('~ DEPARTMENT OF HEALTH & HUMAN SERVICES 	 Public Health Service \:# 

Nationa I Institutes of Health AUG 2 8 2014 Bethesda, Maryland 20892 

TO: Institutional Biosafety Committee (IBC) Chairs 

Biological Safety Officers 

Contacts for IBCs 

FROM: Director, NIH 

SUBJECT: Participation in National Biosafety Stewardship Month 

Recent reports of lapses in biosafety practices involving Federal laboratories have served to remind 

us of the importance of constant vigilance over our implementation of biosafety standards. These 

events potentially put individuals at risk, undermine public confidence in the research enterprise, 

and must be addressed to prevent their reoccurrence. Efforts to strengthen biosafety oversight and 

practice must be supported and carried out by organizational leadership, biosafety programs, and 

individual laboratories. 

As a measure toward preventing future lapses as well as promoting stewardship of the life sciences 

and biosafety awareness across Federal entities, Federal laboratories will reinforce their attention to 

safe practices in biomedical research. In that regard, the NIH and other HHS agencies will be 

instituting National Biosafety Stewardship Month, and we urge all NIH grantee institutions to do the 

same at the local level (please see the applicable notice in the NIH Guide for Grants and Contracts ). 

In this effort, as critically important leaders at the local level, the biosafety community has a vital 

role. I am hoping that you can support this effort at your institution by reinforcing and optimizing 

activities that are already part and parcel of how you normally do your jobs. 

What is National Biosafety Stewardship Month? 

During the month of September, NIH laboratories will, and NIH grantee institutions are encouraged 

to, do the following: 

• 	 Reexamine current policies and procedures for biosafety practices and oversight to ascertain 

whether they require modification to optimize their effectiveness; 

• 	 Conduct inventories of infectious agents and toxins in all laboratories (regardless of whether 

they involve recombinant or synthetic nucleic acids) to ensure that the institution has a 

record of which infectious agents and toxins are being utilized, has documentation that 

those materials are properly stored under the appropriate containment conditions, and has 

documentation that cites the party responsible for appropriate stewardship of the materials; 

and 
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• 	 Reinforce biosafety training of investigators, laboratory staff, and members of IBCs to 

include 

o 	 Reexamining training materials and practices being utilized by the institution; 

o 	 Updating materials as appropriate; and 

o 	 Ascertaining the appropriate frequency of training and conduct training when the 

interval between training or other considerations warrant it. 

What's my role? 

You already have important responsibilities to oversee implementation of the NIH Guidelinesfor 

Research Involving Recombinant or Synthetic Nucleic Acid Molecules {NIH Guidelines) at your 

institution. Under the NIH Guidelines, institutions, IBCs, and Biological Safety Officers are expected 

to run rigorous programs of biosafety oversight that include attention to safe laboratory practices, 

training, appropriate policies and procedures, and more. National Biosafety Stewardship Month is 

an opportunity for you to reinforce what you do in that regard, to optimize further biosafety 

oversight, and to strengthen your partnership with your institution's investigator community and 

senior leadership to achieve shared biosafety goals. 

What should my institution do if we uncover problems· such as inadequate training or improperly 

stored samples? 

Our common aim is to correct any problems as soon as possible. So, a priority is to discern the 

nature of the problem, identify its root cause, and to implement immediately corrective actions. You 

should also be empowered to undertake the necessary follow-up activities with regulatory and 

oversight authorities that would be expected. For example, if violations of the NIH Guidelines are 

found, or other significant problems involving research subject to the NIH Guidelines, you should 

report those to NIH, as required by the NIH Guidelines. If a problem involves a Select Agent, it 

should be reported to the CDC or USDA Select Agent program as appropriate. Other problems may 

require notification of public health officials or law enforcement. In short, all existing reporting 

requirements should continue to be followed, and your institutional leadership should partner with 

you and give you the necessary support to see that this happens. 
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What if I have questions about our efforts to participate in National Biosafety Stewardship Month? 

Please feel free to contact NIH as follows: 

Questions about adherence to the NIH Questions about the NIH Guide notice, or 

Guidelines can be directed to: NIH grants requirements: 

Program on Biosecurity and Biosafety Policy Office of Policy for Extramural Research 

Office of the Director Administration 

National Institutes of Health Office of Extra mu raI Research 

6705 Rockledge Drive, Suite 750 National Institutes of Health 

Bethesda, MD 20892-7985 6705 Rockledge Drive, Suite 3500 

301-496-9838 (ph) Bethesda, MD 20892-7985 

301-496-9839 (fax) 301-435-0949 (ph) 

PBBP@od.nih.gov 301-435-3059 (fax) 

Grantslnfo@nih.gov 

Thank you for your attention to this important matter. 

Francis S. Collins, M.D., Ph.D.