Primary_Barrier__Exhibit_Biological_Surety_Program_Written_Description_2017_.pdf

April 7, 2017

National Institutes of Health Biological Surety Program Description

I. Introduction

The National Institutes of Health (NIH) mission is based upon the advancement of medical research for the protection and improvement of the Nation’s public health. In keeping with this mission, NIH conducts and supports much of the research aimed at developing new and improved medical tools against potential bioterrorism agents, for use in our civilian population.

Since 2001, NIH has greatly accelerated its biodefense research program, launching a variety of new initiatives to catalyze development of vaccines, therapies, and diagnostic tests. These initiatives are predicated upon studies in basic biology, pathogenesis, immunology and host responses. A major effort within the civilian biodefense initiative is to provide research resources through the establishment of containment laboratories, databases, and other resources to help scientists conduct safe and effective biodefense research.

To ensure that this important work is performed in the safest and most responsible manner possible, the NIH Biological Surety Program (BSP) has been developed. The NIH BSP describes control measures to ensure that there is a trained, responsible and reliable workforce and rigorous procedures to protect employee health and ensure a safe work environment; preserve the integrity of the research being conducted; and to protect valuable research materials and products.

Compliance with the occupational health and safety and personnel policies, practices, and procedures described in the BSP is the responsibility of each individual working within a BSP Space. BSP Spaces are defined as unique areas designed to accommodate the safe and secure manipulation of Tier I Select Agents and Toxins or other designated materials required for vaccine development and basic research on emerging diseases that may pose a potential threat to human, animal and plant life. All NIH BSL-3 and BSL-4 facilities, including areas of critical infrastructure and information systems, are designated BSP Spaces under the NIH BSP.

II. Applicability

The BSP applies to all intramural NIH personnel, Federal or non-federal and visitors assigned to work in Biosurety Spaces.

III. Responsibilities

A. Deputy Director for Intramural Research (DDIR), Office of Intramural Research, OD, is responsible for oversight of the NIH Biological Surety Program. Notification of non-compliance by individuals covered by this program will be reported to the DDIR by the Director, Division of Occupational Health and Safety.

B. NIH Biological Surety Program Certifying Official (CO), is responsible for the quality assurance of the Biological Surety Program, certification of Biosurety participants and final approval of personnel for access into Biosurety Spaces.

C. Biological Surety Program (BSP) Manager, DOHS, ORS is responsible for the day-to-day operations of the BSP. BSP Managers are located on each campus where the BSP is in use (i.e. Frederick and Bethesda, MD and Hamilton, MT).

D. NIH Select Agent Program (SAP) Responsible Official: The Responsible Official (RO) and the Alternate Responsible Officials (AROs) are the centralized point persons for the dissemination of information and forms at each NIH site having a SAP (e.g., Rocky Mountain Laboratories [RML], Integrated Research Facility-Frederick [IRF-Frederick], Bethesda, MD). They are also the only conduits of action to and from the Federal Select Agent Program (FSAP).

E. Institute/Center (IC) Scientific Directors will provide general IC direction for personnel in laboratories and animal facilities and establish IC policies supporting the implementation of the NIH Biological Surety Program.

F. Division of Personnel Security and Access Control (DPSAC), SER, ORS adjudicates and grants clearances for the Secret, Top Secret or Public Trust Level positions for all individuals whose position description includes Biosurety Space duties. The NIH Facility Security Officer (FSO) is responsible for establishing the criteria for performance of background investigations for all personnel assigned to work in Biosurety Spaces as required by DHHS security policies.

G. Director, Occupational Medical Service, DOHS, ORS as the Certifying Medical Authority

(CMA) is responsible for providing occupational medical services as required by the Biological Surety Program. This may include consultation and coordination as needed with subject matter experts and occupational medical providers outside of the NIH, as authorized by the CO.

H. Principal Investigator (PI) is responsible for ensuring and documenting that all personnel are trained and proficient in the skills and aptitudes required by the agent-specific work being conducted within a Biosurety Space. Additionally, the PIs are also responsible for hazardous materials communication and appropriately identifying and registering all materials potentially infectious for humans, plants, animals, and/or recombinant DNA research. All PIs working with select agents and toxins must register with the facility SAP.

IV. Select Agent Management

The possession, use and transfer of select agents and toxins at the NIH are managed through the NIH SAP in accordance with 42 CFR 73, Possession, Use, and Transfer of Select Agents and Toxins; 7 CFR Part 331 and 9 CFR Part 121, Agricultural Biological Terrorism Protection Act of 2002; Possession, Use, and Transfer of Select Agents and Toxins. These federal regulations establish requirements regarding possession and use in the United States of America (USA), receipt from outside the USA, and transfer within the USA, of select agents and toxins. These select agents and toxins have been determined to have the potential to pose a severe threat to human, animal and plant health or products. The NIH BSP ensures the safe handling of such agents and toxins, and to secure the use of such agents and toxins contained within NIH Biosurety Spaces.

NIH research personnel may only possess and use a select agent upon compliance with these regulations and with internal NIH SAP registration procedures.

Key components of this management process include the following:

• PI Registration

• Identification of authorized users through the Security Risk Assessment (SRA) process

• Select Agent Transfers

• Training

• Inventory Management

V. Personnel Reliability

A. Personnel Investigations All NIH personnel undergo a Special Agreement Check (SAC) prior to receiving an NIH Identification Card. These checks are performed through the DPSAC and are the initiation point for all subsequent DHHS background investigations.

Personnel assigned to work in a Biosurety Space will receive a Personnel Security Investigation (PSI) corresponding to position sensitivity. The DPSAC, in consultation with the BSP Manager, will make the determination of appropriate PSI relevant to the position.

Personnel assigned to work in a Biosurety Space are responsible for completing required application materials and submitting to DPSAC.

Personnel enrolled in BSP will obtain at a minimum a favorable Access National Agency Check with Inquiries (ANACI) or an equivalent designation.

Additional requirements are required for personnel assigned to have “access” to a Select Agent and/or Toxin.

The Certifying Official may approve interim access for personnel to work with a Select Agent(s) and/or Toxin(s) prior to the receipt of a favorable ANACI investigation provided that:

1. Personnel have received, at a minimum, a favorable SAC.

2. Personnel have received the paperwork necessary to initiate the appropriate background investigation for the job being performed through the DPSAC.

3. Personnel have received a favorable Collective Foreign Threats Assessment

4. Personnel have completed the NIH USA PATRIOT Act Notice

5. The CDC has granted the individual approval to access the specified Select Agent(s) and/or Toxin(s) at the registered locale if applicable.

Continuous enrollment in the NIH Biosurety Program requires annual recertification.

B. Foreign Nationals In keeping with the NIH’s mission to form collaborative research efforts on a national and international stage, foreign nationals are eligible to participate in the NIH BSP and may be authorized to enter and work in Biosurety Spaces. Foreign nationals participating in the BSP must not be restricted persons as defined by the USA PATRIOT Act and must be residing legally in the US and authorized to work within the US. DHHS policy restricts foreign nationals from obtaining a Secret or Top Secret clearance.

C. Drug Testing

DHHS policy states that law enforcement personnel, personnel with Top Secret clearances and personnel whose position description includes duties as a government motor vehicle operator be subject to random drug testing.

VI. Biosurety Medical Evaluations:

Medical evaluations are performed for individuals working in Biosurety Spaces or with select agents or toxins prior to receiving initial work clearance, annually, and following specific events.

The CMA or designee assesses whether existing medical conditions or treatments may compromise, unacceptably, the individual’s ability to perform occupational duties safely and reliably.

A. Medical Qualification Request and Data Review

The BSP Manager notifies OMS that a worker needs to be medically cleared to enroll in the BSP by sending the relevant OMS clinic a completed Medical Qualification Request form.

The form identifies the worker and, the type of BSP Space the individual will access, and related information. OMS clinicians review the form and the employee’s clinical and electronic medical records to determine what medical services are needed. The BSP Manager repeats this process annually for all BSP participants.

B. Behavioral Health Screening All BSP participants receive a behavioral health screening to evaluate their resilience to enhanced physical and behavioral stressors that may result from working in Biosurety Spaces.

The screening utilizes established methodologies and is administered by a DOHS Behavioral Health Screening Official or Behavioral Health professional. The screening includes an assessment for untreated or uncontrolled anxiety or depression and willingness to comply with safety and security procedures in the Biosurety Space.

C. Medical Clearance Evaluation

The complexity of the evaluation is tailored to the worker’s proposed duties. Specific elements and select agent requirements are detailed in the OMS Biosurety procedure. There are several levels of medical clearances:

1. BSL-3 General Medical Clearance: all workers enrolled in the BSP are evaluated for a general medical clearance. Those not working directly with agents or animals in BSL-3 labs receive a general medical clearance.

2. Agent-Specific Medical Clearance: workers identified as working with specific pathogens are medically cleared when they meet the requirements for a general medical clearance and receive the required minimum medical services defined for the specified pathogen.

3. BSL-4 General Medical Clearance: workers identified as working in a BSL-4 facility, but not within a biosafety cabinet are medically cleared when they:

a. Meet the requirements of a general medical clearance; and

b. Successfully complete the behavioral health screening.

4. BSL-4 Suit & BSL-4 Cabinet Medical Clearance: workers identified as working with a specific pathogen in a biosafety suit or cabinet within a BSL-4 laboratory when they:

a. Meet the requirements for a general medical clearance, including expanded vision testing with depth perception, audiometric baseline testing, and lipid profile to determine the ASCVD Risk Estimator;

b. Successfully complete the behavioral health screening; and

c. Receive all applicable agent-specific medical services.

The medical provider is alert for medical issues that may impair the worker’s alertness, judgment, concentration, ability to utilize personal protective equipment, or perform the physical requirements of the position safely.

D. Medical Clearance Determinations The CMA reviews the Medical Qualification Request form, the Behavioral Health Screening, and clinical evaluation, and exercises his or her medical judgement to determine whether a worker is medically cleared to participate in the BSP. If the CMA reports that a worker is medically cleared by completing a Medical Qualification Assessment form and a Biosurety Personnel Reliability Record and forwarding them to the BSP Manager. If the CMA determines that an individual is not medically qualified to work in a Biosurety Space or with select agents or toxins. The CMA promptly notifies the CO by telephone and by completing a

Medical Qualification Assessment form.

E. Event-Driven Evaluations Medical evaluations are also provided to all BSP individuals following potential exposures to the agent handled in the laboratory, for symptoms suggestive of an occupational illness related to the agent, and for specific life events.

1. Immediate medical evaluation is provided following any potential exposure to an agent (e.g., by percutaneous injury, splash, inhalation, or ingestion).

a. The individual notifies the PI of the suspected exposure. The individual initiates first aid while a coworker alerts the CMA, or designee, of the event. The individual temporarily stays in place, while arrangements in compliance with the agent-specific response plan are confirmed.

b. The CMA, or designee, makes emergency arrangements to transfer the individual to an appropriate facility for further evaluation and care.

c. The CMA, or designee, evaluates the injured worker, consults with subject matter experts, and arranges for appropriate follow-up care either as an out-patient or in-patient, depending on the agent involved and the circumstances of the potential exposure.

d. The CMA, or designee, promptly notifies the CO of the occurrence.

2. Immediate medical evaluation is also provided when an individual develops symptoms suggestive of a laboratory-acquired infection or contamination. In these circumstances:

a. The ill individual immediately alerts the PI and CMA, or designee, when symptoms suggestive of an occupational illness are suspected.

b. The CMA, or designee, advises the worker to stay in place and reviews the agent-specific procedures the individual should follow to minimize exposures to others.

c. The CMA, or designee, consults with a subject matter expert, as necessary, to confirm the appropriate next steps and advises the ill individual accordingly.

d. The CMA, or designee, alerts the CO.

e. If in-patient evaluation is recommended, the CMA, or designee, enacts established facility-specific transport protocols. The CMA, or designee, arranges for appropriate emergency transport and notifies the patient care area.

3. Specific life events may trigger a medical evaluation of the individual’s fitness to continue to work in a Biosurety Space. Examples of such events include, but are not limited to, the following: in- or out-patient care for substance abuse issues;

performance or conduct issues suspected to result from a medical condition;

injuries, illnesses and/or new medications that might impair an individual’s judgment or ability to wear personal protective equipment for prolonged periods.

a. The PI, supervisor and individual employee are responsible for identifying when this evaluation is necessary.

b. The CMA, or designee, interviews the worker and determines what, if any, additional information is needed. The evaluation may involve a physical exam, diagnostic testing, and a review of relevant personal medical records.

c. The CMA, or designee, consults with appropriate medical specialists, as warranted, prior to issuing a recommendation on the worker’s readiness to resume routine work duties.

d. The CMA, or designee, conveys the recommendation to the PI on a NIH Form 2558. If the CMA, or designee, recommends that the individual should not be permitted to resume the duties of the position, the CMA, or designee, also notifies the CO. NIH policies for medical referrals and subsequent medical record reviews are followed.

F. Medical Care for Contractors

Contractors working in a Biosurety Space are entitled to all of the services listed above without charge. If they elect to receive any portion of these services from the contracting agency’s healthcare provider, during the employee’s initial evaluation an OMS healthcare provider:

1. Reviews copies of relevant medical records from the contractor’s healthcare provider to assess the individual’s:

a. Personal medical and immunization history,

b. Findings on the physical exam and diagnostic testing, and

c. Medical clearance for respirator fit testing;

2. Reviews the worker’s behavioral health screen results which must be administered by the Behavioral Health Screening Official or designee;

3. Administers occupationally-relevant immunizations;

4. Provides counseling provided regarding worksite safety awareness and OMS injury reporting protocol;

5. Provides an assessment of the individual’s medical fitness and any functional restrictions; and

6. Completes an Medical Qualification Assessment and Biosurety Personnel

Reliability Record and forwards them to the BSP Manager.

VI. Physical Security of Biological Assets

The NIH facility Security Plan establishes the security policies and procedures governing the conduct of work with hazardous biological materials in the research environment, including:

recombinant DNA materials; toxins and human pathogens classified at Biosafety Level 2 (BSL-2) and higher; select agents and toxins as defined in 42 CFR 73, Possession, Use and Transfer of Select Agents and Toxins; Final Rule; and any other agent considered sensitive with respect to national security. Additional security measures are required for Tier 1 Agents as defined by 42CFR

Any loss or breach in security measures, to include tampering with agent inventories, is immediately reported to the SAP.

VII. Occupational Health and Safety

In order to actively promote a comprehensive and effective Occupational Safety and Health Program at the NIH, the DOHS is charged with the establishment of the NIH Occupational Health and Safety Committee, the IC Safety and Health Committees, and the IBC. These Committees represent the NIH commitment to a safe and healthful workplace. Their scopes and objectives are outlined in Manual Chapter 1340, NIH Occupational Safety and Health Management.

All Biosurety Spaces establish agent-specific, facility-specific and site-specific biosafety and operational manuals. These manuals encompass at a minimum, personal protective equipment, waste handling and disposal, training, entry/exit procedures, security, inventory controls, and are reviewed and approved annually by the NIH BSP

One aspect of a successful occupational health program for containment laboratories is to ensure the individual receives prompt medical attention in the event of an emergency. For this reason, the NIH BSP evaluates each facility’s needs individually to establish stringent standard operating procedures. Any additional safety features are contained in laboratory-specific biosafety manuals;

reviewed annually and whenever programmatic changes to the facility occur.

VIII. Biological Accident or Incident Response

Emergency incident response procedures are outlined in the NIH Crisis Mitigation Plan for all NIH facilities. Each Biosurety space establishes site-specific incident response procedures in concert with individual NIH facility policies. These procedures will be designed in coordination with local emergency response personnel and the SAP/BSP.

The procedures encompass spills of biological, radiological and chemical material, medical emergencies, natural and man-made disaster response and workplace violence.

For Biosurety Spaces registered with select agents and toxins, the procedures will also include the requirements as outlined in 42 CFR 73, 7 CFR 331 and 9 CFR 121. These procedures are documented in an Incident Control Plan as a section of the Laboratory Biosafety Manual. The Incident Control Plan is reviewed on an annual basis by the SAP and as part of an incident review to ensure the procedures contained within are as efficient and safe as possible.

On a regular basis, drills and exercises will be performed engaging personnel assigned to a Biosurety Space to ensure all established incident response procedures are followed appropriately.

Upon the completion of each drill, the SAP/BSP will review and revise the procedures, as necessary, and document any adjustments made to further enhance the program.

IX. Training

All personnel assigned to Biosurety Spaces are provided training on the Biological Surety Program in addition to receiving site-specific training. This training encompasses at minimum, personal protective equipment, entry and exit procedures, medical surveillance programs, emergency response, select agent procedures, physical security and the running specialized equipment unique to Biosurety Space environments. Prior to being granted access to a Biosurety Space, personnel must demonstrate that they possess the technical proficiency needed to safely and securely perform their duties.

X. Records Retention and Management

All records pertaining to Biosurety facilities will be maintained by the NIH for three years according to NIH policy or for a longer period of time as required by existing federal regulations.

These documents will include at a minimum, training, individual security records, and records concerning emergency incidents and response.

Clinical records are plainly marked “NIH Biological Surety Program”. Medical records are retained for 30 years after the date of last employment.

XI. Management Control

Management of this document and program is the responsibility of DOHS. Annual reviews of this document will be conducted to ensure the effectiveness of the Program and continued compliance with all applicable federal regulations.

Additionally, medical support services provided for the NIH Biological Surety Program are reviewed at least annually by the Director, OMS. Event-driven evaluations are reviewed in detail to determine the appropriateness and effectiveness of the service. Based upon this review, the Plan is revised as needed.

XII. References

A. 42 CFR 73 Possession, Use And Transfer of Select Agents and Toxins; Final Rule, March 18, 2005.

B. 7 CFR 331and 9 CFR 121 Agricultural Bioterrorism Protection Act of 2002; Possession, Use And Transfer of Biological Agents and Toxins; Final Rule, March 18, 2005.

C. NIH Policy Manual, 1340 – NIH Occupational Safety and Health Management; Issuing Office: ORS/DOHS; Release Date: 2/27/06.

D. NIH Facility Security Plan E. NIH Crisis Mitigation Plan.

DOCUMENT ACRONYMS

NACI

Access National Agency Check and Inquiries

ARO

Alternate Responsible Official

BSO

Biological Safety Officer

BSP

Biological Surety Program

BSL

Biological Safety Level

CDC

Centers for Disease Control and Disease Prevention

CFR

Code of Federal Regulation

CMA

Certifying Medical Authority CO Certifying Official

DDIR

Deputy Director, Intramural Research

DF

Designated Facility

DHHS

Department of Health and Human Services

DOHS

Division of Occupational Health and Safety

DPSAC

Division of Personnel and Security Control

EAP

Employee Assistance Program

FBI

Federal Bureau of Investigation

FSO

Facility Security Officer

HSPD-12

Homeland Security Presidential Directive

IBC

Institutional Biosafety Committee

IC

Institute/Center IRF-Frederick Integrated Research Facility-Frederick

NACI

National Agency Check and Inquiries

NIH

National Institutes of Health

NIAID

National Institute of Allergy and Infectious Disease

OD

Office of the Director

OMS

Occupational Medical Service

ORS

Office of Research Services

PI

Principal Investigator

PSI

Personnel Security Investigation

RML

Rocky Mountain Laboratories

RO

Responsible Official

SAC

Special Agreement Check

SAP

Select Agent Program

SER

Security and Emergency Response Resources

SRA

Security Risk Assessment

USDA

United States Department of Agriculture