Section II ! Biological Risk Assessment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iological Risk Assessment HAZARDOUS CHARACTERISTICS OF AN AGENT ! "#$!%&'()'%*+!#*,*&-./0!)#*&*)1$&'01')0!.2!*(!*3$(1!*&$4!'10!)*%*5'+'16!1.!'(2$)1!*(-!)*/0$! -'0$*0$!'(!*!0/0)$%1'5+$!#/7*(!.&!*('7*+!#.018!'10!9'&/+$()$!*0!7$*0/&$-!56!1#$!0$9$&'16! .2!-'0$*0$8!*(-!1#$!*9*'+*5'+'16!.2!%&$9$(1'9$!7$*0/&$0!*(-!$22$)1'9$!1&$*17$(10!2.&!1#$! -'0$*0$:!"#$!;.&+-!<$*+1#!=&3*(',*1'.(!>;<=?!#*0!&$).77$(-$-!*(!*3$(1!&'0@!3&./%! )+*00'2')*1'.(!2.&!+*5.&*1.&6!/0$!1#*1!-$0)&'5$0!2./&!3$($&*+!&'0@!3&./%0!5*0$-!.(!1#$0$! %&'()'%*+!)#*&*)1$&'01')0!*(-!1#$!&./1$!.2!1&*(07'00'.(!.2!1#$!(*1/&*+!-'0$*0$:A!"#$!2./&! 3&./%0!*--&$00!1#$!&'0@!1.!5.1#!1#$!+*5.&*1.&6!B.&@$&!*(-!1#$!).77/('16:!"#$!NIH Guidelines $01*5+'0#$-!*!).7%*&*5+$!)+*00'2')*1'.(!*(-!*00'3($-!#/7*(!$1'.+.3')*+!*3$(10! '(1.!2./&!&'0@!3&./%0!.(!1#$!5*0'0!.2!#*,*&-:C!"#$!-$0)&'%1'.(0!.2!1#$!;<=!*(-!DE<!&'0@! 3&./%!)+*00'2')*1'.(0!*&$!%&$0$(1$-!'(!"*5+$!A:!"#$6!).&&$+*1$!B'1#!5/1!-.!(.1!$F/*1$!1.! 5'.0*2$16!+$9$+0:!G!&'0@!*00$007$(1!B'++!-$1$&7'($!1#$!-$3&$$!.2!).&&$+*1'.(!5$1B$$(!*(! *3$(1H0!&'0@!3&./%!)+*00'2')*1'.(!*(-!5'.0*2$16!+$9$+:!!I$$!I$)1'.(!J!2.&!*!2/&1#$&! -'0)/00'.(!.2!1#$!-'22$&$()$0!*(-!&$+*1$-($00!.2!&'0@!3&./%0!*(-!5'.0*2$16!+$9$+0:! ! TABLE 1 CLASSIFICATION OF INFECTIOUS MICROORGANISMS BY RISK GROUP RISK GROUP CLASSIFICATION NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA 2 MOLECULES 2002 WORLD HEALTH ORGANIZATION LABORATORY BIOSAFETY MANUAL 3RD EDITION 2004 * !K'0@!L&./%!A! ! ! G3$(10!1#*1!*&$!(.1!*00.)'*1$-!B'1#! -'0$*0$!'(!#$*+1#6!*-/+1!#/7*(0:! ! >D.!.&!+.B!'(-'9'-/*+!*(-!).77/('16!&'0@?! G!7')&..&3*('07!1#*1!'0!/(+'@$+6!1.!)*/0$! #/7*(!.&!*('7*+!-'0$*0$:! K'0@!L&./%!C! ! ! ! G3$(10!1#*1!*&$!*00.)'*1$-!B'1#!#/7*(! -'0$*0$!B#')#!'0!&*&$+6!0$&'./0!*(-!2.&! B#')#!%&$9$(1'9$!.&!1#$&*%$/1')! '(1$&9$(1'.(0!*&$!often!*9*'+*5+$:! ! K'0@!L&./%!J! ! ! ! G3$(10!1#*1!*&$!*00.)'*1$-!B'1#!0$&'./0! .&!+$1#*+!#/7*(!-'0$*0$!2.&!B#')#! %&$9$(1'9$!.&!1#$&*%$/1')!'(1$&9$(1'.(0! may be!*9*'+*5+$!>#'3#!'(-'9'-/*+!&'0@! 5/1!+.B!).77/('16!&'0@?:! ! G3$(10!1#*1!*&$!+'@$+6!1.!)*/0$!0$&'./0! .&!+$1#*+!#/7*(!-'0$*0$!2.&!B#')#! %&$9$(1'9$!.&!1#$&*%$/1')!'(1$&9$(1'.(0! *&$!not usually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iological Risk Assessment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ontrol of Communicable Diseases Manual .,!'0!%D-%22%0#! &%/%&%0-%!/*&!.)%0#./6.01!4*#$!0'#+&'2!'0)!*/#%0!0*#%)!2'4*&'#*&6!5*)%,!*/!#&'0,5.,,.*09L! 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