September 2015 SPADA Meeting

Draft, Do Not Distribute

129 Part 2: Environmental Panel Organisms - This list is comprised of identified organisms from the 130 environment. 131 132 Inclusion of all environmental panel organisms is not a requirement if a method developer provides 133 appropriate justification that the intended use of the assay permits the exclusion of specific panel 134 organisms. Justification for exclusion of any environmental panel organism(s) must be documented 135 and submitted. 136 137 Organisms and cell lines may be tested as isolated DNA, or as pools of isolated DNA. Isolated DNA 138 may be combined into pools of up to 10 panel organisms, with each panel organism represented at 139 10 times the AMDL, where possible. The combined DNA pools are tested in the presence (at 2 times 140 the AMDL) and absence of the target viral gene or gene fragment. If an unexpected result occurs, 141 each of the individual environmental organisms from a failed pool must be individually re-tested at 142 10 times the AMDL with and without the target viral gene or gene fragment at 4,000 genome 143 equivalents/mL in the candidate method DNA elution buffer.

144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176

• Potential bacterial biothreat agents

Bacillus anthracis Ames Yersinia pestis Colorado-92

Francisella tularensis subsp. tularensis Schu-S4

Burkholderia pseudomallei

Burkholderia mallei Brucella melitensis

• Cultivatable bacteria identified as being present in air and soil

Acinetobacter lwoffii

Agrobacterium tumefaciens Bacillus amyloliquefaciens Bacillus psychrosaccharolyticus Bacillus benzoevorans Bacillus megaterium Bacillus horikoshii Bacillus macroides Bacteroides fragilis Burkholderia cepacia Burkholderia gladoli Burkholderia stabilis Burkholderia plantarii Clostridium sardiniense Clostridium perfringens Deinococcus radiodurans Chryseobacterium indologenes Bacillus cohnii

Delftia acidovorans Escherichia coli K12

Fusobacterium nucleatum Lactobacillus plantarum

6 Draft SMPR Coxiella burnetii v7