Biological Materials Reporting System (BMRS)

Frequently Ask Questions

• Do I have to complete the BMRS even if I don’t use or store biological materials?

  Yes. If you don’t use any biological materials in the lab, log in to the BMRS and select “I attest that the PI does not have any biological materials in their possession in any of their spaces”. Then save and continue. Follow the “How-To Guide”.

• Why do some materials have two options: one with just the genus, and one with genus and species?

  Biological materials listed with the genus and species are a higher risk material that require you to create a lab-specific SOP that is reviewed and approved by the Biological Safety Division. Biological materials with only the genus listed are considered to be a standard risk and can use a biological material-specific general SOP provided by the Biological Safety Division, as long as the lab is not performing any unusual (aerosol-generating) manipulations with the biological material.

• Help! The biological material I use is not listed in BMRS!

  See the “How-To Guide” Part E for visual and step-by-step instructions. Or do the following:

  1. Click the “suggest a new biological material” button at the bottom of the Add Biological Material Tab
  2. Type out the biological material you would like to add to the list
  3. Press “send”. Continue through the rest of the system and finalize your submission.
  4. An email will be sent to the OESO Biological Safety Division, who will review your request and contact you if needed.

• If samples are kept in a freezer room/freezer farm, should I still report it?

  Yes, all types of samples belonging to the Principal Investigator (PI) must be reported even if they are kept outside of the primary laboratory space. See Help Guide Part G for how to add additional rooms to the PI’s profile.

• How do I add a room under the PI’s list?

  See the “How-To Guide” Part G for visual and step-by-step instructions. 

• Do I need to track the number of vials?

  The BMRS is not an inventory-tracking tool, except for exempt quantity select toxins. Additionally, the amount should be in milligrams (mg) of the total amount, not in terms of vials or other measurements.

• Which toxins need to be reported?

  While it is important to keep an inventory of all hazardous toxins, all biologically-derived toxins must be reported on the BMRS. Here are some examples:

   

  Select Toxins	Non-select Toxins
  Abrin Botulinum neurotoxins Short, paralytic alpha conotoxins Diacetoxyscirpenol (DAS) Ricin Saxitoxin Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E) T-2 toxin Tetrodotoxin	Botulinum neurotoxin, Select Agent excluded Cholera toxin Diphtheria toxin Lipopolysaccharide/endotoxin Resiniferatoxin Staphylococcus enterotoxin not A-E

• Why do I need to report the amount of certain toxins?

  The amount of select toxins must be reported because the amount under the control of a principal investigator must not exceed, at any time, the amounts indicated in the table below to be considered exempt from the Select Agent Federal Regulation. If the lab will have, at any point in time, an amount that exceeds the permissible amount in the table below, a Principal Investigator must first register with the Federal Select Agent Program by contacting the Biological Safety Division (biosafety@duke.edu; 919-684-8822).

   

  Toxin	Amount
  Abrin	1000 mg
  Botulinum neurotoxins	1 mg
  Short, paralytic alpha conotoxins	100 mg
  Diacetoxyscirpenol (DAS)	10,000 mg
  Ricin	1000 mg
  Saxitoxin	500 mg
  Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)	100 mg
  T-2 toxin	10,000 mg
  Tetrodotoxin	500 mg

• Do I need to report select agents or toxins to this reporting system?

  Yes. Exempt quantities of select toxins must be chosen and the total amount held in the laboratory, at the time of the report, recorded in the system. If your laboratory holds select agents or if the amount of select toxins exceeds the permissible limits, please reach out to the Biological Safety Division (biosafety@duke.edu, 919-684-8822).

• What does “Storage Only” mean?

  If anyone in the lab has not worked with the biological material or does not anticipate working with the biological material in any manner for a 12-month span, then it can be considered to be in “storage only”. 

• What is a select agent or select toxin?

  Select Agents and Toxins are biological agents and toxins that have been determined by federal authorities (Department of Health and Human Services [HHS] and United States Department of Agriculture [USDA]) to have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products. These include viruses, bacteria, fungi, and toxins (some attenuated versions are excluded). The law requires HHS and USDA to review and republish the lists of Select Agents and Toxins on at least a biennial basis or as a result of in advances in research. Contact the Duke Select Agent Program at 919-684-8822 for more information.

• What is an exempt quantity of select toxin?

  Exempt quantity refers to the fact that if the PI stays under the amount of toxin listed in the table below, at all times, then the toxin is not regulated as a select toxin and the laboratory does not need to be registered with the Federal Select Agent Program. 

   

  Toxin	Amount
  Abrin	1000 mg
  Botulinum neurotoxins	1 mg
  Short, paralytic alpha conotoxins	100 mg
  Diacetoxyscirpenol (DAS)	10,000 mg
  Ricin	1000 mg
  Saxitoxin	500 mg
  Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)	100 mg
  T-2 toxin	10,000 mg
  Tetrodotoxin	500 mg

• Where can I find more information about select agents or select toxins?

  For information about the Duke Select Agent Program, please visit the Select Agent Program page or reach out to Duke’s Responsible Official – Dr. Antony Schwartz (antony.schwartz@duke.edu, 919-684-8822).

• Why do I have to complete an attestation regarding select agents/toxins?

  This is Duke’s Due Diligence mechanism to ensure that laboratories use or store select agents/toxins only with approval by Duke’s Responsible Official. The PI or designee must sign this annually. This is how Duke documents a legitimate purpose to store or use select toxins. (https://www.selectagents.gov/compliance/guidance/toxin/diligence.htm)