The Situation

Recent congressional hearings and media reports have highlighted the widespread compliance problems at many BSL-3 and BSL-4 facilities. The biocontainment facilities that are being targeted conduct research with Select Agents and toxins. According to the Centers for Disease Control and Prevention (CDC) Select Biological Agents and Toxins Rule (42 CFR §73.16), "The HHS Secretary, without prior notification and with or without cause, shall be allowed to inspect any site at which activities regulated by this part are conducted and shall be allowed to inspect and copy any records relating to the activities covered by this part.

The purpose of the inspections is to:

  • Verification of information provided in registration package sent to CDC
  • Ensure the facility meets the safety and security requirements of the rule
  • Review records required by regulation…"

Is Your Biocontainment Facility Prepared?

There have been many compliance issues that have come to the attention of Congress and the media including accidental exposures, inappropriate biosafety systems, failure to maintain training records, uncontrolled access to inventories and improper transfer of agents.

Having a biocontainment facility that is not in compliance can result in:

  • Research misconduct
  • Adverse publicity
  • Cancellation of federal research funding
  • Suspension of grants
  • Suspension of or debarment from future federal research funding
  • Individual and institutional federal, state and local civic and criminal penalties and liability

Why Take the Risk?

World BioHazTec Corp. (WBHT) ensures that your biocontainment facility is in compliance with:

  • Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) Biosafety in Microbiological and Biomedical Laboratories Guidelines (BMBL), 5th Edition (2007)
  • Select Biological Agents and Toxins Rule (42 CFR §73.16)
  • NIH Biosafety Level 3 – Laboratory Certification Requirements (2007)
  • U.S. Department of Agriculture (USDA) Animal Research Service Guidelines
  • NIH Design Requirements
  • World Health Organization (WHO) Guidelines