National Biosafety Stewardship Month

Frequently Asked Questions

1. What is National Biosafety Stewardship Month?

   In 2014, the NIH and other Department of Health and Human Services agencies announced National Biosafety Stewardship month as a new initiative to promote stewardship of the life sciences and biosafety awareness. National Biosafety Stewardship Month is a period during which institutions are encouraged to reinforce their attention to biosafety policies, practices and procedures. In 2015, we are encouraging participating institutions to focus their efforts on sustaining and enhancing a culture of safety/responsibility in life science research laboratories. Thematic elements of enhancing a culture of safety/responsibility include:

   Training

   • Enhancing biosafety training for all staff involved in both the conduct and oversight of life sciences research; and
   • Promoting the development of comprehensive Standard Operating Procedures (SOPs), and ensuring all personnel are familiar with those SOPs.

   Engagement

   • Engaging senior institutional research administrators to support and communicate the importance of biosafety;
   • Encouraging principal investigators to take an active role with respect to biosafety in their laboratories; and
   • Encouraging institutions to foster the development of non-punitive incident reporting systems that provide lessons learned regarding optimal responses to incidents and identification of strategies to minimize risks.

   Transparency

   • Highlighting successes the institution has had in conducting vital research responsibly through a safe and ethical framework; and
   • Promoting public transparency regarding institutional oversight of biosafety.

   NIH is encouraging grantee institutions to develop policies, procedures, and programs that further the above goals.

2. When is National Biosafety Stewardship Month?

   National Biosafety Stewardship Month will be held in October 2015. One benefit of this timing is that National Biosafety Stewardship Month will coincide with the annual conference of the American Biological Safety Association (ABSA).

3. What is the role of NIH funded institutions during National Biosafety Stewardship Month?

   As part of their typical practice, NIH funded institutions 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 occasion for all institutions to reinforce what they do in that regard and develop new efforts as needed to further optimize their programs of biosafety oversight. The Institutional Biosafety Committees (IBCs) and Biological Safety Officers (BSOs) have an important role to play in the success of this effort, and NIH strongly encourages institutional leadership to do what it can to support IBCs and BSOs in this effort and in the conduct of their duties generally.

4. Do we have to complete all of the activities that are the focus of National Biosafety Stewardship Month during the month of October?

   National Biosafety Stewardship Month is a period during which institutions are encouraged to reinforce their attention to biosafety policies, practices and procedures However, the activities suggested as the focus for National Biosafety Stewardship Month in 2015 are ones that are important to continue throughout the year. During National Biosafety Stewardship Month institutions are also encouraged to commit to continually reinforcing existing biosafety practices; further optimize their systems of biosafety oversight; and strengthen partnerships to achieve biosafety goals.

5. Is participation in National Biosafety Stewardship Month mandatory?

   No, participation in National Biosafety Stewardship Month by Federally funded institutions is voluntary, but the NIH strongly encourages institutions to participate.

6. Are there any educational materials or other resources available to institutions to use during National Biosafety Stewardship Month?

   The NIH Office of Science Policy has an extensive collection of educational materials available to assist institutions with training biosafety staff, IBC members, and investigators on various topics related to the oversight and safe conduct of research subject to the NIH Guidelines. These materials include guidance documents, frequently asked questions, as well as brochures and posters to promote awareness of investigator responsibilities. These material are available online at: http://osp.od.nih.gov/office-biotechnology-activities

   Copies of posters and brochures can be requested by emailing: SciencePolicy@od.nih.gov.

   A number of biosafety resources are also available on the Department of Health and Human Services website of the S3: Science, Safety, and Security program, which addresses biosafety, biosecurity, biocontainment, and biorisk management: http://www.phe.gov/s3/Pages/default.aspx

   The following policies, regulations, and guidelines are among other resources available for use in developing and implementing health and safety operating procedures and practices for both personnel and facilities:

   • NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines): http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines
   • 29 CFR 1910.1030, Blood borne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories: https://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=1910.
   • 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331, select agent regulations: http://www.selectagents.gov/Regulations.html
   • Biosafety in Microbiological and Biomedical Laboratories: http://www.cdc.gov/biosafety/publications/bmbl5/index.htm.
   • Prudent Practices for Safety in Laboratories (1995): http://www.nap.edu/catalog/4911/prudent-practices-in-the-laboratory-handling-and-disposal-of-chemicals.

7. Where can institutions obtain further information about participating in National Biosafety Stewardship Month?

   Questions about National Biosafety Stewardship Month can be directed to:

   Office of Science Policy
   National Institutes of Health
   6705 Rockledge Drive, Suite 750
   Bethesda, MD 20892-7985
   Phone: 301-496-9838
   Fax: 301-496-9839
   Email: SciencePolicy@od.nih.gov