1 | 1 | | |
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2 | 2 | | |
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3 | 3 | | EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW. |
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4 | 4 | | [Brackets] indicate matter deleted from existing law. |
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5 | 5 | | *hb1448* |
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6 | 6 | | |
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7 | 7 | | HOUSE BILL 1448 |
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8 | 8 | | J1 5lr2984 |
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9 | 9 | | |
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10 | 10 | | By: Delegate Cullison |
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11 | 11 | | Introduced and read first time: February 7, 2025 |
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12 | 12 | | Assigned to: Health and Government Operations |
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13 | 13 | | |
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14 | 14 | | A BILL ENTITLED |
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15 | 15 | | |
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16 | 16 | | AN ACT concerning 1 |
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17 | 17 | | |
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18 | 18 | | Animal Testing and Research – Alternative Nonanimal Test Methods 2 |
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19 | 19 | | |
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20 | 20 | | FOR the purpose of prohibiting certain research facilities in the State from using a 3 |
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21 | 21 | | traditional animal test method if an alternative nonanimal test method has received 4 |
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22 | 22 | | certain approval or the requirement to use a traditional animal test method is 5 |
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23 | 23 | | waived; requiring certain research facilities to conduct testing using traditional 6 |
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24 | 24 | | animal test methods in a certain manner; requiring certain research facilities to 7 |
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25 | 25 | | annually submit a report to the Attorney General regarding the test methods used; 8 |
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26 | 26 | | requiring the Attorney General to make the reports publicly available; requiring the 9 |
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27 | 27 | | Attorney General to enforce this Act; and generally relating to the use of alternative 10 |
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28 | 28 | | nonanimal test methods. 11 |
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29 | 29 | | |
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30 | 30 | | BY adding to 12 |
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31 | 31 | | Article – Health – General 13 |
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32 | 32 | | Section 24–23A–01 through 24–23A–05 to be under the new subtitle “Subtitle 23A. 14 |
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33 | 33 | | Alternative Nonanimal Test Methods” 15 |
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34 | 34 | | Annotated Code of Maryland 16 |
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35 | 35 | | (2023 Replacement Volume and 2024 Supplement) 17 |
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36 | 36 | | |
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37 | 37 | | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 18 |
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38 | 38 | | That the Laws of Maryland read as follows: 19 |
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39 | 39 | | |
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40 | 40 | | Article – Health – General 20 |
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41 | 41 | | |
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42 | 42 | | SUBTITLE 23A. ALTERNATIVE NONANIMAL TEST METHODS. 21 |
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43 | 43 | | |
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44 | 44 | | 24–23A–01. 22 |
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45 | 45 | | |
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46 | 46 | | (A) IN THIS SUBTITLE T HE FOLLOWING WORDS H AVE THE MEANINGS 23 |
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47 | 47 | | INDICATED. 24 2 HOUSE BILL 1448 |
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48 | 48 | | |
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49 | 49 | | |
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50 | 50 | | |
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51 | 51 | | (B) (1) “ALTERNATIVE NONANIMAL TEST METHOD ” MEANS A TEST 1 |
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52 | 52 | | METHOD THAT : 2 |
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53 | 53 | | |
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54 | 54 | | (I) DOES NOT USE A LIVE VERTEBRATE AN IMAL; AND 3 |
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55 | 55 | | |
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56 | 56 | | (II) PROVIDES INFORMATION OF EQUIVALENT OR BET TER 4 |
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57 | 57 | | SCIENTIFIC QUALITY AND RELEVANC E COMPARED TO A TRAD ITIONAL ANIMAL TEST 5 |
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58 | 58 | | METHOD. 6 |
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59 | 59 | | |
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60 | 60 | | (2) “ALTERNATIVE NONANIMAL TEST METHOD ” INCLUDES: 7 |
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61 | 61 | | |
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62 | 62 | | (I) COMPUTATIONAL TOXICOL OGY AND BIOINFORMATI CS; 8 |
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63 | 63 | | |
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64 | 64 | | (II) HIGH–THROUGHPUT SCREENING METHODS; 9 |
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65 | 65 | | |
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66 | 66 | | (III) TESTING OF CATEGORIES OF CHEMICAL SUBSTANCES ; 10 |
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67 | 67 | | |
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68 | 68 | | (IV) TIERED TESTING METHOD S; 11 |
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69 | 69 | | |
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70 | 70 | | (V) IN VITRO STUDIES; AND 12 |
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71 | 71 | | |
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72 | 72 | | (VI) MICROPHYSIOLOGICAL SY STEMS. 13 |
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73 | 73 | | |
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74 | 74 | | (C) “TRADITIONAL ANIMAL TE ST METHOD ” MEANS A PROCESS , 14 |
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75 | 75 | | PROCEDURE , OR EXPERIMENT USING LIVE VERTEBRATE ANIM ALS TO: 15 |
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76 | 76 | | |
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77 | 77 | | (1) OBTAIN INFORMATION ON THE C HARACTERISTICS OF A PRODUCT, 16 |
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78 | 78 | | INCLUDING: 17 |
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79 | 79 | | |
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80 | 80 | | (I) A CHEMICAL; 18 |
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81 | 81 | | |
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82 | 82 | | (II) AN INGREDIENT; 19 |
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83 | 83 | | |
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84 | 84 | | (III) A DRUG; 20 |
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85 | 85 | | |
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86 | 86 | | (IV) A VACCINE; OR 21 |
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87 | 87 | | |
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88 | 88 | | (V) A PRODUCT FORMULATION ; AND 22 |
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89 | 89 | | |
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90 | 90 | | (2) GENERATE INFORMATION REGARDING THE ABILIT Y OF THE 23 |
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91 | 91 | | PRODUCT TO PRODUCE A SPECIFIC B IOLOGICAL EFFECT UND ER SPECIFIED 24 |
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92 | 92 | | CONDITIONS. 25 HOUSE BILL 1448 3 |
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93 | 93 | | |
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94 | 94 | | |
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95 | 95 | | |
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96 | 96 | | 24–23A–02. 1 |
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97 | 97 | | |
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98 | 98 | | THIS SUBTITLE APPLIES ONLY TO A RESEARCH F ACILITY THAT IS LOCA TED IN 2 |
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99 | 99 | | THE STATE AND REQUIRED TO SUBMIT AN ANIMAL AND PLANT HEALTH 3 |
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100 | 100 | | INSPECTION SERVICE FORM 7023, AS DEFINED IN § 24–2301 OF THIS TITLE. 4 |
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101 | 101 | | |
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102 | 102 | | 24–23A–03. 5 |
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103 | 103 | | |
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104 | 104 | | (A) THIS SECTION DOES NOT APPLY WITH RESPECT TO: 6 |
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105 | 105 | | |
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106 | 106 | | (1) ANIMAL RESEARCH CONDU CTED FOR THE PURPOSE S OF 7 |
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107 | 107 | | BIOMEDICAL RESEARCH TO INVESTIGATE : 8 |
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108 | 108 | | |
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109 | 109 | | (I) THE BIOLOGICAL PROCES S; 9 |
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110 | 110 | | |
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111 | 111 | | (II) CAUSES OF DISEASE ; OR 10 |
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112 | 112 | | |
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113 | 113 | | (III) HOW PROCESSES IN LIVI NG ORGANISMS DEVELOP AND 11 |
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114 | 114 | | FUNCTION; OR 12 |
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115 | 115 | | |
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116 | 116 | | (2) A TRADITIONAL ANIMAL T EST METHOD USED TO C OMPLY WITH: 13 |
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117 | 117 | | |
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118 | 118 | | (I) THE REQUIREMENTS OF A FEDERAL OR STATE AGENCY; OR 14 |
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119 | 119 | | |
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120 | 120 | | (II) A WRITTEN REQUEST FROM A FEDERAL OR STATE AGENCY 15 |
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121 | 121 | | WHEN THE AGENCY HAS EXPRESSLY CONCLUDED THAT A TRADITIONAL A NIMAL 16 |
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122 | 122 | | TEST METHOD IS NEEDE D TO FULLY ASSESS TH E IMPACT ON THE HEAL TH OR SAFETY 17 |
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123 | 123 | | OF CONSUMERS . 18 |
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124 | 124 | | |
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125 | 125 | | (B) A RESEARCH FACILITY MA Y NOT USE A TRADITIO NAL ANIMAL TEST 19 |
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126 | 126 | | METHOD IF: 20 |
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127 | 127 | | |
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128 | 128 | | (1) AN ALTERNATIVE NONANI MAL TEST METHOD HAS BEEN 21 |
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129 | 129 | | APPROVED BY THE FEDERAL OR STATE AGENCY RESPONSIBLE F OR REGULATING 22 |
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130 | 130 | | THE SPECIFIC PRODUCT OR ACTIVITY BEING TE STED; OR 23 |
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131 | 131 | | |
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132 | 132 | | (2) THE FEDERAL OR STATE AGENCY RESPONSIBLE F OR 24 |
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133 | 133 | | REGULATING THE SPECI FIC PRODUCT OR ACTIV ITY BEING TESTED HAS MAD E 25 |
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134 | 134 | | AVAILABLE OR GRANTED A WAIVER FROM USING A TRADITIONAL ANIMAL TEST 26 |
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135 | 135 | | METHOD. 27 |
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136 | 136 | | 4 HOUSE BILL 1448 |
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137 | 137 | | |
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138 | 138 | | |
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139 | 139 | | (C) IF ALLOWED TO USE A TRADITIONAL ANIMAL TEST METHOD , A 1 |
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140 | 140 | | RESEARCH FACILITY SHALL: 2 |
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141 | 141 | | |
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142 | 142 | | (1) USE THE FEWEST NUMBER OF ANIMALS PO SSIBLE; AND 3 |
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143 | 143 | | |
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144 | 144 | | (2) REDUCE THE LEVEL OF PAIN, SUFFERING, AND STRESS OF THE 4 |
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145 | 145 | | ANIMALS USED FOR TESTING . 5 |
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146 | 146 | | |
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147 | 147 | | 24–23A–04. 6 |
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148 | 148 | | |
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149 | 149 | | (A) (1) ON OR BEFORE JANUARY 20 EACH YEAR, BEGINNING IN 2027, 7 |
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150 | 150 | | EACH RESEARCH FACILIT Y SHALL SUBMIT A REPORT TO THE ATTORNEY GENERAL 8 |
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151 | 151 | | WITH INFORMATION RELATED TO THE TRADITIONAL ANIMAL T EST METHOD S AND 9 |
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152 | 152 | | ALTERNATIVE NONANIMA L TEST METHOD S USED BY THE RESEARCH FACI LITY IN 10 |
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153 | 153 | | THE IMMEDIATELY PRECEDIN G CALENDAR YEAR . 11 |
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154 | 154 | | |
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155 | 155 | | (2) THE REPORT REQUIRED UNDER PARAG RAPH (1) OF THIS 12 |
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156 | 156 | | SUBSECTION SHALL INCLUDE : 13 |
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157 | 157 | | |
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158 | 158 | | (I) IF THE RESEARCH FA CILITY USED TRADITIO NAL ANIMAL 14 |
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159 | 159 | | TEST METHODS DURING THE REPORTING PERIOD : 15 |
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160 | 160 | | |
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161 | 161 | | 1. A DESCRIPTION OF EACH TRADITIONAL ANIMAL T EST 16 |
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162 | 162 | | METHOD USED AND THE REASON THE TEST METH OD WAS REQUIRED ; AND 17 |
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163 | 163 | | |
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164 | 164 | | 2. THE NUMBER AND SPECIE S OF ANIMAL USED ; AND 18 |
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165 | 165 | | |
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166 | 166 | | (II) IF THE RESEARCH FACILITY US ED ALTERNATIVE 19 |
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167 | 167 | | NONANIMAL TEST METHO DS DURING THE REPORT ING PERIOD: 20 |
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168 | 168 | | |
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169 | 169 | | 1. THE TYPE S AND NUMBER OF ALTERN ATIVE 21 |
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170 | 170 | | NONANIMAL TEST METHO DS USED; AND 22 |
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171 | 171 | | |
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172 | 172 | | 2. THE NUMBER OF WAIVERS RECEIVED BY THE 23 |
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173 | 173 | | RESEARCH FACILITY UN DER § 24–23A–03 OF THIS SUBTITLE. 24 |
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174 | 174 | | |
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175 | 175 | | (B) ON OR BEFORE APRIL 20 EACH YEAR, BEGINNING IN 2027, THE 25 |
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176 | 176 | | ATTORNEY GENERAL SHALL MAKE THE INFORMATION SUBMITTED UNDER 26 |
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177 | 177 | | SUBSECTION (A) OF THIS SECTION PUBL ICLY AVAILABLE. 27 |
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178 | 178 | | |
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179 | 179 | | 24–23A–05. 28 |
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180 | 180 | | |
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181 | 181 | | (A) THE ATTORNEY GENERAL SHALL ENFORCE THIS SUBTITLE. 29 HOUSE BILL 1448 5 |
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182 | 182 | | |
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183 | 183 | | |
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184 | 184 | | |
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185 | 185 | | (B) THE ATTORNEY GENERAL MAY PETITION THE CIRCUIT COURT TO: 1 |
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186 | 186 | | |
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187 | 187 | | (1) ISSUE AN ORDER RESTRA INING OR ENJOINING A VIOLATION OF 2 |
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188 | 188 | | THIS SUBTITLE; AND 3 |
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189 | 189 | | |
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190 | 190 | | (2) GRANT ANY OTHER RELIE F THAT THE COURT DET ERMINES IS 4 |
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191 | 191 | | NECESSARY. 5 |
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192 | 192 | | |
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193 | 193 | | SECTION 2. AND BE IT FURTHER ENACTED, That th is Act shall take effect 6 |
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194 | 194 | | January 1, 2026. 7 |
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