# Safety Safety Standards For Microbiological And Biomedical Laboratories

Headquarters Department of the Army Washington, DC 6 May 2009

## Summary Of Change

DA PAM 38569 Safety Standards for Microbiological and Biomedical Laboratories This major revision, dated 6 May 2009--

o Incorporates requirements of the Centers for Disease Control and Prevention
publication Biosafety in Microbiological and Biomedical Laboratories (para 1-1).
o Clarifies applicability to microbiological activities in a clinical
laboratory and in a biomedical research setting (para 1-1).
o Adds guidance and standards on infectious agents and toxins risk
assessment(para 2-4).
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 transfer
of infectious agents and toxins (chap 9).
o Updates emergency planning and response requirements (chap 11).
Headquarters Department of the Army Washington, DC 6 May 2009

## Safety Safety Standards For Microbiological And Biomedical Laboratories

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 procedures applicable to contractor operations.

Applicability. This pamphlet applies to t 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 l Guard/Army National Guard of the United States, the U.S. Army Reserve, the Army civilian employees, and the Army contractors with a responsibility for biological defense research, development, test, and evaluation operations, and other Federal a 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 e o 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 e Army.

H i s t o r y .  T h i s  p u b l i c a t i o n  i s  a  m a j o r revision.

Summary. This pamphlet establishes the Army safety program for all aspects of the Biological Defense Program. This pamphlet implements the Centers for Disease Control - National Institutes of Health Guidelines on Laboratory Biosafety, Department of Defense and Department of t 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 r Federal regulations. It prescribes procedures for safety studies and reviews of biological defense research, development, Proponent and exception authority.

The proponent of this pamphlet is the Director of the Army Staff. The proponent has the authority to approve exceptions or waivers to this regulation that are consistent with controlling law and regulations. The proponent may delegate this approval authority, in writing, to a division chief within the proponent agency or its direct reporting unit or field operating agency, in the grade of colonel or the civilian equivalent. Activities may request a waiver to this regulation by providing justification that includes a full analysis of the expected benefits and must include formal

## Contents (Listed By Paragraph And Page Number)

Chapter 1 Introduction, page 1
Purpose - 11, page 1 References - 12, page 1 Explanation of abbreviations and terms - 13, page 1
Background - 14, page 1
Provisions - 15, page 1
Chapter 2 Principles of Biosafety, page 1
General - 21, page 1 Biological safety program - 22, page 1
Mishap risk management - 23, page 2 Biological risk assessment and determination of biosafety levels - 24, page 2

# *Department Of The Army Pamphlet 38569

review by the activity's senior legal officer. All waiver requests will be endorsed by the commander or senior leader of the requesting activity and forwarded through t 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 y proponent. Refer to AR 25-30 for specific guidance.

Suggested improvements. Users are invited to send comments and suggested improvements on DA Form 2028 (Recomm 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 d Blank Forms) directly to the Office of the Army Safety Office (DACSSF), Chief of S 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 n DC 203100200.

Distribution. This publication is available in electronic media only and is int 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 e Active 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 d States, and the U.S. Army Reserve.

## ContentsContinued

Safety controls - 25, page 2
Chapter 3 Biological Safety Program, page 2
General - 31, page 2 Biological safety committee - 32, page 3 Biosafety officer - 33, page 3 Risk assessment and management - 34, page 3 Standing operating procedures - 35, page 3 Facility design and commissioning - 36, page 4 Access control - 37, page 4
Personnel qualifications and training - 38, page 5
Safety information - 39, page 6
Inspections - 310, page 6 Mishap notification, investigation, and reporting - 311, page 6
Recombinant deoxyribonucleic acid - 312, page 7 Contract acvtivities - 313, page 7
Chapter 4 Occupational Health, page 8
Occupational health program - 41, page 8 Competent medical authority qualifications - 42, page 8
Medical surveillance examinations - 43, page 8 Health hazard education - 44, page 10 Immunoprophylaxis - 45, page 10 Illness and absence monitoring - 46, page 11 Fitness for duty - 47, page 12
Chapter 5 Facility Safety Controls, page 12
Facility design (secondary barriers) - 51, page 12 Large scale facilities - 52, page 12
Chapter 6 Safety Equipment (Engineering Controls - Primary Containment), page 12
General - 61, page 12 Laboratory chemical hoods - 62, page 13 Glove boxes - 63, page 13
Ventilated balance enclosures - 64, page 14
Ventilated cage enclosures - 65, page 14 Ventilated cage areas - 66, page 15
Chapter 7 Biosafety Practices, page 15
General practices for infectious agents and toxins - 71, page 15
Additional techniques applicable to work with infectious agents and toxins - 72, page 15
Operations with radioactive material - 73, page 16 Certification of inactivated microorganisms - 74, page 16
Working with vertebrate animals - 75, page 16 Working with invertebrate vectors and hosts - 76, page 16
Specific requirements for biosafety level 4 - 77, page 16
Toxins - 78, page 17 Integrated pest management - 79, page 17

## ContentsContinued

Chapter 8 Personal Protective Equipment, page 17
General - 81, page 17
Specific requirements for individual personal protective equipment - 82, page 18
Chapter 9 Import, Export, Transportation, and Transfer of Infectious Agents and Toxins, page 18
General - 91, page 18
Transportation, and transfer of infectious agents and toxins - 92, page 18
Chapter 10 Decontamination and Disposal of Infectious Agents and Toxins, page 19
General - 101, page 19
Methods of decontamination - 102, page 19
Disposal - 103, page 20
Chapter 11
Emergency Planning and Response, page 20
General - 111, page 20
Emergency procedures - 112, page 20
Spills - 113, page 21

## Appendixes

A.
References, page 22
B.
Laboratory Safety Inspection Checklist, page 24
C.
Biosafety Level 3 and Biosafety Level 4 Facility Commissioning Criteria, page 26
D.
Sample Risk Assessment, page 28

## Table List

Table 61: Laboratory Chemical Hood Performance Criteria, page 13 Table C1: Biosafety Level 3 and Biosafety Level 4 Facility Commissioning Criteria, page 27

## Figure List

Figure D1: Sample of Composite Risk Management Worksheet, page 29 Figure D1: Sample of Composite Risk Management Worksheet continued, page 30

## Glossary

11. Purpose This pamphlet prescribes the technical safety requirements for the use, handling, transportation, transfer, storage, and disposal of infectious agents and toxins (IAT) rated at biosafety level 2 (BSL2) and above used in microbiological activities in clinical laboratories, biomedical and biological research settings, microbiology teaching laboratories, and veterinary reference laboratories. This pamphlet requires the mandatory use of the latest edition of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) and National Institutes of Health's Biosafety in Microbiological and Biomedical Laboratories (BMBL). The requirements stated in the BMBL and this pamphlet apply to all U.S. Army activities and facilities in which IAT are used, produced, stored, handled, transported, transferred or disposed, to include the Army National Guard (ARNG) and the U.S. Army Reserve, and to contractors and consultants conducting microbiological and biomedical activities for the Army.

## 12. References Required And Related Publications And Prescribed And Referenced Forms Are Listed In Appendix A. 13. Explanation Of Abbreviations And Terms Abbreviations And Special Terms Used In This Pamphlet Are Explained In The Glossary.

14. Background Microbiological and biomedical activities are conducted by the U.S. Army in developing measures to identify, detect, diagnose, treat, and protect against IAT. To meet these objectives, IAT are used when conducting the necessary research, development, test, evaluation, and sampling and analysis. The U.S. Army needs clear standards to protect personnel and the environment from exposure to IAT. Since the BMBL has been recognized as the code of practice for biosafety, the U.S. Army has decided to make the BMBL mandatory for biological activities using IAT assessed at BSL-2 or above. This pamphlet contains requirements and resources in addition to the BMBL for the safe use, production, storage, handling, transportation, transfer, and disposal of IAT.

15. Provisions a. This pamphlet and the BMBL have mandatory procedures and guidance as well as preferred and acceptable methods of accomplishment.

b. The words "shall," "will," and "must" are used to state mandatory requirements in both this document and the BMBL. Deviation from these provisions requires a Certificate of Risk Acceptance per provisions of Army Regulation (AR) 385-10 and Department of Army Pamphlet (DA PAM) 385-30.

c. The word "should" in both this document and in the BMBL indicates an optional or preferred method of accomplishment. Deviation from these provisions requires written authorization from the local commander/senior manager or his/her written designee.

d. The word "may" indicates an acceptable or suggested means of accomplishment.

## Chapter 2 Principles Of Biosafety

21. General The implementation of a structured biological safety program, mishap risk management, biological risk assessments to determine BSLs, and the implementation of safety controls provide the means through which employees and members of the public are protected against the hazards associated with IAT involved in microbiological activities in clinical laboratories and in biomedical research settings.

22. Biological safety program a. Each Army Headquarters, major subordinate command, and agency conducting microbiological activities in a clinical laboratory or in a biomedical research setting will include a biological safety section in their written safety and occupational health program. The biological safety section will prescribe responsibilities and procedures for implementing requirements of AR 385-10, Chapter 20, and this pamphlet. The safety program will be carried out as stated in AR 38510. Additionally, the program will contain the following:
b. The biological safety section of the installation, institute, or activity's written safety and occupational health program will include a biological occupational health element meeting the requirements of this pamphlet.

c. When the military department, command, or agency conducting microbiological and biomedical activities is a tenant on an installation, that organization shall coordinate their biological safety and occupational health program with the installation commander.

23. Mishap risk management a. The mishap risk management process is the process of identifying and assessing hazards; determining their risk;
developing, evaluating and selecting controls; making risk decisions; and implementing and managing those decisions to improve operational effectiveness and conserve Army resources. The mishap risk management process is also the process of providing recommendations on whether to accept or resolve potential consequences of hazards associated with a given activity.

b. The mishap risk management process consists of the following five steps: (1) Identify hazards. (2) Assess hazards to determine risk. (3) Develop possible countermeasures and make risk decisions. (4) Implement controls. (5) Supervise and evaluate.

24. Biological risk assessment and determination of biosafety levels Biological risk assessment (as opposed to risk assessment in general) is conducted to determine the BSL for handling a particular IAT. Procedures for defining BSL are contained in the BMBL. BSLs (the four ascending levels of containment, referred to as BSL1 through BSL4) describe the microbiological practices, safety equipment and facility safeguards for the corresponding level of risk associated with handling a particular IAT based on that IAT's infectivity, severity of disease, the availability of preventive measures and effective treatments for the disease, transmissibility, the nature of the work being conducted, and the origin of the agent (whether indigenous or exotic).

25. Safety controls
Safety controls will be identified through the risk management process as well as prescribed in statutory and regulatory requirements. Safety controls include the following - as further defined throughout this pamphlet - and will be documented in the agency/facility safety program, the laboratory specific biosafety manual, standing operating procedures (SOPs), and so forth.
a. Facility safety controls (for example, directional airflow, emergency back-up power, continuity of seal between
the floor and wall).
b. Safety equipment (for example, biological safety cabinets, glove boxes, laboratory chemical hoods). c .  L a b o r a t o r y  p r a c t i c e s  a n d  s a f e t y  r e q u i r e m e n t s ,  i n c l u d i n g  a l l  a p p l i c a b l e  S O P s  a n d  s p e c i a l  p r a c t i c e s  a n d
requirements.
d. Personal protective equipment (PPE). e. Access control and rosters. f. Signage, labeling of containers, and safety communications. g. Medical surveillance and immunizations. h. Disinfection and sterilization. i. Hazardous biological waste handling, decontamination, packaging, and disposal. j. Emergency procedures.

## Chapter 3 Biological Safety Program

31. General
Agencies and facilities conducting microbiological activities in clinical laboratories and in biomedical research settings will develop and implement a biological safety program, as stated in AR 385-10. Biological safety programs will address the following:
a. Program policy and goals. b. Program responsibilities. c. Biological safety committee. (See sec 32.) d. Requirements and procedures for risk assessments and selection of appropriate BSL. (See secs 23, 24, and
34.)
e. Requirements and procedures for SOPs. (See sec 35.) f. Occupational health requirements and procedures. (See chap 4.) g. Facility design and commissioning. (See sec 36 and chap 5.)
h. Access control. (See sec 37.)
i. Engineering controls/safety equipment (selection, use, training, testing, and maintenance). (See chap 6.) j. Biosafety practices. (See chap 7.) k. The PPE (selection, use, training, testing, and maintenance). (See chap 8.) l. Labeling and posting of hazards (See AR 38510, para 2015). m. Chemical hygiene plan. n. Personnel qualifications and training. (See sec 38.) o. Safety information. (See sec 39.) p. Inspections. (See sec 310.) q. Facility, utilities, and equipment continuing maintenance plan (See AR 38510, para 2016). r. Pest management (See sec 79). s. Transportation and transfer of IAT (See chap 9). t. Decontamination and disposal of IAT (See chap 10). u. Emergency planning and response (See chap 11). v. Mishap investigation and reporting (See sec 311). w. Select agent registration, if applicable. x. Recombinant deoxyribonucleic acid (DNA), if applicable (See sec 312). y. Radiation safety, if applicable (See chaps 7, 10 and 11). z. Animal safety, if applicable (See chaps 6 and 7). aa. Contract activities, if applicable (See para 313).
32. Biological safety committee a. Facilities conducting IAT activities will establish and charter a biological safety committee or similar committee consisting of representatives of the following: commander or institute director or designee, laboratory supervisors, biosafety officer, occupational health, industrial hygiene, facility maintenance, safety, and an employee representative. At a minimum, the committee will review proposed work activities, facility modifications, and assist in performing biological risk assessments. Biomedical activities that are a tenant on an installation shall have a garrison representative on their biological safety committee.

b. The biological safety committee will meet at least quarterly. Minutes will be prepared and staffed through the institute commander/director, will be available for review, and will be maintained for at least 3 years.

33. Biosafety officer a. Facilities conducting IAT research and all facilities that store select agents and toxins as defined in 7 Code of Federal Regulations (CFR) Part 331, 9 CFR Part 121, and 42 CFR Part 73 will designate an individual as the biosafety officer. Other IAT activities (for example, clinical laboratories) will have access to a biosafety officer, such as on a regional support basis. Biosafety officers will be trained and qualified as specified in paragraph 38a.

b. Biosafety officers will serve as a facility/activity's biosafety subject matter expert and will provide/support risk assessments, risk management, biosafety controls, biological safety program management, standing operating procedures, biosafety training, inspections, mishap notification, investigation and reporting, and emergency planning and response.

34. Risk assessment and management a. A risk assessment will be conducted for every microbiological and biomedical laboratory activity or activity involving IAT. In assessing and managing risk, the activity will be broken down into subtasks, and for each subtask the hazards, initial risk level, recommended controls (personnel training and qualification, procedures, containment equipment, and facility design), residual risk level, and the means for implementing the recommended control will be identified. A sample risk assessment is at appendix D. It is recommended that risk assessments be documented on DA Form 7566, Composite Risk Management Worksheet.

b. A risk assessment will be performed and documented for any deviation from a required or recommended procedure or safeguard. DA Pam 38530 has a recommended risk acceptance matrix.

c. The principal investigator or immediate supervisor is responsible for conducting the risk assessment in close coordination with safety and occupational health subject matter experts and the safety committee to ensure compliance with established guidelines and regulations.

35. Standing operating procedures a. An SOP will be established for each laboratory activity or activity involving IAT. A copy of the SOP will be maintained or available electronically in each work area in which the activity is conducted. SOPs will address the following:
(1) Any unique procedures and requirements needed that are not described as universally required in the biosafety program (for example, signs, waste disposal, building systems operation and maintenance, decontamination, immunizations, emergency procedures, and personnel monitoring).

(2) Specialized orientation or training of personnel beyond that required in the biosafety program. (3) Emergency procedures. b. If the laboratory uses external-agency standardized SOPs (for example, CDC SOPs for Laboratory Response Network laboratories), any of the above items that are not addressed in the SOP will be addressed in the laboratoryspecific safety manual or an addendum to the SOP.

c. Standing operating procedures will periodically be reviewed and updated. Each activity will establish a method for reviewing and revising SOPs based upon the complexity and hazardous-nature of the process. The review cycle should not exceed twelve months for any SOP.

d. Standing operating procedures will limit personnel to the minimum number of appropriately qualified and trained personnel to engage in the activity, for the shortest period of time and with the minimum amount of material, consistent with program objectives and safe operations and maximize use of engineering and administrative controls to preclude or minimize the need for PPE.

e. Personnel with specialized knowledge (for example, safety, occupational health, industrial, environmental, logistics, quality assurance, fire and emergency services, engineering) will review SOPs (or the laboratory-specific safety manual or SOP addendum if the laboratory uses external-agency standardized SOPs) for accuracy, compliance with standards and regulation, and conformity with accepted practices and provide concurrence with the SOP prior to it being signed by the approving authority.

f. The SOPs will include a cover sheet containing the following information: (1) Activity name. (2) Name of process. (3) Unique SOP number. (4) Date of SOP. (5) Name of preparer, title, and phone number. (6) Signatures/office titles of individuals responsible for reviewing/concurring with SOP (for example, safety, emergency services, engineering).

(7) Name and title of approving authority and date of approval. (8) Signatures of supervisors/person-in-charge indicating they have read the SOP and associated risk assessment, understand operations involved in the task, have verified that operators (and will ensure that new operators) are trained and understand the SOP, and that the task can be executed in a safe and efficient manner.

(9) Signatures of operator(s) to attest to the fact that they have read or have had read to them and understand the SOP and the associated risk assessment.

g. Operators and the supervisor/person-in-charge will sign the SOP cover sheet or SOP signature page indicating they have read the SOP, understand operations involved in the task, have verified that operators are trained and understand the SOP, and that the task can be executed in a safe and efficient manner when:
(1) First assigned to supervise the task. (2) Beginning an operation that is intermittent and has not been performed for 90 days. (3) A change is made to the SOP. (4) Following periodic reviews/updates as described in para 3-5c.

h. An index of all approved SOPs will be available and contain the following information:
(1) SOP number and title. (2) Name of office submitting the SOP. (3) Date of approval. (4) Next review date.

36. Facility design and commissioning As required by paragraph 20-8c of AR 385-10, prior to initial use BSL3 and BSL4 laboratories are required to be validated for safe operation through a commissioning survey. Facility design and commissioning survey criteria are contained in appendix C.

37. Access control a. Access to areas defined as BSL-2 and higher where work with IAT is in progress is limited in accordance with institutional policies. Only persons who have been advised of the potential hazard and meet specific entry requirements (for example, approval of Principle Investigator or supervisor, required PPE, training, medical screening) may enter the individual laboratory or animal rooms. The laboratory supervisor will enforce institutional policies that control access to the laboratory.

b. Access to areas defined as BSL-3 is limited in accordance with paragraph 3-7a, and in addition is restricted to those persons whose presence in the facility or individual laboratory rooms is required for program or support purposes. Doors leading to these areas will have access restriction signs posted and be secured with locks (or equivalent means) to prevent unauthorized entry.

c. Access to BSL-4 facilities is limited as stated in paragraphs 37a and 37b. This is done with secure, locked doors with access controlled by the commander or institute director, safety or biosafety officer, or other person(s) responsible for the physical security of the facility. Before entry, all persons will be advised as to the appropriate safeguards for ensuring their safety. Authorized persons must comply with these instructions and all other applicable entry and exit procedures. A record will be maintained for all personnel to indicate the date and time of each entry and exit.

38. Personnel qualifications and training a. Biosafety Officers will meet the following qualifications: (1) Bachelor's Degree with background in science. (2) One year of laboratory experience at equivalent BSL/Animal BSL. (3) The 4-day Service-approved biosafety course (commercially available). (4) The 4-8 hours of Department of Defense (DOD) biosafety requirements course. (5) Training in Service-specific safety policy and standards and risk management. b .  S u p e r v i s o r s  a r e  r e s p o n s i b l e  f o r  u n d e r s t a n d i n g  I A T  o p e r a t i o n s  a n d  A r m y  s a f e t y  p o l i c y  a n d  s t a n d a r d s  f o r microbiological and biomedical activities.

c. Supervisors are responsible for ensuring that employees have received the training to enable them to safely execute the operation; and ensuring safety equipment and controls are available, safe, functioning, inspected, tested, and maintained.

d. Supervisors are responsible for ensuring that personnel entering a clinical or biomedical research laboratory meet applicable access control, medical, and safety and occupational health training requirements.

e. Prior to performing assigned duties, personnel working with IAT will be aware of the associated hazards, will receive instruction that adequately prepares them for their assigned duties, and will be proficient in microbiological practices and procedures. Training will be developed in coordination with the safety office and will be documented to include the date of the training session, the contents or a summary of the training, and employee's name. Training will include:
(1) Risk management principles and techniques. (2) Concept and definition of BSLs. (3) Modes of transmission, infectivity, time delay to onset of signs and symptoms, as well as the potential acute and chronic health effects and signs/symptoms associated with the IAT to which workers are potentially exposed.

(4) Facility safety controls. (5) Selection and use of safety equipment (for example, biological safety cabinets, glove boxes, laboratory chemical hoods).

( 6 )  L a b o r a t o r y  p r a c t i c e s  a n d  s a f e t y  r e q u i r e m e n t s ,  i n c l u d i n g  a l l  a p p l i c a b l e  S O P s  a n d  s p e c i a l  p r a c t i c e s  a n d requirements.

(7) Bloodborne pathogens (per 29 CFR 1910.1030), hazard communication (per 29 CFR 1910.1200), and occupational exposure to hazardous chemicals in laboratories (per 29 (CFR) 1910.1450).

(8) Selection and use of PPE (per 29 CFR 1910 Subpart I). (9) Access control.

(10) Facility signage, labeling of containers, and safety communications. (11) The purpose and description of the occupational health program, including specific medical surveillance and immunization requirements associated with the IAT to which workers are potentially exposed.

(12) Hazardous biological waste handling, approaches to minimizing the volume of waste, decontamination, packaging, and disposal.

(13) Disinfection and sterilization. (14) Emergency procedures. (15) Reporting mishaps. (16) Inspection requirements. (17) Transportation (packaging and shipment) and transfer of IAT, when applicable. f. Training for all new employees working with IAT will include a period of supervised orientation in the facilities, as prescribed in the agency/facility biological safety program, by a scientist or technician with specific training in the procedures and properties of the IAT in use. During the training period, new laboratory personnel will be under the supervision of appropriately trained personnel.

g. Biosafety personnel working with Biological select agents and toxins (BSAT) will comply with 42 CFR 73.15
refresher training requirement.

39. Safety information A system of communication will be established to:
a. Provide information addressing useful biological safety advice and accounts of laboratory mishaps, along with the lessons to be learned from them.

b. Ensure reference books and regulations concerning laboratory hazards, occupational health, containment, and proper laboratory practices are readily available (however, it is not necessary to maintain these in the laboratory work area).

c. Ensure that material safety data sheets (MSDS) for hazardous chemicals and IAT (when an MSDS is available for the IAT) used in the work area are readily available to employees in the work area. Each employee will be trained in, and will demonstrate the knowledge of, accessing these MSDSs.

d. There must not be any hindrance to employee accessibility to MSDSs or other appropriate health and safety references. If MSDSs are accessed electronically (for example, computer via internet or CD-ROM), each employee will also be trained on a back-up access procedure in the event the electronic system is not available.

310. Inspections a. Before performing operation with IAT, operators will survey the work area. Operators will have a means to correct the deficiencies found or to report any unsafe conditions and have them corrected prior to beginning operations.

b. A qualified (see para 38d, above) laboratory safety point of contact (POC) will be designated for each laboratory room or suite.

(1) Laboratory safety POCs will be responsible for monitoring the availability, safety, functioning, inspection, testing, and maintenance of required laboratory safety controls and equipment. Logs will be posted on specific items (such as biological safety cabinets, chemical hoods, autoclaves, centrifuges, freezers, and refrigerators) and laboratory personnel will document daily checks to ensure proper operation and identify any malfunction or safety concern.

(2) Laboratory safety POCs will ensure that malfunctions of room or building systems are reported to his/her supervisor. Laboratory safety POCs will ensure that any malfunctioning laboratory safety controls or equipment or shortages in required equipment and supplies are reported to the appropriate individuals. Laboratory safety POCs will ensure that the laboratory room and/or safety controls and equipment are labeled to warn of the malfunction and indicate that it should not be used until repaired and, as applicable, tested.

c. The laboratory supervisor - or a designated qualified (see para 38, above) individual - will conduct and document a monthly inspection of his/her laboratories.

d. The safety officer, biosafety officer, or qualified safety and occupational health personnel (see glossary) designated by the commander/director will inspect BSL2 and toxin laboratories at least semi-annually, and BSL3 and BSL4 laboratories and those in which dry forms of toxins are handled at least quarterly. A representative of the occupational health staff will participate in inspections at least annually. These documented inspections may be unannounced and will include coverage of general safety practices as well as requirements applicable to the laboratory's BSL. One of the semi-annual or quarterly inspections can be a Standard Army Safety and Occupational Health Inspection (SASOHI) as required by AR 38510.

e. A qualified Industrial Hygienist (GS-0690 job series) will conduct an industrial hygiene survey of research microbiology laboratories on an annual basis. Surveys will identify and document chemical, physical, biological and ergonomic hazards. Industrial hygienists will evaluate and assign a risk assessment code to each hazard and recommend appropriate hazard control. (See DA Pam 40503.)
f. Deficiencies or procedures that create a potentially life threatening situation shall be immediately referred to supervisory personnel, the safety office, the commander or institute director, and, if the facility is a tenant on an installation, the Garrison Commander. The operation will be stopped, and corrective actions will be immediately implemented or the residual risk will be accepted at the appropriate level in accordance with Army Headquarters (for example, Army Materiel Command, US Army Medical Command, and Army Test and Evaluation Command) risk acceptance policy.

g. Reports of deficiencies for other than life-threatening situations shall be made as soon as possible to the appropriate supervisor, with copies furnished to the safety office. If a problem is widespread, all affected personnel will be notified.

311. Mishap notification, investigation, and reporting a. Biological mishap reporting and investigation will be in accordance with requirements of this pamphlet, AR
38510, AR 501, DA Pam 38540, 7 CFR 331, 9 CFR 121, 42 CFR 73, and applicable State and local requirements. Commanders will establish procedures to ensure initial notification, investigation, and reporting of a biological mishap is accomplished in accordance with the requirements of these documents as follows, as well as applicable State and local requirements. All biological mishaps will be investigated for the purpose of accident prevention.

b. The term "biological mishap" is defined as an event in which the failure of laboratory facilities, equipment, or procedures appropriate to the level of potential pathogenicity of an IAT may allow the unintentional, potential exposure of humans or the laboratory environment to that agent.

c. Biological select agents and toxins (BSAT) (including clinical, diagnostic, or proficiency test specimens of BSAT).

(1) In accordance with 7 CFR 331, 9 CFR 121, AND 42 CFR 73, upon discovery of a release of a BSAT causing occupational exposure or release of a BSAT outside of the primary containment barriers (for example, biological safety cabinet, trunnion centrifuge cups, and aerosol-containing blenders) of the biocontainment area (including clinical or diagnostic laboratories and other entities that possess, use or transfer BSAT contained in a specimen presented for diagnosis, verification, or proficiency testing), an individual or entity must immediately notify the CDC or the Animal and Plant Health Inspection Service (APHIS). The following information must be provided:
(a) The name of the BSAT and any identifying information (for example, strain or other characterizing information). (b) An estimate of the quantity released. (c) The date, time and duration of release. (d) The environment into which the release occurred (for example, in building or outside of building, waste system, and so forth).

(e) The location (installation/activity, building, room) from which the release occurred or where the exposure occurred.

(f) The number of individuals potentially exposed at the entity. (g) Brief description of what happened (for example, spill, needle stick). (h) Actions taken to respond to the release. (i) Hazards posed by the release. (2) The entity should notify the appropriate local and state health agencies. (3) All mishaps reported to CDC or APHIS will be reported concurrently to the first General Officer (or equivalent)
in the mishap reporting chain. If the facility is a tenant on an installation, the mishap will also be reported to the garrison commander. The first General Officer (or equivalent) receiving the report will forward it up the chain of command to the Office of the Director of Army Safety (ODASAF).

(4) In addition, per guidance published by the Office of the Provost Marshal General, a category 1 serious incident report will be submitted for the following BSAT mishaps:
(a) Discharge of BSAT external to the containment laboratory and into the ambient air or environment. (b) Mishaps in which there was direct evidence of an exposure to BSAT, such as a measurable rise in specific antibody titer to the BSAT in question, or a confirmed diagnosis of intoxication or disease.

(5) A completed APHIS/CDC Form 3 must be submitted to the CDC or APHIS within 7 calendar days, with a copy forwarded through the first General Officer in the chain of command to ODASAF.

(6) A close-out report will be submitted to ODASAF with copy furnished through normal command channels after the mishap investigation is complete.

d. Non-BSAT (IAT not characterized as BSAT). (1) Upon discovery of a non-BSAT occupational exposure or release of a non-BSAT outside of the laboratory, an individual or entity must immediately notify the first General Officer (or equivalent) in the mishap reporting chain. Reports will include the information required in paragraph 311c(1), above. If the facility is a tenant on an installation, the mishap will also be reported to the garrison commander. The first General Officer (or equivalent) receiving the report will forward it up the chain of command to the ODASAF. The entity should notify the appropriate local and State health agencies.

(2) A close-out report will be submitted to ODASAF with copy furnished through normal command channels after the mishap investigation is complete.

e. Class A-D accidents, as defined in AR 38510, occurring during biological activities will be reported in accordance with requirements of AR 38510.

f. All biological mishap investigation reports will be shared with the Department of the Army Biological Safety and Health Council (DABSHC) in order to disseminate lessons learned to other Army organizations.

312. Recombinant deoxyribonucleic acid a. When work with recombinant DNA is undertaken, an institutional biosafety committee (IBC) will be established to review recombinant DNA activities and protocols. The IBC will function as stated in the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules.

b. Activities funded by the NIH involving recombinant DNA will comply with all requirements of the NIH
Guidelines for Research Involving Recombinant DNA Molecules and are subject to IBC approval. Facilities conducting work with recombinant DNA that are not funded by the NIH should adopt these guidelines as best practices.

313. Contract acvtivities a. Contracting agencies, or agencies performing safety and health oversight for a contracting agency, will develop and document procedures for reviewing contractors' capability to perform activities with IAT safely in accordance with AR 38510 and this pamphlet.

b. Upon award, the contracting agency or agency performing safety and health oversight will conduct a survey of the contractor's biological safety program to determine if it meets the intent of paragraph 31, above. In addition, the laboratory facilities to be used for Army-contracted IAT activities will be inspected for compliance with safety and occupational health requirements, using the checklist in appendix B as a guide. For contract laboratory facilities working at BSL3 or BSL4, the contracting agency or agency performing safety and health oversight will reinspect the laboratory facilities on a twelve-month basis. Surveys and inspections may be accomplished by a qualified, independent third party using contracting agency approved survey and inspection criteria. Survey and inspection reports will be provided to the contracting officer.

## Chapter 4 Occupational Health

41. Occupational health program a. The Army Occupational Health Program consists of capabilities and activities necessary to identify, assess, and control disease and injury risks to military and eligible civilian personnel from exposures to IAT encountered due to their occupation. These exposures may occur in a clinical laboratory or in a biomedical research setting.

b. The occupational health program is a part of the installation, medical treatment facility, or laboratory biological safety and health program, which encompasses many disciplines and may cut across different Army commands. The occupational health program should address the relevant requirements from AR 405, DA PAM 4011, the occupational health and immunoprophylaxis section of the BMBL, and the other specific elements as they apply to the biological safety program. An occupational health program should be established to ensure that:
(1) Supervisors have identified to the competent medical authority (CMA) the employees' proposed tasks for working with IAT.

(2) Supervisors and biosafety professionals have conducted detailed risk assessments to determine exposure hazards and have communicated those to the CMA and employees.

(3) The CMA has based the content of pre-placement, periodic, and termination medical surveillance examinations on the exposure hazards identified in the risk assessments, and the functional requirements of the job.

(4) The CMA informs the workers as to availability of medical support services, examinations, immunizations, and post-exposure prophylaxes.

(5) The CMA provides licensed vaccines (when available and recommended based on risk assessment and medical opinion) for personnel whose duties may potentially expose them to etiologic agents (see latest recommendations from the Advisory Committee on Immunization Practices, Department of Health and Human Services and the CDC).

(6) The CMA refers employees to the Special Immunization Program (SIP) when risk assessments indicate that the individual may be a candidate to receive investigational new drug (IND) vaccines for possible workplace exposures to IAT.

(7) The CMA conducts periodic workplace visits with biological safety professionals to laboratories with etiologic agents to identify potential workplace hazards.

(8) The CMA, with the assistance of biological safety professionals, annually reviews occupational illness and injury reports to determine if revision of exposure preventions strategies is indicated.

42. Competent medical authority qualifications Medical officers responsible for treating IAT exposures and conducting medical surveillance for personnel working with IAT will receive specialized training on the hazards of IAT and recommended medical therapies, such as the Medical Management of Chemical and Biological Casualties course or the Fundamentals of Occupational Medicine course and may strongly consider the CDC's International Symposium on Laboratory Biological Safety ("Protecting Workers in Clinical Laboratories, Research, Animal Care, and Public Health Communities") based on processes and risk assessments. Medical professionals should have this training to be considered a CMA. A CMA is a physician, physician assistant, or nurse practitioner (military, civilian, or contract), appropriately trained and privileged to provide medical services or clinical evaluations in support of biosafety programs. Physician assistants must be supervised by licensed physicians. Nurse Practitioners must have a licensed physician available for consultation. Delineation of Clinical Privileges - Occupational Medicine DA Form 544053, FEB 2004 Category I Clinical Privileges provides a strong framework for recommended requirements for physicians, which includes the Army Medical Department (AMEDD) Fundamental of Occupational Health Course, 6H-F20 or equivalent. See also definition of CMA in glossary.

43. Medical surveillance examinations a. Pre-placement examinations. Workers who may be exposed to human pathogens should receive a pre-placement medical evaluation. The CMA should be cognizant of chemical, physical, and biological potential hazards encountered by the worker. The supervisor incorporates relevant portions of the risk assessment or job hazard analysis associated with the position, and completes an occupational health survey form (MEDCOM 760 or equivalent) detailing the requirements for the position, the potential exposure hazards, and PPE requirements, and provides this to the CMA
prior to the examination. The CMA should review the worker's previous and ongoing medical problems, current medications, allergies to medicines, animals, and other environmental proteins, and prior immunizations. With that information, the CMA determines the content of the medical surveillance examination and what medical services (for example, serologies, immunizations, and so forth) are indicated to permit the individual to safely assume the duties of the position. Occasionally, it may be useful to review pre-existing medical records to address specific concerns regarding an individual's medical fitness to perform the duties of a specific position. The CMA should determine an individual's vulnerability to infection with specific agents that he or she may be working with as part of the preplacement medical surveillance examination. Some occupational exposures present substantially more hazard to identifiable sub-populations of workers. Immunodeficient workers or non-immune pregnant female workers may experience devastating consequences from exposures that pose a chance of risk to pregnant women with prior immunity and other immunocompetent workers (for example, cytomegalovirus or toxoplasmosis). Where appropriate, the CMA should use serologic testing to document baseline vulnerability to specific infections to which the worker might be exposed, and non-immune workers should be adequately informed about risks. In specific settings, serologic documentation that individual workers have pre-existing immunity to specific infections also may be required for the protection of research animals. During the visit, the CMA should also inform the worker of potential health hazards in the work area and review steps that should be taken in the event of an accidental exposure, and conform to any relevant bloodborne pathogen program requirements described in DA PAM 385-10, chapter 14.

b. Periodic medical surveillance.

(1) The CMA should conduct periodic medical surveillance that includes updating the employee's medical and occupational history from the previous year, reviewing any changes in job activities or exposure hazards, and updating respirator clearances, as required. In special circumstances, it may be appropriate to offer booster immunizations, or periodic laboratory testing to workers with substantial risk of exposure to infectious agents to detect pre-clinical or subclinical evidence for an occupationally acquired infection. Before asymptomatic workers without specific exposures are tested for seroreactivity, the benefit of such testing should be justified, plans for further investigation of indeterminate test results should be delineated, and clearly defined criteria for interpretation of results should be developed.

(2) Workers and support personnel that have been designated or granted approval of facility access during etiological agent operations will be identified, and their risk assessment will be reviewed in conjunction with all occupational health examinations or screenings.

c. Termination examinations.

(1) Employees enrolled in medical surveillance from working in a BSL3 or BSL4 laboratory areas will suspend work in those laboratories 30 days prior to termination to ensure proper medical surveillance.

(2) The CMA performs a termination of employment examination or a termination of exposure examination on individuals within 30 days after the employee's removal from the exposure that requires the medical surveillance. The examination documents the employee's health status at the time of termination, particularly for organ systems that may have been affected by etiologic agent exposure.

(3) The supervisor ensures that a termination examination has been administered or offered to workers who have been enrolled in the medical surveillance program.

d. Post-exposure examinations for occupational illnesses and injuries.

(1) In the event of injury, consultation between the CMA, employee, and the employee's supervisor is required for proper medical management and recordkeeping (mishap and Office of Workers Compensation Program reports and Occupational Safety and Health Administration (OSHA) logs). The supervisor and biological safety officer should report all occupational injuries, including exposures to human pathogens, to the CMA. Strategies for responding to biohazard exposures should be formulated in advance. The CMA should develop exposure-specific protocols that define appropriate first aid, potential post-exposure prophylaxis options, recommended diagnostic tests, and sources of expert medical evaluation. These protocols should address how exposures that occur outside of regular work hours are handled and these protocols should be distributed to potential healthcare providers (for example, local hospital emergency departments) with whom the competent medical authorities have developed external support agreements. The adequacy and timeliness of wound cleansing or other response after an exposure occurs may be the most critical determinant in preventing infection. The CMA should review and define appropriate first aid treatment, and promulgate this information through the appropriate safety or supervisory management chain. Laboratory SOPs should include a printed summary of the recommended medical response to specific exposures that can guide immediate response in the work place and that the injured worker can provide to the treating facility. The CMA's description of the injury should include:
(a) The potential infectious agent. (b) The mechanism and route of exposure (percutaneous, splash to mucous membranes or skin, aerosol, and so forth).

(c) Time and place of the incident. (d) The PPE used at the time of the injury.

(e) Prior first aid provided (for example, nature and duration of cleaning and other aid, time that lapsed from exposure to treatment).

(f) Aspects of the worker's personal medical history relevant to risk of infection or complications of treatment. (2) In some instances, it may be possible to prevent or ameliorate illness through post-exposure prophylaxis. The CMA should develop protocols in advance that clearly identify the situations in which post-exposure prophylaxis are to be considered, the appropriate treatment, and the source of products and expert consultation within (and outside) the Army Medical Department (AMEDD). Post-exposure regimens may involve off-label use of licensed products (for example, use of smallpox vaccine for workers exposed to monkey pox) in settings where there is insufficient experience to provide exact guidance on the safety or likely protective efficacy of the prophylactic regimen. Thus, protocols should exist that delineate the circumstances under which it would be appropriate to consider use of each product following exposure, as well as the limits of our understanding of the value of some post-exposure interventions. In these cases, consultations with subject matter experts are especially useful. Appropriate post-exposure prophylactic response is always pathogen- and exposure-dependent, may be host-factor dependent, and may also be influenced by immediate post-exposure management. Before prophylactic treatment is undertaken, the CMA should confirm the likelihood that an exposure occurred, that prophylaxis is indicated and is not contraindicated by past medical history. Conveying this information to the injured worker requires clear, honest communication. The clinical risk assessment and treatment decision process, and the medical follow-up plan, should be carefully explained and documented in the medical record. Each incident should receive prompt reconsideration of the initial risk assessment and reevaluation of current strategies to reduce the possibility of future exposures.

e. Documentation of medical opinion. The CMA records a written opinion in the medical record for each medical surveillance examination. This opinion includes:
(1) The results of the medical examination and testing. (2) A statement about any detected medical condition that would place the individual's health at an increased risk of impairment if exposed to etiologic agent.

(3) Any recommended limitations on the potential exposure to etiologic agent or on the use of PPE. (4) A statement that the employee has been informed of the above.

44. Health hazard education a. Supervisors. Supervisors will ensure that health care providers are made aware, at the time of the medical examination, of all hazardous substances with which each employee works. The CMA's findings will include assessment of whether an employee has any health condition that would preclude work with etiologic agent. If any of the findings obtained during the examination are outside the normal range, the employee will be notified and counseled on the courses of action available. The employee's supervisor will be notified of any duty limitations. In addition, a safety and health audit will be conducted to identify any potential occupational causes for the abnormalities, and corrective measures will be taken if applicable.

b. Employee health education.

(1) *Employee health training.* The CMA should review and provide input on employee-training materials, local plans, policies or procedures dealing with the health effects or treatment aspects of etiologic agent exposure, patient or skin decontamination procedures, use of respiratory, ocular or dermal protective equipment to protect against etiologic agent exposure, and all first aid practices. The CMA should conduct and document (for example, memorandum for record) this review on an annual basis.

(2) *Access to health education materials.* The biosafety officer ensures that a copy of health education materials used in the employee training programs are readily available to all individuals with an exposure potential to etiologic agents. Consider should be given to co-location of these documents with MSDSs used in the laboratory.

45. Immunoprophylaxis
a. Competent medical authorities offering immunoprophylaxis as a means of personal protection will develop a
written immunoprophylaxis program and SOPs. SOPs will address procedures for vaccine administration, follow-up, and recordkeeping.
b. Written immunoprophylaxis programs will address the following: (1) Identification of personnel responsible for development and administration of the program. (2) Requirements for higher-headquarters oversight and program approval. (3) Responsibilities and criteria for determining personnel to receive vaccines. (4) Requirements and recommendations for specific vaccines. (5) Requirements and procedures for informing employees of vaccine requirements and recommendations, benefits/
risks of vaccines, and possible systemic reactions.
(6) Requirements and procedures for employees to notify immunization program administrators, supervisors, or the
CMA of changes in the status of their health and of possible systemic reactions.
(7) Recordkeeping requirements.
c. Immunoprophylaxis programs will be reviewed and approved by the medical treatment facility or institute commander/director.

d. Recommendations for the use of vaccines are contained in the following documents (these documents shall be consulted for current recommendations):
(1) Biosafety in Microbiological and Biomedical Laboratories (most current edition), U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health, U.S. Government Printing Office, Washington.

(2) Centers for Disease Control and Prevention, General Recommendations on Immunization Recommendations of the Advisory Committee on Immunization Practices (ACIP), most recent edition.

e. Recordkeeping requirements. (1) All immunizations, to include lot number and date of manufacture, and related laboratory data will be documented in the employee's occupational health record and the recommended DOD approved electronic immunization tracking record, for example, Medical Protection System (MEDPROS) for Army (see reference AR 40562, para 27a(1)).

(2) Vaccine reactions and untoward effects will be reported and documented in accordance with medical treatment facility policy.

f. Special Immunization Program. (1) The SIP was established so that vaccines would be available and controlled in order to provide an additional level of protection to at-risk individuals involved in biological defense activities. The SIP utilizes Food and Drug Administration licensed vaccines as well as unlicensed vaccines given under IND protocols. The U.S. Army Medical Research and Materiel Command is the proponent for the SIP.

(2) Immunization with a licensed vaccine, or a statement of declination from the individual, may be required as a prerequisite for working with certain biological agents. Licensed vaccines are currently available for anthrax, hepatitis B, Japanese encephalitis, rabies, smallpox, and yellow fever. Required immunizations will be administered by local medical facilities or a means will be made available to provide them without cost to the employee or defined in contacts.

(3) Due to the investigational, unlicensed status and the limited availability of vaccines given under IND protocols, immunization with an IND vaccine is strictly voluntary and is limited to those individuals to whom the risk of their use has been fully analyzed and justified. Vaccines given under IND protocols are only to be used to provide an additional level of protection, and are not to be used in lieu of safe laboratory practices, agent containment, or PPE. Vaccines given under IND protocols are currently available, in limited supply, for Botulinum toxin, Eastern equine encephalitis virus, Rift Valley fever virus, Venezuelan equine encephalitis virus (TC 83), Venezuelan equine encephalitis virus (C 84), and Western equine encephalitis virus.

(4) In order to avoid placing individuals at undue risk and to ensure the continued availability of SIP vaccines, individuals will not be enrolled in the SIP unless the following criteria are met:
(a) The hazard analysis/risk assessment (completed by the individual's supervisor and endorsed by the agency Safety Manager) of the activity presenting the potential exposure lists, as a hazard of the activity, one or more of the twelve etiological agents for which a SIP vaccine is available and justifies use of the SIP vaccine as an added level of protection.

(b) The individual has been informed by qualified medical personnel of the purpose, benefits, and risks (and possible side effects including those resulting from interaction of the vaccine with other drugs or treatments being administered to the individual) of the specific SIP vaccine and the individual consents to participation in the SIP.

(5) If an IND is to be used, the individual has been informed by qualified medical personnel that the vaccine is an IND and provided specific information on whether the IND is approved by the Food and Drug Administration and/or whether it is unapproved for its applied use.

(6) When requesting enrollment or re-enrollment in SIP, documentation showing satisfaction of the above requirements, along with a copy of the applicable research protocols, will be provided to the SIP program coordinator at the U.S. Army Medical Research and Materiel Command. Medical records for individuals enrolled in SIP will accurately document the receipt of SIP vaccines and satisfaction of the above criteria. Medical records should be maintained for the duration of employment plus thirty years.

46. Illness and absence monitoring a. Personnel enrolled in the medical surveillance program who have an unplanned absence from the workplace should be contacted by the supervisor that day to rule out an occupational-related concern. Personnel absent three or more work days due to a medical condition should be evaluated and cleared by occupational health prior to resumption of duties.

b. Personnel who are enrolled in the medical surveillance program may be required to report all illnesses, health care received, and medication use to the CMA, regardless of whether or not it led to absence from the workplace. The CMA will make recommendations to the supervisor on the disposition of the employee.

c. Supervisors, in coordination with safety and occupational health subject matter experts, should address in SOPs the need for "illness contact cards" based on the activity's risk assessment. If it is determined that employees will be issued "contact cards", the process will be described in the SOPs and cards made available for the employees.

d. Occupational health in the BSL4 setting. Work with BSL4 agents involves special challenges for occupational health. Infections of laboratory staff by such agents may be expected to result in serious or lethal disease for which limited treatment options exist. In addition, BSL4 agents are frequently geographically exotic to the areas in which high containment labs are located but produce immediate public health concern if infections occur in laboratory staff. Potential (if unlikely) transmission from infected staff into the human or animal populations in the areas surrounding the laboratories may raise such concerns to higher levels. Thus, SOPs for BSL4 settings require special attention to management of unexplained worker absence, including protocols for monitoring, medical evaluation, work-up, and follow-up of workers with unexplained nonspecific illness. Advance planning for the provision of medical care to workers potentially infected with BSL4 agents is a fundamental component of an occupational health program for a BSL4 facility.

47. Fitness for duty a. Supervisors will assure that employees are referred for required job-related medical surveillance. b. The CMA should conduct or coordinate medical surveillance and health hazard training for military and civilian employees potentially exposed to work-related hazards, and evaluate employees in positions requiring specific standards of physical fitness.

c. Guidelines from DOD 6055.05M C1.4.7 should be considered. Where promulgated medical standards may not address all conditions that may influence safe worker health, physical standards or deficiencies may be documented by the CMA. These deficiencies may need to be communicated to the local management level by the worker and CMA for decision of waiver. Waivers are an administrative and human resources process that may require detailed medical input. An example could be an employee with a recent seizure history or high risk cardiovascular disease, where working in a BSL3 or BSL4 laboratory could pose increased risk from incapacitation or delays in receiving medical care. Supervisors and human resource staff should be advised of the increased risks and determine if it can be accommodated or waived.

## Chapter 5 Facility Safety Controls

51. Facility design (secondary barriers)
The design of the facility is important in providing a secondary barrier to protect individuals inside and outside the facility. Facility requirements for each BSL are outlined in the BMBL.

a. Prior to selecting facility equipment, an evaluation of the function of the equipment should be made, and the methods for testing and decontamination will be analyzed and documented.

b. The BSL3 and BSL4 facilities shall be commissioned using criteria set forth in appendix C. c. If laboratory mission requirements dictate operations or substances not suited to the existing facilities or equipment, the laboratory supervisor will, assisted by the safety or biosafety officer, advise and assist the laboratory worker in developing or obtaining adequate facilities or equipment and designing appropriate work procedures, prior to work commencing.

52. Large scale facilities Large-scale facilities and laboratories will be designed in accordance with requirements described in appendix K, Physical Containment for Large Scale Uses of Organisms Containing Recombinant DNA Molecules of the NIH Guidelines for Research Involving Recombinant DNA Molecules. These guidelines are written for cultures of viable organisms containing recombinant DNA molecules, however Army research and production will follow these regardless of whether the IAT has recombinant DNA.

## Chapter 6 Safety Equipment (Engineering Controls - Primary Containment)

61. General Safety equipment includes primary barriers such as biological safety cabinets and chemical fume hoods and other enclosed containers (for example, the safety centrifuge cup) and are the primary means of protecting personnel and the environment from exposure to IAT.

a. Engineering Controls Certification. (1) Local, State, and Federal emissions standards will be met during use and certification.

(2) Biosafety cabinets (BSCs) will be certified annually and after repair, movement, maintenance or filter change.

(3) Class II BSCs must conform and be certified to meet National Sanitation Foundation (NSF)/American National Standards Institute (ANSI) 49 for the applicable type of cabinet. Cabinets will be tested according to NSF/ANSI 49 and the manufacturer's recommendations after installation and before use, annually thereafter, and whenever high efficiency particulate air (HEPA) filters are changed, whenever maintenance repairs are made to internal parts, whenever cabinets are moved, and whenever changes are made to the heating, ventilating, and air conditioning (HVAC) system, equipment or room geometry which could affect the cabinet's performance. Certification and testing must be performed by experienced, qualified personnel. It is strongly recommended that, whenever possible, accredited field certifiers are used to test and certify BSCs .

b. All individuals using engineering controls will be trained in their use and will demonstrate both an understanding and skill to use these devices properly and safely.

c. The BSC requirements are outlined in the BMBL. Requirements for other types of engineering controls are discussed below.

d. The BSC internal electrical outlets must be protected by ground fault circuit interrupters and should be supplied by an independent circuit. When propane or natural gas is provided, a clearly marked emergency gas shut-off valve outside the cabinet must be installed for fire safety. All non-electrical utility services should have exposed accessible shut-off valves. The use of compressed air within a BSC must be carefully considered and controlled to prevent aerosol production and reduce the potential for vessel pressurization. Additional guidance on the design, selection, function and use of BSCs is contained in "Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets" available from the U.S. Department of Health and Human Services.

62. Laboratory chemical hoods Laboratory chemical hoods are designed to contain chemical vapors, gases, and fumes within the hood, thereby reducing airborne chemical exposure to workers. Conventional laboratory chemical hoods must not be used for biological hazards/infectious agents (work with toxins is allowed). For example, they are not HEPA filtered to protect the environment from IAT aerosols and they do not provide product protection from contaminated air within the room.

a. Laboratory chemical hoods will meet all three performance criteria specified in table 61. b. Laboratory chemical hoods used with toxins will be provided with an audible alarm to give a warning should the ventilation system fail or the hood face velocity fall below an average of 80 linear feet per minute (lfpm).

c. Hood certification tests will be conducted at least annually and whenever the system has undergone repairs, maintenance, filter change or a significant change has been made to the operational characteristics of the system.

63. Glove boxes A glove box is an enclosure that provides a positive barrier from liquids, solids, aerosols, and chemical vapors. The box maintains personnel protection through solid barriers and maintenance of a negative pressure relative to its surroundings. Glove boxes are used when extreme containment is needed for IAT and highly toxic chemicals, especially for substances that can be swept out of containers by the airflow in hoods. Glove boxes must not be used with volatile flammable materials and should not be used for volatile toxic materials unless dilution ventilation is provided.

a. The glove box will be maintained at a pressure of at least 0.25 inches water gauge less than its surroundings when all openings are closed, and at least 100 feet per minute (fpm) inward air velocity when the largest operating opening is open. A manometer or magnehelic gauge will indicate the pressure differential. Indicator devices will display a loss of pressure below 0.25 inches water gauge.

b. Gloves will be changed at appropriate intervals (dependent on the box contents) to ensure they provide the protection needed.

c. Inlets that provide dilution air will be protected by appropriate filtration.

## Laboratory Chemical Hood Performance Criteria

| Performance Criteria                                                                                       |
|------------------------------------------------------------------------------------------------------------|
| 1 - Hood face velocity                                                                                     |
| 2, 3, 4, 5                                                                                                 |
| Each hood shall have an average face velocity of 80-120 fpm through the "working opening," with no         |
| point velocity measurement used to compute the average face velocity deviating more than 20% from          |
| the average face velocity.                                                                                 |
| 2 - Cross-drafts at the face of                                                                            |
| the hood                                                                                                   |
| With the hood exhaust off (or with the hood sash closed), the average velocity of air currents at the face |
| of the hood shall not exceed one-third the average face velocity.                                          |
| 3 - Hood containment aerosol                                                                               |
| tests                                                                                                      |
| 1, 2, 3                                                                                                    |
| Sash in static positions: no visible aerosol (for example, smoke) shall escape from the face of the hood   |
| with someone standing in front of the hood and smoke source, all along the "working opening," with the     |
| sash in the minimum and maximum "working opening" position.                                                |

## Table 61 Laboratory Chemical Hood Performance CriteriaContinued

Sash movement effect: no visible aerosol (for example, smoke) shall escape from the face of the hood with someone standing in the front and center of the hood working opening and smoke source, while the sash is raised from the minimum "working opening" position to the fully open "working opening" position, and lowered from the fully open "working opening" position to the minimum "working opening" position. The sash will be raised and lowered in a smooth motion at a rate of between 1.0 feet per second (fps) and 1.5 fps.

Notes:
1 During hood containment aerosol tests, the smoke source must be placed inside the hood at the required minimum source-to-sash working distance, which should be demarcated (for example, with paint or tape).

2 The "working opening" should be limited by sash stops (for example, spring loaded) if there are other positions whereby the above criteria (for example, face velocity, cross drafts, hood containment aerosol tests) cannot be met.

3 When volatile chemicals having low parts per billion (ppb) occupational exposure limits are used inside laboratory chemical hoods, even when hoods meet all three-performance criteria, air sampling and medical surveillance should be conducted initially for several days during an operation when such chemicals are not sufficiently dilute.

4 The maximum permissible average face velocity of 120 feet per minute (fpm) need not be observed if any of the following are met: An American National Standards Institute/American Society of Heating, Refrigerating and Air-Conditioning Engineers (ANSI/American Society of Heating, Refrigeration, and Air Condition Engineers, Inc (ASHRAE) 110-1995 hood performance test has been conducted and where a control level of 4 AM 0.01 or 4 AI 0.05 or 4 AU 0.1 has been demonstrated at the working opening used during procedures (AM, AI, and AU are abbreviations for "As Manufactured," "As Installed," and "As Used"). If using 4 AM 0.01 as evidence that the hood performance is acceptable, then the average velocity of the cross drafts at the hood face must not exceed one-third the average face velocity in the laboratory where the hood is installed. Only chemicals having occupational exposure limits (for example, threshold limit value (American Conference of Governmental Industrial Hygienists (ACGIH)), permissible exposure limit (OSHA), airborne exposure limit) are used within the hood until it has been proven (by an Industrial Hygienist) that exposures will not exceed occupational exposure limits.

5 The maximum permissible average face velocity of 120 feet per minute (fpm) need not be observed if any of the following are met: The hood meets all of the performance criteria (for example, face velocity, cross drafts, and hood containment aerosol tests) with the sash in the minimum and maximum "working opening" position, except that the average face velocity exceeds 120 fpm at the minimum "working opening" position, and either of the following has been met: Personal air sampling conducted or supervised by an Industrial Hygienist has clearly proven that exposures are less at the minimum "working opening" position than at the maximum "working opening" position. Lowering the sash height causes the average face velocity to exceed 120 fpm, yet an Industrial Hygienist or Safety Professional has determined that a safety hazard (for example, potential of a splash hazard, runaway reaction, fire, and so forth) exists with a particular operation which has significant injury consequences. If an Industrial Hygienist has determined that the potential for increased airborne vapor concentrations outside the hood is not of any health significance, then the Industrial Hygienist may provide for an exception to the maximum average face velocity requirement of 120 fpm while that particular operation is in progress.

64. Ventilated balance enclosures A ventilated balance enclosure is a box that surrounds a balance and has a small open area for access and handling material in the front. Air is exhausted out the rear of the enclosure. A ventilated balance enclosure is used when containment of a balance is required to weigh hazardous materials that have a low vapor pressure (such as toxins). These enclosures are also used when it is best to use the balance in other than a laboratory chemical hood (due to the turbulence and vibration) and when biological safety cabinets or glove boxes are inappropriate or unavailable. Dry forms of toxins may be weighed in these enclosures. Volatile or highly toxic volatile materials must not be handled in ventilated balance enclosures unless they are placed in closed containers in a properly functioning laboratory chemical hood before being transferred to the balance enclosure.

a. The flow through the openings in the enclosure will be at least 60 lfpm and must average between 60 and 80
lfpm.

b. Containment will be certified prior to first use and annually thereafter by smoke tubes. c. The airflow will be certified initially and annually by averaging readings taken from the face of the opening.

65. Ventilated cage enclosures Ventilated cage enclosures are used to house animals at levels corresponding to the various classes of biological safety cabinets. A brief description of four different types of ventilated animal cages is given below. This is not a complete description of all the different ventilated animal cages available. The proper functioning of these will be tested initially, upon each connection to exhaust sources, and at least annually. The inward flow rates on the partial containment systems and pressure checks on the total containment cages will be performed.

a. Filter-top cages are small laboratory animal polystyrene or polycarbonate cage bottoms fitted with a dome shaped glass fiber or polyester filter cage cover. The dome shaped filters help reduce the dissemination of aerosols. Adequate ventilation around cages fitted with a dome shaped filter is essential since they may contain elevated ammonia and carbon dioxide levels, and high temperature and humidity. Ventilation recommendations in the National Research Council Guide for the Care and Use of Laboratory Animals (latest version) will be followed.

b. A forced ventilation cage is a small HEPA filtered animal cage connected to a centralized exhaust system. A
minimum airflow of 0.03 cubic meters per minute (m3/min) per cage is required. Ventilation rates may vary with the size of the cage, and the number and type of animals being housed.

c. A cubicle-type isolation cage is a partial containment unit that holds several animal cages. This unit is a negative pressure HEPA filtered stainless steel cage. A minimum airflow of 0.3 m3/min per cage is required for a 0.24 cubic meter (m3) unit. Ventilation rates may vary with the size of the cage and the number and type of animals being housed.

d. A total containment cage is a negative pressure or positive pressure HEPA filtered stainless steel cage that has the filters incorporated into the design. It is halogen gas leak tight and can be considered a class III biological safety cabinet. A minimum airflow of 0.3 m3/min per cage is required for a 0.24 m3 unit. Ventilation rates may vary with the size of the cage, and the number and type of animals being housed.

66. Ventilated cage areas Ventilated cage areas are areas within a room that have solid walls for containing multiple cages housing infected or intoxicated animals. The containment for these areas is equivalent to the class I biological safety cabinet. Smoke tests will be performed annually to verify containment.

## Chapter 7 Biosafety Practices

71. General practices for infectious agents and toxins Biological facilities will develop or adopt a laboratory biosafety manual based on the recommendations found in the latest edition of the BMBL. The following are Army specific requirements that must be included in facility safety plans or biosafety manuals.

a. Hallways and stairways will not be used for storage. b. Labeling. (1) *Chemicals.* All solutions and reagents will be labeled in accordance with local policy. When working with chemicals, operators will be knowledgeable of their hazards.

(2) *Infectious agents and toxins.* All primary or secondary containers will be labeled with contents (for example, the rack containing 100 microfuge tubes with the same culture can be labeled instead of the individual tubes).

c. Storage. (1) Equipment used to store IAT (for example, freezers and refrigerators) will be labeled with the universal biohazard sign and indicate the IAT identity and BSL contained in them.

(2) Refrigerators, deep freezers, and dry ice chests will be inspected periodically for integrity of any ampoules, tubes, or other vessels stored. Refrigerators and deep freezers will be defrosted and cleaned out in accordance with the manufacturer's recommendations and when broken ampules/tubes are found or spills visible.

(3) Flammable solutions, required to be kept cold, will be stored in approved laboratory safe refrigerators or freezers.

d. Emergency eyewash and shower equipment will be installed, used, inspected, tested and maintained in accordance with ANSI Z358.1, latest edition.

72. Additional techniques applicable to work with infectious agents and toxins The major objective of these techniques is to assist in protection against laboratory acquired infections. Air sampling studies have shown that aerosols are generated from most of the manipulations of bacterial and viral cultures common to research laboratories. The generation of aerosols during routine laboratory manipulations must be considered when evaluating the individual degree of risk, keeping in mind the four main factors governing infection: dosage, virulence of the organism, route of infection (for example, skin, eyes, mouth, lungs), and host susceptibility (for example, state of health, natural resistance, previous infection, response to vaccines and toxoids). The requirements stated below are minimum handling requirements to prevent accidental infection created by incidental aerosols.

a. Centrifuges and shakers. (1) Centrifuges will be on a preventive maintenance program as recommended by the manufacturer. (2) Before centrifuging, tubes, rotors, seals, and gaskets will be checked for cleanliness and integrity. Tubes that show cracks of stress marks shall not be used. Seals on safety buckets and rotors shall be inspected prior to use.

(3) Centrifuge safety cups or sealed rotor heads will be used for all centrifugation in the open laboratory, and must be loaded and unloaded in a biological safety cabinet or equivalent.

(4) Decanting from centrifuge tubes will be avoided. If decanting is necessary, the outer rim will be wiped with a disinfectant after decanting so that material on the lip cannot spin off as an aerosol.

(5) Centrifuge tubes will not be filled beyond the level the manufacturer recommends. Ensure that the load is balanced prior to centrifugation.

(6) Employees will be trained on proper use and care of centrifuges and the owner's manual will be available to provide safety and other relevant information.

b. Broth cultures will be shaken in a manner that avoids wetting the plug or cap. Plugs or caps must be removed in a biological safety cabinet in the event that they become contaminated.

c. Since disinfectants vary, instructions on water bath disinfection will be incorporated into the lab specific biosafety manual to identify appropriate anti-microbial disinfectants against the agent and change frequency.

d. Care should be exercised when using membrane filters to obtain sterile filtrates of viable IAT. Due to the fragility of the membranes and other factors, such filtrates cannot be considered noninfectious until laboratory culture or other tests have proven their sterility.

e. Work with dry powders of IAT in open containers should be carried out in gas-tight biological safety cabinets.

Dry powders in open containers may also be manipulated in a glove bag within a BSC, in a BSC or chemical fume hood with proper respiratory protection or in other ways as determined by a risk assessment.

73. Operations with radioactive material Operations combining IAT with radioactive material present unique problems. When this is the case, the following apply.

a. A radiation program meeting the requirements of DA Pam 38524 and Nuclear Regulatory Commission (NRC)
standards for the radionuclide U.S. Department of Energy 10 CFR Part 20 is required and will be implemented. The requirements for acquisition, handling procedures, labeling, storage, training, monitoring, and disposal will be described in an organizational policy document.

b. The Radiation Safety Officer (RSO) will approve all SOPs involving the use of radioactive materials. Laboratory operators must be fully trained, with annual training updates as required by the existing license.

c. Special situations. (1) Radioactive waste must be segregated, labeled and disposed of as such after the etiological agent has been decontaminated. Radiological material must not be autoclaved. Do not mix non-radioactive waste with radioactive waste as the disposal of radioactive waste is much more complex and expensive. When Resource Conservation and Recovery Act (RCRA) listed chemicals are mixed with radioactive waste, it becomes "mixed waste" which must be disposed of in accordance with all applicable federal and state regulations.

(2) Use of radioisotopes should be confined to the smallest number of areas or rooms consistent with requirements. (3) Decontamination methods specific to IAT will not always remove residual radioactivity. The RSO should be consulted for appropriate decontamination methods, such as specialized detergents and solvents designed for this use.

74. Certification of inactivated microorganisms a. For the purpose of this pamphlet the word "inactivated" means that a microbiological sample is free from living organisms, including spores. The organisms are nonviable and cannot under any circumstance be viable (infectious). Prior to working with inactivated organisms, the laboratory supervisor shall obtain a written statement that the microorganisms have been killed. (Certification of inactivated organisms is not required for Food and Drug Administration (FDA) cleared assays and kits.) The statement will include the following:
b. Name of supplier. c. Date the microorganisms were killed (sterilized). d. Method of sterilization. e. The test procedure performed by the supplier on the sample and the control to ensure there were no infectious microorganisms in the sample.

f. Date of the test.

75. Working with vertebrate animals a. If experimental animals are used, the facility biological safety program and appropriate SOPs will address hazards a n d  c o n t r o l s  a s s o c i a t e d  w i t h  a n i m a l s .  S p e c i a l  c o n s i d e r a t i o n s  m a y  i n c l u d e  a e r o s o l  g e n e r a t i o n ,  a n i m a l  b i t e s  a n d scratches, and working with animals infected with zoonotic disease or intoxicated. Consult the Occupational Health and Safety in the Care of Research Animals (National Academy Press, Washington, DC) for additional information.

b. Laboratory animal facilities, operational practices, and animal care will meet the following requirements: (1) National Research Council Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC).

(2) Laboratory animal welfare regulations of the U.S. Department of Agriculture, 9 CFR, Subchapter A, Parts 1, 2, and 3.

76. Working with invertebrate vectors and hosts Facility standards and practices for invertebrate vectors and hosts can be found in Laboratory Safety for Arboviruses and Certain Other Viruses of Vertebrates, published by the American Committee on Arthropod-Borne Viruses, Subcommittee on Arbovirus Laboratory Safety. 1980. American Journal of Tropical Medicine and Hygiene 29 (6): 13591381.

## 77. Specific Requirements For Biosafety Level 4 In Addition To Requirements Listed In The Bmbl, U.S. Army Bsl4 Facilities Will Meet The Following Requirements:

a. Laboratory staff members are supervised by competent scientists who are trained and experienced in working with these agents.

b. All activities involving Risk Group 4 agents (see BMBL) will be conducted in class III biological safety cabinets or in class I or II biological safety cabinets in conjunction with a one-piece positive pressure personnel suits ventilated by a life-support system.

c. No materials, except for biological materials that are to remain in a viable or intact state, are removed from the maximum containment laboratory unless they have been autoclaved or decontaminated before they leave the facility. Equipment or material, which might be damaged by high temperature or steam, is decontaminated by gaseous or vapor methods in an airlock or chamber designed for this purpose.

d. Supplies and materials entering or exiting maximum containment areas present unique hazards. Each institution must have an approved SOP detailing methods and procedures for the movement of various types of materials (paper, heavy equipment, cages, PPE, and so forth) in and out of maximum containment areas.

e. If water fountains are provided in a cabinet laboratory, they will be foot operated and located in the facility corridors outside the laboratory.

f. A ventilation system that is dedicated to the BSL-4 laboratory and provides fresh air meeting ASHRAE Standard
62.

g. The BSCs are tested and certified at the time of installation, at least annually thereafter, or whenever HEPA
filters are damaged, maintenance repairs made to internal parts or the cabinet is moved. If the filtered cabinet exhaust is discharged through the building exhaust system, it will be connected to this system in a manner that avoids any interference with the air balance of the cabinets or the building exhaust system. Note: class II Type B1 and B2 BSCs must be hard-ducted/directly connected to the exhaust system to function properly and cannot use a thimble unit.

h. The BSL-4 animal areas may be included as an integral part of BSL-4 Cabinet laboratories or Suit laboratories.

The facility requirements for a BSL-4 Laboratory should be utilized in conjunction with Animal BSL-4 (ABSL-4) facility requirements listed in the BMBL.

78. Toxins The following requirements in addition to those listed in the BMBL apply to the use of toxins of biological origin.

a. Two knowledgeable individuals will be present in the laboratory during high-risk operations involving dry forms of toxins, intentional aerosol formation, or the use of hollow-bore needles in conjunction with amounts of toxin estimated to be lethal for humans. One individual is to conduct the high-risk activity, the other to act as a safety observer and emergency responder in the event of an incident.

b. All facilities in which toxins are used will: (1) Have a ventilation system that provides a negative pressure in the laboratory room (a directional airflow inward relative to the access halls).

(2) Have a quick-drench shower readily available within the facility and in accordance with the latest edition of ANSI Z358.1, American National Standard for Emergency Eyewash and Shower Equipment.

c. Glove box or class III BSC and toxin use . (1) All items inside the glove box or class III BSC will be decontaminated upon removal. Materials such as experimental samples that cannot be decontaminated directly will be placed in a closed secondary container, the exterior of which will be decontaminated. Secondary containers will be labeled appropriately immediately upon removal from the glove box or class III.

(2) The interior of the glove box or cabinet and all items will be decontaminated periodically, for example, at the end of a series of related experiments. Until decontaminated, the box or cabinet will be posted to indicate that toxins are in use, and access to the equipment and apparatus restricted to necessary, authorized personnel.

d. It should be noted that laboratory safety precautions appropriate for handling toxins closely parallel those for handling non-volatile hazardous chemicals.

79. Integrated pest management Clinical laboratories and biomedical research facilities will institute an effective integrated pest management (IPM) program to identify, and control the infestation by and harborage of, animal or insect vectors or pests. See AR 2001 and AR 405.

## Chapter 8 Personal Protective Equipment

81. General a. Personal protective equipment (PPE) includes clothing and equipment used to protect the laboratory worker from contact with infectious, toxic, and corrosive agents, as well as excessive heat, fire, and other physical hazards. The appropriate PPE for any activity depends upon the proposed operations and the potential hazards associated with that activity. While PPE is an important item of personal protection, it serves as only a secondary line of protection against hazards in the workplace laboratory. Engineering controls, combined with common sense, education, experience, good microbiological practices, and adherence to SOPs, are the primary barriers to exposure. There are some situations, however, in which it is either impractical or impossible to rely exclusively on engineering controls and microbiological practices.

b. The PPE including equipment for the eyes, face, head, and extremities, protective clothing, respiratory devices, and protective shields and barriers, shall be provided by the employer at no cost to the employee and shall be used and maintained in a sanitary and reliable condition. PPE shall be utilized wherever it is necessary by reason of hazards of processes or environment, chemical hazards, radiological hazards, or mechanical irritants encountered in a manner capable of causing injury or impairment in the function of any part of the body through absorption, inhalation, or physical contact. All PPE will be of safe design and construction for the work to be performed and will properly fit employees. Defective or damaged PPE will not be used.

c. The PPE selection will be based on a risk assessment and at a minimum will be closed toed shoes in addition to the requirements listed in the BMBL to provide the appropriate level of protection to affected employees from the identified hazards. Supervisors will verify that the required risk assessment has been performed and documented. The risk assessment showing the PPE selection decisions will be available and communicated to each affected employee.

d. Each affected employee will demonstrate an understanding of the training and the ability to use PPE properly before being allowed to perform work requiring the use of PPE. When a supervisor or safety and occupational health professional believes any trained employee does not have the requisite understanding of the training and ability to use PPE properly, the employee will be retrained.

82. Specific requirements for individual personal protective equipment a. Eye and face protection. Eye and face protection will meet or exceed the requirements of ANSI Z87.1, Occupational and Educational Personal Eye and Face Protection Devices, latest version. Special eyewear may be required when working near ultraviolet (UV) light source and lasers.

b. Gloves. Users will examine prior to each use and replace or change as necessary during operations.

c. Class III BSC Gloves. Users will inspect gloves prior to each operation and after each sterilization.

d. Laboratory clothing. Users will check clothing before wearing it to ensure that it is free from defects that would compromise its usefulness. Laboratory clothing will not be released for laundering from the laboratory until decontaminated or until a risk assessment has been performed to show there is an acceptable low risk of contamination.

e. One-piece positive pressure suits. Suits will be inspected before each use to check for indications of significant wear or leakage. A life-support system will be provided with alarms and emergency backup breathing tanks. The air provided will meet OSHA breathing air requirements found in 29 CFR 1910.134. A HEPA filter will be in-line between the disconnect on the suit and the breathing space in the suit. When these are used in other than an emergency situation, a chemical shower must be provided to decontaminate the surfaces of the suit as the worker leaves the containment area. The suits will be worn with impervious boots over the foot area of the suit and the outer gloves will be attached over the hand portion. Suits maintained for emergency use will be inspected at least quarterly and respiratory equipment will be inspected monthly.

f. Respiratory protection equipment. When respirators are used, a respiratory protection program will be established that conforms to AR 11-34, DA Pamphlet 40-503, and 29 CFR 1910.134.

## Chapter 9 Import, Export, Transportation, And Transfer Of Infectious Agents And Toxins

91. General Commanders and institute directors will establish controls to ensure that IAT are transported or transferred with proper authorization, controls, and procedures.

92. Transportation, and transfer of infectious agents and toxins a. Shipping unlabeled or improperly packaged IAT is prohibited. All IAT will be packaged for shipment according to applicable current Department of Transportation (DOT), International Civil Aviation Organization Technical Instructions (ICAO TI) on the Safe Transport of Dangerous Goods by Air , and International Air Transport Association (IATA) packing instructions.

b. Infectious substances will be packaged, shipped and transported according to the requirements (as applicable)
found in DOD 4500.9-R, Defense Transportation Regulation, Part II, Section 204, Hazardous Material and Army policy.

c. All personnel who certify a shipment of infectious substances will be trained in accordance with Section 204 of DOD 4500.9-R.

## Chapter 10 Decontamination And Disposal Of Infectious Agents And Toxins

101. General All material or equipment that is potentially contaminated with IAT must be rendered non-hazardous before disposal. In general, all contaminated materials and equipment or apparatus will be decontaminated before being washed and stored or discarded.

a. Consult with installation legal counsel regarding local, federal, state or host country safety, health and environmental requirements for necessary approvals (for example, the use of formaldehyde may require a permit from the Environmental Protection Agency (EPA) or a state agency).

b. Follow decontamination requirements listed in the latest version of the BMBL.

102. Methods of decontamination a. Autoclave.

(1) *General.* The use of wet heat and high pressure is the most dependable procedure for destroying all forms of microbial life. In addition to being effective for viable agents, autoclaving effectively inactivates most protein toxins.

(2) *Validation.* Sterilization will be verified using biological indicators (for example, Bacillus stearothermophilus
(Geobacillus stearothermophilus) spores) at locations throughout the autoclave, to include placement in the center of test loads, when the autoclave is first put into service, after any maintenance or repairs, and on a monthly basis. Each autoclave sterilization operation will be verified through the use of chemical indicators (for example, autoclave tape, labels, or strips) at locations throughout the autoclave and an autoclave thermometer capable of indicating the maximum temperature of the operation. In addition, each autoclave will be equipped with a permanent means to record time and the temperature of each operational event as a means of ensuring sterilization. The type of materials, volume, contamination level and other factors of materials being autoclaved must be reviewed and standard conditions for sterilization must be established. As a guide, the manufacturer's manual for the autoclaves will be consulted as a starting point in establishing these conditions. In each case, the conditions will be established based on tests, which verify that the conditions selected are effective.

b. Dry Heat. Dry heat requires longer times and/or higher temperatures than wet heat requires. If used, the specific sterilization times and temperatures must be determined for each type of material being sterilized. In general, sterilization by dry heat can be accomplished at 169-170 degrees Celsius (o C) for periods of 2 to 4 hours. Higher temperatures reduce the time requirements. The heat transfer properties and spatial relation or arrangement of materials in the load are critical in ensuring effective sterilization.

c. Liquids.

(1) If used as a disinfectant, liquids must be proven effective against the organism or toxin in use. Liquid disinfectants will be made up and used in accordance with the manufacturer's instructions and the BMBL.

(2) If used for sterilization there must be a validation method in place to ensure sterility.

d. Vapors and gases.

(1) *General.* Vapors and gases such as formaldehyde-paraformaldehyde, hydrogen peroxide and chlorine dioxide can be used for room or space decontamination.

(2) *Validation.* A validation method will be in place when this method is used to decontaminate.

e. Ultraviolet radiation.

(1) *General.* The UV light exposure at a wavelength of 253.7 nanometers is a practical method for inactivating airborne viruses, Mycoplasma, bacteria, and fungi on clean surfaces such as a laboratory bench. However, the usefulness of UV radiation on exposed surfaces is limited by its low penetrating power and will only be used to decontaminate surfaces when conventional methods, such as autoclaving or the use of liquid disinfectants, would make the product unusable. An example is data sheets that must be brought out of a BSL-3 or BSL-4 laboratory. The UV
intensity must be at least 40 microwatts per cubic centimeter (cm3) on the surface to be treated. Single sheets of paper may be treated by exposing them to this radiation for a minimum of 15 minutes. Protective eye wear and clothing may be necessary when working around UV radiation.

(2) *Validation.* A calibrated photoelectric UV intensity meter, capable of measuring UV radiation at a wavelength of
253.7 nanometers, will be used whenever a new UV source is installed, and quarterly thereafter, to ensure the UV
source is providing at least 40 microwatts per cm3 at the work surface. Bulbs should be cleaned routinely to remove any accumulated dust and prolong bulb performance and assure proper energy output.

f. Gamma irradiation.

(1) *General.* Gamma irradiation can be used to sterilize medical devices, organisms or unknown agents.

(2) *Validation.* A method will be in place to check sterility of organisms or objects decontaminated with gamma irradiation.

103. Disposal Consult with installation legal counsel and follow all applicable local, state, federal and host nation procedures for disposal of infectious agents and toxins. Disposal will be conducted only after materials have been properly treated by autoclaving, decontamination, or other appropriate means.

## Chapter 11 Emergency Planning And Response

111. General All IAT biological laboratories will establish specific emergency plans for their facilities. Plans will include liaison through proper channels with local emergency groups and with community officials. These plans will include both the building and the individual laboratories. Emergency plans for individual laboratories will include SOPs for personal decontamination and responsibilities for spill control and emergency shut down. Each facility must have a plan that describes evacuation routes, assembly areas, procedures to account for all individuals, facilities for medical treatment, and procedures for reporting mishaps and emergencies. Emergency groups and community officials must be informed of emergency plans in advance of any call for assistance. Emergency plans will be tested, to ensure they are capable of effectively responding to the emergency in a timely manner, before they are adopted. The plans will be reinforced by drills at least annually: after-action reviews will be conducted to identify lessons learned and incorporate these into emergency plan updates and future drills. Facilities/installations will include the participation of external agencies that support emergency plans in an exercise at least once every two years. Basic drills of plans and communications will be conducted by simulating an emergency, and requiring applicable agencies (for example, on- and off-site) identified in the plan to simulate their communication and response procedures. See AR 385-10 for further information and requirements. Emergency plans may be stand-alone or may be incorporated into an installation emergency response plan.

112. Emergency procedures a. General emergency procedures. The following emergency procedures will be followed for laboratory mishaps. (1) Using appropriate personal protection, assist persons involved, remove contaminated clothing if necessary, decontaminate affected areas, and remove personnel from exposure (Note: do not move an injured person who is not in danger of further harm). Render immediate first aid if necessary.

(2) Warn personnel in adjacent areas of any potential hazards to their safety. (3) In case of fire or explosion, immediately activate the emergency alarm system and, call the appropriate emergency services, fire department or community fire brigade immediately. Follow local rules for dealing with incipient fire. If personnel are expected to use portable fire extinguishers they will be trained in their use. Supporting emergency agencies, such as law enforcement, fire departments, health departments, and governments will be informed of infectious agent and toxin activities and the appropriate support necessary, to include any equipment and training to provide effective emergency response. Agreements with external agencies must be formalized.

(4) Laboratories must be prepared for problems resulting from severe weather or loss of a utility service. In the event of the latter, most ventilation systems not supplied with emergency power will become inoperative. All potentially hazardous laboratory work must stop until service has been restored and appropriate action has been taken to prevent personnel exposure to IAT.

(5) In a medical emergency, summon medical help immediately. Laboratories and facilities without access to a medical treatment facility or health care providers within ten minutes must have personnel trained in first aid available during working hours in accordance with 29 CFR 1910.151.

(6) For mishaps with mixed hazards (for example, a substance or mixture that may be infectious and radioactive, or infectious and chemically toxic), respond with procedures addressing the greater hazard first, and then follow through with those for the lesser hazards to ensure that all appropriate steps have been taken.

b. Emergency alarm system.

(1) There will be a system to alert personnel to an emergency that requires evacuation of the laboratory or building.

Laboratory personnel must be familiar with the location and operation of alarm equipment.

(2) Isolated areas (for example, cold, warm, or sterile rooms) will be equipped with an alarm or communication system that can be used to alert others outside to the presence of a worker inside, or to warn workers inside of an emergency that requires evacuation. Plans must be made for individuals with hearing and vision impairments or other physical challenges.

(3) Emergency alarm systems should include a strobe light in containment, maximum containment, cage wash, and other areas with loud background or nuisance noise.

c. Shut-down and start-up procedures
(1) The SOPs for shutting down operations during an emergency evacuation will be developed and available in writing. These SOPs will include procedures for handling emergencies related to any power failures and start-up operations for the laboratory emergency.

(2) Written procedures will also be provided to ensure that personnel do not return to the building, laboratory, or enter any emergency area until the emergency is declared ended and the authorization has been made by the incident commander. Those procedures must also contain start-up operations for the laboratory.

113. Spills a. All areas where work with IAT is performed will have designated personnel trained to respond to spills of hazardous materials being utilized in their areas. Appropriate PPE, safety equipment, and materials necessary to contain and clean up the spill will be available. PPE used in general laboratory operations may not be sufficient for spill cleanups and may have to be supplemented based on the hazardous materials being utilized. There will be sufficient and appropriate supplies on hand to control the hazard and quantities of the spilled substance.

b. The supervisor and safety office will be notified of spills (other than minor spills). The first line supervisor will ensure that proper clean-up techniques are employed.

c. A spill control plan must be available in the laboratory. This plan will include the containment method to limit spread of a spill, the disinfecting agent, the approach to its application, contact time and other parameters such as volume, degree of hazard of materials and associated laboratory reagents. Agents requiring BSL3 and BSL4 containment pose a high risk to workers and possibly to the environment and should be managed by well-informed professional staff trained and equipped to work with Risk Group 3 or 4 IAT (see BMBL). The plan will be reviewed by safety and environmental offices.

d. General procedures for cleaning up a spill. (1) Generally, response to a spill of IAT is as follows: the spill should be contained using absorbent material to limit spread and confined to a small area while minimizing the substance's conversion to an aerosol. The area of the spill should be marked or annotated (absorbent material placed over the spill can fulfill this purpose). If the spill is outside of engineering controls, the room will be evacuated, all doors closed, and clothing decontaminated. The spill will be chemically decontaminated or neutralized (beginning at the perimeter of the spill and working towards the center allowing a sufficient contact time) followed by a cleanup with careful disposal of the residue. If the spilled material is volatile, it may be allowed to evaporate but must be exhausted by a chemical hood or ventilation system.

(2) A spill of IAT material within a biological safety cabinet requires a special response and cleanup procedure.

Cleanup will be initiated while the cabinet continues to operate, using an effective chemical decontaminating agent. Aerosol generation during decontamination and the escape of contaminants from the cabinet must be prevented. Caution must be exercised in choosing the decontaminant, keeping in mind that fumes from flammable organic solvents, such as alcohol, can reach dangerous concentrations within a biological safety cabinet.

e. When reentry is necessary to clean up a spill outside of a hood or biological safety cabinet a risk assessment will be performed to determine PPE requirements, entry and exit procedures (leaving outer garments of PPE in the laboratory or going through a personal decontamination station), and or other specialized procedures. The risk assessment will be conducted with those knowledgeable of the spill, safety and environmental offices, and those performing the clean-up.

f. Procedures to cleanup combined radioactive and biological spills are as follows: (1) The RSO and safety personnel must be notified immediately whenever there is a spill of radioactive biological material, regardless of amount. Laboratory personnel may be expected to clean up the spill. The RSO will direct the cleanup, in accordance with the NRC license for the facility.

(2) The spill will be cleaned up in a way that minimizes the generation of aerosols and spread of contamination. All items used in cleaning up the spill must be disposed of as radioactive waste.

(3) Following cleanup, the area, affected protective clothing, and all affected equipment and supplies must be surveyed for residual radioactive contamination. All potentially affected areas and items that are not disposable will be wipe tested to verify that unfixed radioactive contamination has been removed. If fixed contamination is found, the RSO will determine the requirements for additional cleanup.

## Appendix A References Section I Required Publications Ar 1134 The Army Respiratory Protection Program (Cited In Para 82F.)

AR 405
Preventive Medicine (Cited in paras 41b, 79.)
AR 501
Biological Surety (Cited in para 311a.)
AR 2001
Environmental Protection and Enhancement (Cited in para 79.)

## Ar 38510 The Army Safety Program (Cited In Paras 22A, 31L, 31Q, 36, 310D, 311A, 311E, 313A, 111.) Da Pam 4011 Preventive Medicine (Cited In Para 41B.) Da Pam 40503 Industrial Hygiene Program (Cited In Paras 82F, 310E.) Da Pam 38524 The Army Radiation Safety Program (Cited In Para 73A.) Da Pam 38530 Mishap Risk Management (Cited In Paras 15B, 34B.) Da Pam 38540 Army Accident Investigation And Reporting (Cited In Para 311A.)

DOD 4500.9R
Defense Transportation Regulation, Part II, Section 204 (Cited in paras 92b, 92c.) (This publication is available at http://transcom.mil/j5/pt/dtrpart2/dtr_part_ii_204.pdf)
DOD 6055.05M
Occupational Medical Examinations and Surveillance Manual (Cited in para 47c.) (This publication is available at www.dtic.mil/whs/directives/corres/pdf/605505mp.pdf)
Department of Health and Human Services, Centers for Disease Control and Prevention Biosafety in Microbiological and Biomedical Laboratories (Cited in paras 11, 14, 15, 24, 25, 25d, 45d(1), 71, 77, 78, 81e, 101b, 102c(1), 113c.) (This publication is available at http://www.cdc.gov/od/ohs/biosfty/bmbl5/ bmbl5toc.htm.)
National Institutes of Health NIH Guidelines for Research Involving Recombinant DNA (Cited in paras 21x, 312, 52.) (This publication is available at http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Gdlnes_lnk_2002z.pdf and from the Office of Biotechnology Activities, National Institutes of Health.)
National Institutes of Health Publication 8623
Guide for the Care and Use of Laboratory Animals (Cited in paras 65a, 75b(1).) (This publication is available from the Office of Laboratory Animal Welfare, NIH or the National Academy Press. It is also available at http:// www.nap.edu/readingroom/books/labrats/.)
National Institutes of Health Biosafety Level 3 Laboratory Certification Requirements (Cited in para Appendix C.) (This publication is available at http://orf.od.nih.gov/NR/rdonlyres/9EC84DBBAC8D409C9783025830F47D5A/15898/ BSL3CertificationRequirements.pdf.)
American Society of Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE) Standard 62
Ventilation for Acceptable Indoor Air Quality (Cited in para 77f.) (This publication is available through the American Society of Heating, Refrigerating and Air-Conditioning Engineers, Inc.)
American National Standards Institute ANSI Z87.1, Occupational and Educational Personal Eye and Face Protection Devices (Cited in para 82a.) (This publication is available from the American National Standards Institute, 25 West 43rd Street, New York, NY 10036.)
American National Standards Institute ANSI Z358.1, American National Standard for Emergency Eyewash and Shower Equipment (Cited in paras 71d, 78b(2).) (This publication is available from the American National Standards Institute, 25 West 43rd Street, New York, NY 10036.)
National Sanitation Foundation NSF/ANSI 49, Class II (laminar flow) biosafety cabinetry (Cited in para 61a(3).) (This publication is available from the National Sanitation Foundation International, 789 North Dixboro Road, P.O. Box 130140, Ann Arbor, Michigan, 481130140.)

## Section Ii Related Publications A Related Publication Is Merely A Source Of Additional Information. The User Does Not Have To Read It To Understand This Regulation.

AR 4201
Army Facilities Management

## Occupational Health And Safety In The Care Of Research Animals, Committee On Occupational Safety And Health In Research Animal Facilities, Institute Of Laboratory Animal Resources, Commission On Life Sciences, National Research Council (Cited In Para 55A.) (This Publication Is Available From The National Academy Press.) Laboratory Safety For Arboviruses And Certain Other Viruses Of Vertebrates, The Subcommittee On Arbovirus Laboratory Safety Of The American Committee On ArthropodBorne Viruses (Cited In Para 56.) (This Publication Is Available From The American Journal Of Tropical Medicine And Hygiene, 29 (6): 13591381.)

American National Standards Institute/American Society of Heating, Refrigerating, and Air Conditioning Engineers (ANSI/ASHRAE) 110
Method of Testing Performance of Laboratory Fume Hoods. (Cited in Table 61.) (This publication is available through the American Society of Heating, Refrigerating and Air-Conditioning Engineers, Inc.)
Bacterial Toxins: A Table of Lethal Amounts Gill, D. M. (1982) Microbiological Reviews, 46:8694. Contains a useful table of mammalian toxicities of numerous toxins.

MEDCOM Circular 4019
Guidance on Occupational Health Practices for the Evaluation and Control of Occupational Exposures to Biological Select Agents and Toxins (BSAT) (For Form 760R Cited in 43a.) (Referenced in AKO, U.S. Army Organizations, MEDCOM, AMEDD Pub, Policies & FMs, MEDCOM Pubs and Policies, Comd Circulars (CIR) and MEDCOM E Forms).

Title 9 Code of Federal Regulations, Parts 13, Subchapter A
Animal and Plant Health Inspection Service, Department of Agriculture (This publication is available at http:// www.access.gpo.gov/nara/cfr/waisidx_08/9cfr1_08.htm.)
Title 10 Code of Federal Regulations, Part 20
Standards for Protection against Radiation (Cited in para 53 (Cited in para ).) (This publication is available at http:// www.access.gpo.gov/nara/cfr/waisidx_08/10cfr20_08.html)
Title 29 Code of Federal Regulations, Part 1910
Occupational safety and health standards (Cited in para 72a, 72e, 72f, 102a(5).) (This publication is available at http://www.access.gpo.gov/nara/cfr/waisidx_08/29cfrv5_08.html)

## U.S. Department Of Health And Human Services, Primary Containment For Biohazards Selection, Installation And Use Of Biological Safety Cabinets (This Publication Is Available On The Internet.)

Section III Prescribed Forms DA Forms are available on the Army Publishing Directorate Web site http://www.apd.army.mil. SFs and OFs are available on the GSA Web site (http://www.gsa.gov). OSHA Forms are available on the OSHA Web site (http:// www.osha.gov).

## Da Form 7566 Composite Risk Management Worksheet (Prescribed In Para 34A.)

MEDCOM Form 760
Medical Record-BSAT Occupational Health Survey (Prescribed in para 43a.) (Referenced in AKO, U.S. Army Organizations, MEDCOM, AMEDD Pub, Policies & FMs, MEDCOM Pubs and Policies, and MEDCOM E Forms).)
Section IV Referenced Forms DA Forms are available on the Army Publishing Directorate Web site (http://www.apd.army.mil); DD Forms are available on the OSD Web site (http://www.dtic.mil/whs/directives/infomgt/forms/formsprogram.htm). SFs and OFs are available on the GSA Web site (http://www.gsa.gov). OSHA Forms are available on the OSHA Web site (http:// www.osha.gov).

## Da Form 544053 Delineation Of Clinical Privileges - Occupational Medicine

Appendix B Laboratory Safety Inspection Checklist The checklist that follows is not an exhaustive list of the items to consider when inspecting facilities where IAT are used. It does provide some basic guidelines to remind safety and non-safety professionals of the specific requirements for biological laboratories.

B1. Basic checklist for infectious agents and toxins laboratories (Biosafety level 2)
a. Laboratory supervisor enforces institutional policies that control access to the laboratory and personnel with access have been screened for or enrolled in appropriate medical surveillance program.

b. Personnel wash hands after working with potentially hazardous materials and before leaving the laboratory. c. Eating, drinking, smoking, handling contact lenses, applying cosmetics, and storing food for human consumption are not allowed in laboratory areas.

d. Mouth pipetting is prohibited; mechanical pipetting devices are used. e. Sharps such as needles, scalpels, pipettes, and broken glassware are handled safely. Precautions taken include:
needles are never bent, sheared, broken, recapped, removed from disposable syringes, or otherwise manipulated by hand before disposal, puncture-resistant containers are accessible for sharps disposal, broken glassware is not handled directly, and plastic-ware is substituted for glassware whenever possible.

f. Work surfaces are decontaminated after completion of work and after any spill or splash of potentially hazardous material.

g. Potentially infectious materials are decontaminated before disposal. h. Biohazard symbol at entrance to laboratory with the laboratory's BSL, supervisor's name (or other responsible personnel), telephone numbers (office, cell, and home) and required procedures for entering/ exiting lab.

i. All people who enter the laboratory are advised of potential hazards. j. A laboratory-specific biosafety manual is available and accessible.

k. Potentially infectious materials must are placed in a durable, leak proof container during collection, handling, processing, storage, or transport within a facility.

l. Laboratory equipment is routinely decontaminated, as well as, after spills, splashes, or other potential contamination and before repair, maintenance or removal from the laboratory. Animals and plants not associated with the work being performed are not permitted in the laboratory.

m. Any procedure involving the manipulation of infectious materials that may generate an aerosol should be conducted within a BSC or other physical containment device.

n. PPE worn when working with hazardous materials. PPE is removed before leaving for non-laboratory areas. o. Eye, face and respiratory protection used in rooms containing infected animals if required by risk assessment. p. Laboratory doors should be self-closing and have locks in accordance with institutional policies. q. Laboratories have a sink for hand washing. It should be located near the exit door. r. The laboratory is designed so that it can be easily cleaned and decontaminated. There are no carpets and rugs. s. Laboratory furniture is capable of supporting anticipated loads and uses. Spaces between benches, cabinets, and equipment should be accessible for cleaning.

t. Bench tops are impervious to water and resistant to heat, solvents, acids, and other chemicals. u. Chairs used in laboratory work are covered with a non-porous material that can be easily decontaminated. v. Laboratory windows that open to the exterior are fitted with screens. w. BSCs should be located away from doors, windows that can be opened, heavily traveled laboratory areas, and other possible airflow disruptions.

x. Vacuum lines should be protected with HEPA filters, or their equivalent. Filters must be replaced as needed.

Liquid disinfectant traps may be required.

y. An eyewash station is readily available. z. BSCs are certified annually. aa. There is a way to decontaminate all laboratory wastes (should be in the facility). For example, autoclave, chemical disinfection, incineration, or other validated decontamination method.

B2. Biosafety level 3 supplemental checklist a. All procedures involving the manipulation of infectious materials must be conducted within a BSC (preferably class II or class III), or other physical containment device.

b. The PPE with a solid-front such as tie-back or wraparound gowns, scrub suits, or coveralls are worn by workers in the laboratory. PPE is not worn outside of the laboratory.

c. Reusable clothing is decontaminated with appropriate disinfectant before being laundered. d. Eye, face, and respiratory protection must be used in rooms containing infected animals. e. Laboratory doors must be self closing and have locks in accordance with institutional policies. The laboratory must be separated from areas that are open to unrestricted traffic flow within the building. Access to the laboratory is restricted to entry by a series of two self-closing doors.

f. Laboratories have a sink (hands-free or automatically operated) for hand washing. If the lab is segregated into different laboratories, a sink must also be available for hand washing in each zone.

g. Seams, floors, walls, and ceiling surfaces should be sealed. Spaces around doors and ventilation openings should be capable of being sealed to facilitate space decontamination.

h. Floors must be slip resistant, impervious to liquids, and resistant to chemicals. i. Walls should be constructed to produce a sealed smooth finish that can be easily cleaned and decontaminated. j. Ceilings should be constructed, sealed, and finished in the same general manner as walls. k. All windows in the laboratory are sealed. l. A ducted air ventilation system present and provides sustained directional airflow by drawing air into the laboratory from "clean" areas toward "potentially contaminated" areas.

m. Laboratory personnel are able to verify directional air flow. A visual monitoring device which confirms directional air flow and room negative pressure is provided at the laboratory entrance.

n. Laboratory exhaust air is not recirculated to any other area of the building. o. A method for decontaminating all laboratory wastes is available in the facility, preferably within the laboratory
(for example, autoclave, chemical disinfection, incineration, or other validated decontamination method).

p. Equipment that may produce infectious aerosols is contained in devices that exhaust air through HEPA filtration or other equivalent technology before being discharged into the laboratory. These HEPA filters should be tested and/or replaced at least annually.

B3. Biosafety level 4 supplemental inspection checklist
a. Precautions for all areas. (1) All penetrations through the walls and ceilings are sealed.
(2) The appropriate decontaminants are available and used properly.
(3) All entrances to the facility posted with: (a) The appropriate special provisions for entry.
(b) The universal biohazard symbol. (c) The name and telephone number of the laboratory director or other responsible person.
(4) Access to the laboratory is controlled strictly and documented. (5) Monitors indicate that the room is under negative pressure relative to all entrances. (6) All vacuum lines are protected with HEPA filters and liquid disinfectant traps. (7) The autoclave is properly maintained and certified. (8) Foot, elbow, and automatic hand wash sinks operate properly. (9) Self-closing doors to the facility operate properly. (10) Personnel completely exchange street clothing for laboratory clothing before entry and shower upon exiting. (11) The dunk tank disinfectant is fresh and appropriate for the agents in use. b. Suit areas. (1) All operations with IAT are conducted in class I or II biological safety cabinets. (2) Procedures are in place ensure that, as much as possible, contamination remains inside the cabinets (such as
ensuring that everything removed from the cabinets, such as gloves, instruments, glassware, or similar items, are first decontaminated and properly packaged first).
(3) Class I or II cabinets in the facility are certified every 6 months. (4) The suit decontamination shower has adequate appropriate decontaminant available. (5) The suit decontamination shower has been used or tested in the last month. (6) The ventilated suit air supply and emergency air supply are adequate and working properly. (7) The emergency alarm system is working properly. (8) All of the one-piece positive pressure suits available for use are in serviceable condition. (9) Infected animals are housed in appropriate primary containment systems. (10) The static pressure in the suit area is negative to all surrounding areas. c. Non-suit areas. (1) All operations with IAT are conducted inside class III biological safety cabinets. (2) Class III biological safety cabinets were certified before personnel initiated the current operation. (3) All infected animals are housed in class III cabinet containment caging systems.

## Appendix C Biosafety Level 3 And Biosafety Level 4 Facility Commissioning Criteria

C1. Commissioning requirements Prior to initial use, BSL3 and BSL4 laboratories are required to be validated for safe operation through a commissioning survey.

a. The "National Institutes of Health Biosafety Level 3 Laboratory Certification Requirements" and the following requirements will be used as criteria in commissioning BSL3 and BSL4 laboratories.

b. The criteria in table C1 are segregated by method of primary control: laboratory siting; laboratory containment perimeter; air handling; decontamination, sterilization, and waste disposal systems; safety and health equipment utilities; and performance, verification and testing. Compliance with all criteria in table C1, as well "National Institutes of Health Biosafety Level 3 Laboratory Certification Requirements" for BSL-3 laboratories, is required for successful completion of the commissioning survey

## Biosafety Level 3 And Biosafety Level 4 Facility Commissioning Criteria

BSL
3
4
Laboratory Siting
O
X
Containment labs located away from outside building envelope walls
O
X
Containment labs located adjacent to or nearby mechanical rooms to minimize lengths of containment ducts
X
X
Office areas must be outside laboratory containment zone
3
4
Laboratory Containment Perimeter
O
X
Walls are reinforced structural masonry, reinforced non-load-bearing masonry, steel frame reinforced non-load-bearing masonry, or reinforced concrete
O
X
Entrance doors to be interlocked with manual overrides
3
4
Air Handling
O
X
Room air supply independent from adjoining laboratory zones
O
X
Room air supply HEPA-filtered or provided with bubble tight dampers
3
4
Decontamination, Sterilization, and Waste Disposal Systems
O
X
Provide refrigerated space for lockable, closed storage for biomedical waste which will be disposed of off site
3
4
Safety and Health Equipment
O
X
Eye/face wash facilities equipped with in-use audio/visual alarm (not applicable for positive pressure suit mode)
O
X
Clothing change area adjacent to containment area (0.5 m2 per person)
O
X
Provide storage space for laboratory clothing in lab or adjacent change area (minimum 300 linear mm for each peg)
3
4
Utilities
X
Equipped with bottled back-up breathing air sufficient to provide 30 minutes per person
O
X
Equipped with positive-pressure hood respirators with compressed breathing air cylinders located in support area
3
4
Performance, Verification, and Testing
X
Construction of laboratory perimeter to be leak-proof and able to withstand loading characteristics imposed by negative air pressure required in laboratory operation; integrity of seals demonstrated by visual inspection
X
Construction of laboratory perimeter to be leak-proof and able to withstand loading characteristics imposed by negative air pressure required in laboratory operation; integrity of room tightness demonstrated by physical testing (pressure decay 0.05 wg loss/min) at 2" wg
O
X
All air supply and exhaust ductwork tested in situ to be leak-tight by pressure decay: BSL 3 not >
0.2% duct vol/min at 2" wg (500 Pa); BSL 4 not > 0.1% duct vol/min at 2" wg (500 Pa)
X
X
All air supply and exhaust ductwork verified to have back-draft protection
X
X
All HEPA filters tested to meet required specification after installation
O
X
All HEPA-filter housings tested to be leak tight: not > 0.2% of vol/min at 10" wg (2500 Pa) and located outside of containment
X
X
Testing of BSCs meets required specifications after installation. All BSC must be equipped with a monitoring gauge
X
X
HEPA filters must be tested as installed and be accessible to facilitate decontamination
X
X
Testing of autoclaves to meet specified standards after installation by the use of biological indicators
X
X
Testing of fume hoods according to Table 61 of this pamphlet
X
Drainage and liquid-waste-disposal systems including sampling ports tested to ensure efficacy by use of biological indicators
X
Verification of integrity of sewage lines; all waste directed to sewer
X
X
Verification of alarm systems for air systems failure (exhaust, supply, room pressure, breathing air)

## Biosafety Level 3 And Biosafety Level 4 Facility Commissioning CriteriaContinued

BSL
X
X
Verification of alarm systems for electrical failure and back up generators: back-up generators are required for essential equipment, including biological safety cabinets
X
X
Verification of fire alarm systems
O
X
Verification of communication systems between containment area and outside support areas
X
X
Testing of directional airflow demonstrated by field tests with visual smoke: verify elimination of 'dead' zones within laboratory
X
Verification of integrity positive pressure suits
X
Testing of breathing air as per CSA Standard Z180.1M85
X
Testing of regular and emergency air system
O
X
Ventilation, electrical, compressed gas cylinders, and plumbing and so forth are accessible from outside of the containment lab
X
X
Verification of operation of backflow preventers on air, gas, and water supply lines

Legend for Table C-1: X - mandatory O - optional C2. Documentation Commissioning survey criteria and results, including back-up documentation, shall be maintained for the life of the laboratory.

a. Successful completion of the commissioning survey is required prior to requesting a pre-operational survey from the Office of the Director of Army Safety b. Commissioning survey documentation must be available for the pre-operational survey team.

## Appendix D Sample Risk Assessment

D1. Risk Management As specified in paragraph 34, laboratories will conduct and document a risk assessment and mange risks for every microbiological or biomedical activity (task) or activity (task) involving IAT.

a. It is recommended that DA Form 7566, Composite Risk Management Worksheet, be used to document risk assessment and management.

b. A sample of a microbiological risk assessment and management using DA Form 7566, Composite Risk Management Worksheet, is at figure D1.

D2. Documentation a. As demonstrated by the sample in figure D1, a properly executed and documented risk assessment identifies the unique task, subtasks, and for each subtask the hazards, initial risk level, recommended controls, residual risk level, and the means for implementing the recommended controls. A properly executed and documented risk assessment also identifies the name of the individual preparing the risk assessment and the name of the risk decision authority (established in accordance with the Commander's published risk decision making approval authority).

b. Risk assessments will be used to provide safety training to employees and supervisors as well as in development of the standing operating procedure for the task.

## Glossary Section I Abbreviations

ABSL
animal biosafety level ACGIH
American Conference of Governmental Industrial Hygienists ACIP
Advisory Committee on Immunization Practices AI
as installed AM
as manufactured AMEDD
Army Medical Department ANSI
American National Standards Institute APHIS
Animal and Plant Health Inspection Service AR
Army Regulation ARNG
Army National Guard ASHRAE
American Society of Heating, Refrigerating, and Air Condition Engineers, Inc.

AU
as used BMBL
Biosafety in Microbiological and Biomedical Laboratories BSAT
biological select agents and toxins BSC
biosafety cabinet BSE
bovine spongiform encephalopathy BSL
biosafety level C
centigrade CDC
Centers for Disease Control

## Cfr Code Of Federal Regulations Cjd Cretuzfeldt-Jakob Disease

CM
centimeter CMA
Competent Medical Authority DA
Department of Army DABSHC
Department of Army Biological Safety and Health Council DNA
deoxyribonucleic acid DOD
Department of Defense DOT
Department of Transportation EPA
Environmental Protection Agency FDA
Food and Drug Administration FPS
foot per second HEPA
high efficiency particulate air HVAC
heating, ventilating, and air conditioning IAT
infectious agents and toxins IATA
International Air Transport Association IBC
Institutional Biosafety Committee ICAOTI
International Civil Aviation Organization Technical Instructions IND
investigational new drug IPM
integrated pest management

## Ipm Linear Foot Per Second Medcom U.S. Army Medical Command Medpros Medical Protection System

MSDS
material safety data sheet NIH
National Institute of Health NRC
Nuclear Regulatory Commission NSF
National Sanitation Foundation

## Odasaf Office Of The Director Of Army Safety Osha Occupational Safety And Health Administration

PAM
pamphlet POC
point of contact PPB
parts per billion PPE
personal protective equipment PRP
Personnel Reliability Program

## Rcra Resource Conservation Recovery Act

RDTE
research, development, testing, and evaluation RSO
Radiation Safety Officer SASOHI
Standard Army Safety and Occupational Health Inspection SIP
Special Immunization Program

## Sop Standing Operating Procedure

TSE
transmissible spongeiform encephalopathies UV
ultraviolet vCJD
variant Cretuzfeldt-Jakob disease wg water gage

## Section Ii Terms

Aerosol Particles of respirable size generated by both humans and environmental sources and that have the capability of remaining viable and airborne for extended periods in the indoor environment.

Airborne transmission A means of spreading infection when airborne droplet nuclei (small particle residue of evaporated droplets <5 m in size containing microorganisms that remain suspended in air for long periods of time) are inhaled by the susceptible host.

Biological safety cabinets Engineering controls designed to enable laboratory workers to handle IAT and to provide primary containment of any resultant aerosol. There are three major classes of cabinets (Class I, II, and III) and several subclasses of class II cabinets. Each type of cabinet provides a different degree of protection to personnel, to the products handled within them, and the environment.

Biological mishap A biological mishap is an event in which the failure of laboratory facilities, equipment, or procedures appropriate to the level of potential pathogenicity or toxicity of a given etiologic agent (organism or toxin) may allow the unintentional, potential exposure of humans or the laboratory environment to that agent.

## Biomedical Research The Application Of Biological Science For Medical Research, Development, Test And Evaluation.

Biosafety level 2 (BSL-2)
Practices, equipment, and facility design and construction applicable to clinical, diagnostic, or teaching laboratories, in which work is being done with indigenous moderate risk agents that are present in the community and associated with human disease of varying severity. Primary hazards to personnel working with these agents relate to accidental percutaneous or mucous membrane exposures, or ingestion of infectious materials. See BMBL (latest edition) for complete definition.

Biosafety level 3 (BSL-3)
Practices, equipment, and facility design and construction applicable to clinical, diagnostic, research, or production facilities in which work is done with indigenous or exotic agents with a potential for respiratory transmission and which may cause serious or potential lethal infection. Primary hazards to personnel working with these agents relate to autoinoculation, ingestion, and exposure to infectious aerosols. See BMBL (latest edition) for complete definition.

Biosafety level 4 (BSL-4)
Practices, equipment, and facility design and construction applicable for work with dangerous and exotic agents that pose a high individual risk of life-threatening disease which may be transmitted via the aerosol route and for which there is no available vaccine or therapy. The primary hazards are respiratory exposure to infectious aerosols, mucous membrane or broken skin exposure to infectious droplets, and autoinoculation. See BMBL (latest edition) for complete definition.

Building A structure that contains the requisite components necessary to support a facility that is designed according to the required BSL. The building can contain one or more facilities conforming to one or more BSL.

Cleaning The removal of visible soil and organic contamination from a device or surface, using either the physical action of scrubbing with a surfactant or detergent and water, or an energy-based process (for example, ultrasonic cleaners) with appropriate chemical agents.

Competent By way of training, experience, education, licensing, and/or certification (as appropriate), is knowledgeable of applicable principles, practices, and standards, is capable of identifying risks and hazards relating to the activity, is designated by the employer, and has authority to take appropriate actions.

Competent Medical Authority (CMA)
A physician, physician assistant, or nurse practitioner (military, civilian, or contractor) employed by or under contract or subcontract to the U.S. Government or a U.S. Government contractor. A CMA is someone who has been awarded clinical privileges for independent practice granted by the health care facility responsible for the provider's place of duty OR if not privileged for independent practice (for example, a physician assistant or nurse practitioner), then is supervised by an appropriately trained CMA physician who is privileged to practice independently. A CMA is someone who has been specifically trained as a CMA and appointed in writing as a CMA by the medical treatment facility commander (or COR) responsible for reviewing healthcare services or conducting clinical evaluations for purposes of the Personnel Reliability Program (PRP). For activities that do not require a PRP, a CMA may be required to have training and qualifications supporting risk management of the specific processes. Occupational Medicine privileges would be sufficient and the requirement of appointment in writing as a CMA would not be required. AR 40-68 provides specific guidance for Licensure, Certification, and/or Registration of Health Care Professionals and Delineation of Clinical Privileges - Occupational Medicine DA Form 5440-53 provides detailed privileges that may be required for different levels of Occupational Medicine support.

Decontamination The physical or chemical processes by which an object or area, contaminated with a harmful or potentially harmful IAT, is made safe for handling or use. Such processes include physical removal of most contaminants, thermal destruction of biological activity (sterilization), chemical inactivation (biocidal process), or a combination of these methods.

Disinfection A generally less lethal process of microbial inactivation (compared to sterilization) that eliminates virtually all recognized pathogenic microorganisms but not necessarily all microbial forms (for example, bacterial spores).

Germicide A chemical that destroys microorganisms. Germicides may be used to inactivate microorganisms in or on living tissue (antiseptics) or on environmental surfaces (disinfectants).

High Efficiency Particulate Air (HEPA) filter A filter that removes particulate matter down to sub-micron sized particles from the air passed through it with a minimum efficiency of 99.97%. While the filters remove particulate matter with great efficiency, vapors and gases (for example, from volatile chemicals) are passed through without restriction. HEPA filters are used as the primary means of removing etiological agents from air exhausted from engineering controls and facilities High-level disinfection A disinfection process that inactivates vegetative bacteria, mycobacteria, fungi, and viruses, but not necessarily high numbers of bacterial spores.

Infectious agents and toxins (IAT)
Fungi, virus, bacteria, prions, rickettsia, parasites or a viable microorganism, or its toxin, or a prion that lacks nucleic acids, that causes or may cause disease, and any material of biological origin that poses a degree of hazard similar to those organisms.

## Institute Director Or Commander The Institute Director Or Commander Of An Army Activity Conducting Research, Development, Test, Evaluation, Or

sampling and analysis with IAT, or the equivalent at a research organization under contract to the biological defense program.

Institution An organization such as an Army RDTE activity (institute, agency, center, and so forth) or a contract organization such as a school of medicine, or research institute that conducts research, development, test, evaluation, or sampling and analysis with IAT.

Intermediate-level disinfection A disinfection process that inactivates vegetative bacteria, most fungi, mycobacteria, and most viruses (particularly the enveloped viruses), but does not inactivate bacterial spores.

Laboratory An individual room or rooms within a facility that provide space in which work with IAT can be performed. It contains all of the appropriate engineering features and equipment required at a given BSL to protect personnel working in it and the environment external to the facility.

## Large-Scale Operations Research Or Production Involving Viable Iat In Quantities Greater Than 10 Liters Of Culture.

Low-level disinfection A disinfection process that will inactivate most vegetative bacteria, some fungi, and some viruses, but cannot be relied upon to inactivate resistant microorganisms (for example, mycobacteria or bacterial spores).

Maximum containment laboratory or suite A laboratory or suite that meets the requirements for a BSL4 facility. The area may be an entire building or a single room within the building.

## Microbiology The Science And Study Of Microorganisms, Including Protozoans, Algae, Fungi, Bacteria, Viruses, And Prions.

Negative pressure Air pressure differential between two adjacent airspaces such that air flow is directed into the room relative to the corridor ventilation (for example, room air is prevented from flowing out of the room and into adjacent areas).

Positive pressure Air pressure differential between two adjacent air spaces such that air flow is directed from the room relative to the corridor ventilation (for example, air from corridors and adjacent areas is prevented from entering the room).

Prion Proteinaceous infectious particle. Considered to consist of protein only, and the abnormal isoform of this protein is thought to be the causative agent in transmissible spongiform encephalopathies (TSEs) that causes diseases such as Creutzfeldt-Jakob disease (CJD), kuru, scrapie, bovine spongiform encephalopathy (BSE), and the human version of BSE which is variant CJD (vCJD).

Qualified Safety and Health Personnel Civilian personnel who meet Office of Personnel Management standards for Safety and Occupational Health Manager/ Specialist GS-018, Safety Engineering Technician GS-802, Safety Engineer GS-803, Safety Technician GS-019, Aviation Safety Officer GS-1825, Air Safety Investigating Officer GS-1815, Fire Protection Engineer GS-804, Fire Protection Specialist/Marshall GS-081, Medical Officer GS-602, Health Physicist GS-1306, Industrial Hygienist GS- 690, Occupational Health Nurse GS-610, Environmental Health Technician GS-699, and military personnel equally qualified when compared to the above OPM standards. In addition, in order to be considered safety and occupational health qualified for microbiological and biomedical safety, the individual must demonstrate they have attended and successfully completed microbiological and laboratory courses of instruction as approved by the Office of the Director of Army Safety.

Resource Conservation Recovery Act of 1976 Listed Hazardous Waste The waste materials listed by the Environmental Protection Agency under authority of the RCRA for which the agency regulates disposal. A description and listing of these wastes is located in 40 CFR Part 261.

Risk assessment An assessment of the probability that harm, injury, or disease will occur. In the context of the microbiological and biomedical laboratories, risk assessment focuses primarily on the prevention of laboratory-associated infections. Risk assessment is used to assign the BSLs (facilities, equipment, and practices) that reduce the workers' and the environment's risk of exposure to an agent to an absolute minimum.

Sterilization The use of a physical or chemical procedure to destroy all microbial life, including large numbers of highly-resistant bacterial endospores.

Toxin Toxic material of biologic origin that has been isolated from the parent organism; the toxic material of plants, animals, or microorganisms.

Vegetative bacteria Bacteria that are actively growing and metabolizing, as opposed to a bacterial state of quiescence that is achieved when certain bacteria (gram-positive bacilli) convert to spores when the environment can no longer support active growth.

## Section Iii Special Abbreviations And Terms There Are No Special Abbreviations Or Terms. Usapd

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