Biosafety

Are Biological Toxins Being Used in Your Laboratories?

Biological toxins are poisonous substances produced by certain microorganisms, animals, insects, and plants. They can be harmful when inhaled, ingested, injected, or absorbed.

Biological toxins cause diverse toxic effects that can range from relatively minor (skin or eye irritation, headache, nausea) to severe (respiratory distress, muscle weakness, seizures, death). Many biological toxins are highly toxic or fatal even in small quantities (e.g., nanogram amounts) and they are often more toxic than many chemicals.

Numerous biological toxins have been identified with nine of them being on the HHS and USDA Select Agents and Toxins List that includes biological agents and toxins that 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 botulinum neurotoxins, abrin, paralytic alpha conotoxins, diacetoxyscirpenol, ricin, saxitoxin, staphylococcal enterotoxins (subtypes A–E), T-2 toxin, and tetrodotoxin. Biological toxins on the select agent list require registration with the  Federal […]

Is Improper BSC (Biological Safety Cabinets) Use the Cause of Contamination at Your Facility?

Biological Safety Cabinets (BSCs) serve two main purposes: protecting employees from the biological material being handled and preventing contamination of the work being conducted.  However, improper use of BSCs can result in a decreased ability of the cabinets to provide personnel protection and prevent contamination. With proper planning and by following appropriate work practices, BSC performance can be maximized to protect the researcher and their work.

Before Working in the BSC

  • Some BSCs are designed to run 24/7; however, for those that are designed to be shut off, they should be turned on at least 10 minutes before starting work. This allows the cabinet blowers to remove contaminated air and particulates from the cabinet.
  • The work surface, back, and sidewalls, and back of the sash should be decontaminated with an appropriate disinfectant (e.g., 70% ethanol) to minimize or eliminate surface contamination. All items required to be placed into the cabinet should also be surface decontaminated […]

Are You Properly Managing Your Universal Waste?

The Massachusetts Department of Environmental Protection (MA DEP) has specific requirements for the collection and management of universal waste. These requirements can be found in 310 CMR 30.1000, the Standards for Universal Waste Management.

What is Universal waste? Universal waste includes:

  • Hazardous batteries (e.g., nickel cadmium, button batteries); note that alkaline batteries are not considered universal waste, but can still be collected for disposal through the waste ​​hauler or a battery recycling vendor
  • Mercury-containing devices such as thermostats, thermometers, and gauges
  • Mercury-containing lamps such as fluorescent lamps and bulbs
  • Hazardous pesticides

When collecting universal waste, it’s important to dedicate a universal waste accumulation area that is clearly segregated and signed.  If the universal waste accumulation area and main accumulation area for hazardous waste are located within the same room, be sure to clearly define and sign the areas as separate accumulation areas.

All universal waste containers must be labeled with the contents and the words universal […]

Risk Groups and Biosafety Levels: Understanding the Differences

It’s often assumed that a biological agent’s risk group (RG) and the biosafety level at which it should be handled are synonymous, when in fact this is not always the case. In addition to an agent’s risk group, there are many other factors to consider when designating a biosafety level for a biological agent.

Risk group describes the relative risk to the individual and the environment by the organism. There are four risk group classifications described in the NIH Guidelines and in the World Health Organization’s Laboratory Biosafety Manual:

  • Risk Group 1 agents are not associated with disease in healthy adults
  • Risk Group 2 agents are associated with human disease that is rarely serious and for which preventative or therapeutic interventions are often available
  • Risk Group 3 agents are associated with serious or lethal human disease for which preventative or therapeutic interventions may be available
  • Risk Group 4 agents are likely to […]

A Mouse and a Needlestick

“A Mouse and a Needlestick” featured in Incidents, Accidents, and Near Misses in Laboratory Research, Volume 3, tells a real-life story about what can happen when safety procedures aren’t followed in animal care facilities. Read on to learn what happens:

I had just started a new job in an Animal Care Facility at an academic research lab in the heart of Kendall Square. I had three years of lab experience. I was confident in my new role and new procedures. I learned the hard way that I was overconfident.

A New Procedure

During my first month of on-the-job training, I learned how to do intraperitoneal (IP) injections into the body cavities of mice. We were working with a blank carrier and with a pretty potent chemical that basically stimulates the blood stem cells to evacuate the bone marrow. We did this to collect bone cells.

I’d done the IP Injection three or four times with no problems. So, […]

OSHA Issues Proposed Rule to Update the Hazard Communication Standard

On February 16, 2021, the Occupational Safety and Health Administration (OSHA) published a Notice of Proposed Rule Making (NPRM) to amend the Hazard Communication Standard (HCS). The current HCS was last updated in 2012 to align the standard with the third revision of the United Nations (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The proposed changes are to update the HCS to align it with the seventh revised edition of the GHS.

Highlights of the proposed changes include:

Definitions

  • Updates to three existing definitions (exposure/exposed, hazardous chemical, physical hazard)
  • Addition of eight new definitions (bulk shipment, combustible dust, gas, liquid, solid, immediate outer package, physician or other licensed health-care professional (PLHCP), and released for shipment)

Hazard Classification

  • Clarification that the hazard classification has to consider both normal considerations of use and foreseeable emergencies
  • Additional requirements that the hazard classification must include any hazards associated with a change in the chemical’s physical form or […]

Are You Ready for the March 1st Tier II Reporting Deadline?

Section 312 of the Emergency Planning and Community Right-to-Know Act (EPCRA) describes reporting requirements for facilities that possess chemicals above established reporting thresholds. For those facilities subject to reporting, submission of a Tier II Emergency and Hazardous Chemical Inventory Form to the State Emergency Response Commission (SERC), Local Emergency Planning Committee (LEPC), and local Fire Department is required by March 1st of every year for the previous calendar year.

These reporting requirements allow state and local emergency response and planning committees to be aware of the hazardous materials present within their communities and to prepare for emergency responses.

Which facilities have to report?

Facilities storing a hazardous chemical that is an Extremely Hazardous Substances (EHS) in an amount equal to or greater than 500 pounds or above the Threshold Planning Quantity (TPQ), whichever is lower, are required to submit Tier II reports. EHS and TPQs can be found in 40 CFR part 355 Appendix B and the EPA’s […]

OSHA Violations and the Bloodborne Pathogens Standard

Did you know that the most frequent cause of OSHA violations related to the Bloodborne Pathogens Standard is outdated, or otherwise non-compliant, Exposure Control Plans?

It is generally known in the biotech community that Exposure Control Plans are required to be in place for any facility working with blood or other potentially infectious material (OPIM). What is often overlooked is that there is a specific regulatory requirement to update the Plan.

The Bloodborne Pathogens Standard (in section 1910.1030(c)(1)(iv) ) specifies that the Exposure Control Plan must be reviewed and updated at least annually and whenever necessary to include new or modified tasks and procedures which affect occupational exposure and to address new or revised employee positions with occupational exposure.

The review and update of the Exposure Control Plan must also reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens and document annually consideration and implementation of appropriate commercially available and effective safer medical […]

Remember to Post OSHA Form 300A!

OSHA Form 300A, Summary of Work-Related Injuries and Illnesses, is used to summarize the recordable injuries and illnesses for the previous year and includes the number of days work was lost or restricted, and the types of injuries and illnesses that occurred.

Information about the company, including the average number of employees and total hours worked by all employees, must also be recorded.

Form 300A must be posted from February 1 through April 30 each year.  If no recordable incidents or illnesses occurred during the previous year, the form must still be completed and posted reflecting zero recordable cases. The information in Form 300A is based on information recorded in OSHA Form 300, Log of Work-Related Injuries and Illnesses. However, certain employers are exempt from these reporting requirements.

Employers with 10 or fewer employees are not required to prepare Form 300 or Form 300A. In addition, only industries within certain North American Industrial Classification (NAICS) codes are […]

New Watertown Regulation Biotechnology & the Use of rDNA Molecule Technology: Sharing Our Tips!

In my April 16th  2020 blog, I wrote about the new Watertown regulation Biotechnology and the Use of Recombinant DNA Molecule Technology which became effective July 1, 2020. Existing facilities located in Watertown​ will have one year from the effective date to come into compliance, but new companies moving to Watertown must comply before work covered by the regulation can begin.

The regulation covers recombinant DNA (rDNA) work as well as non-rDNA research involving biologic agents at Biosafety Level 2 (BSL-2) and Biosafety Level 3 (BSL-3). (BSL-4 work is prohibited in Watertown.) Examples of agents at BSL-2 include non-recombinant work with Salmonella entericaStaphylococcus aureus, Hepatitis B, and Herpes Simplex Virus.

Non-exempt rDNA work and work with regulated biologic agents requires a permit. However, low risk facilities may conduct rDNA work without a permit provided that they register with the Watertown Biosafety Committee (WBSC).  A low risk facility is one that creates, propagates, imports or uses rDNA […]