1 | 1 | | I |
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2 | 2 | | 119THCONGRESS |
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3 | 3 | | 1 |
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4 | 4 | | STSESSION H. R. 123 |
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5 | 5 | | To direct that certain assessments with respect to toxicity of chemicals be |
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6 | 6 | | carried out by the program offices of the Environmental Protection |
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7 | 7 | | Agency, and for other purposes. |
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8 | 8 | | IN THE HOUSE OF REPRESENTATIVES |
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9 | 9 | | JANUARY3, 2025 |
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10 | 10 | | Mr. B |
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11 | 11 | | IGGSof Arizona introduced the following bill; which was referred to the |
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12 | 12 | | Committee on Science, Space, and Technology, and in addition to the |
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13 | 13 | | Committee on Energy and Commerce, for a period to be subsequently de- |
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14 | 14 | | termined by the Speaker, in each case for consideration of such provisions |
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15 | 15 | | as fall within the jurisdiction of the committee concerned |
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16 | 16 | | A BILL |
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17 | 17 | | To direct that certain assessments with respect to toxicity |
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18 | 18 | | of chemicals be carried out by the program offices of |
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19 | 19 | | the Environmental Protection Agency, and for other pur- |
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20 | 20 | | poses. |
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21 | 21 | | Be it enacted by the Senate and House of Representa-1 |
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22 | 22 | | tives of the United States of America in Congress assembled, 2 |
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23 | 23 | | SECTION 1. SHORT TITLE. 3 |
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24 | 24 | | This Act may be cited as the ‘‘Improving Science in 4 |
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25 | 25 | | Chemical Assessments Act’’. 5 |
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27 | 27 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 |
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28 | 28 | | •HR 123 IH |
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29 | 29 | | SEC. 2. RESEARCH NEEDS AND PRIORITIES OF EPA PRO-1 |
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30 | 30 | | GRAM OFFICES. 2 |
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31 | 31 | | The Environmental Research, Development, and 3 |
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32 | 32 | | Demonstration Authorization Act of 1978 is amended by 4 |
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33 | 33 | | striking section 7 (42 U.S.C. 4364) and inserting the fol-5 |
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34 | 34 | | lowing new sections: 6 |
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35 | 35 | | ‘‘SEC. 7. RESEARCH NEEDS AND PRIORITIES OF EPA PRO-7 |
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36 | 36 | | GRAM OFFICES. 8 |
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37 | 37 | | ‘‘(a) I |
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38 | 38 | | NGENERAL.—The Administrator of the Envi-9 |
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39 | 39 | | ronmental Protection Agency shall assure that the expend-10 |
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40 | 40 | | iture of any funds appropriated pursuant to this Act or 11 |
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41 | 41 | | any other provision of law for environmental research and 12 |
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42 | 42 | | development related to regulatory program activities shall 13 |
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43 | 43 | | be coordinated with and reflect the research needs and pri-14 |
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44 | 44 | | orities of the relevant program offices, as well as the over-15 |
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45 | 45 | | all research needs and priorities of the Agency, including 16 |
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46 | 46 | | those defined in the five-year research plan. 17 |
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47 | 47 | | ‘‘(b) H |
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48 | 48 | | AZARDIDENTIFICATION ANDDOSE-RESPONSE 18 |
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49 | 49 | | A |
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50 | 50 | | SSESSMENTS.—Beginning on the date of the enactment 19 |
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51 | 51 | | of the Improving Science in Chemical Assessments Act, 20 |
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52 | 52 | | any covered assessments carried out with respect to a 21 |
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53 | 53 | | chemical substance through the Integrated Risk Informa-22 |
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54 | 54 | | tion System program of the Environmental Protection 23 |
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55 | 55 | | Agency as of the day before such date of enactment shall, 24 |
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56 | 56 | | in lieu of being carried out through such program, be car-25 |
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57 | 57 | | ried out by the relevant program office of the Environ-26 |
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58 | 58 | | VerDate Sep 11 2014 05:56 Jan 29, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H123.IH H123 |
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59 | 59 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 3 |
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60 | 60 | | •HR 123 IH |
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61 | 61 | | mental Protection Agency, so long as the relevant program 1 |
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62 | 62 | | office determines there is a need for such an assessment. 2 |
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63 | 63 | | Such an assessment shall be carried out using the sci-3 |
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64 | 64 | | entific standards specified in section 7B and be based on 4 |
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65 | 65 | | the weight of the scientific evidence. 5 |
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66 | 66 | | ‘‘(c) T |
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67 | 67 | | OXICITYVALUES.—In carrying out a covered 6 |
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68 | 68 | | assessment with respect to a chemical substance under 7 |
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69 | 69 | | subsection (b), the relevant program office shall assign a 8 |
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70 | 70 | | toxicity value or values, when scientifically supported by 9 |
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71 | 71 | | the available data, for such chemical substance. With re-10 |
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72 | 72 | | spect to that assignment, the following shall apply: 11 |
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73 | 73 | | ‘‘(1) When supported by the available data, the 12 |
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74 | 74 | | toxicity value or values shall include a range of point 13 |
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75 | 75 | | estimates of risk, as well as sources and magnitudes 14 |
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76 | 76 | | of uncertainty associated with the estimates. 15 |
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77 | 77 | | ‘‘(2) When multiple point estimates can be de-16 |
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78 | 78 | | veloped, the relevant program office shall— 17 |
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79 | 79 | | ‘‘(A) consider all datasets; and 18 |
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80 | 80 | | ‘‘(B) make a determination about how best 19 |
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81 | 81 | | to represent the human health risk posed by the 20 |
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82 | 82 | | chemical substance involved. 21 |
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83 | 83 | | ‘‘(d) C |
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84 | 84 | | HEMICALASSESSMENTDATABASE.— 22 |
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85 | 85 | | ‘‘(1) I |
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86 | 86 | | N GENERAL.—A toxicity value or values 23 |
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87 | 87 | | assigned to a chemical substance under subsection 24 |
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88 | 88 | | (c) shall be included in a chemical assessment data-25 |
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90 | 90 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 4 |
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91 | 91 | | •HR 123 IH |
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92 | 92 | | base to be maintained by the Office of Research and 1 |
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93 | 93 | | Development of the Environmental Protection Agen-2 |
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94 | 94 | | cy. 3 |
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95 | 95 | | ‘‘(2) C |
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96 | 96 | | OMPLETED ASSESSMENTS .—All covered 4 |
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97 | 97 | | assessments stored, as of the date of the enactment 5 |
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98 | 98 | | of this Act, in the IRIS database of the Environ-6 |
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99 | 99 | | mental Protection Agency shall be retained in the 7 |
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100 | 100 | | chemical assessment database established pursuant 8 |
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101 | 101 | | to paragraph (1). 9 |
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102 | 102 | | ‘‘(3) U |
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103 | 103 | | PDATES.—Such database shall be up-10 |
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104 | 104 | | dated pursuant to a covered assessment performed 11 |
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105 | 105 | | by a relevant program office, including to make a 12 |
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106 | 106 | | change in the existing toxicity value or values for a 13 |
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107 | 107 | | chemical substance included in such database. 14 |
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108 | 108 | | ‘‘(e) C |
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109 | 109 | | ERTIFICATION.—Beginning 2 years after the 15 |
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110 | 110 | | date of the enactment of the Improving Science in Chem-16 |
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111 | 111 | | ical Assessments Act and every 2 years thereafter, the Of-17 |
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112 | 112 | | fice of Research and Development of the Environmental 18 |
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113 | 113 | | Protection Agency shall submit to the Committee on 19 |
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114 | 114 | | Science, Space, and Technology and the Committee on 20 |
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115 | 115 | | Energy and Commerce of the House of Representatives 21 |
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116 | 116 | | and the Committee on Environment and Public Works of 22 |
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117 | 117 | | the Senate a report containing a certification that each 23 |
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118 | 118 | | covered assessment completed during the period covered 24 |
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120 | 120 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 5 |
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121 | 121 | | •HR 123 IH |
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122 | 122 | | by the report was conducted using the scientific standards 1 |
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123 | 123 | | specified in section 7B. 2 |
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124 | 124 | | ‘‘(f) D |
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125 | 125 | | EFINITIONS.—In this section, section 7A, and 3 |
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126 | 126 | | section 7B: 4 |
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127 | 127 | | ‘‘(1) C |
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128 | 128 | | OVERED ASSESSMENT .—The term ‘cov-5 |
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129 | 129 | | ered assessment’ means, with respect to the evalua-6 |
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130 | 130 | | tion of the human health effects resulting from 7 |
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131 | 131 | | chronic exposure to a chemical substance, a chemical 8 |
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132 | 132 | | hazard identification and dose-response assessment 9 |
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133 | 133 | | (as such terms are defined by the Environmental 10 |
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134 | 134 | | Protection Agency on the day before the date of the 11 |
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135 | 135 | | enactment of this section). 12 |
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136 | 136 | | ‘‘(2) R |
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137 | 137 | | ELEVANT PROGRAM OFFICE .—The term 13 |
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138 | 138 | | ‘relevant program office’ includes the following of-14 |
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139 | 139 | | fices of the Environmental Protection Agency: 15 |
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140 | 140 | | ‘‘(A) The Office of Water. 16 |
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141 | 141 | | ‘‘(B) The Office of Air and Radiation. 17 |
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142 | 142 | | ‘‘(C) The Office of Land and Emergency 18 |
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143 | 143 | | Management. 19 |
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144 | 144 | | ‘‘(D) The Office of Chemical Safety and 20 |
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145 | 145 | | Pollution Prevention. 21 |
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146 | 146 | | ‘‘(E) Any successor to an office specified in 22 |
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147 | 147 | | subparagraphs (A) through (D) and any other 23 |
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148 | 148 | | office determined to be relevant by the Adminis-24 |
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149 | 149 | | trator of the Environmental Protection Agency. 25 |
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151 | 151 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 6 |
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152 | 152 | | •HR 123 IH |
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153 | 153 | | ‘‘SEC. 7A. HAZARD IDENTIFICATION AND DOSE-RESPONSE 1 |
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154 | 154 | | STEERING COMMITTEE. 2 |
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155 | 155 | | ‘‘(a) E |
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156 | 156 | | STABLISHMENT.—Not later than 30 days after 3 |
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157 | 157 | | the date of the enactment of the Improving Science in 4 |
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158 | 158 | | Chemical Assessments Act, the Administrator of the Envi-5 |
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159 | 159 | | ronmental Protection Agency shall establish a chemical 6 |
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160 | 160 | | hazard identification and dose-response steering com-7 |
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161 | 161 | | mittee (referred to in this section as the ‘steering com-8 |
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162 | 162 | | mittee’) to coordinate the conduct of covered assessments 9 |
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163 | 163 | | by relevant program offices for purposes of ensuring that, 10 |
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164 | 164 | | with respect to such assessments, there is no duplication 11 |
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165 | 165 | | of effort by such offices. 12 |
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166 | 166 | | ‘‘(b) D |
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167 | 167 | | UTY.—The duties of the steering committee 13 |
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168 | 168 | | are the following: 14 |
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169 | 169 | | ‘‘(1) If the steering committee learns that more 15 |
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170 | 170 | | than one relevant program office intends to conduct 16 |
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171 | 171 | | covered assessments with respect to the same chem-17 |
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172 | 172 | | ical substance, the steering committee shall deter-18 |
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173 | 173 | | mine the most effective means of carrying out a sin-19 |
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174 | 174 | | gle covered assessment to prevent duplication of ef-20 |
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175 | 175 | | fort by such offices. 21 |
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176 | 176 | | ‘‘(2) For purposes of supplementing a covered 22 |
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177 | 177 | | assessment, the steering committee shall consider 23 |
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178 | 178 | | any third-party assessment of a chemical substance 24 |
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179 | 179 | | generated by another Federal, State, or inter-25 |
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180 | 180 | | national agency or agencies or members of the sci-26 |
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182 | 182 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 7 |
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183 | 183 | | •HR 123 IH |
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184 | 184 | | entific community that meets the requirements spec-1 |
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185 | 185 | | ified in subsection (e). 2 |
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186 | 186 | | ‘‘(c) C |
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187 | 187 | | HAIR; COMPOSITION.— 3 |
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188 | 188 | | ‘‘(1) C |
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189 | 189 | | HAIR.—The steering committee shall be 4 |
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190 | 190 | | chaired by the Assistant Administrator of the Office 5 |
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191 | 191 | | of Research and Development of the Environmental 6 |
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192 | 192 | | Protection Agency. 7 |
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193 | 193 | | ‘‘(2) C |
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194 | 194 | | OMPOSITION.—The steering committee 8 |
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195 | 195 | | shall be composed of 15 members, all of whom shall 9 |
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196 | 196 | | be active, full-time employees of the Environmental 10 |
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197 | 197 | | Protection Agency, with at least one member rep-11 |
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198 | 198 | | resenting each relevant program office and each re-12 |
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199 | 199 | | gional office of the Environmental Protection Agen-13 |
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200 | 200 | | cy. The members of the steering committee shall be 14 |
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201 | 201 | | appointed by the Administrator of the Environ-15 |
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202 | 202 | | mental Protection Agency. Any vacancy shall be 16 |
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203 | 203 | | filled in the same manner as the initial appointment. 17 |
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204 | 204 | | ‘‘(d) M |
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205 | 205 | | EETINGS.—The steering committee shall meet 18 |
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206 | 206 | | at least once each calendar year. 19 |
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207 | 207 | | ‘‘(e) T |
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208 | 208 | | HIRD-PARTYASSESSMENTREQUIREMENTS.— 20 |
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209 | 209 | | The requirements specified in this subsection with respect 21 |
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210 | 210 | | to a third-party assessment of a chemical substance are 22 |
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211 | 211 | | that the assessment— 23 |
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212 | 212 | | ‘‘(1) is conducted using scientific standards 24 |
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213 | 213 | | specified in section 7B; 25 |
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216 | 216 | | •HR 123 IH |
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217 | 217 | | ‘‘(2) has undergone independent scientific re-1 |
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218 | 218 | | view for transparency, completeness, and quality; 2 |
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219 | 219 | | and 3 |
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220 | 220 | | ‘‘(3) reflects the best available science and the 4 |
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221 | 221 | | weight of the available scientific evidence. 5 |
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222 | 222 | | ‘‘SEC. 7B. SCIENTIFIC STANDARDS. 6 |
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223 | 223 | | ‘‘Covered assessments carried out under section 7 7 |
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224 | 224 | | and discussion of such assessments and review of third- 8 |
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225 | 225 | | party assessments carried out under section 7A shall be 9 |
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226 | 226 | | conducted using scientific information, technical proce-10 |
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227 | 227 | | dures, measures, methods, protocols, methodologies, or 11 |
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228 | 228 | | models in a manner consistent with the best available 12 |
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229 | 229 | | science. In carrying out such an assessment, the relevant 13 |
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230 | 230 | | program office shall integrate all lines of scientific evi-14 |
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231 | 231 | | dence and consider, as applicable, the following: 15 |
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232 | 232 | | ‘‘(1) The extent to which the scientific informa-16 |
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233 | 233 | | tion, technical procedures, measures, methods, proto-17 |
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234 | 234 | | cols, methodologies, or models employed to generate 18 |
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235 | 235 | | the scientific information are reasonable for and con-19 |
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236 | 236 | | sistent with the intended use of the scientific infor-20 |
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237 | 237 | | mation. 21 |
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238 | 238 | | ‘‘(2) The extent to which the scientific informa-22 |
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239 | 239 | | tion is relevant for the relevant program office’s use 23 |
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240 | 240 | | in making a decision regarding a chemical sub-24 |
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241 | 241 | | stance. 25 |
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243 | 243 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 9 |
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244 | 244 | | •HR 123 IH |
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245 | 245 | | ‘‘(3) The degree of clarity and completeness 1 |
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246 | 246 | | with which the data, assumptions, methods, quality 2 |
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247 | 247 | | assurance, and analyses employed to generate the 3 |
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248 | 248 | | scientific information are documented and publicly 4 |
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249 | 249 | | available in a manner that honors legal and ethical 5 |
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250 | 250 | | obligations to reduce the risks of unauthorized dis-6 |
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251 | 251 | | closure and re-identification. 7 |
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252 | 252 | | ‘‘(4) The extent to which the variability and un-8 |
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253 | 253 | | certainty in the scientific information, or in the pro-9 |
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254 | 254 | | cedures, measures, methods, protocols, methodolo-10 |
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255 | 255 | | gies, or models, are evaluated and characterized. 11 |
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256 | 256 | | ‘‘(5) The extent of independent verification or 12 |
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257 | 257 | | peer review of the scientific information or of the 13 |
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258 | 258 | | procedures, measures, methods, protocols, meth-14 |
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259 | 259 | | odologies, or models. 15 |
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260 | 260 | | ‘‘(6) The ability of the scientific findings and 16 |
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261 | 261 | | research to be replicated or reproduced. 17 |
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262 | 262 | | ‘‘(7) The extent to which the available scientific 18 |
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263 | 263 | | information supports dose-response modeling, using 19 |
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264 | 264 | | non-linear approaches.’’. 20 |
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265 | 265 | | Æ |
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