Chapter 1: Biological Safety Program: Purpose, Scope, and Responsibilities

Purpose

The purpose of this Biosafety Manual is to define policies and procedures pertaining to use of biological materials in research at Boston University (BU) and Boston Medical Center (BMC). The policies and procedures within this document are designed to safeguard personnel and the environment from biologically hazardous materials without unduly limiting academic research. This manual also offers guidelines to comply with federal and state regulatory requirements.

The work practices, procedures, and policies specified in this manual are based on current regulatory requirements and accepted best biosafety practices. Implementation of these measures will reduce the likelihood that an incident involving a biological agent will occur and will fulfill regulatory biosafety expectations. Laboratory microbiological work usually involves potential exposure to biological hazards, as well as to chemical and radiological hazards. Consequently, this manual should be used in conjunction with the BU Chemical Hygiene Plans and Radiation Safety Manual, respectively. This manual will be reviewed tri-annually by Environmental Health & Safety, in coordination with Research Compliance, and updated as needed in accordance with any change in local, state, or federal biosafety regulations.

For information about specific biological safety programs for operations not covered in this manual, contact the Institutional Biosafety Committee (IBC) office or the Biological Safety Officer (BSO).

Scope

This manual applies to all individuals engaged in research at or under the jurisdiction of BU.

Affiliated Institutions

This manual also applies to all individuals engaged in research at or under the jurisdiction of Boston Medical Center (BMC).

Biological materials include:

• All infectious microorganisms (i.e., virus, bacteria, fungi, parasite, prion, rickettsia) and the toxins derived from such organisms (biological toxins) that can cause disease in humans or pose significant environmental or agricultural impact
• Recombinant or synthetic nuclei acid molecules;
• Human or non-human primate materials including blood, plasma, serum, body fluids, unfixed tissues, organs, and cells;
• Field studies involving wild animals and vectors including samples that may be inherently infected or would be experimentally infected with Biosafety Level 2 (BSL2) or higher agents;
• Transgenic plants, animals, or vectors.

Biological Safety Program Goals

The goals of the Biological Safety Program, referenced in this manual as the Biosafety Program, are to protect laboratory workers, the public, and the environment from potentially hazardous biological agents. The IBC advocates the use of biosafety precautions that effectively reduce or eliminate the risk of exposure to potentially hazardous agents used in research. In developing its guidelines, the IBC is ensuring that all policies and procedures are in accordance with both the regulatory frameworks governing the use of biological materials and the best practices adopted nationally.

Chapter 3: List of Regulations and Guidelines contains a listing and summary of the regulations and guidelines that govern the use of biological materials in research.

Roles and Responsibilities

The success of the Biosafety Program, like any other safety program, requires a team effort involving the IBC, Research Compliance staff, Principal Investigators, laboratory workers, the Research Occupational Health Program (ROHP), and Environmental Health and Safety (EHS). Principal Investigators are responsible for ensuring compliance with this policy as it applies to laboratory areas they may occupy, oversee or share, and ensuring that laboratory personnel who work under their supervision and occupy their laboratory space are informed of this policy and follow it. The BU administration, the IBC, and the EHS endorse this manual and encourage active participation in maintaining high standards.

Associate Vice President, Research Compliance (AVPRC)

The AVPRC has overall responsibility for:

• Oversight for the control of hazards in the research laboratories and for ensuring that comprehensive, enterprise-wide programs are in place for the safe handling of all hazardous (e.g., biological, chemical, radiological) materials;
• All non-financial research compliance at BU;
• Direct functional responsibility for the IBC, Biosafety Program, EHS, Laboratory Safety Committee, Laboratory animal use and care programs (Institutional Animal Care and Use Committees (IACUC), Institutional Review Board (IRB), BU animal care programs, and other research-related oversight committees;
• Acts as the Responsible Official (RO) for the City of Boston’s Public Health Commission (BPHC) laboratory regulations;
• In consultation with provosts and deans at the Medical Campus and the Charles River campus, as well as the BMC leadership, appoints various committee members. The IBC, Research Compliance staff, the Research Safety Director, the BSO, ROHP, and EHS have been charged with planning and implementing the Biosafety Program, the purpose of which is to protect all personnel, the public, and the environment from biohazardous or infectious agents.

Institutional Biosafety Committee

The IBC is responsible for overall oversight of the Biosafety Program at BU. The IBC carries out these functions pursuant to requirements set forth by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), the City of Boston Public Health Commission (BPHC), the Massachusetts Department of Public Health (DPH), and Boston University.

The IBC’s responsibilities are located in the IBC charter.

IBC Program

The IBC Program staff (housed in Research Compliance) responsibilities include, but are not limited to:

• Initiates the review process of the Biosafety Manual in consultation with EHS, ROHP, the IBC, and other BU stakeholders;
• Receipt and review of BUAs via RIMS submission process;
• Monitoring and communication in consultation with EHS, BSO, ROHP, and other offices as needed;
• Providing ancillary review of IACUC and IRB protocols using biohazardous materials;
• Advising PIs on BUA submissions in the RIMS system and in completing their BUAs;
• Assigning review of BUAs for scheduled IBC meetings;
• Documenting IBC meeting discussion and votes;
• Submitting annual IBC registration updates to NIH.

Biological Safety Officer (BSO)

The BSO is responsible for providing guidance on the safe handling of biological agents and contributing to the overall management of the Biosafety Program. The BSO is a voting ex-officio member of the IBC.

The BSO’s responsibilities include, but are not limited to:

• Provides technical advice to the IBC, PI and researchers on laboratory containment, security, and safety procedures;
• Works with EHS on oversight of periodic and unscheduled inspections to ensure that laboratory standards are rigorously maintained;
• Develop emergency plans for handling spills and personnel contamination;
• Develop guidelines and procedures for safe laboratory practices and oversee their implementation;
• Develop design specifications and criteria for laboratory containment facilities;
  Develop and implement training programs in consultation with the IBC;
• Prepare and provide reports on the Biosafety Program to the IBC. The BSO’s report includes routine operational updates, any significant problems or regulatory violations and any research-related accidents or illnesses that have occurred;
• Work with the appropriate Institutional Official of BU, BMC, and BU tenant laboratories to prepare, renew, and submit the recombinant DNA permit application to BPHC;
• Prepare response to BPHC on inquiries concerning laboratory related incidents reported by ROHP;
• Act as a liaison and work with regulatory agencies during visits and inspections of laboratories;
• Oversee follow-up investigation and response to laboratory incidents involving biological, and rDNA materials.

Research Safety Director

The Research Safety Director (RSD) works with the different safety committees to ensure that laboratory research is conducted in appropriate facilities, using safety equipment, and implementing safety processes.

The RSD’s responsibilities include, but are not limited to:

• Oversee Research Safety activities and response during regulatory inspections and visits of laboratories;
• Provide update as necessary to leadership;
• Works with the AVPRC, Research Compliance, IBC, and other institutional officials to coordinate responses to any regulatory findings;
• Reviews new and proposed regulations and other requirements and summarizes impact to the institution;
• Determine programs and processes necessary for an effectively safe process to conduct laboratory research.

Environmental Health and Safety

The various programs within EHS work closely with the BSO to ensure that operations for which EHS has responsibility are conducted in accordance with the criteria and guidelines established by the BSO. These include, but are not limited to:

• Storage and disposal of biological and medical waste;
  Selection of appropriate Personal Protective Equipment (PPE) for individuals working with hazards, including biohazardous materials;
• Development and implementation of emergency response and preparedness plans;
• As necessary, assess and monitor work areas, including the presence of allergens.

Principal Investigators

Principal Investigators (PIs) or Laboratory Directors are responsible for ensuring compliance with this manual as it applies to laboratory areas they may occupy or oversee; and ensuring all laboratory personnel who work under their supervision and occupy their laboratory space are aware of this manual and understand how it applies to their areas. The PI responsibilities should include, but are not limited to, the following:

• Ensures that specific laboratory hazards are effectively communicated to laboratory personnel; personnel have received appropriate training and are competent to conduct procedures performed in the laboratory, and that appropriate controls are in place to minimize risks associated with these hazards;
• Ensures that specific laboratory hazards are effectively communicated to laboratory visitors prior to entering the laboratory, including posting of signs at the entrance to the laboratory to inform individuals of laboratory hazards; and that visitors have met the specific requirements prior to entering or exiting the laboratory;
• Develops standard operating procedures (SOPs), when warranted, to address the hazards so that work can be performed safely;
• Ensures that engineering controls are available, in good working order, and are used appropriately to prevent or minimize exposure to biohazardous materials;
• Ensures that appropriate PPE are available and used by laboratory personnel;
• Ensures that all laboratory personnel receive appropriate training including biosafety training that is conducted as part of the Biosafety Program, as well as specific training on the hazards, procedures, and practices relevant to the laboratory in which they are working. Documents and maintains all training records;
• Ensure that research personnel have completed their required medical clearance from ROHP before starting work on an approved IBC protocol;
• Notifies the IBC and obtains IBC approval prior to starting work with recombinant or synthetic nucleic acid molecules and/or biohazardous material, and conforms to all terms and conditions of the IBC approval;
• Ensures that laboratory workers are provided access to immunizations and medical surveillance prior to, and in the event of, exposure to biohazardous agents as appropriate (based on current CDC and IBC recommendations). Immunizations are provided through BU’s ROHP;
• Notifies the BUMC Control Center at (617) 358-4144or EHS emergency telephone, (617) 414-4075 at the Charles River Campus, of any spills or incidents involving biological agents. The Control Center notifies the BSO;
• Ensures that all biological wastes including biological agents are disposed of according to regulations, as outlined in this manual;
• Ensures that biohazardous materials to be transported are packaged, transferred, or shipped in accordance with regulations and BU policies;
• Ensures that periodic self-inspections of the laboratory are conducted by the PI or designee.

Laboratory Safety Coordinators

The Laboratory Safety Coordinator’s responsibilities include, but are not limited to:

• Supports the PI and ensures that safety practices are implemented and followed in the lab’s daily operations;
• Represents the PI in matters related to the implementation of laboratory and worker safety.
• Serves as the primary laboratory contact with EHS for issues related to safety (e.g., biological, chemical, fire, general safety, controlled substances, etc.);
• Takes positive actions to help reduce the potential for accidents and incidents associated with laboratory operations;
• Instructs all laboratory personnel and students in safe work methods;
• Informs laboratory personnel and/or students of the safety hazards associated with their work;
• Reports all accidents or safety concerns to the PI and EHS;
• Ensures that appropriate SOPs are established and that lab personnel and students are appropriately trained to follow them;
• Works with EHS to determine best safe practices and procedures;
• Works with EHS to ensure that lab personnel and students complete all required safety trainings in a timely manner;
• Ensures that all deficiencies identified by EHS or outside regulatory inspectors are addressed and corrected within the time required;
• Participates in the incident review process;
• Stop operations that are in clear violation of the safety requirements, approved SOPs, or may potentially result in injuries or potential exposures.

ROHP and Occupational Health Officer (OHO)

The OHO has overall responsibility for the ROHP and is responsible for reporting BU exposure incidents involving select agents (see Chapter 10 CDC/USDC Select Agents). ROHP is responsible for establishing and performing appropriate medical surveillance for all personnel performing or supporting research, such as animal care workers, facilities, EHS, Police and Public Safety. Medical surveillance is required at the time of hire, or transfer into the research environment, prior to beginning work on an IBC-approved protocol, and periodically depending on the work environment, occupational exposure, and risk for each position or job category.

The ROHP and Occupational Health Officer’s responsibilities include, but are not limited to:

• Develops exposure treatment and management plans for laboratory exposures or incidents, including post-exposure management and monitoring;
• Reviews IBC protocols and determine additional medical surveillance requirements for PI’s and other personnel included in protocols; creates and issues wallet-sized agent cards, agent; information sheets, and emergency medical response protocols to those personnel approved by the IBC to work with biological agents with the potential to cause LAI (see Appendix G, List of Biological Agents with the Potential to Cause LAI in Use at Boston University);
• Participates in Laboratory Safety Committee, IBC, IACUC, Radiation Safety Committee and other committee meetings, as required, to ensure appropriate health and safety practices are followed;
• Assists PIs and EHS in the preparation and presentation of biosafety and agent specific training;
• Provides medical support coverage 24 hours a day, 7 days a week, for researchers and other personnel to call for triage, evaluation, and medical care referral based on severity, location and time of laboratory exposure or incident;
• Works with EHS to develop SOPs and appropriate health and safety practices;
• Performs return to work assessments in conjunction with BPHC for laboratory exposures involving “high risk” agents;
• Issues generic wallet-sized agent cards to personnel with potential to exposure with hazardous materials in research laboratories and animal care facilities.

Laboratory Workers

Laboratory workers are an important element in developing and maintaining a safe laboratory environment. An incident caused by one laboratory worker can have a widespread effect on others.

Laboratory workers responsibilities include, but are not limited to:

• • Follows procedures and practices established by BU, the IBC, and the laboratory;

• • Uses best biosafety laboratory practices to minimize exposures to biological agents and to avoid other incidents (such as personal injuries, chemical and radiation spills, laboratory fires, explosion, etc.);

• • Completes the required Laboratory Safety Training and annual refresher training thereafter.

• • Follow established procedures and report spills, accidents, and unsafe laboratory conditions to the PI, EHS, and other responsible parties;

• • Utilizes control measures, such as biological safety cabinets and PPE, to prevent or minimize exposure to biological agents and contamination of personnel and facilities;

• Immediately contacts ROHP at (617) 358-ROHP (7647) in the event of an exposure or injury so that medical triage and evaluation, documentation and notification can be performed.

Dual Use Research of Concern Committee

Academic research institutions are expected to comply with the federal requirement for institutional Dual Use Research of Concern (DURC) oversight. The federal requirement applies to all institutions that receive federal funding to perform life science research that meets the DURC standard. BU’s DURC committee is responsible for the oversight and implementation of the standards in the research community at BU.

The Dual Use Research of Concern’s responsibilities include but are not limited to:

• Develop the policy that all research projects as specified in the US Governmental Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern are subject to review and approval prior to the initiation of the project;
• Identify and develop a process for reviewing the proposed research protocol and identify key stakeholders and their responsibilities;
• Review research protocols and determine if fully compliant with the standard; determine and identify the risk mitigation plan to be implemented with the PI;
• Review and as needed, revise or update approved risk mitigations plans annually;
• Provide a report of the final Committee review of protocols determined as DURC to the Office of Research Compliance. The report shall be submitted to the appropriate funding agency;
• Report lab noncompliance to the approved risk mitigation plan to the appropriate funding agency and impose sanctions as appropriate on the PI or the lab. Review appeals by the PI to the sanctions. Such sanctions may include but are not limited to restriction or suspension of research work;
• Identify the process for keeping of all documents and records for protocols that were reviewed as DURC including reports to funding agencies, risk mitigation plans, others.