(FEB.20.2014 Department of Health and Human Sewices 'Atianta. Georgia Centers for Disease Controi'enrt Prevention Division of Select Agents and Toxins . . 1 Paul Kimsey (Responsible Official) - California Department of Public Health, Richmond 550 Marina Bay PerKWay . Richmond, FAX: (510) 551245848 I P. 1 1 L13. Department otAgricuiture I I ?7 Animtat and Plant Health inspection service . Agriculture SeiectAgent Services a Riverdale, Maryland February 20, 2014 . RE: Entity.5n?pecfi0n Report: Geiifornia Department ofPublicl?Eaith, Richmond Pursuant to the Publlo_l-lealth Securityr entl Eiloter orient Preparedness and Respenee Act of 2002, the Unltetl States Department of Health and Human services (HHS) and the United States Department of Agriculture (USDA) have . established regulatory requirements for the possession. es, and transfer of biological agents and toxins that have the potential to pose a setters threat to public health'anrl safety. animal and plant health. and animal and plant products. These requirements can be found ?at42 CFR Part 73 (HHS), 7 CFR Part 331 (USDA-FPQ), and 9 CFR Part121 (USDANS). The Centers for Disease Control and Division of Select Agentsend Toxins (BEAT) inspects entities to evaluate whether they meet the regulatory requirements set torth in 42 CFR Part 73, and .the Animal and Plant Health inspection Service Agriculture Select Agent Services, (AQSAS) inspects entities tin-evaluate whether they meet the regulatory requirements set forth in 7 CFR Part 33.1 and 9 CFR Part 121. The above referenced regulations encieupporting guidance information may be found at W. inapeotore visited your reollity locateo at 850 Merlne'Beir Permey Richmond, CA 94304 from December 03, 2013 to December DB, 201;. A list of laboratories inspected on these dates is on file with this letter at CDC. . - The following pcreonnei from the one ere-rent Agent Prog Michele Hovterd. Lee'cl inspector Lonnie Bryantinspector. vJuritth Green, - Kathleen Halnes,lnspeotor Kurtie Streub, inspector- rlem inspected the facility: individuals from Ohiifornie Department'of Public Health,- Ftlohrnond present tithing the inspection included:- Stephen Amen, Pi and Chief, I Jason Baresh, Public Health Microbiologlst Specialist . Margaret Bencsik. Biologicar'scrennat Terry Bergen chief of il'_ Rite Brenden, $eotion Chief, EMDS 3 Christine Browne, MDL-Puhllo Health Miorohiologiet ll_ Vishnu Charlurvedi. Gary Geeoigne, Chief. Margot-Groves; Public Health lli Supervisor .nn Hacker, Section ohier'vnoi. veer-r Carl Henson. Pl, - . . Robin Hogue', Public Health Microbiologiet Gregory inamh Public Health Microbiologlsi Supervisor David Kleng1 FDLB Microbiology Section .Ghiei? Paul 80, Lab Director Sharon Mee?sen'ger, Research Scientist Supervisorl! Kerry Padgett, Supervising Public Health Meyun? Panditrao. oar-Ere Fellow, - Paul Park. Research Scientist i (j . FEB. 2032014 Dapartment?of Health and Hurnan Services Centers far Dis?ase? Control and Prevention Division of Select Agents and Toxins Atlanta, Georgla ?burial-1:0? 4* re, a? my: mg. Christopher Frees. Pu b?ltc Health Supervisor William Probert. Section enter SP Charles Rani-(Itsl AIH. FMS Charming-Sheets, ARC. Biosafety Officer 'Pat Stall, Public Health Microbiolagtst II Janis: Thcmasr?ldg. Manager. FMS AlbettTrinh. M?Dleqular Btnlogist Debra Wadford, Res?a?arch Scientist Supervisor II DongXi?tng Xla. Chief, VRDL Shig so Yagt. Research Scientist ,F?eng Zhang'. Research Scientist . P. 2 .U.S. Department of Agriculture Animai and Plant Health Inspection Service are!? Agriculture Select Agent Services Rtverdaie, Maryland.? . \5 Ir Department of Health and Hum'en Services NO. 3758 i. 3 . - Uhs: Decertment ongricuitui-e Animal and Eiant Health inspection Service V. 53 "Giantere for Disease Control and Preven?cn - E. Division of Select Agents and Toxins Agriculture Select-Agent Services its; Riverdate, Maryland . I . - than 30 calendar days from receipt of this ifetier.? An' 9 Sindereiy; Attaehrnent: requirements cited above were noted. Please ,address'eac?c??e items described in Attachment 1 (List cf Entity Departures) and include in-your response the Speci?c actions or changes to be adopted to correct these departures: A detailed response-encuch be. received by this office not iater lectronio copy of your reepcnee'sl'nouid be sent to the lead inspector. Failure tctully respond may result in the initiation of'prcceedlnge for the withdrawal of ycur facility registration to possess. use, rat-transfer select agents and toxins. - - . ns ccnceming this? correspondence please contact Michele chatd at. 404315-2000: During the inspection. departures from regulatory if you have any questic .fMi 5 Mai?wi ?Freede E. Isaa_c.DVM - . -. I -- .. Director, Division of Select I Agent Services Agents and Toxins United States Department 0 Department at Health and Human - Agriculture . Services . - . . Animal and Fient Health Centers Disease Control and lnspecticn Service Prevention - - List cf' Entity Departure; . I . . Veri?cation FEB. '20. toil <9 5. n4 otw'wmh-qtr Department oft-tealth'and Human Services - centers for Dr Division of Select Agents and Toxins r, Atlanta, Georgia, . NO. 3758 P. 4 us. Department ofA?grlculture USDA Animal and Plant Health inspection Service "pa-M I Agriculture Select AgentServic'es Riverdalo. Maryland sense-Control and Prevention - Departures noted from December 03,2013 to December cc, 2013 at California Department or Public Health, Richmond (citations from 42 CFR Part 73 specifying each requiron'iehtare given in brackets). I Requirement: A codi?cate of registration maybe amended to' reflectchanges in circumstances tag" replacement of the Responsible Of?cial or other personnel changes, changes in ownership or control of the entity. changes in the activities involving any select agents or toxins, "or the addition or removal of select agents. ortoxlnc), Prior to any - Requi change'the Of?cial must apply for an amendment to a certi?cate of registration by submitting the - relevant page(s) of the registration application. [Section observation: During the laboratory tour. the'lhspec?rors Were informed by Hanson that room n" considered registered space. Also. the inspectors were informed by ARC Ghanning Sheets that room is considered store a only. However. the entity had not requested an amendment to of registration removing room?or designating room -as storage only; Furthennore. ARO Ghannihg Sheets informed the inspectors that room -wasiconsidered. registered spacerhowever, th of registration had not been amended to change. As part attire-responses to this inspection reportl please submit an amendmentto update-thsontity?s certi?cate of registration designating room -as storage only and remove room Alternatively. please-submit an amendment to update the entityfs certi?cate of registration to designate rooms - as a suite. Furthermore please smeit an amendment to the certificate of registration to desig hate rooms asasulte. . - I -. rem ent: An individual or entity required to registerundsr-thls part must designate an individual to be the Responsible Of?cial. The Responsible Of?cial must: have authority and responsibility to act-on behalf of the-entity; [Section 9(5) (3)1 - - . Obsonratiorr: At the time. of the'inspectlon. the Rsponsibia Of?cial did not hairs the atrihorlty or did not'exercise the. authority. to ensure adequate oversight of th California Department of Health1 Richmond's select agent and toxin program in order to ensure compliance with the requiren'icntsof 42 CFR part 73: Speci?cally: - - The Florence-to implement 2'1 regulatory requirements that want into effect April 3. requirements 718,9,10L?i 3S). (2) The RO allowed entry into registered areas by non-SEA approved individuals-which le'inoonsistent With the provisions of the entity?s security- plans (see (Si'i'he failed to implement systems to accuracy of select agent and toxin area access in order to Ensure that unauthorized access had nct'occurred in 2011, 2012,.end 2013.(sce reqtlircmont#43). (4) The R'O'failod to correct departures cited In the report from the November 27:29} 2012 I. . inspection (see requirements and #65 report). (5) he R0 failed to ensure that the entity's revised plans had been reviewed for accuracy prior to submission to the DSAT. (Sill-re R0 failed to - implem ant-provisions to correct deficiencies cited in the repo rttrom the November 27-29, 2012 inspection; Please provide the measures implemented to ensure the RC) has the authority'and control to provide properoveraight to ensure compliance with the requirements ores CFR part 73.,ln addition. please provide-evidence that all responses to the observations noted from the November 27-29. 20,12 inspection have been implemented._ Requirement: An individual or entity required to register undcr thi?'part must develop and implement a written .- . security plan. Thesecurity plan must be suf?cient to safeguard agent or toxin against unauthorized access, theft, loss'I or release. [Section '1 ?1 Observation: The FDLB Microbiology Section Security Plan stated that "Any cleaning, maintenance-or repair work to be performed by otherpereonnsl requires authorized personnel to escortthese individuals, until their service is. . complete and they nxittlre area.? Also, the Tier 1 BSAT Laboratory Biological Security Plan stated that employees with BRA-unrestricted access must escortthe visitor at all times while in the laboratory." The entity is - currently not following the procedures outlined in the?seourity plans. inspectors observsd thatthe following noanRA approved FMS personnel have accessto all select agent registered rooms; Berger, R. Brandenbur G. Kilbourrte. R. Laurie. A. Horas. andC- Rachilts. Furthermore. seven FMS supervisors have - FEB. 20. 2014' ?o?t??mm?ica, Dparimcnt of Health and Human Services are? ~er under which a hard key is used to access reg response to the November 27:29. 2012 inspection.- - Observation: The Tieri BSAT Laboratory Biological Security Pi for Pi Amen that addresses this requirement. - Atlanta, Georgia . combinations, etc. on . Observe?on; The Tier 1. BSAT for addressing loss or comproml no. 3758 r. '5 I US. Department of Agriculture Animal and Pient Health inspection Service rear-w Agriculture Select Agent Services . Riverdele, Maryland Centers for Disease Control and Preventiori Division of Select Agents and Toxins that override the: access system and" allow access to all select agent registered rooms. in addition, access records for rooms indicated that non-SRA approved individuals. L. Kits and J. Mdrgen, entered this registered space without an escort. Piece provide revised sections of all Pi's security plans that 1) describes how the entity prevents unauthorized accesstc select agents and toxins. particularly to non-SPA approved personnel who enter select agent registered space when Work is activer occurring orwhen stored/being manipulated in unlocked devices incubator, centrifuge, bench top), 2) describes'how the entity maintains three security barriers that lead to the delay in reaching Tier 1 select agents and toxins with the final banter preventing access to non?SPA approved individuals, and 3)_describcs the use of- that are used to override the system. including new records of this event are recorded and maintained, who is in possession of chord key, and circumstances lstere'd spaces. Please provide evidence that California Department of ctions to; ensure thatthe provisions in the security plans and - tin regards to entry into areas containing select agents and see note that a similar departure was previously cited in Public Health. Richmond has taken the appropriate or the practices implemented by the entity are consisten toxins escorting practices for these areas Pie Requirement:.The security plan must: establish procedures torremovlng unauthorizedpr Suspicious'persons. - [Section ?Al?l?iOi'i did not contain procedures The plan musiiuliy describe procedures. for begins? with the person who identi?es the unauthorized or eves the person. Please provide an updated section of see:- tor removing unauthorized or suspicious persons from?_ removing the person; for example, .a response chain'that suspicious person and ends with the responder who ram 3 Requirement: The security plan must: describe. procedures for addressing loss or compromiseof keys, passwords, - protocols for changing access. numbers or looks following staff changes.- [Section Laboratory Biotodical Security Flori Sone for Pl Arnon did not contain procedures ?se or keys, passwords; or combinations. Also, the SSA?Laboratory 'Bio'saf?ety and Bicsecurity Plan SOP 7,0 for Pl Ai'i'iOi'i did describe procedures for addressing lessor compromise or kayh,.passwords, or combinations for-hoWeverthe plan did not address the procedures to . procedures for addressing loss or compromise activities, loss or theft of select agents or toxins. Furthermore, the MDL-VRDL Safety Manual for Pis, Hanson, Brandon. and Prchert did not adequately descriheth's Please provide the updated sections ofthe security plans for PisArnon, Hanson, Brenden,'and Prohert that address this requiremen Please note that a similar, departure was previously cited in response'to the November-27429. ZD'lEIrtspection.. - - contain procedLIres tor reporting unauthorized or suspicions persons or Requirement: The security pian'r'nust: . release of select agents ortoxlne,?cr alteration of inventory records [Section 11 rcxsii Observation: TheTieri BSAT Laboratory Biological Security Plan for Pl Arnon did not describe to whom, . unauthorized or suspicious persons or should be reported, and did not contain procedures for alteration of address this requirement. - inventory rebords. Also. the SA arboreton Bicsafety and Biosecuriiv?Pian for P1 Arnon did not contain procedures for release of select agents and toxins. Please provide the updated sections of the security plans that Requirem and The security plan must: describe-procedures for how the Responsible Of?cial will be informed of suspicious activity that may ice-criminal in nature and related to its personnel. or its select agents or . .tmiin?s; [Section (oii?li thervat?ron: The FDLB Microbioloov 3901?? Plan for.? and the safety manual for PPS 2014 N0. 3758 6 Department of Health and Human Services LLS. Department ongriouiture Centers Control and Prevention Animal end-Plant Health inspection Service ?lming . .l?ianSon; Brenden. andProbert. the SAAnimal Laboratory Biosa'fsty and Eiosecurlty Plan and the Tier 1 related information, tiles, equipment servers or mass storage devices) and applications as necessary to ful?ll - their rolesand responsibilities. Procedures should include, but are not limited tp.?howthe entity will approve 1D Requirement: The security plan must: describe procedures for how the entity will notify the aptziropriete'taderaiI updated security plans that include this Infonnailon. I . When the year's rcles'and responsibilities When their access to select-agents and toxins ls- suspendedor revoked; Please provide updated sections or the it 12 Observation: Atthe tithe of the inspectihn. the security'pians for PI Arnon did not?oontain provisions forlnfonnatlon fa Division of Select Agents and Toxins . . Atlanta, Georgia servers or mass storage devices) and app -ohservetion:.At the time of the inspection, the security plans for Pl Amen did not contain provisions for? information patching . the security plans that indoors this information or references the applicable California Departmehtof Public Health Agriculture Select Agent Sen/ices Riverciale, Maryland Hanson. Brandon, and Probsrt did not describe procedures. for notifying the R0- of suspicious activity that may be criminal in nature and related to the entity, its personnel. orlts select agents and toxins. Also, the security plans for Pi Arnon did not describe procedures for notifying the R0 oisuspici?w may be criminal in nature and relatedio the entity. its personnel. or its select agents and toxins. Piease provide the updated sections of the security plans that address tltis'requirement. state, or local law enforcement agencies of such activity. [section ?(oxen Observation: The FDLB Microbiology Section Security Plan for Pi Kiting-the MDL-VRUL safety anuai for Pie. BSAT-Laboratory Biological Security Pian for Pi Arnon did notdescribe procedures tor'noiifying federal. state. .or local law enforcement of suspicioussotivitis that may be criminal In nature and reistedto the reality. its personnel.- shits select agents and toxins. Please provide updated sections of the security plans that address this?reduirement. Reouirsment: The security plan must: contain provisions for information security that ensure that authorized and authenticated users are only granted access to select agent and toxin related information, ?ies. equipment [learions sis-necessary to fulfill their roles-and responsibilities. [Section . security that ensure that authorized and authenticated users are only granted-access to select agent and toxin authorized and utheniioete'd users who access. the systems that controiaocess and records. Please provide Requirement: The security plan must: contain provisions fortniontiation securitythatansure access is modified ha? nge or when their access to seiect agents and toxins is suspended-or. revoked; {Section 11(9) (9) (WI Upset-Vatloni The FDLB Microbloiogy section Security Plan for PI Kisng. the DL Safety Manualtcr' Hanson, Brandon. and Probert, and the security plans for Pl Amen did not contain sufficient provisions for information security to ensure that ?accesses modi?ed When the user?s roles and responsibilities change or security plans that address this requirement. I - . Requirement: The? security plan must: containprovlslons torinl?onnation security that establish a robust I con?guration management practice for information systems to include regular patching and updates made to . I . operating systems and individual applications. [Section ti security that establish szrohust con?guration management practiceror information systems to include regular and updates made to operating systems and individual-applications. Please provide updated sections of Information Security Policies. Requirement: The security'pian must: contain provisions for informationvseourity that establish procedures that provide backup security measures in the event that access control systems, surveillance devices. andl'cr systems that manage the requirements of section 17 or this part are rendered inoperable. [Section '1 (exit-) -r'rB.2o.20i4 - - runny-lei Department of Health and Human Services Agriculture Centers for Disease Control and Prevention Animal and Plant Health inspection Service a??Pa?e-d? Division of SelootAgents and Toxins - Agriculture BeleotAgent Services - - Rivardaie, Maryland Atlanta. Georgia ObservationrAt the time oithe inspection, the Tieri BSAT Laboratory Biologicai Security Plan for PI Arnon and the . Safety Manual for Pie Hanson, Brenden, and Probert did not centain provisions'for information security that establish procedures that provide backup security measures in the event that access control systems, surveillance dayloes. and/or systems that manage the requirements of section ?17 of this part are rendered . inoperable. Please provide updated sections otthe. security plans that include this information. 13 Requirement: The security plan must: contain provisions and policies for shipping, receiving, and storage of. select agents and toxins, including documented procedures for receiving, monitoring1 and shipping of ail select agents and toxins. These provisions must provide that an entity wiil. properly secure containers on. site and have a-vriritteh' contingency plan for unexpected shipments. [section it(o)(10)i . . Observation: The FDLB Microbiology Section Security Plan 'forPl Kiang? the Safety Manual for I Hanson. Brendenend Probert, and the security plans for PI Arnon did not contain provisions and policies for shipping, receiving, and storage of select agents and toxins. Further, SOP 2.9 was provided for Pi Arnon and - contained policies for shipping, receiving, and storage of select agents and toxins; however, it was not referenced in . the security plans. Pteese provide the updated sectionCs) of the security plans for. PI Mangand Pie Hanson, Brenden, and Probert that descripe the provisions and policies for shipping; receiving. and storageotselect agents and toxins. Also. please provide updated sections ofthe security plans forFi SOP 2.9. I Procedures must describe the receiving. monitoring, and shipping oirall select agents and toxins, and provisions must provide that will properly secure containers on site contingency plan for unexpected shipments: 14 Requirement: An individual orentity must adhere to the following security'requirerrients orirnplement measures to - Or achieve an ?equlvalent?or greater ievel of security: establish a protocol for intra-entity transfers underthe-supeniislon or an individual with access approval from the HHS Secretary or Administrator, lnciodlnd chain-of-oustody - documents and?pr?ovisions for safeguarding against theft, toss; or release. [Section iildl(5)] I . - I Dbsawatlpni At the tirhe of the inspection, the inspectors Were informed that Pl Arnon follows" the protocols for intro-entity transfers-as described in the Safety Manual; however, these procedures were not written or referenced in Pl Amon's security plans. Furthermore, the FDLB Microbiology Section Security Plan for Pl Kiang did not describe nor reference protocols forintra-entity transfers. Please provide the updated sections ofthe security . plans for FilArnon and Pi Kiang that describe the protocols for intra?eniity transfers, including- information pertaining to the use of chalnaof custody- doouments and provisions for safeguarding against theft, loss. and release. - - Alternatively, the entity may provide copies of the applicable intro-entitytranerer SDPs. i - . <15 Requirement; An individual or entity must adhere to the following security requirements or lmplementmeesdres to achieve an equivalent orgreater level of security: require that individuals with access appmyaltrom-tite-HHS Secretary or Administrator immediately report any of the following to the Responsible Official: Any-suspicious . -. persons or activities. [Section - - . . Oneal-vouch: The Tiert'l BSAT Laboratory Biological Security Plan SOP 2.3,for Pl Arnon did not describethe appropriate actions taken by individuals with access approval from the HHS Secretary or Administrator when reporting any suspicious. persons or activities to the Respon??bte Official. Fleece provide the updateci sectionis) of the security plan for Pl Amen that addresses this requirement. Please note that a similar departure was previously . cited in response to, the November-2749, 20t2 inspection, is Requirement: An individual or entity must editors to?the following security requirements or implement measures to . achieve an equivalent or greater level of security: require that indivtduaia With access APDFWEI the HHs, - Secretary or Administrator immediately report any ot?the following to the Responsible Of?cial: Any sign that inventory or Use-records tor selectagents or toxins have been altered or otherwise compromised. [Section 1 hoarse its . ef?mm??o, Department of Health and Human Services . . U3. Department ongricultu'e (A) 5' Centers for Disease Control and Prevention Animal and Plant Health inspection Service 2 Division of Select Agents and Toxins - Agriculture SeiectAgentServioa's 5% I Atlanta. Georgia . - - . Riverdale. Maryland I . . "bio Observation: The Tier-1 BEAT Laboratory Biological Security Plan SOP 2.3 for Pl Amen dld'nct contain procedLres requiring that individuais with access approval from the HHS Secretary or Administrator immediately report to the Responsible Of?cial any sign that inventory or us records for select agents ortoxins hevs been altered or othenriise compromised. Please provide the updated section or the Tleri BSAT Laboratory Biological Security Plan SOP 25 . for PiArnon that addresses this requirement. 17 . Requirement: in addition to the requirements contained in paragraphs sordid) of this section, the security plan for an individual or entity possessing a Tier 1 select agent ottoxinrnust also: describe procedures for conducting a pro?access suitability assessment of persons who will have access "to a Tier it select agent or torrid. [section it Observation: The FDLB Section Security Plantar Pi Klang did not describe procedures for condoning 5 discusses suitability assessment of persons who will have access to a Tier 1 select agent or toxin. Further, the Tier 1 BEAT Laboratory Biological Security Plan for PI Arnon did notadequately determines that a new Tier '1 employee has succ?esstuliy completed the pro-access suitability assessment and how the decision was reached. Please provide updated sections or the security plans for Pi Klang and Pi Arhon that speci?cally describes- the procedures for conducting prereccess suitability assessments. Alternatively, please include the sections I plans that reference or the documents that detail the entity?s Tler'l suitability program. i '18 Requirement: in additiontothe requirements contained in paragraphs (stand it!) of this section, the security plan for an individual or entity possessing a Tier 1 select agent or toxin must also describe procedures for how an shingle. Responsible Of?cial will coordinate. their, efforts with the entity's safety and security professionals to ensure security. . other 1 select agents and as appropriate, relevant information. [Section owejwm?v Section Security Plan for Pl Kieng. the MDL-VRDL Safety Manual for Pis- . Henson, Brenden, and the security Bl Anton did procedures for how an entity's . Responsible Official will coordinate their efforts the entity's safety and security professionals to ensure security of Tier 1 select agents and toxins. Please provide updated sections of the security plans thatspecifi'ealiy describe theprocedures that the entity will use for coordinating with safety and security professionals to ensure the security or. ?flat select agents and"toxinsrAlternetivelyr Please includethe sections of the plans that reference SOPsor the document that details the entity?s "Tier 1 suitebilityhrogrem. '19 Requirementr'lh addition to the requirements contained in paragraphs of this sectionI the security plan - for an Individual or entity possessing a Tier tselect agent or toxin must alsoi describe procedures for the ongoing . . assessment or the suitability of personnel with aocess?to a Tier tselect egent or toxic. The procedures must include: . satin and peer-reporting of incidents or conditions that could affect on individuals ability to access to or - . won: with select agents?and toxins. or to safeguard select agents and toxins ffom theft, loss, or release. [Section Observation: At the time of the inspection.?the FDLB Microbiology Section Security Plan for Pl and the Tler'l - Laboratory Biological Security Plan SOP 2.3 for PI Arnon did not adequately describe procedures for self-end pearsrepomng or conditions that could-effect an to have access to or work safely wilh Tier '1 select agents and toxinsJ or to safeguard Tier 1 select agents and toxins from theft. loss, or release. speci?cally] thegscurlty plans must describe the types of reportable-incidents or.cond'rllons, including how the entity uses the information as part of the ongoingvessessment ofthe person's suitability. Please provide the updated sections of the security plans that address this requirement. - 20 Requirement; in addition to the requirements contained in paragraphs and cithls section the security plan for an individual or entity possessing a Tier 1 select agent ortoitlnmust also: describe procedures for the ongoing assessment or? the soitecllity or personnel with access to a'iierfl select agent or toxin. The procedures must include: the training of employees with access to Tier'l selectagents and toxins on entity policies and proceduresfor reporting. evaluation, and corrective actions concerning the assessment of Personnel SUiiebi?tr- [Section 2'1 2.2 Rhett (?the us. Department of Agriculture Animal and Plant Health inspection Service Agriculture Select Agent Services 'Riverdaie, Maryland Department of Health and Human Services . Centers for Disease Control and PreVentin Division of Select Agents and Toxins - Atlanta, Georgia . I - bbsewatiom Al the time ofihe inspection, the FDLB Microbiology Section Security Plan for PI Kiang and the Tier Laboratory Biological Security Plan 2.3 for Pl Amen did not describe procedures for training employees. - with access to Tier1 select agents and toxins on the entity?s policies and procedures for reporting, evaluation. and corrective actions concerning the assessment of personnel suitability. Please provide updated sections of the security plans for Pi.i