Nuclear and Chemical Weapons and Materiel

## Biological Surety

Headquarters Department of the Army Washington, DC 28 July 2008

## Unclassified Summary Of Change Ar 501 Biological Surety

This new Department of the Army regulation, dated 28 July 2008--

o Identifies the purpose, concept, and responsibilities for the biological
surety program (chap 1).
o Identifies the following: procedures for requesting exceptions and waivers to
biological surety policies; procedures for initiating and terminating surety
status; and requirements for surety officers and surety boards (paras 1-5e,
1-6, and 1-7).
o Establishes procedures for the biological personnel reliability program
(chap 2).
o Provides guidance for acquisition, inventory management, and transfer of
biological select agents and toxins (chap 3).
o Provides guidance for transportation of biological select agents and toxins
(chap 4).
o Identifies applicable guidance for safety and occupational health programs
(chap 5).
o Identifies applicable guidance for biological select agents and toxins
security and provides guidance for threat information collection and reporting (chap 6).
o Provides guidance for planning and exercising mishap or incident response and
for reporting mishaps or incidents (chap 7).
o Provides guidance for biological surety program evaluations, including
Department of the Army Inspector General technical inspections, surety management reviews conducted by Army Commands, Army Service Component Commands, Direct Reporting Units, and assistance visits conducted by U.S. Army Nuclear and Combating Weapons of Mass Destruction Agency (chap 8).
o Provides guidance for Army-managed contractor operations involving
Department of Defense-provided biological select agents and toxins (chap 9).
o Provides guidance on categories of biological agent (biological select agents
and toxins and non-surety biological materiel) (app B).
o Identifies requirements under the Chemical Weapons Convention applicable to
the biological select agents and toxins ricin and saxitoxin (app D).
o Synchronizes the biological surety program and the chemical surety program
(throughout).

## Nuclear And Chemical Weapons And Materiel Biological Surety

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  n e w Department of the Army regulation.

The proponent of this regulation is the Deputy Chief of Staff, G3/5/7. The proponent has the authority to approve exceptions or waivers to this regulation that a r e c o n s i s t e n t w i t h c o n t r o l l i n g l a w a n d regulations. The proponent may delegate this approval authority, in writing, to a d i v i s i o n  c h i e f  w i t h i n  t h e  p r o p o n e n t 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 prov i d i n g  j u s t i f i c a t i o n  t h a t  i n c l u d e s  a  f u l l analysis of the expected benefits and must i n c l u d e f o r m a l r e v i e w b y t h e a c t i v i t y ' s senior legal officer. All waiver requests will be endorsed by the commander or s e n i o r  l e a d e r  o f  t h e  r e q u e s t i n g  a c t i v i t y and forwarded through their higher headquarters to the policy proponent. Refer to AR 2530 for specific guidance.

Army management control process.

This regulation contains management cont r o l  p r o v i s i o n s  i n  a c c o r d a n c e  w i t h  A R 112, but it does not identify key management controls that must be evaluated.

S u m m a r y .  T h i s  r e g u l a t i o n  p r e s c r i b e s policies, procedures, and responsibilities for the Army Biological Surety Program i n  a c c o r d a n c e  w i t h  D O D D  5 2 1 0 . 8 8 . Along with guidance to be published by the Office of the Provost Marshal General, it also implements DOD physical secur i t y  r e q u i r e m e n t s  p e r t a i n i n g  t o  s u r e t y matters for biological select agents and toxins.

S u p p l e m e n t a t i o n .  S u p p l e m e n t a t i o n  o f this regulation and establishment of command and local forms are prohibited without prior approval from the Deputy Chief o f  S t a f f ,  G - 3 / 5 / 7  ( D A M O - S S D ) ,  4 0 0 A r m y  P e n t a g o n ,  W a s h i n g t o n ,  D C 203100400.

Applicability. This regulation 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, and the U.S. Army Reserve, unless otherwise stated. This regulation applies when units of these organizations support the biological surety program as well as Army contractors and consultants that are provided biological select agents and toxins by the Department of Defense.

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 D e p u t y  C h i e f  o f  S t a f f ,  G - 3 / 5 / 7
Proponent and exception authority.

# Army Regulation 501 Effective 28 October 2008

( D A M O - S S D ) ,  4 0 0  A r m y  P e n t a g o n , Washington, DC 203100400.

C o m m i t t e e  C o n t i n u a n c e  A p p r o v a l .

The Department of the Army Committee Management Officer concurs in the establishment and/or continuance of the comm i t t e e ( s )  o u t l i n e d  h e r e i n ,  i n  a c c o r d a n c e with AR 151. The AR 151 requires the proponent to justify establishing/continuing its committee(s), coordinate draft publ i c a t i o n s ,  a n d  c o o r d i n a t e  c h a n g e s  i n committee status with the Department of the Army Committee Management Office (AARPZA), Office of the Administrative Assistant, Resources and Programs Agency, 2511 Jefferson Davis Highway, Taylor B u i l d i n g ,  1 3 t h  F l o o r ,  A r l i n g t o n ,  V A 222023926. Further, if it is determined t h a t  a n  e s t a b l i s h e d  " g r o u p "  i d e n t i f i e d within this regulation later takes on the characteristics of a committee, the proponent will follow all AR 151 requirements for establishing and continuing the group as a committee.

Distribution. This publication is available in electronic media only and intended command levels C, D, and E for the Act i v e  A r m y ,  t h e  A r m y  N a t i o n a l  G u a r d / 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.

## 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 Responsibilities - 14, page 1 Biological surety program concept - 15, page 4 Initiation and termination of facility surety status - 16, page 4
Surety officers and surety boards - 17, page 5

## Chapter 2 Personnel Reliability, Page 5

Section I
Introduction, page 5
General - 21, page 5 Identifying Biological Personnel Reliability Program duties - 22, page 6
Certifying and reviewing officials - 23, page 6 Biological duty position roster - 24, page 7
Section II Standards, page 7
Reliability assessment - 25, page 7 Qualifying factors/requirements - 26, page 8 Mandatory disqualifying factors - 27, page 8 Other disqualifying factors - 28, page 9
Section III Screening Process, page 10
DA Form 3180 - 29, page 10 Initial interview - 210, page 10
Personnel records screening - 211, page 11
Personnel security records screening - 212, page 11 Medical evaluation - 213, page 12
Drug testing - 214, page 13
Certifying official's evaluation and briefing - 215, page 13
Technical proficiency - 216, page 14 Rescreening requirements for the Biological Personnel Reliability Program-certified individuals - 217, page 14
Section IV Continuing Evaluation, page 14
General - 218, page 14 Individual and supervisor responsibilities - 219, page 15
Medical evaluation - 220, page 15
Drug/substance and alcohol abuse - 221, page 16
Personnel security investigations/periodic reinvestigations for Biological Personnel Reliability Program purposes
- 222, page 16
Section V Removal from Biological Personnel Reliability Program Duties, page 16
General - 223, page 16 Restriction - 224, page 16 Suspension - 225, page 17

## ContentsContinued

Disqualification - 226, page 18
Administrative termination - 227, page 19
Section VI Requalification of personnel, page 19
Request for requalification - 228, page 19 Special procedures for alcohol abuse/dependence - 229, page 20
Special procedures for drug/substance abuse - 230, page 20
Section VII Annual Personnel Reliability Program Status Report (RCS DDPC3I (A) 1403), page 20
Information requirements - 231, page 20 Preparation guidance - 232, page 20
Chapter 3 Control of Biological Select Agents and Toxins, page 21
General - 31, page 21
Acquisition of biological select agents and toxins - 32, page 21
Responsibilities for control of biological select agents and toxins - 33, page 21 Biological select agents and toxins inventory management - 34, page 21 Records retention - 35, page 21
Transfer of biological select agents and toxins - 36, page 21
Annual reporting on contractor facilities - 37, page 22
Chapter 4 Transportation of biological select agents and toxins, page 22
Transportation - 41, page 22
Movement limitations - 42, page 22
Chapter 5 Biological Select Agent and Toxin Safety and Occupational Health Program, page 22
General - 51, page 22
Occupational health - 52, page 23
Chapter 6 Biological Select Agent and Toxin Security Program, page 23
General - 61, page 23
Threat information collection and reporting - 62, page 23
Chapter 7 Biological Mishap or Incident Response, page 23
General - 71, page 23
Biological mishap or incident response planning - 72, page 23
Reporting of biological mishaps or incidents - 73, page 23 Exercise program - 74, page 24
Chapter 8 Biological Surety Program Evaluations, page 24
General - 81, page 24
Department of the Army Inspector General technical inspections - 82, page 24
Biological management evaluations - 83, page 25
Biological surety inspections - 84, page 25 Technical inspection reports - 85, page 26 Ratings - 86, page 26 Biological surety reports - 87, page 27 Issue resolution and reclamas - 88, page 28

## ContentsContinued

Army Organization's biological surety management - 89, page 28
U.S. Army Nuclear and Combating Weapons of Mass Destruction Agency surety assistance visits - 810, page 28
Chapter 9
Managing Biological Select Agents and Toxins Contracts, page 30
General - 91, page 30 Source of Biological Select Agents and Toxins - 92, page 30
Biological Personnel Reliability Program - 93, page 30
Contracts and contract clauses - 94, page 30 Provisions for organizations that support multiple biological surety contracts - 95, page 30 Applicability of the biological surety program to contract operations - 96, page 31

## Appendixes

A.
References, page 32
B.
Categories of biological agents, page 35
C.
Applicable Provisions of Federal Law and Regulations, page 36
D.
Chemical Weapons Convention (CWC) Requirements for Ricin and Saxitoxin, page 36

## Table List

Table 81: Biological Surety Inspection Functional Areas and Sub-areas, page 25 Table 82: BSI Ratings, page 26 Table 83: Biological Surety Inspection Results Processing Matrix, page 29 Table 91: Contractor quick reference to requirements, page 31

## Glossary

11. Purpose a. This regulation establishes Department of Army (DA) policies, assigns responsibilities, and prescribes procedures for the Army Biological Surety Program. It is Army policy that biological select agents and toxins (BSAT) in the possession or custody of the Army shall be properly safeguarded against theft, loss, diversion, or unauthorized access or use, and that operations with such agents are conducted in a safe, secure, and reliable manner.

b. Biological select agents and toxins subject to the provisions of the Army Biological Surety Program are listed in appendix B. The requirements for managing recovered biological warfare material (RBWM) are outside of the Army's Biological Surety Program, and are the responsibility of the Assistant Secretary of the Army (Installations and Environment) (ASA(I&E)).

## 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 Regulation Are Explained In The Glossary.

14. Responsibilities a. The Assistant Secretary of the Army (Installations and Environment) (ASA(I&E)) will (1) Provide the principal Army Secretariat oversight responsibility for all DA matters/programs relating to installations, real estate, recovered chemical and biological warfare material, and environment, safety, and occupational health.

(2) Set the strategic direction, determine objectives, establish policy, and set program standards. In addition, the ASA(I&E) is the Headquarters, Department of the Army (HQDA) Treaty Compliance Review Manager.

b. The Assistant Secretary of the Army (Acquisition, Logistics, and Technology) (ASA(ALT)) will establish acquisition policy.

c. The Assistant Chief of Staff for Installation Management (ACSIM) is the Army proponent for Installations and will
(1) Provide policy guidance and program management on all matters relating to the overall management and resourcing of Army installations worldwide.

(2) Ensure availability of efficient, effective base services and facilities. d. The Deputy Chief of Staff, G3/5/7 (DCS, G3/5/7) has overall Army Staff (ARSTAF) responsibility for the Army Biological Surety Program. Within the G3/5/7, the Director, Strategy, Plans, Policy, and Joint/International Affairs (DAMOSS) will
(1) Establish overall policy for the surety program. (2) Function as the ARSTAF focal point for surety matters. (3) Integrate other ARSTAF program responsibilities into the overall surety program. (4) Resolve reclamas to surety inspections conducted by The Inspector General (TIG). (5) Serve as the Army Staff proponent for arms control treaty implementation and compliance. (6) Monitor the lists of Department of Health and Human Services (DHHS) and Department of Agriculture BSAT
and inform the Under Secretary of Defense for Intelligence (USD(I)) and the Assistant to the Secretary of Defense for Nuclear and Chemical and Biological Defense Programs (ATSD(NCB)) of any changes in the lists.

(7) Review for approval requests for saxitoxin and ricin submitted in accordance with appendix D, section D3. e. The Deputy Chief of Staff, G1 (DCS, G1) will establish personnel policies to support implementation of the Army Biological Surety Program.

f. The Deputy Chief of Staff, G2 (DCS, G2) will provide counterintelligence and personnel security support to the Army Biological Surety Program.

g. The Deputy Chief of Staff, G4 (DCS, G4) will establish policy for the logistical support for the Army Biological Surety Program.

h. The Deputy Chief of Staff, G8 (DCS, G8) will develop and coordinate security classification guidance, as appropriate, and provide that guidance to Department of Defense (DOD) Components to ensure consistency in classification and dissemination of information related to BSAT.

i. The Inspector General (TIG) will (1) Conduct biological surety inspections (BSIs) and biological management evaluations (BMEs) of the Army Biological Surety Program.

(2) Establish standard inspection policies, procedures, and techniques for the conduct of the inspections to include periodic coordination and consultation with HQDA offices and Army Organizations to help ensure a common understanding of regulations and guidance.

(3) Request support from the Army Staff and subordinate headquarters for the resources and expertise necessary to ensure accomplishment of the technical inspection mission.

j. The Office of the Provost Marshal General (OPMG) has overall Army Staff responsibility for the DA BSAT
Security Program. The Chief, Operations will
(1) Establish overall policy for the physical security aspects of the program. (2) Function as the Army Staff focal point for physical security matters. (3) Establish minimum physical security standards, criteria, and procedures for protecting BSAT. (4) Prepare DA Implementing Instructions to the DOD Postulated Threat to BSAT. k. The Surgeon General (TSG) will (1) Designate, in writing, a staff officer to consult on medical aspects of biological surety for HQDA. (2) Maintain a postgraduate medical education program in Occupational and Environmental Medicine for health care providers supporting biological surety facilities and installations.

(3) Provide trained staff to participate in surety management reviews and staff assistance visits. (4) Ensure that any electronic medical records used for the documentation of surety medical evaluations and/or care of personnel enrolled in a surety program support the requirements of this regulation.

l. The Chief of Public Affairs (CPA) will provide public affairs support for the Army Biological Surety Program, and coordinate public releases of information regarding BSAT at Army facilities with the Directorate, Freedom of Information and Security Review, Washington Headquarters Services, in accordance with DODI 5230.29.

m. The Judge Advocate General will provide advice on the applicability of laws to biological surety operations. n. The Director of Army Safety will (1) Develop, manage, and serve as proponent for an Army biological defense safety program per AR 38510. (2) Establish policy for investigating biological mishaps. (3) Review surveys, inspections, installation plans, and general construction plans for biological agent facilities and installations.

(4) Conduct periodic safety management evaluations of biological defense safety programs to ensure consistency with DA policy and advise the Army Staff of concerns, trends, and required corrective actions.

o. Army Commands (ACOM), Army Service Component Commands (ASCC), and Direct Reporting Units (DRU)
with BSAT missions will
(1) Establish and maintain command biological surety programs consistent with this regulation. (2) Designate, in writing, a biological surety officer as the focal point for the headquarters biological surety program.

(3) Identify, establish, and maintain training programs to support the Biological Surety Program. (4) Assess subordinate organizations for compliance with applicable surety regulatory requirements. (5) Ensure, in coordination with Installation Management Command (IMCOM), when appropriate, facilities with biological surety programs are provided appropriate installation and external support.

(6) Review, approve and submit requests for waivers and exceptions, as required. p. The Commanding General, U.S. Army Materiel Command (AMC) will (1) Assist the U.S. Army Medical Command (MEDCOM) in the development and maintenance of standard biological surety contract clauses for both on-site and off-site contractors.

(2) Designate the DOD accountability manager for Schedule 1 chemicals. (Appendix D provides guidance for ricin and saxitoxin, BSAT which are also Schedule 1 chemicals under the Chemical Weapons Convention (CWC).)
(3) Operate the Single Small Scale Facility (SSSF), for production of Schedule 1 Chemicals for research, medical, pharmaceutical, or protective purposes, per the applicable provisions of the CWC.

q. The Commanding General, U.S. Army Forces Command (FORSCOM) will provide technical escort support for the Army Biological Surety Program through the 20th Support Command, as required.

r. The Commanding General, U.S. Army Medical Command will (1) Oversee the medical aspects of the BPRP for HQDA. This includes establishing guidance for individuals performing BPRP duties regarding what medical information must be reported to the competent medical authority (CMA), guidance to the CMA describing what medical information should be considered potentially disqualifying for the BPRP, and the required medical documentation in the health record, with respect to medical assessment and information communicated to certifying officials.

(2) Provide and maintain adequately trained and resourced occupational health, industrial hygiene, and emergency medical service staff for the installation medical treatment facilities that support biological surety programs.

(3) Designate, in writing, the contracting officer's representative (COR) to review health services provided by medical contractors at facilities with biological surety programs.

(4) Serve as lead command for the maintenance of biological surety contract clauses as identified in chapter 9. (5) Determine the cost of surety operations that exceed normal or routine base medical services and forward these
"surety-unique" budget estimates and programming submissions to the surety mission commander for inclusion in the overall budget submission.

(6) Negotiate for provision of specific/specialized support required by the surety mission commander which are above and beyond the recognized and accepted common levels of support but are required by this regulation or in other mutually agreed to signed documents.

(7) Forward implementing procedures for overseas laboratory surety programs to HQDA, G3/5/7 (DAMOSSD)
for approval.

s. The Commander, Installation Management Command (IMCOM) will (1) Designate, in writing, an individual as the HQ IMCOM surety focal point. (2) Provide oversight of garrison support to tenant organizations with biological surety missions on installations within its jurisdiction.

(3) Provide assistance to surety mission commanders in resolving issues of support from the garrison commander. (4) Provide assistance to the garrison commander in coordinating Army Command surety staff assistance visits and surety management reviews of garrison elements required to be inspected by the Department of the Army Inspector General (DAIG).

(5) Provide assistance to the garrison commander in correcting deficiencies by advocating for resources and funding. (6) Coordinate the submission of surety-related waivers and exceptions from the garrison commander through HQ
IMCOM to the appropriate HQDA staff proponent.

(7) Coordinate with MEDCOM on who is responsible for providing emergency medical services (EMS) at IMCOM
installations, and where IMCOM has EMS responsibilities, ensure garrison commanders establish, train, and maintain EMS in support of biological mishaps or incidents.

t. The Director, U.S. Army Nuclear and Combating WMD Agency (USANCA) will (1) Provide advice and assistance to the ARSTAF and other Army organizations on surety matters by providing an interface between policy developers and operators.

(2) Conduct surety assistance visits when requested by the Army Command or a specific facility to enhance the effectiveness of the surety program.

( 3 )  C o o r d i n a t e  s u r e t y - r e l a t e d  i n f o r m a t i o n  w i t h  H Q D A  O D C S  G - 3 / 5 / 7  ( D A M O - S S D ) ,  a n d  p u b l i s h  t h r o u g h USANCA publications.

(4) Prepare and forward the annual BPRP status report to the USD(I). (5) Establish and maintain a database of Army facilities that work with, transfer, or store BSAT, and of Armymanaged contractors that use DOD-provided BSAT.

(6) Perform other surety-related tasks as directed by HQDA ODCS G3/5/7. u. Commanders/Directors of activities and organizations with assigned missions to maintain custody, handle, or transport BSAT will
(1) Establish command biological surety programs and publish local plans and procedures that implement and standardize the program, and ensure that any contracts incorporate these local plans and procedures.

(2) Appoint, in writing (a) A biological surety officer for the facility. (b) A responsible official (RO), alternate RO, and biological storage custodians to manage the day-to-day matters involved in the inventory management of BSAT (see chap 3).

(3) Ensure contractors are obligated to appoint biological storage custodians to request, receive, and manage DOD-
furnished BSAT in contractor-operated facilities. For Schedule 1 material (for example, ricin or saxitoxin), the contractor will notify the DOD Accountability Manager for Schedule 1 Chemicals of these appointments.

(4) Establish biological mishap and incident response plans. Facilities that are tenants on an installation will ensure facility-specific information is included in the installation response plans as appropriate.

(5) Ensure BSAT is maintained under a system of records that provide an audit trail of BSAT custody from receipt to destruction or transfer.

(6) Forward a copy of the Laboratory Registration Certificate, section 3 of the registration package and summary of select agent transfers to external agencies through the appropriate Army Command to DA, G35SSD annually in accordance with chapter 3 of this regulation.

(7) Ensure that Army Command-approved biological surety clauses are included in each contract requiring the use of Army- or DOD-provided BSAT.

(8) Ensure that contracts are modified to reflect updates to this regulation and supporting regulations. v. Garrison Commanders on installations hosting tenant organizations with a biological surety mission will (1) Develop, in coordination with the surety mission commander, surety-related waivers and exceptions (as required for garrison functions) and submit them through HQ IMCOM and/or owning Army Command channels (as appropriate) to the HQDA staff proponent. Provide a courtesy copy of all surety waiver or exemption requests to the surety mission commander.

(2) Ensure garrison functions in support of surety tenants are adequately staffed, resourced, trained, and executed in accordance with policy/guidance.

(3) Support the surety mission commander with common levels of support as provided to other tenant organizations on the installation.

(4) Determine the cost of support functions for surety operations which are above and beyond the recognized and accepted common levels of support, but are required by this regulation or in other mutually agreed to signed documents. Forward these "surety unique" budget estimates and programming submissions through appropriate command channels for inclusion in the overall budget submission.

(5) Support biological mishap or incident response exercises per chapter 7. (6) Ensure relevant garrison staff elements support surety assistance visits and inspections.

15. Biological surety program concept a. Biological surety activities include (1) Compliance with mandated and approved safety, environmental, occupational health, operational, and technical procedures.

(2) Physical security measures to preclude unauthorized access to or use of BSAT. (3) Procedures to assess the reliability of personnel designated for, or assigned to, BPRP duty positions. (4) Training and/or experience applicable to the position assigned and verification that each individual is proficient in the duties to be performed.

(5) Safe and secure acquisition, storage, handling, maintenance, transportation, inventory management, and disposal of BSAT.

(6) Emergency response to biological mishaps and incidents. (7) Assessment of organizations that possess, use or transfer BSAT and the organizations that support the surety effort.

b. This regulation applies to contractors who have access to Army- or DOD-supplied BSAT. Where requirements pertaining to contractors differ from those for military or DOD civilian employees, they are discussed in the body of the text. In addition, chapter 9 provides a consolidated index of contractor requirements. Applicability of this regulation for transfer of BSAT to non-Army organizations is addressed in chapter 3.

c. Commanders/Directors may cite this regulation as the authority for requesting resources necessary to meet the safety, security or personnel reliability requirements of BSAT operations.

d. Commanders/Directors will restrict access to BSAT to authorized persons and keep the number of persons allowed such access to a minimum consistent with mission, safety, and security requirements.

e. Commands will forward requests with recommendations for exceptions and waivers to the policies in this regulation through command channels to HQDA ODCS G3/5/7, ATTN: DAMOSSD, 400 Army Pentagon, Washington, DC 203100400.

(1) Requests for exceptions and waivers will identify compensatory measures, as appropriate. (2) A request for a waiver must include the plan of action and milestones to correct the circumstances requiring the waiver.

f. Material weaknesses will be reported in compliance with AR 112, paragraphs 26 and 29. g. The Army is, and will remain, in compliance with international treaties to which the United States is a party, including the Biological Weapons Convention and the Chemical Weapons Convention.

h. Users of this regulation will establish written local procedures to facilitate the implementation of this regulation.

The biological surety program is a commander's/director's program therefore, when a process is established that is neither prescribed nor prohibited by this regulation, the judgment of the commander/director shall take precedence. For purposes of this regulation, "Commander/Director" is the individual with responsibility for executing the biological surety mission.

16. Initiation and termination of facility surety status a. The ACOM, ASCC, or DRU will notify HQDA ODCS G3/5/7 (DAMOSSD) at least sixty days prior to receipt of BSAT at any new DOD BSAT facility.

b. Army facilities that have terminated work with BSAT will notify HQDA ODCS G3/5/7 (DAMOSSD) through command channels when BSAT are no longer maintained at the facility.

c. The HQDA ODCS G3/5/7 (DAMOSSD) will furnish a copy of new facility notifications (prior to initial operation of the facilities) and notification of facilities that have terminated BSAT work to the Assistant to the S e c r e t a r y  o f  D e f e n s e  ( N u c l e a r ,  C h e m i c a l ,  a n d  B i o l o g i c a l  M a t t e r s )  ( A T S D ( N C B ) ) .  T h e  H Q D A  O D C S  G - 3 / 5 / 7 (DAMOSSD) will also notify HQDA Office of The Inspector General (OTIG), ATTN: SAIGTI, so the facility can be scheduled for inspection, and USANCA, ATTN: MONACWZ for inclusion in the BSAT facility database.

d. Termination of the biological surety mission does not abrogate responsibility to maintain a safety program commensurate with remaining missions. These facilities will continue to comply with biological event reporting requirements.

17. Surety officers and surety boards a. Biological surety officers.

(1) The commander or director of a facility with a biological surety mission will appoint a biological surety officer in writing. IMCOM and the ACOM/ASCC/DRU responsible for supporting biological surety programs will designate a biological surety officer in writing. Commands between facility and ACOM/ASCC/DRU level may appoint biological surety officers at their discretion. The biological surety officer may be a part-time or full-time duty depending on the facility mission.

(2) Biological surety officers will (a) Manage day-to-day operations of the biological surety program. (b) Monitor and evaluate the biological surety program. (c) Act as the focal point for biological surety matters. (d) Monitor biological safety, security, mishap and incident response, inventory management, and personnel reliability to ensure these programs are receiving the necessary emphasis.

(e) Expeditiously bring any apparent incidents or shortcomings to the attention of the commander/director. (f) Serve as liaison with organizations that provide external support to the biological surety mission. (3) Contractor Biological Surety Officers. For contracts that require access to Army- or DOD-supplied BSAT, the contracting organization will ensure that the statement of work requires the designation in writing of a contractor biological surety officer. The contractor biological surety officer or equivalent will have responsibilities as identified in paragraph (2)(a) to (d) above, and will expeditiously bring any apparent incidents or shortcomings to the attention of the contracting officer's representative. The contractor biological surety officer's position should be designated as a "key position." The individual selected as contractor biological surety officer must have the technical knowledge of biological agent operations and experience or training in surety procedures. The contractor biological surety officer may be part-time or full-time duty depending on contract requirements.

b. Biological surety boards. The commander/director of a facility with a biological surety mission will establish a local biological surety board to assist in managing the biological surety program. The composition of the board depends on the command's mission and the staff elements and external supporting agencies that support it. The commander/director who establishes a board will document its composition and responsibilities (local standing operating procedure (SOP), memorandum, or charter). For facilities on installations with multiple surety missions, the surety board may be consolidated at the installation level.

## Chapter 2 Personnel Reliability Section I Introduction

21. General a. This chapter establishes the Biological Personnel Reliability Program (BPRP) as a tool for commanders/directors to make risk-based assessment decisions to ensure that persons with access to biological select agents and toxins (BSAT) meet high standards of reliability. The BPRP includes
(1) Identifying positions with duties that afford access to BSAT. (2) Designating certifying officials who will certify the reliability and suitability of individuals for the BPRP
(described below).

(3) Screening, evaluating, and certifying individuals for the BPRP (Section III). (4) Continuing evaluation in the form of periodic reinvestigations (PR), drug tests, and evaluation by supervisors, fellow workers, certifying officials, and support agency personnel, as well as self-reporting by individuals enrolled in the BPRP (Section IV).

(5) Removing an individual from BPRP duties due to medical restriction, suspension, disqualification, or administrative termination (Section V).

b. Explosive ordnance disposal (EOD) and mishap/incident response personnel are not required to meet the reliability standards of this chapter and will be given access to BSAT only to the extent necessary to mitigate or eliminate a hazard during an emergency.

c. Requests for access by foreign nationals to BSAT under authorized visits, assignments or exchanges will be processed in accordance with DOD Directive 5230.20, AR 38010, and DOD 5200.2R.

d. To ensure compliance with the Privacy Act of 1974 and AR 34021, all personnel who wish to be considered for assignment to BPRP duties must grant authority for release of information and records to allow the certifying official and other authorized officials to receive and review medically potentially disqualifying information, and to review personnel and security files. If an individual does not grant permission for the records check and review, that person is not eligible for BPRP duties. (Exception: Eligibility for BPRP duties will not be affected if DOD contractor and government civilian employees decline to provide written consent to release drug/substance or alcohol abuse information. See paragraph 213b).

e. At facilities or installations where individuals may be in multiple personnel reliability programs (for example, the biological and chemical PRP), separate screening is not required for each program. Written local procedures will address PRP processing for such individuals, to include addressing any program differences and training requirements specific to each program. Procedures for transferring between PRP programs are covered in paragraph 21.

f. An individual who is certified in another DOD PRP can be accepted into the BPRP at the discretion of the facility commander/director.

g. Commanders/directors may authorize escorted and/or supervised access to BSAT for individuals who are not in the BPRP but who have a favorably-adjudicated personnel security investigation (PSI) per paragraphs 212b and 212c and who meet the requirements of paragraph 21h. Only BPRP-certified persons can conduct the escort/supervision.

h. Any individual who requires access to BSAT as defined in paragraph 22a, must first have valid approval based on a security risk assessment per Title 42, Code of Federal Regulations, Part 73 (42 CFR 73), 7 CFR 331, or 9 CFR 121 (see app C).

22. Identifying Biological Personnel Reliability Program duties a. Commanders/directors responsible for BSAT will identify each position that requires access to BSAT. Contractor organizations responsible for DOD-provided BSAT will recommend in writing to the COR those BPRP duty positions required for the operation of their facility. The COR is responsible for approving the list of positions. Although the following list is not all-inclusive, BPRP duty positions are held by personnel who
(1) Require routine access to BSAT. In cases where access is required "routinely," but "infrequently," the commander/director will make the decision whether or not the person is granted access or requires escort.

(2) Are authorized to escort visitors to areas containing BSAT. (3) Control direct access to BSAT material. (4) Issue proximity cards, personal identification numbers, keys, combinations, biometric codes, or any other mechanism that provides direct access to BSAT materiel.

(5) Are Army motor vehicle operators transporting BSAT unless the driver is accompanied by a BPRP-certified escort.

(6) Are responsible officials and alternate responsible officials. b. Commanders/Directors may authorize individuals who are not in the BPRP to have access to and work with BSAT. Such individuals must have a favorably adjudicated PSI per paragraphs 2-12b and c, and must be supervised by a BPRP-certified person.

23. Certifying and reviewing officials a. Commanders/directors will act as certifying officials and/or designate, in writing, certifying official(s), to certify an individual's reliability and suitability for the BPRP. The decision to designate certifying officials and the selection of the individuals so designated is entirely at the commander's/director's discretion. Optimally, the certifying official is a person in the individual's supervisory chain, such as a supervisor, team leader, laboratory manager, department head, or the deputy commander/director or equivalent.

b. Certifying officials must be military or DOD civilian personnel. DOD contract personnel are prohibited from acting as certifying officials. At government-owned, contractor-operated (GOCO) and contractor-owned, contractoroperated (COCO) facilities, the contracting officer (either the procuring contracting officer or the administrative contracting officer) will designate, in writing, the Army COR or other appropriate military or DOD civilian as the certifying official.

c. A commander/director (or a contracting officer in the case of paragraph 23b) who designates certifying officials becomes the reviewing official for those certifying officials. In cases where the commander/director is a certifying official, then his or her rater becomes the reviewing official.

d. Commanders/directors may appoint BPRP monitors to assist certifying officials in administering day-to-day functions. The BPRP monitors may also be appointed at installation or activity level to administer the consolidated day-to-day functions of multiple certifying officials. The BPRP monitor duties include coordinating and disseminating BPRP information, training PRP personnel on reliability objectives and procedures, and maintaining the biological duty position roster (BDPR) (para 24).

e. Unless otherwise required by paragraph 22, or unless directed by the commander/director, the position of certifying official or designated monitor is not a BPRP duty position.

f. Administration Officials. (1) At COCO and GOCO facilities, the certifying official may designate one or more senior supervisory contractor employees to serve as the BPRP administration official(s) to assist in administering day-to-day certifying official duties. The contractor must nominate the administration official and the COR must approve the nomination. The administration official will be enrolled in the BPRP.

(2) The BPRP administration official may perform all duties normally associated with the certifying official except for the decision-making functions of determining BPRP suitability, the review of potentially disqualifying information (PDI) gained through security investigations, and disqualifying personnel from the BPRP. The certifying official must complete DA Form 3180, parts V and IX. The BPRP administration official may be delegated the authority to sign part VI.

(3) The BPRP administration official may be delegated the authority to medically restrict an individual from performing duties with BSAT; and to remove medical restrictions he/she has imposed, based on CMA recommendation. However, in cases where the individual does not wish medical authorities to forward such personal information to the BPRP administration official, the certifying official must execute the medical restriction. Written local procedures will address procedures for informing the individual of this option.

g. A facility commander/director may be in a BPRP position as identified in paragraph 22. Such commanders/
directors will be certified by their rater. The commander's/director's position will be listed on the facility BDPR. The reviewing official for such a commander/director will be the senior rater.

h. See paragraph 217 for procedures when a certifying official changes or is absent when a required BPRP action must be completed for personnel already in the BPRP.

24. Biological duty position roster a. Each commander/director responsible for BSAT will establish and maintain a biological duty position roster
(BDPR). The BDPR will be used as a management tool by the certifying official and the commander/director. The BDPR identifies individuals certified and assigned by the certifying official to those BPRP duty positions established by the commander/director. Each commander/director responsible for BSAT will determine whether to institute a consolidated BDPR or separate BDPRs maintained by individual certifying officials.

b. The BDPR will contain, at a minimum, the following information, formatted in accordance with written local procedures:
(1) Effective date. (2) Unit or organization. (3) Name. (4) Last 4 digits of social security number (SSN). (5) Job title or BPRP duty per local procedure. (6) Interim certification status, if applicable, based on personnel security investigation status. (7) Names of certifying official and reviewing official for the certified individuals. c. The BDPR will be authenticated (for example, signature or electronic authentication) and distributed per local procedures to the offices supporting the BPRP.

d. Certifying officials will ensure that individuals who are administratively terminated or disqualified are removed from the BDPR.

e. At facilities or installations where individuals may be in multiple personnel reliability programs (for example, the biological and chemical PRP), a combined duty positions roster may be established in accordance with written local procedures.

## Section Ii Standards

25. Reliability assessment a. Persons who do not meet BPRP standards will not perform BPRP duties. The certifying official will make a judgment on the reliability and suitability of an individual for a BPRP duty position. In the absence of mandatory disqualifying factors, the certifying official will consider both affirmative qualifying factors and potentially disqualifying factors. Although the certifying official may request information or advice from any support agency or activity capable of providing or interpreting such information, the decision to qualify an individual for, or to disqualify an individual from the BPRP, is the responsibility of the certifying official.

Note. No one will be entered into the BPRP until the certifying official screens and certifies the individual as reliable and suitable for specific BPRP duties assigned.
b. Certifying officials will (1) Determine reliability and suitability and ensure that individuals are appropriately qualified and trained before
being assigned to BPRP duties.
(2) Continuously evaluate personnel assigned to BPRP duty positions. (3) Suspend from BPRP duties any individual whose reliability becomes suspect. If the individual being suspended
is an on-site contractor, the government certifying official will remove the individual from the BPRP duties. If the individual being suspended is an off-site contractor, the government certifying official will direct the contractor to remove the individual from BPRP duties. The certifying official will expeditiously resolve the issue and either reinstate or disqualify the individual.

c. Section III describes the following sources of information the certifying official will use to determine that the individual is qualified for the BPRP:
(1) Initial interview. (2) Personnel Security Investigation (PSI). (3) Personnel records review. (4) Medical evaluation. (5) Drug testing. d. The reviewing official may monitor certifying official decisions to qualify individuals to oversee the status or quality of the program, and may overturn certifying official decisions to qualify individuals when procedures have been unfairly, inconsistently, or incorrectly applied. Reviewing officials will review all disqualification decisions per paragraph 226.

e. Individuals who were appropriately certified into the BPRP under previous guidance are not required to be rescreened using the standards of this regulation except in circumstances addressed in paragraph 217. However, the standards for continuing evaluation in this regulation do apply.

26. Qualifying factors/requirements The following are the general suitability and reliability standards expected of all BPRP members:
a. Individuals will be mentally alert, mentally and emotionally stable, trustworthy, physically competent, and free of unstable medical conditions. This includes dependability in accepting responsibilities and effectively performing in an approved manner, flexibility in adjusting to changes in the working environment, good social adjustment, ability to exercise sound judgment in meeting adverse or emergency situations, physical ability to perform duties required by the position, and positive attitude toward BPRP duties and the BPRP.

b. Individuals will be the subject of a current and favorably adjudicated PSI per paragraph 212. c. Individuals will be free from drug/substance and alcohol abuse and/or dependence and will participate in initial and periodic testing on a random basis to ensure the deterrent value of testing and to ensure that each individual is tested at least once in a twelve month period. For additional contractor requirements, see paragraph 221 of this regulation.

d. Individuals will comply with training requirements specified in local SOPs, plans, and regulations for the biological duties they perform.

e. Foreign nationals (including local nationals at facilities outside of the United States) are eligible for certification into the BPRP provided they are not restricted persons as designated by the USA PATRIOT Act (Public Law 10756) (see app C). In general, foreign nationals are restricted persons if
(1) They are illegally or unlawfully in the United States, or (2) They are a national of a country currently determined by the Secretary of State to repeatedly have provided support for acts of international terrorism, and have not been lawfully admitted into the United States for permanent residence.

27. Mandatory disqualifying factors The certifying official will disqualify individuals from the BPRP when any of the traits, diagnoses, conditions, or conduct listed below exists. The certifying official will submit disqualification actions to the reviewing official for review. If, during this review, the reviewing official discovers extraordinary circumstances that warrant an exception to disqualification, he or she may submit a request through Army Command channels to HQDA, ODCS G3/5/7, ATTN: DAMOSSD. The individual remains disqualified until and unless the exception is approved.

a. Current diagnosis of drug/substance or alcohol dependence based on a determination by an appropriate medical authority in accordance with the current Diagnostic and Statistical Manual of Mental Disorders (DSM) of the American Psychiatric Association.

b. Drug/substance abuse within the five years previous to the initial BPRP interview. Certifying officials having any doubt on the status of a certain drug as illegal or controlled should consult the CMA, local law enforcement officials, or the supporting legal office. Exceptions: isolated incidents of use of another person's prescribed drug, self-medication exceeding the recommended safe dosage on the medication's packaging of over the counter substances, or improper use of an individual's own prescribed medications will be evaluated per paragraph 28 of this regulation.

c. Trafficking in illegal or controlled drugs as well as cultivating, processing, or manufacturing illegal or controlled drugs within the last 15 years.

d. Drug/substance abuse while enrolled in the BPRP, whether admitted or as the result of a verified positive drug test. Exceptions: isolated incidents of use of another person's prescribed drug, self-medication exceeding the recommended safe dosage on the medication's packaging of over the counter substances, or improper use of an individual's own prescribed medications will be evaluated per paragraph 28 of this regulation.

e. Inability to meet safety requirements, such as unable to correctly wear personal protective equipment required for the assigned position, other than temporary medical conditions. Questions regarding the duration of medical conditions will be referred to the CMA.

f. Meeting the criteria of a Restricted Person (see glossary).

Note. For individuals requiring Centers for Disease Control and Prevention (CDC) or Animal and Plant Health Inspection Service (APHIS) registration for access to BSAT, such registration is sufficient determination that the individual is not a restricted person.

28. Other disqualifying factors Any of the following traits, diagnoses, conditions, or conduct listed below may be grounds for the disqualification of an individual from the BPRP, based on the certifying official's informed judgment.

a. Alcohol-related incidents/abusing alcohol.

(1) Certifying officials will evaluate the circumstances of alcohol-related incidents that occurred in the five years prior to the initial interview and request a medical evaluation. An individual diagnosed through such medical evaluation as currently alcohol-dependent will be disqualified per paragraph 27a. Individuals diagnosed as abusing alcohol will be handled per paragraph (2) below. For an individual not diagnosed as a current alcohol-dependent/ abusing alcohol, including those individuals identified as recovering alcoholics, the certifying official will determine reliability based on results of the investigation, the medical evaluation, and any extenuating or mitigating circumstances (such as successful completion of a rehabilitation program). The certifying official will, as appropriate, then qualify or disqualify the individual from the BPRP.

(2) Individuals diagnosed as abusing alcohol but who are not alcohol-dependent shall, at a minimum, be suspended from BPRP processing pending completion of the rehabilitation program or treatment regimen prescribed by the CMA. Before the individual is certified into the program, the certifying official will assess whether the individual has displayed positive changes in job reliability and lifestyle, and whether the individual has a favorable medical prognosis from the CMA and a psychological evaluation is completed. The individual will complete a 1 year period of strict compliance with an aftercare program. Failure to satisfactorily meet these requirements shall result in disqualification.

b. Drug/substance abuse.

(1) In situations not otherwise addressed in paragraph 27b, a certifying official may qualify or disqualify an individual who has abused drugs/substances more than five years before the initial PRP interview. In deciding whether or not to disqualify individuals in these cases, the certifying official will request CMA evaluation and may consider extenuating or mitigating circumstances. To qualify the individual for the BPRP, the certifying official's documentation of the PDI (para 215a) must include an approval signed by the reviewing official. If the reviewing official does not approve, the individual will be disqualified from the BPRP (para 226). Examples of potential extenuating or mitigating circumstances include, but are not limited to
(a) Successful completion of a drug rehabilitation program. (b) Participation in a twelve-step program. (c) Isolated experimental drug abuse. (d) Age at the time of the drug abuse ("youthful indiscretion"). (2) Certifying officials may qualify or disqualify individuals who have isolated episodes of use of another's prescription drugs, or who, in an effort to self-medicate, inadvertently or deliberately exceed the recommended safe dosage on the medication's packaging of over the counter substances, or who improperly use their own prescribed medications.

(a) If the use occurred while the individual was enrolled in the BPRP, the certifying official will request CMA
evaluation. If the certifying official believes the use does not represent a reliability concern and desires to retain the individual in the BPRP, the documentation recording the PDI (para 215a) must include an approval signed by the reviewing official. If the reviewing official does not approve, the individual will be disqualified from the BPRP (para 226).

(b) If the abuse occurred within 15 years before the initial BPRP interview, the certifying official will request CMA
evaluation. Certifying officials will consider such abuse in conjunction with other PDI in determining reliability of the individual.

c. Medical condition.

(1) Any significant mental or physical medical condition, medication usage, or medical treatment, which may result in
(a) An altered state of consciousness. (b) Impaired judgment or concentration. (c) Increased risk of impairment if exposed to biological agents. (d) Impaired ability to safely wear personal protective equipment required for the biological surety position, or
(e) Inability to perform the physical requirements of the biological surety position, as substantiated by a CMA to the certifying official.

(2) Medical information that falls within these parameters is disqualifying if and when the certifying official considers it prejudicial to reliable performance of BPRP duties.

(3) The CMA will evaluate individuals and make recommendations to the certifying official on suitability for duty in the BPRP for individuals currently under treatment with hypnotherapy.

(4) The CMA will obtain a mental health assessment, evaluate individuals, and make recommendations to the certifying official on suitability for duty in the BPRP for individuals who have attempted or threatened suicide before entry into the BPRP or while enrolled in the BPRP. To qualify individuals who have attempted or threatened suicide while enrolled in the BPRP, the certifying official's documentation of the PDI (para 215a) must include an approval signed by the reviewing official.

d. Inappropriate attitude, conduct, or behavior. In determining reliability, the certifying official will conduct a careful and balanced evaluation of all aspects of an individual. Specific factors to consider include, but are not limited to
(1) Negligence or delinquency in performance of duty. (2) Conviction of, or involvement in, a serious incident indicating a contemptuous attitude toward the law, regulations, or other duly constituted authority. Serious incidents include, but are not limited to assault, sexual misconduct, financial irresponsibility, contempt of court, making false official statements, habitual violation of traffic laws, and domestic violence.

(3) Poor attitude or lack of motivation. Poor attitude can include arrogance, inflexibility, suspiciousness, hostility, flippancy toward BPRP responsibilities, and extreme moods or mood swings.

(4) Aggressive/threatening behavior toward other individuals. (5) Attempting to conceal PDI from certifying officials through false or misleading statements, or by willfully neglecting to report current PDI.

## Section Iii Screening Process

29. DA Form 3180
a. DA Form 3180 (Personnel Screening and Evaluation Record) will be completed for each individual screened and evaluated for the BPRP. The sequence of medical and personnel screening and administrative processing may be adapted to meet the needs of the certifying official or agencies.

b. All signatures on the original DA Form 3180 will be in ink. Facsimile stamps will not be used for signatures on the DA Form 3180. Any facility that institutes procedures for electronic processing of the DA Form 3180 will ensure that electronic signatures are used as appropriate to validate the form.

c. Errors in the DA Form 3180 discovered prior to initial certification will be corrected by lining through the error and/or inserting the correction as appropriate, and initialing and dating the correction.

d. Corrections to errors discovered after the individual is enrolled into the BPRP should be documented in Part VI
of the DA Form 3180 and (if necessary) by placing additional documentation in the individual's file as appropriate.

e. DA Form 3180, Part VI can also be used to document changes in the individual's status and/or administrative data (for example, movement from interim-certified to fully-certified, change in job, change in grade, and so forth).

f. Any DA Form 3180 initiated prior to publication of this regulation remains in effect and does NOT need to be redone.

210. Initial interview a. The certifying official (or representative(s) designated in writing) will conduct a personal interview with each candidate for BPRP duties to look for evidence of the individual's perception of responsibility, exercise of sound judgment, effective performance, and ability to adjust to changes in the work environment. In addition, the certifying official will
(1) Inform the candidate of the Privacy Act of 1974, AR 34021, and the Health Insurance Portability and Accountability Act (HIPAA). If the candidate objects to the required screening, the screening process will be discontinued.

(2) Inform the candidate that he/she will be subject to random drug testing on an unannounced basis as a condition of certification in the BPRP, and that an initial negative test will be required prior to certification. For contractor requirements, see paragraph 221 of this regulation.

(3) Review with the candidate the concept of the BPRP and the reliability standards, both qualifying and disqualifying (section III) for assignment to or retention in a BPRP position. The certifying official will ensure that the candidate understands the traits and conduct normally considered disqualifying.

(4) Determine whether any of the traits or conduct normally considered disqualifying exist. (5) Explain that personnel assigned to BPRP duty positions may be required to wear personal protective equipment.

If there is any concern about an individual's ability to wear personal protective equipment, the matter will be resolved promptly.

(6) Explain the importance of BPRP assignments and the responsibilities involved in associated BPRP duties. (7) Explain the continuing evaluation aspects of the BPRP to include each individual's responsibility to actively participate in this evaluation and that personnel found suitable for BPRP duties remain under continual evaluation until either disqualified or administratively terminated.

(8) Explain the requirement to self-report information, such as the use of prescribed drugs, which may have a bearing on performance of PRP duties. Failure to self-report may be considered a disqualifying factor, as per paragraph 28d(5).

(9) Complete the appropriate section of DA Form 3180. b. The certifying official may make a determination of an individual's unsuitability at any time during the screening process, and terminate the evaluation. If the candidate is found to be unsuitable for the BPRP, the certifying official will terminate the BPRP screening process and follow procedures for disqualification (para 226). For civil service applicants who are not current Federal employees, the certifying official will terminate the screening process and return the interview referral slip to the placement specialist.

c. Should the certifying official determine that the candidate is acceptable for further screening, the screening process will be completed in accordance with written local procedures.

211. Personnel records screening The supporting personnel officer (or contractor's personnel manager) or representative (designated in writing) will screen the individual's personnel records. The screening official will
a. Determine the individual's citizenship and identify it to the certifying official. b. Determine if the individual's personnel records contain information that may preclude assignment to a BPRP
position (see para 27 and 28). When potentially disqualifying information (PDI) is identified, provide it to the certifying official per local procedures, assuring Privacy Act requirements are not violated.

c. Process the DA Form 3180 (as appropriate) in accordance with written local procedures.

212. Personnel security records screening a. The security manager or a representative (designated in writing) will determine whether (1) The PSI is valid and favorably adjudicated for BPRP purposes (paras 212b and c). If the PSI is not valid for BPRP, the security manager will notify the certifying official per local procedures.

(2) Local security records (EPSQ, SF 85 (Questionaire for Non-Sensitive Positions)/SF 86 (Questionaire for National Security Positions) or equivalent questionnaires) contain PDI. When PDI is identified, provide it to the certifying official per local procedures, assuring Privacy Act requirements are not violated. In the case of medical, drug, or alcohol-related PDI uncovered through a records check, consult the CMA to determine the need for further evaluation.

b. Personnel scheduled for initial assignment to BPRP positions must have the appropriate and favorably adjudicated PSI completed within the 5 years preceding certification to the BPRP. The minimum PSI required for military or contractor employees is the National Agency Check with Local Agency and Credit Check (NACLC). Access to BSAT and classified information for consultants will be adjudicated in accordance with DOD 5200.2R. The minimum PSI for DOD civilian employees is the Access National Agency Check with Credit Checks and Written Inquiries (ANACI). A NACLC is also acceptable for civilian employees. In cases where the investigation ended more than 5 years before BPRP certification, the PSI is outdated for BPRP purposes and a new investigation is required. Foreign nationals (including local nationals at facilities outside of the United States) with requirements for both access to classified information and access to BSAT will be adjudicated in accordance with a Limited Access Authorization (LAA) in lieu of NACLCs or ANACIs per DOD 5200.2R.

c. The PSI is considered favorably adjudicated in any of the following circumstances: (1) The DOD-authorized central adjudication facility has granted the individual a security clearance of SECRET or higher, or has determined that the individual is eligible for a secret clearance. In either case, dossier review is not required.

(2) The PSI has no derogatory information (a "non-issue" PSI), based either on a "non-issue" case code or on contact with the investigating agency. In this case, dossier review is not required.

(3) The certifying official has requested the PSI investigative files (dossier) per AR 38145 for review, the certifying official has reviewed the PSI investigative files against the criteria in paragraphs 27 and 28, and the certifying official has determined that the individual meets the reliability requirements of this regulation. The certifying official will document PDI per paragraph 215a.

(a) Note that PSI investigative files contain sensitive information, and the provisions of DOD 5200.2R apply.

Individuals reviewing dossiers must have at a minimum a National Agency Check with Local Agency and Credit Check (NACLC) or Access National Agency Check with Credit Checks and Written Inquiries (ANACI) found to be favorable for government employment.

(b) PSI investigative files will be retained only for the time necessary to determine suitability for the BPRP, and will be destroyed no later than 90 days following the suitability determination (for disqualifications, no later than 90 days following the reviewing official's review of the disqualification).

(c) Certifying officials will not conduct independent investigations into unsubstantiated allegations in the PSI
investigative files. If the allegations are relevant to the criteria in paragraphs 27 and 28, the certifying official will consider the allegation in light of other information available during screening. If the individual is found to be reliable, document the PDI per paragraph 215a, but without reference to information that would identify the person making the allegation (for example, "The dossier reflected a single unsubstantiated allegation of drug use over 10 years ago," followed by the certifying official's decision.).

d. A security clearance is not required for qualification into the BPRP, and will not be requested solely for that purpose. If access to classified information is required for the assignment, certifying officials will follow the provisions of AR 38067 and DOD 5200.2R.

e. Interim certification. (1) In circumstances where official functions must be performed prior to completion of the investigation and adjudication process, the certifying official may grant interim BPRP certification, provided the request for the PSI has been submitted (electronically transmitted or mailed to the investigating agency) and all other requirements of the BPRP screening process have been completed
(a) If the appropriate PSI was completed less than ten years before BPRP certification.

(b) If the PSI is at a level less than a NACLC or ANACI, provided the PSI was completed less than five years before BPRP certification.

(c) In any other circumstance, if a certifying official determines that a person's expertise is critical to the performance of an official government mission, the certifying official may submit a written request for interim certification to the ACOM/ASCC/DRU for adjudication. The ACOM/ASCC/DRU may grant or deny interim certification, and will establish conditions or require compensatory measures for the interim certification.

(2) Once granted, interim certification will be valid until completion of the requested PSI and adjudication.

However, the certifying official may revoke it at any time based on unfavorable information identified in the course of the investigation, or if the certifying official has reason to suspect the person's reliability.

(3) Interim-certified individuals must be identified to supervisory personnel, personnel who directly control access to exclusion areas, and others, as necessary. The BDPR, entry authorization lists, and any individual access badges (if used) must be specifically marked to designate interim certification status. Interim-certified individuals will not have access to BSAT unless escorted by a fully-BPRP-certified individual.

(4) The certifying official will enter a date in DA Form 3180, Part V, to indicate the individual's interim certification status. DA Form 3180, Part VI will be used to record the individual's move from interim-certified status to fully-certified status.

f. When security records reviews are completed, complete and process the DA Form 3180 in accordance with written local procedures.

213. Medical evaluation a. The certifying official must be confident that the individual meets the standards of paragraph 26a. The primary responsibility of the CMA is to identify to the certifying official any PDI that may reflect on an individual's suitability for assignment to a BPRP position, and to provide a recommendation to the certifying official as to whether the PDI will preclude the individual from performing BPRP duties. Significant medical conditions that may constitute medical PDI are defined in paragraph 28c of this regulation.

(1) The CMA will review the military health records or government civilian employee medical records. The individual may also provide copies of their medical records from their personal health care provider, if outside MEDCOM. The CMA can review contractor records consistent with the on-site contract.

(2) If available medical records are incomplete, inadequate, or unavailable, the CMA will conduct a medical evaluation to determine medical qualification under BPRP standards. The medical evaluation will include a mental health consultation if either the CMA determines that such an evaluation is prudent or the certifying official requests it. The CMA will make a medical entry to document all significant medical conditions in the individual's medical/health records along with the medical reasoning why the conditions are or are not potentially disqualifying.

(3) The CMA will annotate the medical record entry with a statement indicating that the individual and/or individual's records have been screened under the reliability standards of this regulation. If the CMA identified PDI, the medical record entry will indicate the nature of the PDI and the date the certifying official was notified. The medical record entry will include the name, grade, and signature of the CMA and the date of the screening.

(4) The CMA will complete the appropriate section of DA Form 3180. If PDI was identified, the CMA will provide an evaluation and recommendation to the certifying official in sufficient detail so he or she can make a sound decision concerning the individual's suitability for the BPRP. The CMA will provide this information to the certifying official per local, DOD, DA, and MEDCOM procedures, assuring provisions of the Privacy Act, The Army Privacy Program, and the Health Insurance Portability and Accountability Act (HIPAA) are not violated. The DA Form 3180 will be processed in accordance with written local procedures.

(5) The CMA's recommendation will identify any limitations in duties or reasonable accommodations that might allow the individual to safely and reliably perform BPRP duties (see Title 42, United States Code, Chapter 126 (42 USC Chapter 126), and implementing regulations in 29 CFR Part 1630). The certifying official may request a safety assessment of the reasonable accommodation, if desired. Worker safety will not be compromised. Accommodations that could cause injury to the individual or another worker will not be implemented.

b. The Army Substance Abuse Program (ASAP) Clinical Director will make available to the certifying official all PDI related to a Soldier's participation in ASAP clinical services: screening, evaluation, and counseling (authorized under AR 60085, para 74). For civilian personnel, the authority to review health records in the Employee Assistance Program (EAP) (established by 5 USC 7904) is limited by 42 USC 290dd2, as implemented by 42 CFR Part 2, which prohibits the release of drug/substance abuse information from the patient's records without the patient's written consent. Certifying officials cannot require civilian employees to release this information as a condition of employment or entry into the BPRP. Certifying officials must rely on the continuing evaluation aspects of the BPRP in such circumstances to detect drug/substance abuse/dependence problems.

c. Certifying and reviewing officials may not release or discuss the content of health records, except as provided in the preceding paragraphs or as otherwise permitted by the Privacy Act of 1974, AR 34021, and HIPAA Privacy and Security Rules. Certifying and reviewing officials may refer questions concerning this restriction to their servicing legal office.

d. Certifying officials of organizations receiving medical support from non-Army medical facilities or contract physicians will provide a copy of this regulation and any MEDCOM guidance on medical PDI to the supporting medical facility contract physicians for use in evaluating personnel for the BPRP.

e. Dental records screening is not required for the BPRP. The CMA should screen for active dental conditions that may be potentially disqualifying during the medical evaluation.

214. Drug testing Upon approval by appropriate authority, all candidates for the BPRP must complete drug testing per AR 60085 within six months prior to initial certification into the BPRP. All drug test results will be submitted to the certifying official before the individual is certified into the BPRP, and positive test results indicating illegal drug use will result in disqualification. Provisions in AR 60085 pertaining to medical review of screening results will apply to the BPRP. Note that the requirement for written consent identified in paragraph 213b does not apply to drug testing conducted under the provisions of AR 60085. Drug tests reported as "verified positive" or "refusal to test" will be reported to the certifying official and will result in disqualification. Initial drug testing will be documented on DA Form 3180, Part IV in accordance with written local procedures.

215. Certifying official's evaluation and briefing After the screening process is completed, the certifying official will review DA Form 3180 and any PDI provided during the screening process.

a. If the certifying official determines that PDI identified during the screening is not disqualifying, he or she will document the PDI and the decision in accordance with written local procedures. (Medical PDI will be identified merely as "medical PDI from CMA.") The certifying official will maintain this documentation until the individual is administratively terminated or disqualified from the BPRP, when it will be destroyed.

b. The certifying official will ensure that all core safety, security, and emergency training is completed and documented per local SOPs, plans, and regulations.

c. For individuals found suitable for interim- or full-certification into the BPRP, the certifying official will complete the appropriate section of DA Form 3180, and brief the individual in the following areas:
(1) The individual has been found suitable for the BPRP. (2) The duties and responsibilities of the individual's BPRP position, to include the required use of personal protective equipment.

(3) Each person's obligations under the continuing evaluation aspects of the BPRP (per Section V). (4) A review of the disqualifying factors in paragraph 26 through 28. This includes a discussion of any incidents or medical issues that have occurred since the initial interview.

(5) The use of all prescription drugs must be under the supervision of a health care provider. While in the BPRP, any use of drugs prescribed for another person is unacceptable and must be reported to the certifying official immediately for evaluation.

(6) Any restrictions placed on an individual due to interim certification requirements. d. At the close of the briefing, the individual and the certifying official will complete the appropriate section of DA
Form 3180. The individual's signature indicates that a briefing on the standards and objectives of the BPRP was received and understood. Once a determination regarding an individual's certification for access to BSAT is made, the Certifying Official will notify the Responsible Official. The certifying official will retain the original DA Form 3180 and ensure distribution according to local procedures as follows:
(1) One copy to be retained in the individual's official personnel records.

(2) One copy to the CMA.

e. If the certifying official determines an individual unsuitable for a BPRP assignment, the certifying official will terminate the screening process, complete the appropriate section of DA Form 3180, and follow procedures for disqualification (para 226).

216. Technical proficiency a. Supervisors will ensure that individuals have the additional training appropriate or required for the technical duties the individual performs. It is also the supervisor's responsibility to keep the certifying official informed of any issues pertaining to an individual's training status.

b. Technical training that requires access to BSAT will be under the supervision of a BPRP-certified individual who has completed technical training.

217. Rescreening requirements for the Biological Personnel Reliability Program-certified individuals a. When a BPRP-certified individual transfers to another BPRP position with a different certifying official and reviewing official, the individual will be administratively terminated by the old certifying official and will be screened by the new certifying official (see para 227, Administrative Termination).

b. When a certifying official is replaced but the reviewing official remains the same, a complete rescreening of the individuals on the BDPR is not required. In order for the new certifying official to become familiar with the individuals on the BDPR, he or she must review all DA Form 3180s and any documentation addressing previous PDI, and interview each individual. If questions arise during the reviews or the interviews, the certifying official will attempt to resolve them through consultation with the CMA and/or supporting agencies. If questions remain, the certifying official will suspend the individual per paragraph 225 until the matter is resolved. The new certifying official must complete the review process within 30 days of appointment unless an extension is approved by the reviewing official. Upon completion of the reviews and interview and/or resolution of any concerns, the certifying official and the individual will document it by signing the DA Form 3180, Part VI. A new certifying official will also notify the CMA and supporting agencies of his or her appointment to the position so that PDI or other information can be appropriately addressed.

c. When a PRP-certified individual transfers to a new BPRP position or changes status (for example, a contractor is hired on as a government employee or vice versa), a new screening is not required. The current or gaining certifying official (as appropriate) must review the existing DA Form 3180 and any documentation addressing previous PDI, and interview the individual. This review is intended to identify any gaps in certification requirements due to the difference in job or status, all of which must be addressed prior to performing BPRP duties. Upon completion of the reviews and interview and/or resolution of any concerns, the certifying official and the individual will document it by signing the DA Form 3180, Part VI.

d. Neither a new screening nor a review is required when the reviewing official is replaced. e. If the certifying official will be unavailable for time-sensitive actions required by this regulation, the commander/
director may designate in writing an acting certifying official for the duration of the absence, and will provide a copy of the designation to supervisors, the CMA, and supporting agencies. Acting certifying officials are not required to conduct the reviews and interviews per paragraph 217b or create a new BDPR. If the designated reviewing official is unavailable for time-sensitive actions required by this regulation, the reviewing official may designate in writing an acting reviewing official for the duration of the absence.

## Section Iv Continuing Evaluation

218. General
a. Certifying officials will ensure that all personnel assigned to BPRP positions are subject to a continuing
evaluation of their reliability. Qualifying and disqualifying factors in Section III continue to apply unless modified in this section. Continuing evaluation includes
(1) Self-reporting. (2) Peer and supervisor observation and reporting. (3) Evaluation of medical treatment by the CMA. (4) Periodic reinvestigations. (5) Periodic drug testing. (6) Certifying official observation and evaluation. b. When an individual is in an administrative absence (leave, temporary duty (TDY), and so forth), the certifying
official may choose to
(1) Rely on the individual's obligation to self-report PDI. (2) Restrict administratively, the individual per paragraph 224b, or (3) Establish a relationship with the leadership at the gaining site for PDI reporting back to the home station.
c. To ensure that continuing evaluation is effective, certifying officials will establish and maintain close working relationships with supporting activities to ensure they are fully aware of their BPRP responsibilities and that they provide required support.

d. When the certifying official determines that PDI identified during continuing evaluation is not disqualifying, he or she will document the PDI and the decision in accordance with written local procedures. (Medical PDI will be identified merely as "medical PDI from CMA".) The certifying official will maintain this documentation until the individual is administratively terminated or disqualified from the BPRP, when it will be destroyed.

219. Individual and supervisor responsibilities a. Individuals assigned to BPRP duties are responsible for monitoring their own reliability and the reliability of others performing BPRP duties. Individuals will advise their supervisor, certifying official, or administration official of any factors that could have an adverse impact on their performance, reliability, or safety while performing BPRP duties. Individuals will inform their supervisor and certifying official when another individual in the BPRP appears to be involved in situations that may affect reliability. The certifying official will consider failure to discharge these responsibilities when assessing an individual's reliability.

b. Information that would be identified during the next periodic reinvestigation (SF 86 Part 2) should be reported to the certifying official as soon as possible, and not just during the reinvestigation process. Information that should be reported will include
(1) Leaving a job (including part-time/second jobs) under unfavorable circumstances. (2) Being charged with, or convicted of, any criminal offense, including those under the Uniform Code of Military Justice.

(3) Illegal use of drugs/substances or illegal drug activity. (4) Alcohol abuse and other BPRP reportable incidents and behaviors including serious driving infractions such as reckless driving, driving under the influence, and driving while intoxicated.

(5) Significant financial problems such as filing for bankruptcy, garnishment of wages, property repossession, lien against property for failure to pay taxes or debts, unpaid court judgments, debt delinquency greater than 90 days.

(6) Being a party to any public record court action. c. If the certifying official is not the immediate and only supervisor of the individual, the certifying official will ensure all the individual's immediate supervisors know that the individual is subject to the reliability standards in this regulation. Supervisors will monitor the reliability of their subordinates and notify the certifying official of any PDI.

d. Individuals performing BPRP duties will notify the CMA of medical conditions and medical treatment, including medications, in accordance with guidance established by the Commanding General, MEDCOM, to ensure that the conditions and treatment can be evaluated by the CMA and reported to the certifying official if there is a potential effect on the individual's reliability or duty performance.

220. Medical evaluation a. The CMA will evaluate the reported and/or observed medical condition and/or treatment to determine if it is significant with respect to any disqualifying factors, such as an altered level of consciousness, impaired judgment or concentration, impaired ability to safely wear required personal protective equipment, or impaired ability to perform the physical requirements of the BPRP position. The CMA will ensure any reported medical conditions are documented in the individual's employment health records per MEDCOM guidance.

(1) Medical information that is obtained by the CMA from BPRP-certified civilian employees will be maintained in confidential civilian employee medical records. The information will be collected and maintained in accordance with 29 CFR 1630.14, 29 CFR 1910.1020, and AR 4066.

(2) The CMA will provide sufficient details in clear and understandable form so the certifying official can make a sound decision concerning an individual's continued suitability to perform BPRP duties.

(3) The CMA will provide PDI to the certifying official per local procedures, complying with the DOD, DA, and MEDCOM provisions of the Privacy Act, The Army Privacy Program, and HIPAA.

(4) Written local procedures will address provisions to promptly alert the certifying official when the CMA has forwarded information that warrants immediate review and action by a certifying official. In urgent medical situations, the CMA may direct the immediate supervisor to remove the individual from biological surety duties pending a decision by the certifying official. Such information will include
(a) Any prescribed or administered medication or treatment that could affect an individual's physical or mental capabilities (for example, local anesthetics, narcotics, sedatives, and tranquilizers).

(b) Any behavior that suggests emotional or mental instability (including suicide attempt or suicide threat) or current drug/substance or alcohol abuse.

b. When a BPRP-certified individual is subject to medical surveillance under the occupational health provisions of DA Pam 38569, the CMA will review the results of medical examinations and health screening. For BPRP-certified individuals not subject to occupational health medical surveillance, the CMA will perform an annual health screening at a minimum.

c. Certifying and reviewing officials may direct the review of occupational health, civilian employee medical, or military health records for medical PDI by the CMA for personnel currently in the BPRP at any time, for the purpose of making suitability determinations required by this regulation. The CMA will conduct the review to prevent any possible misinterpretation of health record data. Because of the sensitive and confidential nature of health records, authority to direct such a review extends only to certifying officials and reviewing officials.

d. Certifying officials receiving medical information regarding a BPRP employee from other than the CMA, will refer the employee to the CMA for an evaluation.

221. Drug/substance and alcohol abuse a. The certifying official will suspend an individual suspected of drug/substance and alcohol abuse while in the BPRP and will refer the individual to the CMA. The CMA will refer the individual for an ASAP or Employee Assistance Program evaluation.

b. The DOD civilian and military personnel in the BPRP will undergo drug testing per AR 60085. Provisions in AR 60085 pertaining to medical review of screening results will apply to the BPRP. Contractor personnel shall u n d e r g o  d r u g  t e s t i n g  i n  a c c o r d a n c e  w i t h  a n y  a p p l i c a b l e  c o n t r a c t  r e q u i r e m e n t s  ( r e f e r e n c e  D F A R S ,  S u b p a r t 252.2237004). Verified positive test results will be submitted to the certifying official.

c. Certifying officials will suspend any individual in the BPRP who is involved in an alcohol-related incident. The certifying official will evaluate the circumstances and request a medical evaluation.

d. After evaluating the situation, the certifying official will take action per the standards in paragraph 27 or 28.

222. Personnel security investigations/periodic reinvestigations for Biological Personnel Reliability Program purposes a. All personnel assigned to BPRP duties are required to have a favorably adjudicated periodic reinvestigation (PR)
every five years. A PR will be determined as favorable following the criteria in paragraph 212.

b. The certifying official may at any time request a local records check if an individual's reliability becomes suspect, or may consult with the security manager to determine if a special investigative inquiry is warranted.

c. A request for PR will be submitted before the PSI expires and the individual will remain qualified while the PR is being conducted. If the request for PR is not submitted before expiration of the PSI, the certifying official will suspend the person from the BPRP until the PR is submitted (electronically transmitted or mailed to the investigating agency). Once the PR is submitted, the certifying official can return the individual to a fully qualified status.

d. The PR will not be coded for a security clearance adjudication unless the individual requires a security clearance.

In such cases, the requirements of AR 38067 must be met.

e. Upon notification of the completion of the PR, the security manager will notify the certifying official of the new PSI date, and whether the PR is favorable, or if PDI was discovered requiring certifying official review.

## Section V Removal From Biological Personnel Reliability Program Duties

223. General Removal from the BPRP can be temporary (restriction or suspension), long-term (disqualification), or administrative (administrative termination) depending on the particular circumstances. The type of removal depends on the circumstances, character, and transitory or continuing nature of the cause of the unsuitability or suspected unsuitability.

General guidelines are listed as follows:
a. When making a reliability determination, the issue is not an individual's guilt or innocence of some particular offense; rather, the issue is whether the individual will be retained in a BPRP position. It is not necessary to complete an investigation, take disciplinary action (either civil or military), or complete other personnel actions before the certifying official decides whether to disqualify or retain an individual in the BPRP. Determination of an individual's reliability and suitability rests solely with the certifying official, subject to the review of the reviewing official.

b. Disqualification from the BPRP is neither an adverse personnel action nor the basis for disciplinary action.

However, the reason for disqualification may warrant further action.

c. Separation from employment/service may be appropriate for a disqualified individual, if BPRP certification is a condition of employment/service and if no positions are available for which the individual is qualified.

d. The BDPR will be updated according to local procedures when individuals are administratively terminated or disqualified. Personnel suspended or restricted from BPRP duties will not be deleted from the BDPR.

e. Written local procedures will govern actions taken by supervisors to immediately restrict access when unexpected situations arise pending resolution by the certifying official.

224. Restriction a. Medical restriction. When performance of BPRP duties may be impaired by a temporary medical condition
(including medication for the condition) or psychological condition (such as short-term stress), the certifying official will determine if the individual should be restricted from performing those BPRP duties. Medical restriction is a precaution based on the possibility of duty impairment, and is not an assessment of unreliability.

(1) The certifying official may restrict an individual based on information from the individual, supervisor, or the CMA. When the information did not come from the CMA, the certifying official will consult the CMA as soon as practical, but may restrict the individual from BPRP duties pending that consultation.

(2) The certifying official will temporarily remove the individual from affected BPRP duties. The certifying official will notify the individual and the individual's immediate supervisor, in writing, of the nature and probable duration of the restriction. "Nature of the restriction" refers to the specific duties being restricted. The restriction may apply to some assigned duties but not to others. Maintain a copy of the notification with the individual's file with the DA Form 3180.

(3) The individual remains under continuing evaluation while restricted. No entry on the DA Form 3180 is required. (4) When the temporary condition or situation is resolved, the certifying official will notify the individual and immediate supervisor per local procedures that the individual can resume assigned BPRP duties. Restriction notifications will be destroyed.

(5) Examples of when medical restriction may be appropriate include, but are not limited to, the following: (a) An individual taking a medically prescribed drug that may impair duty performance. (b) Presumed temporary departures from normal emotional or mental health. Related factors may include stressful family issues, relationship/marital problems, financial trouble, bereavement, and postpartum depression, among others.

(c) A physical injury or other condition (including pregnancy) that temporarily impairs the individual's ability to perform assigned BPRP duties or correctly wear personal protective equipment. Medical restriction may be extended to include both a pregnancy's full term and postpartum recovery period.

(d) The CMA determines that a medical condition or symptoms require further medical evaluation to determine effects on an individual's suitability for the BPRP.

(6) Except for restrictions due to pregnancy, medical restrictions will not normally exceed 180 days. If the condition is expected to persist beyond this point, the certifying official will consult with the CMA and determine what action to take from this point (revalidation of the medical restriction, suspension or disqualification, as appropriate).

(7) Medical restriction will not be used in cases of drug/substance or alcohol abuse, when attempted suicide is suspected or threatened, in the case of an alcohol-related incident, or in cases of aberrant behavior where a medical evaluation is requested. In these instances, certifying officials will immediately suspend individuals from BPRP duties.

b. Administrative restriction. When a BPRP-certified individual will be absent from BPRP duties for a significant period of time (for example, leave of absence or TDY to attend a school), the certifying official must decide if effective continuing evaluation can be maintained. When the ability to maintain continuing evaluation is questionable, the certifying official may administratively restrict such individuals from BPRP duties for the duration of the absence. Administrative restriction is not an assessment of unreliability.

(1) The certifying official will temporarily remove the individual from BPRP duties and access to BSAT. The certifying official will notify the individual and the individual's immediate supervisor in writing of the administrative restriction, and identify the individual's responsibilities (para 224 b (2)) upon return from absence. Maintain a copy of the notification with the individual's file with the original DA Form 3180.

(2) When the individual returns from the absence, the certifying official will interview the individual to discuss any areas of PDI and to reinforce BPRP standards. It is the individual's responsibility to disclose any PDI that may have occurred during his or her absence. If the individual identifies any instances of medical PDI, the certifying official will refer the individual to the CMA for further evaluation.

(3) After the interview and resolution of any PDI, the certifying official will notify the individual and immediate supervisor per local procedures that the individual can resume assigned BPRP duties. Restriction notifications will be destroyed.

225. Suspension When a certifying official determines that an individual's reliability is suspect, the certifying official will immediately suspend the individual from the BPRP. Suspension is also appropriate when a medical condition unexpectedly becomes prolonged, and the certifying official determines continued medical restriction is not appropriate. The certifying official will also suspend an individual whose PSI has expired unless and until a PR has been requested. If an individual is certified in more than one program (for example, biological and chemical PRP), the certifying official must indicate at the time of suspension whether it is applicable to both programs.

a. The certifying official will immediately remove the individual from assigned BPRP duties, restrict access to BSAT, and advise the individual and the immediate supervisor in writing of the reason for suspension. (Medical PDI will be identified merely as "medical PDI from CMA".) The individual will remain under continuing evaluation. The certifying official will annotate the original DA Form 3180, Part VII, (pencil entry) to reflect the date of the suspension.

b. The certifying official will promptly evaluate all circumstances and obtain information pertaining to the reliability of the individual in order to determine whether to reinstate or disqualify the individual.

c. If the individual is reinstated, the certifying official will inform the individual and immediate supervisor in writing and erase the pencil entry in DA Form 3180, Part VII. The certifying official will maintain the notification and reinstatement memoranda with the individual's DA Form 3180 while the individual remains in the BPRP.

d. Suspended military personnel will not be permanently reassigned or separated from service until reinstated into or disqualified from the BPRP, unless suspension is the result of a medical condition. In that case, the individual will be administratively terminated from the BPRP before separation or reassignment.

e. Suspension will not normally exceed 180 days. The certifying official may extend the period of suspension beyond 180 days in 30-day increments when there is not sufficient information to remove the suspension and return the individual to BPRP duties, or to disqualify the individual. Extension decisions and their justification must be documented and maintained by the certifying official for the duration of the suspension. After 270 days, ACOM/ASCC/ DRU approval is required for further extensions.

226. Disqualification When the certifying official determines that an individual does not meet the reliability standards of this chapter, the certifying official will initiate disqualification from the BPRP.

a. For individuals being screened for initial entry into the BPRP (1) The certifying official will terminate the screening process. (2) The reviewing official will review the action to ensure the correct, fair, and consistent application of the reliability standards in this regulation.

(3) If disqualification is inappropriate, the certifying official will complete the screening and BPRP processing. (4) If disqualification is appropriate, the certifying official will destroy the DA Form 3180 and notify the individual in writing. Do NOT destroy the DA Form 3180 if the individual is certified in more than one PRP and has not been disqualified from other programs. In this case, attach the notification letter to the DA Form 3180 and maintain it in the individual's file. The notification letter will cite the disqualification factor(s) and the specific circumstances supporting the decision to disqualify. For medical conditions, the citation will be "medical conditions as documented in your medical records." This will preclude violations of the Privacy Act. In these cases, the individual may obtain information pertaining to the disqualifying medical condition by contacting the certifying official or the CMA. The certifying official will maintain a copy of the notification letter for five years.

b. For individuals in the BPRP, the certifying official will terminate access to BSAT, remove the individual from BPRP duties and follow the procedures below. If the individual is certified in multiple PRPs and is not being disqualified for all, modify the procedures below to ensure the action is taken only for the appropriate program.

(1) The certifying official will advise the individual in writing ('the notification letter") of his or her decision to initiate disqualification from the BPRP within seven of the certifying official's regularly scheduled working days. The notification letter will
(a) Cite the disqualification factor(s) and the specific circumstances supporting the decision to disqualify. For medical conditions, the citation will be "medical conditions as documented in your medical records."
(b) Advise the individual that the disqualification action is subject to mandatory review by the reviewing official before any permanent entries are made in the individual's records and that the certifying official or reviewing official will advise the individual of the outcome of the review.

(c) Inform the individual that a written explanation or rebuttal may be submitted through the certifying official to the reviewing official within five days of the individual's regularly scheduled workdays of receipt of the letter.

(d) Request written acknowledgement of receipt of the notification letter. If the individual refuses to acknowledge receipt, the certifying official will add a statement to the notification letter explaining the refusal.

(2) The reviewing official will review each disqualification action to ensure uniform application of the reliability standards specified by this chapter.

(a) The certifying official will forward a copy of the notification letter, any written explanation or rebuttal submitted by the individual, and any other pertinent information to the reviewing official. This will be done between six and ten of the individual's regularly scheduled workdays after receiving the notification letter.

(b) The reviewing official will review the case. The reviewing official may seek additional information or explanations of extenuating circumstances from the certifying official, CMA, personnel officials, and the individual concerned if needed.

(c) Within fifteen of the reviewing official's regularly scheduled workdays after receipt of the disqualification documents, he or she will furnish a written decision to the individual through the certifying official. If the individual has departed the certifying official's organization, the certifying official will forward a copy of the reviewing official's decision either directly to the individual, or through his or her new chain of command or supervisory chain.

(d) When the reviewing official does not approve the disqualification, the individual's records will show the individual as BPRP-certified.

(3) If the reviewing official approves disqualification of an individual (a) The certifying official and reviewing official will complete Part IX of the original DA Form 3180. In DA Form
3180, Part IX, item D, the certifying official will provide sufficient detail so that any requests for requalification can be appropriately assessed (see Section VI). For medical conditions, the citation will be "medical conditions as documented in medical records."
(b) The certifying official will provide a copy of the DA Form 3180, and a copy of the notification letter to the custodian of the individual's personnel records for filing. The DA Form 3180 will be annotated with the date and method of notifying the individual.

(c) The certifying official will notify the CMA. If the individual is disqualified for medical reasons, the CMA will annotate the medical record entry with the following statement; "Disqualified (date) for assignment to BPRP positions per AR 501," and will state the medical reason for disqualification. The CMA will remove and destroy the DA Form 3180 from the individual's medical record.

(d) The certifying official will ensure the BDPR is updated per local procedures, and will notify the individual's immediate supervisor in writing of the disqualification.

(e) The certifying official will notify the supporting security manager for appropriate action per AR 38067, when the disqualification is based on credible derogatory information that could affect the individual's security clearance.

c. For a contractor employee disqualified from the BPRP (1) If the disqualification is based solely on information developed from the PSI, the reasons for disqualification will not be disclosed to the individual's employer, to include the BPRP administration official. The certifying official may communicate or correspond directly with the individual being disqualified. The certifying official will give the individual's employer written notice that the individual is disqualified because of an unfavorable PSI, without specifying the reasons.

(2) The certifying official will keep the original DA Form 3180, with copies of the written notification and the signed acknowledgment, plus a copy of the final action by the reviewing official. The certifying official will provide copies, or memos, to appropriate personnel and medical support offices.

(3) If the individual has been cleared under the DOD Industrial Security Program and was disqualified for acts reflecting adversely on loyalty, character, integrity, or discretion; and the acts were clearly not consistent with National interest (as outlined in DOD 5220.22M, Chapter 2), the certifying official (or contractor) must also report this information to Defense Security Service (DSS) offices for necessary action and to clear files.

227. Administrative termination a. Administrative termination (1) Occurs when an individual transfers from a duty position requiring BPRP certification to one not requiring BPRP certification.

(2) Occurs when an individual is permanently removed from BPRP duties within the organization. (3) Establishes the date an individual was removed from a BPRP position for reasons other than disqualification. (4) Terminates the requirement for continuing evaluation. (5) Does not indicate unsuitability or unreliability. b. The certifying official
(1) Terminates the individual's access to BSAT. (2) Completes appropriate section of the DA Form 3180 and forwards it to the custodian of the individual's personnel records.

(3) Ensures the BDPR is updated per local procedures. (4) Notifies the CMA, that the individual is no longer in the BPRP and no longer requires continuing evaluation.

The CMA will remove and destroy the DA Form 3180 from the individual's medical record.

## Section Vi Requalification Of Personnel

228. Request for requalification a. An individual disqualified from the BPRP may request requalification based on substantive evidence that the cause for disqualification no longer exists. Approval of requalification does not require that the individual be assigned or reassigned to a BPRP position. However, requalified personnel are eligible for certification into such positions.

b. The individual may submit a request for requalification to a certifying official of the organization to which he or she is currently assigned, or to a certifying official of the organization where the disqualification occurred. This request will explain the circumstances leading to the disqualification, the basis for disqualification, and the action taken to correct or eliminate the cause for disqualification.

c. The certifying official will review the request, and either disapprove it or recommend its approval to the reviewing official. If the certifying official disapproves the request, it will be returned to the individual with the rationale for disapproval and a copy forwarded to the reviewing official. If the certifying official decides to recommend requalification, the certifying official will endorse and forward the request for requalification to the reviewing official.

d. The reviewing official will review the request and the certifying official's recommendation. The reviewing official will either approve or deny the requalification, and forward the approval or denial through the certifying official to the individual.

e. If the reviewing official approves the requalification, the certifying official will (1) Forward a copy of the approval to the custodian of the individual's official personnel records, to be attached to the DA Form 3180 that reflected the disqualification.

(2) Provide a copy to the CMA. If the individual was disqualified for medical reasons, the individual's SF 600
(Chronological Record of Medical Care) will be annotated with the following statement - "Requalified (date) for assignment to a BPRP position per AR 501."
(3) If the individual is being considered for an assignment to a BPRP position, the certifying official will complete the procedures outlined in Section III, except that information pertaining to the previous disqualification will not be considered disqualifying in itself. When completed, the new DA Form 3180 will replace the previous DA Form 3180 reflecting the disqualification, which will be destroyed.

229. Special procedures for alcohol abuse/dependence a. An individual disqualified for alcohol dependence may be requalified for BPRP duties only after meeting the following conditions:
(1) The individual successfully completes an initial intensive rehabilitation, if prescribed, followed by a 1-year period of strict compliance with aftercare requirements, regular and frequent participation in meetings with Alcoholics Anonymous or a similar organization, and abstention from alcohol.

(2) Submission of a request for requalification per paragraph 228, including a mental health evaluation and a favorable prognosis by the CMA.

(3) The certifying official must determine that the value of returning the individual to the BPRP outweighs the risk from potential future alcohol-related incidents and must document the fact that the certifying official has full trust and confidence in the individual's reliability.

b. An individual disqualified for abusing alcohol but who is not alcohol-dependent may be requalified for BPRP
duties after meeting the following conditions:
(1) The individual successfully completes a minimum 180-day rehabilitation program, or treatment regimen, prescribed by or acceptable to the CMA, and demonstrates positive changes in job reliability and lifestyle.

(2) Submission of a request for requalification per paragraph 228, including a favorable prognosis by the CMA.

230. Special procedures for drug/substance abuse Individuals who were disqualified for drug/substance abuse that occurred while they were in the BPRP are generally ineligible for requalification. Under extraordinary circumstances that the reviewing official believes warrant consideration for requalification, he or she may submit a written waiver request through ACOM/ASCC/DRU channels to HQDA ODCS G3/5/7 (DAMOSSD).

## Section Vii Annual Personnel Reliability Program Status Report (Rcs DdpC3I (A) 1403)

231. Information requirements Each ACOM/ASCC/DRU having personnel in the BPRP will prepare DA Form 7422 (Annual Personnel Reliability Program (PRP) Status Report) annually, as of 31 December of each year. Send this report to Director, USANCA (MONACWZ), 7150 Heller Loop, Suite 101, Springfield, VA 221503198, to arrive annually no later than 1 February.

232. Preparation guidance a. Block 1. List the installation or ACOM/ASCC/DRU submitting the report.

b. Block 2. Indicate the year for which the information is being reported. c. Block 3. Indicate the type of report by checking the appropriate block. Prepare and report biological, chemical and nuclear PRP reports separately.

d. Block 4. List the total number of personnel at each installation actually certified into the BPRP as of 31
December. All biological positions will be listed as controlled positions and will be broken out separately for military, DOD civilian, and contractor employees.

e. Block 5. List the total number of BPRP-certified personnel at each installation disqualified during the calendar year. All positions will be broken out separately for military, DOD civilian, and contractor employees.

f. Block 6 a through g. List the installation disqualifications categorized by primary reason for disqualification using the disqualifying factors listed. The totals calculate automatically if a forms generator is used.

g. Block 7. Include any comments here noting trends or other relevant factors to assist future historical analysis.

## Chapter 3 Control Of Biological Select Agents And Toxins

31. General This chapter provides guidance for control of BSAT. Heads of contracting activities will ensure that provisions of this chapter are implemented by contractually binding agreements.

32. Acquisition of biological select agents and toxins All facilities located within the United States using, possessing, transferring, or receiving BSAT must be registered and operate in accordance with 42 CFR 73, 7 CFR 331, and 9 CFR 121.

33. Responsibilities for control of biological select agents and toxins a. Commanders/directors will (1) Appoint a responsible official (RO), alternate RO, and biological storage custodians in writing to oversee the implementation of this chapter. This includes, the drafting of a facility-specific BSAT inventory management standing operating procedure/internal operation procedure (SOP/IOP).

(2) Ensure BSAT are maintained under a system of records that provide audit trail of BSAT custody from receipt to destruction or transfer.

(3) Forward a current list of BSAT at the facility through the appropriate ACOM/ASCC/DRU to HQDA, ODCS
G3/5/7, with a copy furnished to USANCA (MONACWZ). The list will be provided annually in accordance with guidance to be provided by HQDA ODCS G3/5/7.

b. Contractors will designate, in writing, contractor personnel to perform the duties and responsibilities of the RO, custodian, and alternates, authorized to request and receive BSAT, and submit their names to the responsible COR and ACOM/ASCC/DRU. For Schedule 1 material (for example, ricin or saxitoxin), the contractor will also submit their names to the DOD Accountability Manager for Schedule 1 Chemicals. This requirement will be included in the biological surety contract clauses.

34. Biological select agents and toxins inventory management
a. The site-specific BSAT inventory management SOP/IOP will include at a minimum (1) Instructions for completing APHIS/CDC Form 2 (Request to Transfer of Select Agents and Toxins) for transfer
of BSAT.
(2) Methods for documenting agent use, transfer, or destruction. (3) Documentation of BSAT destruction. (4) Record keeping instructions. (5) Frequency of inventories. (6) Method of resolving inventory discrepancies.
b. Inventory management and custodial records consist of a combination of inventories, shipping and transfer
documents, location records, destruction certificates, and other documents as directed by the RO. Laboratory notebooks may be used as part of the documentation.
35. Records retention The transferring facility will retain a copy of the completed APHIS/CDC Form 2 for a period of five (5) years after the date of shipment. The receiving facility will retain a copy of the completed APHIS/CDC Form 2 for a period of five (5) years after the agents are consumed or destroyed.

36. Transfer of biological select agents and toxins a. Army facilities may provide DOD or Army BSAT to other DOD Components, who will assume responsibility for the BSAT under DOD guidance and their own component regulations. Transfer may be to the other DOD Component's contractor, at the DOD Component's request and under the DOD Component's responsibility. Transfer of the BSAT will be in accordance with 42 CFR 73, 7 CFR 331, and 9 CFR 121 as applicable. No further Army oversight of the transferred BSAT is required.

b. Army facilities may provide DOD or Army BSAT to other U.S. governmental agencies in support of the recipient governmental agency's mission. Transfer may be to the other agency's contractor via Material Transfer Agreement (MTA), at the government agency's request. For example, Army BSAT may be transferred to a CDC-designated BSAT
reference repository, to support a Department of Agriculture research program, or to the Federal Bureau of Investigation (FBI) when required for forensic analysis. Transfer of the BSAT will be in accordance with federal regulations. No further Army oversight of the transferred BSAT is required.

c. Army facilities will not provide DOD or Army BSAT in any other circumstances (including Cooperative Research and Development Agreements, Small Business Innovative Research Agreements, or to governmental agencies for a DOD purpose), unless approval has been received from ATSD(NCB). Request approval through HQDA ODCS G3 (DAMOSSD), 400 Army Pentagon, Washington, DC 203100400. Requests will identify recipient information, name and quantity of BSAT to be provided, purpose for which the BSAT will be used, and rationale for providing BSAT. Approval will identify if any surety and security measures are required for the recipients beyond those required by federal regulations.

d. Export Control requirements for BSAT will be implemented in accordance with DOD Directive (DODD) 2040.2. e. Note that this chapter only addresses procedures for transfer of BSAT based on their status in the biological surety program. This chapter does not provide independent authority to transfer DOD property. Transfers must be executed in accordance with the provisions specified in the Defense Financial Management Regulation, and they must be based upon substantive legal authority, such as the Economy Act or other similar statute when applicable.

37. Annual reporting on contractor facilities Each ACOM/ASCC/DRU will annually provide a list of all DOD contracts requiring the use of Army-furnished BSAT in contractor facilities. The list will be prepared per guidance to be provided by HQDA ODCS G3/5/7.

## Chapter 4 Transportation Of Biological Select Agents And Toxins

41. Transportation The transportation of BSAT will be in accordance with 42, CFR Part 73; 7 CFR Part 331, 9 CFR Part 121; and 49 CFR Parts 171178. Biological select agents and toxins will be secured in accordance with AR 19017 while awaiting transportation and during transport in an Army vehicle. Delivery receipts will be maintained for at least 5 years.

42. Movement limitations a. Movement of BSAT on DOD installations between limited areas will be kept to a minimum, consistent with operational, research, training, teaching, and safety requirements.

b. During the planning and preparation stages of off-station transportation of BSAT, a current risk assessment shall be completed, including known threats and hazards. Planning for the move shall include appropriate security measures, such as the mode of shipment, the availability of security resources, and the source and availability of emergency assistance. All reasonable precautions shall be taken to ensure the safety and security of personnel and the BSAT.

## Chapter 5 Biological Select Agent And Toxin Safety And Occupational Health Program

51. General a. The main purpose of a BSAT safety program is to provide maximum protection to workers, the environment, and surrounding communities, consistent with operational requirements. Commanders/directors will implement a program that complies with AR 38510, DA Pam 38569, applicable safety guidance issued by their higher headquarters and HQDA, and appropriate national, state, and local regulations.

b. Requirements of AR 38510 and DA Pam 38569 apply to medical facilities that retain BSAT as part of their participation in the Laboratory Response Network.

c. When safety standards in Army publications differ from Occupational Safety and Health Administration Standards promulgated under section 6 of the Occupational Safety and Health Act of 1970, 29 USC 655, the standard that provides the greater protection will apply.

d. Commanders/Directors will conduct a hazard analysis for each laboratory operation involving BSATs. Hazard analyses will be performed on the total operation and not just on the BSATs themselves. Each hazardous condition will be assigned a Risk Assessment Code (RAC) as defined in AR 38510, DA Pam 38561, or other appropriate guidance. Hazard analysis documentation will show the RAC before a control is placed on the hazard, use of a control to eliminate or mitigate a hazard, and the RAC after application of the control.

e. The supporting industrial hygiene service will conduct health hazard inventories and hazard exposure assessments of other associated laboratory hazards. Results of monitoring will be placed in individuals' health records.

f. Material Safety Data Sheets will be available for all BSATs used in the laboratory, and all individuals working with BSATs will be educated on their content and location. Where a Material Safety Data Sheet has not been developed for a BSAT, an equivalent document will be prepared and available.

g. Commanders/Directors will provide a copy of the hazard analysis to the garrison commander for situational awareness where appropriate.

52. Occupational health Commanders/directors will establish and implement an occupational health program, occupational health examinations, and industrial hygiene services, in support of the biological surety program.

## Chapter 6 Biological Select Agent And Toxin Security Program 61. General Commanders/Directors Will Implement A Bsat Security Program Per The Standards Of Ar 19017.

62. Threat information collection and reporting a. Commanders/Directors will establish and maintain close coordination with supporting military intelligence units, local civil and Federal law enforcement agencies, and request that such agencies provide timely information that may affect the installation security.

b. Military intelligence sources will conduct foreign counterintelligence collection and disseminate information on foreign threats against the Army as appropriate. Under AR 52513, paragraph 217, U.S. Army Criminal Investigation Division Command (USACIDC) will collect, analyze, and disseminate criminal information pertaining to threat activities within applicable statutes and regulations.

c. Commanders/Directors will coordinate and disseminate threat information per AR 52513. Commanders/Directors will periodically brief personnel on the threat to themselves and the installation as well as personal security measures to protect themselves and deter the threat.

d. Commanders/Directors will report any penetration, attempted penetration, or other unexplained degradation of security through command channels to HQDA, OPMG (DAPMMPDLE) per AR 19045.

## Chapter 7 Biological Mishap Or Incident Response

71. General a. Biological mishap or incident response encompasses those mitigating actions taken to save lives, preserve health and safety, protect the environment, secure BSAT, and protect property in the event of a biological mishap or incident.

b. Commanders/Directors of facilities with a biological surety mission will establish plans to address biological mishaps and incidents as identified in this chapter, AR 38510, DA Pam 38569, 42 CFR 73.14, and guidance published by the Office of the Provost Marshal General (OPMG). These plans may be standalone or incorporated into the installation emergency response plan to ensure that all biological mishap/incident response resources on the installation are available to the response force commander.

72. Biological mishap or incident response planning a. Plans will specifically address response to natural disasters such as severe weather and earthquakes and response to incidents during movement or transportation of BSAT.

b. Facilities and installations/garrisons will coordinate plans with external agencies (local, regional, State, or Federal) that provide support identified in the plans. Facilities will coordinate any changes to the plan that affect external support with the affected external agencies.

c. Facilities will forward biological mishap and incident response plans to the responsible ACOM/ASCC/DRU for review.

73. Reporting of biological mishaps or incidents a. Facility commanders or directors will telephonically report biological incidents to the HQDA Army Operations Center (AOC) as soon as possible, and in no case later than 8 hours after the event. Notification will not be delayed due to lack of detailed information. Facility commanders or directors will make parallel notification to intermediate commands as directed by their higher headquarters. Format will be in accordance with AR 19045.

b. The AOC will notify HQDA, ODCS G3/5/7 and other Army staff elements per notification instructions; HQDA, ODCS G3/5/7 will notify Director of Security, Under Secretary of Defense for Intelligence (USD(I)), as soon as possible, and in no case later than 24 hours after the mishap or incident.

c. Facility commanders or directors will report biological mishaps per the procedures in DA Pam 38540.

74. Exercise program a. Facilities/installations will conduct exercises and drills of emergency plans as identified in AR 38510, DA Pam
38569, 42 CFR 73.14, and guidance published by OPMG. Commanders/Directors will ensure that exercises periodically integrate safety and security responses (that is, that security exercises periodically involve lab safety procedures and lab safety drills periodically include security force actions).

b. Facilities/installations will include the participation of external agencies that support emergency plans in an exercise at least once every two years.

(1) The intended level of participation is for the external agency to exercise planned support. The minimum level of participation is as an observer of an exercise. The level of participation will be documented in the exercise after-action report.

(2) If the external support agencies are unable or unwilling to participate in exercises, the facility/installation will reevaluate the plan to determine if revisions are appropriate, and will provide the appropriate ACOM/ASCC/DRU the results of that reevaluation.

c. Commanders/Directors will ensure that "lessons learned" from exercises are validated and documented in written after action reports. A copy of the after-action report will be provided to USANCA. Commanders/directors will develop programs to ensure timely remedial actions are taken to correct shortcomings discovered during exercises and to update local SOPs/IOPs as appropriate. Records and reports will be maintained for 5 years and then adjudicated according to appropriate administrative instructions.

## Chapter 8 Biological Surety Program Evaluations

81. General
This chapter prescribes policies and procedures for assessing and evaluating facility biological surety program. It describes technical inspections conducted by the DAIG, surety management reviews conducted by ACOM/ASCC/ DRU, and assistance visits conducted by USANCA. These assessments are conducted to determine
a. The capability of each organization to accomplish its assigned biological surety mission. b. The adequacy of support and guidance provided to each biological surety organization. c. Systemic issues affecting the organization's capability to accomplish its assigned biological surety mission.
82. Department of the Army Inspector General technical inspections a. The DAIG conducts biological management evaluations (BME) and biological surety inspections (BSI) in order to
(1) Ensure adherence to the technical, health, safety, accountability, security, and reliability standards and procedures detailed in appropriate regulations.

(2) Determine the adequacy of support and guidance provided to the organization.

(3) Provide ACOMs/ASCCs/DRUs with inspection results to assist in determining the mission capability of organizations and facilities with a biological surety mission, and
(4) Keep Army leaders, ACOMs/ASCCs/DRUs, and appropriate authorities informed of the status of the execution of the Army's Biological Surety Program.

b. The DAIG will publish an annual schedule of BSIs and BMEs not less than 90 days before the beginning of each f i s c a l  y e a r .  C o p i e s  o f  t h i s  s c h e d u l e  w i l l  b e  p r o v i d e d  t o  a f f e c t e d  A C O M s / A S C C s / D R U s ,  I M C O M ,  H Q D A (DAMOSSD, DAPMMPDPS, and DACSSF), and Director, USANCA (MONACWZ).

c. The HQDA surety, safety, or security regulation proponent and/or IMCOM, may send a representative to accompany the DAIG inspection team during all or a portion of the inspection of one or more organizations. If the proponent/IMCOM exercises this option, the representative(s) will do so at their parent organization's expense and will perform no formal inspection function. Rather, they will observe the inspection process and provide regulatory clarifications to the DAIG team or organization as requested.

d. The DAIG will provide inspector access rosters to inspected organizations at least 30 days before scheduled inspections. DAIG access rosters will include security clearances and qualifications of inspectors and any accompanying HQDA proponent/IMCOM representatives. HQDA proponent/IMCOM representatives will comply with DAIG requirements and suspenses for access roster data.

e. HQDA agencies and ACOMs/ASCCs/DRUs may be requested to provide subject-matter experts on a temporaryduty basis to assist in the conduct of BSIs and BMEs.

83. Biological management evaluations BMEs inquire into the biological surety missions and responsibilities of Army organizations, facilities, and activities to identify management, systemic, or functional problem areas in the Army Biological Surety Program.

84. Biological surety inspections a. The DAIG will conduct BSIs of all Army activities, organizations and contractor operations with biological surety missions. Biological surety inspections, other than scheduled reinspections, normally will be every 24 months, and not more frequently than every 18 months, unless otherwise directed. The DAIG will schedule BSIs when facilities are operational if at all possible.

b. Biological surety inspections of organizations having management responsibility for administering contracts involving Army- or DOD-supplied BSAT will include assessment of the contract oversight program.

c. The scope of a specific BSI is determined by the structure of the organization's mission statements or other appropriate mission directives. The functional areas to be assessed during a BSI may include, but are not limited to, those listed in table 81 below. The focus of the BSI will be on the time period since the last BSI.

Biological Surety Inspection Functional Areas and Sub-areas
MISSION/OPERATIONS
SECURITY
Research and development
Security planning procedures
Test and evaluation
Perimeter security
Storage and surveillance
Storage requirements
Training
Support facilities
Escort and transportation (on and off-installation)
Key and lock control
Special projects
Security forces, including augmentation
Calibration, maintenance, and readiness
Training program
Inspection program
Transportation security
Adequacy of physical facilities
Waivers and exceptions
Inventory management
Recovery operations
Disposal programs for unneeded agent
Emergency response capability
Quality assurance programs
Internal and external inspections
Adequacy of resources
Access control
Environmental compliance program
Intrusion detection and assessment
Maintenance of NBC defense equipment used in chemical surety operations
Security of arms room and ammunition
Laboratory operations (including protocols)
SAFETY
SURETY MANAGEMENT
Plans and procedures
BPRP management
Personnel protection and protective equipment
Adequacy of manning
Hazard analysis program
Mechanisms for monitoring safety, security, surety management and external support
Inspection and compliance monitoring program
EMERGENCY RESPONSE
Biological mishap or incident response planning Biological mishap or incident reporting
MEDICAL SUPPORT
EXTERNAL SUPPORT

## Biological Surety Inspection Functional Areas And Sub-AreasContinued

Medical Surety Management Medical Records and Documents
Conditions beyond the capability of the inspected organization to avoid, influence, or correct which are the responsibilities of supporting activities. Deficiencies will be attributed to the supporting activity and not to the inspected organization.
Occupational Health Medical Laboratory Support
Industrial Hygiene Support Medical Training Credentials/Certifications Other Medical Services

85. Technical inspection reports a. The DAIG will prepare a separate written report for each BSI and BME. b. Inspection findings will provide sufficient information to allow the inspected activity and the affected proponent offices to clearly link findings to the requirements contained in appropriate regulatory guidance and to correct shortcomings and deficiencies. Findings may also identify potential requirements to change or clarify regulatory guidance.

c. Inspection findings will be identified as "factors affecting operations" or as "deficiencies." Factors affecting operations identify issues and potential problems and provide recommendations for their resolution. Deficiencies identify deviations from, or noncompliance with, standards (law, policy, regulation, or published procedures). Deficiencies that are failing, as described in paragraph 86, will be marked as such.

86. Ratings For BSIs, inspected organizations will be given one of the ratings in table 82 for each of the functional areas inspected. No ratings will be assigned for BMEs.

a. A DEFICIENCY: FAILING may be given in the appropriate functional area when any of the following conditions exist:
(1) Failure to achieve or maintain assigned mission capability. This may include shortages in personnel, equipment, or supplies that prevent accomplishment of the biological surety mission.

(2) Loss of accountability or custody of BSAT. (3) Failure to provide a safe environment for BSAT operations. (4) Failure to provide a secure environment for BSAT. (5) Failure to respond to an actual biological mishap or incident as outlined in the facility/organizational plans.

Included are actions that could permit unnecessary loss of life, personal injury, destruction of property, compromise of classified materiel or information, loss of accountability or control of BSAT, or avoidable post-mishap or incident contamination.

(6) A pattern of deficiencies in any one or several of the functional areas sufficient to demonstrate a manner of performance indicating a lack of competence or a disregard for prescribed procedures.

(7) Failure to establish or maintain an effective program for biological surety management. b. External support may be given a DEFICIENCY: FAILING when any of the conditions above exist that are beyond the capability of the inspected organization to avoid, influence, or correct, and are attributable to a supporting activity.

BSI Ratings
| RATING                                                               | DEFINITION                                                             |
|----------------------------------------------------------------------|------------------------------------------------------------------------|
| NO DEFICIENCIES                                                      | When an organization demonstrates that it can accomplish critical      |
| tasks while providing a safe and secure environment in full compli-  |                                                                        |
| ance with approved publications and directives.                      |                                                                        |
| DEFICIENCIES: NONE FAILING                                           | When deficiencies exist, but the organization demonstrates that it can |
| accomplish critical tasks while providing a safe and secure environ- |                                                                        |
| ment under approved publications and directives.                     |                                                                        |
| DEFICIENCIES: FAILING, CORRECTION VERIFIED                           | When one or more conditions found in paragraph 86                     |
| a                                                                    |                                                                        |
| existed but                                                          |                                                                        |
| were corrected by the inspected organization and verified by the in- |                                                                        |
| spection team.                                                       |                                                                        |
DEFICIENCIES: FAILING, RESOLUTION / REINSPECTION REQUIRED
When one or more conditions found in paragraph 86a existed, but were not, or could not, be corrected for verification by the inspection team.

87. Biological surety reports a. The DAIG inspection team will provide a draft final BSI report to the inspected organization at the inspection team's exit briefing. After review by the Army Inspector General, the DAIG will forward the approved final inspection r e p o r t  t o  t h e  r e s p o n s i b l e  A C O M / A S C C / D R U ,  H Q D A  ( D A M O - S S D ,  D A P M - M P D - P S ,  D A C S - S F ) ,  D i r e c t o r , USANCA (MONACWZ), and HQ, IMCOM (as applicable).

(1) When an organization receives ratings of NO DEFICIENCIES, DEFICIENCIES: NONE FAILING, or DEFI-
CIENCIES: FAILING, CORRECTION VERIFIED, the DAIG will generally forward the approved final inspection report within thirty days of the inspection. A written response of corrective actions will normally not be required. However, selected factors affecting operations or deficiencies may require a response. The DAIG final report will specify which findings, if any, require a written response of corrective actions and the timeline for response.

(2) When an organization receives a rating DEFICIENCIES: FAILING, RESOLUTION/REINSPECTION RE-
QUIRED, the inspection team will ensure that the responsible ACOM/ASCC/DRU is provided a copy of the report within thirty days of the completion of the inspection. This report will identify the target date for reinspection.

b .  W h e n  a n  o r g a n i z a t i o n  r e c e i v e s  a  r a t i n g  D E F I C I E N C I E S :  F A I L I N G ,  R E S O L U T I O N / R E I N S P E C T I O N  R E -
QUIRED, the organization will forward a written response of corrective actions to the failing deficiencies and any reclama (per paragraph 88 below) to the ACOM/ASCC/DRU within 30 days of the receipt of the final report by the ACOM/ASCC/DRU.

c. Within sixty days of the receipt of the report indicating DEFICIENCIES: FAILING, RESOLUTION/REINSPEC-
TION REQUIRED, the ACOM/ASCC/DRU will
(1) Review the inspection report, the written report of corrective actions taken and planned by the organization, and any reclama to the failing deficiencies.

(2) Determine whether to forward any reclama to HQDA and/or submit an ACOM/ASCC/DRU -level reclama per paragraph 88.

(3) Make one of the following "mission capability" determinations pertaining to the inspected organization: (a) MISSION CAPABLE. This determination allows the facility to continue normal operations while completing corrective actions.

(b) MISSION CAPABLE WITH LIMITATIONS. This determination allows the facility to continue operations within specified limitations while completing corrective actions.

(c) NOT MISSION CAPABLE. This determination requires the facility to secure all BSAT until specified corrective actions are completed. The responsible ACOM/ASCC/DRU will verify compliance with this restriction, and will verify the completion of the corrective actions before the facility can resume operations with BSAT.

(4) Convey the "mission capability" determination with implementing instructions to the organization. (5) Provide a copy of the "mission capability" determination and the organization's written response of corrective actions to the DAIG, with copies furnished to HQDA (DAMOSSD, DAPMMPDPS, and DACSSF).

d. Within twenty days of the receipt of the organization's written response of corrective actions from the ACOM/
ASCC/DRU, the DAIG will
(1) Review the response and make a determination about the type of reinspection that the DAIG will conduct for each recorded deficiency; either on-site or document review.

(2) Provide confirmation to the ACOM/ASCC/DRU and organization of the nature and timeline of the DAIG's intended reinspection.

e. The DAIG will normally conduct on-site reinspection of failing deficiencies within 120 days of the original inspection. The scope of such a reinspection will be limited to the specific area, activity, or operation that was the basis for the original failing deficiencies. The DAIG will confirm the intent to conduct an on-site reinspection to the Army Command and inspected facility at least thirty days prior to the desired reinspection date. The DAIG may elect to conduct a document review reinspection, consisting of the review and acceptance of documentation supporting the corrective action identified in the organization's written response.

f. The DAIG will provide applicable extracts from the inspected organization's final report to the activity cited for inadequate external support.

(1) For deficiencies that were not corrected during the inspection, the supporting agency will prepare a written reply stating corrective action taken or planned (with milestones for completion). The report of corrective action taken will be forwarded within thirty days through command channels to HQDA, OTIG (SAIGTI), with copies furnished to the inspected/supported organization, its ACOM/ASCC/DRU (or IMCOM, as appropriate), and HQDA ODCS G3/5/7, ATTN: DAMOSSD.

(2) For external support ratings of DEFICIENCIES: FAILING, RESOLUTION / REINSPECTION REQUIRED, the inspected organization's ACOM/ASCC/DRU will accomplish the mission-capability determination per paragraph 87c. If the ACOM/ASCC/DRU determines that the facility is MISSION CAPABLE WITH LIMITATIONS or NOT MISSION CAPABLE, the ACOM/ASCC/DRU will ensure that the external support issues are resolved expeditiously. Issues that cannot be resolved between ACOMs/ASCCs/DRUs or between an ACOM/ASCC/DRU and IMCOM will be forwarded to the appropriate HQDA office for resolution.

(3) For external support ratings of DEFICIENCIES: FAILING, RESOLUTION / REINSPECTION REQUIRED, DAIG will normally re-inspect within 120 days. The scope of a reinspection will be limited to the specific functional area, activity, or operation that was the basis for the failing deficiencies. Reinspection of the external support activity may consist of review and acceptance of the written response of corrective action.

g. Table 83 summarizes the timelines associated with inspection reports.

88. Issue resolution and reclamas a. The DAIG team chief and the commander/director will make every effort to resolve issues prior to the publication of a final report.

b. As required, the DAIG team chief and the commander/director will contact the proponent of the regulation to resolve differences in interpretation of a regulatory requirement. Should the difference not be resolved prior to the inspection's completion, the inspection team will publish a draft report; the final report will be published upon the resolution of the issue with the proponent.

c. Any commander/director in the chain of command of the inspected organization or external support organization may submit a reclama to a BSI report. Reclamas will be sent through the organizational chain of command to HQDA ODCS G3/5/7, ATTN: DAMOSSD, Washington, DC, 203100400 for adjudication.

d. Each commander/director in the chain of command will evaluate the reclama and forward it to the next higher headquarters, identifying the commander's/director's concurrence or nonconcurrence with the reclama. The ACOM/ ASCC/DRU will determine whether or not to forward the reclama to HQDA and whether to submit an ACOM/ASCC/ DRU -level reclama.

e. HQDA ODCS G3/5/7 (DAMOSSD) will coordinate the reclama with HQDA proponent offices and with the DAIG Technical Inspections Division. If any of the coordination offices nonconcur with the proposed reclama resolution, the issue will be taken to higher channels for adjudication; the final adjudication authority, if required, is the Secretary of the Army.

f. HQDA ODCS G3/5/7 (DAMOSSD) will forward final decisions to the ACOM/ASCC/DRU within sixty days of receipt; for reclamas to failing deficiencies, this will normally be done within thirty days of receipt. HQDA ODCS G3/5/7 (DAMOSSD) will furnish copies of final decisions to HQDA, OTIG (SAIGTI), other staff elements as appropriate, and Director, USANCA (MONACWZ).

g. Where an interpretation or clarification of a regulation or policy has been made during the reclama process, the proponent will prepare a formal notification of the interpretation/clarification to all affected ACOMs/ASCCs/DRUs and HQDA staff agencies not later than thirty days following the reclama resolution.

89. Army Organization's biological surety management ACOMs/ASCCs/DRUs with organizations and activities assigned biological surety missions (including management of biological surety contracts) will do the following:
a. Provide oversight to ensure surety organizations and activities are funded and staffed appropriately, are complying with biological surety requirements, and are provided adequate support from external agencies (including IMCOM- managed garrison/installation support).

b. Conduct surety management reviews approximately every 24 months to determine the adequacy of unit training, support, guidance provided to its assigned surety organizations, and compliance with applicable regulations.

810. U.S. Army Nuclear and Combating Weapons of Mass Destruction Agency surety assistance visits U.S. Army Nuclear and Combating Weapons of Mass Destruction Agency (USANCA) will conduct surety assistance visits at the request of a facility commander/director, higher-level commander, or ARSTAF office or other Army organization. Such a request can be made directly to the USANCA Operations Division (ATTN: MONACWZ). The intent of the surety assistance visit is to provide an independent review and assessment of all or a portion of biological surety program, and to provide assistance in interpreting surety requirements and correcting problem areas.

a. The requesting commander/director will coordinate the scope and specific objectives of the surety assistance visit with USANCA.

b. A report of the surety assistance visit will be provided to the requesting commander/director, with a copy retained by USANCA. The USANCA will not distribute the report further without written approval of the requesting commander/director. Any observations derived from surety assistance visits and used for subsequent USANCA informational publications will not be attributed to specific locations or commands.

## Biological Surety Inspection Results Processing Matrix

| Day                           | Suspense                       | Inspection with reinspec-   |
|-------------------------------|--------------------------------|-----------------------------|
| tion/ resolution required     |                                |                             |
| Inspection with no            |                                |                             |
| reinspection/ resolution      |                                |                             |
| required                      |                                |                             |
| 0                             | Exit Briefing                  | DAIG provides draft BSI     |
| report to inspected organi-   |                                |                             |
| zation.                       |                                |                             |
| 30                            | 30 days after inspection       | DAIG will provide copy of   |
| final report to ACOM/ASCC/    |                                |                             |
| DRU, HQDA staff, USANCA       |                                |                             |
| 30                            | 30 days after receipt of final |                             |
| report                        |                                |                             |
| Inspected organization: Pre-  |                                |                             |
| pares written response of     |                                |                             |
| corrective actions taken and  |                                |                             |
| planned.                      |                                |                             |
| Prepares reclama to failing   |                                |                             |
| deficiencies, if applicable.  |                                |                             |
| Forwards response and         |                                |                             |
| reclama to ACOM/ASCC/         |                                |                             |
| DRU.                          |                                |                             |
| 60                            | 60 days after receipt of final |                             |
| report                        |                                |                             |
| ACOM/ASCC/DRU: Re-            |                                |                             |
| views inspection report, cor- |                                |                             |
| rective actions response,     |                                |                             |
| and reclama.                  |                                |                             |
| Forwards organization and/    |                                |                             |
| or ACOM/ASCC/DRU              |                                |                             |
| reclama to HQDA               |                                |                             |
| (DAMOSSD), if applicable.    |                                |                             |
| Makes "mission capability"    |                                |                             |
| determination about organi-   |                                |                             |
| zation and conveys determi-   |                                |                             |
| nation to the organization    |                                |                             |
| and provides a copy to        |                                |                             |
| DAIG and HQDA                 |                                |                             |
| (DAMOSSD).                   |                                |                             |
| Forwards corrective actions   |                                |                             |
| response to DAIG.             |                                |                             |
| 80                            | 20 days after receipt of writ- |                             |
| ten response from ACOM/       |                                |                             |
| ASCC/DRU                      |                                |                             |
| DAIG:                         |                                |                             |
| Reviews corrective action     |                                |                             |
| response.                     |                                |                             |
| Determines whether to con-    |                                |                             |
| duct reinspection of the fa-  |                                |                             |
| cility.                       |                                |                             |
| Forwards memo identifying     |                                |                             |
| reinspection date to ACOM/    |                                |                             |
| ASCC/DRU and inspected        |                                |                             |
| organization.                 |                                |                             |
| 90                            | 30 days after receipt of       |                             |
| reclama from ACOM/ASCC/       |                                |                             |
| DRU                           |                                |                             |
| Appropriate HQDA offices      |                                |                             |
| review reclama.               |                                |                             |
| DAMOSSD prepares and         |                                |                             |
| sends response to ACOM/       |                                |                             |
| ASCC/DRU (copy to DAIG).      |                                |                             |
| 120                           | 60 days after receipt of writ- |                             |
| ten response from ACOM/       |                                |                             |
| ASCC/DRU                      |                                |                             |
| DAIG conducts reinspec-       |                                |                             |
| tion.                         |                                |                             |
| Appropriate HQDA offices      |                                |                             |
| review reclama.               |                                |                             |
| DAMOSSD forwards             |                                |                             |
| reclama response to           |                                |                             |
| ACOM/ASCC/DRU and             |                                |                             |
| DAIG.                         |                                |                             |
All deficiencies attributed to External Support
DAIG provides draft BSI report to inspected organization.
DAIG provides copy of final report to ACOM/ASCC/ DRU, HQDA staff, USANCA
DAIG provides extract of the report to the cited supporting agency.
Inspected organization: Prepares written response of corrective actions taken and planned for the findings/ deficiencies specified by DAIG, and forwards to ACOM/ASCC/DRU. Prepares reclama and forwards to ACOM/ASCC/ DRU, if applicable.
For all deficiencies not corrected during inspection, supporting agency: Prepares written response of corrective action taken or planned through its command channels to DAIG, with copies to supported organization, its ACOM/ASCC/DRU, and HQDA. Prepares reclama to deficiencies, forwards to HQDA (if applicable). For failing external support deficiencies, the supported organization's ACOM/ASCC/DRU makes "mission capability" determination about organization.
ACOM/ASCC/DRU: Reviews inspection report (and corrective actions response and reclama, if applicable). Forwards organization and/ or ACOM/ASCC/DRU reclama to HQDA (DAMOSSD) and corrective action response to DAIG, if applicable. DAIG reviews corrective action response.
DAIG reviews corrective action response. For failing external support deficiencies, DAIG determines whether to conduct reinspection of the failed areas at the facility. Forwards memo identifying
reinspection date to supporting
organization, with copy furnished to ACOM/ASCC/DRU and supported organization. Appropriate HQDA offices review reclama. DAMOSSD prepares and sends response to supporting agency (copy to DAIG and ACOM/ASCC/DRU of supported organization). DAIG conducts reinspection.

## Managing Biological Select Agents And Toxins Contracts

91. General a. This regulation applies to Army-managed contractor operations involving DOD-provided BSAT regardless of place of performance. Contractor operations occur at government facilities, government-owned, contractor-operated (GOCO) or contractor-owned, contractor-operated (COCO) facilities. This regulation applies to any BSAT furnished on or after the effective date of this regulation. Contracts executed before the effective date of this regulation are exempt from its provisions. Contract extensions will be in accordance with this chapter.

b. Army contracting agencies must identify the source of BSAT for the contract in the statement of work (SOW).

92. Source of Biological Select Agents and Toxins Chapter 3 of this regulation governs acquisition and transfer of BSAT by Army contractors. Contractors having BSAT on hand as of the implementation date of this regulation, but lacking documentation of its origin, may assume that BSAT to be non-DOD sourced.

93. Biological Personnel Reliability Program a. Commanders/Directors of Army BSAT facilities may elect to include in their facility BPRP those on-site contractor personnel directly supporting the facility and working with BSAT owned by the facility.

b. Facility BPRP procedures for such contractor personnel will be forwarded for contracting officer approval with a copy furnished to ACOM/ASCC/DRU, and will be implemented by contractually binding agreements. Further provisions of this chapter would not apply to such on-site contractor support.

c. Alternately, on-site contractor personnel may be included in a contractor BPRP per this regulation.

94. Contracts and contract clauses a. Contracting officers will ensure that Army biological surety clauses are made contractually binding on all contractors required to possess or use DOD or Army-furnished BSAT.

b. The Contracting Officer will designate a COR to monitor BSAT contracts. c. The SOW for the contract will state that quantities/amounts of DOD-provided BSAT will be appropriate to that necessary for performance of the contract.

d. At the conclusion of the contract, the contractor will manage the final disposition of the BSAT in accordance with the plan specified in the contract.

e. The AMC and MEDCOM are jointly responsible for the development of biological surety contract clauses in the areas of personnel reliability, security, safety, and accountability of BSAT. Biological surety contract clauses will share common technical terminology and will include technical procedures as required. The AMC and MEDCOM will ensure that such clauses are promulgated in accordance with Federal Acquisition Regulation (FAR), Subparts 1.3 and 1.4, Defense FAR Supplement, Subparts 201.3 and 201.4, and the Army FAR Supplement, Subparts 5101.3 and 5101.4.

(1) The MEDCOM is the lead command for the maintenance of these biological surety clauses, and will provide a copy of the clauses and any revisions to HQDA, ODCS G3/5/7, ATTN: DAMOSSD.

(2) The HQDA, ODCS G3/5/7 (DAMOSSD), will coordinate HQDA adjudication and resolution of any disagreements between ACOM/ASCC/DRUs during the development and maintenance of these biological surety clauses.

f. The Army will not furnish BSAT until a contractor facility demonstrates compliance with the biological surety contract clauses.

g. Each responsible ACOM/ASCC/DRU will ensure that contract facilities handling BSAT are pre-inspected and periodically inspected (in accordance with para 89 of this regulation) for compliance with biological surety contract clauses.

95. Provisions for organizations that support multiple biological surety contracts a. The minimum requirement for a contract organization is that each contract employee in a BPRP duty position be on a BDPR and enrolled in the BPRP, with a designated government certifying official and a designated contractor biological surety officer. It is not required that a contract employee be on a separate BDPR for each contract he or she supports.

b. Once a contract organization has established a BDPR and BPRP, the ACOM/ASCC/DRU may determine that it is in the best interests of the Government to use a single certifying official for subsequent contracts, even if the certifying official is not the COR for all of the contracts. Those ACOMs/ASCCs/DRUs will establish procedures to ensure
(1) The certifying official appraises other contracting officers or CORs of BPRP disqualifications and contractor noncompliance.

(2) The transition of certifying official responsibilities when the initial contract is terminated. c. Any consolidation of certifying official responsibilities between ACOMs/ASCCs/DRUs will be coordinated with HQDA, ODCS G3/5/7 (DAMOSSD) and will require a memorandum of agreement (MOA), with a copy furnished to HQDA, ODCS G3/5/7 (DAMOSSD).

d. Each ACOM/ASCC/DRU is responsible for biological surety management for its contracts. Where two or more ACOMs/ASCCs/DRUs have biological surety contracts with one contractor organization, the ACOMs/ASCCs/DRUs are encouraged to coordinate their management responsibilities as appropriate (for example, a consolidated surety management review team, or sharing of review results).

96. Applicability of the biological surety program to contract operations The provisions of this regulation apply to contractor operations in general, but specific references to contractor to contractor requirements are identified in the table below.

Contractor quick reference to requirements
| Chapter                                                       | Reference                                                               |
|---------------------------------------------------------------|-------------------------------------------------------------------------|
| Chapter 1                                                     | Program concept, 15                                                    |
| b                                                             |                                                                         |
| .                                                             |                                                                         |
| AMC responsibility for contract oversight, 14                |                                                                         |
| o                                                             |                                                                         |
| .                                                             |                                                                         |
| MEDCOM responsibility for contract oversight, 14             |                                                                         |
| r                                                             |                                                                         |
| .                                                             |                                                                         |
| USANCA responsibility for database management, 14            |                                                                         |
| t                                                             |                                                                         |
| .                                                             |                                                                         |
| Commander/Director responsibility for contract oversight, 14 |                                                                         |
| v                                                             |                                                                         |
| .                                                             |                                                                         |
| Initiation and termination of surety status, 16              |                                                                         |
| a                                                             |                                                                         |
| and                                                           |                                                                         |
| b                                                             |                                                                         |
| .                                                             |                                                                         |
| Contractor biological surety officer, 17                     |                                                                         |
| a                                                             |                                                                         |
| .                                                             |                                                                         |
| Chapter 2                                                     | General policy on BPRP, 21                                             |
| d                                                             |                                                                         |
| .                                                             |                                                                         |
| BPRP duty position designation, 22.                          |                                                                         |
| Certifying officials, 23                                     |                                                                         |
| b                                                             |                                                                         |
| .                                                             |                                                                         |
| Reviewing officials, 23                                      |                                                                         |
| c                                                             |                                                                         |
| .                                                             |                                                                         |
| Administration officials, 23                                 |                                                                         |
| f                                                             |                                                                         |
| .                                                             |                                                                         |
| Reliability assessment, 25                                   |                                                                         |
| b                                                             |                                                                         |
| .                                                             |                                                                         |
| Personnel records screening, 211.                            |                                                                         |
| Personnel security records screening, 212                    |                                                                         |
| b                                                             |                                                                         |
| .                                                             |                                                                         |
| Drug testing, 214.                                           |                                                                         |
| Drug testing during continuous evaluation, 221               |                                                                         |
| b                                                             |                                                                         |
| .                                                             |                                                                         |
| Disqualification, 226                                        |                                                                         |
| c                                                             |                                                                         |
| .                                                             |                                                                         |
| Annual PRP report, 232.                                      |                                                                         |
| Chapter 3                                                     | Control of BSAT.                                                        |
| Chapter 8                                                     | Biological surety inspections, 84.                                     |
| ACOM/ASCC/DRU biological surety management, 89.              |                                                                         |
| Chapter 9                                                     | Managing BSAT Contracts.                                                |
| Appendix D                                                    | Chemical Weapons Convention (CWC) Requirements for Ricin and Saxitoxin. |

## Appendix A References Section I Required Publications

AR 19017
Biological Select Agents and Toxins Security Program (Cited in paras 41, 61.)
AR 19045
Law Enforcement Reporting (Cited in paras 62d, 73a.)
AR 34021
The Army Privacy Program (Cited in paras 21d, 210a(1), 213a(4), 213c, 220a(3).)
AR 38067
The Department of the Army Personnel Security Program (Cited in paras 212d, 222d, 226b(3)(e).)
AR 38510
The Army Safety Program (Cited in paras 14n(1), 51, 71b, 74a.)
AR 52513
Antiterrorism (Cited in paras 62b, 62c.)
AR 60085
Army Substance Abuse Program (ASAP) (Cited in paras 213b, 214, 221b.)
DA Pam 38540
Army Accident Investigation and Reporting (Cited in para 73c.)
DA Pam 38561
Toxic Chemical Agent Safety Standards (Cited in para 51d.)
DA Pam 38569
Biological Defense Safety Program (Cited in paras 220b, 51b, 51a, 71b, 74a.)
Army Federal Acquisition Regulation Supplement Subparts 5101.3 and 5101.4 (Cited in para 94e.) (Available at http://farsite.hill.af.mil/vfafar1.htm.)
Defense Federal Acquisition Regulation Supplement Subparts 201.3 and 201.4 (Cited in para 94e.) (Available at http://www.acq.osd.mil/dpap/dars/dfarspgi/current/ index.html.)
Defense Federal Acquisition Regulation Supplement Subpart 252.2237004 (Cited in para 221b.) (Available at http://www.acq.osd.mil/dpap/dars/dfarspgi/current/ index.html.)
DOD 5200.2R
Personnel Security Program (Cited in paras 21c, 212b, 212c(3)(a), 212d.) (Available at http://www.dtic.mil/whs/
directives.)
Federal Acquisition Regulation Subparts 1.3 and 1.4 (Cited in para 94e.) (Available at http://www.arnet.gov/far.)
7 CFR 331
Possession, Use, And Transfer Of Select Agents And Toxins (Cited in paras 21h, 32, 36a, 41, B2, C3.) (Available at http://www.gpoaccess.gov/cfr/index.html.)
9 CFR 121
Possession, Use, And Transfer Of Select Agents And Toxins (Cited in paras 21h, 32, 36a, 41, B2, C2.) (Available at http://www.gpoaccess.gov/cfr/index.html.)
42 CFR Part 2
Confidentiality of Alcohol and Drug Abuse Patient Records (Cited in para 213b.) (Available at http:// www.gpoaccess.gov/cfr/index.html.)
42 USC 290dd2
Confidentiality of records (Cited in para 213b.) (Available at http://thomas.loc.gov.)
42 CFR Part 73
Select Agents and Toxins (Cited in paras 21h, 32, 36a, 41, 71b, 74a, B2, C2.) (Available at http:// www.gpoaccess.gov/cfr/index.html.)
49 CFR Parts 171178
Transportation (Cited in para 41.) (Available at http://www.gpoaccess.gov/cfr/index.html.)
5 USC 7904
Employee assistance programs relating to drug abuse and alcohol abuse (Cited in para 213b.) (Available at http:// www.gpoaccess.gov/uscode.)
18 USC 175
Prohibitions with respect to biological weapons (Available at http://thomas.loc.gov.)

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

AR 1201
Army Inspection Policy AR 1016
U.S. Army Nuclear and Chemical Agency AR 112
Management Control AR 1134
The Army Respiratory Protection Program AR 156
Procedures for Investigating Officers and Boards of Officers AR 201
Inspector General Activities and Procedures AR 405
Preventive Medicine AR 4066
Medical Record Administration And Health Care Documentation AR 4068
Clinical Quality Management AR 19014
Carrying of Firearms and Use of Force for Law Enforcement and Security Duties

## Da Pam 60085 Army Substance Abuse Program Civilian Services

CDC
Biosafety in Microbiological and Biomedical Laboratories (Current Edition) (Available at http://www.cdc.gov/OD/ohs/ default.htm.)

## Dod 5220.22M National Industrial Security Program Operating Manual (Available At Http://Www.Dtic.Mil/Whs/Directives.) Dod 6025.18R Dod Health Information Privacy Regulation (Available At Http://Www.Dtic.Mil/Whs/Directives.)

DOD Directive 2040.2
International Transfers of Technology, Goods, Services and Munitions (Available at http://www.dtic.mil/whs/ directives.)

## Dod Directive 5210.88 Safeguarding Biological Select Agents And Toxins (Available At Http://Www.Dtic.Mil/Whs/Directives.) Dod Directive 5230.20 Visits And Assignments Of Foreign Nationals (Available At Http://Www.Dtic.Mil/Whs/Directives.) Dod Instruction 5010.40 Managers' Internal Control (Mic) Program Procedures (Available At Http://Www.Dtic.Mil/Whs/Directives.)

DOD Instruction 5210.89
Minimum Security Standards for Safeguarding Biological Select Agents and Toxins (Available at http://www.dtic.mil/ whs/directives.)

## Dod Instruction 5230.29 Security And Policy Review Of Dod Information For Public Release (Available At Http://Www.Dtic.Mil/Whs/Directives.)

Public Law 107188
Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Available at http://thomas.loc.gov.)
Public Law 10756
Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT ACT) Act of 2001 (Available at http://thomas.loc.gov.)
29 CFR 1630
The Equal Employment Provisions Of The Americans With Disabilities Act (Available at http://www.gpoaccess.gov/ cfr/index.html.)

## 29 Cfr 1910.1020 Access To Employee Exposure And Medical Records (Available At Http://Www.Gpoaccess.Gov/Cfr/Index.Html.) 29 Cfr 1910.1030 Bloodborne Pathogens (Available At Http://Www.Gpoaccess.Gov/Cfr/Index.Html.) 29 Cfr 1910.1200 Hazard Communication (Available At Http://Www.Gpoaccess.Gov/Cfr/Index.Html.)

29 CFR 1910.1450
Occupational Exposure to Hazardous Chemicals in Laboratories (Available at http://www.gpoaccess.gov/cfr/ index.html.)
29 USC 655
Occupational Safety and Health Standards (Available at http://www.gpoaccess.gov/uscode.)
42 USC 126
Equal Opportunity for Individuals with Disabilities (Available at http://thomas.loc.gov.)

## Section Iii Prescribed Forms Except Where Otherwise Indicated Below, The Following Da And Sf Forms Are Available On The Apd Web Site (Http:// Www.Apd.Army.Mil). Da Form 3180 Personnel Screening And Evaluation Record (Prescribed In Para 29.) Section Iv Referenced Forms

DA Form 7422
Annual Personnel Reliability Program (PRP) Status Report SF 85
Questionnaire for Non-Sensitive Positions SF 86
Questionnaire For National Security Positions SF 600
Chronological Record Of Medical Care APHIS/CDC Form 2
Request to Transfer Select Agents and Toxins (Available at http://www.cdc.gov/od/sap.)

## Appendix B Categories Of Biological Agents B1. General The Army Biological Surety Program Applies To Biological Select Agents And Toxins.

B2. Biological select agents and toxins For the purposes of this regulation, BSAT are biological agents and toxins selected by the Department of Health and Human Services (DHHS) and the Department of Agriculture that present a high bioterrorism risk to national security and have the greatest potential for adverse public health impact with mass casualties of humans and/or animals or that pose a severe threat to plant health or to plant products. The lists of select agents and toxins are reviewed and updated by the Centers of Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service, and are found in 42 CFR, Part 73; 7 CFR, Part 331; and 9 CFR, Part 121. These agents and toxins are also known as high consequence non-overlap agents and toxins, overlap agents and toxins, and listed plant pathogens. The lists include specific genetic elements, recombinant nucleic acids, and recombinant organisms. The lists also identify exclusions that are not considered as select agents or toxins; these exclusions are likewise not considered BSAT in the Army biological surety program. The referenced Federal Regulations also exempt clinical and diagnostic laboratories presented with specimens for diagnosis or verification, provided that specified actions are taken; such exempted laboratories are also exempt from the provisions of this regulation.

B3. Non-surety biological materiel a. Biological agents ("nonselect"). Biological Surety Program provisions in this regulation apply only to biological select agents and toxins, and are not applicable to other biological agents and toxins.

b. Recovered biological warfare material.

(1) Biological Surety Program provisions in this regulation are not applicable to recovered biological warfare material. Guidance for recovered biological warfare materiel will be provided by the Assistant Secretary of the Army (Installations and Environment).

(2) Use of recovered biological warfare material for destruction research (such as in a prototype or test destruction device) is not subject to the Biological Surety Program.

(3) Any biological select agent or toxin fill removed from the recovered biological warfare material that is subsequently used for biological defense research purposes becomes subject to the Biological Surety Program provisions in this regulation.

B4. Special instructions for ricin and saxitoxin Ricin and saxitoxin are accountable under the Chemical Weapons Convention as Schedule 1 chemicals. Any production, retention, consumption, transfer, and receipt of ricin and saxitoxin must be in accordance with the provisions in appendix D of this regulation, even when ricin or saxitoxin might otherwise be exempt from this regulation.

## Appendix C Applicable Provisions Of Federal Law And Regulations

C1. Title 18 USC, Chapter 10, Section 175, as amended by PL 10756
Title 18 USC, Chapter 10, Section 175b prohibits possession of select agents by restricted persons, and defines "restricted person." (Available at http://www.gpoaccess.gov/topics/military.html.) One type of "restricted person" is a national of a country currently determined by the Secretary of State to repeatedly have provided support for acts of international terrorism, and who has not been lawfully admitted into the United States for permanent residence. The Secretary of State determination for State Sponsors of Terrorism is available at http://www.state.gov/s/ct/c14151.htm.

C2. Title 42, CFR, Part 73 and Title 9, CFR, Part 121
Title 42, CFR, Part 73 and Title 9, CFR, Part 121 establish requirements regarding possession and use in the United States, receipt from outside the United States, and transfer within the United States, of select agents and toxins. They include requirements concerning registration, security risk assessments, safety plans, security plans, emergency response plans, training, transfers, record keeping, inspections, and notifications.

C3. Title 7, CFR, Part 331
Title 7, CFR, Part 331 sets forth the requirements for possession, use, and transfer of biological agents or toxins that have been determined to have the potential to pose a severe threat to plant health or to plant products. The purpose of this part is to ensure the safe handling of such agents or toxins, and to protect against the use of such agents or toxins in domestic or international terrorism or for any other criminal purpose.

## Appendix D Chemical Weapons Convention (Cwc) Requirements For Ricin And Saxitoxin D1. General Ricin And Saxitoxin Are Accountable Under The Cwc As Schedule 1 Chemicals.

D2. Accountability Manager for Schedule 1 Chemicals Responsibilities a. The Commander, Army Materiel Command (AMC) will designate the DOD Accountability Manager for Schedule
1 Chemicals. Responsibilities of the accountability manager include monitoring, tracking, and reporting of DOD production, retention, consumption, transfer, and receipt of Schedule 1 chemicals. The Commander, AMC also operates the single small scale facility (SSSF), for production of Schedule 1 chemicals for research, medical, pharmaceutical, or protective purposes, per the applicable provisions of the CWC.

b. Heads of contracting activities will ensure that provisions of this appendix are implemented by contractually binding agreements.

D3. Ricin and saxitoxin obtained from the single small scale facility a. DOD organizations and their contractors must obtain ricin and saxitoxin from the SSSF if used for protective purposes (those purposes directly related to protection against toxic chemicals and to protection against chemical weapons, including chemical defensive training).

b. For other purposes permitted under the CWC (research, medical, or pharmaceutical), DOD organizations and their contractors may acquire ricin and saxitoxin from the SSSF, or they may synthesize or acquire ricin and saxitoxin as described in paragraphs D4 and D5 below.

c. Submit requests for ricin and saxitoxin from the SSSF to the DOD Accountability Manager for Schedule 1
Chemicals (address: Edgewood Chemical and Biological Center, AMSRDECBCBC/DOD Accountability - E3942,
5183 Blackhawk Road, Aberdeen Proving Ground, MD, 210105424). The Army will transfer ricin and saxitoxin to DOD organizations and their contractors per ATSD(NBC) guidance. Production, transportation, and overhead costs incurred by AMC will be reimbursed by the requesting organization.

d. Recipients will comply with guidance from the DOD Accountability Manager for Schedule 1 Chemicals for accountability and reporting (ACOMs/ASCCs/DRUs will report per paragraph D7 below).

D4. Production DOD organizations (other than the SSSF) and their contractors are authorized to produce (synthesize) ricin and saxitoxin for research, medical, or pharmaceutical purposes only. Concurrence of the DOD Accountability Manager for Schedule 1 Chemicals is required for production of ricin or saxitoxin that exceeds 100 milligrams per year; in addition, Army organizations require the approval of DAMOSSD. Submit requests at least 60 days before the first production and include the following information:
a. The location(s) where production will take place, including building and room numbers and mailing address(es). b. The quantities planned to be produced and consumed per year for the duration of the production, and the purpose of consumption (research, medical, or pharmaceutical, with a brief description of the projects).

Note. If the total of all Schedule 1 chemicals produced at the facility exceeds 100 grams per calendar year, special procedures will apply and one-year advance notification is required. See AR 506, chapter 4 for details.

D5. Other transfer or acquisition DOD organizations and their contractors may transfer or acquire ricin or saxitoxin for research, medical, or pharmaceutical purposes from sources other than the SSSF. Concurrence of the DOD Accountability Manager for Schedule 1 Chemicals is required for acquisition or transfer of ricin or saxitoxin that exceeds 100 milligrams per year; in addition, Army organizations require the approval of DAMOSSD. Submit approval requests at least 60 days before the transfer or acquisition and include the name of the source and recipient facilities, the quantity of ricin and saxitoxin transferred or acquired, and a brief description of the project(s), specifying the permitted purpose under the CWC (research, medical, or pharmaceutical).

D6. Requests associated with non-DOD work Requests from any organization (DOD or non-DOD) for use of Army-produced saxitoxin or ricin for any non-DOD work will be made to the Assistant to the Secretary of Defense (Nuclear, Chemical, and Biological) (ATSD(NCB)). The Army will provide saxitoxin and ricin per ATSD(NCB) guidance.

D7. Reporting requirements Each ACOM/ASCC/DRU will prepare semiannual reports of all supported organizations (including government, industry, academic, and contractor facilities, but not including the SSSF) that possess, acquire, produce, consume, store, or transfer ricin and saxitoxin. Reports are not required if the total quantity of ricin or saxitoxin under the control of the organization does not exceed 100 milligrams at any time during the calendar year.

a. One report will be prepared and submitted by 1 February to address the entire previous calendar year (December inventory to December inventory); an interim report will be submitted by 1 August for the current calendar year (previous December inventory to June inventory). The report will include the following information for each facility and each toxin:
(1) Facility name, address, and point of contact information for the principal investigator.

(2) Maximum total quantity stored at any time during the reporting period. (3) Quantity stored at the facility at the end of the reporting period. (4) Quantity consumed during the reporting period, and the purpose of consumption (research, medical, pharmaceutical, or protective).

(5) Quantity produced or acquired during the reporting period. (6) Destination, quantity, and purpose for ricin and saxitoxin transferred to other facilities. Provide contract numbers for other service or agency contracts supported with chemical agent.

(7) For contractor facilities, the name of contractor and contract number, duration of contract, and the date of most recent survey of the contractor's facility and surveying agency.

b. ACOMs/ASCCs/DRUs will send reports to the DOD Accountability Manager for Schedule 1 Chemicals (address:
Edgewood Chemical and Biological Center, AMSRDECBCBC/DOD Accountability - E3942, 5183 Blackhawk Road, Aberdeen Proving Ground, MD, 210105424).

c. The DOD Accountability Manager will review the reports and provide a consolidated report to DA G35SSD
(address: HQDA, ODCS G3, ATTN: DAMOSSD, Washington, DC 203100400) and USANCA (address: Director, USANCA ATTN: MONACWZ, 7150 Heller Loop, Suite 101, Springfield, VA 221503198).

d. Contact DA G35SSD, for reporting procedures for sensitive or classified projects.

## Glossary Section I Abbreviations

ACOM
Army command ACSIM
Assistant Chief of Staff for Installation Management AMC
Army Materiel Command ANACI
access national agency check with credit checks and written inquiries AOC
Army Operations Center APG
Aberdeen Proving Ground APHIS
Animal and Plant Health Inspection Service ARNG
Army National Guard ARNGUS
Army National Guard of the United States ARSTAF
Army staff ASA(I&E)
Assistant Secretary of the Army (Installations and Environment)
ASA(ALT)
Assistant Secretary of the Army (Acquisition, Logistics, and Technology)
ASAP
Army Substance Abuse Program ASCC
Army service component command ASD(C3I)
Assistant Secretary of Defense (Command, Control, Communication, Intelligence)
ATSD(NCB)
Assistant to the Secretary of Defense (Nuclear, Chemical, and Biological)
ATTN
attention BDPR
biological duty position roster BPRP
biological personnel reliability program

## Bme Biological Management Evaluation

BSAT
biological select agents and toxins BSI
biological surety inspection CDC
Centers for Disease Control and Prevention CFR
Code of Federal Regulations CMA
competent medical authority COCO
contractor-owned, contractor-operated COR
contracting officer's representative CPA
Chief of Public Affairs CWC
Chemical Weapons Convention DA
Department of the Army DAIG
Department of the Army Inspector General DCS, G3/5/7
Deputy Chief of Staff, G3/5/7
DOD
Department of Defense DHHS
Department of Health and Human Services DRU
direct reporting unit DSM
Diagnostic and Statistical Manual of Mental Disorders DSS
Defense Security Service EAP
Employee Assistance Program EMS
emergency medical services

## Epsq Electronic Personnel Security Questionnaire Eod Explosive Ordnance Disposal Far Federal Acquisition Regulation Fbi Federal Bureau Of Investigation Forscom Forces Command Goco Government-Owned, Contractor-Operated Hipaa Health Insurance Portability And Accountability Act Hqda Headquarters, Department Of The Army Imcom Installation Management Command Iop Internal Operating Procedure Laa Limited Access Authorization Mc Management Control Medcom Army Medical Command Moa Memorandum Of Agreement

MTA
material transfer agreement NAC
national agency check

## Naclc National Agency Check With Local Agency Checks And Credit Checks Opm Office Of Personnel Management Opmg Office Of The Provost Marshal General Otig Office Of The Inspector General Otsg Office Of The Surgeon General

PDI
potentially disqualifying information PR
periodic reinvestigation PRP
personnel reliability program PSI
personnel security investigation RAC
risk assessment code RBWM
recovered biological warfare material RCS
report control system RO
responsible official SOP
standing operating procedure SSN
social security number SSSF
single small scale facility TDY
temporary duty TIG
The Inspector General TSG
The Surgeon General U.S.

United States USACIDC
U.S. Army Criminal Investigation Division Command USANCA
U. S. Army Nuclear and Combating Weapons of Mass Destruction Agency USAR
U.S. Army Reserve USC
United States Code

## Usapd U.S. Army Publishing Directorate Usd(I) Under Secretary Of Defense For Intelligence Section Ii Terms

Access An individual is deemed to have access at any point in time if the individual has possession of a select agent or toxin (for example, ability to carry, use, or manipulate) or the ability to gain possession of a select agent or toxin (per 42 CFR Part 73.10). For BPRP purposes, an individual is not considered to have access if escorted and/or under observation by at least one BPRP-certified individual capable of preventing the individual from gaining possession of BSAT.

Accountability The obligation to keep accurate records of property, documents, or funds. Accountability is concerned primarily with the records and does not necessarily imply actual possession.

Administration official Senior supervisory contractor employee(s) designated by the certifying official at a COCO or GOCO facility to assist in administering day-to-day certifying official duties per paragraph 23f.

Administrative termination An action taken to remove an individual from the BPRP when the individual transfers from a duty position requiring BPRP certification to one that does not or when an individual leaves an organization.

Alcohol abuse The use of alcohol to the extent that it has an adverse effect on the user's health, behavior, family, community, or the Department of Defense, or leads to unacceptable behavior as evidenced by one or more acts of alcohol-related misconduct and/or the illegal use of alcohol. Alcohol abuse may include a diagnosis of alcohol dependence.

Alcohol dependence Psychological and/or physiological reliance on alcohol as such reliance is defined in the current Diagnostic Statistical Manual (DSM) of the American Psychiatric Association.

Alcohol-related incident Any substandard behavior or performance in which the consumption of alcohol by the individual is a contributing factor as determined by the certifying official with consultation from the CMA (such as intoxicated driving, domestic disturbances, assault, disorderly conduct, personal injury, failure to go to prescribed alcohol abuse counseling, or voluntary consumption of alcohol by an individual previously diagnosed as alcohol-dependent, underage drinking).

## Biological Agents See Appendix B.

Biological duty position A duty position that requires access to biological surety material or control direct access to biological surety material. Biological duty positions are contained in paragraph 22. Individuals assigned to biological duty positions must be in the BPRP.

Biological incident Security event involving unauthorized access or use of BSAT; attempts to steal, release, or divert BSAT outside physical security controls; or deliberate acts (terrorism or criminal) where required control of biological select agent or toxin is threatened or compromised.

Biological management evaluation An evaluation conducted by the DAIG or ACOM/ASCC/DRU Inspector General of biological operations with inquiry into the biological agent functions and responsibilities of staff agencies, inspection teams, major and intermediate command levels, and assistance teams to identify management, systemic, or functional problem areas in the Army Biological Surety Program at any level.

Biological mishap Unintentional event resulting from a non-deliberate act where biological select agent or toxin is released into the ambient atmosphere and has the potential to threaten unprotected personnel.

Biological surety inspection An inspection of Army organizations with biological agent surety missions, conducted by the Inspector General, to determine their capability to accomplish biological agent missions in a safe and secure environment through examination of the following functional areas: mission operations, safety, security, surety management, emergency response, medical support, demilitarization, and external support.

Biological surety operation Any operation that involves biological surety material is a biological surety operation (for example, storage, shipping, handling, maintenance, laboratory activities, surveillance, decontamination, disposal, and training).

Biological surety program A system of control measures designed to provide protection to the local population, workers, and the environment by ensuring that BSAT operations are conducted safely; that BSAT are secure; and that personnel involved in those operations meet the highest standards of reliability.

Certification A determination by a certifying official that an individual meets the personnel reliability criteria established for assignment to a BPRP position.

Certifying official For military and Army civilian personnel, the commander/director or DOD civilian responsible for chemical surety operations and having sufficient personal contact with subordinate BPRP personnel to permit continual evaluation of their performance and reliability. For Army contractor personnel, the Army COR designates the certifying official. The certifying official certifies that personnel being considered for assignment to chemical duties meet the requirements of the BPRP.

Competent medical authority A U.S. 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 BPRP.

Continuing evaluation The process by which a BPRP-certified individual is observed and evaluated for compliance with reliability standards. This is an ongoing process that considers duty performance, and on and off duty behavior and reliability on a consistent and frequent basis.

Contracting organization The organization that has primary responsibility for awarding, monitoring, administering, and ensuring compliance with a contract.

Custody Responsibility for the control of, transfer and movement of, and access to BSAT. Custody may or may not include accountability.

Decontamination The process of decreasing the amount of biological agent on any person, object, or area by absorbing, neutralizing, destroying, ventilating, or removing biological agents.

Deficiency A variance from prescribed procedures or criteria prescribed in technical manuals or other applicable regulations or publications.

Disqualification An action taken based on the receipt of disqualifying information to remove from the BPRP an individual who has been screened and certified into the BPRP or to terminate the BPRP screening process of an individual being considered for assignment to BPRP duties.

DOD personnel Active duty military personnel, full-time support personnel to Reserve components, civilian employees of the Department of Defense or, for BPRP purposes, DOD contractors and their employees.

Drug/substance abuse The wrongful use, possession, or distribution of a controlled substance, prescription medication, over-the-counter medication, or intoxicating substance (other than alcohol) or the wrongful introduction of these onto a military installation or DOD-contracted facility. For the purposes of this regulation, wrongful is defined as without legal justification or excuse, and includes use contrary to the directions of the manufacturer or prescribing healthcare provider, and the use of any intoxicating substance not intended for human consumption. It also includes all drugs and substances on the Federal Illicit Drug List.

Drug/substance dependence Psychological and/or physiological reliance on a chemical or pharmacological agent as such reliance is defined in the current Diagnostic Statistical Manual (DSM) of the American Psychiatric Association. The term does not include the continuing prescribed use of pharmaceuticals as part of the medical management of a chronic disease or medical condition.

## Exception An Approved Long-Term Exemption Or Deviation To A Requirement In This Regulation.

Exclusion area A designated area immediately surrounding one or more receptacles in which biological agents are contained. Normally, the boundaries of an exclusion area are the walls, floor, and ceiling of a storage structure, secure container, or a barrier that establishes the boundary of the exclusion area (such as a fence). The inside of a biological agent secure container is an exclusion area. In the absence of positive preventive measures, access into the exclusion area constitutes access to biological agents.

Explosive ordnance disposal The detection, identification, field evaluations, rendering safe, recovery, and final disposal of unexploded explosive ordnance or munitions.

Facility Unless otherwise characterized (for example, medical treatment facility), for the purposes of this regulation "facility" refers to an organization or program whose mission requires the storage or use of biological select agents or toxins, and the associated areas (laboratories or buildings) containing the biological select agents or toxins.

Factor affecting operations A situation or condition that may or may not be attributable to the inspected organization but significantly affects the organization's ability to perform its biological surety mission. It may pertain to such matters as command guidance; the adequacy of support; the availability or condition of facilities; the status of personnel, equipment, materiel, maintenance, or training; the provision of a safe and secure environment for biological surety material or the capability to adequately respond to a biological mishap or incident.

## Health Records Combined, The Treatment Record And Dental Record.

Interim certification Same as "certification," except performance of duty is subject to the restrictions of paragraph 212e pending receipt of the results of a new personnel security investigation.

Limited access authorization Authorization for access to Confidential or Secret information granted to non-United States citizens and immigrant aliens, which is limited to only that information necessary to the successful accomplishment of their assigned duties and based on a background investigation scoped for 10 years (per DOD 5200.2R).

Monitors, Biological Personnel Reliability Program Individual(s) appointed by the certifying official to assist in administering day-to-day functions of the program. Monitors may also be appointed by the reviewing official to administer the consolidated day-to-day functions of multiple certifying officials. Monitor duties are specified in the appointment memorandum.

National agency check A personnel security investigation consisting of records reviews of certain National agencies. As a minimum, it includes checks of the Defense Clearance and Investigation Index, the FBI Headquarters, and FBI Identification Division. A technical fingerprint search of the FBI's files is started as part of a NAC. If the fingerprint is not classifiable, a "name check only" of those files is conducted.

National agency check with local agency and credit check A personnel security investigation conducted by the Office of Personnel Management (OPM) that combines a NAC with local law enforcement agencies and credit histories.

## Periodic Reinvestigation An Investigation Conducted At Specified Intervals For Updating A Previously Completed Personnel Security Investigation. Personal Protective Equipment Protective Clothing And Equipment Used To Protect An Individual From The Effects Of Biological Agents.

Personnel security investigation Any investigation required for determining the eligibility of DOD military or civilian personnel and contractor employees for access to classified information, acceptance, or retention in the Armed Forces, or assignment to, and retention in, sensitive duties (for example, the BPRP).

Potentially disqualifying information Any information regarding an individual's physical, mental, or emotional status, conduct, or character, on- or off-duty, which may cast doubt about the individual's reliability or ability to perform duties involving biological agents.

## Protective Purposes Purposes Directly Related To Protection Against Toxic Chemicals And Chemical Weapons. See Appendix D.

Random drug testing A program of drug abuse testing where each member of the testing population has an equal chance of being selected. Random testing may be either testing of designated individual occupying a specified area, element, or position, or random testing of those individuals based on a neutral criterion, such as a digit of the SSN. Individuals will be tested at a minimum for cocaine, marijuana, methamphetamines, opiates, and PCP.

Recovered biological warfare materiel Biological warfare materiel that was previously discarded, buried, or fired, and discovered either unexpectedly or during planned environmental restoration operations.

Responsible official An official authorized to transfer and receive biological select agents and toxins on behalf of the facility. The responsible official is also responsible for the implementation of biological select agent and toxin inventory management procedures.

Restricted person For individuals who require CDC or APHIS registration for access to BSAT: an individual who has been denied such registration as a result of an FBI determination that the individual has met the "restricted person" criteria of 18 USC, Section 175b. For individuals who require BPRP certification but do not require CDC or APHIS registration: a person restricted from access to biological agents for one or more of the following reasons: Is under indictment or has courtmartial charges referred to a special or general court-martial that involves a crime punishable by imprisonment for a term exceeding l year. The person has been convicted in any court of the United States of a crime, was sentenced to imprisonment for a term exceeding one year and was incarcerated as a result of that sentence for not less than a year. Is a fugitive from justice. Is an alien illegally or unlawfully in the United States. Has been adjudicated as a mental defective or has been committed to any mental institution within the seven years preceding the person's consideration for access to chemical agents. Is an alien (other than lawfully admitted for permanent residence) who is a national of a country that the Secretary of State has determined (that remains in effect) that such country has repeatedly provided support for acts of international terrorism. Has by court-martial received a dishonorable or bad conduct discharge.

Reviewing official The commander or designated DOD military or civilian official responsible for BSAT operations or contracts at a level above (or overseeing) the certifying official, and responsible for monitoring the BPRP and reviewing designated BPRP actions.

Schedule 1 chemicals Those chemicals listed in Schedule 1 of the Chemical Weapons Convention (CWC) Schedule of Chemicals and other toxic chemicals or precursors that: have been developed, produced, stockpiled or used as a chemical weapon; otherwise pose a high risk to the object and purpose of the CWC by virtue of its high potential for use in activities prohibited under the CWC because one or more of the following conditions is met: (a) It possesses a chemical structure closely related to that of other toxic chemicals listed in Schedule 1, and has, or can be expected to have comparable properties; (b) It possesses such lethal or incapacitating toxicity as well as other properties that would enable it to be used as a chemical weapon; or (c) It may be used as a precursor in the final technological stage of production of a toxic chemical listed in Schedule 1, regardless of whether this stage takes place in facilities, in munitions, or otherwise; have little or no use for purposes not prohibited under the CWC.

Significant medical condition Acute or chronic medical condition with a reasonable likelihood of recurrence, which may result in (a) an altered state of consciousness, (b) impaired judgment or concentration, (c) increased risk of infection/impairment if exposed to biological agents, (d) impaired ability to safely wear personal protective equipment required for the biological surety position, or (e) inability to perform the physical requirements of the biological surety position, as substantiated by a CMA to the certifying official. A significant medical condition does not include prior medical conditions, or previously prescribed medication for such conditions, that have resolved without sequel or consequences, for example, uncomplicated surgeries, lacerations, broken bones, or musculoskeletal injuries.

Suspension An action taken to temporarily remove an individual from the BPRP when the certifying official has information that could be expected to affect an individual's job performance or reliability.

Technical escort Individuals technically qualified and properly equipped to accompany designated materiel, which requires a high degree of safety and security during shipment.

## Trafficking The Selling Of Illegal Drugs, Or Possession With The Intent To Sell Illegal Drugs. Waiver A Temporary Relief From Specific Requirements Of This Regulation, Pending Corrective Action To Conform To The Regulation. Section Iii Special Abbreviations And Terms This Section Contains No Entries. Usapd

# Electronic Publishing System Onecol Formatter Win32 Version 247

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DATE:
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DOCUMENT:
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DOC STATUS: NEW PUBLICATION