program. Information on our program can be viewed at: 

www.medicinereturn.com. Enclosed for your information is a 

report on our state's pilot project for the collection of 

pharmaceuticals from households - Disposal of Medications from 

Residential Consumers - October 2005, revised November 2007. 

[See PDF] 

We need support from EPA and other federal agencies to help 

remove the barriers to safe and responsible pharmaceutical 

take-back programs. We hope EPA will join in watching closely 

the efforts of the Drug Enforcement Administration as they move 

to amend their regulations to better accommodate the proper 

disposal of unwanted medicines (see enclosed April 23, 2008 

from Mark Caverly, DEA). [See PDF] In addition, EPA's assistance is 

needed to bring the producers of pharmaceuticals into the 

discussions of responsible stewardship. Those manufacturing 

and profiting from the sale of these products should provide 

the resources necessary to ensure proper collection and 

disposal of their products when they are no longer needed. 
Federal Leadership is Needed 

Federal leadership in the development of a national chemical 

policy is badly needed. More thoughtful and meaningful 

oversight is needed in the review and approval of PPCPs and 

endocrine disrupting chemicals (EDCs) for use in our country. 

In order to protect our overall environment, including the 

quality of our waters, the U.S. Food and Drug Administration 

should more thoroughly screen pharmaceuticals for environmental 

persistence and accumulation prior to approval for use. In 

addition, harmful EDCs need to be identified and action taken 

to phase out the production and use of the most harmful of 

these chemicals. As a nation, we need to be positioned better 

in the future to prevent contamination of environment, rather 

than responding to the many complex issues which arise once we 

have discovered contamination has occurred from products 

approved for use by inadequate review processes. 

Greater Outreach and Education is Needed 

Resources and support are also needed to help develop and 

implement programs to reach out to inform the public, health 

care providers, and veterinarians about this very complicated 

and important issue. Understanding the effects of PPCPs on our 

health and environment is challenging for everyone. Awareness 

and education efforts must be enhanced and be targeted towards 

the public as well as the physicians and veterinarians that 

prescribe pharmaceuticals to the people they serve. It is 

important to engage in a meaningful public dialogue on these 

issues so that the public can help in developing, supporting, 

and using the protections that are necessary. 

 

CS Title: 0151 

Company/group/association name: 

Comment: 

May 13, 2008 

United States Environmental Protection Agency 

Mr. Benjamin H.Grumbles, Assistant Administrator 

Ariel Rios Building 
1200 Pennsylvania Avenue, N.W. 

Washington, D.C. 20460 

Dear Mr. Grumbles: 

Thank you for your letter dated March 28, 2008, seeking input 

regarding the Contaminant Candidate List (CCL3) and requesting 

information regarding pharmaceuticals and personal care 

products (PPCPs) in ambient water and treated drinking water in 

Texas. 

The Texas Commission on Environmental Quality (TCEQ) supports 

the goals you stated in the letter to partner with governmental 

agencies, stakeholders, and the private sector. A rulemaking 

process that includes strong technical and stakeholder 

partnerships results in more equitable rules. We appreciate 

every opportunity to partner with the Environmental Protection 

Agency (EPA). 

The contaminant candidate list development process is peer- 

reviewed process that includes many stakeholders, including 

TCEQ. The process that was used in developing CCL3 had 

previously been used in developing CCL1 and CCL2. It has been 

modified and strengthened over time through the input of many 

experts. The screening process that EPA currently uses to 

choose which contaminants should be on the list is based on 

good science. The TCEQ is not aware of any new scientific 

evidence that would require mid-course changes to CCL3. 

In the period of time before CCL4, EPA should continue to 

gather data about PPCPs. Specifically, EPA should attempt to 

gather health effects information related to very low levels of 

PPCPs in drinking water and ambient water. 

EPA should not consider reprioritizing contaminants for CCL3 

without obtaining new scientific information that would change 

how specific PPCPs should be ranked for CCL3. The current list 

should be abandoned, and the process should be reinitiated 

taking into account that new information. Recent elevation of 

the topic of PPCPs in the news media should not be taken as a 

mandate to change the normal process of evaluating contaminants 
for any contaminant candidate list. PPCPs in drinking water and 

ambient water is a major concern to the public and therefore 

additional research on health effects by EPA is warranted. 

The TCEQ does not have any additional information regarding the 

presence of PPCPs in ambient water or treated drinking water. 

Although we are aware that some universities and other agencies 

in Texas are doing work in this area, TCEQ has not funded any 

work in this area. 

The TCEQ understands that EPA will be doing additional 

monitoring of PPCPs in ambient water as part of its Large River 

Project. The TCEQ's Water Quality Monitoring and Assessment 

Section is ready to assist in this effort. 

The TCEQ wishes you great success in bringing together 

nationwide information related to PPCPs that will help the 

process of developing future contaminant candidate lists. We 

appreciate the opportunity to comment on this topic. 

If we can be of any further service, please do not hesitate to 

contact Todd Chenoweth, Director of the Water Supply Division 

at (512) 239-4691. 

Sincerely, 

Buddy Garcia, Chairman 

Texas Commission on Environmental Quality 

BG/AD/hh 

CS Title: 0152 

Company/group/association name: 

Comment: 

April 11, 2008 

Benjamin H. Grumbles 

Assistant Administrator 
United States Environmental Protection Agency 

Washington, D.C. 20460 

Dear Mr. Grumbles: 

We recently received your letter regarding trace amounts of 

pharmaceuticals in water and drinking water systems. This issue 

does not come under the purview of the Health Department, 

however, we have been in contact with the Oklahoma State 

Department of Environmental Quality and they do plan to respond 

to you as requested. 

Sincerely, 

James M Crutcher, MD, MPH 

Secretary of Health and 

Commissioner of Health 

CS Title: 0153 

Company/group/association name: 

Comment: 

May 19, 2008 

Benjamin H. Grumbles 

Assistant Administrator 

United States Environmental Protection Agency 

East Building 

1201 Constitution Avenue NW 

Room 3219 

Washington, D.C. 20460 

Dear Mr. Grumbles: 

I am writing in response to your March 28 letter requesting 

information about pharmaceuticals in surface water and drinking 

water systems in New Jersey. 

New Jersey Department of Environmental Protection (DEP) has 

been active in this area, and I am pleased to provide you with 

an overview of our activities (see enclosure). This is in 
addition to the discussion between DEP Division of Water Supply 

Director Michele Putnam and Assistant Director Barker Hamill at 

the March 26, 2008, regional meeting in New York City with 

yourself, Mike Shapiro and staff. In addition, Assistant 

Director Hamill emailed two presentations authored by NJDEP 

Division of Science, Research and Technology Director Dr. 

Eileen Murphy to EPA Office of Science and Technology Deputy 

Director Suzanne Rudzinski, as she had requested following the 

regional meeting. 

We are aware of the release of the CCL 3 and are preparing 

comments from New Jersey. As you know, the issue of 

pharmaceuticals in drinking water is still being investigated 

by many states. Our concern in New Jersey is not so much the 

presence of any individual compound (which occur at sub parts 

per billion levels), but of the fact that we find mixtures of 

these and other chemicals in our samples. It was not uncommon 

to find ten different synthetic organic compounds (some of 

which were pharmaceuticals or their breakdown products) in a 

drinking water compound. Assuming each were detected at one 

part per billion, the additive concentration is ten. The 

science is not available to assess the human health impacts of 

this scenario. Further, while we cannot say definitely that 

pharmaceuticals or other contaminants are causing ecological 

effects, we are indeed observing feminization of fish and other 

detrimental aquatic life effects downstream of wastewater 

discharges. 

Also of note in New Jersey is the fact that we are conducting 

demonstration projects at two ground water systems to 

investigate the idea of a treatment-based regulatory approach 

for unregulated synthetic organic contaminants, including 

pharmaceuticals and their by-products. The State has awarded $1 

million contracts with the Fairlawn Water System and 

Merchantville - Pennsauken Water System to install full-scale 

carbon units within their systems. Advanced analytical 

techniques will be used to track the fate, transport and 

removal of organic contaminants from the raw ground water 

through the carbon. The information acquired from these two 

projects will help inform us as we consider this treatment- 

based approach to deal with multiple organic contaminants. 
I am glad to provide you with this summary information of what 

New Jersey has and continues to do in this area. If you would 

like additional information about any of these projects, please 

contact Eileen Murphy at 609-984-6070, Director of Science, 

Research and Technology or Michele Putnam, Director of Water 

Supply at 609-292-5550. 

Sincerely, 

Lisa P. Jackson 

Commissioner 

Enclosed: Summary of Projects -Unregulated Contaminants in 

Drinking Water 

Summary of Projects 

Unregulated Contaminants in Drinking Water 

Completed Projects 

Studies conducted cooperatively with the New Jersey Department 

of Environmental Protection (NJDEP) with the Environmental and 

Occupational Health Sciences Institute (EOHSI) of New Jersey and 

the United States Geological Survey (USGS) with the federal 

Centers for Disease Control and Prevention (CDC) have shown 

that water samples analyzed by advanced analytical methods 

contain low levels of household (including pharmaceutical), 

commercial, and industrial compounds. The studies show that 

while the number of unregulated organic contaminants is highest 

for raw waters (i.e., rivers, ground water), many of these 

chemicals are not removed by current conventional water 

treatment technologies. 

* NJDEP-DSRT/EOHSI "TIC" study: 

NJDEP worked with analytical chemists at the EOHSI to analyze 

raw and finished drinking water for the presence of synthetic 

organic contaminants, indicated as Tentatively Identified 
Compounds (TICs). The study, which focused on ground water 

systems near hazardous waste sites, showed that both raw and 

finished drinking water at vulnerable areas contain a number of 

TICs at low levels (at or below one part per billion). Over the 

course of the 4-year study, approximately 600 tentatively 

identified organic compounds were detected in 199 water samples 

collected (including five bottled waters that are sold in 

New Jersey). Follow-up research with EOHSI and the School of 

Public Health at the University of Medicine and Dentistry 

of New Jersey show that there is little to no information on 

toxic effects for most of the chemicals detected in the 

previous study. 

* UMDNJ/NJDEP-DSRT/USGS/CDC cooperative project: 

NJDEP/USGS cooperative: The Passaic Valley Water Commission's 

Little Falls Water - Treatment (LFWT) plant is located in the 

heavily populated, highly urbanized Passaic River drainage 

basin which includes more than 50 wastewater facilities that 

discharge effluent to the two streams from which the LFWT plant 

withdraws its raw-water supplies. Forty-five wastewater related 

organic chemicals were detected in samples of source water and 

34 were detected in samples of settled sludge and (or) filter- 

backwash sediments. The number of wastewater compounds 

increased during conditions of low flow in the river. The 

average percent removal of these was 53% of the chemicals 

removed by granular activated carbon filtration; 32% removed by 

disinfection; and 15% by clarification. 

Projects Underway: 

* Settlement of Environmental Penalty (SEP) with New Jersey 

American Water Company (NJAWC) 

The primary objectives of this study are to document the 

occurrence and concentration of synthetic organic contaminants 

in raw and finished water supplies from New Jersey American 

Water Company's water treatment facilities that are supplied by 

surface waters and to identify the primary physical and 

chemical processes that govern the fate of synthetic organic 

contaminants through select water treatment facilities. 

Specific objectives are to: 
1. determine the occurrence and concentration of synthetic 

organic contaminants in coupled raw-and finished-water samples 

from four NJAWC water treatment facilities that are supplied by 

surface waters; and 

2. at a select water treatment facility, identify the physical 

and (or) chemical unit processes by which synthetic organic 

contaminants are most effectively removed from raw-water 

supplies, assess sludge from sedimentation tanks and activated 

carbon from filter systems as potential sinks for the removal 

of synthetic organic contaminants from source waters, identify 

the synthetic organic contaminants that persist through water 

treatment and determine their occurrence and concentrations at 

select locations throughout the distribution system. 

* Demonstration Projects: 

Based on a literature review prepared for NJDEP by Black & 

Veatch, it was determined that the best available technology 

for removing a broad number of synthetic organic chemicals from 

New Jersey ground water was activated carbon. 

The two ground water candidate systems that have been evaluated 

for contamination are the Fairlawn (Bergen County) and 

Merchantville/Pennsauken (Camden County) systems. They were 

selected because they both contained high numbers of 

unregulated synthetic contaminants in raw-water when they were 

sampled in previous studies. 

Granular activated carbon (GAC) units are being constructed at 

both of these utilities. A report funded by NJDEP and conducted 

by Black & Veatch indicates that GAC is the most practical and 

effective treatment technology for removal of classes of 

synthetic organic chemicals from ground water. A fundamental 

issue that these demonstration projects will address is how to 

measure effectiveness of removal for the unregulated 

contaminants. If a treatment approach regulatory strategy is 

adopted, it is important to know how to monitor removal 
efficiency of the treatment. 

* Tailored Collaboration : 

NJDEP is collaborating with Black & Veatch Consultants and with 

several water utilities throughout the state (including Passaic 

Valley) to conduct comprehensive studies on the occurrence and 

removal of unregulated contaminants, including nanomaterials, 

in drinking water. A proposal has been submitted to the 

American Water Works Association Research Foundation for 

funding consideration. It is anticipated that at least six 

surface water utilities will participate and possibly several 

groundwater systems. 

* DEP Response: 

* Development of a "treatment-based" MCL for synthetic organic 

contaminants. 

* Begin a literature review for treatment of wastewater 

treatment plants similar to the one done for drinking water 

plants. This would represent the first step in determining 

how/if wastewater plants can address the persistence of these 

chemicals throughout the existing treatment. 

CS Title: 0154 

Company/group/association name: 

Comment: 

May 21, 2008 

Mr. Benjamin H. Grumbles, Assistant Administrator 

Office of Water 

U.S. Environmental Protection Agency 

Washington, DC 20460 

Dear Mr. Grumbles: 

This is in response to your letter of March 28, 2008, 

requesting information on the State of Delaware's activity in 

investigating "emerging" contaminants of concern. 
One of the main contaminant initiatives of the Delaware 

Department of Natural Resources and Environmental Control 

(DNREC) was the collection of data on polybrominated diphenyl 

ethers (PBDE) as a part of a toxics in biota monitoring 

program. This is due to its long-known widespread occurrence in 

the Delaware basin. DNREC analyzed PBDEs in 80 fish and 

shellfish samples collected over the period between fall 2003 

through fall 2005 and in 33 additional samples during the 2006 

monitoring cycle. However, only a fraction of the samples were 

collected from the main-stem tidal Delaware River. Several 

samples were collected from the Delaware Bay or tributaries 

that flow into the Delaware Bay. The results of the project 

were presented on July 23, 2007, at the National Forum on 

Contaminants in Fish, in Portland, ME (Greene, R. 2007. 

Polybrominated Diphenyl Ethers (PBDEs) in Fish from the Delaware 

River Drainage Basin). In summary the study showed that while 

fish species in the Delaware Estuary have comparatively high 

concentrations of PBDE compared to other waters, nationally and 

globally, the human health risks from consumption of this 

specific compound appear to be very low. 

The Delaware River Basin Commission conducted studies (noted 

below) at regional levels and included substantial samplings in 

the main-stem tidal Delaware River, along with various sampling 

localities in the Delaware portion. Sampled were a wide variety 

of pharmaceuticals (prescription and non-prescription drugs, 

steroids, and antibiotics) and assorted industrial and 

household wastewater constituents. 

MacGillivray, AR. 2008. Monitoring Emerging Contaminants in the 

Tidal Delaware River. Presented February 20, 2008, Delaware 

River Basin Commission's Ambient Toxicity Workgroup, West 

Trenton, NJ. 

MacGillivray, AR. 2007. Emerging Contaminants of Concern in the 

Delaware River Basin, Vulnerability Assessment Preliminary 

Report. Delaware River Basin Commission, West Trenton, NJ. 

The sampling done for the above studies will be repeated later 
this year. 

Currently the United States Geological Survey (USGS) is 

conducting an ongoing statewide survey in cooperation with the 

Pennsylvania Department of Environmental Protection to 

investigate primarily pharmaceuticals, antibiotics, and 

hormones in their surface waters and ground water. Delaware 

requested, and the project sponsors agreed, to augment their 

sampling network to include the upper Brandywine Creek because 

it is the headwater for the City of Wilmington's water supply. 

The USGS began sampling in 2007 and plans to conduct quarterly 

sampling at all locations for a total of five years. 

The completed and ongoing studies, similar to many others 

conducted across the nation, revealed a widespread occurrence 

of numerous species in ground water, surface water, and aquatic 

organisms. Again, similar to findings elsewhere, the 

concentrations of the contaminants are exceedingly low-below all 

thresholds of known human health effects - with concentration 

typically in the parts per trillion range. 

Delaware also is preparing to do statewide sampling of the 

shallow ground water and all surface water intakes used for 

public water supply in the state. This is an extension of a 

similar study targeted at public water supply sources at 

potential risk due to proximity to known contaminant sources 

conducted several years ago. The work is being conducted by 

the Division of Public Health and funded by the Delaware Cancer 

Consortium. This study was primarily focused on volatile 

organics and will include two radionuclides. It did not 

originally include "emerging" contaminants; however, due to the 

latter being the recent object of national and local media 

attention, a select set of compounds is included for sampling. 

This list was provided to the Region III Office of Drinking 

Water and is attached for your reference. Approximately two 

hundred samples will be collected statewide and will be 

conducted in late May and June 2008. The findings will be made 

public online. 

Delaware has taken steps that will help reduce "emerging" 
contaminants into our surface waters and aquifers. Our main 

approach is to encourage land-based reuse and recycling 

alternatives for wastewater management, as opposed to direct 

surface water discharges. Delaware encourages municipalities 

and wastewater utilities to reuse and recycle highly treated 

wastewater for irrigation purposes. 

It bears mentioning that Delaware has not issued any new 

National Pollutant Discharge Elimination System (NPDES) permits 

in over 15 years; and in order to comply with Total Maximum 

Daily Load (TMDL) regulations issued for almost every watershed 

in the state, DNREC has capped the loading limit of many NPDES 

facilities. We require them to seek land-based wastewater 

management alternatives if they plan to increase their nutrient 

load. 

Furthermore, Delaware eliminated five NPDES dischargers in the 

Inland Bays basin and two more currently are reviewing 

alternatives in order to eliminate their discharges. 

Delaware finds that land application of highly treated 

wastewater provides additional barriers and hostile pathways 

that reduce overall pollutant loads to the environment and will 

do likewise for "emerging" comtaminants. Delaware will 

continue to stress the environmental benefits ofreusing and 

recycling treated wastewater. 

Other action to reduce this contaminant stream is handled by 

the Solid and Hazardous Waste Management Branch (SHWMB). SHWMB 

provides case-by-case advice for the proper disposal of 

pharmaceuticals and personal care products. Our pollution 

prevention program is co-sponsoring a collection drive for 

unused drugs with the Delaware Nursing Association. One recent 

drive resulted in the collection and eventual destruction of 

46,000 prescription pills. Three more statewide drives are 

planned for this year. The Delaware Solid Waste Authority 

offers regular household hazardous waste collection events 

throughout the State where unwanted pharmaceuticals and 

personal care products are accepted. 
In addition, you requested comment on the EPA's draft 

contaminant candidate list (CCL 3) dated February 21, 2009 

(73 FR9628-54). I understand that only one of the candidates 

labeled as emerging is included on the list. This seems to 

indicate that EPA is moving with proper prudence. Since the 

Division of Public Health, Office of Drinking Water, is the 

primacy agency for the Safe Drinking Water Act in Delaware, I 

wish to defer specific comment on the CCL 3 to that agency. 

Much research remains to be conducted in this area to determine 

potential human health and ecological effects. While we may 

have limited understanding and an absence of regulations, that 

is not an excuse to avoid reducing the release of these 

compounds into the environment whenever possible. This only 

can reduce the possibility of risks in the future. Therefore, 

Delaware remains committed to continuing our efforts in this 

area of concern. 

I appreciate the opportunity to share information on Delaware's 

activities. Please contact me if you have any questions or 

wish to discuss this further. 

John A. Hughes 

Secretary 

Enclosure -contaminant list 

cc: Jamie Rivera, M.D. 

Katherine Bunting-Howarth 

Study of Source Water for Potential Carcinogens in Delaware 

Delaware Cancer Consortium Project 

Water Supply Survey 

May -June 2008 
List of "Emerging" Contaminants Detection Limit [See PDF] 

CS Title: 0155 

Company/group/association name: 

Comment: 

MAY 27 2008 

Mr. Benjamin H. Grumbles 

Assistant Administrator 

United States Environmental Protection Agency 

Ariel Rios Building 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20460 

Dear Mr. Grumbles: 

Thank you for your letter regarding pharmaceuticals in water 

and drinking water. I share your commitment to addressing this 

important issue through a collaborative approach that makes the 

most of the collective state and federal resources that can be 

brought together to assure that the citizens of New York State 

share a toxic-free future. In support of that commitment and in 

response to your request, I offer the following information on 

DEC's activities related to pharmaceuticals, as well as 

feedback on EPA's activities regarding these substances. 

DEC Activities 

DEC recognizes that pharmaceuticals and personal care products 

(PPCPs) in the water is a multifaceted issue with no single 

solution. Sources include unused drugs flushed by individuals 

and institutions, the discharge of pharmaceutical waste from 

drug manufacturers, and the passage of used pharmaceuticals 

through human bodies. Wastewater treatment plants (WWTPs) are 

not designed to remove these drugs, so treatment of municipal 

and industrial discharge is not the entire answer. DEC has 

established an internal Pharmaceuticals Work Group that 

includes staff from our Divisions of Water, Solid and Hazardous 

Materials, Pollution Prevention, Public Affairs and Policy 

Office. The group has initially focused on reducing the 

disposal of unused pharmaceuticals into the waters of New York 
State. This work group assures that the multiple programs that 

have a role in addressing this issue are coordinated and in 

constant communication. 

The work group's initial aim is to achieve a major reduction in 

the flushing of unused pharmaceuticals by individuals and 

institutions. To that end, DEC hosted a roundtable discussion 

in Albany on May 15, 2008. The purpose of the roundtable was 

to convene stakeholders to discuss management options for 

unused pharmaceuticals so that consumers can avoid flushing and 

ensure unused products are safely managed. I am pleased that 

EPA accepted our invitation to participate in these discussions 

and I look forward to the Agency's input. 

DEC is also participating in a newly formed pharmaceuticals- 

related work group sponsored by the New England Interstate 

Water Pollution Control Commission (NEIWPCC) that will be 

fostering interstate communication and collaboration in 

addressing a variety of issues associated with pharmaceuticals 

in the environment. Last year, DEC staff worked with NEIWPCC to 

plan the "2007 Northeast Water Science Forum Pharmaceuticals 

and Personal Care Products: State of the Science" in Portland, 

Maine. 

DEC is working closely with the U.S . Geological Survey (USGS) 

and New York State Department of Health on the monitoring of 

the New York City water supply watershed (NYC Watershed) for 

pharmaceuticals. Since 2003 USGS, in cooperation with DEC, has 

been conducting a study of the occurrence of trace organic 

compounds, including pharmaceuticals in the NYC Watershed. Much 

of the USGS effort in monitoring for trace organic compounds, 

including pharmaceuticals, has focused on assessing the 

effectiveness of wastewater treatment plant processes on the 

removal of these compounds. Sampling of these compounds has 

expanded in the last few years to include critical locations in 

the water supply system and source waters within the New York 

City reservoir system and tributary streams. As expected, the 

levels identified were a function of effluent concentration and 

proportion of discharge to stream flow. DEC is committed to 

continuing to work with USGS in this endeavor. Future work with 

USGS will assess the fate of these compounds in the aquatic 
environment as well as the effectiveness of various treatment 

technologies. 

In addition to our internal activities, DEC will work closely 

with our Legislature on any bills associated with PPCPs in the 

environment and drinking water. To date, a product stewardship 

bill has been introduced. 

DEC is also participating in the Product Stewardship 

Institute's (PSI) pharmaceuticals initiative. PSI works with 

federal, state, local government agencies, manufacturers, 

retailers, environmental groups, and other stakeholders to 

reduce the health and environmental impacts of consumer 

products. The PSI pharmaceuticals initiative seeks to evaluate 

the need and opportunities for a nationally coordinated system 

for the management of unwanted pharmaceuticals. Through this 

process, we hope to work with other states and stakeholders to 

develop a viable return system for unused pharmaceuticals. 

EPA Activities 

The Toxic Substances Control Act appears to have been wholly 

ineffective at preventing occurrences of these chemicals in our 

nation's waters. Consequently, the nation is once again on 

track to repeat history - chasing after chemicals that have 

been already discharged for several decades. It appears that 

the Contaminant Candidate List process, required by Section 

1412(b) (1) of SDWA, as amended in 1996, requires both 

information on the adverse effects of a chemical as well as 

indications that it is found at levels of concern in drinking 

water before EPA will take action to regulate it. DEC believes 

that EPA should take a more proactive and precautionary 

approach toward limiting the levels of contaminants that enter 

into sources of drinking water by determining effects and 

setting standards before the waters of the nation become 

contaminated. 

Most states, including New York, do not have the resources to 

derive ambient water quality criteria for more than a small 

handful of contaminants of concern and EPA has moved at a less 
than satisfactory pace on publishing new and revised criteria. 

Most of EPA's Ambient Water Quality Criteria date from around 

1980. The Department urges EPA to significantly increase and 

expedite efforts to derive new and revised criteria, including 

criteria for pharmaceuticals and personal care products. 

One of the biggest impediments to reducing the loading of unused 

drugs is the regulations of the federal Drug Enforcement 

Administration (DEA). The DEA does not permit consumers to 

return unused controlled substances to the point of sale 

(pharmacy) or to other third parties. This has made it 

extremely difficult and, in some cases impossible, for many 

states and local governments to implement a viable drug return 

program. The ideal return program needs to be simple, 

convenient for the consumer, and economical. EPA should work 

expeditiously with DEA and the White House Office of National 

Drug Control Policy to facilitate DEA revision of its 

regulations to allow properly supervised collection programs to 

move forward. 

New York and other states across the country are looking to EPA 

to provide guidance on treatment methods that are effective at 

removing such chemicals from both wastewater and drinking 

water. This guidance can then be used by the states as they 

implement their wastewater and drinking water programs. 

I would appreciate a detailed summary of each state's reply to 

your letter. I thank you for your time and attention regarding 

this important matter and look forward to working together to 

address it. 

Sincerely, 

Alexander B. Grannis 

CS Title: 0156 

Company/group/association name: 

Comment: 

May 6, 2008 
Mr. Benjamin H. Grumbles 

U.S. EPA Headquarters 

Ariel Rios Building 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460 

Dear Mr. Grumbles: 

Thank you for your letter requesting to share information on 

state activities and initiatives concerning pharmaceuticals in 

water. Pennsylvania has been involved in emerging contaminant 

research since 2006. Our primary concerns and comments include 

the following three areas: 

First, in February 2007, the U.S. Environmental Protection 

Agency (EPA), the White House Office of National Drug Control 

Policy, and the Department of Health and Human Services jointly 

released guidelines covering the safe disposal practices of 

unused pharmaceuticals. However, the guidelines still encourage 

the flushing of controlled substances into our nation's waters. 

We understand the concern associated with the diversion of 

controlled substances, but we encourage the creation of a 

national pharmaceutical take-back program that permits the 

collection of all substances, therefore eliminating the 

practice of flushing completely. 

The Pennsylvania Department of Environmental Protection (DEP), 

Bureau of Waste Management, is planning to initiate one-day 

pharmaceutical collections through county recycling 

coordinators. DEP bureau staffs have encountered roadblocks 

during the initial collection event scheduled this summer. In 

order to hold such an event, the Bureau of Waste Management 

requires the presence of a pharmacist to sort controlled and 

non-controlled returned pharmaceuticals. The federal Drug 

Enforcement Agency's regulations prohibit anyone, except law 

nforcement, from handling the collection or transportation of 

these substances. Consequently, law enforcement officials will 

need to accept all controlled substances. Additionally, a 

licensed hazardous waste hauler is required to transport the 

non-controlled material to a licensed hazardous waste 

incinerator. This will require identification and 
transportation to incinerators outside the state. Presently, 

there are no licensed hazardous waste incinerators in 

Pennsylvania. 

Second, DEP requests the addition of the following compounds to 

EPA's Contaminant Candidate List 3 for the following reasons: 

* Estrone - hormone effects on aquatic organisms 

* 17 alpha estradiol - hormone effects on aquatic organisms 

[Second, DEP requests the addition of the following compounds to EPA's Contaminant Candidate List 3 for the following reas

* Carbamazepine - most frequently detected pharmaceutical in 

numerous studies as well as Pennsylvania's; appears resistant 

to treatment removal technologies and tends not to break down 

in the environment 

* Sulfamethoxazole - most frequently detected antibiotic; 

possible concerns with antibiotic resistance 

* Azithromycin -leading antibiotic prescribed to humans; 

possible concerns with antibiotic resistance 

The health effects information from the Food and Drug 

Administration database on Maximum Recommended Daily Doses 

(MRDD) is derived based on the effects of single compounds. In 

reality, these compounds exist as mixtures in the environment. 

EPA should address the cumulative and synergistic effects 

of these compounds as well. 

Finally, concerning Pennsylvania's research, in 2006, DEP 

entered into a cooperative agreement with the U.S. Geological 

Survey (USGS) to conduct a reconnaissance study to screen for 

pharmaceuticals and antibiotic compounds in surface and well 

waters in southcentral Pennsylvania. The study does not 

represent typical surface waters across the state because it 

targeted effluent-dominated streams. 

* Sampling for pharmaceutical and antibiotics has occurred at 

the following number of locations: 

6 - Groundwater 
6 - Intensive agricultural areas 

5 - Wastewater treatment plants 

* Samples were collected upstream and downstream of the 

agricultural and wastewater sites. 

* Samples were collected each quarter to determine if seasonal 

variation was evident. A total of 120 water samples were 

analyzed in Phase I. 

* Samples were analyzed for 15 pharmaceutical and 31 antibiotic 

compounds. In the stream samples, 13 pharmaceuticals and 11 

antibiotics were detected at least one time. For additional 

details, please refer to the published data series, dated 

September 2007, at http://pubs.water.usgs.gov/ds300/. 

To build on the first study, DEP entered into a three year 

cooperative agreement with the USGS titled Characterization of 

Emerging Contaminants and Fish Health in Pennsylvania Surface 

Waters. Samples will be collected and analyzed for antibiotics, 

pharmaceuticals, hormones, pathogens (Cryptosporidium), 

and bacteria (E.coli & Enterococcus). 

The sites identified in our previous study, which are located 

downstream from wastewater treatment plants, will undergo 

ongoing sampling for three additional years. We have expanded 

the study to include both water and bed sediment samples. Also, 

the study will include hormones and organic wastewater 

compounds in addition to analyzing for pharmaceutical and 

antibiotic compounds. A final report is anticipated in 2010. We 

are only beginning to receive provisional data from last year's 

analyses and will be happy to share future data as it becomes 

available. 

Should you require additional information, please contact me or 

Deputy Secretary Cathy Myers by telephone at 717-787-4686. 

 

Sincerely, 

Kathleen A. McGinty 
Secretary 

CS Title: 0157 

Company/group/association name: 

Comment: 

April 30, 2008 

Mr. Benjamin H. Grumbles 

Assistant Administrator 

United States Environmental Protection Agency 

Washington, D.C. 20460 

Dear Mr. Grumbles: 

Thank you for the opportunity to discuss Minnesota's efforts in 

monitoring the occurrence of pharmaceuticals and personal care 

products in the environment. 

As you know, the U.S . Geological Survey (USGS) published its 

national reconnaissance of organic wastewater compounds, which 

included select pharmaceuticals, in 2002. This was followed by 

a similar study in Minnesota, published by USGS in 2004 (Lee et 

al), that focused not only on the presence of these compounds 

in surface water, but also in ground water in the proximity of 

landfills. In response to the concerns raised by these studies, 

Minnesota initiated several efforts to help us better 

understand the extent to which these chemicals are present in 

Minnesota's environment. 

Specifically, the Minnesota Pollution Control Agency (MPCA) is 

planning the following monitoring programs to analyze 

pharmaceuticals and personal care products in surface water and 

sediments in lakes and streams throughout the state: 

* Endocrine Disruptor Statewide Monitoring Study - MPCA, in 

cooperation with the USGS and Dr. Heiko Schoenfuss of St. Cloud 

State University, will collect and analyze surface water and 

sediments from lakes and streams throughout Minnesota for a 

suite of pharmaceuticals and personal care products. Sampling 
will take place in summer 2008. 

* EPA National River Survey - MPCA will sample and analyze 

ambient surface water from 50 streams throughout the state for 

the antidepressant selective seratonin reuptake inhibitors and 

a suite of personal care products as part of EPA's National 

River Survey. Sampling will take place in summer 2009. 

These studies will provide valuable data regarding the 

occurrence and distribution of pharmaceuticals in ambient 

surface waters and sediments in Minnesota. 

The EPA has many opportunities to help improve National, 

Tribal, and State responses to pharmaceuticals and personal 

care products in the environment, with improving communication 

and partnerships being key. Our partnership with the USGS's 

Toxics Substances Hydrology Program is benefiting national as 

well as local efforts to determine occurrence and presence of 

organic wastewater compounds and pharmaceuticals and personal 

care products by building on their datasets. 

There are several ways EPA could improve its efforts in the 

area of pharmaceutical monitoring. First, the national lake and 

flowing rivers surveys that began in 2007 should include 

pharmaceutical monitoring as a component of these studies. 

Second, EPA should actively foster collaborative studies with 

state programs through its Office of Research and Development 

(ORD) Laboratories. 

There are several lines of inquiry that states cannot assume 

due to financial constraints or lack of technical expertise. 

EPA ORD is uniquely positioned to undertake studies that would 

assist states in answering questions about the presence, 

effect, and fate of pharmaceuticals in the surface water, 

ground water, and soil environments. Third, more work is needed 

on the transformation of pharmaceuticals in wastewater 

treatment, data critical to examining various treatment 

options. Fourth, EPA should begin to explore, in coordination 

with state programs, effective methods for intercepting 
pharmaceuticals before they enter the waste stream. 

In addition, through programs such as the Contaminant Candidate 

List (CCL), data on pharmaceutical and personal care product 

use, occurrence, and fate can be combined, either through 

monitoring results or models to determine which compounds are 

the most persistent and toxic. This would allow EPA to focus 

monitoring and stewardship efforts. These data would also 

support the FDA's reviews of environmental impacts 

of pharmaceuticals and enhance green pharmacy initiatives. 

Many high production volume compounds are used in personal care 

products and other commercial products. More information is 

needed on product sources to help determine loadings from point 

versus non-point sources. Addressing pharmaceuticals and 

personal care products at wastewater treatment plants may focus 

on what may actually be a minor conduit to the environment. 

The CCL3 process should continue to evaluate any chemicals that 

may have been omitted from the process based on gaps in the 

data sources used and clearly define those groups of chemicals. 

A few personal care products that were not in the preliminary 

CCL that may have been expected were: polycyclic musk 

fragrances, mainly 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8- 

hexamethylcyclopenta(g)-2- benzopyran (HHCB) and 7- 

acetyl-1,1,3,4,4,6-hexamethyltetrahydronaphthalene (AHTN), 

triclosan, bisphenol A, and nonylphenol. These compounds are 

persistent, high production, and detected in surface waters 

based on USGS studies (http://toxics.usgs.gov/regional/emc/index.html). 

The CCL3 process, in cooperation with USGS, should re-consider 

any pharmaceuticals and personal care products eliminated 

during the initial evaluation for possible inclusion in the 

next Unregulated Contaminants Monitoring round. 

Please note that MPCA is not the lead state agency for the Safe 

Drinking Water Act; the Minnesota Department of Health serves 

this role. However, MPCA's Water Quality Standards include 

Maximum Contaminant Levels in Minnesota's water quality rules, 

giving the MPCA a lead role in tracking this program. 
Thank you again for the opportunity to comment on these 

important issues. Please feel free to contact us if you have 

any questions or would like further information. 

Sincerely, 

Brad Moore 

Commissioner 

BM:cmbg 

 

CS Title: 0158 

Company/group/association name: 

Comment: 

May 21, 2008 

Mr. Benjamin Grumbles 

Assistant Administrator 

Office of Water 

United States Environmental Protection Agency 

Washington, D.C. 20460 

Dear Mr. Grumbles: 

Re: Pharmaceuticals 

Thank you for your March 28, 2008, letter to Commissioner of 

Health Richard F. Daines, M.D. requesting information about New 

York State Department of Health actions concerning 

pharmaceuticals in ground, surface, and drinking water. We have 

been aware of the potential for contamination of source water 

and possibly drinking water supplies by pharmaceuticals and 

personal care products (PPCPs) and are continuing to evaluate 

the information as it becomes available for potential adverse 

health outcomes. 

In cooperation with the New York City Department of 
Environmental Protection, the New York State Department of 

Environmental Conservation (DEC) and funds from the Safe 

Drinking Water Act, we analyzed the effluent of four wastewater 

treatment plants (WWTPs) that discharge into NYC's Watershed 

for PPCPs. We also analyzed water samples collected downstream 

of these discharges at the entrance and exit of selected 

reservoirs. This sampling was conducted in 2003 and 2004, with 

a final report (shared with your Region 2, EPA) published in 

June 2006 and in Science of the Total Environment, Vol. 394, 

pages 90-102. 

This survey detected some pharmaceuticals in the WWTP effluent 

discharging into the NYC Watershed, but at concentrations much 

lower than therapeutic doses. Only a very small percentage of 

the samples collected downstream of the discharges contained 

detectable levels of pharmaceuticals. These detections and most 

f the detections in the WWTP effluent were observed in part 

per trillion concentrations. Further study is needed to better 

characterize potential site-specific drinking water issues and 

aquatic effects. 

In 2006, the Department provided significant comments on the 

"universe" of chemicals under consideration for the EPA's 

Contaminant Candidate List (CCL). PPCPs should be included in 

the CCL universe, and we are pleased to see that was 

accomplished. The attachment to your letter describes that only 

one pharmaceutical, nitroglycerin, was selected from the CCL3 

universe to the draft list. We believe the screening criteria 

for selecting chemicals to a CCL is appropriate and we have 

provided more comments on the draft CCL3. 

With respect to further monitoring, it is not our intent to 

initiate universal monitoring at pubiic water systems in NYS. 

We are considering, however, the possibility of sampling 

targeted systems to further explore the extent and level of 

PPCPs in drinking water sources. We will keep your agency 

informed of our progress. 

In conjunction with DEC, we co-sponsored a "roundtable" 

discussion held on May 15, 2008 among various experts and 
stakeholders to generate ideas on disposal of unused medicines. 

These ideas may help to reduce the potential amount 

of pharmaceuticals entering our water resources. 

In summary, we appreciate the EPA's interest pertaining to 

pharmaceuticals and our drinking water, surface water, and 

ground water. EPA, in collaboration with other scientific and 

drinking water organizations, should continually evaluate the 

need for additional information to understand and, if needed, 

to take action to mitigate any potential impacts. We also 

recognize the importance to understand and address any 

potential ecologic effects of these PPCPs. We will continue to 

investigate funding opportunities for research and monitoring, 

and work collaboratively with federal and state agencies on 

specific issues such as the disposal of unused medicines. 

f you have any questions, please feel free to contact me at 

518 402-7650. 

Sincerely, 

Victor E. Pisani 

Director 

Bureau of Water Supply Protection 

Center for Environmental Health 

cc: N. Kim, Ph.D. 

R. Svenson, P.E. 

J. Dunn, P.E . 

L . Wilson, Ph.D . 

P. Palmer 

ECU #2008098.39527 

 

CS Title: 0159 

Company/group/association name: 

Comment: 

May 12, 2008 

Mr. Ben Grumbles 
Assistant Administrator 

United States Environmental Protection Agency 

Washington, DC 20460 

Dear Mr. Grumbles: 

Thank you for your inquiry regarding Tennessee's thoughts about 

waste pharmaceuticals and personal care products (PPCPs) in 

water. Tennessee is aware of reports indicating that these 

contaminants are found in many of this nation's streams and 

that some researchers have reported adverse effects on aquatic 

biota. We share EPA's concern about this issue. 

While we understand that some PPCP research has taken place in 

Tennessee, we currently lack the resources and laboratory 

capabilities to undertake any systematic study of this issue. 

Staff at our state laboratory tell us that significant 

purchases of equipment would be needed to quantify these 

materials in environmental samples and that the reliability of 

analytical methods have not been fully established. We would be 

interested in undertaking some limited sampling of ambient 

waters and could possibly contract with university laboratories 

to begin gathering data on PPCP occurrence and concentration 

However, with Tennessee's current budgetary restraints, this is 

not a certainty. 

We certainly agree that proper disposal of discarded 

contaminants is a necessary component of an overall strategy to 

minimize their entry to streams, and we're working with other 

state agencies and our cities to help educational efforts on 

the subject. 

Regarding the candidate contaminant list, perhaps like other 

commenters, we were surprised that the only pharmaceutical EPA 

listed was nitroglycerine. However, we understand that EPA will 

continue to refine its screening process based on comments 

received from those doing primary research into PPCPs. We will 

continue to be interested in the results of this process. 

Again, thank you for EPA's leadership in the area of detection, 
removal, and prevention of PPCPs and your willingness to share 

information. As always, we look forward to continuing our 

partnership to develop clean water goals and to protect human 

health and the aquatic ecosystem. 

Should you have any questions or wish to discuss this matter 

further, please feel free to call me at 615-532-0102 or Mr. 

Robert Foster at 615-532-0155. 

Sincerely, 

Paul L. Sloan 

Deputy Commissioner 

PLS:cm 

 

CS Title: 0160 

Company/group/association name: 

Comment: 

May 5, 2008 

Mr. Benjamin H. Grumbles 

Assistant Administrator 

United States EPA 

Washington, D.C. 20460 

Subject: Pharmaceutical and Personal Care Products in 

groundwater and surface water 

Dear Mr Grumbles (Ben): 

Thank you for your letter outlining EPA's plans for addressing 

pharmaceutical and personal care products (PPCPs). The State of 

Montana Department of Environmental Quality (DEQ) also has 

concerns about the growing national issue of PPCPs being found 

in the nation's waters. That is why the DEQ is participating in 

a multi-disciplinary task force of state agencies that is 

looking at the various issues and how we can respond. We are 

also cooperating with other entities, such as the US Geological 

Survey and the Bureau of Mines and Geology that are either 

planning or looking at performing additional studies in 
Montana. 

The task force has drafted a fact sheet/guidance document that 

is to be released to the public when it is completed. The 

purpose is to provide factual information about the emerging 

issue of PPCPs in water. It is our goal to keep concerned 

citizens informed so that they can make reasonable decisions 

about protecting their health. In addition, the task force 

will work to coordinate efforts to identify any viable PCPP 

disposal solutions in Montana. 

The DEQ will be participating and cooperating with PPCP studies 

as much as resources allow. One such study was performed in the 

Helena valley and published by the Montana Bureau of Mines and 

Geology at the University of Montana, Montana Tech in Butte, 

Montana. For more information on this study please contact: 

Montana Bureaus of Mines and Geology 

MT Tech 

1300 West Park Street 

Butte, Montana 59701-8997 

Telephone: 406/496-4167 

E-mail: pubsales@mtech.edu 

We believe that much more research and analysis of this issue 

is needed and we support the incorporation of PPCPs into the 

EPA's Contaminate Candidate List. Regulation of contaminates 

such as PPCPs needs to come from sound scientific research and 

not knee-jerk reactions to public perceptions. 

I thank you for contacting us and providing the opportunity to 

relay what activities the EPA is pursuing in relation to this 

troubling issue. If you have any questions, please feel free to 

contact me. 

Sincerely, 

Richard H: Opper 
Director 

c: John Warrdell, US EPA Region 8 Montana Office, Federal 

Office Building, 10 West 15 St., Suite 3200, Helena, MT 59626 

 

CS Title: 0161 

Company/group/association name: 

Comment: 

May 21, 2008 

Mr. Benjamin H. Grumbles, Assistant Administrator 

Office of Water 

United States Environmental Protection Agency 

Ariel Rios Building 

1200 Pennsylvania Avenue, NW 

Washington, D.C. 20460 

Dear Mr. Grumbles: 

Thank you for your March 28, 2008 letter regarding 

pharmaceuticals and personal care products (PPCP) in water and 

drinking water and requesting comments on how to address 

control matters. Illinois is receiving many of the same 

questions as USEPA regarding human health effects. To address 

these questions and other associated issues, USEPA should 

initiate data collection, research and information exchange on 

the presence, impacts and treatability of PPCP. At the same 

time, USEPA needs to join with states, water utilities and 

associations and agricultural interests to initiate steps that 

will reduce levels of pharmaceuticals in waters. 

This joint pollution prevention effort will need to be fueled 

by up-to-date information that can be widely distributed and 

understood by the general public. Informational brochures and 

possibly other outreach tools are needed that describe the 

health effects that are now known about trace levels of the 

drugs and what plans are being made to resolve problems. 

Outreach efforts should be led by programs to remove unused 

drugs from wherever they are kept (focusing especially on 

health care facilities), to disposal sites that will destroy or 

keep the PPCPs from reentering the environment. This needs to 
be coupled with a program discouraging the flushing of drugs. 

USEPA will need to interact with other federal agencies in 

making sure that laws and regulations are not being violated or 

modifications will be made to assist with the removal program. 

This initial step will need to be followed by longer term 

programs that will take some time to develop and evolve into 

operational programs. 

The Illinois EPA is embarking on a sampling program for 

community water systems that utilize a surface water source of 

supply. One of the major obstacles encountered in trying to 

obtain laboratory service was the lack of laboratories offering 

to perform analyses of PPCPs. Perhaps some of the USEPA 

laboratory capability can be utilized to initially assist with 

some analyses. Further, it was noted that the analytical 

methods were more of the experimental type than anything 

approaching a uniform procedure. USEPA needs to gather the 

appropriate laboratory leaders and come to some sort of interim 

agreement until such time as a consensus on and standardization 

of methods can be reached. 

Some information exists for water and wastewater treatment to 

remove PPCPs; however, more work is needed in the refinement of 

the processes to achieve optimal plant operations. Other 

treatment options need to be explored such as in-stream 

treatment; non-point control with perhaps in situ treatment; 

bio-solids and treatment residuals handling and disposal; and 

perhaps other methods that are under development. 

There appears to be an appreciable amount of information 

indicating a fairly wide-spread dispersal of PPCPs in surface 

waters; however, at some future date, groundwaters will need to 

receive the same level of attention. The existing information 

does need to be refined to determine if there is a prevalence 

of PPCPs in one region/area over another. This will allow for a 

focus on monitoring parameters in specific geographic areas and 

eventually identify predominant PPCP types. 

With the present knowledge of the levels of PPCPs in waters, 

efforts need to get underway to establish health effects levels 
based on peer reviewed research. It is understood that there is 

presently no reliable evidence that levels of PPCPs being found 

are causing adverse health effects. This will require perhaps 

the longest period of time because of the extremely dilute 

concentrations of drugs being encountered and a lack of 

understanding of how these dilute solutions might function. 

Until health effects information has been reasonably derived, 

for both individual chemicals, and for selected mixtures of 

similar-acting chemicals for additive effects, it will be 

difficult to make convincing arguments that the PPCPs need to 

be removed from drinking water. Perhaps certain cutting-edge 

procedures, such as computational toxicology and toxico- 

genomic methods, could be employed in these efforts. 

USEPA should continue to use the Contaminant Candidate List 

process because this uses a reliable, time tested method of 

research based on science that will yield risk based results 

that can be addressed with a suitable degree of certainty that 

public health protection is being provided. We recommend that 

PPCPs, as a class, be placed on the list for further 

evaluation. Similarly, the Unregulated Contaminant Monitoring 

Rule should be used to collect the data. However, because of 

the extremely high costs of the analyses, financial or other 

assistance will be needed to pay for the laboratory services. 

The cost of the analyses may drop once a large enough demand is 

established, but until the price drop occurs, financial 

assistance is needed. 

Illinois EPA appreciates the difficulties USEPA is facing at 

this time and is prepared to participate with USEPA in the 

resolution of needed program development for pharmaceuticals. 

As noted above, one of the activities the Illinois EPA is 

embarking on is a sampling program for community water systems 

that utilize a surface water source of supply. Raw and finished 

water samples will be collected and analyzed in a contract 

laboratory that has capability to detect PPCPs at the extremely 

low levels being encountered. We will be happy to share this 

information with USEPA as it becomes available. Illinois EPA is 

also including a drug collection effort as part of periodic 

hazardous waste collections made in various communities around 

the state and at four permanent hazardous waste collection 

sites. We are also developing a program to coordinate with 
county health departments in drug collection efforts. 

Illinois EPA encourages your leadership in the areas discussed. 

If you have any follow-up questions, please contact Marcia 

Willhite at (217) 782-1654. 

Very truly yours, 

Douglas P. Scott 

Director 

cc: Damon T. Arnold, M.D., M.P.H., Director 

Illinois Department of Public Health 

 

CS Title: 0162 

Company/group/association name: 

Comment: 

May 22, 2008 

Benjamin H. Grumbles 

Assistant Administrator 

U.S . EPA Headquarters 

Ariel Rios Building 

1200 Pennsylvania Ave. NW 

Washington, D.C. 20460 

Dear Mr. Grumbles: 

Thank you for your letter dated March 28, 2008 concerning 

pharmaceuticals in source water and treated drinking water. 

Your letter was addressed to Dr. Dwelle, State Health Officer, 

North Dakota Department of Health, and copied to me. You asked 

for our input on the following three issues: 1) programs ND is 

currently implementing, or planning to implement, to monitor 

for pharmaceuticals and personal care products (PPCPs) in 

surface water, ground water, or tap water; 2) how EPA 

considered pharmaceuticals within the recently-released 

(February 1, 2008) draft Contaminant Candidate List (CCL3); 

and, 3) stewardship programs ND is actively pursuing to ensure 

proper disposal of unused medications. 
The Department does not presently have a monitoring program or 

occurrence data for PPCPs. There are several non- 

Department sampling initiatives which will soon provide some 

occurrence data. In September and October of 2007, the U.S. 

Geological Survey sampled three locations on the Missouri 

River, above and below Bismarck and just above the Fort Yates 

drinking water intake. Samples (both water and sediment 

samples) are being tested for hormones, wastewater indicators, 

pharmaceuticals, and antibiotics. To date, only results for 

wastewater indicators and antibiotics are available (the 

results are all below detection limits). The results for 

hormones and pharmaceuticals are not expected until fall. In 

addition, two ND cities that utilize the Red River (and major 

tributaries) as their source of drinking water have recently 

elected to sample for PPCPs. It is our understanding that the 

sampling will include raw and treated drinking water as well as 

raw and treated wastewater. The results of this sampling are 

also not yet available. The Department may consider an expanded 

screening study based on the above results. However, in the 

absence of federal requirements, the Department does not 

envision mandating PPCP monitoring or treatment (water and/or 

wastewater) to lower PPCPs. 

EPA evaluated 284 data sources to identify potential CCL3 

candidates. EPA then applied screening criteria to identify 

candidates that should be further evaluated. The screening 

criteria, based on a contaminant's potential to occur in public 

water systems and the potential for public health concern, were 

used to narrow the candidates to a preliminary CCL3 for 

comment. This process was based on experience gained,from 

previous efforts; and recommendations from the National 

Academy of Sciences' National Research Council and the 

National Drinking Water Advisory Council. 

It appears that EPA used a transparent and science-based 

process to identify and evaluate CCL3 candidates. To the 

maximum extent possible, we encourage EPA to continue to 

consider all peer-reviewed data as well as agency-generated 

data in constructing CCLs. We also encourage EPA to fully 

consider such data in developing unregulated contaminant 
monitoring regulations. 

The 1996 SDWA Amendments specify three criteria to determine 

whether a contaminant may require regulation: the contaminant 

may have an adverse effect on the health of persons; the 

contaminant is known to occur or there is a substantial 

likelihood that the contaminant will occur in public water 

systems with a frequency and at levels of public health 

concern; and, in the sole judgement of the Administrator, 

regulation of such contaminant presents a meaningful 

opportunity for health risk reduction for persons served by 

public water systems. These criteria in combination with the 

present CCL process appear to establish a sound and science- 

based approach for decisions on regulating new contaminants in 

drinking water. 

The Department currently recommends that households dispose of 

unused medications in the solid waste stream versus wastewater 

system. This is done as one means to reduce the potential 

contribution of PPCPs into surface waters via wastewater 

discharges. 

Under a new state law effective July 1, 2007, individuals 

may return unused prescription drugs to pharmacies or clinics 

for reuse (NDCC Ch. 43-15.2, Legend Drug Donation and 

Repository Program). The law sets forth specific requirements 

for the program including conditions for acceptance, storage, 

distribution, and re-dispensing of returned drugs. According to 

the North Dakota State Board of Pharmacy, pharmacies in 25 

North Dakota cities participated by accepting and distributing 

donated drugs in 2007. It is too early to predict the long-term 

effectiveness and success of the program. However, it would 

seem that such stewardship programs have the potential to 

significantly reduce the quantity of PPCPs that ultimately end 

up in source and treated drinking waters. 

Thank you for the opportunity to provide input on this 

important public health issue. Please feel free to contact me 

if you have questions or wish to discuss this matter. My 

telephone number and email address are 701.328.5152 and 
dglatt@nd.gov, respectively. 

Sincerely, 

L. David Glatt, P.E., Chief 

Environmental Health Section 

North Dakota Department of Health 

cc: Dr. Dwelle, NDDH 

Loreetta Canton, NDDH 

Dennis Fewless, NDDH 

Wayne Kern, NDDH 

 

CS Title: 0163 

Company/group/association name: 

Comment: 

April 21, 2008 

Benjamin H. Grumbles, Assistant Administrator 

United States Environmental Protection Agency 

USEPA Headquarters 

Ariel Rios Building 

1200 Pennsylvania Avenue, N.W. 

Mail Code 4101 M 

Washington, DC 20460 

Dear Assistant Administrator Grumbles: 

 

Given our joint responsibilities for the management and 

protection of water resources, both drinking water and surface 

waters in the state, we are responding to your letter of March 

28, 2008 on behalf of Commissioner J. Robert Galvin, M.D., 

M.P.H., M.B.A and Commissioner Gina McCarthy pertaining to 

trace amounts of pharmaceuticals in surface waters and drinking 

water systems. Both of our Departments of Public Health (DPH) 

and Environmental Protection (DEP) appreciate EPA's timely 

communication on this topic and are pleased to hear more about 

the Agency's activities on this issue. 

Unlike other parts of the United States where pharmaceuticals 
have been detected in drinking water, Connecticut has a 

longstanding prohibition on the discharge of sewage into all 

Class A and AA waters, as adopted in our Water Quality 

Classifications and Standards. Class A and AA waters include 

any stream, river or lake that is tributary to a drinking water 

reservoir or water supply impoundment. Because of this unique 

prohibition, wastewater treatment discharges that could 

potentially contain trace levels of pharmaceuticals do not 

blend with Connecticut's highly protected public drinking water 

sources. Therefore, until more is known about the occurrence 

and human health effects of pharmaceuticals and personal care 

products (PPCP) in drinking water, Connecticut has no immediate 

plans to implement a testing program. 

DPH and DEP are concerned that EPA's decision to include 

nitroglycerin on the CCL3 list as the sole pharmaceutical 

compound to be monitored will not provide the meaningful data 

needed to make a reasonable assessment of PCPP occurrence in 

drinking water. To this point, we are providing more detailed 

comments about the CCL3 and the selection of nitroglycerin in 

the attached addendum. [See PDF] 

The DEP has growing concerns over the presence of PPCPs and 

related contaminants that are believed to affect aquatic life 

forms through disruption of endocrine related processes. There 

is a growing literature on indications of these potential 

effects, and research conducted in our area by the U.S. 

Geological Survey and the University of Connecticut has 

documented the presence of PPCPs in major rivers that receive 

treated sewage. 

Ongoing research at Stony Brook University on Long Island has 

begun to identify some of the physiological effects on aquatic 

life that is related to PPCPs. While DEP is not in a position 

to conduct monitoring for these effects on a continuing basis 

because of cost, analytical uncertainties, and lack of 

definitive direction on key indicator contaminants, we are 

staying updated with the latest science as opportunities permit 

through conferences and participation in work groups 

established by the New England Interstate Water Pollution 

Control Commission and ASIWPCA. DEP has also looked at 
pollution prevention options as the first line of defense as 

indicated below. We encourage you to direct more attention 

towards the aquatic life effects, as they are likely to be the 

most sensitive receptors of PPCP stressors; your letter and the 

excerpt from the Federal Register notice appeared to be 

primarily focused on human health effects. 

That said, the Departments look to the USEPA for guidance 

before requiring any pharmaceutical testing in Connecticut's 

public drinking water supplies or contributing surface waters. 

In anticipation that testing requirements may evolve as more 

data become available, the Departments are interested in 

learning more about: 

* Which specific compounds or key compound classes should be 

tested as anthropogenic markers; 

* The availability of sampling and analytical methods that 

could be reasonably expected to yield reliable data; and 

* Which laboratories across the country currently have the 

experience and capacity to test for trace amounts of PPCP's in 

drinking water, and at what cost. 

To further our knowledge and understanding of this issue, 

particularly as it relates to environmental effects in all 

waters of the state, the Departments are also interested in 

learning more about: 

* PPCP occurrence in groundwater; including their fate and 

transport; 

* The relative importance of PPCP disposal with domestic 

wastewater compared to amounts excreted, washed from people, or 

contributed via other pathways; 

* Human health and ecological effects attributable to trace 

levels of PPCP's in water and drinking water; 

* The performance of contemporary drinking water treatment 

processes relative to PPCP removal; 
* The available technologies effective in removing PPCPs from 

sewage treatment plants and subsurface disposal systems; and 

* Possible additive and/or synergistic effects of PPCPs as they 

affect both human health and aquatic life. 

Notwithstanding these information gaps, the DPH developed a 

fact sheet using available information shortly after the AP 

story broke to assist it in responding to a small number of 

inquires from concerned citizens and the media. Interestingly, 

there have been no recent citizen or media inquires about 

PPCP's in drinking water after the week of March 17th. The 

Department's fact sheet is available on the Drinking Water 

Section webpage at: 

http://www.ct.gov/dph/lib/dph/drinking_water/pdf/Pharmaceutical 

_Fact_Sheet.pdf 

Regarding Connecticut's stewardship and pollution prevention 

efforts, the DEP has been recommending for some time that 

unused prescription and over-the-counter medications be 

properly disposed of as described in the a fact sheet available 

on-line at: 

http://www.ct.gov/dep/cwp/view.asp?a=2708&q=335480&depNav_GID= 

1763 

In closing, the Departments pledge to continue working closely 

with the numerous state, interstate and federal agencies that 

are studying pharmaceuticals and personal care products in 

water and drinking water and will adopt any prudent measures 

necessary to safeguard public health and the environment as new 

information becomes available. 

Sincerely, 

Darrell B. Smith, Acting Section Chief 

Department of Public Health 

Drinking Water Section 

Betsey Wingfield, Chief 
Department of Enivronmental Protection 

Bureau of Water Protection and Land Reuse 

cc: J. Robert Galvin, M.D., M.P.H., M.B.A, DPH Commissioner DPH 

Ellen Blaschinski, Branch Chief 

Gina McCarthy, Commissioner DEP 

STATE OF CONNECTICUT

DEPARTMENT OF PUBLIC HEALTH

ADDENDUM

Connecticut's Comments Regarding the Inclusion of Nitroglycerin

within CCL3

Your letter and associated enclosure indicates that the CCL-3

process has selected nitroglycerin as the sole representative

of pharmaceutical contamination of drinking water resources in

the draft CCL-3 list. Although DPH is not totally familiar with

the CCL-3 decision-making process, the selection of only one

analyte to further explore the pharmaceuticals in drinking

water issue does not seem adequate. Moreover, nitroglycerin is

a curious choice for a number of reasons. The USGS database,

which is considered one of the largest for pharmaceuticals and

personal care products in water resources in the US, has never

sampled for nitroglycerin (D. Kolpin, USGS, personal

communication). USGS prioritized chemicals on the basis of use,

persistence, reliable analytical methodology, and where

possible, health implications. Their database indicates the

detection of 95 organic wastewater contaminants in streams

receiving wastewater discharges (Kolpin, et al. ES&T 36:

1202-1211, 2002). Regarding nitroglycerin, according to the

enclosure in your letter, this drug has release data but

apparently has not actually been detected in surface waters .

Nitroglycerin is rapidly metabolized by the human body to a

variety of nitrate metabolites that are both part of its

mechanism of pharmacologic action and eventual elimination.

Very little unchanged nitroglycerin is expected to appear in

human urine or feces (Dollery, C. Therapeutic Drugs, Churchill

Livingston Pubs, Edinburgh, 1999). Therefore, while some

information may point to the listing of nitroglycerin in the

CCL-3, it is important that additional analytes, particularly

those that are frequently detected in surface and groundwaters,

be included for consideration in the CCL-3. Broadening the list
to include different types of chemistry and life cycle may be a

wise approach. For example, the USGS database shows the

frequent appearance of lifestyle chemicals (particularly

caffeine) , antibiotics (particularly erythromycin and

trimethoprim) personal care ingredients (particularly DEET),

consumer product chemicals (particularly bis- phenol A) and a

variety of estrogenic contaminants as among the most common

constituents detected (Kolpin, et al., 2002).

Apart from the CCL3 list, a sampling program which targets

leading indicator compounds across a variety of pharmaceutical,

personal care and consumer product classes may provide the

benchmarks needed to follow trends, extrapolate to other

chemicals not specifically targeted, understand the

effectiveness of wastewater treatment options, and ultimately

project to human health and ecological risk. While it is

comforting to know that initial screens show detected analytes

are generally at concentrations that are well below healthbased comparison values, the uncertainties in these analyses

warrant additional testing and prioritization, and the

application of best management practices to minimize human

exposure. Addition of a representative array of indicator

compounds to the CCL-3 such as those found in USGA studies

would further these public health goals.

Gary Ginsberg, Ph.D., Toxicologist

Environmental Health Section

Connecticut Department of Public Health

April 18, 2008

CS Title: 0164

Company/group/association name: 

Comment: 





Comment on Proposed EPA Drinking Water Contaminant Candidate

List 3

Docket: EPA-HQ-OW-2007-1189

April 25, 2008 





Pursuant to the proposed list of contaminants on the Federal

Register, I request that:




i) Mycobacterium avium remain on the CCL and that





ii) Mycobacterium avium be given the significantly higher score

it merits.





M. avium and related strains of mycobacteria (nontuberculous

mycobacteria, or NTM) are known water contaminants that are

currently being assessed relative to human morbidity and

mortality.





Environmental Source and Infection





In April 2008, the Centers for Disease Control convened a

meeting of leading experts to discuss priorities for better

surveillance and understanding of this disease. NTM Info &

Research (NTMir), the national not-for-profit organization for

pulmonary NTM infection, is currently funding a pilot study

[FNi: http://www.ntminfo.org/default-aspx/p/article/id/16.aspx]

to determine the connection between household water, which

includes drinking water, and pulmonary NTM infection. Of five

initial patients suffering from pulmonary NTM disease and their

households surveyed thus far, four (or 80%) were determined to

have lung infection identical to the strain in the water.[FNii:

http://www.ntminfo.org/files/Apri12008Newsletter.pdf] At least

20 additional patient homes are currently being studied and

compared to sputum.





Epidemiology - Increasing Prevalence 





A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore

P, Ying AM, Jamieson F Isolation prevalence of pulmonary non-

tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007;

62:661-6.] provides concrete evidence that the prevalence of

pulmonary NTM infections is much higher than previously

understood. A pilot study is currently in process by NAIAD and

Kaiser Permanente of Southern California to provide a snapshot

of the epidemiology of pulmonary NTM in the United

States.[FNiv:
http://www.ntminfo.org/default_aspx/p/article/id/16.aspx]





Health Effects 





As data is not currently collected by the CDC or any other

agency, it is difficult to assess the mortality rates of

pulmonary NTM in the United States until completion of the

NAIAD/Kaiser Permanente study mentioned above.





M. avium and other NTM cause pneumonia and other severe

manifestations of illness frequently requiring hospitalization

in excess of one week. Many, if not most NTM-related

hospitalizations last more than 7 days.





M. avium and other NTM infections can cause long term

dysfunction or disability due to progressive and permanent loss

of lung function.





M. avium and other NTM's cause illness requires long-term

physician intervention as initial treatment typically requires

18-24 months of multi-antibiotic therapy, frequent CT scans,

and frequent sputum testing.





Aging Population at Greater Risk 





There appears to be an increase in pulmonary NTM infection in

the immune competent population over age 60 with a majority

being women.[FNv: Official ATS/IDSA Statement: Diagnosis,

Treatment and Prevention of Nontuberculous Mycobacteria. Am. J.

Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in

addition to individuals with underlying vulnerability such as

Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune

compromised patients (HIV/AIDS, chemotherapy),





I believe that removing M. avium from the CCL is not in the

public's best interest and will have a negative impact on the
U.S. population. Pulmonary NTM disease is being diagnosed with

increasing frequency across the United States. We request that

the EPA continue to monitor M. Avium in the water supply and

give it a higher score.



I'm an active 72 yr old and in remission from Mycobacterium

Avium. In Kenywood Texas there are 3 women and 2 men in Houston

Support Group of around 45 members. Dr. Wallace of U of Texas

Health Center at Tyler is getting patients from all over U.S.

We need lung doctors to be educated about this serious disease.

I was on antibiotics for 2 years and have to be tested every

month at Tyler for new infections. I have Bronchiectasis.





Thank you for your attention and consideration in this matter. 





Sincerely, 



Marjorie Mazurek

CS Title: 0081 

Company/group/association name:  

Comment:  

 

 

700 John Ringling Blvd. #1814  

Sarasota, FL 34236  

April 25, 2008  

 

 

Comment on Proposed EPA  

Drinking Water Contaminant Candidate List 3  

Docket: EPA-HQ-OW-2007-1189  

 

 

Pursuant to the proposed list of contaminants on the Federal 

Register, I request that: 

 

 

i) Mycobacterium avium remain on the CCL and that  

 

 

ii) Mycobacterium avium be given the significantly higher score 

it merits. 
 

 

M. avium and related strains of mycobacteria (nontuberculous 

mycobacteria, or NTM) are known water contaminants that are 

currently being assessed relative to human morbidity and 

mortality. 

 

 

Environmental Source and Infection  

 

 

In April 2008, the Centers for Disease Control convened a 

meeting of leading experts to discuss priorities for better 

surveillance and understanding of this disease. NTM Info & 

Research (NTMir), the national not-for-profit organization for 

pulmonary NTM infection, is currently funding a pilot 

study[FNi] to determine the connection between household water, 

which includes drinking water, and pulmonary NTM infection. Of 

five initial patients suffering from pulmonary NTM disease and 

their households surveyed thus far, four (or 80%) were 

determined to have lung infection identical to the strain in 

the water.[FNii] At least 20 additional patient homes are 

currently being studied and compared to sputum. 

As the leader of the NTMir support group serving NTM patients 

in coastal Southwest Florida, I currently represent 40 patients 

in various stages of illness. 

 

 

One of my patients recently died from an NTM infection 

identical to the strain in the sample taken from his hot tub. 

 

 

Epidemiology - Increasing Prevalence  

 

 

A recent study from Toronto, Ontario,[FNiii: Marras TK, Chedore 

P, Ying AM, Jamieson F Isolation prevalence of pulmonary non- 

tuberculous mycobacteria in Ontario 1997-2003. Thorax 2007; 

62:661-6.] provides concrete evidence that the prevalence of 

pulmonary NTM infections is much higher than previously 

understood. A pilot study is currently in process by NAIAD and 

Kaiser Permanente of Southern California to provide a snapshot 

of the epidemiology of pulmonary NTM in the United 

States.[FNiv: 
http://www.ntminfo.org/default_aspx/p/article/id/16.aspx ] 

 

 

Health Effects  

 

 

As data is not currently collected by the CDC or any other 

agency, it is difficult to assess the mortality rates of 

pulmonary NTM in the United States until completion of the 

NAIAD/Kaiser Permanente study mentioned above. 

 

 

M. avium and other NTM cause pneumonia and other severe 

manifestations of illness frequently requiring hospitalization 

in excess of one week. Many, if not most NTM-related 

hospitalizations last more than 7 days. 

 

 

M. avium and other NTM infections can cause long term 

dysfunction or disability due to progressive and permanent loss 

of lung function. 

 

 

M. avium and other NTM's cause illness requires long-term 

physician intervention as initial treatment typically requires 

18-24 months of multi-antibiotic therapy, frequent CT scans, 

and frequent sputum testing. 

 

 

Aging Population at Greater Risk  

 

 

There appears to be an increase in pulmonary NTM infection in 

the immune competent population over age 60 with a majority 

being women.[FNv: Official ATS/IDSA Statement: Diagnosis, 

Treatment and Prevention of Nontuberculous Mycobacteria. Am. J. 

Resp. Crit. Care Med., Vol. 175, 2007. Page 371.] This is in 

addition to individuals with underlying vulnerability such as 

Cystic Fibrosis, Alpha-1 deficiency, bronchiectasis or immune 

compromised patients (HIV/AIDS, chemotherapy), 

 

 

I believe that removing M. avium from the CCL is not in the 

public's best interest and will have a negative impact on the 
U.S. population. Pulmonary NTM disease is being diagnosed with 

increasing frequency across the United States. We request that 

the EPA continue to monitor M. Avium in the water supply and 

give it a higher score. 

 

 

Thank you for your attention and consideration in this matter.  

 

 

Sincerely,  

 

 

Mary K. Allyn 

NTM Support Group Leader, Sarasota, FL 

Board Member, NTMir Inc. 

Document ID: EPA-HQ-OW-2007-1189-0166 

Last Name: Ambrose 

First Name: Richard J 

Title: US Product Registration Manager 

Organization: DuPont Crop Protection 

City: Newark 

State: DE 

Zip Code: 19714 

Phone Number: 

Fax Number: 

Country Code: 

Email Address: 

Current Category Code: 

Comment: 

October 6, 2008 

Via Mail: 

Docket ID No. EPA-HQ-OW-2007-1189 

Water Docket 

U.S. Environmental Protection Agency 

Mail Code: 2822T 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460 

RE: E.I. duPont de Nemours and Company Comments on EPA's Draft Drinking Water 

Contaminant List 3 
To whom it may concern: 

E.I. duPont de Nemours and Company ("DuPont") appreciates the opportunity to 

provide comments on the draft "Drinking Water Contaminant List 3" released by 

EPA on February 21, 2008 (EPA-HQ-OW-2007-118, FRL-8529-7). As the primary 

manufacturer of the chemical diuron (CAS 330-54-1), DuPont recommends that EPA 

remove diuron from the draft list for regulation as a contaminant under the Safe 

Drinking Water Act. 

In our May 21, 2008 comments we stated that we would submit a more detailed 

rationale to support this recommendation in the proceeding weeks. This more 

detailed rationale includes more discussion of the current reduced risk of 

occurrence and other pertinent health effects information. 

To reiterate DuPont's May 21, 2008 comments, DuPont provided rationale for this 

recommendation based on current labeled use practices that reduced the risk of 

occurrence compared to the environmental release data reported for 2004 from the 

Toxic Release Inventory and the National Pesticide Use Database, developed by 

the National Center for Food and Agricultural Policy used for this draft 

determination. Due to the risk mitigation requirements now required on all 

registrants labeling diuron end-use products from the September 30, 2003, EPA 

Reregistration Eligibility Decision for diuron, the current risk of occurrence 

is dramatically reduced from what the above 2004 data would conclude. These risk 

mitigation requirements include: 

- Reduction of application rates and increased retreatment intervals between 

applications in numerous crops 

- Elimination of aerial applications with some specific exceptions 

- Implementation via labeling of best management practices to reduce spray drift 

In addition, In the EPA's Contaminant Information Sheets for the PCCL Chemicals 

Considered for CCL 3, February 2008, on page77 in the Health Effects data on 

diuron, under the EPA OPP RfD, a value of 0.003 mg/kg-d is given. The critical 

effects cited are "Hemolytic anemia & compensatory hematopoiesis (decreased 

erythrocyte count, hemoglobin level, etc.). Known, likely, Q1*0.0191 (mg/kg- 

day)-1". Although a 1964 DuPont document is cited, in EPA OPP's, March 6, 2002 

Diuron - Phase 2: Revised Toxicology Disciplinary Chapter for the Reregistration 

Eligibility Decision, a similar assessment is given based on more recent chronic 

toxicity/oncogenicity study in Wistar rats (MRID 40886501; supplementary data 

provided in MRIDs 43871901, 43804501, and 44302003). Based on the attribute 

scores in the Contaminant Information Sheets for the PCCL Chemicals Considered 

for CCL and the mention of a Reference Dose on page F-10 in the Contaminant 
Candidate List 3 Chemicals: Classification of the PCCL to CCL, both dated Feb. 

2008, it appears that the agency used the non-cancer endpoint of hemolytic 

effects to assign severity. 

Regarding this endpoint, OPP's, March 6, 2002 Diuron - Phase 2: Revised 

Toxicology Disciplinary Chapter came up with a LOAEL of 1.0 mg/kg bw, to which 

an extra assessment factor of 3 was added to the 100 fold uncertainty factor. 

However, we believe the assignment of 1.0 mg/mg as a LOAEL is inconsistent with 

the way EPA has interpreted other findings with compounds that lead to increased 

red cell turnover. Further, we have conducted a pathology peer review of the 

hemolytic changes and splenic changes in rats after diuron treatment. In 

addition, the red cell mass parameter data has been recently reviewed by a 

clinical pathologist. These expert reviews concluded that 25 ppm (1.0 and 1.7 

mg/kg bw/day in males and females, respectively) in this 2-year rat study should 

be considered a NOAEL. Most critically, our recent evaluation of this study 

revealed three animals at this dose level had very low decreased red cell mass 

parameters which impacted the erythrocyte counts at 12 and 24 months. When these 

three animals are excluded, the red cell mass changes at 12 and 24 months are no 

longer to a degree considered adverse. Evidence for a lack of diuron being 

causative for the decrease in red cell mass parameters in these three animals 

includes: 

- Effects of such a magnitude were not observed in animals fed 100-fold higher 

concentrations of diuron 

- Such effects were not consistent over time 

- The animal with the decreased red cell mass at 12 months died shortly after 

the blood collection (autolysis precluded identification of the cause of death) 

- Both rats with low red blood cell mass at 24 months had other non-compound 

related conditions that likely contributed to the red blood cell effects. 

The following DuPont reviews will be made available to the EPA upon request: 

- Pathology Working Group review, DuPont-18976 

- Biological Significance of Haematologic Effecs of Diuron in the Rat, 

DuPont-18974 

While the non-threshold q1*cancer risk assessment for diuron was mentioned, but 

may not have been used for the classification of the PCCL to CCL, it is worth 

noting that a study has recently been published which strongly suggests that a 

threshold approach to diuron's cancer risk assessment should be considered [see 

M.G. Nascimento et al., (2006), Effects of Diuron [3-(3,4- dichlorophenyl)-1,1- 

dimethylurea on the urinary bladder of male Wistar rats, Toxicology 224, 66- 

73)]. This publication demonstrated that necrosis occurs in the urothelium of 

rats after dietary administration of diuron and that this along with subsequent 
hyperplasia is the probable mechanism for urothelial carcinogeneis in rats. 

The EPA evaluation of Prevalence Data relied on criteria for frequency and 

concentration that are intended to meet the goal of selecting drinking water 

contaminants that may be present at levels of public health concern and would 

allow meaningful reduction in health risk. The databases examined in the 

evaluation show clearly that diuron detections occur in a small percentage of 

samples, except in specific geographical areas that have been targeted for 

monitoring programs. Using the NAWQA database as an example, a query of the 

database shows that 13586 surface and groundwater samples were analyzed for 

diuron, which was detected in approximately 15% of the samples with a 90th 

percentile concentration of <0.079 ug/l (all samples) and 0.6963 ug/l for 

samples with detectable residues. In the post model refinements to the CCL3 

process, EPA calculated an HRL/Concentration ratio as a criterion for listing. 

In all the databases examined, the 90th or 95th percentile diuron concentrations 

detected are well below the DWEL (0.1 mg/l) established by EPA Office of Water 

(EPA 822-R-06-013, 2006 Edition of Drinking Water Standards and Health 

Advisories). The HRL/Concentration ratio is greater than 10 for all databases 

examined, leading to a NL decision. The results of the Pesticide Pilot 

Monitoring Program provide further support for the NL decision by showing that 

water treatment processes reduce the concentration of diuron in finished water 

compared to ambient water. The result is consistent with the scientific 

literature on the effects of water treatment processes on diuron. 

Diuron is readily degraded by typical processes used in drinking water 

treatment. Chlorination, ozonation and filtration are common process used in 

water treatment. The two chemical treatments depend on the addition of highly 

reactive chemicals, chlorine and ozone, that are introduced to react with 

organic substances, such as natural humic substances, microorganisms, viruses, 

inorganic chemicals and man-made chemicals. Water treatment generally includes 

filtration steps to remove solids, flocculated organic matter and 

microorganisms. The filtration steps also will remove chemicals that are sorbed 

to organic matter. 

Diuron, a phenylurea, undergoes reactions with the active species in 

chlorination processes that are well known and a standard feature of the 

chemical literature dating from the 19th century (Hoffman degradation reaction). 

Publications in the scientific literature report the ready degradation of 

phenylurea herbicides, such as isoproturon, chlortoluron, diuron and linuron, by 

ozone (Camel and Bermond, 1998 and references therein). Initial reactions occur 

along well established degradation pathways and lead to products that may be 

removed by filtration. 

The low frequency of detection and the low concentrations relative to the DWEL 
support a NL decision. Regulation of diuron under the national primary drinking 

water regulation will not give a meaningful reduction in risk to public health 

as the ambient water concentrations are already well below established water 

quality criteria and water treatment processes further reduce the concentrations 

in finished water. 

Sincerely, 

Richard J. Ambrose 

US Product Registration Manager 

DuPont Crop Protection 

Document ID: EPA-HQ-OW-2007-1189-0167 

Last Name: Hilbert III 

First Name: John W. 

Title: President 

Organization: The Vanadium Producers & Reclaimers Association 

City: Washington 

State: DC 

Zip Code: 20002 

Phone Number: 202 842 3204 

Fax Number: 202 842 0439 

Country Code: 

Email Address: 

Current Category Code: 

Comment: 

November 18, 2008 

Via U.S. Mail 

Water Docket 

U.S. Environmental Protection Agency 

Mailcode: 2822T 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460 

Re: Supplement to Comments on Drinking Water Contaminant Candidate List 3- 

Draft, Docket ID No. EPA-HQ-OW-2007-1189; Chemical Abstract Services Registry 

Number (CASRN) 7440-62-2 



We write to supplement comments provided on May 21, 2008 by the Vanadium 

Producers and Reclaimers Association (VPRA) concerning the U.S. Environmental 

Protection Agency's (EPA) draft Contaminant Candidate List (CCL 3),[FN1: 73 FED. 

REG. 9628 (Feb. 21, 2008).] specifically with respect to the EPA's 
recommendations with respect to elemental vanadium (CASRN 7440-62-2).[FN2: Id. 

at 9633, Exh. 2.] We are enclosing a recent study entitled "Evaluation of 

genotoxicity of oral exposure to tetravalent vanadium in vivo," by P. Villani et 

al. This study, the first in vivo genetox comparative study of which the VPRA is 

aware, is important to EPA's consideration of elemental vanadium because it 

reports essentially negative results from the tetravalent form of vanadium 

compared to previously-reported positive findings with vanadium's pentavalent 

form. Critically, as this study concluded, "repeated oral exposure to 

tetravalent vanadium, up to few tens of micrograms perk kg body weight, may be 

devoid of significant genotoxic effects both at somatic and germ cell levels." 

For these reasons and the reasons stated in the VPRA's original comments, the 

VPRA is asking EPA to decide not to list elemental vanadium on the CCL 3 list 

because the record in this rulemaking has not sufficiently established the 

factual basis by which to determine that vanadium "may require regulation under 

[the SDWA]."[FN3: 42 U.S.C. § 300g-1(b)(1)(B)(i)(1).] 

The VPRA appreciates this opportunity to provide this supplemental information, 

and would be pleased to address any questions the EPA may have about it. 

Questions may be directed to John Hilbert, President of the VPRA, at (202) 

842-0219. 

Respectfully submitted, 

John W. Hilbert III, President 

The Vanadium Producers and Reclaimers Association 

900 Second Street, N.E. 

Suite 201 

Washington, D.C. 20002 

Tel: (202) 842-3204 

Fax: (202) 842-0439 

Of Counsel: 

Martha E. Marrapese, Esq. 

Jason E. Yearout, Esq. 

Keller and Heckman LLP 

1001 G Street, N.W. 

Suite 500 West 

Washington, DC 20001 
LETTER_ID COMMENTER_ID LAST_NAME FIRST_NAME

6081 55646 Murray P.R.

6082 55647 Leitman Philip

6083 55648 Anonymous

6084 55649 Taft James

6502 56803 Anonymous

6503 56804 Pedersen B.

6504 56805 Jurasits Donna

6505 56806 Weinberg Laura

6506 56807 Bowman Lori G.

6507 56808 Finger K.

6508 56809 Anonymous

6509 56810 Anonymous

6510 56811 Watkins J.

6511 56812 Anonymous

6512 56813 Coniglio T.J.

6513 56814 Hoos Phil

6514 56815 Boisvert J.

6515 56816 Breslawsky D.

6516 56817 McMurrough A.

6517 56818 DeLong R.

6518 56819 Greenfield E.

6519 56820 Greenfield E.

6520 56821 Mass Comment Campaign sponsoring org unknown (59)

6521 56822 Anonymous

6522 56823 Clarkson-Shorter J.

6523 56824 Ordway Diane

6524 56825 Cherrnay A.

6525 56826 Ratchye J.

6526 56827 LaMontagne C.

6527 56828 York Deanna

6530 56831 Funari Enzo

6531 56832 Racke Kenneth D.

6532 56833 Brenner Barbara A.

6533 56834 Goodman Miriam

6534 56835 Lynn John

6535 56836 Kneiss Sharon H.

6536 56837 Falkinham, III Joseph O.

6537 56838 Carey Sandra

6538 56839 Falconer I.R.

6539 56840 Davis J.

6540 56841 Hoel J.

6541 56842 Chan Ed

6542 56843 Iseman Michael D.
6543 56844 Wells Martha J.M.

6544 56845 Neustadt Debbie

6545 56846 Kloska Kenneth

6546 56847 Smith Charlotte D.

6547 56848 T.&J. and Family

6548 56849 Anonymous

6549 56850 Heminway Diane

6550 56851 Mayer Mark S.

6551 56852 Bellet E.M.

6552 56853 Louis Judith

6553 56854 Santoro Michael A.

6554 56855 McLallen Sarah

6555 56856 Anonymous

6556 56857 Gibson Patrick L.

6557 56858 Hilbert, III John W.

6558 56859 Adams William J.

6561 56860 Anonymous

6562 56861 Cotruvo Joseph

6563 56862 Garvin Michael

6564 56863 Berger P.S.

6565 56864 Halverson Paul

6566 56865 Greenwood Beau

6567 56866 Van De Hei Diane

6568 56867 Nogaki Jane

6569 56868 Bennett Karen

6570 56869 Comstock Jeff

6571 56870 Sieben Katie

6572 56871 Wu Mae

6573 56872 Naidenko Olga V.

6574 56873 Connor Hannah

6575 56874 Macedo Julie E.

6576 56875 Bain Cynthia

6577 56876 Wegner William

6578 56877 Berkelman Ruth

6579 56878 Ambrose Richard

6580 56879 Ellis George

6581 56880 Knowlton Kim

6582 56881 Caldwell Michael

6583 56882 Pisani Victor

6584 56883 Hutcheson Michael S.
6585 56884 Yamamoto Gary

6586 56900 Curtis Thomas W.

6587 56902 Wilson Shari T.

6588 56903 Moore Mary

6601 56904 Becky

6602 56905 Herma

6603 56906 Selecky Mary C.

6604 56907 Garcia Buddy

6605 56908 Crutcher James M.

6606 56909 Jackson Lisa P.

6607 56910 Hughes John A.

6608 56911 Grannis Alexander B.

6609 56912 McGinty Kathleen A.

6610 56913 Moore Brad

6611 56914 Pisani Victor E.

6612 56915 Sloan Paul L.

6613 56916 Opper Richard H.

6614 56917 Scott Douglas P.

6615 56918 Glatt L. David

6616 56919 Smith Darrell B.

6621 56924 Mazurek Marjorie

8582 59134 Ambrose Richard J

8583 59135 Hilbert III John W.

6641 59136 Allyn Mary K.
TITLE

Ph.D.

President

Executive Director

Bureau Director

PhD., Assistant Professor

East Texas Support Group Leader

Regulatory Manager - Insecticides

President & Chief Executive Officer (CEO)

Vice President, Products Division

HSE Executive

Leader

MD, Associate Professor of Medicine
Ph.D. Professor

Chair

Director Environmental Services - Global Operations

Environmental Projects Coordinator, USW Health Safety 

and Environment Department

P.E., Natural Resources Administrator

PhD., Technical Manager

Ph.D., Chief Bureau of Environmental Assessment, Division 

of Science Research and Technology

Director, Specialty Materials

Manager

Chair

President

Ph.D., Chairman

Joseph Cotruvo and Associates LLC

Pharm.D., Assistant Vice President

DrPH, FACHE, Director and State Health Officer

Acting Chair

Executive Director

Vice Chair

Vice President, Environmental Affairs

Agrichemical Management Section, Vermont Agency of 

Agriculture

Senator

Staff Attorney

Ph.D., Senior Scientist

Staff Attorney

Attorney

Staff Scientist

M.D., Chair Public and Scientific Affairs Board

US Product Registration Manager

President

Dr.Ph.; Science Fellow, Global Warming and Health

Zausmer, Kaufman, August, Caldwell & Tayler, P.C .; 

Attorneys & Counselors

Director, Bureau of Water Supply Protection

Head
Assistant Chief

Deputy Executive Director

Secretary

Vice President

Secretary

Chairman

Secretary of Health and Commissioner of Health

Commissioner

Secretary

Commissioner

Secretary

Commissioner

Director, Bureau of Water Supply Protection

Deputy Commissioner

Director

Director

Chief

Acting Section Chief

US Product Registration Manager

President

NTM Support Group Leader and Board Member
ORGANIZATION

NTM (Nontuberculous Mycobacteria) Information & Research Inc. (NTMir)

Association of State Drinking Water Administrators (ASDWA)

The Babylon Breast Cancer Coalition

Great Neck Breast Cancer Coalition

Agrichemical Management, Wisconsin Department of Agriculture, Trade and Consumer Protection

Earthjustice

College of Veterinary Medicine and Biomedical Sciences, Department of Microbiology, Immunology and 

Pathology, Colorado State University

NTM (Nontuberculous Mycobacteria) Support Group

Mechanisms of Toxicity Unit, Environment & Primary Prevention Department, Istituto Superiore di Sanità 

(Italian National Institute for Health)

Dow AgroSciences LLC (DAS)

Breast Cancer Action

Mid-Island Radiation Alert

Methanol Institute (MI)

Olefins Panel, American Chemistry Council (ACC)

Department of Biological Sciences, Virginia Tech (Virginia Polytechnic Institute and State University)

International Molybdenum Association (IMOA)

Pharmacology, University of Adelaide-5005 and Cooperative Research Centre for Water Quality and Treatment

West Central Florida NTM Support Group

National Jewish Medical and Research Center
Environmental Chemistry Center for the Management Utilization and Protection of Water Resources and 

Department of Chemistry, Tennessee Technological University (TTU)

National Water Committee, Sierra Club

Climax Molybdenum Company (Climax)

Charlotte Smith & Associates Inc. (CS&A)

United Steel Workers (USW)

SD Drinking Water Programs, South Dakota Department of Environment and Natural Resources (SDDENR)

Metolachlor Task Force

New Jersey Department of Environmental Protection (NJDEP)

Environmental Health, Safety and Regulatory Affairs, 3M Company

Ethylene Oxide (EO) and Ethylene Glycols (EG) Panel, American Chemistry Council (ACC)

N-Methylpyrrolidone Producers (NMP) Group, Inc.

Vanadium Producers and Reclaimers Association (VPRA)

North American Metals Council (NAMC)

WateReuse Foundation

Science and Regualtory Affairs, Pharmaceutical Research and Manufacturers of America (PhRMA)

Arkansas Department of Health

Pesticide Policy Coalition

Association of Metropolitan Water Agencies (AMWA)

NJ Environmental Federation (NJEF)

National Mining Association (NMA)

State-FIFRA Issues Research and Evaluation Group-Water Quality-Pesticide Disposal Working Committee (SFIREGWQPD-WC)

District 57, Minnesota State Senate

Natural Resources Defense Council (NRDC)

Environmental Working Group (EWG)

Waterkeeper Alliance

Pillsbury Winthrop Shaw Pittman LLP, on behalf of City of Rialto, Rialto Utility Authority

City of Peoria, Arizona (AZ)

Riverkeeper

American Society for Microbiology (ASM)

Dupont Crop Protection, Stine-Haskell Research Center

Pennsylvania Coal Association

Natural Resources Defense Council (NRDC)

Gelman Sciences, Inc., d/b/a Pall Life Sciences (PLS)

New York State Department of Health

Air & Water Toxics, Massachusetts Department of Environmental Protection (MADEP)
Division of Drinking Water and Environmental Management, State of California-Health and Human Services 

Agency, California Department of Public Health (CDPH)

American Water Works Association (AWWA)

Maryland Department of the Environment

Lindon Park Neighborhood Association

State of Washington Department of Health

Texas Commission on Environmental Quality

Oklahoma State Department of Health

State of New Jersey Department of Environmental Protection (DEP)

Delaware Department of Natural Resources and Environmental Control (DNREC)

State of New York Department of Environmental Conservation

Pennsylvania Department of Environmental Protection (DEP)

Minnesota Pollution Control Agency

New York State Department of Health

State of Tennessee Department of Environment and Conservation

Montana Department of Environmental Quality (DEQ)

Illinois Environmental Protection Agency

North Dakota Department of Health, Environmental Health Section

State of Connecticut

DuPont Crop Protection

The Vanadium Producers & Reclaimers Association

NTMir Inc.
CITY STATE ZIP_CODE PHONE_NUMBER FAX_NUMBER COUNTRY_CODE

Arlington VA 22209 7038129508 7038129506

Madison WI 537088911 6082244550

Calistoga CA

Camp Hill PA

Wilmington DE 19807

Highland Village TX 75077 9723188970

Roma IT

Blacksburg VA 24061 5402315931 5402319307

BE

Adelaide AU

Denver CO 80206 3033981491 3033981806
Cookeville TN 38505 9313726123 9313726346

Phoenix AZ

Orinda CA 9253771891

Pittsburgh PA

Stillwell KS

St. Paul MN 55144

Washington DC

Washington DC 20002 2028423204 2028420439

Alexandria VA 8015580222

Washington DC

2022961585

Washington DC 20006

Marlton NJ 8053

Washington DC 20001 2024632600

St. Paul MN 55155 6512978060

Washington DC 20009 2029399157

Irvington NY 10533 9146740622 9146744560

4159831590

Washington DC

Newark DE 197140030

Harrisburg PA 17101

New York NY 10011 2127274579 2127271773

Farmington Hills MI 483342374 2488514111 2488510100

Albany NY 12237 5184027650

Boston MA 2108
Sacramento CA 95899 9164495577

Baltimore MD 21230 4105373000

Phoenix AZ 85008

Olympia WA 985047890 3602364501 3605867424

Austin TX 787113087 5122391000

Oklahoma City OK 731171299

Trenton NJ 86250402 6092922885 6092927695

Dover DE 19901 3027399000 3027396242

Albany NY 122331010

Harrisburg PA 171052063 7177872814

St. Paul MN 551554194 6512966300

Albany NY 12237

Nashville TN 372430435

Helena MT 596200901 4064442544

Springfield IL 627949276 2177823397

Bismarck ND 585011947 7013285152

Hartford CT 6134

Newark DE 19714

Washington DC 20002 2028423204 2028420439

Sarasota FL 34236
EMAIL

dosterhoudt@asdwa.org

breslaw1@gmail.com

emanuela.testai@iss.it

chane@njc.org
mjmwells@tntech.edu

olga@ewg.org

hconnor@waterkeeper.org

kknowlton@nrdc.org
rda@rushmore.com

dglatt@nd.gov
CLINE_ID COMMENT_ID LETTER_ID BEGINNING_LINE_NUMBER ENDING_LINE_NUMBER

19751 17287 6083 6 21

19752 17288 6082 6 9

19754 17289 6082 12 107

19755 17290 6081 6 23

19756 17291 6081 26 44

19757 17292 6084 6 30

19759 17293 6084 33 49

19760 17294 6084 52 60

19761 17295 6084 63 101

19763 17297 6084 104 214

19764 17298 6084 217 227

19765 17299 6084 229 233

21363 18840 6534 6 8

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21365 18842 6534 28 48

21366 18843 6534 51 83

21367 18844 6534 86 104

21368 18845 6534 107 182

21369 18846 6534 185 191

21370 18847 6534 194 220

21371 18848 6534 223 227

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21374 18851 6535 48 61

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21377 18854 6535 146 153

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21380 18857 6535 204 240

21381 18858 6535 243 250

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21384 18861 6535 332 405

21385 18862 6535 408 437

21386 18863 6535 440 445

21387 18864 6535 448 479

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21389 18866 6535 747 839

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21392 18869 6536 32 380

21393 18870 6536 383 596

21394 18871 6537 6 20

21395 18872 6537 23 28

21396 18873 6537 31 40

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21400 18877 65556 17

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21403 18880 6544 177 230

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21420 18897 6552 472 491

21421 18898 6552 494 579

21422 18899 6552 582 733

21423 18900 6552 736 744

21424 18901 6552 747 769

21425 18902 6552 772 800

21426 18903 6552 803 810

21427 18904 6552 813 822

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21429 18906 6552 834 879

21430 18907 6552 882 889

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21435 18912 65536 25

21436 18913 6553 28 261

21437 18914 6553 264 311

21438 18915 6553 314 325

21439 18916 6553 328 419

21440 18917 65546 24

21443 18918 6554 27 43

21446 18919 6554 46 58

21448 18920 6554 67 71

21450 18921 6554 327 347

21451 18922 6554 350 381

21452 18923 6554 384 395
21453 18924 6554 398 415

21454 18925 6554 418 540

21456 18927 6554 710 718

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21511 18966 65506 17

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21515 18968 6550 55 69

21516 18969 6550 72 87

21517 18970 65516 24

21519 18971 6551 27 37
21521 18972 6551 40 78

21522 18973 65466 22

21525 18974 6546 25 42

21526 18975 6546 108 127

21528 18977 65076 27

21529 18978 6507 30 30

21530 18979 65086 12

21531 18980 651869

21533 18981 6518 12 38

21534 18982 6518 47 48

21535 18983 651969

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21541 18988 652169

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21597 19044 6511 169 210

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21599 19046 6511 229 255

21600 19047 6511 258 296

21601 19048 6511 299 306

21602 19049 6511 309 386

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21605 19052 651368

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21609 19056 65156 10

21610 19057 6515 13 18

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21613 19060 65166 11

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21616 19063 65176 19

21617 19064 6517 22 24

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21619 19066 6517 43 46

21620 19067 6517 49 103

21621 19068 6517 106 165

21622 19069 6517 168 175

21623 19070 6517 178 182

21624 19071 6517 204 204

21625 19072 6517 207 224
21626 19073 6517 227 257

21627 19074 6517 260 274

21628 19075 6517 277 289

21629 19076 65576 17

21630 19077 6557 19 51

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21637 19084 6557 161 236

21638 19085 6557 239 246

21639 19086 6557 249 284

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21666 19113 6563 124 134

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21668 19115 6563 198 206

21669 19116 65646 20

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21672 19119 6564 48 51

21673 19120 6564 54 70

21674 19121 6564 73 77

21675 19122 65656 17

21676 19123 6565 20 49
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21678 19125 6565 106 122

21679 19126 6565 125 134

21680 19127 65666 41

21681 19128 6566 44 81

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21683 19130 6566 110 145

21684 19131 6566 148 168

21685 19132 6566 171 197

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21688 19135 65686 17

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21693 19140 6568 185 202

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21700 19147 6569 117 134

21701 19148 6569 137 165

21702 19149 6569 168 250

21703 19150 6569 253 283

21704 19151 6569 286 327

21705 19152 6569 330 350

21706 19153 6569 353 372

21707 19154 6569 375 386

21708 19155 65706 29

21709 19156 6570 32 50

21710 19157 6570 53 87

21711 19158 6570 90 95

21712 19159 6570 98 120

21713 19160 65716 13

21714 19161 6571 16 17

21715 19162 6571 20 26

21716 19163 6571 29 41

21717 19164 6571 44 57

21718 19165 6571 60 64

21719 19166 65726 26

21720 19167 6572 29 39

21721 19168 6572 42 46

21722 19169 6572 49 52

21723 19170 6572 55 62

21724 19171 6572 65 75
21725 19172 6546 45 105

21726 19173 6546 130 571

21727 19174 6546 574 588

21728 19175 6572 78 78

21729 19176 6572 81 82

21730 19177 6572 85 92

21731 19178 6572 94 94

21732 19179 6572 96 99

21733 19180 6572 102 109

21734 19181 6572 112 123

21735 19182 6572 126 192

21736 19183 6572 195 394

21737 19184 6572 397 523

21738 19185 6572 526 534

21739 19186 6572 537 610

21740 19187 6572 613 703

21741 19188 6572 706 710

21742 19189 6572 713 722

21743 19190 6572 725 759

21744 19191 6572 762 929

21745 19192 6572 932 1058

21746 19193 6572 1061 1093

21747 19194 6572 1096 1209

21748 19195 6572 1750 1838

21749 19196 6572 1841 1973

21750 19197 6572 2164 2316

21751 19198 6572 2319 2366

21752 19199 6572 2369 2376

21753 19200 6572 2378 2381

21754 19201 6572 2384 2387

21755 19202 6572 2390 2393

21756 19203 6547 32 41

21757 19204 657367

21758 19205 6573 10 21

21759 19206 6573 24 37

21760 19207 6573 40 67

21761 19208 6573 70 87

21763 19210 6573 200 202

21764 19211 6573 205 287

21765 19212 6573 290 300

21766 19213 6573 303 380

21767 19214 6573 383 407

21768 19215 6573 410 416

21769 19216 6573 419 429

21770 19217 6573 432 451

21771 19218 6573 454 507

21772 19219 6573 510 528
21773 19220 6573 531 920

21774 19221 65746 47

21775 19222 6574 50 62

21776 19223 6574 65 72

21777 19224 6574 75 145

21778 19225 6574 148 204

21779 19226 6574 207 216

21780 19227 6549 62 67

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21782 19229 6574 219 225

21783 19230 6574 228 233

21784 19231 6574 236 265

21785 19232 6574 268 295

21786 19233 6574 298 312

21787 19234 6574 315 350

21788 19235 6574 353 362

21789 19236 6574 365 1130

21794 19241 6574 1133 1248

21795 19242 6574 1250 1290

21796 19243 6574 1292 1308

21797 19244 6574 1311 1331

21798 19245 6550 31 42

21799 19246 6550 45 52

21800 19247 6551 81 94

21801 19248 6551 97 104

21802 19249 65756 23

21803 19250 6575 26 106

21804 19251 6575 109 116

21805 19252 65766 22

21806 19253 6576 35 47

21807 19254 6576 50 77

21808 19255 65776 19

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21812 19259 6578 20 32

21813 19260 6578 35 50

21814 19261 6578 53 59

21815 19262 6578 62 73

21816 19263 6578 76 85

21817 19264 6578 88 101

21818 19265 6554 102 104

21819 19266 6554 107 158

21820 19267 6554 161 179

21821 19268 6554 182 194

21823 19270 6554 238 324

21824 19271 65796 24
21825 19272 6579 27 63

21826 19273 6579 66 71

21827 19274 65806 19

21828 19275 6580 22 50

21829 19276 6580 53 58

21830 19277 6580 61 71

21831 19278 6554 689 707

21832 19279 6554 917 922

21833 19280 65816 11

21834 19281 6581 14 25

21835 19282 6581 28 46

21836 19283 6581 49 57

21837 19284 6581 60 128

21838 19285 6581 131 165

21839 19286 6581 168 176

21840 19287 6581 179 185

21841 19288 6581 188 192

21842 19289 6581 195 204

21843 19290 65826 21

21844 19291 6582 24 49

21845 19292 6582 52 73

21846 19293 6582 76 81

21847 19294 6582 84 96

21848 19295 65836 19

21849 19296 6583 22 31

21850 19297 6583 33 39

21851 19298 6583 42 50

21852 19299 6583 53 62

21853 19300 6583 65 84

21854 19301 65846 18

21855 19302 6584 21 45

21856 19303 6584 48 56

21857 19304 6584 59 67

21858 19305 6584 70 75

21859 19306 6584 78 106

21860 19307 6584 109 124

21861 19308 6584 127 142

21862 19309 6584 145 161

21863 19310 6584 164 172

21864 19311 65856 20

21865 19312 6585 22 35

21866 19313 6585 37 71

21867 19314 6585 73 184

21868 19315 6585 187 211

21869 19316 6558 62 93

21870 19317 65676 20

21871 19318 6567 23 33
21872 19319 6567 36 58

21873 19320 6567 61 70

21874 19321 6567 73 85

21875 19322 6567 88 120

21876 19323 6567 123 157

21877 19324 6567 160 166

21878 19325 6567 169 189

21879 19326 6567 192 195

21880 19327 6567 198 234

21881 19328 6567 237 246

21882 19329 6567 249 273

21883 19330 6567 276 281

21884 19331 6567 284 288

21885 19332 6567 291 300

21886 19333 65616 35

21887 19334 65626 13

21888 19335 6562 16 59

21889 19336 6562 62 69

21890 19337 6562 72 93

21891 19338 6562 96 132

21892 19339 6562 135 139

21893 19340 6562 142 145

21894 19341 6562 148 155

21895 19342 6562 158 173

21896 19343 6562 175 193

21897 19344 6562 195 197

21898 19345 6572 2396 2404

21899 19346 6577 169 177

21900 19347 6577 180 187

21901 19348 6539 91 95

21902 19349 6538 38 56

21903 19350 6538 59 79

21904 19351 6538 82 95

21905 19352 6538 98 121

21906 19353 6538 124 142

21907 19354 6543 30 112

21908 19355 6543 115 132

21909 19356 6542 57 66

21910 19357 6541 123 137

21923 19360 65876 28

21924 19361 6587 30 63

21925 19362 6587 65 80

21926 19363 6587 82 94

21927 19364 6587 96 115

21928 19365 65886 19

21929 19366 6588 21 82

21930 19367 6588 84 93
21931 19368 6586

6 51

21932 19369 6586 55 84

21933 19370 6586 87 93

21934 19371 6586 96 98

21935 19372 6586 101 109

21936 19373 6586 112 115

21937 19374 6586 118 127

21938 19375 6586 130 303

21939 19376 6586 306 366

21940 19377 6586 369 440

21941 19378 6586 443 514

21942 19379 6586 517 610

21943 19380 6586 613 645

21944 19381 6586 648 714

21945 19382 6586 717 742

21946 19383 6586 745 851

21947 19384 6586 854 880

21948 19385 6586 883 903

21949 19386 6586 906 1007

21950 19387 6586 1010 1038

21951 19388 6586 1041 1111

21952 19389 6586 1114 1141

21953 19390 6586 1144 1320

21954 19391 6586 1323 1329

21955 19392 6586 1332 1415

21956 19393 6586 1418 1430

21957 19394 6586 1433 1437

21958 19395 6586 1439 1445

21959 19396 6586 1448 1589

21960 19397 6586 1592 1647

21961 19398 6586 1650 1789

21962 19399 6586 1792 1810

21963 19400 6586 1813 1885

21964 19401 6586 1888 1933

21965 19402 6586 1936 1986

21966 19403 6586 1989 2012

21967 19404 6586 2015 2057

21968 19405 6586 2060 2072

21969 19406 6586 2074 2084

21970 19407 6586 2087 2118

21971 19408 6586 2121 2150

21972 19409 6586 2153 2188

21973 19410 6586 2191 2237

21974 19411 6586 2240 2275

21975 19412 6586 2278 2310

21976 19413 6586 2313 2375

21977 19414 6586 2378 2430
21978 19415 6586 2433 2453

21979 19416 6586 2456 2475

21980 19417 6586 2478 2491

21981 19418 6586 2494 2776

21983 19420 660155

21984 19421 660179

21985 19422 660266

21986 19423 660299

21987 19424 66036 13

21988 19425 6603 15 51

21989 19426 6603 54 79

21990 19427 6603 81 235

21991 19428 66046 14

21992 19429 6604 16 20

21993 19430 6604 23 40

21994 19431 6604 42 76

21995 19432 6604 79 89

21996 19433 66056 13

21997 19434 6605 15 20

21998 19435 6605 22 27

21999 19436 66066 35

22000 19437 6606 38 54

22001 19438 6606 57 69

22002 19439 6606 72 85

22003 19440 6606 89 228

22004 19441 66076 17

22005 19442 6607 20 39

22006 19443 6607 42 84

22007 19444 6607 87 149

22008 19445 6607 152 169

22009 19446 6607 172 192

22010 19447 6607 195 195

22011 19448 66086 16

22012 19449 6608 18 158

22013 19450 6608 161 169

22014 19451 66096 14

22015 19452 6609 16 53

22016 19453 6609 56 61

22017 19454 6609 62 129

22018 19455 6609 132 139

22019 19456 66106 14

22020 19457 6610 16 123

22021 19458 6610 126 144

22022 19459 66116 16

22023 19460 6611 19 90

22024 19461 6611 92 110

22025 19462 66126 12
22026 19463 6612 14 55

22027 19464 6612 58 67

22028 19465 66136 16

22029 19466 6613 18 60

22030 19467 6613 63 75

22031 19468 66146 15

22032 19469 6614 17 128

22033 19470 6614 131 142

22034 19471 66156 15

22035 19472 6615 17 52

22036 19473 6615 55 73

22037 19474 6615 76 88

22038 19475 6615 91 110

22039 19476 6615 113 129

22040 19477 66166 27

22041 19478 6616 30 43

22042 19479 6616 46 52

22043 19480 6616 55 152

22044 19481 6616 155 169

22045 19482 6506 34 40

22063 19500 6563 108 113

22064 19501 6554 61 64

22065 19502 6554 74 93

22066 19503 6554 96 99

22067 19504 6554 232 235

22068 19505 6554 210 229

22073 19510 6554 197 200

22075 19512 662169

22076 19513 6621 12 115

22077 19514 6621 118 123

22083 19520 6554 203 207

22084 19521 6554 543 575

22085 19522 6554 578 603

22086 19523 6554 606 686

22087 19524 6535 275 319

22088 19525 6535 320 329

22089 19526 65326 13

22090 19527 6532 14 14

22091 19528 6552 399 420

22092 19529 6552 423 469

22093 19530 6552 383 391

22094 19531 6552 392 396

22095 19532 6573 90 115

22096 19533 6573 118 155

22097 19534 6573 158 197

22098 19535 6084 63 101

22099 19536 6081 26 44
22100 19537 6544 177 230

22101 19538 6554 418 540

22102 19539 6554 721 769

22103 19540 6534 51 83

22104 19541 6534 86 104

22105 19542 6535 408 437

22106 19543 6537 114 123

22107 19544 6554 27 43

22110 19547 6554 772 893

22111 19548 6554 896 914

22112 19549 65026 24

22113 19550 65496 14

22114 19551 6550 55 69

22115 19552 6511 68 69

22117 19554 6563 124 134

22118 19555 6565 20 49

22119 19556 6612 14 55

22120 19557 6616 30 43

22121 19558 6616 46 52

22122 19559 6616 55 152

22123 19560 6563 92 99

22125 19562 6557 129 148

22126 19563 6604 16 20

22127 19564 6604 42 76

22128 19565 6554 74 93

22129 19566 6554 96 99

22130 19567 6554 232 235

22131 19568 6554 210 229

22132 19569 6572 2384 2387

22133 19570 6607 42 84

22134 19571 6613 18 60

22135 19572 6565 106 122

22136 19573 6574 365 1130

22137 19574 6614 17 128

22138 19575 6615 17 52

22139 19576 6615 91 110

22140 19577 6554 61 64

22141 19578 6610 16 123

22142 19579 6568 20 25

22143 19580 6568 157 182

22144 19581 6554 689 707

22145 19582 6554 917 922

22146 19583 6554 197 200

22149 19586 6556 156 190

22150 19587 6574 148 204

22151 19588 6574 207 216

22154 19591 6573 90 115
22155 19592 6573 118 155

22156 19593 6573 158 197

22158 19595 6572 112 123

22159 19596 6556 44 51

22161 19598 6585 37 71

22162 19599 6587 30 63

22163 19600 6587 82 94

22164 19601 6573 432 451

22165 19602 6573 510 528

22166 19603 6583 53 62

22167 19604 6603 15 51

22168 19605 6603 81 235

22169 19606 6608 18 158

22170 19607 6611 19 90

22171 19608 6554 203 207

22172 19609 6576 35 47

22173 19610 6573 205 287

22174 19611 6573 410 416

22175 19612 6574 315 350

22176 19613 6574 1292 1308

22177 19614 6549 62 67

22178 19615 6549 196 221

22179 19616 6554 102 104

22180 19617 6554 161 179

22182 19619 6584 59 67

22183 19620 6563 108 113

22184 19621 6586 118 127

22185 19622 6556 84 128

22186 19623 6556 84 128

22204 19641 66411 13

22205 19642 6641 16 116

22206 19643 6641 119 127

22218 19655 6535 64 67

22219 19656 6556 193 195

22220 19657 6576 25 32

22221 19658 6517 185 201

22384 19821 6565 52 103

22397 19834 6574 65 72

22874 20316 6572 1212 1301

22875 20317 6572 1304 1389

22876 20318 6572 1392 1516

22877 20319 6572 1519 1569

22878 20320 6572 1572 1657

22879 20321 6572 1660 1747

22880 20322 6572 1976 2033

22881 20323 6572 2036 2104

22882 20324 6572 2107 2161
28209 25320 6616 170 235

28225 25336 8582 17 32

28226 25337 8582 34 166

28227 25338 8582 168 171

28228 25339 8583 17 27

28229 25340 8583 31 50

28230 25341 8583 52 72
COMMENT_ID LETTER_ID

17287 6083

17288 6082

17289 6082

17290 6081

17291 6081

17292 6084

17293 6084

17294 6084

17295 6084

17297 6084

17298 6084

17299 6084

18840 6534

18841 6534

18842 6534
18843 6534

18844 6534

18845 6534

18846 6534
18847 6534

18848 6534

18849 6535

18850 6535

18851 6535

18852 6535

18853 6535

18854 6535

18855 6535

18856 6535

18857 6535

18858 6535
18859 6535

18861 6535

18862 6535

18863 6535

18864 6535

18865 6535

18866 6535
18867 6536

18868 6536

18869 6536

18870 6536

18871 6537

18872 6537

18873 6537

18874 6537

18875 6537

18876 6537

18877 6555

18878 6544
18879 6544

18880 6544

18881 6544

18882 6544

18883 6545
18884 6545

18885 6545

18886 6552

18887 6552

18888 6552

18889 6552

18890 6552

18891 6552

18892 6552

18893 6552

18894 6552

18897 6552

18898 6552

18899 6552

18900 6552
18901 6552

18902 6552

18903 6552

18904 6552

18905 6552

18906 6552

18907 6552

18908 6552

18909 6552

18910 6552

18911 6552

18912 6553
18913 6553

18914 6553

18915 6553

18916 6553

18917 6554

18918 6554

18919 6554

18920 6554

18921 6554

18922 6554

18923 6554

18924 6554
18925 6554

18927 6554

18928 6554

18929 6554

18930 6554

18931 6558

18932 6558

18933 6558

18934 6502

18935 6503
18936 6503

18937 6503

18938 6504

18939 6505

18940 6509

18941 6510

18942 6510

18943 6549

18944 6549

18945 6549

18946 6549

18947 6549

18948 6538

18949 6538

18950 6538

18951 6539

18952 6539

18953 6540
18954 6540

18955 6540

18956 6540

18957 6541

18958 6541

18959 6542

18960 6542

18961 6543

18962 6543

18963 6547
18964 6547

18965 6548

18966 6550

18967 6550

18968 6550

18969 6550

18970 6551

18971 6551

18972 6551

18973 6546

18974 6546
18975 6546

18977 6507

18978 6507

18979 6508

18980 6518

18981 6518

18982 6518

18983 6519

18984 6519

18985 6520

18986 6520

18987 6520

18988 6521

18989 6521
18990 6521

18991 6521

18992 6521

18993 6522

18994 6522

18995 6522

18996 6523

18997 6523

18998 6523

18999 6524

19000 6524

19001 6524

19002 6525

19003 6525

19004 6525

19005 6526

19006 6526

19007 6526

19008 6527
19009 6527

19010 6527

19011 6527

19016 6530

19017 6530

19018 6531

19019 6531

19020 6531

19021 6531

19022 6531

19023 6531

19025 6532

19026 6533

19027 6506

19028 6506
19029 6506

19030 6506

19031 6511

19032 6511

19033 6511

19034 6511

19035 6511

19036 6511

19037 6511

19038 6511

19039 6511

19040 6511

19041 6511
19042 6511

19044 6511

19045 6511

19046 6511

19047 6511

19048 6511

19049 6511

19050 6512

19051 6512

19052 6513

19053 6514
19054 6514

19055 6514

19056 6515

19057 6515

19058 6515

19059 6515

19060 6516

19061 6516

19062 6516

19063 6517

19064 6517

19065 6517
19066 6517

19067 6517

19068 6517

19069 6517

19070 6517

19071 6517

19072 6517

19073 6517

19074 6517

19075 6517

19076 6557
19077 6557

19078 6557

19079 6557

19080 6557

19081 6557

19082 6557

19083 6557
19084 6557

19085 6557

19086 6557

19087 6557

19088 6557

19090 6557

19091 6557

19092 6556

19093 6556
19094 6556

19095 6556

19096 6556

19100 6556

19101 6556

19102 6556

19103 6084

19104 6082

19105 6518

19106 6519

19107 6563

19108 6563

19109 6563

19110 6563

19111 6563

19112 6563

19113 6563
19114 6563

19115 6563

19116 6564

19117 6564

19118 6564

19119 6564

19120 6564

19121 6564

19122 6565

19123 6565

19124 6565

19125 6565

19126 6565

19127 6566
19128 6566

19129 6566

19130 6566

19131 6566

19132 6566

19133 6566

19134 6566

19135 6568
19136 6568

19137 6568

19138 6568

19139 6568

19140 6568

19141 6568

19142 6569
19143 6569

19145 6569

19146 6569

19147 6569

19148 6569

19149 6569

19150 6569

19151 6569
19152 6569

19153 6569

19154 6569

19155 6570

19156 6570

19157 6570

19158 6570

19159 6570

19160 6571

19161 6571

19162 6571

19163 6571

19164 6571

19165 6571

19166 6572

19167 6572
19168 6572

19169 6572

19170 6572

19171 6572

19172 6546

19173 6546

19174 6546

19175 6572

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INDIVIDUAL_COMMENT_RESPONSE

Please see response to comment ID 18977 under comment code 1000. EPA also evaluates chemicals under 

several other programs to determine their registration status and uses. The Agency considered all public 

comments and the best available information and science for the chemicals considered on CCL 3.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19058 under comment code 7840.

No response necessary.

Based on comments, EPA changed the pathogens listed on the final CCL 3. EPA removed older, CDC waterborne 

disease outbreaks (WBDO) (prior to 1990) from the occurrence analysis. This and other minor changes to the 

scoring, are discussed in more detail in the final CCL 3 notice. As a result, EPA has added to CCL 3: 

enteroviruses, adenovirus and Mycobacterium avium and removed from CCL 3: Vibrio cholerae and Entamoeba 

histolytica. 

EPA disagrees with the commenter on removing Helicobacter pylori. H. pylori has a total score of 8.0 (out of a 

possible 10) and is well above the cut off of 6.1, therefore, this pathogen remains on the CCL 3. EPA also 

disagrees with the commenter on adding rotavirus to the CCL 3. Rotavirus scored 5.5 due to no CDC WBDO and 

relatively low health effects (see the Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process for more 

information on all the scores).

Furthermore, EPA rescored all pathogens after the Expert Panel met. EPA reviewed and corrected mistakes in 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

The Agency agrees with the commenter that the established protocol to identify potential contaminants for 

regulations provides greater transparency and scientific rigor than an ad-hoc process.

Please see the response to comment ID 18969 under comment code 6100.

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

See the response to comment ID 19338 under comment code 7200. The Agency has also provided a CCL 3 

Universe List in the CCL 3 docket at www.regulations.gov. This list contains all the contaminants considered for 

the CCL 3 and their status in the evaluation. Information collected for individual chemicals on the PCCL and CCL 3 

are listed in the Contaminant Information Sheets also available at www.regulations.gov.

See response to comment ID 19198 under comment code 7150.

Please see responses to comment IDs 19338 and 17297 under comment code 7200. EPA included 

carbamazepine in the CCL 3 Universe; however, although carbamazepine is frequently detected in studies of 

emerging contaminants, it occurs at low levels, and it did not pass screening to the PCCL and did not make the 

Methanol has been included on the final CCL 3. EPA has responded to the specific information and comments 

provided by the Methanol Institute on methanol occurrence under comment code 3860 (see the response to 

comment ID 18847) and on methanol health under comment code 3855 (see the response to comment IDs 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

In general, the criteria for selecting contaminants for the CCL 3 consisted of a multi-step process to determine 

whether the occurrence, or anticipated occurrence, of a contaminant was likely at levels of concern to human 

health. Methanol did pass the occurrence and health effects criteria and based upon these and other data, EPA 

has determined that methanol is known or anticipated to occur in drinking water and may require regulation. 

Therefore, EPA has included methanol on the third CCL. The inclusion of a contaminant on the CCL 3 does not 

necessarily mean that the contaminant will be regulated. As with all contaminants included on the CCL 3, 

methanol will be further evaluated under the regulatory determinations process.
The commenter is correct in noting that a severity score of 6 indicates significant, irreversible, nonlethal 

conditions or disorders for some organs. However, the severity score for methanol was not based on 

alterations to serum enzymes or liver, but is based on the health effect of decrease in brain weight. Appendix A 

of the PCCL to CCL Process Report contains a Compendium of Critical Effects Table that lists a severity score of 6 

for significant decreases in brain weight, separate from scores given to other organs and the irreversible effects. 

Therefore, the severity score for methanol was correctly applied. Based upon these data, EPA concludes that 

methanol is known or anticipated to occur in public water systems and may require regulation. Therefore, EPA is 

In general, the criteria for selecting contaminants for the CCL 3 consisted of a multi-step process to determine 

whether the occurrence, or anticipated occurrence, of a contaminant was likely at levels of concern to human 

health. EPA used prevalence and magnitude as occurrence attributes to describe the potential for a 

contaminant to occur in drinking water (as described in the FR notice for the draft CCL 3). For methanol, there 

was no occurrence information in finished or ambient water, so consistent with the CCL 3 protocol EPA used 

total environmental release data reported in the Toxics Release Inventory (TRI) for 2004 for the magnitude 

attribute and the number of States reporting releases (total) of methanol for the prevalence attribute. EPA 

disagrees with the commenter that consideration for listing [methanol] is likely not based on these health 

effects attributes, but simply because methanol scores highly on the occurrence attributes. The attributes for 

occurrence and adverse health effects taken together were used to evaluate the potential of methanol to occur 

In general, the criteria for selecting contaminants for the CCL 3 consisted of a multi-step process to determine 

whether the occurrence, or anticipated occurrence, of a contaminant was likely at levels of concern to human 

health. EPA used prevalence and magnitude as occurrence attributes to describe the potential for a 

contaminant to occur in drinking water (as described in the FR notice for the draft CCL 3). For methanol, there 

was no occurrence information in finished or ambient water, so consistent with the CCL 3 protocol EPA used 

total environmental release data reported in the Toxics Release Inventory (TRI) for 2004 for the magnitude 

attribute and the number of States reporting releases (total) of methanol for the prevalence attribute. These 

attributes taken together were used to evaluate the potential of methanol to occur in drinking water. 



The commenter provides statistics on the environmental release of methanol from the 2006 TRI reporting. The 

Agency agrees that the amount of methanol released decreased from the 2004 reports. (Surface water: 

5,584,425 lbs in 39 States

Total: 175,205,861 lbs in 52 States) The Agency also notes that the attribute scores and the model results 

would not change based on the 2006 TRI data. 





EPA also conducted a sensitivity analysis to evaluate whether using physical and chemical properties combined 

EPA considered a wide range of health effects, potency values, and occurrence data and scored each chemical 

according to the protocol as discussed in the FR notice and support documents. The data sources used to 

generate scores for methanol are consistent with the protocol and account for the differences in effects at 

specific dosing levels cited by the commenter. The Malcolm Pirnie study cited by the commenter did not meet 

the CCL data requirements based on the hierarchy of data used for the CCL process as discussed in 73 FR 9628.



Therefore, EPA used the IRIS assessment based on the CCL 3 protocols. This assessment is being reviewed by the 

Agency and will provide an assessment of the most up to date information available for methanol and provide 

additional toxicity information that EPA can use to evaluate contaminants on the CCL 3. Based upon these data, 

EPA concludes that methanol is known or anticipated to occur in public water systems and may require 

regulation. Therefore, EPA is including this compound on the CCL 3.
EPA disagrees with the commenter that an analysis indicating that methanol appears to be a more 

environmentally benign fuel compared to conventional gasoline" and Toxic Release Inventory (TRI) data are not 

sufficient to anticipate that methanol can occur in PWS. The Agency uses the best available national occurrence 

data to determine if contaminants are known or anticipated to occur in public water systems. The Agency 

collected data and information that methanol can be anticipated to occur in PWS. TRI data showed total 

releases (200 million pounds) in every state. CUSIUR production data also indicated that over a billion pounds of 

methanol was produced. EPA selected the TRI data as the best available data based on the hierarchy described 

in the FR notice (FR vol 73 no 35). Based on these and other data, EPA has determined that methanol is known 

or anticipated to occur in drinking water and may require regulation. Therefore EPA has included methanol on 

the third CCL. EPA has responded in more detail to the information and comments provided by the Methanol 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

1,3-butadiene has been included on the final CCL 3. The Agency has responded to the specific information and 

comments provided by the ACC on 1,3-butadiene under the response to comment IDs 18861 and 19524 in 

comment code 2630 (1,3-butadiene occurrence) and the response to comment ID 19525 in comment code 6146 

EPA disagrees with the commenter that EPA inappropriately used total TRI releases to determine 1,3-

butadienes potential to occur in drinking water and that EPA should define 1,3-butadienes potential to occur 

in drinking water based on surface water releases. EPA believes that it is appropriate to use total environmental 

release data rather than the total quantity released to surface water to evaluate the potential of a contaminant 

to occur in drinking water, as the use of total environmental release data accounts for any releases to 

groundwater and for the propensity of a compound to migrate within the environment; whereas the use of only 

surface water release data would not take into account the release of a contaminant to groundwater or the 

migration or mobility of a compound. Discussion in the National Drinking Water Advisory Council (NDWAC) 2004 

report supports this: In surface waters, which are exposed to the air, compounds that volatilize will not be 

persistent, simply because they evaporate into the air and are not found in the water. However, in ground 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 18850 under comment code 2620.

Please see response to comment ID 18851 under comment code 2630.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 18850 under comment code 2620.

The commenter correctly identifies the major criteria set forth in SDWA to evaluate unregulated contaminants 

for inclusion on the CCL and the subsequent determination of whether or not to regulate a contaminant. EPA 

disagrees with the commenters assertion that a contaminant must remain on the CCL until a regulatory 

determination is made. The CCL process allows for the re-screening and re-classification of the contaminants 

after publication for public comment. New toxicological and/or occurrence data resulting from changes in 

registration status, production and use, or the best available science may warrant a re-evaluation of the 

contaminant. EPA also notes that there is no procedure set forth in SDWA requiring a contaminant to remain on 

subsequent CCLs. EPA has re-evaluated chemicals on CCL 2 and the draft CCL 3 based upon additional 

toxicological and/or occurrence data. The Agency did not include contaminants on the CCL 3 that the Agency 

does not anticipate or know occurs in PWS and may require regulation under SDWA. In addition, a CCL is 

The Agency disagrees that 1,3-butadiene should not be included on the final CCL3. Please see the response to 

comment ID 18850 under comment code 2620.
EPA used prevalence and magnitude as occurrence attributes to describe the potential for a contaminant to 

occur in drinking water (as described in the FR notice for the draft CCL 3). For 1,3-butadiene, there was no 

occurrence information in finished or ambient water, so consistent with the CCL 3 protocol EPA used total 

environmental release data reported in the Toxics Release Inventory (TRI) for 2004 for the magnitude attribute 

and the number of States reporting releases (total) for the prevalence attribute. These attributes taken together 

were used to evaluate the potential of 1,3-butadiene to occur in drinking water. 



EPA disagrees with the commenter that because 1,3-butadiene is a highly volatile gas and is expected to 

partition predominantly to the atmosphere that EPA should consider using surface water releases in determining 

whether 1,3-butadiene should be listed. EPA believes that it is appropriate to use total environmental release 

data rather than the total quantity released to surface water to evaluate the potential of a contaminant to occur 

in drinking water, as the use of total environmental release data accounts for any releases to groundwater and 

for the propensity of a compound to migrate within the environment; whereas the use of only surface water 

release data would not take into account the release of a contaminant to groundwater or the migration or 

mobility of a compound. Discussion in the National Drinking Water Advisory Council (NDWAC) 2004 report 

EPA disagrees with the commenter that Reliance on TRI release data without considering 1,3-butadiene's 

physical properties and fate has led, however, to the erroneous conclusion that 1,3-butadiene might occur in 

drinking water. 



In developing the draft CCL 3, EPA conducted a sensitivity analysis evaluating options using physical and chemical 

properties combined with environmental fate parameters to consider chemicals. These analyses are described 

in the support documents available in the docket and are the basis for the screening and attribute scoring 

protocols (Contaminant Candidate List 3 Chemicals: Screening to a PCCL. EPA 815-R-08-003 and Contaminant 

Candidate List 3 Chemicals: Classification of the PCCL to the CCL, EPA 815-R-08-004). 



The commenter also suggested that EPA consider 1,3- butadiene and its physical properties. EPA evaluated 1,3-

butadiene using physical and chemical properties combined with environmental fate parameters for the 

magnitude attribute score instead of using total environmental release data. For this analysis, EPA followed the 

CCL 3 protocol for those chemicals with only production data and used the persistence and mobility protocols as 

the basis for the magnitude attribute scoring as described in the FR notice and support documents. The model 

results for 1,3- butadiene using the environmental parameter protocols were the same as the results developed 

for the draft CCL 3 using TRI data.



Please see response to comment IDs 18851 and 18861 under comment code 2630.

Please see the responses to comment IDs 18858 and 18850 under comment code 2620.

Please see response to comment ID 18857 under comment code 9100.

Please see the response to comment IDs 18851 and 18861 under comment code 2630. The commenter states 

that, In most cases, groundwater will also be treated before consumption and discusses the estimated 

removal of 1,3-butadiene from several treatment technologies such as aeration. EPA disagrees that standard 

treatment for groundwater includes air stripping and other methods to remove volatile contaminants. Only 13 

percent of community groundwater system plants reported using aeration (See EPA Table 2A of the 2000 

Community Water System Survey). EPA also believes that it is not appropriate to assume that an unregulated 

contaminant will be removed by all drinking water treatment plants. The Agency notes that there is a wide 

variation in the type of treatment that may be used by systems. Selection of treatment to meet SDWA standards 

are made by systems themselves after consideration of factors such as source water, watershed characteristics, 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
Please see response to comment ID 18869 under comment code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

EPA will consider the information provided by the commenter in its analysis for the regulatory determination 

process. As discussed in the preamble to the Draft CCL 3, (see page 9962) a Regulatory Determination requires 

more information and analyses than the analyses used to support the CCL 3 selection process (for example 

treatment). EPA will conduct analyses to support regulatory determinations beginning after the publication of 

the final CCL 3.



Please see response to comment ID 19058 under topic code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

No response necessary.

Please see the response to comment ID 18874 under comment code 4005.

The CCL process was developed to identify known or possible drinking water contaminants of potential health 

concern. The process followed protocols that utilized health effects and occurrence data from acceptable data 

sources for screening to the PCCL and selection of the draft CCL. The protocols established hierarchies for the 

data used at each step and were applied uniformly for all chemical contaminants, including molybdenum. [See 

the docket documents Chemicals: Screening to a PCCL and Classification of the PCCL to the CCL.] Molybdenum 

was selected for the draft CCL 3 based on these uniformly applied processes.



Placement on the CCL enables EPA to examine the available database for toxicity in a more refined process than 

was used for the CCL in order to determine if a contaminant has sufficient data for regulatory determination. 

This will be the next stage for molybdenum. During this process EPA will have the opportunity to examine 

molybdenums full toxicity database. The information available on concentrations in finished water across the 

nation and effective treatment technologies are equally important during regulatory determination.



The IOM assessment for molybdenum was included in the database used in the PCCL and CCL processes as 

EPA used the best available data which was the National Inorganic and Radionuclides Survey (NIRS) in which the 

prevalence (nine) and magnitude (eight) scores for Molybdenum warranted inclusion on the CCL 3 list. NIRS 

measured finished water concentrations and found that Molybdenum had detections in 77 public water systems. 

The 90th percentile concentration was at 30 ug/l. Additionally, EPA provides a detailed response to your specific 

comments on the health effects under comment code 4005. Please see the response to comment 18874 and 

19146. Based upon these data, EPA concludes that Molybdenum is known to occur in public water systems and 

may require regulation. Therefore, EPA is including Molybdenum on the third CCL.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19338 under comment code 7200.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
EPA did not include the health effects for individuals with marked immunosuppression in its health effects 

scoring protocol. EPAs approach used the most common clinical presentation for the specific pathogen for the 

population category under consideration. EPA also considered the adverse health effects associated with the 

following sensitive sub-populations: infants, children, pregnant women, the elderly, and individuals with a 

history of serious illness as directed by SDWA. The SDWA does not direct EPA to specifically consider individuals 

with marked immunosuppression.

As stated in the draft CCL 3 FRN, nearly all pathogens have very high health effects for the markedly 

immunosuppressed individuals. EPA continues to believe that to prioritize among the 29 pathogens on the 

preliminary CCL based on the health effects on the severely immunosuppressed subpopulation is not a useful 

criterion. Based on public comment submitted on the Draft CCL 3, EPA reconsidered all the PCCL organisms for 

their health effects in the markedly immunosuppressed and found that health effects information on the 

severely immunosuppressed was not available for many (11 of 29) of the PCCL microorganisms. Of the 18 

EPA criteria for evaluating and prioritizing pathogens for inclusion in the CCL 3 included health effects, 

waterborne disease outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). Treatability was not part of the 

scoring criteria considered for CCL 3 inclusion.

Criteria described by the commenter do not apply to the CCL 3 Selection process. They apply to the regulatory 

determination process. As discussed in the preamble to the Draft CCL3, (see page 9962) a Regulatory 

Determination requires more information and analyses than the analyses used to support the CCL3 selection 

process. EPA will conduct analyses to support regulatory determinations beginning after the publication of the 

final CCL 3.



EPA disagrees with the comment on meaningful opportunity for health risk reduction. The SDWA language 

cited by the commenter does not apply to the CCL process, but rather to the decision whether to regulate. 



Certain pathogens may be well controlled by drinking water treatment (primarily disinfection), however, not all 

public water systems are required to treat. Ground water systems make up the greatest portion of public water 

systems and most of them do not treat. As discussed in detail in the draft CCL 3 (see page 9648), EPA did not 

preclude pathogens from CCL 3 based on their potential to be controlled by existing treatment technique 

regulations. As discussed in the preamble to the Draft CCL 3, (see page 9629) a Regulatory Determination 

requires more information and analyses than the analyses used to support the CCL 3 selection process. EPA will 

conduct analyses to support regulatory determinations beginning after the publication of the final CCL 3.

EPA disagrees with the comment and believes that the adequacy and effectiveness of regulating N. fowleri 

cannot be determined this early stage of the process. EPA acknowledges the particular conditions in which N. 

fowleri thrives in the environment, however, N. fowleri is on the CCL 3 due to its high score under the CCL 3 

scoring process. EPA criteria for evaluating and prioritizing pathogens for inclusion in the CCL 3 included health 

effects, waterborne disease outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). Pathogens scored high in 

these factors resulted in a decision to list on CCL 3. N. fowleri has most severe health effects and it has been the 

cause of a WBDO as documented by CDC (CDC MMWR 2001  2002).



EPA will evaluate pathogens regarding the potential effectiveness of regulation as part of regulatory 

determination process.

Finally, using the CWA to issue guidance as the commenter recommended is not within the scope of this CCL 

action (required under the SDWA).

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
Please see the responses to comments 18874 and 19146 under comment code 4005.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

As discussed in the preamble to the Draft CCL 3, (see page 9962) a Regulatory Determination requires more 

information and analyses (for example treatment) than the analyses used to support the CCL 3 selection process. 

EPA will conduct further analyses to support regulatory determinations. The Agency will evaluate contaminants 

on the final CCL 3 to determine whether or not they require a national drinking water regulation based upon the 

criteria specified in the SDWA which requires the Agency to promulgate a national primary drinking water 

regulation if EPA determines that: (1) The contaminant may have an adverse effect on the health of Persons; (2) 

The contaminant is known to occur or there is a substantial likelihood that the contaminant will occur in public 

water systems with a frequency and at levels of public health concern; and (3) In the sole judgment of the 

Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reduction for 

persons served by public water systems. The Agency also recognizes the amount of effort and resources required 

to develop risk assessments for chemicals that occur in drinking water with a frequency and at levels of public 

health concern. As the Agency considers whether or not regulation of a contaminant provides a meaningful 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

No response necessary. Please see response to comment ID 18886 under comment code 2100.

Please see response to comment ID 19065 under comment code 9100.

Please see response to comment ID 18886 under comment code 2100.

Thank you for the information on PFOA. Based upon these and other data the Agency has determined that PFOA 

is known or anticipated to occur in public water systems and may require regulation. Therefore EPA is including 

this compound on the CCL 3. PFOA will be further evaluated under the regulatory determinations process.

Please see response to comment ID 19138 under comment code 4515.

See response to comment 18891 under comment code 4520.

Please see response to comment ID 19138 under comment code 4515.

EPA is developing a new risk assessment for 1,2,3-trichloropropane, which will consider the available cancer data 

including the NTP study results. EPA is committed to using sound science in the preparation of its IRIS risk 

assessments. The 1,2,3-trichloropropane IRIS Risk assessment will be available once the Agency has completed 

the appropriate reviews to assure the quality of the assessment, and it will be used to further evaluate this 

Based upon these and other data evaluated for the CCL, EPA concludes that 1,2,3- trichloropropane is known or 

anticipated to occur in public water systems and may require regulation. Therefore, EPA is including this 

The Commenter is correct in noting that the EPA Health Advisory from 1989 and the current IRIS summary have 

not provided a cancer grouping or quantitative risk value for 1,2,3-trichloropropane. The Agency will update the 

Drinking Water Regulations and Health Advisory Tables to correspond with the updated IRIS risk assessment 

following the completion of the peer-review process and uploading of the final assessment for 1,2,3-

trichloropropane on the IRIS database. While the EPA has been completing its risk assessment, some state 

agencies have established risk values based on the cancer endpoint. The CCL 3 protocol places the existing EPA 

assessments higher in the data hierarchy than those from other organizations because regulatory determination 

for chemicals on the CCL has used an EPA health risk assessment. The Agency will continue to use the best 

available science and information to evaluate contaminants on the CCL 3, including any updates to the IRIS risk 

assessment. The Agency will then determine if the information is sufficient for the Agency to make a regulatory 

determination.



Also, see the response to comment ID 18897 under comment code 2595. 

See the response to comment IDs 18897 and 18899 under comment code 2595.
The Agency is including MTBE on the CCL 3. EPA identified information gaps needed to make further 

determinations for MTBE in the July 30 2008 Federal Register notice announcing the Regulatory Determinations 

Regarding Contaminants on the Second Drinking Water Contaminant List (FR Vol 73. No. 147, p. 44260). EPA has 

not yet made any regulatory determination for MTBE. EPA is currently preparing an IRIS risk assessment for 

MTBE. EPA published a drinking water Advisory for MTBE in 1997. EPA also published a summary of the status of 

the regulatory determination from MTBE in May 2007(FR vol72 No 83 p24049) . 

Based upon these data, EPA concludes that MTBE is known or anticipated to occur in public water systems and 

may require regulation. Therefore, EPA is including this compound on the CCL 3. EPA identified health effects 

information gaps needed to make further determinations for MTBE in the July 30, 2008 Federal Register notice 

announcing the Regulatory Determinations Regarding Contaminants on the Second Drinking Water 

Contaminant Candidate List (73 FR 44260). EPA has not yet made any regulatory determination for MTBE. EPA 

is currently preparing an IRIS risk assessment for MTBE that includes a review of the Belpoggi et al. (1998) study 

and the other available studies on MTBE relevant to its drinking water exposure. EPA also published a summary 

of the status of the regulatory determination for MTBE in the preliminary regulatory determinations for 

contaminants on the CCL 2 published in May 2007 (72 FR 24049).



The Agency will continue to use the best available science and information to evaluate contaminants on the CCL 

Please see comment ID 18901 under comment code 3910.

Please see the response to comment ID 19068 under comment code 4450.

Please see the response to comment ID 19068 under comment code 4450.

In October 2008, EPA published a proposed determination that developing a National Primary Drinking Water 

Regulation for perchlorate was not necessary. Based upon the comments that were received in response to that 

notice, and because of evolving science on perchlorate, EPA is revisiting this determination. A notice was 

published in August 2009 requesting public comments on key issues regarding the evaluation of perchlorate. The 

appropriate life stage upon which to base the assessment of perchlorate was one of the issues included in that 

Please see the response to comment ID 19068 under comment code 4450.

No response necessary

Ethylene Glycol is not subject to a federal MCL and is thus eligible for the CCL process. The Agency uses the best 

available science and information to evaluate and list drinking water candidate contaminants. The Agency also 

notes that including a contaminant on the draft or final CCL 3 does not impose any requirements on anyone. (73 

FR 9629). Under SDWA 1412 (b)(1)(B)(ii) EPA makes a separate determination whether or not to regulate a 

contaminants before proposing and promulgating a National primary drinking water rule. The Agency will 

continue to use the best available science and information to evaluate contaminants on the CCL 3 including any 

updates to the IRIS risk assessment to determine if the information is sufficient for the Agency to make a 

EPA appreciates the information that the NJDEP provided on their risk assessment for 1,1-dichloroethane. U.S. 

EPA has not set a reference dose for this chemical. The information that NJDEP has provided on the derivation of 

their RfD and MCL will be useful in EPAs post- CCL 3 evaluation of the toxicity of this chemical and discussion of 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 19136 under comment code 4510 and comment ID 18914 under 

comment code 4520 PFOA occurrence. 
Since the Agency published the draft CCL 3, it has issued Provisional Health Advisories for PFOA and PFOS in 2009 

to provide technical information to State and local officials and PWSs for consideration in addressing local 

contamination of drinking water to protect public health. This basis for the provisional Health Advisory is a 

LOAEL 0.460 mg/kg day (Lau et al 2006), not the 1 mg/kg day-1 LOAEL from EPAs draft risk assessment that was 

used for the draft CCL 3. EPA also derived extrapolation factors for toxicokinetics to better approximate internal 

doses for PFOA in the Provisional Health Advisory. EPA included this step because of the marked differences in 

retention time among humans and the test species in which toxicologic data were collected as noted by the 

commenter. [Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS): Provisional Health Advisory 

http://www.epa.gov/waterscience/criteria/drinking/]. This information has been used to develop the Final 

Contaminant Candidate List (CCL) 3 and is included in the docket and Contaminant Information Sheets for PFOA. 



EPA disagrees that the relative source contribution (RSC) value that EPA used to calculate the health reference 

level (HRL) for PFOA does not follow EPA guidance and that EPA's calculation approach could influence future 

regulatory activity. EPA notes that the commenter stated and recognizes that EPA used this HRL for CCL 

The Agency disagrees that an inappropriate measure was used to include PFOA on the draft CCL 3. The Agency 

uses the best available science and information to evaluate and list drinking water candidate contaminants. The 

commenter states that In using Minnesota prevalence data and West Virginia magnitude data, EPA has derived 

a measure of occurrence for PFOA that does not actually exist in the environment, which creates an artificial and 

inaccurate impression of the extent of PFOAs occurrence in drinking water. The commenter suggested that 

the Agency should use occurrence and magnitude data that actually occur simultaneously in the environment. 

The contaminant information sheets correctly cite that the Minnesota data was used to derive both the 

prevalence and magnitude attribute scores for the models. The CCL process also employs consistent 

development of a health reference level/concentration ratio for all contaminants that had been detected in 

water, either ambient or finished water, in addition to the models. As described in the supporting materials, 

Please see the response to comment ID 19136 under comment code 4510 and comment ID 18914 under 

comment code 4520 PFOA occurrence.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Ethylene oxide and ethylene glycol have been included on the final CCL 3. The Agency has responded to the 

specific information and comments provided by the American Chemistry Council (ACC) on ethylene glycol and 

ethylene oxide under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene 

Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 

3585 Ethylene Oxide health (comment ID 18925), 3590 Ethylene Oxide occurrence (comment IDs 19521 and 

Ethylene oxide has been included on the final CCL 3. The Agency has responded to the specific information and 

comments provided by the American Chemistry Council (ACC) on ethylene oxide under the respective comment 

codes: 3585 ethylene oxide health (comment ID 18925) and 3590 ethylene oxide occurrence (comment IDs 

Please see response to comment ID 18928 under comment code 3555.

The Agency has responded to the specific information and comments provided by the ACC on ethylene oxide and 

ethylene glycol under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene 

Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 

3585 Ethylene Oxide health (comment ID 18925), and 3590 Ethylene Oxide occurrence (comment IDs 19521 and 

Please see response to comment ID 18857 under comment code 9100.

See response to comment ID 18919 under comment code 3580.

No response needed to the commenters characterization of the CCL 3 process.
The commenter reports that EPA used the oral slope factor of 0.31 per mg/kg/day currently available from the 

California Office of Environmental Human Health Agency (OEHHA) Toxicity Criteria Database in scoring for 

potency for ethylene oxide. However, the commenter questions the above slope factor in light of the recent 

assessment from the Office of Pollution Prevention and Toxic Substance and the Office of Research 

Development (ORD). The commenter makes a point that EPA should use the new unit risk numbers that have 

been derived by ORD for the lung tumors observed in male mice and brain tumors observed in male rats, after 

correcting these numbers to a slope factor that is appropriate for an oral route of administration.



For the draft CCL 3, EPA followed the CCL 3 protocol in the scoring for the health effects for ethylene oxide. 

Ethylene oxide received a score of 6 for potency and 8 for severity. The commenter is correct that EPA used the 

oral slope factor of 0.31 per mg/kg/day based on rat mononuclear cell leukemia (MCL) available from OEHHA 

Toxicity Criteria Database at the time the CCL 3 analysis was done. This oral slope factor was derived from the 

extrapolation of inhalation slope factor of 8.80E-05 per μg/cubic meter, for MCL in rats.



Ethylene glycol has been included on the final CCL 3. EPA disagrees with the commenter that ethylene glycol 

should not have moved from the Universe to the PCCL. This is discussed in more detail under the respective 

responses to comment codes: 3555 Ethylene Glycol health (comment IDs 18920, 19520, and 18928), and 3560 

Ethylene Glycol occurrence (comment ID 18929).

EPA disagrees with the commenters opinion that ethylene glycol should be categorized as toxicity category 5 

rather than toxicity category 4 and removed from further consideration. EPA developed the screening protocol 

and toxicity categories to create a framework that was versatile and as simple as possible to identify chemicals 

with categorical or limited data for further evaluation. In using the most conservative toxicological value in the 

screening step the Agency believes that public health is protected and additional resources can then be applied 

to evaluate compounds that passed the screening framework to determine the best available scientific 

information for that compound. 



As the commenter notes, for ethylene glycol, the World Health Organization (WHO) TDI was used for the 

screening as indicated in the protocol described in Contaminants Candidate List 3 Chemicals: Screening to PCCL. 

That value falls in toxicity category 4. It is also correct that EPA used the IRIS RfD as the toxicological value to to 

assign the potency and severity scores used in evaluating the PCCL. This too is consistent with the protocols. The 

use of the WHO TDI for screening had no impact on the selection of ethylene glycol for inclusion on CCL 3 since it 

***Cadmus: Please move response from "response to comment code" section to this comment ID***

Please see response to comment ID 19501 under comment code 6160. Please see response to comment ID 

18929 under comment code 3560 Ethylene glycol occurrence.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 18933 under comment code 4005.

Please see the response to comment IDs 18874 and 19146 under comment code 4005.

EPA agrees that there are long term sequelae associated with Legionella and consequently scored Legionella 

very high on health effects (including long term sequelae) as well as the overall score. Therefore, Legionella 

The likelihood that a contaminant may be anticipated to occur in a public water system (PWS) is one of the 

criteria required by the Safe Drinking Water Act (SDWA). EPA evaluated over 6,000 chemicals to identify those 

that the Agency anticipates may occur in PWSs and require regulation. Under SDWA 1412 (b) (1)(B)(ii), EPA 

makes a separate determination whether or not to regulate a contaminant before proposing and promulgating a 

National primary drinking water rule. The Agency will continue to use the best available science and information 
EPA considered over 6,000 chemicals as it developed the Draft CCL 3. The Agency did not consider including 

broad groups of chemicals to the CCL 3 due to variability in chemical composition and how that variability may 

affect occurrence and toxicological profiles within the group of chemicals. Therefore, the Agency did not 

evaluate large groups such as endocrine disruptors or pharmaceuticals. However, the EPA did evaluate individual 

chemicals within those groups. The Agency also evaluated data and information provided by commenters and 

added nine hormones to the CCL 3 because these hormones were detected in drinking water and may require 

regulation. The Agency did not include bisphenol A or any of the polyalkoxalated phenolics on the CCL 3 due to 

the limited occurrence and health effects information. For additional information on the Agencys evaluation of 

pharmaceuticals please see the response to comment ID 19338 under comment code 7200.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 18939 under comment code 2100.

The Agency will consider your concerns to protect public health as it further evaluates contaminants on the final 

CCL 3. The Agency agrees that the protection of public health is a primary goal of the Drinking water program. 

The Contaminant Candidate List is the first step in identifying contaminants that may require regulation. The 

SDWA instituted the CCL and Unregulated Contaminant Monitoring Rule programs to provide information it 

needs to determine which potential drinking water contaminants present the greatest danger to human health 

and therefore, represent the highest priorities for future drinking water regulation. The CCL is the primary 

mechanism for the identification of these contaminants that may require regulation. Every 5 years, the UCMR 

provides EPA with the national occurrence data in public water systems necessary to determine if a contaminant 

occurs with a frequency and at a level of public health concern. The SDWA also provides EPA with the authority 

to require monitoring of unregulated contaminants under the UCMR. However, SDWA limits the list of 

Please see response to comment ID 18939 under comment code 2100.

Please see response to comment ID 18939 under comment code 2100.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 19136 and 19139 under comment code 4510.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment IDs 19137 and 19580 under comment code 7180.

Please see response to comment ID 19138 under comment code 4515.

Please see the response to comment ID 19136 and 19139 under comment code 4510.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

EPA concludes that three types of cyanotoxins: microcystin, cylindrospermopsin and anatoxin-a, are known or 

anticipated to occur in public water systems and may require regulation. Therefore, EPA is including these 

EPA thanks the commenter for the information provided. The work of WHO is being considered as part of an 

ongoing toxicological review of several Cyanotoxins by EPA. Please see response to comment ID 19016 under 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19058 under topic code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
EPA did not include chloramine in the universe of contaminants considered for CCL 3 because it is regulated 

under 40 CFR 141.65. The Safe Drinking Water Act specifies that CCL contain only unregulated contaminants. The 

Agency also notes that monochloramine, dichloramine, and trichloramine are included in the regulation of 

chloramine. Please see the response to comment ID 18956 under comment code 6180. 

SDWA, as amended in 1996, requires the EPA to develop a list of currently unregulated contaminants that may 

require regulation. Chloramine is a regulated disinfectant (40 CFR 141.65) and was therefore not considered for 

the CCL. EPA provided a list of the Universe of Contaminants considered in the docket and that list is available at 

EPA did not consider chloramine in the universe for the CCL 3. Chloramines are regulated under 40 CFR. The Safe 

Drinking Water Act (SDWA) specifies that the CCL contain only unregulated contaminants. The Agency also notes 

that monochloramine, dichloramine, and trichloramine are included in the regulation of chloramine. Please see 

response to comment ID 18956 under comment code 6180. The Agency does have a similar process to evaluate 

regulated contaminants. SDWA Section 1412(b)(9) requires the Agency to review and revise, as appropriate, 

each national primary drinking water regulation every six years. SDWA also requires that the revision maintain, 

or provide for greater, protection of the health of persons.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19058 under topic code 7840.





Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19058 under topic code 7840.

Please see the response to comment ID 19388 under comment code 6166. EPA only used mobility and 

persistence data to evaluate contaminants when measured occurrence or environmental release data were not 

available. As discussed in support documents available in the docket (Contaminant Candidate List 3 Chemicals: 

Classification of the PCCL to CCL at www.regulations.gov EPA-HQ-OW-2007-1189), the Agency selected the 

highest scores for both persistence and mobility unless those values were not representative of environmental 

conditions in drinking water. The Agency believes that by using the highest scores for these surrogate data to 

evaluate the possible occurrence of chemicals, it has taken a conservative approach that brings more chemicals 

into the Agencys evaluation and accounts for the commenter's recommendation that using a pH-dependent 

value for mobility may bring more hydrophilic contaminants under the evaluation. The Agency also believes that 

choosing the highest possible scores accounts for the variability in scoring pH-dependent factors across the 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
Please see response to comment ID 19338 under comment code 7200.

The Contaminant Candidate List is the first step in identifying contaminants that may require regulation. The 

SDWA instituted the CCL and Unregulated Contaminant Monitoring Rule programs to provide the information it 

needs to determine which potential drinking water contaminants present the greatest danger to human health 

and therefore, represent the highest priorities for future drinking water regulation. The CCL is the primary 

mechanism for the identification of these contaminants that may require regulation. Every 5 years, the UCMR 

provides EPA with the national occurrence data in public water systems necessary to determine if a contaminant 

occurs with a frequency and at a level of public health concern. The SDWA also provides EPA with the authority 

to require monitoring of unregulated contaminants under the UCMR. As discussed in the preamble to the Draft 

CCL3, (see page 9962) a Regulatory Determination requires more information and analyses (for example 

treatment) than the analyses used to support the CCL3 selection process. The Agency will evaluate contaminants 

Please see response to comment ID 18977 under comment code 1000.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

EPA acknowledges receipt of your comment attachment and has responded to your specific information and 

comments under the respective comment codes: 7200 Pharmaceuticals and Personal Care Products (not on 

CCL3) (comment ID 19551) and 6100 Classification Approach for Chemicals (comment ID 18969).

This comment also appears under topic code 7200 - Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

EPA agrees that the CCL is an important step in the regulatory development process. EPA acknowledges the 

potential for synergistic effects, as well as antagonistic effects, from co-occurring contaminants and is working to 

improve the methodologies to consider such effects. However, at this time, the methodologies are not robust 

enough to permit the consideration of potential cumulative health effects for the CCL process. 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

EPA acknowledges the commenters concern about the two metolachlor metabolites [(Metolachlor 

ethanesulfonic acid (ESA) and Metolachlor oxanilic acid (OA)] listed on the Draft CCL 3. Please see response to 

comment ID 19247 under comment code 3940.

Please also see the response to comment ID 19247 under comment code 3940 (Metolachlor and its degradates 

ESA and OA). EPA uses the best available science and information to evaluate and list drinking water candidate 

contaminants. The CCL 3 process for the chemicals, that comprised the universe, relied on readily accessible 

sources of health effects and occurrence data, which could be retrieved for the evaluation. The Agency then 

used the hierarchy described for the screening and classification steps in 73 FR 9636 and 73 FR 9369, 

respectively, to further evaluate potential contaminants. Accordingly, the data cited by the commenter was not 

included in the evaluation. The agency relied on final Office of Pesticide Programs (OPP) registration eligibility 

documents or IRIS risk assessments when available, rather than submitting individual studies to the OPP for 

evaluation.



The Agency also notes that the health risk evaluations for the metolachlor degradates do recognize their lower 

toxicity than the parent pesticide. The potency score for each of the two metolachlor degradates is 2, and the 

severity score for each is 1. In the case of metolachlor, the potency score is 4 and the severity score is 3. 

EPA has kept Helicobacter pylori on the CCL 3.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
Comment is not germane to the CCL but in response EPA provides the following information. As an outcome of 

the recommendations from the M/DBP FAC EPA, in collaboration with industry partners, developed a series of 

distribution system white papers to better understand the potential public health risks from a range of drinking 

water distribution system issues. Following the development of the white papers, EPA convened an exposure 

assessment expert workshop to identify some of the key influences that may lead to exposures and potential 

public health risks from drinking water distribution system issues, as well as the establishment of a National 

Academy of Sciences (NAS) panel, which assessed the potential risks from drinking water distribution systems. 

The NAS provided research recommendations in their final report. Between July 2007 and September 2009, EPA 

convened the Total Coliform Rule/Distribution Systems Advisory Committee (TCRDSAC) to advise and make 

recommendations on what information is needed to better understand the public health impact from the 

Based upon the best available data EPA identified contaminants for the final CCL 3 that are known or anticipated 

to occur in public water systems and may require regulation. EPA considered the potential for the contaminants 

to cause adverse health effects including cancer.

Under SDWA 1412(b)(1)(B)(ii)EPA makes a separate determination on whether or not to regulate a contaminant. 

The Agency will continue to use the best available science and information to evaluate contaminants on the CCL 

3 to determine if the information is sufficient for the Agency to make a regulatory determination. 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 18939 under comment code 2100.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Chloramine is regulated under the Safe Drinking Water Act (SDWA); thus it is not a candidate for the CCL 3. The 

Agency is aware of the heath concerns regarding chloramine use as a disinfectant and is in the process of 

updating the 1994 Criteria Document to include recent literature on health effects. The 1994 document is 

available on the EPA website at http://www.epa.gov/ncea/pdfs/water/chloramine/dwchloramine.pdf. EPA will 

review the updated information in its regulations regarding limits for chloramine and take appropriate action. No 

water supply is required to use chloramine. Water suppliers may choose effective disinfection treatment to 

meet federal standards based on local water quality and cost considerations.

Chloramine is regulated under the Safe Drinking Water Act (SDWA); thus it is not a candidate for the CCL3. The 

Agency is aware of the continued health concerns regarding chloramine use as a disinfectant and is in the 

process of updating the 1994 Criteria Document to include recent literature on health effects. The 1994 

document is available on the EPA Web site at 

http://www.epa.gov/ncea/pdfs/water/chloramine/dwchloramine.pdf. In addition EPA has just released an 

updated version of frequently asked Questions and Answers on chloramine as a disinfectant in drinking water; it 

is available online at: http://www.epa.gov/ogwdw/disinfection/chloramine/index.html. EPA will review the 

updated information regarding chloramine and take appropriate action as part of its periodic review of existing 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

See comment 18981 under comment code 7130 for response

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 19050 under comment code 2460.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 18939 under comment code 2100.

The commenter correctly summarizes the CCL 3 process and no further response is necessary.
EPA evaluated substances registered as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Acts 

as required by SDWA for the CCL 3. The draft CCL 3 contained 42 pesticides and or degradates. The first CCL 

listed 23 pesticides and degradates. The draft FR notice (62 FR 52195) identified, but did not list, an additional 35 

pesticides that were deferred for further evaluation. EPA concluded that 40 pesticides and/or their degradates 

are known or anticipated to occur in PWSs and may require regulation. Therefore, EPA has included them on the 

The Agency disagrees with the commenter that the Agency has failed to enforce testing or set standards for 

unregulated contaminants. The Contaminant Candidate List is the first step in identifying contaminants that may 

require regulation. The SDWA instituted the CCL and Unregulated Contaminant Monitoring Rule programs to 

provide the information it needs to determine which potential drinking water contaminants present the greatest 

danger to human health and therefore, represent the highest priorities for future drinking water regulation. The 

CCL is the primary mechanism for the identification of these potential health hazards. Health effect is not the 

only criterion EPA must consider for making a CCL listing or regulatory determination. Page 9629 of the draft CCL 

3 Notice in the Federal Register discusses the three SDWA criteria to determine whether a contaminant may 

require regulation. The UCMR provides EPA with the national occurrence data in public water systems necessary 

to determine if a contaminant occurs with a frequency and at levels of health concern. The Agency completed 

The commenter correctly summarizes the process to comment on the draft CCL 3 and no further response is 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19058 under comment code 7840.



Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19058 under comment code 7840.



Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19058 under comment code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19058 under comment code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19058 under comment code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
Please see response to comment ID 19058 under comment code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements.

EPA is developing toxicological reviews for three cyanotoxins: anatoxin-a, cylindrospermopsin and microcystins. 

[Toxicological Reviews of Cyanobacterial Toxins: Anatoxin-a, Cylindrospermopsin and Microcystins (LR, RR, YR 

and LA) (External Review Drafts).] The peer review drafts of these documents are available at: 

http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=161263. All three documents have been peer reviewed 

and EPA is making revisions to the documents in response to the peer review comments and information from 

recent publications. Based upon these and other data, EPA concludes that cyanotoxins are known or anticipated 

to occur in public water systems and may require regulation. Therefore EPA is including this group of compounds 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

EPA disagrees with the statement: DAS believes existing regulation of tebufenozide by EPA under FIFRA and 

FEPCA is adequate to protect the environment and human health, including drinking water, and does not believe 

additional regulation under SDWA is warranted. As part of the SDWA, Section 1412 (b) (1)(B)(i) requires EPA to 

consider pesticides that are regulated under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). 

Regulation of a pesticide product under EPAs pesticide program does not exempt it from consideration for the 

CCL. While the label restrictions reduce the likelihood that it will contaminate water, they do not prevent 

contamination. Tebufenozide was listed because the best available health effects and occurrence data showed 

that it was known or anticipated to occur in drinking water and it may require regulation. 

See the response to comment 19019 under comment code 4720.

EPA disagrees with the commenter. Tebufenozide is included in the CCL 3 on the basis of its chronic toxicity, 

potential occurrence in drinking water estimated from annual release (lbs/year), and number of States with 

releases. An RfD of 0.018 mg/kg/day was established on the basis of a NOAEL of 1.8 mg/kg/day from a chronic 

toxicity study in dogs and the use of a total uncertainty factor of 100 to account for intra- (10 x) and interspecies 

(10 x) variations. Growth retardation, alterations in hematological parameters, changes in organ weights, and 

histopathological lesions in the bone, spleen and liver were observed at the LOAEL of 8.7 mg/kg/day in this study 

(64 FR 56690: Tebufenozide; Benzoic Acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl) hydrazide; 

Pesticide Tolerance). Based upon these data, EPA concludes that Tebufenozide is known or anticipated to occur 

in public water systems and may require regulation. Therefore, EPA is including this compound on the CCL 3.



See the response to comment ID 19019 under comment code 4720.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 18939 under comment code 2100.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Based upon these and other data evaluated by the Agency, EPA concludes that the ESA and OA metabolites of 

alachlor, acetochlor and metolachlor are known or anticipated to occur in public water systems and may require 

regulation. Therefore EPA is including this compound on the CCL 3.
EPA acknowledges the commenters request to add dimethanamid and its ESA and OA metabolites to the CCL3. 

Dimethanamid was among over 6,000 contaminants considered for inclusion on the CCL. However, 

dimethenamid did not pass the screen to move on to the PCCL. The release data from the National Center for 

Food and Agricultural Policy and available health effects data did not meet the criteria for dimethenamid to be 

considered for the PCCL. EPA has not received any additional data on the occurrrence or health effects for 

dimethenamid. Therefore the Agency is not including dimethenamid on the CCL 3. 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

For purposes of the CCL 3 evaluation process, fenamiphos will remain on the CCL 3 based on its health reference 

level to occurrence in water ratio. EPA used the reference dose of 0.0001 mg/kg/ day to produce an HRL of 0.7 

ug/L for fenamiphos. When the HRL was compared to the modeled occurrence estimate in water (13.7 ppb for 

surface water and 0.47 ppb for ground water) the ratio is less than 10. These protocols and data are included in 

the CCL 3 docket [See CCL 3 Chemicals: Classification of the PCCL and CCL 3 Contaminant Information Sheets 

Docket ID EPA-HQ-OW-2007-1189-0042]



The registrant has voluntarily withdrawn the registration and existing stock of fenamiphos containing products 

will no longer be distributed or sold after November 30, 2008 (73 FRN 34742 June 18, 2008). The fate 

properties of fenamiphos indicate that it biodegrades slowly, has a moderate octanol-water partitions 

coefficient and can accumulate in sediment. Since fenamiphos is persistent in the environment and it will take 

some time before all of the existing stock of fenamiphos containing products are depleted, it still has the 

EPA continued to incorporate elements of the National Drinking 

Water Advisory Council (NDWAC) recommendations and adopted the 

guiding inclusionary principles in developing the Drinking 

Water Contaminant Candidate List 3 (CCL 3).

The commenter accurately summarizes the data sources and contaminants in the CCL universe considered by 

EPA. No response necessary.

The commenter accurately summarizes the screening steps for CCL. No response necessary.

No response necessary.

No response necessary.

The CCL process allows for the re-screening and re-classification of the contaminants after publication for public 

comment. New toxicological and/or occurrence data resulting from changes in registration status would warrant 

a re-evaluation of the contaminant. EPA has re-evaluated chemicals on the draft CCL 3 based upon additional 

toxicological and/or occurrence data. In addition, the list is reissued every 5 years allowing for periodic rescreening of contaminants based on new information.



EPA re-evaluated fenamiphos based on information provided by commenters. Please see the response to 

comment ID 19032 under comment code 3640 for a detailed response. Based upon the new evaluation, EPA 

concludes that fenamiphos is known or anticipated to occur in public water systems and may require regulation. 

Therefore, EPA is including this compound on the CCL 3.

The commenter accurately summarizes the data sources and number of contaminants in those sources initially 

considered by EPA. No response necessary.

The commenter accurately summarizes the screening steps for CCL. No response necessary.

The commenter correctly summarizes the types of toxicological data evaluated in the CCL 3 process and the 

toxicity categories used to screen contaminants to the PCCL.
EPA agrees with commenters statement that the Agencys multi-step process of identification, screening, and 

evaluation of chemical contaminants, has been successful at encompassing a balanced scope as well as satisfying 

the inclusionary principle of toxicological data in the 'draft CCL' for the Organophosphorus class of compounds. 

The final CCL reflects this process. 

Please see responses to comment IDs 19032 and 19045 under comment code 3640. EPA also notes that 

Population Adjusted Dose (PAD) developed under the Food Quality Protection Act, as cited by the commenter, 

was 1. Therefore, the PADs are identical to the RfDs used in the analyses for the draft and final CCL 3 and 

provided in the Contaminant Information Sheet available in the docket at www.regulations.gov. Therefore the 

Agency anticipates that fenamiphos may occur in PWSs and may require regulation. Therefore fenamiphos is 

The toxicity category 2 would not be changed by mitigating all dietary risks of fenamiphos. All of the toxicity 

data for fenamiphos: RfD, NOAEL, LOAEL and LD50 place fenamiphos in Toxicity Category 2 following the 

guidelines used for screening to the PCCL. The dietary exposure from residues does not have an impact on the 

Toxicity Category It is based the dose-response related toxicity data such as the parameters listed above. These 

protocols and data are included in the CCL 3 docket [See CCL 3 Chemicals: Screening to a PCCL.

The commenter correctly identified the categories of occurrence data used to evaluate unregulated 

contaminants for the CCL 3.

In developing the draft CCL 3 the Agency relied on modeled estimates for the environmental concentration of 

fenamiphos and health effects data developed for the registration eligibility document. EPAs evaluation is 

discussed in detail in the response to comment IDs 19032 and 19045 under comment code 3640. Based upon 

these data, EPA concludes that fenamiphos is known or anticipated to occur in public water systems and may 

require regulation. Therefore EPA is including this compound on the CCL 3. 

See the response to comment ID 19032 under comment code 3640.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Among chemicals considered for the third Contaminant Candidate List (CCL 3) several disinfection byproducts 

(DBPs) believed to be associated with the use of chloramine were evaluated. Based on available toxicity and 

monitoring information, N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine NDEA, N-nitroso-di-npropylamine (NDPA), N-Nitrosodiphenylamine, N-nitrosopyrrolidine (NPYR) and hydrazine were placed on the 

CCL 3. (N-nitrosodimethylamine (NDMA) has been determined to be a probable human carcinogen based on 

evidence of its carcinogenicity in animals; the cancer risk profile for NDMA, as well as the other N-nitrosamines 

listed on the CCL 3, is available online on EPAs website in the Integrated Risk Information System (IRIS) at 

http://cfpub.epa.gov/ncea/iris/index.cfm. Hydrazine has also been deemed a probable human carcinogen based 

on evidence of its carcinogenicity in animals, and the cancer risk profile for Hydrazine is also available on IRIS.) Of 

the N-nitrosamines listed on CCL 3 all but one, N-nitrosodiphenylamine, are being monitored for under the 

second Unregulated Contaminant Monitoring Regulation (UCMR 2). N-nitrosodiphenylamine lacks a monitoring 

method. 

The Contaminant Candidate List (CCL) is intended as a list of potential candidates for regulation and future 

research. When the CCL 3 list becomes final, EPA will use this list of unregulated contaminants to help prioritize 

research and data collection efforts to help the Agency determine whether it should regulate specific 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 19068 under comment code 4450.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
The SDWA requires EPA to publish a list of unregulated contaminants that may require regulation. Chloramine is 

regulated under the Safe Drinking Water Act (SDWA), and thus is not a candidate for placement on the CCL. The 

Agency is aware of the continued heath concerns regarding chloramine use as a disinfectant and is in the process 

of updating the 1994 Criteria Document to include recent literature on health effects. The 1994 document is 

available on the EPA Web site at http://www.epa.gov/ncea/pdfs/water/chloramine/dwchloramine.pdf. In 

addition EPA has just released an updated version of frequently asked Questions and Answers on chloramine as 

a disinfectant in drinking water; it is available online at: 

http://www.epa.gov/ogwdw/disinfection/chloramine/index.html. EPA will review the updated information 

regarding chloramine and take appropriate action as part of its periodic review of existing regulations. Please see 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19412 under comment code 2260.



Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

EPA notes that there is no EPA effort to monitor M. avium in the water supply at this time. Monitoring, required 

by EPA, generally would only begin for pathogens placed on the UCMR, or for compliance purposes after 

promulgation. For more information on these actions, please see page 9629  9630 of the draft CCL 3.

The information provided by the commenter on increasing cases of NTM (due to M. avium) was not considered 

because EPA did not factor in the frequency of disease as a criterion for the CCL 3. In addition, the information 

provided by the commenter on individual cases with severe health effects were not considered by EPA because 

EPA considered the common clinical manifestation of the disease (see page 9646 of the draft CCL 3 for more 

detail) rather than the extreme manifestation. EPA may consider such information during the Regulatory 

Determination process. EPA will conduct analyses to support regulatory determinations beginning after the 

publication of the final CCL 3 (see page 9629 and 9962 of the draft CCL 3 notice).



Based on comments, EPA changed the pathogens listed on the final CCL 3. EPA removed older, CDC waterborne 

disease outbreaks (WBDO) (prior to 1990) from the occurrence analysis. This and other minor changes to the 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19058 under comment code 7840.



Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 19068 under comment code 4450.

The commenter correctly identifies the three criteria EPA uses to make regulatory determinations. The Agency 

also notes that under SDWA 1412 (b)(1)(B)(ii) EPA makes a separate determination whether or not to regulate a 

contaminant before proposing and promulgating a National primary drinking water rule. The Agency will 

continue to use the best available science and information to evaluate contaminants on the CCL 3 including any 

updates to the health effects or occurrence information the Agency used in selecting contaminants for the CCL 

to determine if the information is sufficient for the Agency to make regulatory determinations. 
Please see the response to comment ID 19068 under comment code 4450.

EPA sought and used the best available occurrence data to evaluate perchlorate and whether or not to include it 

on the final CCL 3. EPA used the Unregulated Contaminant Monitoring Regulation (UCMR 1) data of perchlorate 

occurrence in public water systems (PWS) because these data are developed to be nationally representative of 

an anlaytes occurrence in public water systems in the US. UCMR data are also developed by using standardized 

analytic methods and quality assurance procedures that may differ among other site specific studies and 

different laboratories. UCMR occurrence data indicated that approximately 4.1 percent (or 160) of 3,858 PWSs 

that sampled and reported under UCMR 1 had at least 1 analytical detection of perchlorate at levels greater than 

or equal to the minmum reporting level of 4 μg/L. EPA will evaluate other data to determine if they are sufficient 

to include in its evaluations of perchlorate, including those data provided by the commenter and other regional 

monitoring data. However, EPA believes that the UCMR data is a best available of perhclorate occurrence in PWS 

EPA included perchlorate on the first CCL in 1998 and on the second CCL in 2005. EPA is including perchlorate on 

CCL 3 because it is known or anticipated to occur in public water systems and may require regulation. Under 

SDWA 1412 (b)(1)(B)(ii) EPA makes a separate determination whether or not to regulate a contaminant before 

proposing and promulgating a national primary drinking water rule. SDWA requires the Agency to evaluate three 

criteria in order to determine whether a NPDWR should be developed. Those criteria are:



(i) the contaminant may have an adverse effect on the health of persons

(ii) The contaminant is known to occur or there is a substantial likelihood that the contaminant will occur in 

public water systems with a frequency and at levels of public health concern; and 

(iii) in the sole judgment of the Administrator, regulation of such a contaminant presents a meaningful 

opportunity for health risk reduction for persons served by public water systems.



The Agency continues to evaluate the best available scientific information on the occurrence and health effects 

of perchlorate. On October 10, 2008, EPA published a FR Notice requesting public comment on its preliminary 

determination not to regulate perchlorate in drinking water. The October 2008 notice also described the basis 

for EPAs preliminary determination. EPA received comments from over 32,000 individuals and organizations on 

Please see the response to comment ID 19068 under comment code 4450.

Please see response to comment ID 19065 under comment code 9100.

Please see the response to Comment ID 19073 and 18906, under comment code 4455. EPA will continue to 

evaluate the available science related to perchlorate as the Agency makes a regulatory determination for 

Please see the response to comment IDs 19067 and 19333 under comment code 4460.

Based upon the occurrence and health effects data and information evaluated, EPA concludes that perchlorate is 

known or anticipated to occur in public water systems and may require regulation. Therefore EPA is including 

this compound on the CCL 3. Under SDWA 1412 (b)(1)(B)(ii), EPA makes a separate determination of whether or 

not to regulate a contaminant before proposing and promulgating a national primary drinking water rule from 

the decision to include a contaminant on the CCL. The Agency will continue to seek and use the best available 

science and information to evaluate contaminants on the CCL 3. In Oct. 2008 (FR Vol. 73 60262), EPA published a 

proposed determination that developing a national primary drinking water regulation for perchlorate was not 

necessary. Based upon the comments that were received in response to that notice, and because of evolving 

science on perchlorate, EPA is revisiting this determination. A notice was published in August 19, 2009 (FR Vol. 

74 Page 41883) requesting public comments on key issues regarding the evaluation of perchlorate. EPA will 

Please see the response to comment ID 19068 under comment code 4450.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
EPA's listing of vanadium on CCL 3 does not apply to elemental vanadium; it applies to the soluble forms of 

vanadium found in drinking water including a variety of vanadium ions from vanadium salts. The health effects 

data that were used for potency and severity came from a study of vanadate ion in rats (Domingo et al., 1985). 

The best available national occurrence data which were the National Inorganic and Radionuclides Survey 

indicated that vanadium occurs with high prevalence. Therefore, its prevalence in drinking water, persistence in 

the environment and its solubility in water warranted its inclusion on the CCL 3. 

Please see the response to comment ID 19622 under comment code 4125. 

The toxicity categories and the attributes are used in different stages of the CCL 3 process. The toxicity 

categories were used in the screening process in conjunction with the water concentration data from the NIRS 

study. Based on application of the screening protocol, the combination of toxicity and concentration were 

sufficient to place vanadium on the PCCL. The commenter is incorrect in the assumption that category 3 was the 

first grouping in which toxicological effects were observed. All five toxicity categories were associated with 

adverse noncancerous effects. Attribute scores for potency and severity of the toxicological endpoint plus 

prevalence of vanadiums detection in the NIRS survey and magnitude of the concentrations detected were 

considered when determining if vanadium should remain on the PCCL or be selected for the CCL. The application 

of the classification model tools determined that vanadium met the criteria for the CCL as did the ratio between 

its health reference level and the concentration detected in drinking water in some locations. Based upon these 

The critical effects for the ATSDR MRL for vanadium included evidence of cellular damage in the kidney and 

functional impairment as reflected by increased plasma urea and uric acid. These effects are of sufficient 

concern to justify the severity score assigned following the protocols for the PCCL attributes. Severity is scored 

based on observed effects and not the measured endpoints that show no significant change in the critical study. 

The best available national occurrence data were those from the National Inorganic and Radionuclides Survey 

and indicated that vanadium occurs with high prevalence. Prevalence in drinking water, persistence in the 

environment, and its solubility in water warranted its inclusion on the CCL 3. 

The Agency disagrees that EPAs evaluation of Vanadium occurrence makes little sense. EPA used the best 

available national occurrence data which was the National Inorganic and Radionuclides Survey. This survey 

provided nationally representative information on the occurrence of vanadium in public water systems. EPA 

then applied these data to the protocols described in the Federal Register Notice (FR Vol 73. no 35 p.9629). EPA 

used the finished drinking water data in public water systems as the basis for vanadium occurrence. EPA 

believes these data warrants including vanadium on the CCL 3.

The data that were used to score the occurrence attributes for vanadium (see the response to comment 19079 

under comment code 5025) were the number of states where it had been detected in the NIRS survey and the 

concentrations detected. Persistence did not play any direct role in vanadiums selection for the CCL, although 

the fate data are described in the contaminants information sheet for vanadium in the CCL 3 docket 

(Contaminant Candidate List (CCL) Contaminant Information Sheets EPA-HQ-OW-2007-1189-0042). 

EPAs listing of a L? for Vanadium indicated that this contaminant contain attributes that made it more similar 

to contaminants that should be on the CCL. The best available national occurrence data which was that from 

National Inorganic and Radionuclides Survey indicated that vanadium occurs with high prevalance. Therefore, its 

prevalence in drinking water, persistence in the environment and its solubility in water warranted its inclusion 
The Agency disagrees with the commenter. The CCL process was developed to identify known or possible 

drinking water contaminants of potential health concern. The process followed protocols that utilized health 

effects and occurrence data from acceptable data sources for screening to the PCCL and selection of the draft 

CCL. The protocols established hierarchies for the data used at each step and were applied uniformly for all 

chemical contaminants, including vanadium. [See the docket documents Chemicals: Screening to a PCCL and 

Classification of the PCCL to the CCL.] Vanadium was selected for the draft CCL 3 based on these uniformly 

applied processes. EPA has not established an RfD for soluble vanadium salts, the vanadium forms that are of 

greatest interest as drinking water contaminants. According to the protocol, the ATSDR MRL is the available 

benchmark that ranks highest in the established hierarchy for data sources and became the basis for the PCCL 

scoring of vanadiums health effects attributes as the Agency in Chapter 5 of the CCL3 Chemicals: Classification 

The commenter is citing the Contaminant Information Sheet for vanadium pentoxide. Vanadium pentoxide was 

included in the CCL Universe and was evaluated as part of the CCL process. It failed to meet the criteria for 

inclusion on the CCL. The toxicological data for vanadium pentoxide were not used to evaluate vanadium. The 

data responsible for the inclusion of vanadium on the CCL applied to the vanadate ion and are cited on the 

Vanadium Contaminant Information Sheet and are available in the CCL 3 docket at www.regulations.gov (EPAThe CCL 3 process collected data from a large variety of data sources that met specified criteria. The designation 

of vanadium pentoxide as a teratogen came from the list of chemicals considered by the state of California to 

cause developmental effects. This particular designation is part of the dataset for vanadium, but in accordance 

with the protocols for attribute scoring and developing the HRL/concentration ratio, data characterizing 

vanadium pentoxide were not used to evaluate vanadium.

The Agency relied on measured occurrence data from the National Inorganic Radionuclides Survey and not the 

relative persistence cited by the commenter. Therefore, the contaminants Information sheets identified all the 

data the Agency collected for contaminants considered in the CCL 3 process. The Agency has reviewed the 

contaminants information sheets to make sure that they indicated data that were used to support the listing 

The SDWA requires that contaminants included on the CCL are not subject to any proposed or promulgated 

national primary drinking water regulation, which are known or anticipated to occur in public water systems, 

and which may require regulation. The data used to evaluate vanadium meets these criteria. Additionally, the 

Agency described the protocol, assumptions factors, and equations in Chapter 5 of the CCL 3 Chemicals: 

Classification of the PCCL to CCL. In order to develop the HRL concentration ratio, the Agency used the 90th 

percentile concentration level as a conservative benchmark that may identify a possible need for a health 

advisory for areas of the country that may have higher concentrations in drinking water than others. The 

occurrence data, assumptions, and procedures provided by the commenter were not used for the CCL. EPA also 

included the Institute of Medicine nutritional guidelines as part of its dataset for vanadium and recognized that 

traces of vanadium in drinking water can contribute to dietary intake. The relative contributions of vanadium in 

Please see response to comment ID 19077 under comment code 5020.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Based upon the data and information reviewed, the Agency has determined that N-Methyl-2-Pyrrolidone is 

known or anticipated to occur to public water systems and may require regulation. Therefore, N-Methyl-2-

pyrrolidone has been included on the final CCL 3. EPA has responded to your specific comments on N-methyl-2-

pyrrolidone in the response to comment IDs 19094, 19101, and 19622 under comment code 4125 (N-Methyl-2-
The CCL process was developed to identify known or potential drinking water contaminants of possible health 

concern. The process followed protocols that utilized health effects and occurrence data from acceptable data 

sources for screening to the PCCL and selection of the draft CCL. The protocols established hierarchies for the 

data used at each step of the process and were applied uniformly for all chemical contaminants, including Nmethyl-2-pyrrolidone. [See the docket documents Chemicals: Screening to a PCCL and Classification of the PCCL 

to the CCL.] N-methyl-2-pyrrolidone was selected for the draft CCL 3 based on these uniformly applied 

processes. 



N-methyl-2-pyrrolidone was screened as Toxicity Category 4 following the protocol requirements for screening. 

That protocol places a chemical in the highest toxicity category assigned to a toxicity value in the universe for a 

given chemical. Scoring of toxicity for the PCCL to CCL process was done using the World Health Organizations 

(WHO's) Tolerable Daily Intake value as included in the ITER database. The WHO assessment has been peer 

Please see the response to comment ID 19622 under comment code 4125.

The commenter accurately summarizes the screening steps for CCL. No response necessary.

EPA ensured the objectivity, utility, and quality of the information disseminated as part of the CCL.

The ITER database, which was the source of the value used by EPA in the PCCL to the CCL process is a database 

that only includes peer reviewed assessments. In the case of N-methyl-2-pyrrolidone, the data came from the 

peer-reviewed Concise International Chemical Assessment Document from the World Health Organization. The 

draft SIDS report provided by the commenter was not in the Data compilation that comprised the working 

Universe nor were SIDS reports for any other chemicals. However, even if the report had been included in the 

universe, a completed health risk assessment such the CICAD that was used ranked higher in the data hierarchy 

than a compilation of available data as reported in a SIDS report and final documents are used rather than draft 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

The Agency has responded to the specific information and comments provided by PhRMA under the respective 

comment codes: 6100 Classification Approach for Chemicals (comment IDs 19109, 19110, 19111, and 19112), 

7200 Pharmaceuticals and Personal Care Products (not on CCL 3) (comment IDs 19620, 19554, 19114), and 4090 

The Agency agrees that the methodology and factors incorporated into the CCL process are important in 

developing a reproducible and transparent process. The NAS, NDWAC, and subsequent reviews and public input 

provided information that the Agency incorporated to improve the CCL process. 

Please see the response to comment ID 19109 under comment code 6100.

Please see the response to comment ID 19109 under comment code 6100.

Please see the response to comment ID 19109 under comment code 6100.

See the response to comment ID 19338 under comment code 7200 (Pharmaceuticals and Personal Care 

Products (not on CCL3)).
Please see response to comment ID 19338 under comment code 7200. EPA evaluated data for pharmaceuticals 

in the USGS article cited by the commenter (Focazio et al., 2008) based on the hierarchal approach to select the 

data used to evaluate a chemical as described in the draft CCL 3 FR notice (73 FR 9652). While the Schwab et al., 

2005 study used modeled surface water concentrations to evaluate contaminants, EPA used actual available 

water concentration data to evaluate the 26 active pharmaceutical ingredients presented in the Schwab et al., 

2005 study based on the hierarchal approach to select the best available data described in the draft CCL 3 FR 

notice. The information collected and evaluated for individual contaminants is available in the CCL 3 docket in 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19412 under comment code 2260.



EPA agrees that there is more information available for the four pathogens listed above than for many of the 

other pathogens on CCL3; however, EPA disagrees that a regulatory decision [determination] could be made on 

them at this moment. As discussed in the preamble to the Draft CCL3, (see page 9962) a Regulatory 

Determination requires more information and analyses than the analyses used to support the CCL3 selection 

process. EPA will conduct analyses to support regulatory determinations beginning after the publication of the 

Please see response to comment ID 19412 under comment code 2260.



EPA disagrees with the commenter that number of chemicals and microbes on the draft CCL 3 suggests that a 

wildly disproportionate increase in EPA resources will be going to chemicals, compared to, and at the expense 

of, pathogens. Neither the statute nor the list dictate resource allocation, and the number of contaminants in 

any category does not determine how EPA will prioritize further research or regulatory action.



In addition, the CCL is not a comprehensive list of all possible agents of concern to public health. EPA listed the 

microbial contaminants that are the most important agents (or potential agents) of waterborne disease. While 

the processes for chemical and microbial contaminants use different criteria, the Agency has listed contaminants 

that are currently unregulated and may require regulation as required by statute. The Agency developed and 

presented reasonable criteria for selecting contaminants and believes that the process for developing the 

current CCL for chemicals and microorganisms was reasonable and credible.



However, based on comments, EPA changed the pathogens listed on the final CCL 3. EPA removed older, CDC 

Please see the response to comment ID 19349 under comment code 3310. 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19338 under comment code 7200.

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
Please see response to comment ID 19065 under comment code 9100. The commenter is correct that EPA must 

evaluate substances from several sources, including those registered as pesticides under the Federal 

Insecticide, Fungicide, and Rodenticide Act ("FIFRA") and previously made determinations to not develop 

NPDWRs for seven pesticides on CCL 1 and CCL 2.

The PPC accurately summarizes the steps EPA took to develop the draft CCL 3. Please see the responses to 

comment IDs 19130, 19131, and 19132 under comment code 2420 Pesticides on the CCL 3.

EPA does not agree that there is a selection bias for pesticides listed on the CCL. EPA has a peer-reviewed 

process developed to evaluate contaminants for the CCL taken from a broad universe of chemicals. The 

chemicals are subject to screening, and evaluated based on factors such as physical properties, health effects 

data, and their potential to occur in public water systems. The manufacture of Ethion containing products was 

discontinued as of October 1 2003, and existing stocks were prohibited for use after 12/31/2004 (67 FR 13327). 

All remaining ethion tolerances have been revoked, as of 10/1/2008 (69 FR 43918). Therefore, based on 

ethions current use profile, this pesticide will not be included on the CCL 3. Regarding commenters concern 

about fenamiphos, please see response to comment ID 19032 under comment code 3640 (Fenamiphos). 

Regarding the commenters concern about nitrofen, please see response to comment ID 19167 under comment 

The premise of the comment is incorrect. EPA did not simply sweep all of the UCMR 2 chemicals into the draft 

CCL3, even though the UCMR 2 monitoring wont be completed for several years. EPA evaluated contaminants 

for the CCL 3 using a multi-step, data-driven process to determine whether the occurrence, or anticipated 

occurrence, of a contaminant was likely at levels of concern to human health as described in the draft CCL 3 FR 

notice. The chemicals on UCMR 2 are also among those that were evaluated in the CCL 3 process based on their 

best available data and information. No contaminants were added to the CCL 3 based on anticipated occurrence 

results from UCMR 2, and not all of the contaminants on UCMR 2 are on the CCL 3. Data collected under UCMRs 

are an important source of occurrence information for the CCL process, and UCMR 2 data will be appropriately 

The Agency disagrees with the commenter that EPA should limit its CCL3 selection to those with high certainty, 

high quality data. The SDWA does not direct the Agency to limit or reduce the number of contaminants listed 

on the CCL. The Agency also notes that the neither the NRC or NDWAC recommendations on the CCL provide 

any recommendations on reducing the number of contaminants on the CCL. The Agency uses the best available 

science and information to evaluate and list potential drinking water candidate contaminants. Based upon these 

data EPA concludes that these contaminants are known or anticipated to occur in public water systems and may 

require regulation. Therefore EPA included them on the final CCL 3.

EPA has implemented a reproducible and transparent process developed to evaluate contaminants for the CCL 

taken from a broad universe of chemicals. The chemicals are screened based on health effects data and their 

potential to occur in public water systems. All chemicals, including pesticides identified in the universe go 

through the same screening process and EPA does not discriminate as to the number of pesticides or any other 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
PFOA has been included on the final CCL 3. PFOS was not included on the draft CCL 3, but has been included on 

the final CCL 3. EPA evaluated PFOS in the CCL 3 process, and as cited in the Drinking Water Contaminant 

Candidate List 3-Draft Federal Register Notice PFOS was not included on the draft CCL 3 based on the limited 

occurrence data, combined with the phase out of production of PFOS in the U.S. between 2000 and 2002. EPAs 

decision to list PFOS on the final CCL 3 is based on information from a 2007 Significant New Use Rule (SNUR) that 

shows there are ongoing uses of PFOS that could lead to its potential to occur in water. In the SNUR (Reference: 

FR October 9, 2007; Volume 72, Number 194), Rules and Regulations, Page 57222-57235)), EPA granted an 

exemption, for reporting to TSCA, for the use of tetraethylammonium perfluorooctanesulfonate for specified 

industrial uses (particularly metal plating). This perfluorinated compound is of concern to EPA because PFOS is 

the anionic portion of this chemical. PFOS is also appearing in Minnesota wastewater treatment plant influent, 

effluent, and sludge associated with its use in the fume/mist suppressant in metal finishing and plating baths 

(Reference: FR October 9, 2007; Volume 72, Number 194), Rules and Regulations, Page 57222-57235))). A major 

factor in EPAs decision to not include PFOS on the draft CCL 3 was the phase out of production of PFOS. 

Since the Agency published the draft CCL 3, it has issued Provisional Health Advisories for PFOA and PFOS in 2009 

to provide technical information to State and local officials and PWSs for consideration in addressing local 

contamination of drinking water to protect public health. (Perfluorooctanoic Acid (PFOA) and Perfluorooctane 

Sulfonate (PFOS): Provisional Health Advisory http://www.epa.gov/waterscience/criteria/drinking/). This 

information has been used to develop the Final Contaminant Candidate List (CCL) 3 and is included in the docket 

and Contaminant Information Sheets for PFOA at regulations.gov. Based upon these and other data provided by 

commenters, EPA concludes that PFOS is known or anticipated to occur in public water systems and may require 

Since the Agency published the draft CCL 3, it has issued Provisional Health Advisories for PFOA and PFOS in 2009 

to provide technical information to state and local officials and PWSs for consideration in addressing local 

contamination of drinking water to protect public health. [Perfluorooctanoic Acid (PFOA) and Perfluorooctane 

Sulfonate (PFOS): Provisional Health Advisory http://www.epa.gov/waterscience/criteria/drinking/]. This 

information has been used to develop the Final Contaminant Candidate List (CCL) 3 and is included in the docket 

and Contaminant Information Sheets for PFOA at www.regulations.gov. Based upon these and other data 

provided by commenters EPA concludes that PFOA is known or anticipated to occur in public water systems and 

Please see response to comment ID 19136 under comment code 4510 for a more detailed discussion on the 

listing of PFOS. EPA concludes that PFOA and PFOS are known or anticipated to occur in public water systems 

and may require regulation. Therefore EPA is including these compounds on the CCL 3. Under SDWA 1412 

(b)(1)(B)(ii) EPA makes a separate determination whether or not to regulate a contaminant before proposing and 

promulgating a National Primary Drinking Water Rule. The Agency will continue to use the best available science 

and information to evaluate contaminants on the CCL 3 including any updates to the health effects or 

occurrence information to determine if the information is sufficient for the Agency to make a regulatory 

Please see the response to comment ID 19136 and 19139 under comment code 4510.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
The Agency disagrees with the commenter that there is insufficient information to include molybdenum, cobalt, 

vanadium, strontium, and germanium on the draft CCL 3. The data and information collected and evaluated for 

each of these contaminants are described in the contaminant information sheets in the CCL 3 docket 

(Contaminant Candidate List (PCCL) Contaminant Information Sheets EPA-HQ-OW-2007-1189-0042). Based upon 

these data EPA concludes that they are known or anticipated to occur in public water systems and may require 

regulation. Therefore EPA is including molybdenum, cobalt, vanadium, strontium and germanium on the CCL 3. 

The Agency has responded to the specific information and comments provided by the NMA under the respective 

comment codes: 3255 (Cobalt health comment ID 19150), 3700 (Germanium comment ID 19153), 4005 

(Molybdenum health comment ID 19146, 19148, and 19149), 4010 (Molybdenum occurrence comment ID 

EPA used the best available national occurrence data which was the National Inorganic and Radionuclides 

Survey. NIRS measured finished water concentrations and found that Molybdenum had detections in 77 public 

water systems. The 90th percentile concentration was at 30 ug/l. Additionally EPA provides a detailed response 

to your specific comments on the health effects under comment code 4005. Please see the response to 

comment 18874 and 19146. Based upon these data, EPA concludes that Molybdenum is known to occur in 

public water systems and may require regulation. Therefore EPA is including Molybdenum on the third CCL.

Please see the response to comment ID 18874 under comment code 4005. Subsequent to the publication of the 

draft CCL 3, the OW conducted a literature search for new studies of molybdenum (nutritional and toxicological) 

and has identified several recent publications that will be evaluated in deciding which of the CCL contaminants 

will be considered for Regulatory Determination 3.

Please see response to comment 19145 under comment code 4010.

Please see the responses to comments 18874 and 19146 under comment code 4005.

Please see the response to comment IDs 18874 and 19146 under comment code 4005.

The CCL process was developed to identify known or possible drinking water contaminants of potential health 

concern. The process followed protocols that utilized health effects and occurrence data from acceptable data 

sources for screening to the PCCL and selection of the draft CCL. The protocols established hierarchies for the 

data used at each step and were applied uniformly for all chemical contaminants, including cobalt. [See the 

docket documents Chemicals: Screening to a PCCL and Classification of the PCCL to the CCL ]. Cobalt was 

selected for the draft CCL3 based on these uniformly applied processes. The Agency used the ATSDR MRL to 

evaluate the adverse health effects of cobalt and occurrence data from NIRS.



Placement on the CCL enables EPA to examine the available database for toxicity in a more refined process than 

was used for the CCL in order to determine if a contaminant has sufficient data for regulatory determination. 

This will be the next stage for cobalt. During this process, EPA will have the opportunity to examine cobalts full 

toxicity database. The information available on concentrations in finished water across the nation and treatment 

technologies are equally important during regulatory determination.



The best available national occurrence data, which were the National Inorganic and Radionuclides Survey, 

indicated that vanadium occurs with high prevalence. Therefore, its prevalence in drinking water, persistence in 

the environment, and its solubility in water warranted its inclusion on the CCL 3. EPA welcomes any data that 

you may have that can help in the process of determining the occurrence of vanadium in drinking water. The 

ATSDR (1992) and IOM (2001) used the same critical study for their quantitative assessment of risk. The IOM 

(2001) data, although not on the dossier, were considered by EPA. Part of the difference in the outcomes of the 

two assessments relates to the way dose was interpreted and the fact that the ATSDR used a NOAEL as the point 

of departure in their assessment while IOM used the LOAEL. The ATSDR assessment was selected for scoring of 

the health attributes based on the hierarchy for data sources defined by the protocol for selecting the PCCL but 

is also justified because it is the more conservative of the two values derived from the same study. The agency 
While the Agency places great value on ATSDR assessments, the Agencys Contaminant Candidate List (CCL) 

process follows a protocol that ranks EPA assessments higher in hierarchy to the ATSDR process for hazard 

assessment. The CCL process was developed to identify known or possible drinking water contaminants of 

potential health concern. The process followed protocols that utilized health effects and occurrence data from 

acceptable data sources for screening to the PCCL and selection of CCL 3. The protocols established hierarchies 

for the data used at each step and were applied uniformly for all chemical contaminants, including strontium. 

[See the docket documents Chemicals: Screening to a PCCL and Classification of the PCCL to the CCL]. Strontium 

was selected for the CCL 3 based on these uniformly applied processes. Placement on the CCL enables EPA to 

examine the available data for toxicity in a more refined process than was used for the CCL in order to determine 

if a contaminant has sufficient data for regulatory determination. This will be the next stage for strontium. 

EPA calculated the ratio of the health reference level (HRL) divided by the occurrence in water, not the 

DWS/MCGL of 2226 ug/L cited by the commenter. The oral chronic LOAEL (0.318 mg/kg/day) was the basis for 

the HRL (0.744 ug/L) that was then divided by the 90th % detection from the National Inorganic Radionuclides 

Survey (220 ug/L). This information was also provided in the contaminant information sheets in the docket. The 

Agency described the protocol, assumptions factors, and equations in the CCL3 Chemicals: Classification of the 

PCCL to CCL document. The Agency also notes that including a contaminant on the draft or final CCL 3 does not 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

EPA looks forward to participation from SFIREG members for future CCLs.

EPA understands that state lead agencies may lack infrastructure to readily develop standards for pesticides in 

drinking water or risk-based guidance values, communicate potential risks or make risk management decisions. 

EPA endeavors to provide such information as part of the CCL/HA/Regulatory Determination process where 

possible. As described in the draft CCL notice, all pesticides identified in the universe of chemicals must go 

through this screening process and EPA does not discriminate as to the number of pesticides or any other group 

The Agency notes that HRLs were developed for over 500 chemicals listed on the PCCL. These contaminants 

passed through the screening criteria and were subjected to further scrutiny by the Agency. These HRLs are 

listed on the contaminant information sheets that are available in the CCL 3 Docket at regulations.gov. The 

Agency hopes to continue to work with stakeholders as future CCLs are developed. 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 19136 and 19139 under comment code 4510.

Please see the response to comment ID 18891 under comment code 4520.

Please see response to comment ID 19138 under comment code 4515.

Please see the response to comment ID 19136 and 19139 under comment code 4510.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

EPA is not including nitrofen on the Final CCL3. EPA used total Toxic Release Inventory data to anticipate the 

occurrence of nitrofen in PWSs as described in the FR notice announcing the draft CCL 3. After further 

evaluation of these data the Agency notes that stockpiles identified by the TRI data were disposed of in RCRA 

Subtitle C (hazardous waste) landfills. Based on these data, EPA does not anticipate that nitrofen will occur in 

PWSs and does not require regulatory consideration under the SDWA. Therefore EPA is not including nitrofen on 
Please see the response to comment ID 19068 under comment code 4450.

Please see the response to comment ID 19136 and 19139 under comment code 4510. 

Please see the response to comment ID 19190 under comment code 7150.

Please see response to comment ID 19338 under comment code 7200. The data the Agency used to evaluate 

these antibiotics are provided in the Contaminant information sheets in the CCL 3 docket at 

EPA has kept Helicobacter pylori on the CCL 3.

Helicobacter pylori is on the final CCL 3. EPA will review and consider the information provided by the 

commenter together with other relevant data as we conduct analyses to support regulatory determinations 

beginning after the publication of the final CCL 3. 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID# 19192 under comment code 7140 Bisphenol A (and related-phenols).

Please see response to comment ID 19412 under comment code 2260. 

Please see the response to comment for each compound in the following list of comment IDs and individual 

contaminants:

Aldicarb (CAS # 116-06-3): See response to Comment ID 19194 under comment code 7110. 

Azinphos-methyl (CAS # 86-50-0): See response to Comment ID 20316 under comment code 7110.

Carbaryl (CAS # 63-25-2): See response to Comment ID 20317 under comment code 7110.

Chlorpyrifos (CAS # 2921-88-2): See response to Comment ID 20318 under comment code 7110.

Dichlorvos (DDVP) (CAS # 62-73-7): See response to Comment ID 20319 under comment code 7110.

Dicofol (CAS # 115-32-2): See response to Comment ID 20320 under comment code 7110.

In the Agencys Contaminant Candidate List (CCL) process, linuron screened to the PCCL but failed to move to 

the CCL. See the response to comment 19195 under comment code 7630.

Please see the response to comment for each compound in the following list of comment IDs and individual 

contaminants:

Phosmet (CAS # 732-11-6): See response to Comment ID 19196 under comment code 7110. 



Trichlorfon (CAS # 52-68-6): See response to Comment ID 20322 under comment code 7110.



Triclocarban (CAS # 101-20-2): See response to Comment ID 20323 under comment code 7110.



Triclosan (CAS # 3380-34-5): See response to Comment ID 20324 under comment code 7110.

See response to comment ID 19197 under comment code 7210.

Please see response to comment ID 19338 under comment code 7200. EPA concluded that nine hormones (17 

alpha-estradiol, 17 beta-estradiol, equilenin, equilin, estriol, estrone, ethinyl estradiol, mestranol, and 

norethindrone) should be included on the CCL 3 because these contaminants are known or anticipated to occur 

in public water systems and may require regulation. The specific data used to evaluate these contaminants can 

be found in the supporting documents and CCL Contaminant Information Sheets in the docket at 

Please see the response to comment ID 19167 under comment code 4070.

Please see the response to Comment ID 19073 and 18906, under comment code 4455. EPA will continue to 

evaluate the available science related to perchlorate as the Agency makes a regulatory determination for 

Please see the response to comment IDs 19067 and 19333 under comment code 4460.

Please see the response to comment ID 19068 under comment code 4450.

Please see response to comment ID 19138 under comment code 4515.

See response to comment 18891 under comment code 4520.

Please see the response to comment ID 19136 and 19139 under comment code 4510.
EPA considered over 6,000 chemicals as it developed the Draft CCL 3. The Agency uses the best available science 

and information to evaluate and list potential drinking water candidate contaminants. The Agency has 

responded to each of the individual chemicals provided by commenter under separate comment IDs.

EPA considered alkylphenol polyethoxylates in the universe of chemicals evaluated for the CCL 3. The 

commenter provided health effect assay and limited occurrence data that EPA received and evaluated during the 

nominations process and in developing the draft CCL 3. The available occurrence and health effects information, 

provided by the commenter and additional information collected by the Agency, were not sufficient for these 

chemicals to pass from the CCL 3 universe to the PCCL for further evaluation. Therefore, the Agency does not 

anticipate that they will occur in a public water system and require regulation. Therefore, the Agency did not 

include them on the CCL 3. Additional information on these chemicals is available in the CCL 3 docket at 

www.regulations.gov in the support documents (Contaminant Candidate List 3: Identifying the Universe and A 

Summary of Nominations for the Third Contaminant Candidate List). For more information on the Agency's 

efforts to evaluate endocrine disruptors including alkylphenol ethoxylates (APEs) and other endocrine disrupting 

Please see response to comment ID 19338 under comment code 7200. EPA is listing erythromycin on the final 

CCL 3 because it anticipates that the antibiotic may occur in PWS and may require regulation. The commenter 

provided news reports and citations that summarize the potential for other antibiotics to occur in aquatic 

environments and possible public health concerns caused by antibiotic resistant bacteria. EPA relied on 

quantitative occurrence and health effects data to evaluate the antibiotics identified by the commenter. EPA has 

provided these data in the supporting documents and the contaminants information sheets in the CCL 3 docket 

EPA used a reference dose for bisphenol A of 0.05 mg/kg/day based on decreased body weight gain which was 

verified in 1988 and was used in the screening process. EPA has not updated its risk assessment since that time, 

but does acknowledge that there are several new studies under development. Several other government 

agencies are in the process of reassessing the health effects of bisphenol A (National Institute of Environmental 

Health Sciences and the Food and Drug Administration). Those assessments are not yet complete . EPA is 

following the work being done on the health risks for bisphenol A and will incorporate any quantitative exposure 

guidelines developed for BPA into the CCL process for future CCLs. However, it is important to note that 

occurrence data are equally as important as the health data in determining whether a chemical may occur in 

public drinking water systems and require regulation .

Regarding commenters statement A study in Germany found BPA in surface water (0.0005 to 0.41 ug/L), in 

sewage effluents (0.018 to 0.702 ug/L), in sediments (0.01 to 0.19 mg/kg) and in sewage sludge (0.004 to 

1.363mg/kg dw), occurrence information from other countries was not used to evaluate chemicals for the 

Please see response to comment ID 19412 under comment code 2260. 

Aldicarb (CAS # 116-06-3): As noted in the first CCL notice, 63 FR 10278 (March 2, 1998), EPA does not believe 

that it is appropriate to include Aldicarb and its two degradation products of toxicological concern, the sulfoxide 

and sulfone, on the CCL. These contaminants are already required to be regulated by statute. An updated HA 

(1996) is also available for aldicarb and its degradation products.
Linuron was included in the universe of CCL3 contaminants and screened to the PCCL. In EPAs evaluation of 

linuron, the best available data on occurrence was considered from the following sources: US Geologic Survey 

National Ambient Water Quality Assessments, EPA Unregulated Contaminant Monitoring Rule, USDAs Pesticide 

Data Program, and a California Department of Health occurrence study. The data sources are described in the 

contaminant information sheet for linuron, which can be found in the CCL 3 docket (Preliminary Contaminant 

Candidate List (PCCL) Contaminant Information Sheets EPA-HQ-OW-2007-1189-0043). 



EPA acknowledges commenters concern about the Agencys drinking water assessment for linuron. However, 

for purposes of evaluation for the CCL, EPA used the best available information on occurrence at the national 

level, which was taken from NAWQA data. EPA also used the RfD of 0.008 mg/ kg-day, to calculate a health 

reference level of 56 ug/L. When EPA compared the health reference level to the occurrence value of 0.26 ug/L 

(NAWQA 90th percentile), linuron did not pass the screening criteria to move from the PCCL to draft CCL 3. 

Based upon the information available at this time, EPA concludes that linuron has limited potential to occur in 

Phosmet (CAS# 732-11-6): Phosmet was in the Universe of chemicals and it was screened to the PCCL. EPA used 

the best available data to evaluate this contaminant. EPA used the RfD of 0.011 mg/kd-day for health and ~1.3 

million lbs/year application data for exposure. EPA did not use the IRED drinking water assessment to decide 

whether to place phosmet on the CCL. While Phosmet was screened to the PCCL, it was not listed on the CCL 3 

based on a review of its toxicity profile and data on occurrence. The methodology used by EPA to make this 

decision can be found in the following support document, located in the CCL Docket: CCL Chemicals: 

Classification of the PCCL to CCL (EPA 815-R-08-004). Although phosmet did not get listed on the CCL 3, EPA will 

EPA evaluated the information provided by the commenter with respect to the contribution of drinking water to 

overall exposure (includes exposure due to consumer products) of phthalates, particularly in regards to the CDC 

NHANES dataset. However, EPA determined that the EPA data used to screen each phthalate compound were 

more relevant to the CCL process. 

EPA developed assessment factors to evaluate data sources to ensure they are relevant to the CCL process, 

complete in basic documentation, not redundant with other data sources, and are formatted for automated 

retrieval. The commenter submitted ambient water data from the Storage and Retrieval System (STORET) data 

warehouse. Data from STORET is supplemental and does not meet the assessment factors for retrievability. In 

the evaluation of the phthalates, EPA used production and release data, which met all assessment factors. The 

following is a brief summary of the results of EPAs evaluation of each phthalate compound that commenter 

proposed for listing onto the CCL (more detailed analysis is available in the Final CCL 3 Contaminant Information 

Sheets and chemical background documents, which can be found in the CCL Docket, ID No. EPA-HQ-OW-2007-

1189):

1. Benzyl butyl phthalate (BzBP) (CAS # 85-68-7): Butyl benzyl phthalate was screened to the PCCL. Based on an 

analysis of the toxicity and production data, it did not meet EPAs screening criteria to be listed on the PCCL and 

undergo further evaluation.

2. Di-isononyl phthalate (DiNP) (CAS # 28553-12-0): Di-iso-nonyl phthalate was identified in the universe of 

chemicals, but did not meet EPAs screening criteria to be listed on the PCCL and undergo further evaluation. 


Since the draft CCL 3 was published, several publications have focused on the occurrence of pharmaceuticals in 

ambient water and drinking water. Commenters identified quantitative occurrence data from several of these 

publications in their comments on the CCL 3. Other commenters identified summary reports and publications 

that discuss potential public health concerns of pharmaceuticals in general terms. In response to these 

comments, EPA has conducted additional data collection efforts to comprehensively review recent published 

information from the U.S. Geological Survey (USGS) and other sources, including those cited by commenters, to 

identify the best available occurrence information for pharmaceuticals. EPA identified new occurrence data for 

81 contaminants from 22 sources. The Agency also conducted additional literature reviews to identify the best 

available health effects information and identified data from sources including: EPA Office of Pesticide Programs, 

the Food and Drug Administration (FDA) Center for Veterinary Medicine, the Joint Food and Agriculture 

Organization/World Health Organization (WHO) Expert Committee on Food Additives, the European Medicines 

Agency in addition to the FDA Center for Drug Evaluation and Research maximum recommended therapeutic 

doses. The Agency assessed this new data and used the same hierarchal approach described in the draft CCL 3 FR 

EPA considered over 6,000 chemicals as it developed the Draft CCL 3. The Agency uses the best available science 

and information to evaluate and list potential drinking water candidate contaminants. All contaminants that are 

part of the final CCL 3 were known or anticipated to occur in public water systems and may require regulation. 

The Agency has responded to each of the individual chemicals provided by the commenter under separate 

Please see the response to comment ID 19167 under comment code 4070.

Please see the response to comment ID 19136 and 19139 under comment code 4510 for PFOA and the response 

to comment ID 19068 under comment code 4450 for perchlorate.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

The agency has responded to the specific information and comments provided by the EWG under the respective 

comment codes: 2100 General Comments on the List (comment ID 19207), 4510 PFOA (comment ID 19532), 

4515 PFOA health (comment IDs 19533 and 19213), 4520 PFOA occurrence (comment ID 19214), 7180 

Perfluorinated compounds (not on CCL 3) (comment IDs 19591, 19592, 19593, 19610, 19611, 19601, and 

19219), and 7200 Pharmaceuticals and Personal Care Products (not on CCL3) (comment IDs 19208, 19210, 

19218, and 19602). The Contaminant Candidate List is the first step in identifying contaminants that may require 

regulation. The Agency will evaluate contaminants on the final CCL 3 to determine whether or not they require a 

national drinking water regulation in accordance with the criteria specified in SDWA 1412 (b) (1). The Agency will 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
Please see response to comment 19205 under comment code 2100 regarding perfluorinated chemicals and 

pharmaceuticals. 

EPA disagrees with the commenters conclusion that populations are not protected from toxic chemicals in 

drinking water. EPAs conducted evaluations using SDWA risk management provisions and these analyses 

were similar to the results reached by EWG. EPA compared the list of 142 unregulated contaminants that 

were detected in tap water from EWGs National Tap Water Quality Database to those contaminants considered 

in the CCL 3 process. 132 of the 142 contaminants on EWGs unregulated contaminants list were included in the 

CCL 3 Universe and evaluated in the CCL 3 process. Of the 10 contaminants that were not included in the CCL 3 

Universe, 8 have National Primary Drinking Water Regulations therefore, they were removed from consideration 

for the CCL 3. EWG did not detect the two remaining contaminants above any health limit and both of the 

contaminants were only detected in one system. 

EWG identified 29 unregulated contaminants at concentrations above a health limit. All of these contaminants 

that EWG identified were included in the CCL 3 Universe except for two contaminants that have NPDWRs and 

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

Please see the responses to comment ID 19136 and 19139 under comment code 4510 for a more detailed 

discussion on the listing of PFOA and PFOS.

PFBA was not included on the final CCL 3. PFBA was included in the CCL 3 Universe. However the Agency only 

had limited data on PFBA and other PFC potential occurrence in public water systems and environmental 

releases. Based upon these data EPA concludes that PFBA does not meet the critieria for the CCL at this time. 

Therefore EPA is not including this compound on the CCL 3.



Please see the response to comment ID 19384 in comment code 6900 (The interrelation between CCL and UCMR 

for specific chemicals) regarding the selection of contaminants for the UCMR.

See response to comment ID 19136 and 19139 under comment code 4510.

Please see response to comment ID 19138 under comment code 4515.

See response to comment ID 19211 in comment code 4510 PFOA.

See response to comment ID 19211 in comment code 4510 PFOA.

See response to comment ID 19136 and 19139 under comment code 4510.

See response to comment ID 19136, 19139, and 19211 under comment code 4510.

Please see response to comment ID 19338 under comment code 7200. The Agency evaluated contaminants for 

the CCL 3 based on a data-driven approach to determine whether contaminants are known or anticipated to 

occur in PWS and may require regulation. The Agency used data from the Kolpin et al. 2002 study cited by the 

commenter to evaluate pharmaceuticals for the final CCL 3 using the process described in the draft CCL 3 FR 

notice and final CCL 3 FR notice. For those contaminants with ambient or finished drinking water occurrence 

data, EPA used a health reference level to water concentration ratio to evaluate contaminants for the CCL 3. 

Contaminants were selected for the CCL 3 when the ratio was ¡Ü10, representing occurrence in water at a level 

Please see the response to comment ID 19211 under comment code 4510 and the response to comment ID 

19338 under comment code 7200.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
Please see response to comment IDs 18977 and 19373 under comment code 1000. EPA is actively working to 

promote and improve the security of our public water systems and infrastructure. Significant actions are 

underway to assess and reduce vulnerabilities to potential terrorist attacks; to plan for and practice response to 

emergencies and incidents; and to develop new security technologies to detect and monitor contaminants and 

prevent security breaches. The Agency is working with water utilities, state and local governments, public health 

officials, emergency responders and planners, assistance and training providers, environmental professionals, 

researchers and engineers, and law enforcement, among others to promote water security.

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Please see response to comment ID 19065 under comment code 9100. The Agency believes that the regulatory 

development process described by the commenter is one of the many proactive avenues the Agency uses to 

EPA acknowledges your comments about public participation in the listing process. However, EPA respectfully 

disagrees with your comments that an additional public comment period be included in the selection process. 

EPA sought public involvement in the CCL 3 process by receiving input at a public stakeholder meeting in 

September 2004 and as part of the public nominations process in May 2006. Both opportunities were 

announced and published in the Federal Register. EPA also sought public comment on the draft CCL 3 following 

its publication in February 2008. We believe that EPA has provided ample opportunity for the public to provide 

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Please see the response to comment ID 19136 and 19139 under comment code 4510.

Please see the response to comment ID 19137 under comment code 7180 and 19139 under comment code 

EPA agrees that the listed pathogens have adverse health effects. Nonetheless, health effect is not the only 

criterion EPA must consider for making a CCL listing or regulatory determination. EPA will conduct analyses to 

support regulatory determinations beginning after the publication of the final CCL 3. Page 9629 of the draft CCL 

3 discusses the three SDWA criteria to determine whether a contaminant for making the regulation 

Chemical contaminants are included on the Contaminant Candidate List because they are anticipated or known 

to occur in PWSs and may require regulation. Under SDWA 1412b(1)(B)(ii) EPA makes a separate determination 

whether or not to regulate a contaminant before proposing and promulgating a National primary drinking water 

rule. The Agency will continue to use the best available science and information to further evaluate 

contaminants on the CCL 3. For more information on EPAs process of regulation determination, please refer to 

Drinking Water: Regulatory Determinations Regarding Contaminants on the Second Drinking Water 

Contaminant Candidate ListPreliminary Determinations; Proposed Rule (Federal Register. Vol. 72, No. 83, Pg. 

24018 May 1, 2007) or the Agency Web site (www.epa.gov/safwater/ccl). This publication can be found in the 

EPA has not yet determined which of the listed pesticides should be regulated as contaminants under the SDWA; 

that decision is part of the regulatory determination process, rather than the CCL process. EPA does not agree 

with the commenter regarding the list still missing a number of especially hazardous pesticides. EPA has a 

reproducible and transparent process developed to evaluate contaminants for the CCL taken from a broad 

universe of chemicals. The chemicals are subject to screening, and evaluated based on health effects data and 

their potential to occur in public water systems. All pesticides identified in the universe of chemicals must go 

through the same screening process and EPA does not discriminate as to the number of pesticides or any other 

group of chemicals that get listed on the CCL. EPA believes that the final CCL contains the hazardous pesticides 

that meet the CCL statutory criteria, based on the best information available at this time.

Please see response to comment ID 19338 under comment code 7200.
EPA acknowledges your comment, but further evaluation is needed before a determination can be made to 

regulate the draft CCL 3 contaminants. A regulatory determination is a formal decision on whether EPA should 

initiate a rulemaking process to develop a national primary drinking water regulation for a specific contaminant. 

The law requires that we make regulatory determinations for at least five contaminants from the most recent 

CCL every five years.



As the next step in the regulatory process, EPA will evaluate CCL 3 contaminants based upon the criteria above 

and determine whether there is sufficient data to decide if a contaminant should be regulated or not. 

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

See response to comment ID 19198 under comment code 7150.

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Please see the response to comment ID 19198 under comment code 7150. EPA agrees that it is important to 

properly manage chemicals that have the potential to contaminate public water supplies and encourages public 

comment from all interested parties on the Endocrine Disruptor Screening Program (EDSP) and the CCL, 

including the drinking water industry. The first round of screening in the EDSP will assist the Agency in 

understanding the health effects associated with specific pesticides. Nine of the 73 pesticides included in the first 

round of screening are currently regulated by national primary drinking water regulations. The Agency will be 

able to use information from the screening program in determining whether existing regulations need to be 

revised to address health endpoints associated with endocrine disruption. The Agency will also be able to use 

results from the screening program in considering other contaminants for future regulation. All of the 73 

pesticides in the first round of screening were included in the universe of contaminants that EPA evaluated. 

Thirty-three of them were moved to the preliminary CCL 3 and 9 were included on the CCL 3.



Please see the response to comment ID 19233 under comment code 6100. 

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 18967 under comment code 2100. 

The health risk evaluations of the metolachlor degradates do recognize their lower toxicity than the parent 

pesticide. The potency scores for the two metolachlor degradates are 2 for each one, and the severity scores are 

1 for each one. In the case of metolachlor, the potency score is 4 and the severity score is 3. If metolachlor is 

selected for regulatory determination, the final decision concerning whether or not there is a need for a 

regulation will strongly consider the results of the UCMR2 monitoring data and the extent with which there is cooccurrence of metolachlor and its two degradates as well as the relative concentrations of each.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 19068 under comment code 4450.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements.

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

EPA disagrees with your comment and has decided to keep Naegleria fowleri on the CCL 3. EPA criteria for 

evaluating and prioritizing pathogens for inclusion in the CCL 3 included health effects, waterborne disease 

outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). Neither treatability nor rareness/frequency of disease or 

methods availability were criteria considered for CCL 3 inclusion.

Given the severe health effects associated with Naegleria fowleri, EPA believes it is appropriate to include in CCL 

3 to further assess the occurrence and exposure risks posed by this organism which has been detected in 

drinking water in the US (Blair et al., 2008) and has also been the cause of at least one WBDO as documented by 

CDC (CDC MMWR 2001  2002).

EPA commends the different Arizona organizations that have taken the initiative to further study N. fowleri as 

well as the State and County developing the Proposed Operational Practices and look forward to the finalized 

document. Inclusion of N. fowleri on the CCL 3 is a factor EPA considers when prioritizing research needs as well 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

The Agency acknowledges receipt of Riverkeepers comments and has responded to the specific comments 

submitted by Riverkeeper under the respective comment codes: 6550 Nominations and Surveillance (comment 

ID 19346) and 7200 pharmaceuticals and personal care products (not on CCL3) (comment ID 19257). 

Please see response to comment ID 19338 under comment code 7200. The commenter notes that they 

provided nominations for the CCL 3 in response to the October 16 FR Notice requesting nominations (71 FR 

60705). EPA evaluated all the contaminants nominated and provides the CCL 3 status in the docket in the 

Summary of Nominations for the Third CCL at www.regulations.gov. The Agency also reviewed the data and 

information cited by the commenter to develop the final CCL 3. 

The commenter also notes that the Agency should promote a precautionary principle approach and list 

additional contaminants on the CCL. The Agency disagrees that EPA is reactively listing contaminants on the draft 

and final CCL 3. The Agency actively sought out data and information on the potential for contaminants to occur 

in PWSs that have adverse health effects. The Agency used concentrations of contaminants in ambient and 

finished water, estimated concentrations of pesticides, environmental release and application, production, use, 

and environmental fate parameters to evaluate over 6,000 chemical contaminants and their potential to occur in 

PWSs. A wide array of health effects information was also collected under this effort. The Agency documented 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

EPA did develop and implement a systematic strategy and set of criteria for selecting the pathogens for CCL 3 

after the 2006 Nominations request. This is the screening and scoring process described in detail in the support 

documents in the docket of the Final CCL 3 (e.g.,see the Final Contaminant Candidate List 3 Microbes: PCCL to 

CCL Process for more information on all the scores).

The final CCL 3 continues to list the three pathogens mentioned: E. coli 0157:H7, Campylobacteria jejuni, and 

Naegleria folweri.
EPA used the CDC surveillance system as the primary source of data for the waterborne disease outbreaks 

protocol. EPA acknowledges that the WBDOs reported in the surveillance system represent only a portion of the 

burden of illness associated with drinking water exposure. The surveillance information does not include 

endemic waterborne disease risks. EPA believes the CDC WBDO data is the best source of occurrence data to 

compare and rank pathogen-occurrence on because the data is collected with the same epidemiologic criteria 

for every outbreak, i.e., the data can be used to compare and prioritize the pathogens on the CCL.

EPA acknowledges that a few of the CCL pathogens cause diseases that must be reported to CDC; however the 

CDC endemic disease database does not cover all the CCL pathogens nor does it provide the source of the illness 

(ie., drinking water). There is no national database on endemic illness due to drinking water nor are there 

estimates specifically for individual pathogens pathogens due to drinking water exposure. EPA rejected using 

CDCs notifiable diseases data as a criterion because it does not distinguish between exposure through 

drinking water versus other routes of exposure (e.g., food, secondary spread, sewage, and nosocomial 

exposure) also, many of the PCCL pathogens are not on CDCs list (see 

http://www.cdc.gov/ncphi/disss/nndss/phs/infdis2009.htm). EPA found it difficult to compare and prioritize the 

PCCL pathogens based on a data set that does not include half of the PCCL pathogens.

Please see response to comment ID 19412 under comment code 2260.



EPA has retained Salmonella enterica and Shigella sonnei on the CCL 3 based on the scoring process. EPA notes 

that there was a WBDO of Salmonella just this year (unpublished data from Colorado). EPA continues to believe 

that there is a potential need for regulation of these two pathogens.

EPA agrees that the data on occurrence in drinking water is limited.

Please see Comment ID 19261 under comment code 6300 for the response to the comment on endemic disease. 



EPA agrees that for some pathogens fecal contamination of drinking water due to sewage is an important route 

of exposure for many pathogens. EPA can not assume that sewage is the only route of exposure EPA needs to 

consider for occurrence of a pathogen. For example, biofilms in distribution systems may pose significant risks. 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Ethylene oxide and ethylene glycol have been included on the final CCL 3. The Agency has responded to the 

specific information and comments provided by the American Chemistry Council (ACC) on ethylene glycol and 

ethylene oxide under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene 

Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 

3585 Ethylene Oxide health (comment ID 18925), 3590 Ethylene Oxide occurrence (comment IDs 19521 and 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Ethylene oxide and ethylene glycol have been included on the final CCL 3. The Agency has responded to the 

specific information and comments provided by the American Chemistry Council (ACC) on ethylene glycol and 

ethylene oxide under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene 

Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 

3585 Ethylene Oxide health (comment ID 18925), 3590 Ethylene Oxide occurrence (comment IDs 19521 and 

See response to comment 18919 under comment code 3580.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
EPA used the best available data including occurrence data from the Unregulated Contaminant Monitoring Rule 

and health effects data developed for the registration of diuron as a pesticide to evaluate diuron for the CCL3. 

These data are provided in the CCL 3 docket [see Contaminant Candidate List (CCL) Contaminant Information 

Sheets EPA-HQ-OW-2007-1189-0042). Based upon these data, EPA concludes that diuron is known or 

anticipated to occur in public water systems and may require regulation. Therefore EPA is including this 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

The oral Reference dose from the Agencys Integrated Risk Information System (0.005 mg/kg/day) was the basis 

for the HRL (35 ug/L) that was then divided by the 90th% detection from the National Inorganic Radionuclides 

Survey (30 ug/L). This information was also provided in the contaminant information sheets in the docket. The 

Agency described the protocol, assumptions factors, and equations in the CCL 3 Chemicals: Classification of the 

PCCL to CCL document. The activity by the Pennsylvania DEP related to a discharge permit is not related to the 

CCL. That activity involves establishing an Ambient Water Quality Criterion for Human Health under the Clean 

Water Act and is a prerogative granted to the state under the conditions of that Act.



Based on these and other data, EPA has determined that molybdenum is known or anticipated to occur in 

drinking water and may require regulation. Therefore, EPA has included molybdenum on the third CCL. The 

Agency also notes that including a contaminant on the draft or final CCL 3 does not impose any requirements on 

Please see the response to comment ID 19143 under comment code 2100.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see responses to comment ID 19501 under comment code 6160. Ethylene oxide has been included on the 

final CCL 3. The Agency has responded to the specific information and comments provided by the ACC on 

ethylene oxide under the respective comment codes: 3585 ethylene oxide health (comment ID 18925) and 3590 

ethylene oxide occurrence (comment IDs 19521 and 19523).

Please see the response to comment ID 19265 under comment code 3580.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19065 under comment code 9100.

Please see the response to comment ID 19349 under comment code 3310. 

Please see response to comment ID 19412 under comment code 2260.



EPA recognizes the potential health risks associated with Vibrio cholerae, however, there has been only one V. 

cholerae WBDO in the US since 1990. Therefore, EPA will continue to assess any potential or increased health 

risks posed by Vibrio cholerae and other pathogens and consider any new information in future CCLs.



Please see the response to comment ID 19349 under comment code 3310. 

Please see response to comment ID 19283 under comment code 2340.

Please see the response to comment ID 19349 under comment code 3310. 

Please see response to comment ID 19283 under comment code 2340. 

Please see the response to comment ID 18939 under comment code 2100.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

The Agency disagrees that it would not be appropriate or necessary to include 1,4-dioxane on the final CCL3 and 

is therefore including 1,4-dioxane on the final CCL 3. EPA is aware that there is an assessment under 

development by the Office of Research and Developments IRIS program. The Agency uses the best available 

science and information to evaluate and list drinking water candidate contaminants. The Agency also notes that 

including a contaminant on the draft or final CCL 3 does not impose any requirements on anyone. (FR Vol 73. no 

35 p.9629). Under SDWA 1412(b)(1)(B) EPA makes a separate determination to regulate a CCL contaminant 

before proposing and promulgating a national primary drinking water rule. The Agency will continue to use the 

best available science and information to evaluate contaminants on the CCL 3 including any updates to the IRIS 

risk assessment to determine if the information is sufficient for the Agency to make a regulatory determination. 

The Agency uses the best available national occurrence data to evaluate contaminants to determine if a 

contaminant is known or anticipated to occur in public water systems. EPA has also evaluated the information 

provided by the commenter for the occurrence of 1,4-dioxane in 50 public water systems in Michigan. The 

Agency collected data and information that 1,4-dioxane can be anticipated to occur in PWS. Data from Toxic 

release inventory showed total release ( 800 thousand pounds) in 22 states. Production data also indicated 

that 1-10 million pounds of 1,4-dioxane was produced and 1,4-dioxane may be prevalent in the environment 

due to its slow biodegradation. EPA selected the TRI data based on the hierarchy described in the FR notice (FR 

vol 73 no35). Based upon these and other data, The Agency has determined that 1,4-dioxane is known and 

See response to comment 19291 under comment code 2680.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 19376 under comment code 6550.

EPA agrees that expert review was an important component of the CCL 3 and improved the process.

Please see the response to comment ID 19376 under comment code 6550.

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

The Agency has responded to the specific comments submitted by MADEP on MTBE and perchlorate under the 

respective comment codes: 3910 MTBE (comment ID 19307), and 4450 perchlorate (comment ID 19308). RDX, 

1,4-dioxane, NDMA, and PFOA were all included on the final CCL 3. The Contaminant Candidate List is the first 

step in identifying contaminants that may require regulation. The Agency will evaluate contaminants on the final 

CCL 3 to determine whether or not they require a national drinking water regulation. The Agency will publish the 

preliminary regulatory determinations and seek comment at that time.

EPA considered both TAME and TBA in the universe of chemicals for the Draft CCL 3. Both chemicals had limited 

occurrence information. Based upon these data, EPA did not include either chemical on the CCL 3.

Please see response to comment ID 19338 under comment code 7200.
The CCL universe included 8 haloacetonitriles: bromoacetonitrile, bromochloroacetonitrile, 

bromodichloroacetonitrile, chloroacetonitrile, dibromochloroacetonitrile, dichloroacetonitrile, 

tribromoacetonitrile and trichloroacetonitrile. The first 7 did not initially pass to the PCCL because of a lack of 

sufficient occurrence data. All seven were re-screened using the DBP Information Collection Rule (ICR) data and 

none of them met the criteria for inclusion on CCL 3.

The CCL process evaluated three halogenated nitromethanes. Two: bromodichloronitromethane and 

dibromonitromethane were included in the universe, but did not pass to the PCCL because of a lack of sufficient 

occurrence data. Bromonitromethane lacked both health effects and occurrence data. Chloronitromethane, 

dibromochloronitromethane, and dichloronitromethane were not part of the DBP-database that was the main 

source of information on DBPs and were not nominated to the universe. For additional information on DBPs in 

the universe please see the response to comment ID 19342 under comment code 7130. 

EPA encourages the nomination of chemicals to be included in the universe for the next CCL process. Both health 

EPA disagrees with the commenter. In developing the Draft CCL 3, the Agency implemented a different process 

from that used for CCL 1 and CCL 2. This new process builds on evaluations used for previous CCLs and was 

based on substantial expert input and recommendations from the National Academy of Sciences National 

Research Council (NRC), the National Drinking Water Advisory Council (NDWAC), other groups, and public 

comments on CCL 1 and CCL 2, including MassDEP and other states, to make the process more transparent and 

reproducible.



Based upon the available data and information EPA concludes that the contaminants included on the final CCL 3 

are known or anticipated to occur in public water systems and may require regulation. Therefore, EPA has 

included additional contaminants on the CCL 3 than those listed on CCL 2. EPA also notes that it evaluated all the 

contaminants on CCL 2 as it developed a new process for CCL 3.



The Agency uses the best available science and information to evaluate and list drinking water candidate 

contaminants. The Agency also notes that including a contaminant on the draft or final CCL 3 does not impose 

any requirements on anyone. (73 FR 9629). Under SDWA 1412 (b)(1)(B)(ii) EPA makes a separate determination 

whether or not to regulate a contaminants before proposing and promulgating a national primary drinking water 

rule. The Agency will continue to use the best available science and information to evaluate contaminants on the 

CCL 3 including any updates to the IRIS risk assessment to determine if the information is sufficient for the 

Agency to make a regulatory determination. 



EPA is including perchlorate and MTBE on the CCL 3. EPA identified information gaps needed to make further 

EPA is committed to using sound science in the preparation of its IRIS Risk Assessments. The MTBE Risk 

Assessment will be made available once The Agency has completed the appropriate reviews to assure the quality 

and integrity of the risk assessment.

EPA published an Interim Health Advisory for perchlorate in January 2009. The Interim Health Advisory is 

established based on the most sensitive population identified by the NAS, the fetus of the iodide-deficient 

pregnant woman. EPA's August 2009, supplemental FR notice does not change the Interim Health Advisory; 

however, in this notice, EPA requested comment on alternative analyses that result in lower health based levels 

for other sensitive life stages such as infants and children. EPA will consider the comments on these alternative 

approaches as it makes a final regulatory determination and as it decides what modifications are needed to the 

Interim Health Advisory for perchlorate. 


Based upon the available data and information EPA concludes that perchlorate and MTBE are known or 

anticipated to occur in public water systems and may require regulation. Therefore the Agency has included 

them on the final CCL 3.

EPA makes a separate determination using more rigorous evaluation criteria specified under SDWA 

1412(b)(1)(B)(ii) on whether or not to regulate a contaminants before proposing and promulgating a national 

primary drinking water rule. The Agency will continue to use the best available science and information to 

evaluate contaminants on the CCL 3 to determine if the information is sufficient for the Agency to make a 

regulatory determination. 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment 18929 under comment code 3560.

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Please see response to comment ID 17297 under comment code 7200.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

The commenter correctly summarizes the CCL and regulatory determination process and no further response is 

The Agency disagrees with the commenter that EPA should reduce the number of substance included in each 

CCL. The SDWA does not limit the Agency to a particular number of contaminants for the CCL. The Agency also 

notes that the neither the NRC or NDWAC recommendations on the CCL provide any recommendations on 

reducing the number of contaminants in successive CCLs. However, the Agency does recognize the need to 

communicate data needs for contaminants included on the final CCL. The EPAs Office of Water coordinates 

with the Office of Research and Development (ORD) to discuss CCL 3 research needs and priorities. OW is 

working with ORD to incorporate the results from these discussions in the next drinking water multi-year plan. 

The Contaminant Candidate List is the first step in identifying contaminants that may require regulation and 

contaminants that need additional data in order to determine the appropriate Agency action. The drinking water 

Contaminant Candidate List 3-final Notice in the Federal Register contains a table that identifies data needs for 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

EPA agrees with the commenter that public input into the development of the CCL 3 improved the overall 

EPA agrees that expert review was an important component of the CCL 3 process. Please refer to the Chemical 

Expert Input and Review for the Third CCL located in the CCL Docket (EPA-HQ-OW-2007-1189). EPA disagrees 

that the discussion of treatment as a criteria considered for listing and scoring microbes was not discussed. The 

FR notice (73 FR 9628) discusses organisms possibly covered by existing regulations and those possibly covered 

by treatment technique regulations on page 9548. The Agency noted the variability of treatment across systems 

and noted the viruses and Legionella were not excluded from consideration. The Agency also noted that E. Coli 

0157 was not excluded from consideration and stated that including these pathogens on the CCL emphasizes 

their importance in protecting public health. Therefore, Agency opted to not include treatment as a factor for 

removing pathogens from inclusion on the CCL 3. The FR notice and the support documents provide additional 

discussion of consideration of treatment as a factor for removing pathogens from further consideration and why 
The EPAs Office of Water (OW) coordinates with the Office of Research and Development (ORD) to prioritize 

research needs for the CCL 3 contaminants. OW is working with ORD to incorporate these research needs in the 

next drinking water multi-year plan. The Contaminant Candidate List is the first step in identifying contaminants 

that may require further evaluation in order to determine the appropriate Agency action (development of health 

advisories, or regulations, or no action).



The drinking water Contaminant Candidate List 3-final Notice in the Federal Register contains a table that 

identifies data needs for contaminants on the final CCL 3. In general, EPA characterized each chemical 

contaminant included on the final CCL 3 for their data needs in three categories; health effects, occurrence, and 

analytical method. The data needs were characterized as no data needs, specific data needs, or substantial data 

needs. The summary identifies which contaminants have research efforts under way within the Agency. It also 

identifies those contaminants that need additional information to characterize the health effects, occurrence, 

and analytic methods. By identifying those contaminants that need additional research and information, the 

Agency is communicating to stakeholders both research priorities and gaps for these contaminants. The health 

effects, occurrence, and analytical methods data/information used to select contaminants for the CCL 3 are 

EPA believes it is appropriate to consider and list Legionella and viruses on CCL 3. As discussed on page 9648 of 

the draft CCL 3, EPA did not exclude specific viruses and Legionella from consideration for the CCL. There are 

several reasons discussed for listing Legionella and viruses, including numerous WBDOs (e.g., CDC MMWR 

reports, 2006). Even though there is an MCLG, there are no monitoring, treatment or notification requirements 

within the National Primary Drinking Water Regulations that are specific to viruses or Legionella particularly for 

public water systems using ground water as a source. As a result, EPA believes that these contaminants are 

appropriately considered for specific NPDWR regulation through the CCL process rather than through the Six 

EPA disagrees with the commenters concern that EPA should reduce the number of substances on the CCL to 

better focus its resources. EPA assessed the data and information gathered on the CCL 3 chemical contaminants 

and developed a summary of the types of data and information available to help identify needs for regulatory 

determination evaluations and included the summary in the Federal Register notice. In general, EPA 

characterized each chemical contaminant included on the final CCL 3 for their data needs in three categories; 

health effects, occurrence, and analytical method. The data needs were characterized as no data needs, specific 

data needs, or substantial data needs. The health effects, occurrence, and analytical methods data/information 

used to classify data needs are featured in the supporting documentation and in the Final Contaminant 

Candidate List (CCL) 3 Contaminant Information Sheets in the docket (USEPA, 2009d). The summary identifies 

which contaminants have research efforts under way within the Agency. It also identifies those contaminants 

No response necessary to this summary of EPA information.

EPAs Office of Ground Water and Drinking Water (OGWDW) and the Office of Water coordinate with the Office 

of Research and Development (ORD) to discuss CCL 3 research needs and priorities. OGWDW is working with 

ORD to incorporate the results from these discussions in the next drinking water multi-year plan. The 

Contaminant Candidate List identifies contaminants that may require regulation and includes contaminants that 

need additional data in order to determine the appropriate Agency action (development of health advisories, or 

regulations, or no action).



The drinking water Contaminant Candidate List 3-final Notice in the Federal Register contains a table that 

identifies data needs for contaminants on the final CCL 3. EPA assessed the data and information gathered on 

the CCL 3 chemical contaminants and developed a summary of the types of data and information available to 

help identify needs for regulatory determination evaluations and included the summary in the Federal Register 

notice. In general, EPA characterized each chemical contaminant included on the final CCL 3 for their data needs 
EPA disagrees with commenters concern regarding the use of data and information from the High Production 

Volume (HPV) program to screen the PCCL chemicals that did not have detected occurrence data in water. The 

Agency believes it used the best available data to evaluate a broad universe of chemicals and included those that 

the Agency anticipates may occur in PWS and require regulation in accordance with SDWA requirements. The 

Agency notes that the unregulated contaminants only with HPV occurrence information were not included on 

the draft or final CCL 3. EPA summarizes the protocols for different types of occurrence in the support 

documents available at www.regulations.gov (Contaminant Candidate List 3 Chemicals: Classification of the PCCL 

to the CCL). The Agency uses the best available science and information to evaluate and list potential drinking 

water candidate contaminants and will continue to use HPV data and information as EPA collects more 

See response to Comment 19384 under comment code 6900 regarding the general relationship between the CCL 

and UCMR programs. 

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19373 under comment code 1000.

Please see response to comment ID 19338 under comment code 7200 for a discussion of the Agencys efforts 

on stewardship and drug take back programs.

EPA addressed the sources of perchlorate in the May 1, 2007 Federal Register Notice entitled "Drinking Water: 

Regulatory Determinations Regarding Contaminants on the Second Drinking Water Contaminant Candidate ListPreliminary Determinations" (72 FR 24039). The Agency will continue to use the best available data and 

information to evaluate the occurrence of perchlorate in public water systems. The Agency will evaluate other 

data to determine if they are sufficient to include in its evaluation of perchlorate, including those sources of 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 19341 under comment code 2460.

The Agency uses the best available science and information to evaluate and list potential drinking water 

candidate contaminants. All contaminants that are part of the final CCL 3, including those cited by the 

commenter, were included on the CCL 3 because these contaminants are known or anticipated to occur in public 

water systems and may require regulation. EPA also notes that as the Agency learns from previous CCLs it will 

use an adaptive management approach to modify the process of evaluating contaminants for the CCL. As new 

data and information become available the Agency will consider how to include the best available information 

Please see response to comment ID # 19342 under comment code 7130

***Cadmus please move response from "response to comment code" section to this individual response when 

preparing comment response document.***

EPA is conducting several on going and continuing efforts to better understand the potential risks and benefits of 

nanotechnology and agrees with the commenter's assessment of the limited toxicological information available 

for these types of contaminants and therefore, has not included nanoparticles or nanomaterials on the CCL 3. 

EPA will continue to evaluate the best available science and information that describes the occurrence and 

health effects information on nanomaterials as it becomes available. 

EPA provides many forums to meet with researchers and experts on occurrence, exposure, and toxicology issues 

and develop information that is needed to evaluate potential drinking water contaminants and will include the 

commenter as we communicate those opportunities to the public in future. 
In the first attachment (DBP-1), the commenter mentioned N-chloramines as frequent disinfection by products 

that should be considered when evaluating frequent water contaminants. However, N-chloroamines were 

neither in the Universe data compilation nor nominated during the nominations period, and the commenter did 

not submit data values to support their assertion that N-chloramines should be included on the CCL. 

Information on how EPA narrowed the list of possible DBPs to the CCL is available in a document on the EPA 

Web site titled Contaminant Candidate List 3 chemicals: screening to a PCCL at 

http://www.epa.gov/ogwdw/ccl/pdfs/report_ccl3_chemicals_screening.pdf. EPA also provided a list of 

contaminants considered for CCL 3 showing the status of the chemicals in the CCL process and the contaminant 

information sheets for the PCCL. Both of the references are available in the docket at regulations.gov. All 

information provided in Attachment DBP-1 (Disinfection as a Source of Diverse By-Products of Potential 

Concern) had been considered by the Agency in determining the draft final CCL 3. Specifically, the drinking water 

monitoring data submitted by the commenter were the Krasner 2006 and Weinberg 2002 studies. EPA used the 

Krasner 2006 study, which is an intensive summary of the Weinberg 2002 data, as a supplemental data set as 

The CCL3 process evaluated 8 haloacetonitriles, 7 halonitriles, 3 haloaldehydes, 11 halopropanones, 2 

halopicrins, 2 haloacetic acids, 2 halonitromethanes, 8 N-nitrosamines and 8 halo-furanones (Mx-like 

compounds) in the groups identified by the commenter. (Others, including the haloquinones, and Nchloroamines were neither in the Universe data compilation nor nominated during the nominations period.) 

Among the DBPs in the universe benzoic acid, bromochloromethane, dibromomethane, N-nitroso-Ndibutylamine and chloropicrin advanced to the PCCL but did not initially advance to the CCL based on the 

outcome of the classification models and their attribute scores.

The drinking water monitoring data submitted by the commenter were the Krasner 2006 and Weinberg 2002 

studies. EPA used the Krasner 2006 study, which is an intensive summary of the Weinberg 2002 data, as a 

supplemental data set as part of the CCL process. Reevaluation of the universe chemicals using the DBP ICR or 

Krasner occurrence data moved Bromochloroacetonitrile and Dichloroacetonitrile from the universe to the PCCL. 

3-Chloro-4-(bromochloromethyl)-5-hydroxy-2(5H)-furanone, BMX-1; 3-Chloro-4-(dibromomethyl)-5-hydroxy2(5H)-furanone, BMX-2; and 3-Bromo-4-(dibromomethyl)-5-hydroxy-2(5H)-furanone, BMX-3 will all now pass the 

screen to the PCCL based on their carcinogenicity probability. Reevaluation of the chemicals using 90th 

percentile water data for the HRL/water ratio, as opposed to the median, moved Bromochloromethane onto the 

Please see response to comment ID 19338 under comment code 7200. EPA has reviewed these summaries of 

published literature and has collected the cited data for use in the CCL 3 evaluations. The information collected 

and evaluated for individual contaminants is available in the CCL 3 docket in the Contaminant Information Sheets 

EPA reviewed the information provided by the commenter summarizing data from 38 data sets from wastewater 

treatment facilities. While the data provides information on the concentration of constituents in wastewater at 

different points in the treatment train, it does not provide the citation or reference the studies summarized. EPA 

also compiled extensive occurrence data using the protocols and data sources described in the Draft CCL 3 FR 

notice (73 FR 9628). The Agency considered the unregulated contaminants in the summary. The Agency uses the 

best available science and information to evaluate and list potential drinking water candidate contaminants. 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment IDs 19600 under comment code 7200 and 19376 under comment code 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
Based upon these and other data submitted by commenters, EPA concludes that the cyanotoxins included on 

the draft CCL 3 are known or anticipated to occur in public water systems and may require regulation. Therefore, 

EPA is including these compounds on the CCL 3. Additional information is available in the Contaminants 

Information Sheets included in the docket at www.regulations.gov.



EPA recognizes that primary public exposure to algal biotoxins can come from drinking water, recreational 

water, and dietary supplements. Secondary human exposure may come from algal biotoxin residue on fruits and 

vegetables from contaminated irrigation water and consumption of animal tissue. While EPA does not have 

statutory authority to regulate for dietary supplements or residues on foods for cyanotoxins, the Agency actively 

participates in the efforts to better protect public health from exposure to cyanotoxins in committees like 

Interagency International Symposium on Cyanobacterial Harmful Algal Blooms.



EPA also notes that under SDWA 1412 (b)(1)(B)(ii), the Agency makes a separate determination whether or not 

to regulate a contaminant before proposing and promulgating a National primary drinking water rule. The 

Agency will continue to use the best available science and information to evaluate contaminants on the CCL 3 

Please see response to comment ID 19016 under comment code 3315.

Please see the response to comment ID 19349 under comment code 3310. 

Please see response to comment ID 19016 under comment code 3315. EPA disagrees with the commenter. The 

toxicological data that were used in evaluating anatoxin-a for the CCL were derived from a peer reviewed 

publication. The occurrence data applies to ambient water concentrations from Lake Champlain in New York. 

This information for anatoxin, and the other cyanotoxins, is available in the docket at www.regulations.gov 

(Contaminant Information Sheets for the CCL 3). Based on this information EPA anticipates that cyanotoxins may 

occur in PWS and may require regulation. Therefore EPA has included Cyanotoxins on the CCL 3.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment IDs 19388 and 18961 under comment code 6166.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

EPA conducted literature reviews to identify LOAELs or NOAELs for pharmaceutical compounds and only used 

MRDDs when other data were not available. EPA treated MRDD values and applied uncertainty factors as 

described in the support documents available at www.regulations.gov (see Contaminants Candidate List 3 

Chemicals: Classification o the PCCL to CCL, section 5). EPA is actively working with other agencies and 

stakeholders to collect and use the best available scientific data and information to evaluate active 

pharmaceutical ingredients. Please see the responses to comments under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
EPA has included Bromomethane; 1,4-Dioxane; Chloromethane; Methyl Tert-butyl Ether; 1,1,1,2-

Tetrachloroethane; 1,1-Dichloroethane; and Perchlorate on the final CCL 3 because the Agency anticipates or 

knows these chemicals occur in PWSs and may require regulation. As part of the regulatory determination for 

CCL 3, EPA will decide whether to establish MCLs for these contaminants; whether or not to establish such MCLs 

has not yet been decided. The next steps for evaluating chemicals included on the CCL 3 are discussed in the 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

EPA acknowledges and agrees with your comments.

Please see response to comment ID 19378 under comment code 9100.

EPA will review suggestions for revision of the CCL process when work on CCL4 begins. EPA has published several 

documents describing and outlining the selection process used for CCL 3. These documents are available online 

for public perusal at http://www.epa.gov/OGWDW/ccl/ccl3.html See the response to comment ID 19379 under 

comment code 7130 for more information. EPA also plans to conduct a comprehensive review of regulatory 

needs for DBPs at an appropriate time as part of the 6-year review process.

EPA acknowledges the commenter's concern on developing research and information needed to evaluate 

contaminants in a timely manner. The drinking water Contaminant Candidate List 3-final Notice in the Federal 

Register contains a table that identifies data needs for contaminants on the final CCL 3. In general, EPA 

characterized each chemical contaminant included on the final CCL 3 for their data needs in three categories; 

health effects, occurrence, and analytical method. The data needs were characterized as no data needs, specific 

data needs, or substantial data needs. The summary identifies which contaminants have research efforts under 

way within the Agency. It also identifies those contaminants that need additional information to characterize the 

health effects, occurrence, and analytic methods. By identifying those contaminants that need additional 

research and information the Agency is communicating to stakeholders both research priorities and gaps for 

these contaminants. The health effects, occurrence, and analytical methods data/information used to select 

contaminants for the CCL 3 are featured in the supporting documentation and in the final CCL 3 contaminant 

information sheets in the docket.

The Agency agrees that protecting sources of drinking water is an important part of providing safe drinking water 

to the public. Protecting drinking water sources usually requires the combined efforts of many partners such as 

public water systems, communities, resource managers and the public. The Agency continues to work with 

stakeholders from states, water and wastewater utilities, the agricultural community, and the chemical and 

manufacturing industries to evaluate potential contaminants and protect source waters. One example of the 

Agencys efforts to protect source waters is the Source Water Collaborative (SWC). The SWC includes twentythree national organizations in the water and wastewater industries.The SWC recognizes that resources are 

extremely limited and authorities are split among the actors who can actually protect source waters. EPA also 

develops makes available a variety of tools to aid community planners, public water supply operators, and 

members of local source water protection teams in developing source water assessments. The tools include 

Please see response to comment ID 19417 under comment code 2200.
Please see the response to comment ID 19372 under comment code 6000. EPA acknowledges and appreciates 

your commendation of our process. As part of the CCL 3 process, EPA worked with many stakeholders, including 

AWWA, and hopes to continue to develop these partnerships as we evaluate potential drinking water 

contaminants. EPA evaluated thousands of chemicals from different classes and sources, including 1,200 

pharmaceuticals. EPA identified contaminants that have sufficient occurrence and health effects data and 

information to be evaluated in the CCL process. EPA also recognizes that analytical methods and health effects 

research will continue to evolve and will require the same scientific rigor the Agency has applied to 

contaminants on the CCL 3.

EPA also notes the commenters recommendations for additional transparency. The Agency has updated the 

support documents, including the contaminant information sheets identified by the commenter, to improve the 

transparency and clarity of data used to support the decisions made in the development of the CCL 3. The 

EPA has reviewed the commenter's recommendations on the Summary of Nomination for the Third 

Contaminant Candidate List in the docket and made changes to clarify the decisions to list or not list the 

nominated contaminants in that document. Additional information on the status of nominated contaminants is 

provided in the list of contaminants considered in the CCL Universe. For those contaminants that passed from 

the universe to the PCCL the Contaminant Information Sheets provide all the data collected and considered by 

the Agency. Both of these supporting documents are in the docket and can be downloaded from 

www.regulations.gov. EPA agrees with the commenter that nominations and public input are a central 

component of the CCL. EPA will review and consider the commenters recommendations to seek nominations 

EPA recognizes that the amount of information and documents describing the newly developed process for the 

CCL 3 was greatly increased above that for past CCLs and thus may have required more time and effort for the 

public to review all the material. However, EPA believes that it is important to provide detailed information so 

that the process can be viewed as transparent and reproducible. EPA has endeavored to improve the 

transparency and availability of the support documents for the final CCL 3. The Agency also recognizes the 

valuable information provided by stakeholders who participated in the development of the CCL 3 process. The 

Agency will consider the commenter's recommendations to increase the availability and transparency of the 

information and decisions made on the contaminants consider for future CCLs to facilitate public participation 

EPAs Office of Ground Water and Drinking Water (OGWDW) and the Office of Water coordinate with the Office 

of Research and Development (ORD) to discuss CCL 3 research needs and priorities. OGWDW is working with 

ORD to incorporate the results from these discussions in the next drinking water multi-year plan. The 

Contaminant Candidate List is the first step in identifying contaminants that may require regulation and 

contaminants that need additional data in order to determine the appropriate Agency action (development of 

health advisories, or regulations, or no action). 

The drinking water Contaminant Candidate List 3-final Notice in the Federal Register contains a table that 

identifies data needs for contaminants on the final CCL 3. EPA assessed the data and information gathered on 

the CCL 3 chemical contaminants and developed a summary of the types of data and information available to 

help identify needs for regulatory determination evaluations and included the summary in the Federal Register 

notice. In general, EPA characterized each chemical contaminant included on the final CCL 3 for their data needs 
The commenter identifies several concerns regarding the CCL 3 process many related to the lack of DBPs on CCL 

3. A need for clarity regarding the relationship between the CCL and the six-year review of regulations was also 

expressed.

The major database that introduced the DBPs into the CCL 3 Universe was the DSS-Tox database. This database 

provides qualitative characterization of the tumorigenic potential for a large number of DBPs based on QSAR 

projections and expert judgment. The data from the DSS-Tox data base are categorical and were screened based 

on the description of a chemicals probability to cause cancer. All chemicals with a high and high-medium 

probability for the cancer endpoint should have screened to the PCCL regardless of their monitoring data. There 

were three chemicals that should have passed to the PCCL because of their high-medium cancer probability, but 

did not; they are: 3-Chloro-4-(bromochloromethyl)-5-hydroxy-2(5H)-furanone, BMX-1; 3-Chloro-4-

(dibromomethyl)-5-hydroxy-2(5H)-furanone, BMX-2; and 3-Bromo-4-(dibromomethyl)-5-hydroxy-2(5H)-

furanone, BMX-3. They will be included on the PCCL. In response to public comments EPA reevaluated these 

chemicals relative to available occurrence information and found that the available data did not support their 

inclusion on CCL 3.

Please see response to comment ID 19378 under comment code 9100. The Agency disagrees that the number of 

contaminants included on a CCL 3 should be commensurate with what can be supported by EPAs drinking 

water research budget. The Agency described a process to identify contaminants from a broad universe based 

on the best available science and information to evaluate the anticipated occurrence in PWS and adverse health 

effects a contaminant may pose from drinking water exposure. 



EPA identified those contaminants that it knows or anticipates may occur in PWS and may require regulation. 

Implementing the program to identify potential contaminant provides the public and stakeholders with an 

opportunity to provide comment, additional data, and assist the Agency to prioritize research needs on the CCL. 

The Agency also collaborates and coordinates with other agencies and organizations to leverage resources to 

complete the research needed to evaluate drinking water contaminants.



The Agency has also described the linkages between the CCL and the UCMR in the FR notice and in the 

responses to comments under comment code 6900.

Please see the response to comment ID 19372 under comment code 6000. EPA acknowledges that data gaps 

exist for CCL 3 contaminants and that research is needed to gather data for regulatory consideration. EPA sees 

value in communicating those needs and described the research status of health effects, occurrence, and 

analytical methods in the final CCL 3 Federal Register notice. The Agency believes that this table will help to 

identify future research needs. The Agency has identified which contaminants and the type of research currently 

being evaluated by the EPA so that other research organizations may engage in drinking water research, provide 

valuable participation, and, as a whole research community, better leverage resources. The Agency also notes 

that the table identifies those contaminants that require longer-term research and those that have shorter-term 

research needs. EPA looks forward to the results of AWWAs retrospective analysis of the arsenic and DBP 

Please see responses to comment IDs 19378 and 19380 under comment code 9100.
Please see the response to comment IDs 19372 and 19381 under comment code 6000. EPA believes that the 

supporting documentation in the docket sufficiently identifies the types of information the Agency needed to 

consider contaminants for the CCL 3. EPA identified the kinds of occurrence and health effects information and 

the criteria the Agency used to uniformly evaluate individual contaminants. EPA and other Agencies are actively 

developing additional occurrence and health effects data for many of the contaminants initially considered in the 

CCL process that were not included on the final CCL 3. While the Agency recognizes the complexity and breadth 

of evaluating data not only from EPA, but multiple Agencies, we disagree that a formal process or specific 

document identifying data gaps for the numerous contaminants in the universe would provide additional 

valuable information to set research priorities at this time. EPA continues to work both internally and with other 

Agencies, both federal and otherwise, to gather the best available science and information for CCL 3 and future 

The 1996 amendments to SDWA instituted the CCL and UCMR programs to prioritize and focus data collection 

and regulatory consideration on the potential drinking water contaminants that present the highest priorities for 

future drinking water regulation. The CCL is the primary mechanism for the identification of this priority list of 

contaminants that may require regulation, while UCMR provides EPA with the national occurrence data 

necessary to determine if a contaminant occurs with a frequency and at levels of public health concern. The 

statute itself provides a direct linkage between the two programs by requiring EPA to consider the UCMR data in 

establishing the CCL. (Section 1412(b)(1)(B)(i)(I) and 1445(g)(3)). As a result, these two programs support and 

inform each other. While EPA uses the CCL as a primary source to select contaminants that need additional 

occurrence data for monitoring through the UCMR, UCMR occurrence data also informs the CCL process by 

identifying contaminants that occur in drinking water. Data from the UCMR is used by EPA to determine 

whether a contaminant may be anticipated or known to occur in drinking water and may require regulation. 

Based on this and other analysis, contaminants can be added to the CCL. Because the two programs operate 

Please see response to comment ID 19373 under comment code 1000. EPA agrees with the commenter and is 

also working to improve water quality standards and protect source water from animal feeding and production 

operations and other non-point sources of pollution. The Agency is working on protecting source waters form 

the potential sources identified by the commenter under the Water Standards Program, developing and 

improving Concentrated Animal Feeding Operations regulations, and storm water regulations.

EPA notes that AWWA staff and members participated in many of the efforts conducted by the Agency to 

develop the CCL 3. The Agency also acknowledges AWWAs conclusion about the need for more robust analytic 

methods and occurrence data to better inform the CCL process on which chemicals can be anticipated to occur 

in a PWS. In accordance with the NDWAC report and recommendations the Agency anticipates that additional 

information and improvements may be made to future CCLs using an adaptive management approach. 

Information from AWWAs efforts and the proposed publications will assist the Agency to identify potential 

EPA agrees with the commenter's suggestion that it is appropriate to not include treatability considerations in 

the CCL 3 criteria for chemicals.

As described in the FR notice (73 FR 9628), EPA only used release or production data as a surrogate measure for 

occurrence data when detected occurrence data were not available. EPA recognizes that environmental fate and 

transport data are also important factors for the Agency to consider. EPA used a suite of environmental fate 

parameters for those contaminants to evaluate contaminants that used production information as a surrogate 

measure for measured occurrence and did not solely rely on a single parameter such as the octanol-water 

coefficient as cited by the commenter. The protocol the Agency used is summarized in the FR notice for the draft 

CCL 3 (73 FR 9628) and described in detail in the support documents available in the docket (Contaminant 

Candidate List 3 Chemicals: Classification of the PCCL to CCL at www.regulations.gov EPA-HQ-OW-2007-1189). 

EPA also notes that chemicals with only production data as a surrogate for occurrence were not included on the 

Please see response to comment ID 19417 under comment code 2200.
In addition to the Expert Panel summary referred to by the commenter, EPA put into the docket support 

documents describing the selection criteria as well as all the data sources for every score and every decision. 

Please see responses to comment ID 19413 under comment code 2280 and comment ID 19390 under comment 

code 6760 for information. 



EPA requested input from the Expert panels on the on the CCL selection process and the documents supporting 

th draft scores. EPA convened the panels to provide input on the CCL 3 selection process and data prior to 

EPAs final selection actions. 



EPA does not request nor seek comment on the EPA personnel assigned to develop the documents supporting 

the process nor the external experts chosen for the panels. EPA does provide the names of external experts in 

panel summary documents.



The final of the three expert panels (March 2007) is the most relevant to the draft CCL 3 because of the iterative 

nature of the development of the CCL 3 process. All three expert panels (2005, 2006 and 2007) were general 

discussions providing input on the designing the CCL 3 selection process and as EPAs development progressed, 

some of the recommendations became moot. None of the expert panels were intended to provide final analysis 

or final selections of pathogens for the CCL 3. If EPA uses the same selection process for pathogens for the CCL 4 

No response necessary for this description of the comment.

Please see comment ID 19413 under comment code 2280 and comment ID 19390 under comment code 6760 

for a response to this comment.



EPA did not intend for the external panel reviews to be a post-scoring consensus vote or reality/confirmation 

check. Rather, the panels were convened to provide input on the CCL 3 selection process and data prior to 

EPAs final selection of the Draft CCL 3. 

 

The criteria for listing in the CCL 3 are occurrence and risk. The evaluation of treatment is not part of the CCL 3 

process. As discussed in the Draft CCL 3, page 9649, the Regulatory Determination phase will address treatment 

issues. All materials used in the identification, evaluation, and selection process for the CCL 3 are publicly 

available in the docket for this notice. EPA relied on peer reviewed papers or academic manuals for all of the 

scores. A few non-peer reviewed articles were included for informational purposes, however they did not 

support a score. For more detailed information on the identification, evaluation and selection process for the 

CCL 3, please refer to the available supporting documents (listed below) and the final CCL 3 FRN.



Candidate Contaminant List Microbes: Identifying the Universe (EPA 815-R-08-005)



Contaminant Candidate List 3 Microbes: Screening to the PCCL (EPA 815-R-08-006)



Candidate Contaminant List 3 Microbes: PCCL to CCL Process (EPA 815-R-08-007)



Final Candidate Contaminant List 3 Microbes: PCCL to CCL Process
EPA chose to list pathogens at the species level rather than by genus because EPA does not foresee regulation of 

an entire genus. Regulation is usually dependent on the availability of method(s) which are usually species 

specific. Thus, EPA has decided to list organisms at a level that could be considered for regulation. 

However, EPA did consider additional species within a genus by grouping them during the screening step of the 

listing process. Criterion 11 and 12, used for screening microbes from the Universe to the PCCL, state particular 

cases where the Agency decided to use both the genus and specie(s) or serotype to represent a group of 

pathogens sharing essential biological properties in common with the group, for example, Legionella 

pneumophila, represents several other Legionella species. See the supporting document Contaminant 

Candidate List 3 Microbes: Screening to the PCCL for more detailed information. 

EPA recognizes that the pathogenic E. coli includes enterohemorrhagic serotypes other than E. coli O157:H7 as 

well as enterotoxigenic, enteroaggregative and other forms that can cause clinical disease. Severe clinical 

manifestations of enterohermorrhagic serotypes results in a form of kidney failure known as hemolytic uremic 

syndrome (HUS) which can be fatal in children and the elderly. Organ failure is a result of the accumulation of 

toxins that are produced only by E. coli with certain genes (e.g. stx gene). Another CCL organism, Shigella, has 

the same key genes as the enterohemorrhagic E. coli serotype, and produces the same toxins and causes similar 

clinical disease, including HUS. EPA does not believe that it is necessary to list all species, serotypes and 

genotypes that comprise a pathogenic microorganism. Rather, EPA believes that it is sufficient to list one 

organism, such as E. coli O157:H7 that represents a group of similar organisms, genera, serotypes or genotypes. 

As an example of this procedure, EPA lists calicicvirus to represent the noroviruses and sapoviruses. In this case, 

Due to the dynamic nature of microbial research and taxonomy, it is difficult to have an up-to- date list of 

microbial pathogens at all times. As discussed and noted in the support documents Candidate Contaminant List 

Microbes: Identifying the Universe and Contaminant Candidate List 3 Microbes: Screening to the PCCL (both are 

in the docket to the draft CCL 3), EPA made several decisions to group similar organisms, genera, serotypes or 

genotypes. As an example of this procedure, EPA lists calicicvirus to represent the noroviruses and sapoviruses. 

EPA does not believe that grouping Arcobacter with Camplyobacter is appropriate at this time due to ongoing 

research and academic debate. Of note is that neither the CDC WBDO database nor the academic references 

from which the health effects scores were taken group Arcobacter with Campylobacter.

***Cadmus to copy the umbrella response to here.***

Please see response to Comment ID 19400 under comment code 6363 for this summary of earlier comments. 

EPA recognizes the limitations associated with molecular detection methods and scored them lower than the 

CDC WBDOs (CDC relies on culture methods where available). If, however, there is no CDC data or no culture 

method (e.g., Norovirus) EPA used occurrence data based on molecular methods because it implies that 

pathogens are present in water and that they may be capable of causing illness in persons exposed to water by 

ingestion, inhalation, or dermal contact. 



EPA does not distinguish between occurrence data based on molecular versus culture method. Rather EPA 

elevated CDC WBDO data above other occurrence data because of the epidemiological investigation supporting 

the monitoring results. CDC WBDO data that was based on a molecular detection method and linked to illnesses 

and the drinking water (e.g., Norovirus) is scored higher than data based solely on occurrence in drinking water. 

EPAs occurrence attribute is not meant to characterize the extent to which a pathogen poses a public health 

threat from drinking water exposure. Because viability and infectivity cannot be determined by non-cultural 
As the commenters approach suggests EPAs approach also used the most common clinical presentation for 

the specific pathogen for the population category under consideration. Because it is recognized that pathogens 

may produce a range of illness from asymptomatic infection to fulminate illness progressing rapidly to death, 

scoring decisions are based upon the more common clinical presentation and clinical course for the population 

under consideration, rather than the extremes.



Consistent with the recommendation by the 2007 experts workshop EPA based its health effects scores on 

clinical microbiology manuals. EPA went first to The Manual of Clinical Microbiology, 9th. Edition (Murray, P., E. 

Baron, J. Jorgensen, M. Landry, and M. Pfaller) for information to provide a health score. The authors are 

medical clinicians. This manual was specifically recommended by members of the 2007 expert panel. If this 

clinical manual did not have the information needed to score the health effects for a pathogen, EPA moved on to 

other clinical manuals as described in detail in the support document, Final Contaminant Candidate List 3 

Microbes: PCCL to CCL Process. EPA believes this approach to be transparent as well as easily 

traceable/reproducible. 



No response necessary for this summary.

EPA relied on CDC reported outbreaks and peer reviewed literature when evaluating and scoring for WBDOs. 

The occurrence score for Naegleria fowleri, supported by Gerba et al., 2007 resulted in a score of 3 while the 

score for WBDOs was a 4. However, EPA selects the higher score between WBDO and Occurrence, therefore, 

the CDC WBDO score was selected and thus the occurrence score (based on Gerba et al., 2007) simply provides 

additional information and does not impact the final CCL overall score for the organism. EPA agrees that US 

outbreaks with epidemiological data linking the illness to drinking water is the most valuable information. That is 

why CDC WBDOs are given higher scores than occurrence research data. CDC only lists an incident as a WBDO if 

it is in the US (a developed country) and there is epidemiological evidence linking the illnesses to drinking water 

(i.e., not just serological data). Only when there is no CDC WBDO, does the CCL 3 microbial protocol use the 

lower-valued occurrence data. Some pathogens have very little occurrence information, EPA felt that it was 

better to include the information rather than to exclude it.

EPA is unaware of any outbreak data from CDC based solely on serological data.



EPAs WBDO scoring protocol lowest possible score is 1 because of the potential for water-related illness to 

occur in the absence of recognized outbreaks. Furthermore, the use of 1 vs. 0 as the lowest scores of the 

protocol does not impact the end result of prioritizing the PCCL organisms. 



EPA agrees with the commenter that there are differences in water quality between developed and developing 

countries (see the Final Contaminant Candidate List 3 Microbes: PCCL to CCL). 



Selection of the higher score from the WBDO or occurrence protocol elevates pathogens that have been 

detected in drinking water or source water in the U.S. (occurrence score of 2 or 3) above pathogens that have 
Please see the response to comment ID 19261 under comment code 6300 for information on scientific papers 

and comment ID 19400 under comment code 6363 for information on recreational water WBDO.



Most public water systems are ground water systems and ground water systems are not required to treat or 

disinfect. Certain pathogens may be well controlled by drinking water treatment (primarily disinfection). As 

discussed in detail in the draft CCL 3 (see page 9648), EPA did not preclude pathogens from CCL 3 based on their 

potential to be controlled by existing treatment technique regulations. As discussed in the preamble to the Draft 

CCL 3, (see page 9629) a Regulatory Determination requires more information and analyses than the analyses 

used to support the CCL 3 selection process. EPA will conduct analyses to support regulatory determinations 

beginning after the publication of the final CCL 3.



EPAs scoring protocol also used the most common clinical presentation for the specific pathogen for the 

population category under consideration. Because it is recognized that pathogens may produce a range of illness 

from asymptomatic infection to death, scoring decisions are based upon the more common clinical presentation 

and clinical course for the population under consideration, rather than the extremes (73 CFR 9646).



EPA used peer reviewed recently published clinical microbiology manuals as the primary data source to identify 

the most common clinical presentation which can be easily found and used to replicate the process. In contrast, 

the commenters approach seems to have relied on an expert consensus-based health effect scoring process 

which may not be consistently reproducible and is lacking in transparency. The commenter did not provide 

citations to allow for a reproducible process thus EPA is not able to comment on their health effects scoring 

process. The commenters approach also used criteria/sub-criteria (e.g. infectious dose (ID), secondary spread) 

EPA scored pathogens using the WBDO and occurrence protocols, and then selected the highest score between 

the two of them, to prevent double-counting. Selection of the higher score from the WBDO or occurrence 

protocol elevates pathogens that have been detected in drinking water or source water in the U.S. (occurrence 

score of 2 or 3) above pathogens that have caused WBDOs in other countries but not in the U.S. (WBDO score of 

2). 



The Final CCL 3 selection process considered pathogens causing recent waterborne outbreaks more important 

than pathogens detected in drinking water without documented disease from that exposure. As the commenter 

pointed out, EPA considered that occurrence of pathogens indicates the potential for waterborne transmission 

of disease. Documented waterborne disease outbreaks provide an additional weight of evidence that illness was 

transmitted and that there was a waterborne route of exposure. EPA also developed protocols to define a 

hierarchy of the relevance that each of these types of data provide in evaluating microbes for the CCL. 

Combining these two sources of occurrence information (molecular and culture methods) enabled EPA to 

Please see Comment ID: 18881 under comment code 2210 for the response to the comment on treatment; 

please see comment ID 19390 under comment code 6760.

No response necessary to this summary of EPA information.

No response necessary to this summary of EPA information.

No response necessary for this summary.

Please see response to comment ID 19412 under comment code 2260.
Please see response to comment ID 19412 under comment code 2260.

EPA recognizes that enteroviruses are common human viruses associated with a variety of mild to severe clinical 

illnesses. EPA also recognizes that enterovirus is a cause of waterborne disease, and that outbreaks are 

uncommon, perhaps because of laboratory assay complexities which makes it exceedingly difficult to identify 

enterovirus in water samples except at highly specialized laboratories. 

EPA rescored all pathogens after the Expert Panel met. EPA reviewed and corrected mistakes in the health 

effects and occurrence information as recommended by the Expert Panel. All scores were based solely on the 

information presented in the scoring support document in the draft CCL 3 docket and as discussed in the draft 

CCL 3 Federal Register Notice. Enterovirus was not treated any differently in this process. Rather EPA excluded 

the enteroviruses from the draft CCL 3 because the enterovirus occurrence score was moderate and the overall 

score slightly below the draft CCL 3 pathogens. However, enterovirus was added to the final CCL 3 based on 

Please see response to comment ID 19412 under comment code 2260.

EPA rescored all pathogens after the Expert Panel met. EPA reviewed and corrected mistakes in the health 

effects and occurrence information as recommended by the Expert Panel. All scores were based solely on the 

information presented in the scoring support document in the draft CCL 3 docket and as discussed in the draft 

CCL 3 Federal Register Notice.



EPA recognizes that rotavirus is a common childhood virus. The virus is common because it is highly infectious 

and easily transmitted among children in schools and day care centers by person to person transmission. EPA 

also recognizes that there is a significant but unknown component of waterborne rotaviral disease transmission 

among children and adults can also become ill due to waning immunity or exposure to new rotavirus types. 

Rotavirus remains on the PCCL but not on the final CCL 3 because of its health effects score - in both children and 

adults it is almost always mild and self-limiting. 

Based on comments, EPA changed the pathogens listed on the final CCL 3. EPA removed older, CDC waterborne 

disease outbreaks (WBDO) (prior to 1990) from the occurrence analysis. This and other minor changes to the 

scoring, are discussed in more detail in the final CCL 3 notice. As a result, EPA has added to CCL 3: 

enteroviruses, adenovirus and Mycobacterium avium and removed from CCL 3: Vibrio cholerae and Entamoeba 

EPA has kept Helicobactor pylori on the final CCL 3. Consistent with all pathogens evaluated for CCL 3, EPA did 

not consider the culturability (i.e., availability of a method), or route of transmission as a selection criterion for 

the CCL 3 pathogen list.



EPA scored every pathogen on its most severe health effect that is also commonly manifested. H. pylori does 

differ from the other CCL 3 pathogens in that the health effect score is based on a chronic effect (cancer), rather 

than its less severe acute effect. However, the use of the chronic health effect is discussed in the draft CCL 3 

(see page 9653) as well as in the support document on microbial scoring. EPA chose gastric cancer rather than 

gastric ulcers because it is a common manifestation of disease from H. pylori (6,500 deaths per year, CDC see the 

Final Contaminant Candidate List 3: Microbial Scoring Support document for details). 



EPA rescored all pathogens after the Expert Panel met. EPA reviewed and corrected mistakes in the health 

effects and occurrence information as recommended by the Expert Panel. All scores were based solely on the 
EPA disagrees with the comment. EPA criteria for evaluating and prioritizing pathogens for inclusion in the CCL 3 

included health effects, waterborne disease outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). Neither 

treatability nor rareness/frequency of disease were criteria considered for CCL 3 inclusion. 

EPA acknowledges the occurrence of N. fowleri in soils and recreational waters, however, this situation does not 

negate the severe health effects associated with N. fowleri, its occurrence in drinking water in the US (Gerba et 

al., 2007) and the fact that it has also been the cause of at least one WBDO as documented by CDC (CDC MMWR 

2001  2002).

EPA acknowledges the reference provided by the commenter regarding the 2007 Expert Panel recommendations 

on adding a frequency of disease parameter to the health effects scoring protocol for future CCLs to balance the 

consideration of more prevalent illnesses with the more severe but less prevalent responses, such as N. fowleri. 

EPA will take this comment into consideration for future CCLs.

EPA does not agree with the comment that inclusion of Salmonella and Shigella on the CCL violates SDWA 

statutory requirements. They meet the criteria EPA has established for determining the CCL 3. Therefore, they 

will remain on the CCL 3 for the reasons stated below. 



They pose high health risk, occur in drinking water and have caused WBDOs since 1990. Neither Salmonella nor 

Shigella are specifically regulated under the SDWA. Treatability is not a criterion for listing under the CCL 3. 

Ground water systems make up the greatest portion of public water systems and they are not required to treat 

under EPAs drinking water regulations and most of them do not treat

EPA criteria for evaluating and prioritizing pathogens for inclusion in the CCL 3 included health effects, 

waterborne disease outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). Treatability was not part of the 

scoring criteria considered for CCL 3 inclusion.



Please see response to comment ID 19412 under comment code 2260.

EPA did not use the alternative approach proposed by the commenter because we could not evaluate the 

approach due to insufficient information on how the decisions were/could be made and a lack of citations for 

the source of the information used to score the pathogens. For example, it is unclear how a criterion is scored if 

that data is not available (infectious dose is not available for most pathogens). Another example would be in 

calculating the outbreak score -- were the cases of illness added for all outbreaks or were they averaged? 

There is no information given by the commenter on the source of scores for sequellae and secondary spread. 

Even if all the background information was available, EPA would hesitate to use a criterion for scoring pathogens 

(e.g., infectious dose) that is not available for every pathogen. EPA also avoided using professional judgment as 

part of a scoring process because it is difficult, if not impossible to describe for public comment and to reproduce 

in subsequent scoring exercises. EPA will consider AWWAs alternative approach as we develop the CCL 4 

selection process.

EPA disagrees with the commenter on adding rotavirus to the CCL 3 because of rotaviruses low score, specifically 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 19068 under comment code 4450. EPA monitored perchlorate under the 

first Unregulated Contaminant Monitoring Rule (UCMR 1) from 2001-2005. The evaluation of perchlorate 

occurrence under UCMR 1 was published in the May 1, 2007 Federal Register (72 FR 83). 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment IDs 18977 and 19373 under comment code 1000.
Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

EPA agrees that scientific, technical, and stakeholder involvement the Agency conducted in developing the CCL 3 

has improved the process.

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19338 under comment code 7200.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19338 under comment code 7200.

EPA looks forward to considering this new information once it becomes available. 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

EPA looks forward to considering this new information once it becomes available. 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

The Agency is currently monitoring PWS for PBDEs under the UCMR 2. More information on the UCMR can be 

found on the EPAs safewater website at wwwepa.gov/safewater/ucmr. The Agency will use these occurrence 

data to inform decisions on future CCLs. 

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

EPA looks forward to considering this new information once it becomes available. 

The Agency has responded to the specific comments submitted by DNREC under the respective comment codes: 

7100 Chemicals not on CCL 3 (comment ID 19444 and 19447), 7170 PBDEs  flame retardants (and related PBBs) 

(comment ID 19442), and 7200 pharmaceuticals and personal care products (not on CCL3) (comment ID 19570).

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

No response needed.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19338 under code 7200.

See response to comment ID 19198 under comment code 7150.

Please see responses to comment IDs 19338, 17297, and 17299 under comment code 7200.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 
EPA agrees that scientific, technical, and stakeholder involvement the Agency conducted in developing the CCL 3 

has improved the process. Please see the response to comment ID 19384 under comment code 6900 on the 

inter-relationship between CCL and UCMR efforts.

Please see response to comment ID 19065 under comment code 9100.

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

This comment also appears under topic code 7200 - Pharmaceuticals and Personal Care Products (not on CCL3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Please see response to comment ID 19338 under comment code 7200.

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

EPA acknowledges the commenters request to add dimethanamid and its ESA and OA metabolites to the CCL 3. 

Dimethanamid was among over 6,000 contaminants considered for inclusion on the CCL. However, 

dimethenamid did not pass the screen to move on to the PCCL. The release data from the National Center for 

Food and Agricultural Policy and available health effects data did not meet the criteria for dimethenamid to be 

considered for the PCCL. EPA has not received any additional data on the occurrrence or health effects for 

dimethenamid. Therefore the Agency is not including dimethenamid of the CCL 3.

Please see response to comment ID 19338 under comment code 7200 for more discussion of the evaluation of 

pharmaceutical compounds. EPA agrees that expert review was an important component of the CCL 3 process.

EPA disagrees with the commenter that EPA has not made the models publicly available. The Agency describes 

the models and EPAs efforts to develop and use the models for the draft CCL 3 in the supporting 

documentation in Contaminant Candidate List 3 Chemicals: Classification of the PCCL to the CCL. This 

document is available at www.regulations.gov, document ID EPA-HQ-OW-2007-1189-0067. It provides a detailed 

discussion of the assumptions and data used to develop, train and use the models to evaluate contaminants for 

inclusion on the CCL. EPA specifically chose models that are publicly available at no cost so interested 

commenters could retrieve the models for evaluation. In addition to the description of EPAs steps, the Agency 

provided appendices that describe attribute scoring protocols, the hierarchy of data used in those protocols, and 

contaminants used to develop the scoring protocols. Appendix D provides the Web site that each model 

considered by the Agency is available for downloading. Appendix E provides the rules or solutions for each 

Please see the response to comment ID 18929 under comment code 3560 Ethylene glycol occurrence.

Please see response to comment ID 19501 under comment code 6160.

Please see response to comment ID 19501 under comment code 6160.

Please see the response to comment ID 18929 under comment code 3560 Ethylene glycol occurrence.

Please see response to comment ID 19501 under comment code 6160.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19058 under comment code 7840. 




Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 18928 under comment code 3555.

The commenter notes that there were limited occurrence data available for ethylene oxide. However, EPA 

disagrees with the commenter that the Agency made an erroneous conclusion that ethylene oxide might occur 

in drinking water. The Agency provided detailed support documents that discuss the CCL 3 process and the data 

and information used to evaluate contaminants for the CCL 3 that are available in the docket.



In developing the CCL 3, the Agency sought input from the National Academy of Sciences National Research 

Council (NRC), the National Drinking Water Advisory Council (NDWAC), and the Science Advisory Board on how 

to improve the CCL process. Each of these panels recommends that EPA should identify and retrieve data from 

sources that have information about occurrence of contaminants in drinking water or source water including 

sources that have a link (pathway) to drinking water. The Toxics Release Inventory (TRI) was specifically included 

as a data source that could be reviewed as one of the sources that have a link (pathway) to drinking water.



EPA used prevalence and magnitude as occurrence attributes to describe the potential for a contaminant to 

occur in drinking water (as described in the FR notice for the draft CCL 3). For ethylene oxide there was no 

occurrence information in finished or ambient water. So to be consistent with the CCL 3 protocol, EPA used total 

environmental release data reported in the Toxics Release Inventory (TRI) for 2004 for the magnitude attribute 

and the number of States reporting releases (total) of EO for the prevalence attribute. These attributes taken 

The commenter correctly notes that EPA used TRI surface water release greater than 400,000 pounds for CCL 1 

to anticipate occurrence. However, in developing the draft CCL 3, the Agency implemented a different approach 

from that used for CCL 1 and CCL 2. This new approach builds on evaluations used for previous CCLs and was 

based on substantial expert input and recommendations from different groups including stakeholders, the 

National Research Council (NRC) and the National Drinking Water Advisory Council (NDWAC).



EPA disagrees with the commenter that the Agency erred in using a contaminants potential to occur in drinking 

water based on Total TRI releases rather than solely on surface water releases. EPA believes that it is appropriate 

to use total environmental release data rather than the total quantity released to surface water to evaluate the 

potential of a contaminant to occur in drinking water, as the use of total environmental release data accounts 

for any releases to groundwater, air, and any mobility the chemical may exhibit. Please see the response to 

comment ID 18929 under comment code 3560 for a more detailed discussion on the Agencys evaluation 
EPA disagrees with the commenter that EPA Should Define EO's Potential to Occur in Drinking Water Based on 

Surface Water Release Data, Which Are the Most Relevant Data for Characterizing Potential Drinking Water 

Occurrence.



In developing the draft CCL 3, EPA conducted a sensitivity analysis evaluating options using physical and chemical 

properties combined with environmental fate parameters to consider chemicals. These analyses are described in 

the support documents available in the docket and are the basis for the screening and attribute scoring 

protocols (Contaminant Candidate List 3 Chemicals: Screening to a PCCL, EPA 815-R-08-003 and Contaminant 

Candidate List 3 Chemicals: Classification of the PCCL to the CCL, EPA 815-R-08-004).



The commenter also suggested that EPA consider ethylene oxide and its physical properties. EPA evaluated 

ethylene oxides using physical and chemical properties combined with environmental fate parameters for the 

magnitude attribute score instead of using total environmental release data. For this analysis, EPA followed the 

CCL 3 protocol for those chemicals with only production data and used the persistence and mobility protocols as 

the basis for the magnitude attribute scoring as described in the FR notice and support documents. The model 

results for ethylene oxide using the environmental parameter protocols were the same as the results developed 

Please see the response to comment IDs 18851, 18861, and 18865 under comment code 2630.

EPA disagrees with the commenter that it treated chemicals known to occur in water the same as those with no 

evidence of occurrence in water. EPA described categories of occurrence data and how the Agency developed a 

hierarchical scale to select the best available occurrence data to evaluate contaminants and identify which 

contaminants the Agency anticipates or knows occur in PWSs and may require regulation. EPA summarizes the 

screening and classification protocols for different types of occurrence data in the FR notice for the Draft CCL 3 

(73 FR 9628) and in the support documents available at www.regulations.gov (Contaminant Candidate List 3 

Chemicals: Screening to a PCCL and Contaminant Candidate List 3 Chemicals: Classification of the PCCL to the 

CCL, respectively). These documents also describe the NDWAC deliberations and EPAs decision to use a 

hierarchical approach to select the best available occurrence data. Please see the response to comment ID 

18865 under comment code 2630 butadiene occurrence for a detailed discussion on the use of total TRI data for 

Please see response to comment ID 18939 under comment code 2100.

Please see the response to comment ID 19068 under comment code 4450.

See the response to comment IDs 18897 and 18899 under comment code 2595.

Based upon these and other data EPA concludes that 1,2,3- trichloropropane is known or anticipated to occur in 

public water systems and may require regulation. Therefore EPA is including this compound on the CCL 3.

Please see response to comment ID 19138 under comment code 4515.

Please see the response to comment ID 19136 and 19139 under comment code 4510.

See response to comment ID 19211 under comment code 4510.

Please see response to comment IDs 19137 under comment code 7180 and 19138 under comment code 4515.

Please see the response to comment ID 19211 under comment code 4510.

Please see response to comment ID 19338 under comment code 7200.
Based on comments, EPA changed the pathogens listed on the final CCL 3. EPA removed older, CDC waterborne 

disease outbreaks (WBDO) (prior to 1990) from the occurrence analysis. This and other minor changes to the 

scoring, are discussed in more detail in the final CCL 3 notice. As a result, EPA has added to CCL 3: enteroviruses, 

adenovirus and Mycobacterium avium and removed from CCL 3: Vibrio cholerae and Entamoeba histolytica. EPA 

disagrees with the commenter on removing Helicobacter pylori. H. pylori has a total score of 8.0 (out of a 

possible 10) and is well above the cut off of 6.1, therefore, this pathogen remains on the CCL 3. EPA also 

disagrees with the commenter on adding rotavirus to the CCL 3. Rotavirus scored 5.5 due to no CDC WBDO and 

relatively low health effects (see the Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process for more 

information on all the scores). Furthermore, EPA rescored all pathogens after the Expert Panel met. EPA 

reviewed and corrected mistakes in the health effects and occurrence information as recommended by the 

EPA criteria for evaluating and prioritizing pathogens for inclusion in the CCL 3 included health effects, 

waterborne disease outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). Treatability was not part of the 

scoring criteria considered for CCL 3 inclusion. Criteria described by the commenter do not apply to the CCL 3 

Selection process. They apply to the regulatory determination process. As discussed in the preamble to the Draft 

CCL 3, (see page 9962) a Regulatory Determination requires more information and analyses than the analyses 

used to support the CCL 3 selection process. EPA will conduct analyses to support regulatory determinations 

beginning after the publication of the final CCL 3. Please see response to comment ID 19412 under comment 

The commenter reports that EPA used the oral slope factor of 0.31 per mg/kg/day currently available from the 

California Office of Environmental Human Health Agency (OEHHA) Toxicity Criteria Database in scoring for 

potency for ethylene oxide. However, the commenter questions the above slope factor in light of the recent 

assessment from the Office of Pollution Prevention and Toxic Substance and the Office of Research 

Development (ORD). The commenter makes a point that EPA should use the new unit risk numbers that have 

been derived by ORD for the lung tumors observed in male mice and brain tumors observed in male rats, after 

correcting these numbers to a slope factor that is appropriate for an oral route of administration. For the draft 

CCL 3, EPA followed the CCL 3 protocol in the scoring for the health effects for ethylene oxide. Ethylene oxide 

received a score of 6 for potency and 8 for severity. The commenter is correct that EPA used the oral slope 

factor of 0.31 per mg/kg/day based on rat mononuclear cell leukemia (MCL) available from OEHHA Toxicity 

EPA disagrees with the commenters opinion that ethylene glycol should be categorized as toxicity category 5 

rather than toxicity category 4 and removed from further consideration. EPA developed the screening protocol 

and toxicity categories to create a framework that was versatile and as simple as possible to identify chemicals 

with categorical or limited data for further evaluation. In using the most conservative toxicological value in the 

screening step the Agency believes that public health is protected and additional resources can then be applied 

to evaluate compounds that passed the screening framework to determine the best available scientific 

information for that compound. As the commenter notes, for ethylene glycol, the World Health Organization 

(WHO) TDI was used for the screening as indicated in the protocol described in Contaminants Candidate List 3 

Chemicals: Screening to PCCL. That value falls in toxicity category 4. It is also correct that EPA used the IRIS RfD 

as the toxicological value to to assign the potency and severity scores used in evaluating the PCCL. This too is 

The commenter is correct in noting that a severity score of 6 indicates significant, irreversible, nonlethal 

conditions or disorders for some organs. However, the severity score for methanol was not based on 

alterations to serum enzymes or liver, but is based on the health effect of decrease in brain weight. Appendix A 

of the PCCL to CCL Process Report contains a Compendium of Critical Effects Table that lists a severity score of 6 

for significant decreases in brain weight, separate from scores given to other organs and the irreversible effects. 

Therefore, the severity score for methanol was correctly applied. Based upon these data, EPA concludes that 

methanol is known or anticipated to occur in public water systems and may require regulation. Therefore, EPA is 
In general, the criteria for selecting contaminants for the CCL 3 consisted of a multi-step process to determine 

whether the occurrence, or anticipated occurrence, of a contaminant was likely at levels of concern to human 

health. EPA used prevalence and magnitude as occurrence attributes to describe the potential for a contaminant 

to occur in drinking water (as described in 73 FR 9628, the FR notice for the draft CCL 3). For methanol, there 

was no occurrence information in finished or ambient water, so to be consistent with the CCL 3 protocol, EPA 

used total environmental release data reported in the Toxics Release Inventory (TRI) for 2004 for the magnitude 

attribute and the number of States reporting releases (total) of methanol for the prevalence attribute. EPA 

disagrees with the commenter that consideration for listing [methanol] is likely not based on these health 

effects attributes, but simply because methanol scores highly on the occurrence attributes." The attributes for 

occurrence and adverse health effects taken together were used to evaluate the potential of methanol to occur 

Please see the response to comment IDs 18851 and 18861 under comment code 2630.

Please see response to comment ID 19145 under comment code 4010 Molybdenum occurrence.

Ethylene oxide and ethylene glycol have been included on the final CCL 3. The Agency has responded to the 

specific information and comments provided by the American Chemistry Council (ACC) on ethylene glycol and 

ethylene oxide under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene 

Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 

3585 Ethylene Oxide health (comment ID 18925), 3590 Ethylene Oxide occurrence (comment IDs 19521 and 

***Cadmus: Please move response from "response to comment code 3560" section to this comment ID*** 

Please see response to comment ID 19501 under comment code 6160. Please see response to comment ID 

18929 under comment code 3560 Ethylene glycol occurrence.

EPA agrees that there are long term sequelae associated with Legionella and consequently scored Legionella 

very high on health effects (including long term sequelae) as well as the overall score. Therefore, Legionella 

Please see the response to comment ID 19136 and 19139 under comment code 4510. 

Please see response to comment ID 19338 under comment code 7200.

No response necessary.

See the response to comment ID 19338 under comment code 7200 (Pharmaceuticals and Personal Care 

Products (not on CCL3)). 

This comment also appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). 

Please respond to this comment under that topic. Cadmus will ensure the response is copied to this topic in its 

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

Please see the response to comment ID 19109 under comment code 6100.
The data that were used to score the occurrence attributes for vanadium (see the response to comment 19079 

under comment code 5025) were the number of states where it had been detected in the NIRS survey and the 

concentrations detected. Persistence did not play any direct role in vanadiums selection for the CCL, although 

the fate data are described in the contaminants information sheet for vanadium in the CCL 3 docket 

(Contaminant Candidate List (CCL) Contaminant Information Sheets EPA-HQ-OW-2007-1189-0042).

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

Please see the response to comment ID 18929 under comment code 3560 Ethylene glycol occurrence.

Please see response to comment ID 19501 under comment code 6160.

Please see response to comment ID 19501 under comment code 6160.

Please see the response to comment ID 18929 under comment code 3560 Ethylene glycol occurrence.

Please see the response to comment IDs 19136 and 19139 under comment code 4510 for PFOA. Please see the 

response to comment IDs 19333 and 19067 under comment code 4460 perchlorate occurrence and the 

response to comment ID 19068 under comment code 4450 perchlorate.

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200. The commenter also provided 

newspaper articles and summaries of the scientific literature on the occurrence and adverse health effects 

associated with pharmaceuticals. The Agency provided a detailed summary of the types of data and information 

it used to evaluate contaminants for the CCL 3. The support documents describe the process for selecting the 

data to support the inclusion or omission of contaminants from the list and the data used for individual 

contaminants is also available in the docket at www.regulations.gov. 

The commenter also described a process the Agency could use to evaluate pharmaceuticals. The commenter 

provided a detailed discussion of cost-benefit analysis the Agency could undertake to support including 

pharmaceuticals on the CCL. As noted by the commenter, cost-benefit analysis is required under SDWA when 

proposing NPDWRs, but is not required when preparing a CCL. The EPA did not evaluate and did not exclude 

pharmaceuticals from the CCL 3 on the basis of cost-benefit analyses. The process described in the Draft FR 

notice and used to develop the Final CCL 3 evaluated whether or not the contaminants may occur in PWS and 

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

EPA disagrees with the commenter that EPA has not made the models publicly available. The Agency describes 

the models and EPAs efforts to develop and use the models for the draft CCL 3 in the supporting 

documentation in Contaminant Candidate List 3 Chemicals: Classification of the PCCL to the CCL. This 

document is available at www.regulations.gov, document ID EPA-HQ-OW-2007-1189-0067. It provides a detailed 

discussion of the assumptions and data used to develop, train and use the models to evaluate contaminants for 

inclusion on the CCL. EPA specifically chose models that are publicly available at no cost so interested 

commenters could retrieve the models for evaluation. In addition to the description of EPAs steps, the Agency 

provided appendices that describe attribute scoring protocols, the hierarchy of data used in those protocols, and 

contaminants used to develop the scoring protocols. Appendix D provides the Web site that each model 

considered by the Agency is available for downloading. Appendix E provides the rules or solutions for each 

Please see responses to comment IDs 19338 and 17297 under comment code 7200.
PFOA has been included on the final CCL 3. PFOS was not included on the draft CCL 3, but has been included on 

the final CCL 3. EPA evaluated PFOS in the CCL 3 process, and as cited in the Drinking Water Contaminant 

Candidate List 3-Draft Federal Register Notice PFOS was not included on the draft CCL 3 based on the limited 

occurrence data, combined with the phase out of production of PFOS in the U.S. between 2000 and 2002. EPAs 

decision to list PFOS on the final CCL 3 is based on information from a 2007 Significant New Use Rule (SNUR) that 

shows there are ongoing uses of PFOS that could lead to its potential to occur in water. In the SNUR (Reference: 

FR October 9, 2007; Volume 72, Number 194), Rules and Regulations, Page 57222-57235)), EPA granted an 

exemption, for reporting to TSCA, for the use of tetraethylammonium perfluorooctanesulfonate for specified 

industrial uses (particularly metal plating). This perfluorinated compound is of concern to EPA because PFOS is 

the anionic portion of this chemical. PFOS is also appearing in Minnesota wastewater treatment plant influent, 

effluent, and sludge associated with its use in the fume/mist suppressant in metal finishing and plating baths 

(Reference: FR October 9, 2007; Volume 72, Number 194), Rules and Regulations, Page 57222-57235))). A major 

factor in EPAs decision to not include PFOS on the draft CCL 3 was the phase out of production of PFOS. 

Please see response to comment ID 19136 under comment code 4510 for a more detailed discussion on the 

listing of PFOS. EPA concludes that PFOA and PFOS are known or anticipated to occur in public water systems 

and may require regulation. Therefore EPA is including these compounds on the CCL 3. Under SDWA 1412 

(b)(1)(B)(ii) EPA makes a separate determination whether or not to regulate a contaminant before proposing and 

promulgating a National Primary Drinking Water Rule. The Agency will continue to use the best available science 

and information to evaluate contaminants on the CCL 3 including any updates to the health effects or 

occurrence information to determine if the information is sufficient for the Agency to make a regulatory 

Please see responses to comment ID 19501 under comment code 6160. Ethylene oxide has been included on the 

final CCL 3. The Agency has responded to the specific information and comments provided by the ACC on 

ethylene oxide under the respective comment codes: 3585 ethylene oxide health (comment ID 18925) and 3590 

ethylene oxide occurrence (comment IDs 19521 and 19523).

Please see the response to comment ID 19265 under comment code 3580.

Please see response to comment ID 19501 under comment code 6160.

The ITER database, which was the source of the value used by EPA in the PCCL to the CCL process is a database 

that only includes peer reviewed assessments. In the case of N-methyl-2-pyrrolidone, the data came from the 

peer-reviewed Concise International Chemical Assessment Document from the World Health Organization. The 

draft SIDS report provided by the commenter was not in the Data compilation that comprised the working 

Universe nor were SIDS reports for any other chemicals. However, even if the report had been included in the 

universe, a completed health risk assessment such the CICAD that was used ranked higher in the data hierarchy 

than a compilation of available data as reported in a SIDS report and final documents are used rather than draft 

EPA acknowledges your comments about public participation in the listing process. However, EPA respectfully 

disagrees with your comments that an additional public comment period be included in the selection process. 

EPA sought public involvement in the CCL 3 process by receiving input at a public stakeholder meeting in 

September 2004 and as part of the public nominations process in May 2006. Both opportunities were 

announced and published in the Federal Register. EPA also sought public comment on the draft CCL 3 following 

its publication in February 2008. We believe that EPA has provided ample opportunity for the public to provide 

Please see responses to Comment IDs 19338 and 19573 under comment code 7200.

This comment also appears under topic code 4450 - Perchlorate. Please respond to this comment under that 

topic. Cadmus will ensure the response is copied to this topic in its entirety.

See response to comment ID 19211 under comment code 4510.

Please see response to comment IDs 19137 under comment code 7180 and 19138 under comment code 4515.

Please see the response to comment ID 19211 under comment code 4510. 
Please see response to comment ID 19338 under comment code 7200. EPA concluded that nine hormones (17 

alpha-estradiol, 17 beta-estradiol, equilenin, equilin, estriol, estrone, ethinyl estradiol, mestranol, and 

norethindrone) should be included on the CCL 3 because these contaminants are known or anticipated to occur 

in public water systems and may require regulation. The specific data used to evaluate these contaminants can 

be found in the supporting documents and CCL Contaminant Information Sheets in the docket at 

The CCL process was developed to identify known or potential drinking water contaminants of possible health 

concern. The process followed protocols that utilized health effects and occurrence data from acceptable data 

sources for screening to the PCCL and selection of the draft CCL. The protocols established hierarchies for the 

data used at each step of the process and were applied uniformly for all chemical contaminants, including Nmethyl-2-pyrrolidone. [See the docket documents Chemicals: Screening to a PCCL and Classification of the PCCL 

to the CCL.] N-methyl-2-pyrrolidone was selected for the draft CCL 3 based on these uniformly applied 

processes. N-methyl-2-pyrrolidone was screened as Toxicity Category 4 following the protocol requirements for 

screening. That protocol places a chemical in the highest toxicity category assigned to a toxicity value in the 

universe for a given chemical. Scoring of toxicity for the PCCL to CCL process was done using the World Health 

Organizations (WHO's) Tolerable Daily Intake value as included in the ITER database. The WHO assessment has 

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

See response to comment ID 19136, 19139, and 19211 under comment code 4510.

Please see the response to comment ID 19211 under comment code 4510 and the response to comment ID 

19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200. The Agency evaluates water quality 

under Section 304(a)(1) of the Clean Water Act and develops criteria for water quality that accurately reflects 

the latest and best available scientific knowledge. These criteria are based solely on data and scientific 

judgments on pollutant concentrations and environmental or human health effects. Section 304(a) also provides 

guidance to states and tribes in adopting water quality standards. Criteria are developed for the protection of 

aquatic life as well as for human health. More information on water quality criteria are available at: 

http://epa.gov/waterscience/criteria/. For more information on the Agency's efforts to evaluate PPCPs please 

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 18928 under comment code 3555.

Please see responses to comment IDs 19338 and 19573 under comment code 7200.

Please see the responses to comment ID 19136 and 19139 under comment code 4510 for a more detailed 

discussion on the listing of PFOA and PFOS. PFBA was not included on the final CCL 3. PFBA was included in the 

CCL 3 Universe. However the Agency only had limited data on PFBA and other PFC potential occurrence in public 

water systems and environmental releases. Based upon these data EPA concludes that PFBA does not meet the 

critieria for the CCL at this time. Therefore EPA is not including this compound on the CCL 3. Please see the 

response to comment ID 19384 in comment code 6900 (The interrelation between CCL and UCMR for specific 

See response to comment ID 19211 in comment code 4510 PFOA.

Please see responses to comment IDs 19338 and 19573 under comment code 7200.

Please see responses to comment IDs 19338 and 19573 under comment code 7200.

Please see the response to comment ID 19136 and 19139 under comment code 4510. 

Please see the response to comment ID 19137 under comment code 7180 and 19139 under comment code 
Ethylene oxide and ethylene glycol have been included on the final CCL 3. The Agency has responded to the 

specific information and comments provided by the American Chemistry Council (ACC) on ethylene glycol and 

ethylene oxide under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene 

Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 

3585 Ethylene Oxide health (comment ID 18925), 3590 Ethylene Oxide occurrence (comment IDs 19521 and 

Ethylene oxide and ethylene glycol have been included on the final CCL 3. The Agency has responded to the 

specific information and comments provided by the American Chemistry Council (ACC) on ethylene glycol and 

ethylene oxide under the respective comment codes: 3550 Ethylene Glycol (comment ID 18930), 3555 Ethylene 

Glycol health (comment IDs 18920, 19520, and 18928), 3560 Ethylene Glycol occurrence (comment ID 18929), 

3585 Ethylene Oxide health (comment ID 18925), 3590 Ethylene Oxide occurrence (comment IDs 19521 and 

Please see response to comment ID 19338 under comment code 7200.

Please see response to comment ID 19338 under comment code 7200 for more discussion of the evaluation of 

pharmaceutical compounds. EPA agrees that expert review was an important component of the CCL 3 process.

Please see response to comment ID 19417 under comment code 2200.

Please see response to comment ID 19094 under comment code 4125. As stated in the docket document on 

screening from the universe to the PCCL, a chemical is categorized for toxicity by the value in the universe data 

compilation that places it in the highest toxicity category. This decision was based on a desire to be conservative 

because of the coarse screen and limited data available for screening for many chemicals. The evaluation of Nmethyl-2-pyrrolidone followed the screening procedure developed for the PCCL process.

Please see response to comment ID 19094 under comment code 4125. As stated in the docket document on 

screening from the universe to the PCCL, a chemical is categorized for toxicity by the value in the universe data 

compilation that places it in the highest toxicity category. This decision was based on a desire to be conservative 

because of the coarse screen and limited data available for screening for many chemicals. The evaluation of Nmethyl-2-pyrrolidone followed the screening procedure developed for the PCCL process. 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see response to comment ID 19058 under comment code 7840.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the responses to comment IDs 18858 and 18850 under comment code 2620.

See response to comment ID 19093 under comment code 4120.

The Agency agrees with the commenter and also supports the use of sound scientific testing consistent with EPA 

methods. The Agency has responded to the specific information and comments provided by the City of Peoria, 

AZ under the respective comment codes: 2310 Naegleria fowleri (comment ID 19254) and 7200 pharmaceuticals 

and personal care products (not on CCL3) (comment ID 19573). 

Please see the response to comment ID 19068 under comment code 4450.

Please see response to comment ID 19338 under comment code 7200. EPA is evaluating each of the seven 

components cited by the commenter with our stakeholders, regulatory partners, and the public. The response to 

comment ID 19338 also provides Web sites that provide updates to the Agencys progress.

Please see responses to comment IDs 19338 and 19573 under comment code 7200.
Azinphos-methyl (CAS # 86-50-0): Azinophos-methyl was included in the Universe for the CCl and was screened 

to the PCCL. However, using the classification approach described in the selection of the CCL from the PCCL 

(refer to the document CCL 3 Chemicals: Classification of the PCCL to CCL which can be found in the CCL 3 

Docket identified by the two document ID #s EPA-HQ-OW-2007-1189-0046 and EPA 815-R-08-004) , it was not 

listed on CCL3. This result was influenced, in part, by the low concentrations measured in monitoring of ambient 

water. EPA used the health effects information from the OPP RED and the USGS NAWQA data in scoring the 

attributes for azinphos-methyl. EPA also evaluated the data provided by the commenter using the protocols 

described in the draft CCL 3 FR notice (EPA-HQ-OW-2007-1189-0001). Based upon these data EPA concludes 

that azinphos-methyl does not meet the CCL statutory criteria at this time. Therefore EPA is not including this 

Carbaryl (CAS # 63-25-2): We agree with the commenter that the toxicity profile of Carbaryl allows for its 

consideration as a potential drinking water contaminant; however, being a carbamate, it is rapidly degraded, and 

not persistent in the environment. Being a ChE inhibitor, it may be considered for a cumulative carbamates 

approach. During the CCL 3 screening processes, EPA used the RFD of 0.01 mg/kg-day for carbaryl to produce a 

health reference level of 70 ug/L. This health reference level was compared to the best available finished water 

data, from the National Contaminant Occurrence Database  Round 2 (median concentration value of 0.18 ug/L) 

for carbaryl and based on this screen, carbaryl did not get listed onto the CCL 3. EPA also evaluated the data 

provided by the commenter using the protocols described in the draft FR notice (EPA-HQ-OW-2007-1189-0001). 

Based upon these data EPA concludes carbaryl does not meet the CCL statutory criteria at this time. Therefore 

Chlorpyrifos (CAS # 2921-88-2): Chlorpyrifos was included in the universe for the CCL but, based on the CCL 

screening protocol, was not selected for the PCCL (refer to document Contaminant Candidate List 3 Chemicals: 

Screening to a PCCL which can be found in the CCL 3 Docket identified by the two document ID #s EPA-HQ-OW2007-1189-0044 and EPA 815-R-08-003). EPA agrees with the commenter that the toxicity profile of Chorpyrifos 

allows for its consideration as a potential drinking water contaminant; however, being an organophosphate, it is 

rapidly degraded, and not persistent in the environment, a fact that may have influenced its occurrence. EPA 

used the health effects potency information from OPP and release data in the screening of Chlorpyrifos for the 

PCCL. EPA also evaluated the data provided by the commenter using the protocols described in the draft FR 

notice (EPA-HQ-OW-2007-1189-0001). Based upon these data EPA concludes chlorpyrifos does not meet the CCL 

statutory criteria at this time. Therefore EPA is not including this compound on the CCL 3 but will consider it for 

Dichlorvos (DDVP) (CAS # 62-73-7): Dichlorvos was included in the working Universe for the CCL and was 

screened to the PCCL. However using the classification models applied in selection of the CCL from the PCCL, it 

was not chosen (refer to the document CCL 3 Chemicals: Classification of the PCCL to CCL which can be found 

in the CCL 3 Docket identified by the two document ID #s EPA-HQ-OW-2007-1189-0046 and EPA 815-R-08-004). 

The low priority for dichlorvos was strongly influenced by the low detection rate and low concentrations 

measured during unregulated contaminant monitoring. EPA used the health effects information from the OPP 

RED in scoring the health effects attributes for dichlorvos. EPA also evaluated the data provided by the 

commenter using the protocols described in the draft FR notice (EPA-HQ-OW-2007-1189-0001). Based upon 

these data EPA concludes dichlorvos does not meet the CCL statutory criteria at this time. Therefore EPA is not 

Dicofol (CAS # 115-32-2): Dicofol was included in the universe for the CCL but was not selected for the PCCL 

following the protocol described in the document: CCL 3 Screening to a PCCL (EPA-815-R-08-003). EPA used 

the health effects potency information from OPP and release data in the screening of Dicofol for the PCCL. The 

commenter suggested that EPA had erred in not applying the FQPA factor in its evaluation of Dicofol. The FQPA 

is not applicable under the criteria of the Safe Drinking Water Act. Accordingly, consideration of the 

uncertainties represented by this factor would not be considered by OW during the CCL evaluation. EPA also 

evaluated the data provided by the commenter using the protocols described in the draft FR notice (EPA-HQ-OW2007-1189-0001). Based upon these data EPA concludes dicofol does not meet the CCL statutory criteria at this 
Endosulfan (CAS # 115-29-7): We agree with the commenter that the toxicity profile of Endosulfan allows for its 

consideration as a potential drinking water contaminant of concern; this is a chlorinated pesticide and would be 

persistent in water. Endosulfan was identified in the universe of chemicals, screened to the PCCL, but was not 

listed on the CCL 3 based on a review of its toxicity profile and data on occurrence. The methodology used by 

EPA to make this decision can be found in the following support document, located in the CCL Docket: CCL 

Chemicals: Classification of the PCCL to CCL (EPA 815-R-08-004). Although endosulfan did not get listed on the 

CCL 3, endosulfan will be reconsidered for future CCLs. EPA also evaluated the data provided by the commenter 

using the protocols described in the draft FR notice (EPA-HQ-OW-2007-1189-0001). Based upon these data EPA 

Trichlorfon (CAS# 52-68-6); Trichlorfon was included in the universe for the CCl but was not selected for the PCCl 

following the protocol described in the document: CCL 3 Chemicals: Screening to a PCCL (EPA 815-R-08-003). 

EPA used the health effects potency information from OPP and release data in the screening of Trichlorfon for 

Triclocarban (CAS# 110-20-2); Triclocarban was included in the universe for the CCL but was not selected for the 

PCCl following the protocol described in the document: CCL 3 Screening to a PCCL (EPA-815-R-08-003). This 

chemical is an antimicrobial with endocrine disruption properties. OPP announced on 10/29/08 the availability 

of the RED for public comment. EPA will reevaluate triclocarban when the assessment has been finalized to 

assure the best available science is used to develop the CCL 3. EPA did evaluate the data provided by the 

commenter using the protocols described in the draft FR notice (EPA-HQ-OW-2007-1189-0001). Based upon 

these data EPA concludes triclocarbon does not meet the CCL statutory criteria at this time.

Triclosan (CAS# 3380-34-5); Triclosan was included in the universe for the CCL but was not selected for the PCCL 

following the protocol described in the document: CCL 3 Screening to a PCCL (EPA-815-R-08-003). The 

commenter did identify publications regarding the occurrence of Triclosan in wastewater, storm water, raw and 

finished drinking water. Based upon the limited occurrence concentrations reported in these studies triclosan 

does not meet the CCL statutory criteria at this time. Therefore EPA is not including this compound on the CCL 3 

EPA used occurrence data from the Toxics Release Inventory in addition to health effects information to 

evaluate nitroglycerin for the CCL 3. Based on these and other data, the Agency determined that nitroglycerin is 

known or anticipated to occur in public water systems and may require regulation. EPA notes that nitroglycerin 

has multiple uses, and it was not listed on the CCL 3 solely for its use as a pharmaceutical. EPA is not proposing 

to use nitroglycerin as an indicator of pharmaceutical contamination in drinking water. Please see the response 

to comment ID 19338 under comment code 7200 (Pharmaceuticals and Personal Care Products (not on CCL 3)) 

for a discussion of how pharmaceuticals have been further evaluated for the CCL 3. The Agency used data from 

the Kolpin et al. 2002 study cited by the commenter to evaluate pharmaceuticals for the final CCL 3 using the 

process described in the draft CCL 3 FR notice and final CCL 3 FR notice (73 FR 9628). 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

The evaluation of the toxicity data for Diuron was conducted using the protocols described in the docket 

documents Chemicals: Screening to a PCCL and Classification of the PCCL to the CCL. Following those guidelines 

as well as the agency guidelines for data quality, Diuron was scored based on the publically available assessment 

from the EPA published Reregistraion Eligibility Decision document (September 2003). The scores were based 

on the potency associated with the higher of the cancer and noncancer potency scores as described in the 

protocol document. In the case of Diuron, the potency associated with the RfD was higher than that based on 

the cancer slope factor. Regarding the commenter's statement: "The low frequency of detection and the low 

concentrations relative to the DWEL support a NL decision" - Diuron was listed on the CCL 3 because EPA 

concluded that Diuron is known or anticipated to occur in public water systems and may require regulation. This 

decision was upon a review of the best available occurrence data from the Unregulated Contaminant Monitoring 

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements

Please see the response to comment ID 19084 under EPA comment code 5025. The CCL3 listing of vanadium 

applies to the water soluble forms of vanadium compounds that occur in public water supplies and not to 

elemental vanadium. As EPA refines its assessment of vanadium compounds in drinking water as part of a 

potential regulatory determination, consideration will be given to the relative toxicities of the oxidation state 

(i.e. +4 versus +5) as well as any changes in oxidation state that may occur during the water treatment process.

Refer to the response under the comment summary at the beginning of Comment Code 9000 Commenter 

Background and Introductory Statements
EPA_TEAM_MEMBER DRAFT_STATUS

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Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

JLE Final

Carpenter, Benedict Final

Lameka Smith

Lameka Smith

M. Benedict (uploaded by JLE) Final

M. Benedict (uploaded by JLE) Final

HG and JMD (Uploaded by JLE) Final

M. Benedict (uploaded by JLE) Final

Lameka Smith

Lameka Smith

Lameka Smith
M. Benedict (uploaded by JLE) Final

Meredith (MLB uploaded)

Meredith (MB upload)

Microbe Team by TB Final

Microbe by TB Final

Lameka Smith

Lameka Smith

Microbe Team by TB Final

JLE Final

Lameka Smith

JLE Final

JLE Final

Meredith (MB uploaded)

Lameka Smith

HG and JMD (Uploaded by JLE) Final

M. Benedict (uploaded by JLE) Final

M. Benedict (uploaded by JLE) Final
Lameka Smith

Meredith (MLB uploaded)

Meredith (MB upload)

Lameka Smith

Microbe Team by TB Final

JLE Final
Lameka Smith

JLE Final

JLE Final
Meredith (MB uploaded)

Lameka Smith

Lameka Smith

Carpenter, Benedict Final

Lameka Smith

Lameka Smith

Carpenter, Benedict Final

Lameka Smith
Carpenter, Benedict Final

Meredith (MB upload)

Meredith (MB upload)

M. Benedict (uploaded by JLE) Final

M. Benedict (uploaded by JLE) Final

HG and JMD (Uploaded by JLE) Final

M. Benedict (uploaded by JLE) Final

M. Benedict (uploaded by JLE) Final

M. Benedict (uploaded by JLE) Final

M. Benedict (uploaded by JLE) Final

Meredith (MB upload)

Lameka Smith

Lameka Smith
Carpenter (MB uploaded)

Carpenter (MB upload)

Lameka Smith

M. Benedict (uploaded by JLE) Final

M. Benedict (uploaded by JLE) Final

Microbe by TB Final

JLE Final

JLE Final

Meredith (MB upload)
Lameka Smith

Meredith (MB uploaded)

Meredith (MB uploaded)

Lameka Smith

Lameka Smith

Lameka Smith

Carpenter, Benedict Final

Lameka Smith

Lameka Smith

Lameka Smith
Lameka Smith

Microbe Team by TB Final

Lameka Smith

Carpenter, Benedict Final

Meredith (MB upload)

Lameka Smith

Lameka Smith

Microbe Team by TB Final
Microbe Team by TB Final

Microbe Team by TB Final

Microbe Team by TB Final

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith
Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Carpenter, Benedict Final

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Carpenter (MB upload)

Sinclair/ Carpenter (MB upload

Microbe Team by TB Final

Sinclair/ Carpenter (MB upload

Microbe Team by TB Final

Sinclair/ Carpenter (MB upload

Microbe Team by TB Final

Carpenter, Benedict Final

Lameka Smith
Lameka Smith

Lameka Smith

Lameka Smith 

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Carpenter, Benedict Final

Lameka Smith

Meredith (MB uploaded)
J. Keehner Final

Carpenter (MB upload)

Lameka Smith
Carpenter (MB uploaded)

Lameka Smith

Lameka Smith

Lameka Smith

Meredith (MB upload)

Lameka Smith

Lameka Smith

Lameka Smith

Carpenter (MB upload)

Carpenter, Benedict Final

Lameka Smith

Lameka Smith

Lameka Smith
Lameka Smith

Microbe by TB Final

Microbe Team Final
Lameka Smith

Lameka Smith

Meredith (MB upload)

Carpenter (MB uploaded)

Meredith (MB upload)

Lameka Smith

Lameka Smith

J. Keehner Final

Meredith (MB upload)

Lameka Smith

Lameka Smith
J. Keehner Final

J. Keehner Final

Meredith (MB upload)

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith
sinclair/ carpenter (MB upload

Joyce (MB upload)

Sinclair/ Carpenter (MB upload

Joyce (MB upload)

Lameka Smith

C. Townsend (MB uploaded)

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith
JLE Final

Lameka Smith

Lameka Smith

 Selby-Mohamadu Final

Carpenter (MB upload)

J. Keehner Final

Yvette Selby-Mohamadu/Carpente Final

Carpenter (MB uploaded)
Yvette Selby-Mohamadu Final

Lameka Smith

Lameka Smith

Carpenter (MB upload)
J. Keehner Final

Carpenter (MB upload)

Yvette Selby-Mohamadu Final

Carpenter (MB upload)
vette Selby-Mohamadu Final

Lameka Smith

Carpenter (MB uploaded)

Yvette Selby-Mohamadu Final

C. Townsend (MB uploaded)

Microbe Team by TB Final
microbe Team by TB Final

Microbe Team by TB Final

microbe Team final
Microbe Team by TB Final

Microbe Team by TB Final

Microbe Team by TB Final

Microbe Team by TB Final

Microbe Team by TB Final
Microbe Team by TB Final

Microbe Team Final

Microbe Team by TB Final
Microbe Team by TB Final

Microbe Team by TB Final

Microbe Team by TB Final

Microbe Team by TB Final

Microbe Team by TB Final

Microbe Team Final

Microbe Team by TB Final

Microbe Team by TB Final
Microbe by TB Final

Microbe Team by TB Final

microbe Team by TB Final

Microbe Team by TB Final

Microbe by TB Final
Microbe Team by TB Final

Microbe Team by TB Final

Microbe Team by TB Final

Microbe Team by TB

Lameka Smith

Lameka Smith

Lameka Smith

Carpenter (MB uploaded)
Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Meredith (MB upload)

Lameka Smith

Lameka Smith

Meredith (MB upload)

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Carpenter, Benedict Final

Lameka Smith

Lameka Smith

Lameka Smith
Meredith (MB upload)

Lameka Smith

Meredith (MB upload)

Meredith (MLB)

Meredith (MB upload)

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith

Lameka Smith
Lameka Smith

Carpenter (MB upload)

Lameka Smith

Lameka Smith

Lameka Smith

JLE Final

Lameka Smith

Lameka Smith

Lameka Smith

Microbe Team by TB Final
Lameka Smith

JMD (Uploaded by JLE) Final

Meredith (MLB uploaded)

Lameka Smith
Lameka Smith

Carpenter, Benedict Final

Bathija (Uploaded by JLE) Final

Lameka Smith

HG and JMD (Uploaded by JLE) Final

M. Benedict (uploaded by JLE) Final

M. Benedict (uploaded by JLE) Final

HG and JMD (Uploaded by JLE) Final

M. Benedict (uploaded by JLE) Final

Meredith (MB upload)

C. Townsend (uploaded by MB)

Lameka Smith

Lameka Smith

Lameka Smith

Meredith (MB upload)

Lameka Smith

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

MB upload

Meredith (MB upload)

Lameka Smith
Meredith (MB upload)

Meredith (MB upload)

M. Benedict (uploaded by JLE) Final

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

Lameka Smith

Meredith (MB upload)
Lameka Smith

Lameka Smith

Meredith (MB upload)
Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)

Lameka Smith

Meredith (MB upload)

Meredith (MB upload)

Meredith (MB upload)
Lameka Smith

Lameka Smith

Meredith (MB upload)

Meredith (MB upload)

microbe Team by TB Final

Joyce (MB upload)

Lameka Smith

Lameka Smith

Carpenter, Benedict Final

Meredith (MB upload)

Meredith (MB upload)
JLE Final

JLE Final

JLE Final

JLE Final

JLE Final
JLE Final

JLE Final

JLE Final

JLE Final

NOTES

Other EPA Comment Code: 6760 - Microbial Expert Input Panels

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)
Other EPA Comment Code: 6162 - Health Effects Protocol for Chemicals

Other EPA Comment Code: 6166 - Occurrence Protocol for Chemicals

Other EPA Comment Code: 6100 - Classification Approach for Chemicals
Other EPA Comment Code: 4010 - Molybdenum occurrence
Other EPA Comment Code: 6364 - Occurrence Protocol for Microbials


Other EPA Comment Code: 3580 - Ethylene oxide
Other EPA Comment Code: 6162 - Health Effects Protocol for Chemicals

Other EPA Comment Code: 6142 - Health Effects Criteria for Chemicals

Other EPA Comment Code: 6146 - Occurrence Criteria for Chemicals

Other EPA Comment Code: 6160 - Using Classification Models to Develop the Chemical CCL 3

Other EPA Comment Code: 6366 - Health Effects Protocol for Microbials
Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7200 - Pharmaceuticals and Personal Care Products (not on CCL 3)
Note to Cadmus: Insert new chloramine info website when it gets posted. Verify this website: 

http://www.epa.gov/ncea/pdfs/water/chloramine/dwchloramine.pdf prior to submitting the draft comment 

response document.


Other EPA Comment Code: 7110 - Pesticides not on CCL 3

Other EPA Comment Code: 6730 - Chemical Expert Input Panels



Other EPA Comment Code: 5030 - Vanadium occurrence

Other EPA Comment Code: 6142 - Health Effects Criteria for Chemicals

Other EPA Comment Code: 6162 - Health Effects Protocol for Chemicals

Other EPA Comment Code: 6500 - Public Input

Other EPA Comment Code: 7200 - Pharmaceuticals and Personal Care Products (not on CCL 3)
Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3).

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)


Other EPA Comment Code: 7200 - Pharmaceuticals and Personal Care Products (not on CCL 3). 
[The commenter recommends the addition of the following contaminants to CCL 3]

Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)
Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products(not on CCL3)
Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3).

Other EPA Comment Code: 6500 - Public Input

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)
Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3) 
Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL3)
Other EPA Comment Code: 3550 - Ethylene glycol

Other EPA Comment Code: 3550 - Ethylene glycol
Other EPA Comment Code: 6160 - Using Classification Models to Develop the Chemical CCL 3

Other EPA Comment Code: 3550 - Ethylene glycol
Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). This comment also 

appears under topic code 7200 Pharmaceuticals and Personal Care Products (not on CCL 3). Please respond to 

this comment under that topic. Cadmus will ensure the response is copied to this topic in its entirety.
Other EPA Comment Code: 3910 - Methyl tert-butyl ether

This comment also appears under topic code 3910 - Methyl tert-butyl ether. Please respond to this comment 

under that topic. Cadmus will ensure the response is copied to this topic in its entirety.

Other EPA Comment Code: 9100 - Background Statements Related to CCL and Statutory Requirements
Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)



Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)
Other EPA Comment Code: 6300 - Classification Approach for Microbial Contaminants




moved to umbrella location




Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL3)
Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3) 

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)
Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL3)

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL3)

Other EPA Comment Code: 7120 - Degradates/metabolites not on CCL 3

Other EPA Comment Code: 7200 - Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 6500 - Public Input

Other EPA Comment Code: 6140 - Screening Chemicals from the Universe to a PCCL

Other EPA Comment Code: 6160 - Using Classification Models to Develop the Chemical CCL 3

Other EPA Comment Code: 6160 - Using Classification Models to Develop the Chemical CCL 3

Other EPA Comment Code: 3560 - Ethylene glycol occurrence

Other EPA Comment Code: 6500 - Public Input
Other EPA Comment Code: 6140 - Screening Chemicals from the Universe to a PCCL
Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)
Other EPA Comment Code: 6300 - Classification Approach for Microbial Contaminants

Other EPA Comment Code: 2340 - Vibrio cholerae

Other EPA Comment Code: 3585 - Ethylene oxide health

Other EPA Comment Code: 3555 - Ethylene glycol health

Other EPA Comment Code: 3855 - Methanol health
Other EPA Comment Code: 3860 - Methanol occurrence

Other EPA Comment Code: 2630 - 1,3-Butadiene occurrence

Other EPA Comment Code: 4005 - Molybdenum health



This comment also appears under topic code 4005 - Molybdenum health. Please respond to this comment 

under that topic. Cadmus will ensure the response is copied to this topic in its entirety.

Other EPA Comment Code: 3550 - Ethylene glycol

Other EPA Comment Code: 3560 - Ethylene glycol occurrence

Other EPA Comment Code: 3550 - Ethylene glycol

Other EPA Comment Code: 2300 - Legionella pneumophila

Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 6500 - Public Input

Other EPA Comment Code: 4090 - Nitroglycerin

This comment also appears under topic code 4090 - Nitroglycerin. Please respond to this comment under that 

topic. Cadmus will ensure the response is copied to this topic in its entirety.

Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3).

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 4090 - Nitroglycerin

This comment also appears under topic code 4090 - Nitroglycerin. Please respond to this comment under that 

topic. Cadmus will ensure the response is copied to this topic in its entirety.



Other EPA Comment Code: 7200 Pharmaceuticals and Personal Care Products (not on CCL 3)

Other EPA Comment Code: 6100 - Classification Approach for Chemicals
Other EPA Comment Code: 5025 - Vanadium health.

This comment also appears under topic code 5025 - Vanadium health. Please respond to this comment under 

that topic. Cadmus will ensure the response is copied to this topic in its entirety.



Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 3560 - Ethylene glycol occurrence

Other EPA Comment Code: 6500 - Public Input

Other EPA Comment Code: 6500 - Public Input

Other EPA Comment Code: 6140 - Screening Chemicals from the Universe to a PCCL

Other EPA Comment Code: 2100 - General Comments on the List - All Contaminants

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) 

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 6160 - Using Classification Models to Develop the Chemical CCL 3

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)
Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

Other EPA Comment Code: 3580 - Ethylene oxide

Other EPA Comment Code: 3580 - Ethylene oxide

Other EPA Comment Code: 6160 - Using Classification Models to Develop the Chemical CCL 3

Other EPA Comment Code: 4125 - N-Methyl-2-pyrrolidone health

Other EPA Comment Code: 6100 - Classification Approach for Chemicals

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 9100 - Background Statements Related to CCL and Statutory Requirements

Other EPA Comment Code: 4450 - Perchlorate

Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

Other EPA Comment Code: 4515 - PFOA (perfluorooctanoic acid) health

Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)
Other EPA Comment Code: 7150 - Endocrine Disruptors (not on CCL 3)

Other EPA Comment Code: 4125 - N-Methyl-2-pyrrolidone health

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 6140 - Screening Chemicals from the Universe to a PCCL

Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

Other EPA Comment Code: 7180 - Perfluorinated compounds (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 3560 - Ethylene glycol occurrence

Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

Other EPA Comment Code: 4520 - PFOA (perfluorooctanoic acid) occurrence

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)

Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)

Other EPA Comment Code: 4510 - PFOA (perfluorooctanoic acid)
Other EPA Comment Code: 3580 - Ethylene oxide

Other EPA Comment Code: 3580 - Ethylene oxide

Other EPA Comment Code: 7150 - Endocrine Disruptors (not on CCL 3)

Other EPA Comment Code: 6700 - External Expert Review and Input

Other EPA Comment Code: 6100 - Classification Approach for Chemicals

Other EPA Comment Code: 6140 - Screening Chemicals from the Universe to a PCCL

Other EPA Comment Code: 4125 - N-Methyl-2-pyrrolidone health

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3) 

Other EPA Comment Code: 7190 - Personal Care Products (not on CCL 3)



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01-JUL-09

22-JUN-09

25-MAR-09

22-JUN-09

24-AUG-09

16-JUL-09

01-JUL-09

30-JUN-09

30-JUN-09

30-JUN-09

01-JUL-09

01-JUL-09
24-JUN-09

30-JUL-09

13-AUG-09

12-FEB-09

13-AUG-09

20-MAY-09

01-JUL-09

01-JUL-09
09-MAR-09

23-JUL-09

24-JUN-09

13-AUG-09

30-JUL-09

01-JUL-09

01-JUL-09
16-JUN-09

24-NOV-08

23-JUL-09

29-JUL-09

23-JUL-09

23-JUL-09

16-JUL-09

28-JUL-09
16-JUL-09

10-DEC-08

01-JUL-09

01-JUL-09

09-JUL-09

20-MAY-09

16-JUN-09

01-JUL-09

01-JUL-09

29-JUL-09

29-JUL-09

24-JUN-09

29-JUL-09

01-JUL-09

01-JUL-09

11-DEC-08
17-AUG-09

29-JUL-09

16-JUL-09

25-JUN-09

22-JUN-09

22-JUN-09

01-JUL-09

11-DEC-08

22-JUN-09

30-JUL-09

30-JUL-09

30-JUL-09

29-JUL-09

22-JUL-09

29-JUL-09

08-SEP-09

17-AUG-09

17-AUG-09

24-JUN-09

29-JUL-09

29-JUL-09
24-JUL-09

16-JUL-09

25-JUN-09

11-DEC-08

22-JUN-09

18-JUN-09
10-FEB-09

20-MAY-09

17-AUG-09
17-JUL-09

22-JUL-09

29-JUL-09

24-AUG-09

17-AUG-09

01-JUL-09

01-JUL-09

30-JUN-09

01-JUL-09
30-JUL-09

25-JUN-09

25-JUN-09

23-JUL-09

29-JUL-09

24-JUN-09

09-MAR-09

09-MAR-09

29-JUL-09

23-JUL-09

25-JUN-09

22-JUL-09

01-JUL-09

01-JUL-09
24-JUN-09

01-JUL-09

24-JUN-09

23-JUL-09

01-JUL-09

23-JUL-09

22-JUL-09

24-AUG-09

13-AUG-09

20-MAY-09

25-JUN-09
13-AUG-09

01-JUL-09

17-JUL-09

01-JUL-09

13-AUG-09

23-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

16-JUN-09

23-JUN-09

01-JUL-09

01-JUL-09

17-AUG-09

01-JUL-09
17-AUG-09

30-JUN-09

22-JUN-09

01-JUL-09

30-JUN-09

25-JUN-09

01-JUL-09

17-AUG-09

17-JUL-09
17-JUL-09

17-JUL-09

17-JUL-09

01-JUL-09

22-JUL-09

01-JUL-09

22-JUL-09

22-JUL-09

01-JUL-09

01-JUL-09
11-DEC-08

01-JUL-09

01-JUL-09

24-JUL-09

16-JUN-09

01-JUL-09

28-JUL-09

22-JUL-09

01-JUL-09

24-JUN-09

16-JUL-09

22-JUN-09

16-JUL-09

24-AUG-09

16-JUL-09

24-AUG-09

16-JUN-09

01-JUL-09
01-JUL-09

24-NOV-08

10-DEC-08

29-JUL-09

01-JUL-09

01-JUL-09

24-JUL-09

12-JUN-09

24-JUL-09

01-JUL-09

01-JUL-09

01-JUL-09

16-JUN-09

24-JUL-09

22-JUL-09
17-AUG-09

24-JUN-09

10-DEC-08

17-AUG-09
24-JUN-09

01-JUL-09

01-JUL-09

23-JUL-09

01-JUL-09

25-JUN-09

01-JUL-09

01-JUL-09

01-JUL-09

09-JUN-09

16-JUN-09

01-JUL-09

09-JUL-09

24-JUN-09
13-AUG-09

17-JUL-09

09-JUN-09

30-MAR-09

23-JUN-09
24-JUL-09

29-JUL-09

25-JUN-09

24-JUN-09

25-JUN-09

17-AUG-09

29-JUN-09

07-JUL-09

24-JUN-09

24-APR-09

10-JUN-09

22-JUL-09

09-JUL-09
13-AUG-09

20-MAY-09

25-JUN-09

22-JUL-09

01-JUL-09

24-JUL-09

01-JUL-09

01-JUL-09
15-JUL-09

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01-JUL-09

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01-JUL-09

30-JUN-09

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23-JUL-09

01-JUL-09

01-JUL-09
20-MAY-09

01-JUL-09

01-JUL-09

01-JUN-09

24-JUN-09

20-MAY-09

13-AUG-09

24-JUN-09

23-JUL-09
13-AUG-09

24-JUL-09

23-JUL-09

24-JUN-09
20-MAY-09

24-JUN-09

13-AUG-09

24-JUN-09
18-JUN-09

12-FEB-09

24-JUN-09

09-JUN-09

18-JUN-09

17-JUL-09

17-JUL-09
24-AUG-09

26-MAR-09

24-AUG-09
26-MAR-09

25-MAR-09

22-JUN-09

29-JUL-09

24-AUG-09
24-AUG-09

30-MAR-09

24-AUG-09
24-AUG-09

17-JUL-09

17-JUL-09

17-JUL-09

26-MAR-09

30-MAR-09

26-MAR-09

24-AUG-09
24-AUG-09

22-JUN-09

24-AUG-09

22-JUN-09

22-JUN-09
22-JUN-09

17-JUL-09

22-JUN-09

17-JUL-09

01-JUL-09

01-JUL-09

17-AUG-09

01-JUL-09

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16-JUN-09

17-AUG-09

16-JUL-09

11-FEB-09

24-JUN-09

29-JUL-09

22-JUL-09

22-JUL-09

22-JUL-09

25-JUN-09
17-JUL-09

24-AUG-09

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23-JUL-09
21-JUL-09

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18-AUG-09

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13-AUG-09

28-JUL-09

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22-JUL-09

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25-JUN-09

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30-JUN-09

23-JUL-09
28-JUL-09

25-JUN-09

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22-JUL-09

24-JUN-09

24-JUN-09

22-JUL-09

14-AUG-09

30-JUN-09

25-JUN-09

25-JUN-09

25-JUN-09

25-JUN-09

25-JUN-09

25-JUN-09

23-JUL-09

25-JUN-09
23-JUL-09

13-AUG-09

28-JUL-09

22-JUL-09

23-JUL-09

23-JUL-09

22-JUL-09

25-JUN-09

22-AUG-08

22-AUG-08

22-JUL-09

22-JUL-09

22-JUL-09
25-JUN-09

23-JUL-09

25-JUN-09

25-JUN-09

25-JUN-09

23-JUL-09

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25-JUN-09

25-JUN-09

25-JUN-09

25-JUN-09

25-JUN-09

22-JUL-09

30-JUN-09

23-JUL-09

22-JUL-09

25-JUN-09

25-JUN-09

23-JUL-09

22-JUL-09
22-JUL-09

22-JUL-09

25-JUN-09

22-JUL-09

17-JUL-09

24-JUN-09

22-JUL-09

18-SEP-08

28-JUL-09

18-SEP-08

29-JUL-09

29-JUL-09

30-JUN-09

17-AUG-09

25-JUN-09

25-JUN-09
17-AUG-09

17-AUG-09

17-AUG-09

17-AUG-09

17-AUG-09
20-MAY-09

20-MAY-09

17-AUG-09

20-MAY-09

16-JUL-09

28-JUL-09

14-AUG-09

28-JUL-09
28-JUL-09

28-JUL-09

28-JUL-09
EPA_COMMENT_CODE COMMENT_CODE_DESCRIPTION

1000 General Comments

1100 Statutory Requirements for CCL and Regulatory Determinations

1200 The First Contaminant Candidate List

1300 The Regulatory Determinations for CCL 1

1400 The Second Contaminant Candidate List

1500 The Regulatory Determinations for CCL 2

1600 The Unregulated Contaminant Monitoring Regulation

2000 The Draft CCL 3

2100 General Comments on the List  All Contaminants

2200 All Pathogens

2210 Bacteria

2220 Protozoa

2230 Viruses

2240 Caliciviruses

2250 Campylobacter jejuni

2260 Entamoeba histolytica

2270 Escherichia coli (0157)

2280 Helicobacter pylori

2290 Hepatitis A virus

2300 Legionella pneumophila

2310 Naegleria fowleri

2320 Salmonella enterica

2330 Shigella sonnei

2340 Vibrio cholerae

2400 All Chemical Contaminants

2420 Pesticides

2440 Degradates/metabolites

2460 DBPs

2480 Other Groups

2500 alpha-Hexachlorocyclohexane

2505 alpha-Hexachlorocyclohexane health

2510 alpha-Hexachlorocyclohexane occurrence

2530 1,1,1,2-Tetrachloroethane

2535 1,1,1,2-Tetrachloroethane health

2540 1,1,1,2-Tetrachloroethane occurrence

2560 1,1-Dichloroethane

2565 1,1-Dichloroethane health

2570 1,1-Dichloroethane occurrence

2590 1,2,3-Trichloropropane

2595 1,2,3-Trichloropropane health

2600 1,2,3-Trichloropropane occurrence

2620 1,3-Butadiene

2625 1,3-Butadiene health

2630 1,3-Butadiene occurrence

2650 1,3-Dinitrobenzene
2655 1,3-Dinitrobenzene health

2660 1,3-Dinitrobenzene occurrence

2680 1,4-Dioxane 

2685 1,4-Dioxane health

2690 1,4-Dioxane occurrence

2710 1-Butanol

2715 1-Butanol health

2720 1-Butanol occurrence

2740 2-Methoxyethanol

2745 2-Methoxyethanol health

2750 2-Methoxyethanol occurrence

2770 2-Propen-1-ol

2775 2-Propen-1-ol health

2780 2-Propen-1-ol occurrence

2800 3-Hydroxycarbofuran

2805 3-Hydroxycarbofuran health

2810 3-Hydroxycarbofuran occurrence

2830 4,4'-Methylenedianiline

2835 4,4'-Methylenedianiline health

2840 4,4'-Methylenedianiline occurrence

2860 Acephate

2865 Acephate health

2870 Acephate occurrence

2890 Acetaldehyde

2895 Acetaldehyde health

2900 Acetaldehyde occurrence

2920 Acetamide

2925 Acetamide health

2930 Acetamide occurrence

2950 Acetochlor and degradates (ESA and OA)

2955 Acetochlor and degradates (ESA and OA) health

2960 Acetochlor and degradates (ESA and OA) occurrence

2980 Acrolein

2985 Acrolein health

2990 Acrolein occurrence

3010 Alachlor and degradates (ESA and OA)

3015 Alachlor and degradates (ESA and OA) health

3020 Alachlor and degradates (ESA and OA) occurrence

3040 Aniline

3045 Aniline health

3050 Aniline occurrence

3070 Bensulide

3075 Bensulide health

3080 Bensulide occurrence

3100 Benzyl chloride

3105 Benzyl chloride health

3110 Benzyl chloride occurrence
3130 Butylated hydroxyanisole

3135 Butylated hydroxyanisole health

3140 Butylated hydroxyanisole occurrence

3160 Captan 

3165 Captan health

3170 Captan occurrence

3190 Chloromethane (Methyl chloride)

3195 Chloromethane (Methyl chloride) health

3200 Chloromethane (Methyl chloride) occurrence

3220 Clethodim

3225 Clethodim health

3230 Clethodim occurrence

3250 Cobalt 

3255 Cobalt health

3260 Cobalt occurrence

3280 Cumene hydroperoxide

3285 Cumene hydroperoxide health

3290 Cumene hydroperoxide occurrence

3310 Cyanotoxins (3)

3315 Cyanotoxins (3) health

3320 Cyanotoxins (3) occurrence

3340 Dicrotophos 

3345 Dicrotophos health

3350 Dicrotophos occurrence

3370 Dimethipin

3375 Dimethipin health

3380 Dimethipin occurrence

3400 Dimethoate

3405 Dimethoate health

3410 Dimethoate occurrence

3430 Disulfoton

3435 Disulfoton health

3440 Disulfoton occurrence

3460 Diuron 

3465 Diuron health

3470 Diuron occurrence

3490 Ethion

3495 Ethion health

3500 Ethion occurrence

3520 Ethoprop

3525 Ethoprop health

3530 Ethoprop occurrence

3550 Ethylene glycol

3555 Ethylene glycol health
3560 Ethylene glycol occurrence

3580 Ethylene oxide

3585 Ethylene oxide health

3590 Ethylene oxide occurrence

3610 Ethylene thiourea

3615 Ethylene thiourea health

3620 Ethylene thiourea occurrence

3640 Fenamiphos

3645 Fenamiphos health

3650 Fenamiphos occurrence

3670 Formaldehyde
3675 Formaldehyde health

3680 Formaldehyde occurrence

3700 Germanium

3705 Germanium health

3710 Germanium occurrence

3730 HCFC-22

3735 HCFC-22 health

3740 HCFC-22 occurrence

3760 Hexane 

3765 Hexane health

3770 Hexane occurrence

3790 Hydrazine

3795 Hydrazine health

3800 Hydrazine occurrence

3820 Methamidophos

3825 Methamidophos health

3830 Methamidophos occurrence

3850 Methanol

3855 Methanol health

3860 Methanol occurrence

3880 Methyl bromide (Bromomethane)

3885 Methyl bromide (Bromomethane) health

3890 Methyl bromide (Bromomethane) occurrence

3910 Methyl tert-butyl ether

3915 Methyl tert-butyl ether health

3920 Methyl tert-butyl ether occurrence

3940 Metolachlor and its degradates ESA and OA

3945 Metolachlor and its degradates ESA and OA health

3950 Metolachlor and its degradates ESA and OA occurrence

3970 Molinate

3975 Molinate health

3980 Molinate occurrence

4000 Molybdenum

4005 Molybdenum health

4010 Molybdenum occurrence

4030 Nitrobenzene

4035 Nitrobenzene health

4040 Nitrobenzene occurrence

4060 Nitrofen

4065 Nitrofen health

4070 Nitrofen occurrence

4090 Nitroglycerin

4095 Nitroglycerin health

4100 Nitroglycerin occurrence

4120 N-Methyl-2-pyrrolidone

4125 N-Methyl-2-pyrrolidone health

4130 N-Methyl-2-pyrrolidone occurrence
4150 N-nitrosodiethylamine (NDEA)

4155 N-nitrosodiethylamine (NDEA) health

4160 N-nitrosodiethylamine (NDEA) occurrence

4180 N-nitrosodimethylamine (NDMA)

4185 N-nitrosodimethylamine (NDMA) health

4190 N-nitrosodimethylamine (NDMA) occurrence

4210 N-nitroso-di-n-propylamine (NDPA)

4215 N-nitroso-di-n-propylamine (NDPA) health

4220 N-nitroso-di-n-propylamine (NDPA) occurrence

4240 N-Nitrosodiphenylamine

4245 N-Nitrosodiphenylamine health

4250 N-Nitrosodiphenylamine occurrence

4270 N-nitrosopyrrolidine (NPYR)

4275 N-nitrosopyrrolidine (NPYR) health

4280 N-nitrosopyrrolidine (NPYR) occurrence

4300 n-Propylbenzene

4305 n-Propylbenzene health

4310 n-Propylbenzene occurrence

4330 o-Toluidine

4335 o-Toluidine health

4340 o-Toluidine occurrence

4360 Oxirane, methyl4365 Oxirane, methyl- health

4370 Oxirane, methyl- occurrence

4390 Oxydemeton-methyl

4395 Oxydemeton-methyl health

4400 Oxydemeton-methyl occurrence

4420 Oxyfluorfen 

4425 Oxyfluorfen health

4430 Oxyfluorfen occurrence

4450 Perchlorate 

4455 Perchlorate health

4460 Perchlorate occurrence

4480 Permethrin

4485 Permethrin health

4490 Permethrin occurrence

4510 PFOA (perfluorooctanoic acid)

4515 PFOA (perfluorooctanoic acid) health

4520 PFOA (perfluorooctanoic acid) occurrence

4540 Profenofos

4545 Profenofos health

4550 Profenofos occurrence

4570 Quinoline

4575 Quinoline health

4580 Quinoline occurrence

4600 RDX (Hexahydro-1,3,5-trinitro-1,3,5-triazine)

4605 RDX (Hexahydro-1,3,5-trinitro-1,3,5-triazine) health
4610 RDX (Hexahydro-1,3,5-trinitro-1,3,5-triazine) occurrence

4630 Sec-Butylbenzene 

4635 Sec-Butylbenzene health

4640 Sec-Butylbenzene occurrence

4660 Strontium

4665 Strontium health

4670 Strontium occurrence

4690 Tebuconazole

4695 Tebuconazole health

4700 Tebuconazole occurrence

4720 Tebufenozide

4725 Tebufenozide health

4730 Tebufenozide occurrence

4750 Tellurium

4755 Tellurium health

4760 Tellurium occurrence

4780 Terbufos and its degradate terbufos sulfone

4785 Terbufos and its degradate terbufos sulfone Health

4790 Terbufos and its degradate terbufos sulfone Occurrence

4810 Thiodicarb

4815 Thiodicarb health

4820 Thiodicarb occurrence

4840 Thiophanate-methyl

4845 Thiophanate-methyl health

4850 Thiophanate-methyl occurrence

4870 Toluene diisocyanate

4875 Toluene diisocyanate health

4880 Toluene diisocyanate occurrence

4900 Tribufos

4905 Tribufos health

4910 Tribufos occurrence

4930 Triethylamine

4935 Triethylamine health

4940 Triethylamine occurrence

4960 Triphenyltin hydroxide (TPTH)

4965 Triphenyltin hydroxide (TPTH) health

4970 Triphenyltin hydroxide (TPTH) occurrence

4990 Urethane

4995 Urethane health

5000 Urethane occurrence

5020 Vanadium

5025 Vanadium health

5030 Vanadium occurrence

5050 Vinclozolin 

5055 Vinclozolin health

5060 Vinclozolin occurrence

5080 Ziram
5085 Ziram health

5090 Ziram occurrence

6000 What Analyses Did EPA Use To Develop the Draft CCL 3?

6100 Classification Approach for Chemicals

6120 Identifying the Chemical Universe

6122 health effects data sources

6126 occurrence data sources

6140 Screening Chemicals from the Universe to a PCCL

6142 Health Effects Criteria for Chemicals

6146 Occurrence Criteria for Chemicals

6160 Using Classification Models to Develop the Chemical CCL 3

6162 Health Effects Protocol for Chemicals

6166 Occurrence Protocol for Chemicals

6180 Selection of the Draft CCL 3--Chemicals

6300 Classification Approach for Microbial Contaminants

6320 Developing the Microbial Universe

6340 Screening Microbials from the Universe to a PCCL

6360 The PCCL to Draft CCL Process for Microbials

6363 Waterborne Disease Outbreak Protocol

6364 Occurrence Protocol for Microbials

6366 Health Effects Protocol for Microbials

6368 Combining Protocol Scores to Rank Pathogens

6370 Other Criteria Considered for Listing and Scoring Microbes on the Dra

ft CCL 3

6380 Selection of the Draft CCL 3 Microbes From the PCCL

6500 Public Input

6550 Nominations and Surveillance

6700 External Expert Review and Input
6730 Chemical Expert Input Panels

6760 Microbial Expert Input Panels

6900 The Interrelation Between CCL and UCMR for Specific Chemicals and 

Groups?

7000 Contaminants NOT Listed On The CCL 3

7100 Chemicals not on CCL 3

7110 Pesticides not on CCL 3 

7120 Degradates/metabolites not on CCL 3

7130 DBPs not on CCL 3

7140 Bisphenol A (and related - phenols) (not on CCL 3)

7150 Endocrine Disruptors (not on CCL 3)

7160 PAHs

7170 PBDEs  flame retardants (and related PBBs) (not on CCL 3)

7180 Perfluorinated compounds (not on CCL 3)

7190 Personal Care Products (not on CCL 3)

7200 Pharmaceuticals and Personal Care Products (not on CCL 3)
7210 Pthalates (not on CCL 3)
7220 Miscellaneous Groupings

7400 Microbes (not on CCL 3)

7410 Specific bacteria

7420 Specific fungi

7430 Specific helminths

7440 Specific protozoa

7450 Specific viruses and prions (not on CCL 3)

7500 CCL 2 Contaminants not on CCL 3

7510 2,4-Dinitrophenol

7520 p,p-DDE

7530 1,1,2,2-tetrachlorothane

7540 2,4,6-trichlorophenol

7550 o-Cresol

7560 1,2,4-trimethylbenzene

7570 p-cymene

7580 bromobenzene

7590 2,4-dichlorophenol

7600 2,4-dinitrotoluene

7610 1,2-diphenylhydrazine

7620 1,3-dichloropropane

7630 Linuron (not on CCL 3)

7640 Diazinon

7650 1,3-dichloropropene

7660 1,1-dichloropropene

7670 2,2-dichloropropane

7680 2,6-dinitrotoluene

7690 EPTC

7700 DCPA mono-acid degradate

7710 DCPA di-acid degradate 

7720 Prometon

7730 Fonofos

7740 Terbacil

7750 Aluminum

7760 Boron

7770 Organotins

7780 Triazines (total)

7790 Adenoviruses

7800 Aeromonas hydrophila

7810 Coxsackieviruses

7820 Echoviruses

7830 Microsporidia

7840 Mycobacterium avium intracellulare (MAC)
9000 Commenter Background and Introductory Statements

9100 General Statements Related to CCL and Statutory Requirements
COMMENT_CODE_ID

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RESPONSE


The commenter notes that there were limited occurrence data available for ethylene glycol. However, EPA 

disagrees with the commenter that the Agency made an erroneous conclusion that ethylene glycol might occur in 

drinking water. The Agency provided detailed support documents that discuss the CCL 3 process and the data and 

information used to evaluate contaminants for the CCL 3 that are available in the docket.



In developing the CCL 3, the Agency sought input from the National Academy of Sciences National Research 

Council (NRC), the National Drinking Water Advisory Council (NDWAC), and the Science Advisory Board on how to 

improve the CCL process. Each of these panels recommends that EPA should identify and retrieve data from 

sources that have information about occurrence of contaminants in drinking water or source water including 

sources that have a link (pathway) to drinking water. The Toxics Release Inventory (TRI) was specifically included 

as a data source that could be reviewed as one of the sources that have a link (pathway) to drinking water.



EPA disagrees with the commenter that the Agency erred in defining ethylene glycols potential to occur in 

drinking water based on total TRI releases rather than on surface water releases. EPA believes that it is 

appropriate to use total environmental release data rather than the total quantity released to surface water to 

evaluate the potential of a contaminant to occur in drinking water, as the use of total environmental release data 

accounts for any releases to groundwater, air, and any mobility the chemical may exhibit. The use of only surface 

water release data would not take into account the release of a contaminant to groundwater or mobility of a 

contaminant that could reach surface or groundwater. ATSDR notes that ethylene glycol is expected to be highly 

mobile, particularly in moist soils, and it may leach into groundwater upon release to surface soils 

(http://www.atsdr.cdc.gov/toxprofiles/tp96.pdf Page 189). Discussion in the NDWAC 2004 report supports this: 

In surface waters, which are exposed to the air, compounds that volatilize will not be persistent, simply because 

they evaporate into the air and are not found in the water. However, in ground water, the same compounds may 

EPA disagrees with the commenter that “EPA Erroneously Used Total Environmental Releases As the Data 

Element for Characterizing EG's Potential to Occur in Drinking Water." The commenter also states that “Finally, 

should EPA nevertheless use total environmental releases rather than surface water releases for purposes of the 

screening step, EPA should consider the fact that according to the TRI Explorer, total environmental releases of 

EG in 2004 equaled 8,648,773 pounds, not 10,076,483 pounds.” EPA used total environmental release data 

reported in the Toxics Release Inventory (TRI) for 2004 for screening ethylene glycol from the Universe to the 

PCCL and for scoring the magnitude attribute when screening from the PCCL to the CCL. EPA originally compiled 

the total environmental releases for 2004 for ethylene glycol as soon as they were made available on TRI as 

10,076,483 lbs. However, the numbers in the TRI database can change over time because of amendments and/or 

additional submissions or corrections from States and/or individual industrial facilities. The commenter 

submitted that at the time they queried TRI Explorer, the total environmental releases of ethylene glycol in 2004 

equaled 8,648,773 pounds. EPA queried TRI explorer on October 22, 2008 for the total environmental releases of 

ethylene glycol in 2004 and found that releases equaled 8,648,518 lbs. The commenter submitted that at the 



EPA supports and works collaboratively with CDC on the MMWR. Based on our review, EPA concludes that the 

information in the MMWR is useful and reliable. EPA, therefore, continues to be confident in the quality of the 

information in the MMWR. EPA disagrees with the comment recommending the inclusion of frequency (or 

magnitude) as a criterion for scoring the CCL. EPA criteria for evaluating and prioritizing pathogens for inclusion 

in the CCL 3 included health effects, waterborne disease outbreaks (WBDO) and occurrence (73 FR 9646 - B.3). 

Neither treatability nor rareness/frequency of disease were criteria considered for CCL 3 inclusion. EPA 

acknowledges the reference provided by the commenter regarding the 2007 Expert Panel recommendations on 

adding a frequency of disease parameter to the health effects scoring protocol for future CCLs to balance the 

consideration of more prevalent illnesses with the more severe but less prevalent responses, such as N. fowleri 

or Vibrio cholerae. EPA did not directly factor in the magnitude of WBDO (frequency of disease) as a criterion for 

For those pathogens for which there is no US WBDO or occurrence data, EPA uses international information. 

EPA’s WBDO scoring protocol uses the CDC definition for outbreak as two or more persons epidemiologically 

linked by location of exposure to water, time, and illness (CDC, 2006). CDC excludes single cases of illness from 

the definition of WBDO except for single cases of Naegleria fowleri (causing primary amebic 

meningoencephalitis) and Vibrio cholerae. When CDC MMWR data was not used EPA relied on WHO publications 

and other peer reviewed publications for scoring purposes. EPA considered non-CDC data that showed a link 

between human illness defined by a common water source, a common time period of exposure and/or similar 

symptoms including molecular typing data. Only two pathogens were given a WBDO score on this basis, 

Mycobacterium avium and Arcobacter butzlerei. For more detailed information refer to the support document 

titled The Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. Serology data are typically acquired 
Under the CCL 3, EPA evaluated the potential adverse health effects of pharmaceuticals and their occurrence in 

public drinking water systems to determine if pharmaceuticals are anticipated to occur in PWS and may require 

regulations under SDWA. 



As described in the draft CCL 3 Federal Register (FR) Notice (73 FR 9652), the primary source of health effects 

information on pharmaceuticals in the Universe for the draft CCL 3 was the Food and Drug Administration 

Database on Maximum Recommended Daily Doses (MRDD). Occurrence information from USGS Toxics 

Substances Hydrology programs National Reconnaissance of Emerging Contaminants, and related efforts, 

provided ambient water concentration data for pharmaceuticals. Other data sources included TRI and high 

production volume chemical data. From this analysis, EPA included 287 pharmaceuticals in the Chemical 

Universe. These pharmaceuticals had MRDD information that EPA used to evaluate adverse health effects. EPA 

considered those pharmaceuticals for which MRDD values and occurrence information were available and 

pharmaceuticals that were in Toxicity Category 1, using the criteria discussed in Section III.A.2.a of the draft CCL 3 

FR notice to screen contaminants for the preliminary CCL (PCCL). 



The screening process moved 29 of the pharmaceuticals in the Universe to the PCCL. Only one of those chemicals 

(diazinon, a veterinary product as well as a pesticide) had water concentration data. Two other pharmaceuticals: 

phenytoin (an anticonvulsant) and nitroglycerin (treatment of angina), had release data. The remainder were 
Based upon this re-evaluation in response to comments, EPA concluded that one antibiotic (erythromycin) and 

nine hormones (17 alpha-estradiol, 17 beta-estradiol, equilenin, equilin, estriol, estrone, ethinyl estradiol, 

mestranol, and norethindrone), should be included on the CCL 3 because these contaminants are known or 

anticipated to occur in public water systems and may require regulation. The specific data used to evaluate these 

contaminants can be found in the supporting documents (PCCL Contaminant Information Sheets in the appendix 

to “Contaminant Candidate List 3 Chemicals: Screening to a PCCL”, and the “Final Contaminant Candidate List 

(CCL) 3 Contaminant Information Sheets” in the docket at www.regulations.gov.)

Several commenters noted that pharmaceuticals should be included on the UCMR. The 1996 amendments to 

SDWA instituted the CCL and UCMR programs to prioritize and focus data collection and regulatory consideration 

on the potential drinking water contaminants that present the highest priorities for future drinking water 

regulation. The CCL is the primary mechanism for the identification of this priority list of contaminants that may 

require regulation, while UCMR provides EPA with the national occurrence data necessary to determine if a 

contaminant occurs with a frequency and at levels of public health concern. The statute itself provides a direct 

linkage between the two programs by requiring EPA to consider the UCMR data in establishing the CCL. (Section 

Strengthening Science - EPA has several activities underway to strengthen the science for understanding the 

behavior of PPCPs in water including, research, methods development, and occurrence (in fish tissue, wastewater 

and biosolids) studies. EPA's Office of Research and Development is engaged in a broad research portfolio to 

answer key questions associated with exposure pathways, health, and aquatic life effects of pharmaceuticals in 

water. An inventory of projects developed for the period from 1996 through 2014 is available at 

www.epa.gov/ppcp. The Agency also supports and cooperates with research efforts carried out by outside 

groups, such as the American Water Works Association Research Foundation (AwwaRF) and Water Environment 

Research Foundation (WERF). EPA has research underway to help understand whether very low levels of 

pharmaceuticals in water might present a risk to human health. EPA has commissioned the National Academy of 

Sciences to provide their ideas and opinions on how to determine potential risks to human health. 

EPA commissioned the National Research Council (NRC) of the National Academy of Sciences (NAS) to convene 

an expert panel to provide their ideas and opinions on the potential human health risks that may be caused from 

exposure to low levels of pharmaceuticals in drinking water. EPA sought input on approaches to screen 

pharmaceuticals that occur in drinking water at low concentrations. EPA also sought the expert’s views on 

Improving Public Understanding - It is important to communicate with the public about available data and any 

associated uncertainty with the data. To help in this regard, EPA has developed a Web site focusing specifically on 

PPCPs in water (www.epa.gov/waterscience/ppcp), and a website with a primary focus on the Agency's research 

(www.epa.gov/ppcp). 

Identifying Partnerships for Promoting Stewardship - Federal, state and local agencies, industry and others all 

have a role to play in better understanding and addressing issues regarding pharmaceuticals in water. 

Collaboration and building partnerships for stewardship are important components. Below are a few of the 

activities EPA is engaged in on this front. 

EPA sent 112 letters to state public health and environmental departments in March, 2008 requesting 

information on the states’ activities and initiatives involving pharmaceuticals. The Agency specifically requested 

information on pharmaceuticals in the areas of occurrence, human health effects research, analytical methods 

development, and stewardship. EPA received 37 responses to those letters, 16 of which commented specifically 

on the CCL 3. Responses to those 16 letters are included in this response to public comment document.

Comments included under this comment code are background and introductory statements provided by the 

commenter to introduce the organization and its purpose, confirm that the comment is in reference to the draft 

CCL 3, provide the commenter's expertise, or provide an opening or closing of the cover letter. The complete 

references cited are also included under this comment code. EPA reviewed and evaluated the information in the 

references under the specific topic that the commenter cited. The complete list of references is included to 

provide the complete bibliographic citations. The Agency believes that no response is necessary for these 

comments and refers the reader to the specific comment code for the topic of interest and the Agency's 
EPA_TEAM_MEMBER DRAFT_STA

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NOTES


Cadmus: This is the response for comment ID 18929, but it was too long to fit in 

that individual comment field. When developing the comment response 

document please move this response to comment ID 18929.




***Cadmus please move this response to comment ID 19338 when preparing 

comment response document***
COMMENT_ID LETTER_ID COMMENT_CODE_ID

18841 6534 1694

18840 6534 1485

18842 6534 1485

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