Research Safety Management Plan

Boston University
Boston Medical Center

Research Safety Management Plan

Prepared by:
Environmental Health and Safety

March 1, 2014
EHS# 6

704 Commonwealth Avenue
Boston, Massachusetts 02215
(617) 353-4094

85 E. Newton Street, M-470
Boston, Massachusetts 02118
(617) 638-8830

1. Purpose and Scope

The purpose of this document is to describe the Research Safety program at Boston University (BU) and Boston Medical Center (BMC), and to define the interactions, roles, and responsibilities of the Research Safety Division and other BU/BMC departments.

Research Safety is a Division of the EHS Department and has overall responsibility and purview over the implementation and oversight of safety in research and teaching laboratories at BU and BMC. The Research Safety program ensures that institutional policies and procedures relating to the safe conduct of research activities are followed. These policies and procedures are used as a foundation for research safety and environmental health programs throughout schools and departments at BU/BMC.

2. Definitions

• Agent Information Sheet (AIS): Agent Information Sheet is a document that contains information on the hazard, safety and potential health effect of a microbiological agent or select agent biological toxin. This information was prepared for the use of laboratories as part of their information and training program at Boston University.
• Animal and Plant Health Inspection Service (APHIS): A federal agency that is part of the USDA that is responsible for responding to animal and plant diseases and pest emergencies.
• Biosafety Level 3 (BSL3): Biosafety Level 3 practices, safety equipment, and facility design and construction are applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents with a potential for respiratory transmission, and which may cause serious and potentially lethal infection.
• Biosafety Level 4 (BSL4): Biosafety Level 4 practices, safety equipment, and facility design and construction are applicable for work with dangerous and exotic agents that pose a high individual risk of life-threatening disease, which may be transmitted via the aerosol route and for which there is no available vaccine or therapy.
• Boston Public Health Commission (BPHC): An independent public agency comprised of a variety of preventive health services. The BPHC Biosafety Program oversees the city’s regulations on recombinant DNA (deoxyribonucleic acid) and laboratories.
• Boston University (BU): the Charles River Campus (CRC) and Medical Campus (MED).
• European Committee for Standardization – CEN Work Shop Agreements (CEN-CWA): The first internationally recognized standard that specifically address the management of microbiological hazards based on a risk-based approach in all containment levels. The standard is designed to be compatible with ISO 9001 (quality), ISO 14001 (environmental) and OHSAS 18001 (occupational health and safety).
• Centers for Disease Control and Prevention (CDC): A government agency in the Department of Health and Human Services (DHHS) that focuses on public health.
• Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES): An international agreement between governments. Its aim is to ensure that international trade in specimens of wild animals and plants does not threaten their survival.
• Department of Homeland Security (DHS): A federal department that administers all matters relating to homeland security.
• Department of Transportation (DOT): A federal department that institutes and coordinates national transportation programs.
• Environmental Protection Agency (EPA): A branch of the federal government tasked with protecting the environment. The EPA promulgates and enforces environmental regulations on a national level.
• Hazardous Waste: Refers to chemical wastes that are governed under federal or state regulations due to their hazardous nature. In Massachusetts (MA), waste oil is considered to be a hazardous waste.
• Institutional Animal Care and Use Committee (IACUC): BU/BMC’s internal safety committee that is in charge of reviewing research involving vertebrate animals.
• Institutional Biosafety Committee (IBC): BU/BMC’s internal safety committee in charge of reviewing biological research involving recombinant DNA, infectious agents and other potentially infectious materials, human materials, and select biological agents to ensure the health and safety of employees, support staff, the public, and the environment.
• International Air Transport Association (IATA): An international agency that provides shipping regulations for dangerous goods.
• Laboratory Safety Committee (LSC): BU/BMC’s internal technical safety committee in charge of reviewing the overall safety and hazards of lab employees, support staff, the public, and the environment.
• Massachusetts Department of Environmental Protection (DEP): A state agency tasked with protection of the environment. The DEP promulgates and enforces environmental regulations on a state level. DEP regulations must be at least as strict as the national EPA regulations. In many circumstances, including in regards to hazardous waste, water emissions, air emissions, and underground storage tanks, the DEP regulations overlap with and exceed EPA regulations.
• Massachusetts Department of Public Health: A state agency that promulgates and enforces biological waste regulations.
• Medical/Biological Waste: human and animal tissues and fluids, infectious organisms, contaminated items, and sharp medical/research implements.
• National Fire Protection Association (NFPA): A U.S. organization that establishes and updates fire protection and prevention safeguards.
• National Institutes of Health (NIH): A government agency in the Department of Health and Human Services whose mission is to improve human health through the promotion of research studies that aim to discover and develop drugs and therapeutics to cure diseases.
• Occupational Safety and Health Administration (OSHA): A federal agency in the U.S. Department of Labor charged with overseeing workplace health and safety.
• Recombinant DNA: Molecules that are constructed outside living cells by joining natural or synthetic DNA to DNA molecules that can replicate in a living cell. Recombinant DNA also includes molecules that result from the replication of the molecules described above.
• United States Department of Agriculture (USDA): A federal agency in charge of administering programs that affect animals and plants.
• United States Fish and Wildlife: A federal agency that protects domestic and foreign wildlife species that are transported across state and/or international borders. This includes any interstate or international commerce, which is protected by a treaty or otherwise under federal jurisdiction.

3. References

The Research Safety program is responsible for ensuring that BU/BMC is in compliance with appropriate regulations, standards, and best practices that affect the safe conduct of laboratory work for both research and teaching laboratories. They include but not limited to the following that are listed below:

3.1. Regulations, Standards and Guidelines

3.1.1. Federal Regulations

• NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
• Department of Health and Human Services (DHHS)/ Centers for Disease Control (CDC) Select Agent Regulation, 42 CFR (Code of Federal Regulations) Part 73
• United Stated Department of Agriculture (USDA)/APHIS Select Agent Regulation, 9 CFR Part 121
• USDA/APHIS Select Agent Regulation, 7 CFR Part 331
• USA PATRIOT ACT (H.R. 3162) Section 817
• Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens, 29 CFR Part 1910.1030
• Department of Homeland Security (DHS) Chemical Facility Anti-Terrorism Standards (CFATS), 6 CFR Part 27
• OSHA Laboratory Standard, 29 CFR Part 1910.1450
• OSHA Hazard Communication, 29 CFR Part 1910.1200
• OSHA Hazardous Waste Operations and Emergency Response (HAZWOPER), 29 CFR Part 1910.120
• OSHA Personal Protective Equipment (PPE), 29 CFR Part 1910.132-139
• OSHA Hazardous Materials, 29 CFR Part 101
• Department of Transportation (DOT) Hazardous Materials Transportation, 49 CFR Part 100-199
• Hazardous Chemical Waste, 40 CFR 260
• USDA/APHIS Agent Transfer Permit
• CDC Etiologic Agent Import Permit
• Department of Commerce (DOC) Export Control
• USDA/APHIS Import of Animal and Plant Pathogens
• US Fish and Wildlife Import/Export Permit
• Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) Import/Export Permit
• Controlled Substance Act, 21 CFR Part 1300

3.1.2. State Regulations

• Hazardous Chemical Waste, 310 CMR (Code of Massachusetts Regulations) 30
• Medical/Biological Waste, 105 CMR 480
• Massachusetts Controlled Substances, 105 CMR 700

3.1.3. City Regulations

• Boston Public Health Commission (BPHC) Laboratory Regulation
• BPHC Disease Surveillance Reporting
• BPHC Recombinant DNA Ordinance
• Boston Fire Department (BFD), Boston Fire Prevention Code of 1979
• BFD Ordinance Regarding the Registration of Laboratories in the City of Boston

3.1.4. Guidelines and Standards

• CDC/NIH Biosafety in Biomedical and Microbiological Laboratories
• International Air Transport Association (IATA) Dangerous Goods Regulation (DGR)
• American National Standards Institute (ANSI)/American Industrial Hygiene Association (AIHA) Z9.5.2003 Standard for Laboratory Ventilation
• National Fire Protection Association (NFPA) 45, Standard on Fire Protection for Laboratories Using Chemicals
• NFPA 101 Life Safety Code
• National Science Foundation (NSF) 49, Class II Biosafety Cabinets
• European Committee for Standardization (CEN) Laboratory Biorisk Management Standard (CWA 15793)
• American Society of Heating, Refrigerating, and Air Conditioning
• (ASHRAE), HVAC (heating, ventilation and air conditioning) Laboratory Standards
• CDC Primary Containment of Biological Hazards: Biological Safety Cabinets

3.2. Other Standard Operating Procedures (SOPs)

• Comprehensive Laboratory Inspection
• Biological Use Authorization Site Risk Assessment
• Strain Verification of Attenuated BSL3 and BSL4 Agents Origin
• USDA Permit Registration
• Laboratory Shutdown and Decontamination
• High Hazard Chemicals
• Chemical Containment Levels for Animal Research
• Chemical Inventory

3.3. Supplementary Documents

• Biosafety Manual
• Chemical Hygiene Plan
• Exposure Control Plan
• Environmental Health and Safety Plan
• Personal Protective Equipment
• Chemical Containment Level
• Controlled Substance Program

4. Roles & Responsibilities

Each office at Boston University and Boston Medical Center has different roles and responsibilities regarding safe research practices.

Research Safety Division:

• Supporting the BU/BMC core academic mission of teaching and research through the implementation of comprehensive research safety programs involving:
  • Recombinant and Synthetic DNA
  • Infectious Agents and Potentially Infectious Materials
  • CDC/USDA Select Agents and Biological Toxins
  • Human Materials
  • BPHC BSL3/BSL4 (Biological Safety Laboratory)
  • Agent and Material Transfer or Shipment
  • Biological Use Authorization (BUA) Risk Assessment
  • Chemical Inventory
  • High Hazard Chemicals
  • Homeland Security Chemicals of Interest
  • Hazardous Laboratory Gas Management
  • General Laboratory Safety
  • Laboratory Fire and Life Safety
  • Laboratory Emergency Response
  • Use of Controlled Substances in Research
  • Chemical Containment Levels for Animal Research
  • Field Research Activities: diving, snorkeling, small water craft
• Serving as the technical and subject matter expert by consulting with faculty, research personnel, and staff to provide guidance and recommendations on experimental designs, laboratory containment, and other issues related to working with hazardous materials or performing processes that may cause hazardous situations, including:
  • Experimental and research design: Work and assist Principal Investigators (PI) in the development of a safe process for conducting research activities.
  • Laboratory design and construction: Provide input to engineers, architects, project managers, users, and other stakeholders on appropriate laboratory containment design criteria.
  • Drafting of safety SOPs: Prepare safety SOPs to address general laboratory practices to assist laboratories in conducting work safely.
  • Agent and material transfer: Work with the laboratory and appropriate departments and agencies to provide guidance and assistance in the transfer of agents and materials including:
    • USDA/APHIS transfer permit of animal and plant pathogens
    • CDC Import of Etiologic Agents
    • DOC Export Control
    • U.S. Fish and Wildlife Import/Export
    • CITES
    • IATA Shipment of Dangerous Goods
    • CDC/USDA Select Agent Transfer
  • Emergency response and accident investigation: Respond to emergencies and assist in the mitigation and conduct follow up investigations as appropriate.
• Working with the IBC, LSC, IACUC, Radiation Safety Committee and other safety and technical committees to develop and implement policies and procedures for BU/BMC designed to ensure compliance with research related regulations, standards, and guidelines.
• Conducting risk assessments to identify hazards in the workplace, and providing recommendations on appropriate control measures to eliminate or reduce occupational injuries and exposures through the use of:
  • Biological Use Authorization site assessments: A review of research projects submitted to the IBC and performing on-site reviews, inspections, and risk assessments to verify that the work will be performed in an appropriate laboratory facility and with the use of appropriate safety and personal protective equipment. BUA site assessments also ensure that SOPs are in place and that lab personnel have completed the appropriate training and medical clearance/surveillance as necessary.
  • High Hazard Chemical Use site assessments: A review of research projects involving high hazard chemicals. Performing on-site reviews, inspections, and risk assessments to verify that appropriate administrative and engineering controls and personal protective equipment are in place.
  • Review of laboratory processes: Assist laboratories in developing SOPs for safe operations of laboratory processes as needed.
  • Review of emerging technology in research: Assist laboratories review the potential for hazards when using new technology as a part or tool in research activities. This include but not limited to nanotechnology , synthetic biology and others.
• Monitoring programs and the overall health and safety of personnel at BU/BMC laboratories by conducting:
  • Comprehensive laboratory inspections: In conjunction with the IBC, LSC, and other safety and technical committees, verifying laboratory compliance through inspections of laboratory conditions and the use of appropriate laboratory containment, fire and general safety, and work practices and procedures for research that involves biological agents, chemicals, controlled substances, etc.
    • Verifying certification and maintenance of safety equipment including biosafety cabinets, fume hoods, safety showers, eyewashes, fire extinguishers, etc.
    • Verifying decontamination and validation processes, including biological waste treatment and autoclave validations used for wastes.
  • Unannounced follow-up visits: Conducting unannounced follow-up visits to verify the laboratory’s adherence to and completion of corrective actions to ensure compliance.
  • Review of inspection results and providing recommendations for any programmatic corrective actions and modifications necessary to prevent the reoccurrence of non-compliances.
• Developing content for policies and providing training and materials to research personnel as required by external regulations and internal BU/BMC policies to ensure safe research operations. The trainings include, but are not limited to:
  • Laboratory Safety:
    • Emergency response
    • Fire and general safety
    • Safety equipment
    • Biological safety
    • OSHA Bloodborne Pathogen
    • Hazard Communication
    • Chemical Hygiene Plan
    • Laboratory waste management
  • Shipping of Biological Agents
  • Shipping of Chemicals
  • Select Agent
  • BSL3
  • BSL4
• Serving as a liaison for collaborative work with regulatory agencies to implement applicable regulations and standards.
• Coordinating inspections, visits, and walk-throughs with the following regulatory agencies to ensure compliance with regulations and standards:
  • BPHC
  • BFD
  • DEP
  • Massachusetts DPH
  • OSHA
  • CDC
  • USDAUnited States Department of Agriculture
  • NIHNational Institutes of Health
  • Federal Aviation Administration (FAA)
  • Federal Bureau of Investigation (FBI)
  • Others, as appropriate
• Working with BU/BMC school, department, administrative, and laboratory personnel to secure required permits, certificates, and licenses for the operation of laboratories.
• Responding to emergency situations including, but not limited to hazardous materials spills, and assisting laboratories with mitigation measures.
• Conducting follow-up investigations on exposures and accidents, as necessary.
• Identifying the root cause(s) of exposures and accidents as well as recommending changes to prevent such events from reoccurring.
• Acting as a liaison between regulatory agencies and BU/BMC during routine inspections, response to emergencies and accidents, and follow-up investigations.
• Working with BU/BMC schools and departments to ensure that research facilities are operated safely to protect students, staff, university property, the community, and the environment.
• Developing and preparing tools, such as plans, manuals, and informational factsheets that will assist labs, departments, and schools in maintaining compliance with all appropriate requirements and standards. Specific tools include, but are not limited to:
  • Biosafety Manual
  • Chemical Hygiene Plan
  • Exposure Control Plan
  • Laboratory Research Animal Care Safety Plan
  • Agent Information Sheet
  • Chemical Use SOP
  • Guidance for Laboratory Relocation of Hazardous Materials
  • Laboratory and Equipment Decontamination and Decomissioning
• Monitoring changing and emerging regulations and standards such as Dual Use Research and assessing the impact to BU/BMC.
• Working with BU/BMC administration to ensure adequate staffing and resources for the delivery of services.

Individual School, College, and Department:

• Providing a safe work environment where academic research and teaching can be conducted.
• Instituting health and safety programs for the health and well-being of the researchers, teaching community, and staff.
• Working with faculty, researchers, and staff to promote a culture of safety in the workplace.
• Identifying, reporting, and correcting unsafe conditions.

Principal Investigator (PI):

• Implementing health and safety policies, programs, and procedures.
• Ensuring that the laboratory environment is in compliance with all applicable regulations and policies.
• Ensuring the safe maintenance of the workplace and equipment.
• Ensuring that all personnel complete their required trainings, including job-specific work practices training and agent-specific training.
• Reporting unsafe conditions.
• Reporting spills, accidents, and exposures.
• Ensuring that research is reviewed and approved as necessary by the appropriate safety and technical committees prior to start of research.
• Providing appropriate personal protective equipment to laboratory workers.
• Reporting employee absences to the Research Occupational Health Program for those who work with high-risk agents under the BPHC Disease Surveillance and Reporting regulations.

Laboratory Safety Coordinator:

• Assisting the PI with his or her responsibilities, as assigned, and implementing laboratory safety policies and procedures in tandem with the Research Safety Division and other EHS personnel as necessary.
• Taking positive action to determine and reduce, to As Low As Reasonably Achievable (ALARA), the potential for accidents and incidents associated with laboratory operations.
• Working with EHS and informing all laboratory personnel of the safety hazards associated with their work.
• Instructing all laboratory personnel in safe work methods.
• Keeping all individuals performing specific tasks apprised of the most recent procedures and train in implementing said procedures.
• Ensuring that all work is performed in a safe manner and in accordance with regulatory and institutional requirements.
• Working with EHS to determine best (safe) practices and procedures.
• Working with EHS to ensure that all members of the laboratory complete their required training(s) in a timely manner.
• Ensuring that all deficiencies identified by EHS or other regulatory inspectors are addressed and corrected within the required time-frame.
• Ensuring that the Standard Operating Procedures (SOPs) for all laboratories are approved and up-to-date. SOPs should include appropriate safety instructions related to the use of personal protective equipment and implementation of special precautions for use of any infectious agents or highly hazardous chemicals as well as instructions for implementing procedures concerning the use of safety equipment (e.g. fume hood, biological safety cabinet, or sealed centrifuge).

Research Staff and Employees:

• Completing and updating all required trainings in a timely manner including, but not limited to, Laboratory Safety training provided by EHS.
• Completing job-specific and agent-specific training provided by the PI or the supervisor prior to working with hazardous materials.
• Seeking immediate medical attention after injury, exposure, or undefined illness and informing healthcare providers of laboratory work and the agent used.
• Reporting injuries or exposure to the PI and the Research Occupational Health Program.
• Reporting unsafe conditions to the PI and EHS.
• Ensuring compliance with policies and procedures.
• Reporting absences to the PI or supervisor.

Research Occupational Health Program (ROHP):

• Reviewing and conducting medical clearances for employees requiring such clearances and offering vaccines, PPD skin testing, etc., as necessary.
• Preparing follow-up reports for incidents and exposures.
• Providing reports to BPHC in a timely manner, as required.
• Reporting employee absences, as required under the BPHC Disease Surveillance and Reporting regulations.
• Conducting medical follow-up clearances for employees returning to work after recovering from sickness due to exposure or incident in laboratory.
• Conducting employment termination clearances as necessary.
• Providing consultations and agent-specific trainings as requested.

Institutional Biosafety Committee (IBC):

• Reviewing each biological research proposal and recommending appropriate containment level, personal protective equipment use, and other applicable practices, procedures, and medical surveillance that is necessary.
• Reviewing unsafe conduct in research and specifying necessary actions to be taken to ensure such conduct is abated and not repeated.
• Contribute to creating policies and procedures for the safe conduct of biological research.
• Reporting exposures to appropriate regulatory agencies.
• Conducting follow-up investigations on exposures and accidents, as necessary.

Laboratory Safety Committee:

• Review and approval of BU’s Chemical Hygiene Plan.
• Reviewing the use of hazardous chemicals and other similar materials for research protocols and recommending appropriate laboratory containment, personal protective equipment use, other applicable practices and procedures, and medical surveillance.
• Assist in developing SOPs for high hazard chemicals.
• Reviewing unsafe conduct in research and identifying necessary actions to be taken to ensure such conduct is abated and not repeated.
• Contribute to creating policies and procedures for the safe conduct of research.
• Conducting follow-up investigations on exposures and accidents, as necessary.

Scientific Diving & Small Boat Safety Committee (SD-SBSC):

• Oversees diving and boating performed as a necessary component of research or educational activity by faculty, students, and other employees involved in research.
• Fulfills the role of the Diving Control Board (DCB) as described in the BU Diving Safety Manual and Small Boat Safety Manual.

Facilities Management & Planning:

• Conducting routine operation, maintenance, testing, and general management of laboratory facility structures (e.g., maintenance of negative pressure in high and maximum containment lab space) and equipment to ensure it is safe for operation.
• Providing notification prior to alterations to any laboratory installation.
• Involving EHS in the review of laboratory construction and renovation projects.
• Providing adequate space and facilities to store and manage regulated wastes, including those of a chemical, biological, or radioactive nature.

Office of General Counsel:

• Providing advice and counsel in the event of a research-related incident.
• Negotiating with regulators in the event of an enforcement action taken against BU/BMC in response to a research-related incident.

5. Special Requirements

The Research Safety Division develops and maintains resources and tools in order to implement and maintain a comprehensive safety program for the BU and BMC laboratory community. These special requirements are as follows:

5.1. Equipment and Supplies

• Chemical spill kits and materials
• Biological spill kits
• Chemical disinfectants
• Emergency response personal protective equipment
• Air monitoring equipment and supplies

5.2. Safety

Research Safety program operations require compliance with all applicable BU/BMC safety policies and procedures implemented through Environmental Health and Safety.

5.3. Training

The Research Safety staff are trained to maintain competencies to provide subject matter services for research laboratories. These competencies are maintained through continued professional development, trainings, seminars and conferences. Areas and fields of competencies include, but are not limited to, regulatory, best practices, and new or emerging technology. These competencies allow the Research Safety staff to develop and provide training for our lab community. The Research Safety Division provides training on:

• Laboratory Safety:
  • OSHA Bloodborne Pathogens
  • Hazard Communication
  • Hazardous Waste
  • General Laboratory Safety
• Shipping of Biological Agents
• Shipping of Chemicals
• Select Agent
• BSL3
• BSL4
• PPE

5.4. Monitoring

Programs, manuals, SOPs, procedures, trainings, and other critical program components are routinely reviewed and revised to ensure that they meet current regulatory requirements and are in adherence to BU/BMC policies and procedures.

5.5. Personal Protective Equipment

The Research Safety Division utilizes PPE during various aspects of daily operations. Routine visits to laboratories or response to emergency situations in a BU/BMC laboratory require varying levels of PPE, which is dependent upon the level of hazard in a particular area. Staff members are trained in PPE selection and use and utilize such training when completing daily activities.

5.6. Medical Surveillance

Staff members in the Research Safety Division receive annual physical examinations and medical surveillance through the Research Occupational Health Program (ROHP).

5.7. Other Prerequisites

Staff members are required to have a thorough understanding of health and safety requirements for a diverse research-intensive institution.

6. Applicability

All BU and BMC affiliated locations.

7. Procedures and Instructions

Procedures and instructions for the Research Safety program are provided on the Environmental Health and Safety website (e.g., SOPs, guidelines, and safety manuals).

8. Forms

Forms and signage exist for a variety of Research Safety processes. Several attached functional charts further illustrate the disciplines within Research Safety, including the following:

• Laboratory Safety Equipment
• Controlled Substances
• Chemical Safety
• Biosafety

There are several other forms utilized within the Research Safety program. They include various inspection forms, risk assessment forms, space and equipment decontamination forms, etc. These forms are located on Environmental Health and Safety website and are also in the Safety Logbooks provided to all BU/BMC laboratories.

9. Records Management

Records are maintained through the Research Safety Division and EHS. These records include dates, names, and other important information pertaining to inspections, incident and accident reports and investigations, and training sessions.

10. SOP Revision History