International Biosafety Month-2023

October is the American Biological Safety Association (ABSA) International’s Biosafety Month.  Launched in 2013, this initiative was created to promote awareness of biosafety, biosecurity, and biorisk management as a profession and to help those who work with or around biohazards understand how biosafety precautions work to protect them, their colleagues, and the environment from biohazard risks.

Yale EHS is promoting International Biosafety Month electronically this year through this website, which will be updated anytime new innovative or pertinent information is identified through October 2024, when it will be updated with the new theme for next year’s version. 

For more information, visit the ABSA International Biosafety and Biosecurity Month website.

See previous International Biosafety Month pages:

ABSA International Biosafety Month

Sponsored by the American Biological Safety Association (ABSA) International, October 2023  celebrates the 10th anniversary of the International Biosafety Month initiative. There was no specific theme this year, but institutions were reminded to focus on biosafety and biosecurity topics pertinent to their locations. This year, the Yale EHS Biosafety group is focusing on making sure that individuals working with biohazards and regulated biological materials have the core information they need for minimizing or preventing exposure and complying with the various associated regulations, standards, and guidelines.

This year our topics to focus on are:

Principal Investigator and Laboratory Manager Help Page

The information provided here should be very helpful for any new principal investigators or laboratory managers and also for any existing ones. It is intended to help in orienting you to your overall requirements as the responsible party for the research space assigned to you and your responsibilities for those performing research in your labs.

Welcome Letter for New Principal Investigators

This is a comprehensive document outlining all of the major responsibilities, registrations, trainings, and other requirements for laboratory research. View the Welcome Letter for New Principal Investigators.

Your EHS Safety Advisor

Yale EHS has designated a representative from our office to be the first point of contact for safety information for your laboratory. If you have not met your safety advisor (SA), you use the Find Your Safety Advisor search.

You can also call the Yale EHS Office at 203-785-3550 to get contact information for your SA.

Your EHS SA will perform the annual lab inspections for your lab areas and will hold at least one meeting per year with you, your lab manager or other lab representative to review all past, present, and future research to help ensure that you have all the appropriate registrations and approvals. Your SA will be involved in evaluating injuries and exposures and participate in any required follow-up needed. They also will be responsible for connecting you with other EHS subject matter experts whenever needed.

Researcher Competency Verification

A critical requirement for all principal investigators is ensuring that all of the researchers working in their laboratory are trained, have the ability to gain hands-on experience with the lab techniques, are aware of all of the hazards and risks of the materials handled in the lab, and have been trained on all emergency response protocols. Documentation of these requirements is even more imperative.

The Researcher Competence Verification Form has been created to help principal investigators document these important elements. You can use this form for all researchers in your laboratory.

We have also developed a Principal Investigator Responsibilities Checklist to help augment the competency verification form. Both documents can assist with ensuring the duties of the principal investigator have been achieved.

Information for New Principal Investigators Webpage

EHS’s webpage for New Principal Investigators  and the additional links below provide details on how to comply with Yale University’s personal protective equipment policies, a major responsibility of principal investigators.

Responsibilities

Recombinant/Synthetic Nucleic Acid Molucules Research Guidance

*This document illustrates all of the steps that are involved from the initiation of a research project until it is approved, including  any required follow up. Your EHS registration documents help you complete all of your requirements, but this document provides you with a broad spectrum overview of the life of a research protocol.  Please contact your Safety Advisor if you have any questions regarding the protocol tracing pathway.

Biohazard Risk Assessment Guidance

Section 5 of the Yale Biosafety Manual provides an overview of risk assessment for research involving biohazards and how to manage the risk.

The following documents are offered to supplement the risk assessment process for principal investigators:

Health Canada has also provided a very detailed assessment checklist for biohazard risk. Please refer to this for additional information when planning research with biohazards.

Emergency Procedures

Visit EHS’s Emergency Procedures webpage for a summary of a full spectrum of laboratory emergency response protocols. Also ensure that any researchers who are injured contact CorVel, Yale’s worker compensation vendor, to report the incident after seeking emergency assistance at Yale Acute Care.  CorVel can be reached at: 1-833-400-7222.

Laboratory Inspection Help Guides and Checklists

The EHS Biosafety team created a series of documents and help guides for laboratories preparing for a lab inspection by the State of Connecticut Department of Public Health. The State utilizes the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 6th Edition as its requirement for conformity when conducting inspections. This document, along with the NIH Guidelines, are the principal requirements for all labs, and are used by Yale EHS on its annual inspection of your labs. 

Use the documents below to help prepare for your Yale EHS and other regulatory inspections and ask your Safety Advisor if you have any questions with any item on a checklist.

CDC Inspection Checklists

The CDC has created a compilation of various laboratory inspection checklists based on the CDC/NIH Biosafety in Microbiological Laboratories, the NIH Guidelines, and federal regulations. Over 20 checklists for laboratories, animal facilities, arthropod containment labs, toxins, and components of their select agent regulation can be accessed on the Preparing for Inspection webpage. Also see the CDC’s Import Permit Program Inspection Checklists.

Safe Sharps Guidance

Injuries with sharps and exposures to biohazards involving contaminated sharps continue to occur. EHS would like to remind you of existing sharps safety documents that should be reviewed prior to handling sharps when working with biohazards.

Although we have divided the safe sharps guidance and regulatory information into the following categories, many of the precautions are pertinent in all of the settings.

Research Laboratories

The first recommendation for sharps prevention in research laboratories is to avoid them and not use sharps unless they are absolutely needed, such as experiments involving research animals.

Safe Sharps Work Practices:

  • Wherever possible, avoid sharps in lab or cell culture experiments.
  • Use plastic alternatives, wherever possible, such as plastic aspiration pipettes, plastic capillary tubes or mylar wrapped capillary tubes for retroorbital bleeds in animals. 
  • When working with disposable sharps such as needles and syringes, make sure the needle box or sharps container is located within arms reach to permit prompt disposal after use. 
  • Replace needle boxes or sharps containers when they are two-thirds full. 
  • Never allow sharps containers to overfill.
  • Never recap needles. 
  • Never bend, break, or otherwise manipulate the needles by hand.
  • Review and Post the Avoid Recapping Needles Poster

Cryostat/Microtomes

These devices present an inherent risk as they involve an extremely sharp blade. An excerpt from the Yale Biological Safety Manual provides guidance on the safe use of cryostats and microtomes. Also see the Cryostat/Microtome Safety Guidelines.  

The two biggest recommendations for minimizing cuts or lacerations when using these devices along with ensuring proper training and competency in the use of the equipment is to use engineering controls like forceps or tweezers for handling blades and the use of American National Standards Institute (ANSI) Level 4 or higher Kevlar gloves for protection. EHS has evaluated ANSI rated and non-ANSI rated gloves for protection against cuts or slices and the best protection is provided at ANSI Level 4 or higher.

The following video clips show the effectiveness of ANSI Level 4 and 6 gloves vs gloves that are not ANSI rated.

It is important to note that cut-resistant gloves will provide protection against cuts, slices or lacerations. They will not provide protection against direct punctures. There are ratings also for puncture-resistant gloves from ANSI, but absolute protection against needlesticks and other punctures are far from absolute. View of a test of a puncture-resistant glove with a needle. Note that it doesn’t take a lot of force to break through a highly rated puncture-resistant glove. 

This video also demonstrates why safe sharps work practices are always critical in preventing exposures. Personal protective equipment is the last line of defense and is part of a set of protective measures in a laboratory’s standard operating procedures.

Clinical or Healthcare Settings

In 2001, the OSHA Bloodborne Pathogen Standard was updated to provide additional examples and recommendations for safe sharps devices and related engineering controls as part of OSHA’s Needlestick Prevention Act to address the reduction of needlesticks and bloodborne exposures.

Section 7.0 of the Yale Bloodborne Pathogen Training Manual is dedicated to the use of engineering controls to prevent sharps injuries and should be referred to before initiating work with sharps in clinical or healthcare settings. 

Additional information on engineering controls and precautions to take when handling sharps can also be found in the Yale Exposure Control Plan.

The 2001 OSHA Needlestick Prevention Act update of the Bloodborne Pathogen Standard requires employers to constantly evaluate safe sharps devices and engineering controls. The Act also requires the review of any exposure incident that involves a sharp contaminated with human material to determine if the exposure could have been prevented with the use of a safe sharps device. If the evaluation determines that it could have been prevented, then a safe sharps device must be utilized. This also requires an evaluation period by the end users to identify the best device possible and provide time to practice under safe conditions prior to use with biohazards.

Below are a series of safe sharps testimonials and prevention videos created by healthcare professionals and associations. 

Non-Human Primates

Non-human primates represent a very significant risk for researcher and animal care and use staff. These animals are quite strong, fast, agile, playful, reactive, unpredictable, and capable of violent reactions to stimuli they are not accustomed to. The jaw strength of a non-human primate is 10X greater than a human, so bites are extremely painful and potentially disfiguring. In addition, non-human primates can harbor pathogens that are infectious to humans. The most concerning of these is Macacine herpesvirus 1, or B-virus, which has a 60% mortality rate in individuals infected. It is imperative that all individuals who work with non-human primates are aware of the post-exposure response protocols before starting work. At Yale, the exposure response protocol is referred to as the Yale University Bite-Scratch Protocol and involves immediate washing of the exposed areas with soap and water or disinfectant an the immediate use of an eye wash for 15 minutes. This is followed by notification of managers and prompt evaluation by Employee Health or Acute Care for obtaining baseline samples. Samples must also be taken from the animal involved involved. Antiviral post-exposure prophylaxis is also offered to exposed individuals following the incident. Exposed individuals are also resampled for B-virus as part of the post-exposure follow-up.

Sharps risks include bites or scratches from the animals directly, from the research equipment used for inoculations or necropsy, and the edges of cages and transport carriers. All of these factors make the environment associated with research involving non-human primates one with a constant risk. The hands, wrists, forearms, and essentially anywhere on the body is subject to accidental exposure from a non-human primate’s reach envelope or from accidental contact with the metal surfaces and edges of caging and equipment associated with their housing and use.

Kevlar and puncture-resistant gloves and sleeves are highly recommended when directly handling non-human primates.

Small or Conventional Research Animals

Please see Animal Biosafety Levels 1, 2, 3 Safety Videos for comprehensive biocontainment information for safe work with research animals for the three risk classifications applicable to Yale.

Additionally, see a video of safe sharps practices used to protect workers while performing a necropsy on non-infected research animals.

Grant Applications

Principal investigators, researchers, and clinicians may need to provide assurance of compliance statements, or grant letters, to granting agencies to confirm that their proposed research has been reviewed and approved by Yale’s Biological Safety Committee. The research must also be in conformity with all applicable regulations, standards, and guidelines. Journal editors and biological supply companies may also request such assurances before publishing manuscripts or approving purchases.

The Yale EHS Biosafety Office has assisted researchers with providing grant letters or assurance of compliance letters to support their applications. 

Please note that the Yale Biological Safety Committee regulation may be needed for any new unapproved research that may be proposed.  Provide as much advanced notice as possible to your EHS Safety Advisor or to EHS in the event of this requirement.

To help EHS prepare your grant letter, please be prepared to provide the following to Yale EHS:

  • The grant deadline
  • Contact information for the individual submitting the grant application on your behalf if someone different than you
  • The full name of the grant applicant as it appears on the grant application
  • The full title of the grant application
  • The abstract of the grant for review for hazards and review for required registrations and approvals
  • The name and address of the granting agency to which the researcher is applying
  • The name of a contact person representing the grant agency
  • The principal investigator of the laboratory where this research will be performed (if applicable)

It is important to alert EHS as soon as you are aware of the need for the assurance of compliance documentation to help ensure that any deadlines are met or additional reviews are completed.  Please contact your EHS Safety Advisor for more information.

Upcoming Updated Biosafety and Biosecurity Policies

NIH Guidelines for Research with Recombinant or Synthetic Nucleic Acid Molecules

Last updated in 2019, the NIH has proposed three updates of the guidelines that are likely to be published as final at the end of 2023 or early in 2024. Please see the Federal Register announcement with a summary of the proposed updates.

  1. Lowering the risk group designation for two human pathogens

The NIH will reduce the risk group designation from Risk Group 3 to Risk Group 2 for both West Nile virus and Saint Louis Encephalitis virus.  This action follows a similar lowering of the risk group level by the CDC a few years earlier.

  1. Helper virus clarification

The Guidelines will change helper viruses to “helper systems” throughout the NIH Guidelines in alignment with the changes in technology.

  1. Gene drive modified organisms (GDMO) and Gene Editing

The NIH Guidelines are proposed to be updated to include specific considerations and requirements for conducting research involving gene drive modified organisms (GDMO) in contained research settings. Contained research settings indicate that this update will not permit an research in the field with GDMOs.  No changes that would permit field releases of GDMOs will be considered. 

The proposal will define a gene drive as follows:

‘‘Gene drive’’ is defined as a technology whereby a particular heritable element biases inheritance in its favor, resulting in the heritable element becoming more prevalent than predicted by Mendelian laws of inheritance in a population over successive generations.”

The proposal will also:

  • Set the minimum biocontainment level for GDMOs at BSL-2;
  • Not permit any exemptions for research involving GDMOs, requiring review by the entities Institutional Biosafety Committee (the Yale Biological Safety Committee); and
  • Reiterate the prohibition for any research involving the field release of GDMOs.

Throughout the guidelines, updates have been included to ensure that Committees and Biosafety Officers review risk assessment questions related to the use of GDMOs and research involving gene editing. Considerations for conducting risk assessments for research involving gene drive modified organisms might include:

  • Function of the gene drive
  • Source of the genetic material
  • Proposed modifications
  • Consequences of the construct if released to the environment
  • Potential to spread or persist in local populations

When faced with any uncertain risks, Biosafety Committees may have to start with more stringent containment measures until further information is obtained.

Once the NIH Guidelines are updated, EHS will update the Yale recombinant or synthetic nucleic acid molecules registration forms and our help documents pertinent to the guidelines. 

Update of National Dual Use Research of Concern (DURC) Policy

The NIH has also submitted a proposed update to the existing DURC policy to expand the range of biohazards that must be reviewed by NIH funded institutions prior to initiation and the types of research experiments. This change has been proposed to address a need to provide oversight to address research that could enhance the potential of pandemic pathogens (ePPP), experiments that involve gain of function (GOF). The government has been working on a potential framework for the last few years.

The current DURC policy covers 15 pathogens that, if part of any lab, animal or clinical research must be evaluated to see if any of the 7 high-risk research experimental categories are triggered. If any of these experimental categories are part of this research, then the research would be considered DURC and must also be reviewed and approved by the NIH Office of Science Policy.  Please see the following:

Proposed DURC Updates

The main proposed update is to expand the list of 15 agents to include, at a minimum, all Risk Group 3 and 4 pathogens, all Select Agents, and any research experiments that require BSL-3 or BSL-4 containment. The original proposal included “any” human, animal or plant pathogen. The government will also provide clarification on the level of concern for the experiments and also define what reasonably anticipated means. Parts of the consideration will include if the research will create pathogens that are “likely highly transmissible and likely capable of wide and uncontrollable spread in human populations; and likely highly virulent and likely to cause significant morbidity and/or mortality in humans.’’

If the proposed research is reasonably anticipated to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment,  or national security, additional oversight by the government will be required.

The government is also asking the public if the 7 categories of DURC experiments should be altered or expanded. 

The government is also considering expanding those who must conform to the policy to other institutions regardless of the source of their funding. 

Please see the Federal Register announcement with a summary of the proposed updates.

Once the DURC policy has been updated, EHS will update our campus policy, our registration form and our EHS Integrator human pathogen and recombinant or synthetic nucleic acid molecules registration forms.