I ACD,CDC 

Advisory Committee to the Director, CDC 

ZulS PIR~ 28 Prl 12 Ol\ 

May 4, 2015 

The Honorable Sylvia M. Burwell 


Secretary 


Department of Health and Human Services 


200 Independence Avenue, S.W. 


Washington, D.C. 20201 


Dear Madam Secretary: 

The Advisory Committee to the Director, Centers for Disease Control and 

Prevention (CDC), met on Thursday, April 23, 2015, to consider the following 

report: Recommendations of the Advisory Committee to the Director, CDC 

Concerning the National Institutes of Health Intramural Laboratory Safety 

Program. 

The Advisory Committee to the Director unanimously approved forwarding the 

enclosed report to you for distribution as appropriate. 

If you have any questions about the report, please feel free to contact me via 

email at aeg1@gwu.edu or by telephone at (202) 994-0612. 

Sincerely, 

Alan E. Greenberg, M.D., M.P.H. 

Chair 

Enclosure 

Advisory Committee to the Director, CDC 

Recommendations ofthe Advisory Committee to the Director, CDC 

Concerning the National Institutes of Health Intramural Laboratory Safety Program 

23 April 2015 

Jn July 2014, CDC announced the formation of the External Laboratory Safety Workgroup 

(ELSW) ofthe Advisory Committee to the Director (ACD), Centers for Disease Control and 

Prevention. Although the ELSW was established as a workgroup ofthe ACD, CDC, HHS 

Secretary Burwell charged ELSW to review laboratory safety practices at the Food and 

Drug Administration (FDA) and the National Institutes of Health (NIH), in addition to 

CDC. As a workgroup ofthe ACD, the ELSW reports directly to the ACD. ELSW proposals 

are presented to the ACD, and, if adopted, they are provided to the CDC Director and then 

to the HHS Secretary. At the April 23, 2015, meeting of the ACD, the ELSW presented its 

observations and proposals regarding the NIH's intramural laboratory safety program. The 

ELSW met with NIH occupational health and safety leadership and staff via teleconference 

since September 2014, and they had a four-day on-site meeting at NIH's facilities in 

Bethesda and Frederick, Maryland, in February 2015. The proposals were drawn from 

information gathered from these discussions in staff engagement sessions, in-person 

observations oflaboratories, and a review of protocols, policies, and procedures related to 

laboratory safety at the agency. Below are the recommendations ofthe ACD, CDC, that 

were adopted at the April 2015 meeting. 

1. 	 Observation: The research community world-wide looks to the NIH for leadership in 

the realm ofresearch and laboratory safety. The NIH Intramural OOHS Program is a 

model program for institutions supporting extramural NIH research as well as for 

other institutions and agencies. The commitment of NIH leadership toward 

laboratory safety is evident and is demonstrated at all levels examined by the ELSW. 

Safety awareness is viewed as an expectation and this philosophy is exemplified via 

the involvement of senior NIH leadership in the safety infrastructure supporting the 

NIH Intramural Programs. For example, the NIH Deputy Director of Intramural 

Research serves as chair ofthe Dual-Use Research ofConcern (DURC) Review 

Committee. Education and training, including in the realm of laboratory safety, are 

viewed as fundamental missions ofthe NIH and this message is communicated with 

clarity throughout the NIH campus. A good example ofthe commitment of 

leadership to safety and security can be found in a review ofthe incident involving 

the discovery ofthe previously unaccounted-for vial ofsmallpox in a freezer on the 

NIH campus. This finding was promptly communicated to the NIH Director, who 

responded by providing a clear, unambiguous and decisive response that resulted in 

the highly publicized "biosafety stand-down" which was REQUIRED for all labs 

affiliated with the NIH Intramural Program and strongly encouraged for all 

extramural grantee institutions. This incident and the response to it are 

demonstrative of clear and prompt reporting ofincidents and local responsibility to 

respond appropriately. The Division of Occupational Health and Safety staff 

facilitated and executed the NIH Director response mandate and the NIH community 

seemed to be cooperative and committed to this response. Another clear 

demonstration of NIH leadership commitment to research safety was the sentiment 

we heard from numerous persons that when additional financial resources are 

needed for an unanticipated challenges in the realm ofsafety, the resources are 

identified and provided. Again, the discovery ofthe small pox vial led to the hiring of 
ACD: NIH Intramural Laboratory Safety Program 2 

additional staff to exhaustively inventory every freezer, refrigerator and cold room 

on the NIH campus during the "biosafety stand-down." 

2. 	 Observation: Governance structures and committees (e.g. Institutional Biosafety 

Committee, Institutional Animal Care and Use Committee, Institute Safety 

Committees) are supportive in maintaining a culture ofshared responsibility and 

accountability across the Institutes. An electronic database system (Pl Dashboard) 

has been established and is seen by the NIH intramural research community as a 

useful tool to communicate around issues of research safety and compliance. 

Support staff who are assigned to administer these safety governance structures 

take ownership and responsibility toward safety. The scope of protocols reviewed 

by the Institutional Biosafety Committee (IBC) appears to include recombinant 

microorganisms as well as work involving non-recombinant pathogenic 

microorganisms (Risk Group 2, 3 and 4), although there was some inconsistency 

noted as to whether research involving non-recombinant organisms was reviewed 

by the IBC. This inconsistency may stem from the IBC's practice to delegate approval 

authority to the Institutional Biosafety Officer (BSO) for protocols involving nonrecombinant Risk Group 2 pathogens. In addition, under the current system, the IBC 

protocols have no term limits or expiration dates. 

• 	 Recommendation: The Institutional BSO is an extremely competent, 

dedicated biosafety professional who does an exemplary job in 

conducting the preliminary review of all protocols submitted to the IBC 

and in approving those protocols involving non-recombinant Risk Group 

(RG) 2 pathogens. We believe that the resources devoted to this effort 

should be expanded to include at least one additional staff person 

appropriately trained to serve in this review function. We recommend 

further that the IBC participate at some level in the review of these RG 2 

protocols. 

• 	 Recommendation: IBC protocols are kept current by submission of 

protocol amendments via an electronic protocol submission and approval 

system. However, we recommend that the NIH IBC consider assigning an 

expiration date for each protocol such that these protocols are 

periodically reviewed in their entirety. We recommend that the tenure of 

an IBC protocol not exceed five (5) years. 

• 	 Recommendation: Dedicated NIH scientists serve on the NIH IBC and 

other safety committees. We recommend that these scientists be 

acknowledged for their service and that incentives for such committee 

service be considered. 

3. 	 Observation: Risk assessment of research proposals are performed in a 

collaborative effort that involves the Principal Investigator (PI), the Institutional 

Biosafety Committee, and the Biosafety Officer (BSO) and other OOHS staff. As 

stated above, the IBC considers all rDNA protocols, but review of protocols involving 

non-recombinant RG 2 pathogens are delegated to the BSO for review. It is not clear 

that the protocol- driven risk assessment process is a full risk assessment. While it 
ACD: NIH Intramural Laboratory Safety Program 3 

does systematically try to identify risks, it does not always ask Pis to consider 

alternative processes that would further mitigate the risk. 

• 	 Recommendation: As stated above, we recommend that the IBC 

participate at some level in the review of protocols involving RG2 

pathogens. We believe that the manner in which the NIH chooses to 

involve the IBC in the review of non-recombinant RG2 protocols is best 

determined by NIH. 

• 	 Recommendation: The IBC review process be augmented so as to build in 

questions throughout the assessment process that continually ask Pis 

whether and how they have considered ways to approach an experiment 

in ways that would further mitigate risks associated with the proposed 

research activity. 

• 	 Recommendation: DO HS should consider amending the risk assessment 

questions that are asked ofthe Pl about DURC (i.e. the questions derived 

from the Fink Committee report). The PI should be asked not just about 

the potential for harm if the research were used deliberately and 

maliciously, but also about the potential for harm to the public if an 

accident were to occur in the course ofthis research. 

4. 	 Observation: The Division of Occupational Health and Safety (OOHS) is recognized 

across the NIH as the central authority in support and promotion oflaboratory and 

research safety programs at the NIH. The Director of OOHS demonstrates strong 

leadership and command for service-oriented, risk-based safety programs. OOHS 

focus is research safety and demonstrates an appropriate balance between 

regulatory compliance and facilitation of research activities. DOHS staff are 

professional, competent and dedicated and are recognized as such by the NIH 

Intramural community they serve. OOHS staffserve as safety specialists who are 

assigned to Institutes and who serve as the liaison between laboratory staff, DOHS 

and safety committees. Under the unified direction of DOHS, safety programs are 

consistent, respected and standardized across the Institutes ofthe NIH. The DOHS 

work force is stable and home grown, responsive and supportive. DOHS 

communications are frequent and promote strong relationships with research staff. 

• 	 Recommendation: Building on the excellent relationship and 

communication that DOHS has with NIH investigators, we recommend 

that the NIH consider developing a "Culture of Safety" survey tool similar 

to that developed by the CDC in an effort to accurately gauge areas for 

improvement in laboratory and research safety programs currently and 

over time. 

5. 	 Observation: Laboratory safety training is offered centrally through the DOHS via a 

variety of methods, including on-line training as well as classroom and laboratorybased training sessions. All persons, including visiting scientists and students, are 

required to take laboratory safety training. NIH Campus identification cards, and 

thus access to the NIH campus, are provided ONLY upon completion oftraining. 
ACD: NIH Intramural Laboratory Safety Program 4 

Verification of competency for hands-on laboratory activities is currently limited to 

containment laboratories (BSL3 and BSL4). 

• 	 Recommendation: We recommend that competency verification and 

associated documentation be expanded and strengthened. 

6. 	 Observation: The NIH Intramural Occupational Medicine Program is a very strong, 

comprehensive occupational medicine program that serves as a model occupational 

health program for any biomedical research entity. Collaboration with other DOHS 

staff is clear. The Occupational Health Director is an enthusiastic and dedicated 

health care practitioner that the NIH is lucky to have as part of its research 

community. 

7. 	 Observation: During our visit to NIH laboratories, it was noted that the design of 

several of the BSL2 labs visited were not optimal in providing separation of 

laboratory/research materials from desk and personal space assigned to 

investigators. 

• 	 Recommendation: We propose that DOHS staff have an opportunity to 

comment and provide input on the design of new lab space and the 

remodeling of old lab space. 

8. 	 Observation: NIH staff conveys comfort in reporting of incidents, no fear of reprisals. 

This observation was consistently observed in interviews with staff at all levels of 

the NIH. The immediate reporting and the NIH response to the discovery ofthe 

previously unidentified vial of small pox is an excellent example of this culture of 

responsible reporting. 

9. 	 Observation: The NIH community includes a large number of contract employees. 

The process of providing access to the closed NIH campus provides a mechanism to 

ensure that persons are granted access to NIH labs only following an appropriate 

"on-boarding" process, which includes training as needed for their work. We 

recognize that the use of contract employees can be a challenge, particularly from 

the perspective of occupational health and safety and applaud the process that the 

NIH has established to address this challenge. 

10. Observation: Through discussions with lab managers we learned that they 

welcomed opportunities for increased communication between the managers of 

different labs. It was suggested that in instances where a principal investigator may 

not be a supporter of basic biosafety practices (e.g. wearing of lab coats) a forum for 

sharing experiences through lessons learned as well as strategies for improvement 

of the safety culture at the NIH would be helpful in supporting a culture ofsafety. 

• 	 Recommendation: We propose that the NIH establish regular 

opportunities and mechanisms to improve communications between lab 

managers across the NIH. 
..... ...."'~.
 (-i.. DEPARTMENT OF HEALTH AND HUMAN SERVICES 


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Public Health Service 

Centers for Disease Control 

and Prevention (CDC) 

Memorandum 

Date: 	 5/2712015 

To: 	 Jennifer M. Cannistra, Executive Secretary 

U. S. Department of Health and Human Services (DHHS) 

From: 	 Acting Chief, Federal Advisory Committee Management Branch 

Management Analysis and Services Office 

Centers for Disease Control and Prevention 

Subject: Advisory Committee to the Director, CDC-Advisory Committee Recommendations 

Attached is a letter to Secretary Burwell from the Advisory Committee to the Director, 

CDC regarding recommendations concerning the National Institutes of Health Intramural 

Laboratory Safety Program. 

Ifthere are any questions, please contact me.