Safety Standards for Microbiological and Biomedical ...

1 Department of the ArmyPamphlet 385 69 SafetySafety Standardsfor Microbiologicaland BiomedicalLaboratoriesHeadquartersDepart ment of the ArmyWashington, DC6 May 2009 UNCLASSIFIEDSUMMARY of CHANGEDA PAM 385 69 Safety Standards for Microbiological and Biomedical LaboratoriesThis major revision, dated 6 May 2009--o Incorporates requirements of the Centers for Disease Control and Preventionpublication Biosafety in Microbiological and Biomedical Laboratories (para1-1).o Clarifies applicability to Microbiological activities in a clinicallaboratory and in a Biomedical research setting (para 1-1).o Adds guidance and Standards on infectious agents and toxins riskassessment(para 2-4).

2 O Clarifies Standards for biological Safety programs (chap 3).o Clarifies requirements and responsibilities for surveys (paras 3-10e and 3-13b).o Clarifies medical surveillance requirements (para 4-3).o Adds requirements for illness absence monitoring (para 4-6).o Adds requirements for integrated pest management (para 7-9).o Clarifies requirements for the import, export, transportation, and transferof infectious agents and toxins (chap 9).o Updates emergency planning and response requirements (chap 11).HeadquartersDepartment of the ArmyWashington, DC6 May 2009 SafetySafety Standards for Microbiological and Biomedical Laboratories*Department of the ArmyPamphlet 385 69H i s t o r y.

3 T h i s p u b l i c a t i o n i s a m a j o This pamphlet establishes theArmy Safety program for all aspects of theBiological Defense Program. This pam-phlet implements the Centers for DiseaseControl National Institutes of HealthGuidelines on Laboratory Biosafety, De-partment of Defense and Department oft h e A r m y p o l i c y s t a t e m e n t s , a n d o t h e rFederal regulations. It prescribes proce-dures for Safety studies and reviews ofbiological defense research, development,t e s t a n d e v a l u a t i o n p r o j e c t s , a n d p r e -scribes Safety precautions and proceduresapplicable to contractor This pamphlet applies tot h e A c t i v e A r m y , t h e A r m y N a t i o n a lGuard/Army National Guard of the UnitedStates, the Army Reserve, the Armycivilian employees, and the Army contrac-tors with a responsibility for biologicaldefense research, development, test, andevaluation operations.

4 And other Federala g e n c i e s e n g a g e d i n b i o l o g i c a l d e f e n s eo p e r a t i o n s f o r t h e D e p a r t m e n t o f t h and exception proponent of this pamphlet is the Di-rector of the Army Staff. The proponenthas the authority to approve exceptions orwaivers to this regulation that are consis-tent with controlling law and proponent may delegate this approvalauthority, in writing, to a division chiefwithin the proponent agency or its directreporting unit or field operating agency, inthe grade of colonel or the civilian equiv-alent.

5 Activities may request a waiver tothis regulation by providing justificationthat includes a full analysis of the ex-pected benefits and must include formalreview by the activity s senior legal offi-cer. All waiver requests will be endorsedby the commander or senior leader of therequesting activity and forwarded throught h e i r h i g h e r h e a d q u a r t e r s t o t h e p o l i c yproponent. Refer to AR 25-30 for improvements. Users areinvited to send comments and suggestedimprovements on DA Form 2028 (Recom-m e n d e d C h a n g e s t o P u b l i c a t i o n s a n dBlank Forms) directly to the Office of theArmy Safety Office (DACS SF)

6 , Chief ofS t a f f , 2 0 0 A r m y P e n t a g o n , W a s h i n g t o nDC 20310 This publication is availa-ble in electronic media only and is in-t e n d e d f o r c o m m a n d l e v e l D f o r t h eActive Army, the Army National Guard/A r m y N a t i o n a l G u a r d o f t h e U n i t e dStates, and the Army (Listed by paragraph and page number) chapter 1 Introduction, page 1 Purpose 1 1, page 1 References 1 2, page 1 Explanation of abbreviations and terms 1 3, page 1 Background 1 4, page 1 Provisions 1 5, page 1 chapter 2 Principles of Biosafety, page 1 General 2 1, page 1 Biological Safety program 2 2, page 1 Mishap risk management 2 3, page 2 Biological risk assessment and determination of biosafety levels 2 4, page 2*This regulation supersedes DA Pam 385 69, dated 31 December PAM 385 69 6 May 2009iUNCLASSIFIEDC ontents ContinuedSafety controls 2 5.

7 Page 2 chapter 3 Biological Safety Program, page 2 General 3 1, page 2 Biological Safety committee 3 2, page 3 Biosafety officer 3 3, page 3 Risk assessment and management 3 4, page 3 Standing operating procedures 3 5, page 3 Facility design and commissioning 3 6, page 4 Access control 3 7, page 4 Personnel qualifications and training 3 8, page 5 Safety information 3 9, page 6 Inspections 3 10, page 6 Mishap notification, investigation, and reporting 3 11, page 6 Recombinant deoxyribonucleic acid 3 12, page 7 Contract acvtivities 3 13, page 7 chapter 4 Occupational Health, page 8 Occupational health program 4 1, page 8 Competent medical authority qualifications 4 2, page 8 Medical surveillance examinations 4 3, page 8 Health hazard education 4 4, page 10 Immunoprophylaxis 4 5, page 10 Illness and absence monitoring 4 6, page 11 Fitness for duty 4 7, page 12 chapter 5 Facility Safety Controls, page 12 Facility design (secondary barriers)

8 5 1, page 12 Large scale facilities 5 2, page 12 chapter 6 Safety Equipment (Engineering Controls Primary Containment), page 12 General 6 1, page 12 Laboratory chemical hoods 6 2, page 13 Glove boxes 6 3, page 13 Ventilated balance enclosures 6 4, page 14 Ventilated cage enclosures 6 5, page 14 Ventilated cage areas 6 6, page 15 chapter 7 Biosafety Practices, page 15 General practices for infectious agents and toxins 7 1, page 15 Additional techniques applicable to work with infectious agents and toxins 7 2, page 15 Operations with radioactive material 7 3, page 16 Certification of inactivated microorganisms 7 4.

9 Page 16 Working with vertebrate animals 7 5, page 16 Working with invertebrate vectors and hosts 7 6, page 16 Specific requirements for biosafety level 4 7 7, page 16 Toxins 7 8, page 17 Integrated pest management 7 9, page 17iiDA PAM 385 69 6 May 2009 Contents ContinuedChapter 8 Personal Protective Equipment, page 17 General 8 1, page 17 Specific requirements for individual personal protective equipment 8 2, page 18 chapter 9 Import, Export, Transportation, and Transfer of Infectious Agents and Toxins, page 18 General 9 1, page 18 Transportation, and transfer of infectious agents and toxins 9 2, page 18 chapter 10 Decontamination and Disposal of Infectious Agents and Toxins, page 19 General 10 1, page 19 Methods of decontamination 10 2, page 19 Disposal 10 3, page 20 chapter 11 Emergency Planning and Response, page 20 General 11 1, page 20 Emergency procedures 11 2, page 20 Spills 11 3, page , page Safety Inspection Checklist, page Level 3 and Biosafety Level 4 Facility Commissioning criteria , page Risk Assessment, page 28 Table ListTable 6 1.

10 Laboratory Chemical Hood Performance criteria , page 13 Table C 1: Biosafety Level 3 and Biosafety Level 4 Facility Commissioning criteria , page 27 Figure ListFigure D 1: Sample of Composite Risk Management Worksheet, page 29 Figure D 1: Sample of Composite Risk Management Worksheet continued, page 30 GlossaryiiiDA PAM 385 69 6 May 2009 chapter 1 Introduction1 1. PurposeThis pamphlet prescribes the technical Safety requirements for the use, handling, transportation, transfer, storage, anddisposal of infectious agents and toxins (IAT) rated at biosafety level 2 (BSL 2) and above used in microbiologicalactivities in clinical laboratories, Biomedical and biological research settings, microbiology teaching laboratories, andveterinary reference laboratories.