Notice of National Biosafety Stewardship Month and Health and Safety Requirements for NIH Grantees

Notice Number: NOT-OD-15-163

Key Dates
Release Date:  September 29, 2015

Related Announcements
None    

Issued by
National Institutes of Health (NIH)

Purpose

NIH is announcing the 2015 iteration of National Biosafety Stewardship Month and reminding institutions of the NIH requirement to meet all applicable Federal, State, and local health and safety standards, as well as the specific terms and conditions of awards as outlined below.

Background

National Biosafety Stewardship Month is a period during which institutions are encouraged to reinforce their attention to biosafety policies, practices and procedures.  In 2014, NIH announced a new initiative to promote stewardship of the life sciences and biosafety awareness.  NIH also reminded institutions of the NIH requirement to meet all applicable Federal, State, and local health and safety standards, as well as the specific terms and conditions of award outlined below.   National Biosafety Stewardship Month was instituted as a period during which institutions were encouraged to reinforce their attention to biosafety practices. In 2015, October has been designated National Biosafety Stewardship month and NIH is again encouraging institutions to participate and build on last year’s activities. 

National Biosafety Stewardship Month

The focus of National Biosafety Stewardship Month in October 2015 is 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.

Grantees institutions are expected to run rigorous programs of biosafety oversight that include attention to safe laboratory practices, training, appropriate policies and procedures.  National Biosafety Stewardship Month is an opportunity for institutions to optimize further biosafety oversight, and to strengthen the partnership with their investigator community to achieve shared biosafety goals.  Institutional Biosafety Committees (IBCs) and Biological Safety Officers (BSOs) have an important role to play in the continued success of this effort, and NIH will again be sending them a letter to encourage their participation.  Institutional leadership should do what it can to support IBCs and BSOs in this effort and in the conduct of their duties generally.

General Health and Safety Requirements

NIH continues to require its grantees to meet applicable Federal, State, and local health and safety standards and for establishing and implementing necessary measures to minimize their employees' risk of injury or illness in activities related to NIH grants.  In addition to applicable Federal, State, and local laws and regulations, terms and conditions of all NIH grant awards require that grantees adhere to the following when 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.  The NIH Guidelines articulate biosafety practices, containment measures, and oversight requirements that must be employed by institutions receiving NIH funding  for research involving recombinant or synthetic nucleic acid molecules, and applied to all such research regardless of source of funding. The NIH Guidelines may be found at:  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; and other applicable occupational health and safety standards issued by the Occupational Health and Safety and Health Administration (OSHA) and included in 29 CFR 1910.  Moreover, compliance with the regulations will reflect a culture of safety consciousness, accountability, organization, and education.  A sound safety organization that is respected by all requires the participation and support of laboratory administrators, workers, and students. A successful health and safety program requires a daily commitment from everyone in the organization. To be most effective, safety and health must be balanced with, and incorporated into, laboratory processes.
  • These regulations are available at          http://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=1910.

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

  • Biosafety in Microbiological and Biomedical Laboratories, CDC and NIH, HHS. This publication is available at http://www.cdc.gov/OD/ohs/biosfty/bmbl5/BMBL_5th_Edition.pdf.
  • Prudent Practices for Safety in Laboratories (1995), National Research Council, National Academy Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055 (ISBN 0-309-05229-7). This publication can be obtained by telephoning 800-624-8373. It also is available at http://www.nap.edu/catalog/4911.html.
  • The signature of the Authorized Organization Representative on the application certifies that the organization will comply with all applicable assurances and certifications referenced in the application.  By drawing funds from the HHS payment system, the grantee further agrees to the terms and condition of grant award.  Although grantee organizations are not required to submit documented assurance of their compliance with or implementation of these regulations and guidelines, if requested by NIH, grantees should be able to provide evidence that applicable Federal, State, and local health and safety standards have been considered and have been put into practice.

Inquiries

Questions about National Biosafety Stewardship Month or adherence to the NIH Guidelines can be directed to:

NIH Office of Science Policy
Office of the Director
National Institutes of Health
Telephone: 301-496-9838
Fax: 301-496-9839
Email: SciencePolicy@od.nih.gov

Questions about the NIH Guide Notice or NIH grants requirements:

Office of Policy for Extramural Research Administration
Office of Extramural Research
National Institutes of Health
Telephone: 301-435-0949
Fax: 301-435-3059
Email: GrantsInfo@nih.gov

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