Biosafety

SARS-CoV-2: Determining Your Employees’ Exposure Risk Level

OSHA recently issued a guidance document on Preparing Workplaces for COVID-19 that focuses on determining employees’ risk of occupational exposure to SARS-CoV-2 in order to identify the appropriate control measures that can be put in place to protect employees from exposure.

OSHA has divided job tasks into four risk exposure levels:

Very high exposure risk

Jobs with high potential for exposure to known or suspected sources of COVID-19 during specific medical, postmortem, or laboratory procedures. Workers in this category include healthcare workers (e.g., doctors, nurses, EMTs) performing aerosol generating procedures (e.g., intubation, cough induction procedures, invasive specimen collection); healthcare or laboratory personnel collecting or handling specimens from known or suspected COVID-19 patients; and morgue workers performing autopsies on people known or suspected of having COVID-19.

 High exposure risk

Jobs with high potential for exposure to known or suspected sources of COVID-19. Workers in this category include healthcare and support staff (e.g., doctors, nurses, and other hospital staff who […]

COVID-19: Hands-on, Customized Guidance for a Safe Return to Full-scale Operations

Safety Partners support during the Coronavirus Pandemic

The Baker-Polito Administration has issued a comprehensive plan to safely reopen the Massachusetts economy, get people back to work, and ease social restrictions while minimizing the health impacts of COVID-19.  As part of this plan, all businesses must develop a written control plan outlining how its workplace will comply with the mandatory safety standards (see the full announcement at www.mass.gov).

Safety Partners can guide you through the process of developing and/or finalizing your plan, with emphasis on the areas highlighted by the Governor:

  • Social Distancing
  • Hygiene Protocols
  • Staffing and Operations
  • Cleaning and Disinfecting

In addition to following the new state guidelines, CDC, WHO, OSHA, and local guidance, let us guide you through the process of developing your customized policy that fits your corporate culture and timeline for returning to full-scale operations by examining issues including:

• Tiered Staffing
• General Health Checks and Guidance for Sick Employees
• Office Cleanliness
• Use of Shared Lab Equipment
• Working Alone
• Enhanced Cleaning Procedures
• Glove, […]

Risk Assessments: The Key to Working Safely with COVID-19 Positive Samples

We have been getting many questions from clients on appropriate precautions to take when working with COVID-19 positive samples in the lab. The World Organization (WHO), the Centers for Disease Control and Prevention (CDC), the Public Health Agency of Canada (PHAC), and the American Biological Safety Association (ABSA)  have all published extremely informative guidance on this topic:

WHO: Coronavirus Disease (COVID-19) Technical Guidance: Laboratory Testing for 2019-nCoV in Humans

CDC: Information for Laboratories

PHAC: SARS-CoV-2 (Severe acute respiratory syndrome-related coronavirus 2)

ABSA: COVID-19 Toolbox

The information is consistent among these agencies and all stress the importance of starting with a risk assessment. This includes a site and protocol-specific assessment of the procedures to be performed, the identification of the hazards of the processes and procedures, an evaluation of the laboratory facility and equipment, as well as an assessment of available resources including personal protective equipment (PPE).

Coronaviruses generally infect the upper or lower respiratory tract, therefore work with respiratory specimens poses the highest risk. […]

New Watertown Regulation: Biotechnology and the Use of Recombinant DNA Molecule Technology

Watertown announced yesterday that due to the COVID-19 emergency they will be ​postponing the effective date of their new regulation (Biotechnology and the Use of Recombinant DNA Molecule Technology) from May 1 until July 1, 2020. Existing facilities located in Watertown​ will have one year from the effective date to come into compliance.

Overall, the new regulation is similar to other cities and towns in the area. One difference is that Watertown will be regulating non-recombinant DNA (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. BSL-2 agents can also include toxins of biological origin requiring BSL-2.  In comparison, Cambridge, Lexington, and Boston only regulate biologic agents at BSL-3.

The Watertown regulations do not apply to finished products which contain rDNA molecules and which have been approved by other government regulatory […]

Hazard and Risk Analysis

The terms risk and hazard are used often in the safety world, many times interchangeably. They have very different meanings, however, and when using these terms, care should be taken to use them appropriately. When evaluating a process or procedure, assigning these terms appropriately can help simplify the safety assessment process.

What is a hazard?

A hazard refers to a potential source of harm. Examples can include chemical, biological, radiological, and physical hazards. Toxic chemicals, infectious biologics, and moving mechanical parts are all different types of hazards. The hazard level of a particular item or condition is static, meaning it does not vary. However, it can be evaluated relative to other hazards. Simply put, a hazard is a material or condition that can have an adverse effect on a person’s health or physical property.

What is risk?

Risk is the potential for interaction with a hazard. Generally speaking, risk is referenced in relative […]

March is Workplace Eye Wellness Month

Prevent Blindness, the nation’s first eye health and vision care nonprofit organization, has deemed March as Workplace Eye Wellness Month. Did you know that thousands of people are blinded each year from work-related eye injuries? According to the CDC, each day about 2,000 U.S. employees sustain a work-related eye injury that requires medical treatment. About one third of the injuries are treated in hospital emergency departments, and more than 100 of these injuries result in one or more days away from work.

How do eye injuries happen to workers? The majority of eye injuries result from small foreign objects or flying particles getting in the eye. Large objects may also strike the eye or a worker may run into an object causing blunt-force eye trauma. Many eye injuries are also caused by chemical burns from chemicals such as acids and caustics as well as workplace cleaning products.

The encouraging news is that approximately 90% of eye injuries that occur in the workplace are […]

Biennial Reports Are Due March 1, 2020!

 

If your facility is registered with the MA DEP as a Large Quantity Generator (LQG) of hazardous waste, don’t forget that 2020 is a year when biennial reports must be filed.  Biennial reports are due by March 1st of even numbered years for any facility that exceeded the LQG threshold during the preceding odd numbered year, even if your facility is no longer registered as an LQG.  Treatment, Storage, and Disposal Facilities (TSDFs) are also required to report every two years.

Biennial reports provide the DEP with information on the quantity and nature of the hazardous waste that was generated in the previous year and whether the waste was sent for recycling, treatment, storage, or disposal. As of 2018, biennial reports need to be filed electronically using the RCRAInfo Industry Application. The electronic submission includes the following:

  • RCRA Subtitle C Site Identification Form
  • Waste Generation and Management (GM) Form
  • Waste Received From Off-Site (WR) Form, and […]

How to Protect Your Company From OSHA HazCom Violations

Did you know that violations related to the OSHA Hazard Communication standard ranked #2 in the OSHA top 10 list for most frequently cited violations in 2018? Common citations included not having a written program or safety data sheets (SDS) for all chemicals, lack of employee training, and deficiencies related to secondary container labels.

What can you do to protect your company from HazCom violations? Employers are responsible for ensuring that the labels and SDSs are readily available to all employees.  They are also responsible for training employees on how to properly recognize the hazards associated with chemicals and how to properly handle the chemicals based on the hazards conveyed.  For laboratories that use chemicals this specifically means that employers must ensure that:

  • Labels on incoming containers of hazardous chemicals are not removed or defaced. Incoming container labels must include the identity of the hazardous chemical(s), appropriate pictograms and signal word, and hazard and precautionary statements.
  • Labels […]

Is an In-House Blood Donation Program Necessary at Your Company?

The use of fresh blood drawn from company employees is sometimes required when timelines in experiments are too tight to use an outside blood supply vendor. That said, it is considered to be preferable from a safety standpoint, and often a logistical one as well, that an outside blood supply vendor be used rather than establishing an in-house program.

When research needs require establishing an in-house blood donation program, there are numerous considerations to take into account including:

  • Involvement of the legal department to develop an informed consent form for voluntary blood donation. This form should include an explanation of the risks associated with participating in the program, confidentiality concerns, and compensation for program participation, if any.
  • An evaluation of the need to establish an Institutional Review Board. If your company receives federal funding and/or the blood collected is being used to support an FDA submission, it’s very important to determine the need for […]

How Will the 2019 Changes to the NIH Guidelines Affect Your Company’s Research?

Local recombinant DNA ordinances, including those of Boston, Cambridge, and Lexington to name a few, require compliance with the NIH Guidelines for Recombinant DNA Molecules (originally published in1986) as well as revisions and amendments to the Guidelines.  As you may know, the scope of the Guidelines was updated in 2013 to include work with synthetic nucleic acid molecules, and the Guidelines were renamed accordingly and are now called the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.  Are you familiar with the more recent changes to the Guidelines that were published in April 2019?

The April 2019 changes streamline the oversight of human gene transfer (HGT) research.  Because of the FDA’s regulatory authority and oversight of gene therapy trials, NIH has removed the duplicative oversight of gene therapy research from the Guidelines.  The revised Guidelines eliminate the NIH Recombinant DNA Advisory Committee (RAC) review, protocol registration, and reporting requirements associated with gene […]