MANUAL OF STANDARDS ON

BIOSAFETYANDBIOSECURITY

Department of Health

Republic of the Philippines

Manual of Standards on Laboratory Biosafety and Biosecurity

© 2018 by the Department of Health. All rights reserved. Subject to the acknowledgment of the Health Facility Development Bureau (HFDB), Department of Health, the Manual may be freely abstracted, reproduced or translated in part or in whole for noncommercial purposes only. If the entire Manual or substantial portions will be translated or reproduced, permission should be requested from HFDB.Printed in the Republic of the Philippines.

National Library Cataloging-in-Publication Data
ISBN

Published by

Department of Health

San Lazaro Compound Rizal Avenue, Sta. Cruz, Manila 1003 PHILIPPINES

Development of this Manual was initiated and completed, and subsequently published through the Health Facility Development Bureau, Department of Health, Manila.Contact HFDB for inquiries: +63 2 6517800 locals 1401, 1403 and 1408.

Email address: nhln.hfdb@gmail.com / doh.hfdb.od@gmail.com

Republic of the Philippines Department of Health OFFICE OF THE SECRETARY

M E S S A G E

On behalf of the Department of Health, I extend warm salutations to fellow stewards of the health care system and the workers and administrators of health care facilities.

With the DOH at the helm, the Philippines made significant strides over the years in improving the nation's state of health. Inequities

however persist, and these greatly disadvantage the poor and hard-to-reach populations. We echo the call of His Excellency President Rodrigo R. Duterte for partnerships for change, undertake the government's socioeconomic agenda, and advance the Filipinos' aspirations for greater access to health.

As the national technical authority on health, in fulfilling our mandate to ensure the highest achievable standards in health, the Department presents to our partners the Manual of Standards on Laboratory Biosafety and Biosecurity. Biosafety and biosecurity are a matter of interest both timely and enduring among partners and stakeholders of the health system.

The DOH intends that this Manual be a significant contribution in vesting further capacity to our laboratories, fulfill their respective roles in the health system with quality, safety, and efficiency, and altogether achieve the country's targets in sustainable development goals for health.

We enjoin you, our partners, in solidarity to our call: "Boosting Universal Health Care through FOURmula 1 Plus!"

FRANCISCO T. DUQUE III, MD, MSc

Secretary of Health

F O R E W O R D

In line with the thrust of the Department of Health on Service Delivery Network and Good Governance under FOURmula One Plus for Health (F1 Plus), the Health Facility Development Bureau (HFDB) formulates policies and develops standards for the establishment, development, management and operations of health facilities in the country. The HFDB assumes the technical leadership and coordinates the health facility development initiatives of the government and its partners. Efforts to improve the service delivery network and determine the critical areas for continuing quality improvement that ensure patient-centered quality care have been our utmost priority.

Health workers and Health Facility/Hospital Administrators have been continuously confronted with a wide range of issues, new trends and technologies in various health care settings. The development of more relevant and responsive policies and guidelines for patient-centered quality care attunes our health systems to this dynamic environment.

For 2018, the Health Facility Development Bureau (HFDB) proudly endorses a set of Manuals for the Clinical Laboratory. These Manuals are outputs of the National Unit for Health Laboratories and the National Technical Working Groups of the National Health Laboratory Network (NHLN) Program. The authors and contributors in the conceptualization and completion of these manuals are experts in the various fields of laboratory medicine. The Manuals are in congruence with Philippine settings while maintaining consistency with international standards. Each of the following individual manuals is best used in conjunction with the other Manuals in the set:

• 1. Manual of Standards on Quality Management System in the Clinical Laboratory – 2nd edition
• 2. Manual of Standards and Criteria for Laboratory Action Plan
• 3. Manual of Standards on Laboratory Biosafety and Biosecurity
• 4. Manual on Packaging and Transport of Laboratory Specimens for Referral

The above-mentioned Manuals will serve as standard reference materials for the DOH Clinical Laboratories to aid laboratory administrators and clinical practitioners in the management and operations of various laboratory services that contribute directly and indirectly to quality patient care. These Manuals are also recommended for use in the Clinical Laboratories of Local Government Units, Military, Philippine National Police, Academe, and the Private sector.

PREFACE

The primary function of the biosafety specialty is to ensure that students, workers and the public are protected from exposures to potentially infectious agents encountered in the laboratory setting. Hence, a successful biosafety program functions mainly in the REALM of prevention and /or reduction of Biorisk. Biorisk encompasses both biosafety and biosecurity. If Biosafety protects the People from the Bugs, Biosecurity is to protect the Bugs from the People, so that it will not be misused for malicious intent. Biorisk is the likelihood of an exposure to hazard (in biosafety) and/or threat (in biosecurity) with harmful consequence, which needs to be managed with the help of this Manual of Standards on Laboratory Biosafety & Biosecurity. To reiterate, Biosafety looks at appropriate laboratory procedures, and containment practices necessary to prevent exposures and occupationally acquired infections, while Biosecurity addresses procedures and practices to ensure that biological materials and relevant sensitive information remain secure to prevent its loss, theft & misuse.

Unfortunately, a lot of institutions especially the hospital clinical laboratories lack the knowledge and skills to conduct comprehensive Biorisk Management that is comprised of a structured and systematic risk assessment, mitigation and performance/evaluation. Hence, as a result most biosafety risk assessments, mitigation and performance/ evaluation are based purely on subject matter expert opinion. This process lacks repeatability, is difficult to compare, and difficult to communicate. Often laboratories resort to the minimum regulatory requirements, or rely on rules to define safety practices rather than utilize the recommended risk assessed based approach to risk mitigation along its appropriate robust performance evaluation.

Majority of Biorisks, laboratory acquired infections, misses and near misses of bio-accidents and untoward bio-incidents happen or emanate from the laboratories. Thus, this manual of biosafety standard and guidelines is developed to equip our lab personnel in the assessment of any Biorisk in the laboratory, so that such risk can be alleviated by the combination of various mitigation control measures, which will then be monitored for its Performance to sustain safety and secure laboratories. Likewise, this Manual will assist the laboratory to come up with good Biopreparedness plan to manage the threats and dangers posed by biological spectrum of risks. These spectra are comprised of a wide range of threats and hazards, including acts of bioterrorism, cyber-attacks, pandemics (possibly caused by natural and deliberate outbreaks), work related acquired infections, accidents of misses and near misses and catastrophic natural disasters. Recent H1N1, H5N1, H7N9, MERSCoV, Ebola virus outbreaks were generally considered as a mild to moderate virus infections and, as such, could be considered as "a dress rehearsal" for a more severe threat in the future.

The effects of a Biological accident in the laboratories, hospital institution and communities can be severe, dramatic and in the absence of good bio-preparedness plan, they could harshly disrupt the entire groups & general public, creating fear and affecting economic well-being and may even lead to deaths.

This Manual of Standards on Laboratory Biosafety and Biosecurity directs the laboratory staff to attain the following objectives:

• 1. To develop a Biorisk Management strategy as part of the Biopreparedness plan or Biorisk Disaster Reduction Plan for the containment and handling of high risk group infectious pathogens
• 2. To assess, mitigate and evaluate management of hazards and threats, and dangers in Biological Risk Spectrum.
• 3. To integrate Quality Management System in these Activities and Strategies

Finally, this Manual, as a tool for Quality Improvement can be continuously reviewed and revised to make it more relevant, applicable, and useful.

ACKNOWLEDGMENTS

The Manual of Standards on Laboratory Biosafety and Biosecurity was made possible through the contributions of the following whose expertise is gratefully appreciated.

TECHNICAL WORKING GROUP

Dr. Edith S. Tria	Chairperson	San Lazaro Hospital
Dr. Estrella Panganiban	Vice-Chair	Formerly from the Bureau of Animal Industry
Dr. Corazon Alcantara	Member	Tondo Medical Center
Eng. Carlos Bariring	Member	Health Facility Development Bureau
Arch. Ariel Magbanua	Member	Health Facility Development Bureau
Ms. Myrna Reyes, RMT	Member	Formerly from the Health Facility Development Bureau
Ms. Joy P. Calayo, RMT	Member	San Lazaro Hospital
We also acknowledge the inputs from the following experts:
Dr. Socorro P. Lupisan		Research Institute for Tropical Medicine
Dr. Miguel Martin Moreno		St. Luke's Medical Center
Ms. Minda C. Quitoriano, RMT		Food and Drug Administration, detailed at the HFDB
Dr. Evelina Lagamayo		University of Santo Tomas
Ms. Leila Florento, RMT, PhD		Philippine Association of Medical Technologists
Dr. Gloria Lim-Tan		Lung Center of the Philippines
Dr. Marilyn Barza		East Avenue Medical Center
Dr. Mildred Padilla		University of the Philippines, Los Baños
Dr. Emelinda Lopez		Bureau of Animal Industry, Department of Agriculture
Dr. Angel Mateo		Bureau of Animal Industry, Department of Agriculture
Dr. Cynthia Ochona		Bureau of Animal Industry, Department of Agriculture
Dr. Myrna Rivera		Tondo Medical Center

Dr. Herbert Pascual	AFP Medical Center
Dr. Fidel Malbas	Research Institute for Tropical Medicine
Ms. Lydia Sombrero, RMT	Research Institute for Tropical Medicine
Ms. Cristino Narciso, RMT	Research Institute for Tropical Medicine
Dr. Irma Makalinao	College of Pharmacology, University of the Philippines-Manila
Col. Jose Imbang	Anti-Terrorism Council
Ms. Nenita S. Cañafranca, RMT	Lung Center of the Philippines
Ms. Angelita O. Jimenez, RMT	Health Facility Development Bureau, Department of Health
Mr. Richard Albert J. Ramones, RMT	Health Facility Development Bureau, Department of Health
Mr. Henry Ryan Dominic G. Cajandig	Health Facility Development Bureau, Department of Health
Ms. Camille Ann C. Ople	Health Facility Development Bureau, Department of Health

TABLE OF CONTENTS

		PAGE
	Message	iv
	Foreword	v
	Preface	vi
	Acknowledgments	viii
	List of Acronyms	x
	Definition of Terms	xi
Part I	BIOSAFETY
Section A	Biosafety Program Management	2
Section B	Risk Assessment for Biohazards in the Laboratory	5
Section C	Design of Laboratory Containment Facilities	7
Section D	Operation and Maintenance of BSL-2 and BSL-3 Laboratories	9
Section E	Biosafety Operational Practices	11
Section F	Selection and Safe Use of Biological Safety Cabinets	13
Section G	Decontamination and Disinfection of Biological Agents and	15
Section H	Toxins Transport of Infectious Substances, Biological Specimens and	17
Section I	Dangerous Goods Working with Animals	20
Part II	BIOSECURITY
Section A	Development of Biosecurity Program	26
Section B	Biosecurity Risk, Threat and Vulnerability Assessment in the	28
Section C	Laboratory Physical Security Measures	30
Section D	Personnel Management of the Biosecurity Program	33
Section E	Information and Network Security	35
Section F	Material Control, Accountability and Inventory	37
Section G	Material Transfer and Transport Security	40
Section H	Biosecurity Response	43
Section I	Biosecurity Updates and Re-evaluation	45
Section J	Reporting and Communication	47
Section K	Training and Practice Drills	49
	References	52

LIST OF ACRONYMS

ABP – Animal Biosafety Program

ABPM – Animal Biosafety Program Management

ABSL – Animal Biosafety Level

ACUP – Animal Care and Use Program

BSC – Biological Safety Cabinet

BSL – Biosafety Level BSO – Biosafety Officer

CDRRHR – Center for Device Regulation, Radiation Health and Research

DA – Department of Agriculture

DOH – Department of Health

EAWS – Emergency Alert and Warning System

GMO – Genetically Modified Organism

HEICS – Hospital/Health Emergency Incident Command System

HEPA – High-Efficiency Particulate Air HRPT – High Risk Pathogen and Toxin

HVAC – Heating, Ventilation and Air Conditioning

IACUC – Institutional Animal Care and Use Committee

IBC – Institutional Biosafety Committee

ICC – Infection Control Committee LRPT – Low Risk Pathogen and Toxin

LEED – Leadership in Energy Environmental Design

OHSP – Occupational Health and Safety Program

PPE – Personal Protective Equipment

PDCA – Plan, Do, Check, Act

MCA – Material Control Accountability

MOA – Memorandum of Agreement

MRPT – Moderate Risk Pathogen and Toxin

MSDS – Material Safety Data Sheet

RA – Risk Assessment

SOP – Standard Operating Procedures

TNA – Training Needs Analysis

VBM – Valuable Biologic Materials

WHO – World Health Organization

DEFINITION OF TERMS

• Accountability ensures that materials are controlled as intended by formally associating the specified materials with the people who provide oversight.

• Antimicrobial chemical or physical agent used in the decontamination process to prevent microbial growth.

• Antiseptic substance that prevents the growth.

• Antisepsis germicidal inhibition or destruction of microbes on skin or tissue.

• Assessment evaluation using science, observation, experience, professional practice and standards and common sense.

• Autoclave piece of equipment with a chamber that is used to sterilize items by applying heat (i.e. high pressure steam) at temperatures above the normal boiling point of water and pressures above normal atmospheric pressure.

• Biohazard hazard created by potential transmission of a microbiological agent or pathogen to a susceptible host.

• Biohazardous pertains to biological materials that present potential/detrimental risk to the health of humans or other organisms, either directly, through infection or indirectly, through damage to the environment.

• Biological materials broad range of organisms, cells, viruses, and other materials of biological origin that pose different levels of risks to plants, animals, or humans.

• Biological products products derived from living organisms which are manufactured and distributed in accordance with the requirements of appropriate national authorities, which may have special licensing requirements, and are used either for prevention, treatment or diagnosis of disease in humans or animals, or for development, experimental or investigational purposes related thereto.

• Bioprospecting can be defined as the systematic search for and development of new sources of chemical compounds, genes, micro-organisms, macro-organisms, and other valuable products from nature. It entails the search for economically valuable genetic and biochemical resources from nature. So, in brief, bioprospecting means looking for ways to commercialize biodiversity. Lately, exploration and research on indigenous knowledge related to the utilization and management of biological resources has also been included into the concept of bioprospecting. Thus, bioprospecting touches upon the conservation and sustainable use of biological resources and the rights of local and indigenous communities.

• Biosafety refers to the measures undertaken to protect workers from hazards due to the nature of work and to prevent the spread of hazardous agents from the laboratory.

• Biosafety cabinet or biological safety cabinet (BSC) a hood with high- efficiency particulate air (HEPA) filters that provides personnel, environmental and/ or product protection when appropriate practices and procedures are followed.

• Biosafety Officer person that oversees the development and maintenance of the primary structure and function of the Biosafety Program in accordance with the biosafety standards.

• Biosafety Level 1 (BSL-1) suitable for work involving well characterized agents that are not known to cause disease in immune-competent adult humans, and present minimal potential hazard to personnel and the environment.

• Biosafety Level 2 (BSL-2) builds upon the practices, procedures, containment equipment, and facility requirements of BSL-1. BSL-2 is suitable for work involving laboratory both human and animals infected with agents associated with human disease and pose moderate hazards to personnel and the environment. It also addresses hazards from ingestion as well as from percutaneous and mucous membrane exposure.

• Biosafety Level 3 (BSL-3) involves practices suitable for work with laboratory both human and animals infected with indigenous or exotic agents, agents that present a potential for aerosol transmission, and agents causing serious or potentially lethal disease. BSL-3 builds upon the standard practices, procedures, containment equipment, and facility requirements of BSL-2.

• Commissioning verification of the physical construction and performance of critical containment components.

• Community encompasses both human (i.e., the public) and animal populations

• Containment combination of personal practices, procedures, safety equipment, laboratory design, and engineering features to minimize the exposure of workers to hazardous or potentially hazardous agents.

• Contingency Plan for evacuation plan devised for a specific situation when things go wrong in the laboratory. It contains specific strategies and actions in prevention of particular problems or emergencies to recover from serious incident in the minimum time with minimum cost and disruption.

• Control combination of engineered and procedural measures that ensure materials are used only as intended and not diverted for malicious or unknown use.

• Corrective maintenance involves minor repair of building elements and minor servicing of equipment to correct confirmed abnormalities or deteriorating conditions.

• Decontamination inactivation or removal of contaminants to an acceptable level.

• Disease refers to a specific illness or medical condition, irrespective or origin or source that presents or could present significant harm to humans.

• Disinfection selective killing or inactivation of contaminant to include viruses and vegetative bacteria which may not kill spores.

• Emergency Alert and Warning System warning that uses all available means of communication providing a standardized alert protocol and develop infrastructure for notification to geographically appropriate community of responders and affected personnel, and individuals.

• Export Control System scheme to put a regulation and restriction in the distribution overseas or abroad of strategic goods, VBM, dual use commodities, technologies, software, etc.

• Eyewash device used to irrigate and flush the eyes.

• Genetically modified microorganisms and organisms microorganisms and organisms in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally.

• Germicide any antimicrobial chemical agent used for disinfection, antisepsis or sterilization regardless of whether is action is microbicidal or microbistatic; any microbicidal disinfectant, antiseptic or sterilant.

• Hazard refers to any situation that has potential to cause damage.

• High-Efficiency Particulate Air (HEPA) a device composed of fibrous materials capable of trapping and retaining at least 99.97 percent of airborne monodispersed particles 0.3 micrometers in diameter.

• Infectious agent an infectious microbial (e.g. bacteria, protozoa, fungi, viruses, or other agents (e.g. prions) that causes disease in healthy humans.

• Infectious substances substances which are known or are reasonably expected to contain pathogens.

• Inventory identifying and listing of all materials, item by item in a particular area.

• Medical or Clinical Wastes wastes generated or produced as a result of the following: diagnosis, treatment, or immunization of human beings or animals; research pertaining to the diagnosis and treatment, or immunization of human beings or animals; or the production of biological testing.

• Outer packaging outermost enclosure of a composite or combination packaging together with any absorbent materials, cushioning, and any other components necessary to contain and protect inner receptacles of inner packaging from outside influences, such as physical damage while in transit.

• Pathogen infectious microbe (e.g. bacteria, protozoa, fungi, viruses, etc.) or other agent that causes disease in healthy host organism such as humans, animals, or plants.

• Personal Protective Equipment (PPE) clothing or equipment worn by workers to protect the body from injury by hazardous agents or materials. Examples of PPE include foot, hand, eye, face, body and respiratory protection. PPE is one element of biosafety containment.

• Preparedness organizing of a response prior to an event.

• Preventive maintenance consists of planned, scheduled and cyclic tasks of condition checking/monitoring, parts replacement, and gathering of data in order to prevent untimely breakdown of building elements, equipment and utility system, maintain

• desired operating performance levels and generate structures and coherent data needed for planning and decision-making.

• Primary barrier physical barriers (e.g. face mask, gloves, and other PPEs) which are intended to protect the safety of healthcare workers who are in contact with various pathogens.

• Risk probability of an adverse effect, harm, injury or disease occurring as a result of an exposure to one or more hazards.

• Risk Group ranking of a microorganism's ability to cause injury through disease.

• Secondary barrier contains the agent within the room or facility in case an agent escapes from the primary barrier, may either be a separate building or located in an isolated zone inside a building.

• Severity estimation of how serious the potential or probable harm it might cause to people, animal, the environment or damage to property.

• Standards external rules established by the government, contract, and funding regulations, and non-regulatory standards that form the requirements of the Biosafety Program.

• Sterilization process of ensuring the destruction of contaminants and microbiological life.

• Surveillance refers to the regular publication with specific information on the disease under surveillance.

• Toxin poisonous substance, especially a protein that is produced by living cells or organisms, and is capable of causing disease when introduced within the body tissues.

• Virus a small infectious agent that can only replicate inside the cells of another organism.

PART

I

BIOSAFETY

Section A	Biosafety Program Management
Section B	Risk Assessment of Biohazards in the Laboratory
Section C	Design of Laboratory Containment Facilities
Section D	Operation and Maintenance of BSL-2 and BSL-3 Laboratories
Section E	Biosafety Operational Practices
Section F	Selection and Safe Use of Biological Safety Cabinets (BSCs)
Section G	Decontamination and Disinfection of Biological Agents and Toxins
Section H	Transport of Infectious Substances, Biological Specimens and Dangerous Goods
Section I	Working with Animals

SECTION

BIOSAFETY PROGRAM MANAGEMENT

Introduction

Biosafety Program Management (BPM) aims to protect personnel from exposure to infectious agents and toxins, prevent environmental contamination, provide a safe environment for high quality research and comply with applicable national, regional and local requirements/regulations. It fosters biosafety practices and compliance through implementation of policies, guidelines, or regulations set forth by the Institutional Biosafety Committee (IBC), and/or Hospital Patient's Safety Committee and Infectious Control Committee. For the rules and procedures to become effective, it is important that there will be clear lines of communication and command. BPM has a structured administrative format in place which defines the roles and responsibilities of each person or administrative office.

The BPM shall cover the following: (1) Training, (2) Procedures, (3) Medical Surveillance, (4) Risk Assessment, (5) Emergency Response/Contingency Planning, and (6) Reporting Accidents/Incidents.

• Standard 1. There shall be a Biosafety Program Management (BPM) established in all laboratory facilities in the hospital, schools, research laboratories and any free standing laboratories.

  • 1.1 Biosafety Program Management shall provide guidance to employees assigned to work with, or in the vicinity of potentially infectious or otherwise hazardous materials deriving from plant, animal or human.

• Standard 2. The management shall create a Laboratory Institutional Biosafety Committee (IBC), and/or strengthen existing Hospital Infection Prevention Control Committee (IPCC) until such time IBC is established.

  • 2.1 This committee shall meet the requirements set forth by the National Biosafety Committee, Biorisk Management Standard CWA 15793:2011, and/or other professional biosafety organizations.

• Standard 3. The laboratory has a designated, qualified and competent Biosafety Officer (BSO).

  • 3.1 The BSO may be the head of the laboratory or any designated BSO. The BSO possesses competence and skills needed to perform his tasks.

• 3.2 The BSO shall oversee the effective implementation of the BPM.

• Standard 4. There shall be a medical surveillance activity which may be integrated with the infection control or any appropriate committee/collaborating agency.

  • 4.1 The medical surveillance activity shall monitor potential health hazards related to laboratory work.
  • 4.2 The activity shall determine the need to provide and institute appropriate pre-exposure (vaccination and/or oral prophylaxis) and post-exposure prophylactic management.

• Standard 5. The program shall provide training and evaluation on the conduct of risk assessment, response to medical emergencies and on safety of laboratory personnel.

  • 5.1 Training of laboratory personnel for risk assessment who will respond to medical emergencies in a containment laboratory shall be conducted to ensure prompt and appropriate response, assessment, stabilization, and delivery of a victim for appropriate medical treatment.
  • 5.2 The emergency response training shall be conducted in realistic setting in collaboration with local medical response personnel of the institution to determine the most likely emergencies to be encountered or dealt with.
  • 5.3 There shall be training on biosafety enhancement to handle highly hazardous procedures commonly encountered in the laboratories.
  • 5.4 At least an annual evaluation of skill level of personnel at risk, such as laboratory staff, maintenance, housekeeping, and/or animal care personnel shall be conducted.

• Standard 6. The program shall have an effective internal and external communication plans on the activities of laboratory.

  • 6.1 A communication plan to enhance community awareness shall be provided.
  • 6.2 An effective strategy on the implementation and evaluation of the communication plan shall be provided.

• Standard 7. There shall be a system for continual improvement Plan, Do, Check, Act (PDCA).

  • 7.1 The institution shall strive to improve effectiveness of the management system through the use of policies, objectives, self-

audit programme, audit results, analysis of data risk assessment, corrective and preventive actions, and management review using PDCA model.

SECTION

B

RISK ASSESSMENT FOR BIOHAZARDS IN THE LABORATORY

Introduction

Risk Assessment (RA) is a process that determines the risk that exists when handling and storing potentially hazardous biological materials. It is a process done to identify hazards and to measure the occurrence of an incident resulting from the hazards. It focuses primarily on the bio-containment measures to prevent laboratoryacquired infections. It also helps assign the biosafety levels (facilities, equipment and practices) that reduce the worker's and the environment's risk of exposure to an agent in absolute minimum.

• Standard 1. There shall be risk assessment activities to identify the hazards and determine the necessary level of containment (based on infrastructure requirement of existing, and/or planned activities, procedures practices and equipment).

  • 1.1 The risk assessment shall be performed by any one of the following: Principal Investigator, Laboratory Manager, Biosafety Officer, Institutional Biosafety Committee staff, other designated personnel or consultants.
  • 1.2 Risk assessment shall identify the risk factors involving biological agents, host and environment to set the biosafety levels for laboratory operations.
  • 1.3 The characteristics of most infectious agents depending on their risk group classification shall be identified. Information on risk assessment can be obtained from laboratory investigations, disease surveillance, and epidemiological studies.
  • 1.4 An identification of specific hazards present in any particular laboratory facility, varying according to the microbiologic agent involved and the nature of the research activity shall be provided.
  • 1.5 Hierarchy of hazard control or bio-containment shall involve engineering controls of the facility, work practices, administrative controls, use of safety equipment (e.g. BSC) and personal protective equipment.
  • 1.6 A standard assessment matrix form shall be used as a guide to conduct the risk assessment.

• Standard 2. The risk assessment shall be done, if applicable, in coordination with the Institutional Biosafety Committee (IBC), or Hospital Patient Safety Committee and Infection Control Committee, and/or other Biosafety Professionals to ensure compliance with established guidelines and regulations.

  • 2.1 Biological Risk assessment are based on the existing/established guidelines of the IBC or Professional Biosafety Association to alert the hazards of working with infectious agents and the need for developing proficiency in the use of selected safe practices and containment equipment.

• Standard 3. There shall be a risk assessment process to define the scope, nature and timing of assessment applicable to laboratory operations.

  • 3.1 Various risk assessment and methodologies and approaches shall be conducted depending upon the nature of work and risk group of pathogen.
  • 3.2 Laboratory personnel working with hazardous materials shall develop operational standards to meet their own needs on the practices, containment, use of equipment, and facility requirements.
  • 3.3 Laboratory operational standards shall be implemented and documented.

• Standard 4. There shall be risk management strategies to mitigate the assessed risks, which include the utilization of mitigating controls.

  • 4.1 The hierarchy of mitigation controls shall be as follows: Elimination, Substitution, use of Engineering Controls, Administrative Controls, SOP, and use of PPE.
  • 4.2 The choice of controls shall be strictly implemented to address specific risks in the laboratory.
  • 4.3 Mitigation controls shall be monitored and evaluated for effectiveness periodically.

SECTION

C

DESIGN OF LABORATORY CONTAINMENT FACILITIES

Introduction

Laboratory containment facilities are considered secondary barriers where architectural design and engineering controls are provided to ensure containment of agent within the room or facility, in case an agent escapes from the primary barriers. Primary barrier includes Biosafety Cabinet, primary enclosure, animal caging and specialized laboratory equipment.

In the Philippine setting, among the four (4) biosafety levels of a laboratory, BSL-2 and BSL-3 pose practical and potential risk of spread. BSL-4 laboratories are non-existent yet. As to their operations, these facilities are either attached to the Microbiology/Bacteriology of the Clinical Laboratory in an institution, or free standing research laboratories for schools and industries, and animal, insect and plant containment laboratories.

• Standard 1. There shall be a standard architectural design for each level of containment facilities.

  • 1.1 The laboratory facility design plan shall comply with applicable International Guidelines, National Laws/Codes and Local Ordinances.
  • 1.2 The laboratory plan shall be designed to optimize the performance of laboratory work activities and provide adequate area for equipment, fixtures, benches and casework and safety of workers.
  • 1.3 The laboratory design shall provide for additional requirements depending on the type of pathogens handled in the facility. It may have additional structural and/or operational improvements in handling agents beyond the current capacity of the facility.
  • 1.4 The laboratory shall be located according to biosafety level, and with limited access to avoid accidental or willful entry of unauthorized persons.

• Standard 2. There shall be a Design Development Team in the establishment of laboratory containment facility.

  • 2.1 The Team shall be composed of the Laboratory Manager, Biosafety Officer, Laboratory Technologists, Administrative Officer, and other Consultants such as the Architect,

• Mechanical/Electrical/Structural Engineers, and Project Manager or any accredited third party certifier for BSL-3.

• 2.2 The Team shall possess the capability to deliver the required facility design, in conformance to building standards and regulations.

• Standard 3. The laboratory containment facility shall consist of the primary barrier (safety equipment) and the secondary barrier (facility plan).

  • 3.1 The primary and secondary barriers must conform to the functional requirements and regularly maintained according to standards.

• Standard 4. There shall be a standard engineering control for laboratory containment facilities to ensure safe and efficient work operations.

  • 4.1 The mechanical control for heating, ventilation and air conditioning system shall conform to the existing/current National and Local Standards, Codes and Regulations.
  • 4.2 The control systems shall conform to the standard requirements on room pressure control, alarms and critical components such as control dampers, isolation dampers, control panels, sensors, controllers and actuators.
  • 4.3 The plumbing design shall conform to the standard requirements on drainage services, effluent treatment, waste treatment, fixtures and equipment.
  • 4.4 The electrical design shall conform to the standard requirements on lighting, electronic security power supply, communication devices, electric power, door interlock and emergency alarm.
  • 4.5 The structural design shall conform to the standard requirements on service penetration through floors, walls, ceilings, roof, corridors, bearing walls, structural loads, service shaft location, interstitial space, vibration factors, and materials for containment envelope.

• Standard 5. The organization shall establish and maintain documentation for all equipment and elements of the physical plant design and maintenance.

  • 5.1 Documentation shall include: name of equipment, procurement procedure, preventive maintenance such as, but not limited to, calibrations, certification or validation.

SECTION

D

OPERATION AND MAINTENANCE OF BSL-2 AND BSL-3 LABORATORIES

Introduction

Keeping the operation of containment laboratories (BSL-2, BSL-3 and BSL-4) to its optimum and safe use is dependent to a great extent on the level of maintenance program being implemented. The engineering and building maintenance, as well as a degree of equipment maintenance, when properly carried out by competent staff or personnel would result not only to the desired function of the equipment and the facility, but also ensures a safe work environment for its occupants. It is imperative, therefore, that efforts and resources be provided. By giving greater importance in the maintenance services of laboratories, it identifies practices for proper operation and maintenance of biosafety laboratories to extend the life of the building and its systems. An effective program for operation and maintenance will improve efficiencies and replacement costs.

• Standard 1. There shall be an Operations and Maintenance Plan that complies with the Laboratory Biorisk Management Standards CWA 15739 to ensure optimal function of the laboratory building facility, equipment and utility systems.

  • 1.1 The comprehensive strategies in the operation and maintenance shall be responsive to the constant as well as the varying demands of the different laboratories during normal operations and in crisis situations.
  • 1.2 There shall be effective coordination and safe implementation of all maintenance activities.
  • 1.3 There shall be effective documentation and database management of all operations and maintenance activities.
  • 1.4 There shall be a comprehensive monitoring and evaluation scheme for accurate assessment of the program.
  • 1.5 There shall be a continuing education, training and development program of personnel as required by the Biosafety Program Management (BPM).

• Standard 2. There shall be organizational and logistic components to properly implement the Operations and Maintenance Plan.

• 2.1 The laboratory management will set the general direction, goals and policies of the facility.

• 2.2 The key technical personnel (i.e. professional and licensed maintenance staff) will exercise technical and administrative supervision over the skilled and unskilled maintenance workers.

• 2.3 The materials, tools and equipment needed in the operations and maintenance shall be available.

• 2.4 A complete and up-to-date file of pertinent documents and records on the operations and maintenance shall be readily available.

Standard 3. Maintenance activities shall be implemented and documented.

3.1 Preventive/corrective maintenance and major repair/rehabilitation shall be performed and documented.

SECTION

E

BIOSAFETY OPERATIONAL PRACTICES

Introduction

Handling of infectious microorganisms and their by-products remains a source of infection and eventual morbidity/mortality among laboratory workers. This can be effectively and efficiently minimized through the application of appropriate biosafety principles and practices. The most common source of laboratory acquired infections are aerosols, spills, splashes, needle/sharp object injuries, and overt potential exposures to infectious materials.

• Standard 1. Appropriate standard laboratory practices shall be enforced to ensure the safety and health of the laboratory workers.

  • 1.1 The laboratory shall have documented policies and Standard Operating Procedures (SOPs) on good laboratory practices appropriate for all Biosafety Level laboratories.
  • 1.2 The Standard Universal Precautions in handling laboratory specimens shall be strictly observed.
  • 1.3 The laboratory shall have documented policy and procedures for emergency situations such as accidental exposure to pathogens and toxic chemicals, animal escape, mechanical failure, medical emergencies and splashes/spills of infectious substances.
  • 1.4 Laboratory activities that generate aerosols and air droplets from pathogens identified with biosafety concerns shall be performed within appropriate bio-containment facilities and laboratory equipment (i.e. biological safety cabinets or fume hood, or bench top).
  • 1.5 There shall be appropriate Personal Protective Equipment (PPE) in the conduct of laboratory activities**.**

• Standard 2. The laboratory shall ensure that PPE needs are identified and that suitable equipment is specified, used, maintained appropriately, and made available within the facility.

  • 2.1 The laboratory shall have documented guidelines on the selection and use of the PPE, provision of training and competency assessment.

• 2.2 There shall be actual trainings/demonstrations on the proper use of the PPE.

• 2.3 There shall be policies to address the need for, and provision of continuous supply/replacement of PPE.

• 2.4 There shall be measures to identify and control hazards associated with PPE itself.

• 2.5 There shall be an appropriate program to ensure that routine checks and maintenance of PPE are defined and carried out.

• Standard 3. The laboratory shall comply with the Waste Management Manual of the institution, consistent with the National Standards of the Department of Health (DOH), Department of Environment and Natural Resources (DENR) and Local Ordinances.

  • 3.1 There shall be a safe and appropriate system of handling, transport, treatment, and disposal of used laboratory materials and other biological wastes.
  • 3.2 All the laboratory staff and other concerned personnel that handle, treat and dispose biohazardous wastes shall have adequate training on proper waste management.
  • 3.3 Any improvement and change in the system of transport and disposal of used laboratory materials and other biological wastes shall be properly disseminated and complied.
  • 3.4 There shall be a devised monitoring scheme to ensure the efficient implementation of disposal systems/techniques.

• Standard 4. The laboratory shall have guidelines and provisions for proper and safe storage of all biological agents and chemicals.

  • 4.1 There shall be a designated adequate, appropriate and safe storage area for biological agents and chemicals in the laboratory.
  • 4.2 There shall be a Material Safety Data Sheet (MSDS) for chemicals, Pathogen Safety Data Sheets (PSDS) for biological agents, and/or other chemical hazard information that are readily available in the laboratory.
  • 4.3 Storage of chemicals shall be based on their characteristics and properties.
  • 4.4 An updated list of all stored biological agents and chemicals shall be readily accessible and maintained.

4.5 There shall be appropriate biohazard signage posted on applicable areas of the laboratory, equipment and devices.

Part I – Biosafety

SECTION

F

SELECTION AND SAFE USE OF BIOLOGICAL SAFETY CABINETS (BSCs)

Introduction

Biological Safety Cabinets (BSCs) are designed with several modifications to protect the operator, the laboratory environment and work materials from exposure to infectious aerosols and splashes that may be generated when manipulating materials containing infectious agents/toxins such as primary cultures, stocks and diagnostic specimens. BSC, when properly used, is highly effective in reducing laboratoryacquired infections and cross-contaminations of cultures due to aerosol exposures. The addition of High Efficiency Particulate Air (HEPA) filter to the exhaust system remove particles equal to, or greater than 0.3 microns, which essentially include all bacteria, spores and viruses, with an efficiency of 99.97 percent. HEPA filters are effective at trapping particulates and infectious agents, but not at capturing volatile chemicals or gases.

• Standard 1. The laboratory shall have documented guidelines and policies on the selection of BSC.

  • 1.1 Appropriate BSC shall be selected through risk assessment as to the type of protection needed, product protection, and protection of personnel against Risk Group Agents.
  • 1.2 Appropriate BSC shall be selected depending on its airflow characteristic and its application against exposure to infectious substances, radionucleotide, and volatile toxic chemicals or a combination of these.
  • 1.3 A standard policy shall require the presence of marking and product certification and information on its proper use.
  • 1.4 The BSO shall be responsible for the review of the technical specifications of the selected BSC, and extend proper advice and guidance to the end-user regarding the BSC's selection and use.

• Standard 2. The laboratory shall have documented guidelines and policies on the safe use of BSC.

• 2.1 Performance and containment tests shall be conducted on the selected BSC to ensure that routine checks and maintenance are defined and carried out.

• Standard 3. The laboratory shall have documented Quality Control Procedures that ensure the proper operation and maintenance of BSC.

  • 3.1 The laboratory facility shall have internal quality control measures on the use and operation of the BSC.
  • 3.2 An annual audit shall be performed by designated DOH representatives from the Center for Device Regulation, Radiation Health and Research of the Food and Drug Administration (FDA-CDRRHR) and/or any DOH-accredited/certified biosafety professional association to assess continuous compliance product specification.
  • 3.3 A systematic filing and safekeeping of all documents related to the use and operations of the BSC shall be done.

• Standard 4. The laboratory shall have a checklist of procedures and laboratory supplies and materials before, during and after use of BSC.

  • 4.1 A written checklist of materials and procedures for activities done in a BSC shall be documented.
  • 4.2 All necessary materials needed in the operations of the BSC shall be available at all times.

• Standard 5. The BSC operator shall undergo training in the operation, use and preventive maintenance of BSC.

  • 5.1 There shall be training on the operation, use and maintenance of BSC to be conducted by the manufacturer/supplier or the FDA-CDRRHR, or other DOH recognized biosafety professional association.
  • 5.2 The laboratory personnel shall keep an updated preventive and corrective maintenance record of the BSC.

SECTION

G

DECONTAMINATION AND DISINFECTION OF BIOLOGICAL AGENTS AND TOXINS

Introduction

The laboratory shall establish and maintain procedures to ensure that appropriate methods for disinfection and decontamination are chosen and implemented effectively. It shall ensure that all contaminated or potentially contaminated waste items have been identified and documented, and that effective procedures are in place.

• Standard 1. Risk Assessment shall be an integral part of the process to identify and develop effective decontamination methods.

  • 1.1 The nature, hazards and material compatibility issues of material to be decontaminated shall be validated to demonstrate that methodology selected is capable of inactivating biological agents and toxins under the specific conditions encountered in the facility.

• Standard 2. There shall be effective segregation and decontamination methods of biological agents and toxin waste products in the laboratory.

  • 2.1 All potential waste stream and other sources of contamination shall be identified and documented.
  • 2.2 Appropriate disinfectants with their proper concentrations used shall be compatible with working conditions. These shall be maintained throughout the process, including conducting specific validation activities where necessary.
  • 2.3 The laboratory facilities shall provide adequate and appropriate space for storage of segregated waste, including short-term storage.
  • 2.4 The laboratory shall adhere to standards and guidelines in the selection of procedures most appropriate to specific conditions.
  • 2.5 The laboratory shall have provisions/options for decontamination methods applied to heat-sensitive equipment and materials.
  • 2.6 The laboratory shall ensure adequacy of methods and resources for decontamination purposes.

• 2.7 The laboratory shall ensure that any spillages or other incidents during handling and transport of materials inside and outside the facility are properly documented and dealt with.

• Standard 3. There shall be an established procedure to monitor and evaluate the effectiveness of decontamination methods performed in the laboratory.

  • 3.1 There shall be procedure to ensure effective waste audit trails with flow chart.
  • 3.2 Chemicals and/or use of biological indicators shall be employed to evaluate the effectiveness of the decontamination process.
  • 3.3 If possible, studies shall be done to validate the efficacy of the selected procedures.

• Standard 4. There shall be policies and procedures to monitor and evaluate biological waste disposal provider.

  • 4.1 The laboratory/facility shall ensure the availability of a government-accredited/licensed waste disposal provider through a documented appropriate selection procedure.
  • 4.2 The waste disposal provider shall adhere to the SOP and guidelines for waste management set by the laboratory/facility and in accordance to the terms of the MOA/NOA.

SECTION

TRANSPORT OF INFECTIOUS SUBSTANCES, BIOLOGICAL SPECIMENS AND DANGEROUS GOODS

Introduction

Infectious materials are classified as hazardous due to their potential to spread disease. These include viruses, bacteria, parasites, diagnostic specimens and medical wastes.

The laboratory management shall ensure that procedures for the safe and secure transport of cultures, specimens, samples, and contaminated and potentially infectious materials are established, implemented and maintained in accordance with legal requirements and health safety measures. Compliance with these requirements will reduce the likelihood of damaged packages leak, thereby preventing possible infections due to exposures. This will also ensure an improved and efficient package delivery system.

Transport of infectious and potentially infectious materials is subject to strict national and international regulations. These regulations describe the proper packaging and labeling of materials, as well as other shipping requirements.

The authorized/designated laboratory personnel must have undergone proper training on shipping of infectious and biological substances based on existing guidelines and regulations.

• Standard 1. The laboratory shall adhere to transport requirements, including legal requirements, national and international guidelines.

  • 1.1 The laboratory shall maintain a handbook following the national and international guidelines and requirements pertaining to the shipping/transport of infectious and biological specimens.
  • 1.2 There shall be guidelines in classifying infectious substances for appropriate and safe packaging and transport.

• Standard 2. The laboratory shall adhere to the required packaging system, materials, label, PPE and decontamination as part of the proper transport process.

  • 2.1 The packaging of infectious substances shall be designed to prevent damage and/or and spillage/release during transport.

• Standard 3. There shall be a reliable and trustworthy carrier and/or efficient transport/transfer system for infectious materials to handle the packages safely, securely and ensure their timely arrival.

• 3.1 There shall be a system for checking/validating the credibility of the contracted shipper. Terms and conditions shall be properly defined and documented.

• 3.2 Good coordination between the sender/shipper and the carrier/receiver shall ensure the good condition of the transported materials throughout the entire process.

• 3.3 The consignor/shipper shall ensure the correct classification, communication requirement for shipment, packaging, marking, labeling and documentation including permits, documents and manifest of all infectious materials/substances and dangerous goods destined for transport.

• 3.4 The consignee/receiver shall check that the package has not been damaged and shall ensure availability of correct documents. Any damage or non-conformance to agreement shall be reported to the proper authorities. Documents are retained for at least two (2) years.

• 3.5 Personnel shall be trained on the transport, handling or receiving of infectious agents, substances/materials and dangerous goods.

• Standard 4. The laboratory shall have a system for document control to ensure traceability of material movement.

  • 4.1 There shall be an efficient, documented tracking system for importation, exportation and transfer of infectious agent/materials substances and dangerous goods between and among laboratories within the country.
  • 4.2 The tracking system shall comply with current national and international regulations for the transport of infectious substances and patient specimens by all modes of transportation.
  • 4.3 Request for biological agents and toxins or material that may contain viable biological agents and toxins shall be made in writing by a duly-licensed laboratory/facility. Requisition requests are only for legitimate reasons.

• Standard 5. The laboratory shall implement appropriate and adequate emergency response and contingency plans associated with identified problems on the transport of infectious substances and specimens, including safety precautions for handling suspicious packages.

  • 5.1 The laboratory shall have a documented emergency response and contingency plan that is well-communicated to the concerned personnel.

• 5.2 Laboratory personnel shall be aware of certain substances of biological origin, which shall be exempted from dangerous goods requirement and regulations because of the low hazard they present.

• 5.3 Quarantine or special isolation areas/rooms shall be assigned to receive/ship high risk infectious substances/biological specimens.

• 5.4 Appropriate and equivalent controls shall be applied to importation of infectious substances/biological specimens/materials into the facility.

SECTION

I

WORKING WITH ANIMALS

Introduction

The animal facility design and bio-containment level is entirely based upon the risk assessment. Therefore, prior to construction, a comprehensive risk assessment shall be performed to determine what facility features are needed to mitigate the likelihood of harm to humans, animals, and environment that may arise from use of biological agents that are carried/harbored by the animals. The information from the risk assessment will help determine the level of bio-containment, in order to prevent or least minimize risk associated with working with infected or potentially-infected animals.

The design and construction of a safe, practical, functional and efficient animal facility requires professional judgment based on the size, nature and activity of the institutional program related to animal handling and use. Identification of specific, or even specialized animal facility, and other support functions are also necessary because mitigation of the risks identified will be geared towards facility design, practices and procedures, personnel trainings, and use of adequate safety equipment.

Effective planning for an appropriate design of the animal facility also supports programs on proper care and use of animals*.*

Many biomedical, as well as behavioral investigations, require the use of animals to achieve specified outcomes based on scientific methods. The use of laboratory animals, including farm animals in scientific procedures, shall be subject to ethical and welfare considerations.

The responsibility on proper care, use, and humane treatment of animals for scientific procedures, research and production shall be given utmost attention in every institution. The professional staff conducting and supporting the research programs involving hazardous biologics shall be knowledgeable and competent enough to assess the potential dangers associated with the experimental use of animals and be able to reduce the risks to acceptable level, through the risk assessment process.

Animal welfare regulations exist and must be followed. Section 3 of Republic Act (R.A.) 8485, or the Animal Welfare Act of 1998 states "The Director of the Bureau of Animal Industry shall supervise and regulate the establishment, operation and maintenance of pet shops, kennels, veterinary clinics, veterinary hospitals, stockyards, corrals, stud farms and zoos and any other form or structure for the confinement of animals where they are bred, treated , maintained, or kept either for sale or trade or for training purposes as well as the transport of such animals in any form of public or private transportation facility in order to provide maximum comfort while in transit and minimize, if not totally eradicate, incidence of sickness and death and prevent any cruelty from being inflicted upon the animals".

Section 6 of R.A. 8485, as amended by Republic Act 10631 in 2013, states "It shall be unlawful for any person to torture any animal, to neglect to provide adequate care, subject any dog or horse to dog fights or horse fights, kill or cause or procure to be tortured or deprived of adequate care, sustenance or shelter, or maltreat or use the same in research or experiments not expressly authorized by the Committee on Animal Welfare".

Pursuant to Department of Agriculture Administrative Order No. 40 s. 1999 regarding Rules and Regulations for the conduct of Scientific Procedures Using Animals and the Philippine Association for Laboratory Animal Science (PALAS) Code of Practice, the proper waste disposal program for animal facilities is as important as disinfection and decontamination in maintaining animal health, as well as preventing occupational hazards. Environmental contamination by infectious materials can be minimized with the implementation of a proper waste disposal program.

Sub-Section I.1. Risk Assessment Protocol

• Standard 1. Risk Assessment (RA) shall be done by the IBC and a designated trained BSO, together with a laboratory animal specialist trained in working with laboratory animals.
  • 1.1 The risk assessment process is conducted by the IBC, in coordination with Institutional Animal Care and Use Committee (IACUC), laboratory animal specialists, including the Laboratory Director.
  • 1.2 Standardized RA tool and report forms are available.
  • 1.3 Hazards and risks that may arise from the use, handling and care of animals shall be identified comprehensively.
  • 1.4 The results of the RA shall form the basis of the animal facility design, biosafety levels and installation of mitigation controls.
  • 1.5 An RA is performed for purposes of evaluating acceptability of residual risks, or whenever changes are made in the existing controls, policies or procedures.

Sub-Section I.2. Animal Biosafety Program Management (ABPM)

Standard 1. The Director of the Institution shall designate a BSO who shall approve and oversee the implementation of policies, guidelines, references, procedures and protocols on biosafety measures with reference to, and following Standard 3, Section A, Part I of this Manual.

• 1.1 The BSO shall coordinate closely with the laboratory's animal facility director and IACUC in ensuring that the ABPM is properly implemented and evaluated periodically.

• 1.2 The BSO, together with the laboratory animal facility director and IACUC, shall develop its own Biosafety Manual with the approval of the Director of the Institution.

• 1.3 The BSO shall be notified immediately, in case of accident/emergency situations.

• Standard 2. The ABPM shall include RA procedures that will determine the Biosafety Level of the Animal Facility Design.

  • 2.1 The physical design of the animal facility shall be based on the results of the RA.
  • 2.2 The animal facility shall be designed to provide adequate level of safety and protection for the internal and external environments.
  • 2.3 The animal facility shall be designed to provide adequate level of safety and protection for the animals and for the staff/personnel who are working with them.
  • 2.4 The animal facility is designed in accordance with applicable international, national and local building code requirements, including Leadership in Energy and Environmental Design (LEED) certification.
  • 2.5 The animal facility shall be built in accordance with standard architectural and engineering design that meet the requirements needed support for the implementation of the biosafety level.
  • 2.6 The animal facility shall be inspected and maintained to ensure its intended purpose and functions by the IBC.

• Standard 3. The ABPM shall have policies and procedures on Personnel Education and Training on safe animal care, use and handling.

  • 3.1 Laboratory personnel, animal technicians and caretakers shall participate in documented continuing professional education training regarding safe animal care, use and handling.
  • 3.2 Laboratory personnel, animal technicians and caretakers shall have documented training and education on chemical, biological (including zoonotic), radiological, nuclear and physical hazards.
  • 3.3 Laboratory personnel, animal technicians and caretakers shall undergo training and education on good laboratory practices,

• including the use of Personal Protective Equipment (PPE) and proper donning/doffing procedures.

• 3.4 Laboratory personnel, animal technicians and caretakers shall undergo training and education on emergency (accident and incident) response, animal restraint and/or escape procedures and disaster planning/emergency preparedness.

• 3.5 Laboratory personnel, animal technicians and caretakers shall undergo training and education on waste management.

• Standard 4. The ABPM shall have documented policies and procedures, guidelines and references for establishing and maintaining an effective comprehensive Basic Occupational Safety and Health Program (BOSH).

  • 4.1 Each institution shall establish and maintain a BOSH as an essential part of the over-all program of animal care and use.
  • 4.2 The BOSH shall be consistent with the national and local regulations and should focus on maintaining a safe and healthy workplace. The nature of the BOSH will depend on the facility research activities, hazards and animal species involved.
  • 4.3 An effective BOSH requires coordination between research program, the Animal Care and Use Program (ACUP), health and administrative services. Operational and day-to-day responsibilities for safety in the workplace shall reside with the laboratory facility director, and shall depend on safe work practices by all employees.

• Standard 5. The ABPM shall have documented policies and procedures that address Animal Safety and Health.

  • 5.1 Animal Safety and Health policies and procedures shall include baseline blood or tissue testing, prophylaxis and/or immunization.
  • 5.2 There shall be an established treatment and management procedures for animals that are or may become infected with biological agents during or after work activities.
  • 5.3 Animal technicians and caretakers shall be available during holidays, weekends, or in case of emergencies to attend the needs of laboratory animals.

• Standard 6. There shall be a documented procedure to monitor and evaluate the effectiveness, and to address possible inadequacies of the ABPM currently being used.

  • 6.1 The monitoring and evaluation shall be performed by the BSO in coordination with the laboratory animal facility director.

• 6.2 There shall be regular and random checks to determine the degree of implementation and sustainability of the ABPM.

• 6.3 Monitoring and evaluation procedures shall be used as basis for continual improvement and enhancement of the ABPM.

Sub-Section I.3. Operation and Maintenance of Animal Laboratories/Facilities

• Standard 1. There shall be a laboratory animal facility director who possesses the competence for safe, efficient operations and maintenance of its facility.

  • 1.1 The laboratory animal facility director shall monitor the implementation of the animal biosafety policies and procedural changes, and shall ensure that all personnel receive regular updates.
  • 1.2 The laboratory animal facility director shall prepare an annual procurement plan (APP), which will include the needs of the ABPM, as recommended by the BSO with subsequent approval by the Director of the Institution.

• Standard 2. There shall be a system to document all the nature or types of work activities, researches, experiments, or animal manipulations being performed in the laboratory animal facility.

  • 2.1 Prior to conduct of any laboratory work, research projects and/or diagnostic services involving the use of animals, the personnel or staff concerned shall secure a written approval from the laboratory animal facility director or the Director of the Institution, upon the recommendation of Department of Agriculture (DA), in coordination with IACUC and/or Ethics Committee (for human workers who are at risk of exposure to zoonoses).

• Standard 3. There shall be a proper record-keeping and documentation system for all studies using animals in each research, diagnostic and production facility.

  • 3.1 There shall be documented record/information of the animals' pertinent data and research endpoints ranging from identification cards to detailed computerized records.
  • 3.2 There shall be accurate recording of all events using standardized taxonomy.

• Standard 4. There shall be an established Waste Management Program to prevent occupational hazards and ensure animal health.

• 4.1 The Waste Management Program shall be compliant with national and local government regulations and shall be strictly enforced.

• 4.2 There shall be a dedicated area for pooled waste, and placement areas for other types of waste generated through animal use and studies, and shall be kept clean and well-maintained.

• 4.3 Disinfection/decontamination methods and procedures for solid and liquid wastes shall be designed to include pre-treatment of waste prior to disposal.

• 4.4 There shall be a system for the safe transport of infectious materials by means of sterilization, containment or other appropriate means before disposal from the animal facility.

• 4.5 There shall be an appropriate cold storage system for storing pooled carcasses with enough space to accommodate the quantities of waste and animal carcasses for a reasonable amount of time, based on the activities of the institution.

• Standard 5. There shall be documented procedures for maintenance, specifically for all safety controls and measures being used and implemented in the laboratory animal facility.

  • 5.1 Maintenance procedures shall include, but are not limited to performance checks of containment barriers, biosafety equipment/controls, and HVAC system. Appropriate indicators shall measure performance and efficiency.
  • 5.2 Results of preventive, corrective and maintenance procedures shall be reviewed and evaluated, as a reflection of the sustainability of the APBM.

PART

II BIOSECURITY

Section A	Development of Biosecurity Program
Section B	Biosecurity Risk, Threat and Vulnerability Assessment in the Laboratory
Section C	Physical Security Measures
Section D	Personnel Management of the Biosecurity Program
Section E	Information and Network Security
Section F	Material Control, Accountability and Inventory
Section G	Material Transfer and Transport Security
Section H	Biosecurity Response
Section I	Biosecurity Updates and Re-Evaluation
Section J	Reporting and Communication
Section K	Training and Practice Drills

SECTION

DEVELOPMENT OF BIOSECURITY PROGRAM

Introduction

Biosafety and biosecurity programs are based upon risk assessment and management methodology; personnel expertise and responsibility; control and accountability for research materials including microorganisms and culture stocks; access control elements, material transfer documentation, training, emergency planning, and program management.

Laboratories with good biosafety programs already achieved many of the basic requirements for security of biological materials. For laboratories not handling Valuable Biological Materials (VBM), the access controls and training requirements specified for BSL-2 and BSL-3 may provide sufficient security for the materials being studied. Security assessments and additional security measures should be considered when VBM, other agents of high public health and agriculture concern, or agents of high commercial value, such as patented vaccine candidates, are introduced into the laboratory.

The main goal of biosecurity is to prevent loss, theft or misuse of microorganisms, biological materials, and research-related information.

• Standard 1. There shall be a program for the protection of pathogens, toxins and related information/data from loss, theft, diversion, intentional release and misuse.

  • 1.1 The laboratory biosecurity program shall include physical security and access control, material control, accountability, inventory, personnel, transport and information security.
  • 1.2 The protection shall be achieved through graded implementation of security measures that restrict access to pathogens.
  • 1.3 The design or plan of a biosecurity program shall not hamper laboratory operations or interfere in the conduct of research or affect the scientific or business enterprise.

• 1.4 The program shall require familiarity in both administrative and technical skills, and knowledge with microbiology, toxicology, genetics and other materials that requires security.

• 1.5 The health and safety of laboratory personnel and the surrounding environment shall take precedence over biosecurity concerns.

• Standard 2. Development of a biosecurity program shall be a collaborative process involving all stakeholders to include, but not limited to senior management, biosafety officers, scientific staff, human resource officials, information technology staff, engineering officials and safety/security staff.

  • 2.1 The coordinated involvement of personnel responsible for a facility's overall security plan shall ensure that the plan is adequate, reasonable, timely and cost effective.
  • 2.2 The Biosecurity Management Program (BMP) shall be headed by the Biosafety Officer (BSO) who is likewise a member of any of the following committees: IBC, IPCC, and/or Emergency Response Team of the Institution.

• Standard 3. The BMP shall develop a biosecurity risk statement documenting which biosecurity scenarios represent an unacceptable risk and must be mitigated versus those risks appropriately handled through existing protection controls.

  • 3.1 Management shall develop a biosecurity plan to describe how the institution will mitigate those unacceptable risks.

SECTION

B

BIOSECURITY RISK, THREAT AND VULNERABILITY ASSESSMENT IN THE LABORATORY

Introduction

Laboratory work with pathogens always involved some level of safety and security risk. Laboratory management should ensure that risks and threats posed by pathogens, toxins and valuable biological materials, and vulnerability of the laboratory facility are identified, assessed and managed appropriately. In addition, risk mitigation measures decided by the management/ institution should address the risks identified in the risk assessment process. The application and cost of controls must be appropriate and proportional to the risk, allocating resources to the control of the highest risk first.

Risk, threat and vulnerability assessment is performed to determine the appropriate risk mitigation measures and level of control that can be applied in order to prevent access of pathogens and toxins of biosecurity concern, dangerous biological material, and relevant sensitive data/information by dangerous persons. Risk mitigation measures shall include procedural, administrative and engineering controls.

• Standard 1. Biosecurity risk, threat, vulnerability assessment shall involve an overall analysis of the facilities and valuable biologic materials in storage/use, operations, security activities, and risk to the surrounding environment.

  • 1.1 Biosecurity risk assessment shall identify, characterize, classify and prioritize the risk potentials of pathogens, toxins and dangerous biological materials, including the threat and vulnerability of the laboratory facility, and of the environment (assets, properties, and people).
  • 1.2 Biosecurity threat assessment shall identify and analyze the potential/probability of pathogens, toxins being stolen, misused or released, and the threats thereof, and shall determine the consequences/impact of loss, theft, diversion, release and potential misuse of pathogens, toxins, valuable biological materials, and biosecurity-sensitive information.

• 1.3 Vulnerability assessment shall be conducted to determine different security weaknesses and deficiencies of the laboratory/facility/area/setting that may be targeted by dangerous persons.

• 1.4 Biosecurity risk, threat and vulnerability assessment shall be specific for each laboratory/facility/area/setting.

• Standard 2. There shall be a designated risk, threat and vulnerability assessment officer/assessor in the person of the BSO in coordination with concerned stakeholders within and outside the facility.

  • 2.1 The BSO shall develop appropriate procedures to include administrative, engineering controls and incidence response plans to mitigate risks of security incidents, weaknesses and deficiencies identified, and high and moderate malicious use risks, based on established biosecurity risk criteria.
  • 2.2 The BSO shall review the effectiveness of each current biosecurity component of existing laboratory system, and evaluate the potential and consequence of each scenario.

• Standard 3. The risk mitigation measures applied shall be based on the results of risk, threat and vulnerability assessment done, recognizing the different agents, toxins, biological materials, and biosecurity-sensitive information.

  • 3.1 The risks, threats and vulnerability in the laboratory shall be identified, characterized, and prioritized according to the level of malicious use risk. The gaps in existing biosafety and biosecurity measures/practices shall also be identified. All these shall be addressed using appropriate risk mitigation measures.
  • 3.2 The biosecurity risk, threat and vulnerability assessment shall be the basis for making risk management plans and decisions to eliminate or mitigate the identified risks, threats and vulnerabilities.
  • 3.3 Resources shall be allocated to fund various mitigation control measures based on the degree of the biosecurity risk.

SECTION

C

PHYSICAL SECURITY MEASURES

Introduction

Physical Security is one of the aspects of biosecurity intended to prevent the misuse, loss, or theft of biological agents and toxins. It is designed to prevent unauthorized entry into a laboratory and removal of Valuable Biological Materials (VBM) that may be stored there.

Physical security encompasses measures to safeguard and prevent non-official access to these biological assets in the laboratory, building, or medical/research campus. A biosecurity risk assessment determines procedures and practices to ensure that biological materials remain secure. The risk assessment includes a thorough review of the building and premises, the laboratories, and biological material storage areas. Physical security measures should be implemented, as needed, based upon the risk assessment process

The level of physical protection at a facility should be commensurate with the level of hazard or threat associated with the pathogens it houses. Accordingly, the most dangerous agents and strains from the standpoint of public health impact, and potential for misuse or conversion as bio-weapons should have the greatest restrictions on access and use. There are a number of secondary assets that warrant physical protection, including technical information on pathogens and laboratory security systems, personnel files of individuals who work with listed agents or on laboratory security, and control systems involved in facility access, computer networks, and biocontainment.

• Standard 1. There shall be a designated person who shall be in charge of physical security plan.

  • 1.1 The biosafety/biosecurity officer shall be in-charge of the security plan.

• Standard 2. There shall be a comprehensive security plan that addresses the physical security of the building and laboratory, which shall deter, detect and respond to unauthorized attempts to acquire VBM.

• 2.1 The institution shall have a security plan, which comprises of structural, engineering, and security personnel elements.

• 2.2 The security plan shall address concerns associated with access, use, storage, and transfer of sensitive data.

• Standard 3. There shall be corresponding graded or concentric layers of security depending on the type and nature of risk assets, low risks, moderate risks, and exclusion area.

  • 3.1 There shall be levels of physical protection at the facility, commensurate to the level of hazard or threat associated with the pathogens and/or VBM it houses.
  • 3.2 Low risk assets shall be applied to property controlled areas, which may include fences/boundaries and signages.
  • 3.3 Moderate risk assets shall be applied to limited access control areas, which include the laboratory.
  • 3.4 High-risk assets shall be applied to exclusion areas, which include high containment laboratory and computer network hubs.

• Standard 4. There shall be physical security enforcers tasked to prevent and detect intrusions and conduct appropriate responses.

  • 4.1 There shall be an on-site guard forces tasked to detect intrusion devices, assess alarm, motion detectors, control door sensors and logbooks and validate breaches and disruption before appropriate response.
  • 4.2 There shall be local law enforcement (police) support by virtue of Memorandum of Agreement (MOA), which reinforces/substitutes for on-site guard forces.

• Standard 5. There shall be a system of screening visitors, maintenance, housekeeping, and delivery personnel.

  • 5.1 All visitors shall be issued with identification badges, monitored and escorted, as appropriate, in and out of limited areas.
  • 5.2 There shall be procedures for reporting and restricting unauthorized persons. These procedures shall be developed

• through collaboration among senior scientific, administrative, and security management personnel.

• 5.3 There shall be impositions of consequences for security violations committed.

• Standard 6. There shall be security/control devices in areas where VBM are used or stored.

  • 6.1 There shall be consolidated laboratory work areas that will implement security measures more effectively to the greatest extent possible.
  • 6.2 Rooms with sensitive materials stored in freezers/refrigerators shall be kept locked preferably with electronic keys or any alternative locking system, and preferably equipped with security surveillance cameras.
  • 6.3 There shall be periodic performance testing of aforementioned security devices to determine their effectiveness.

• Standard 7. There shall be a Performance Test Plan to evaluate the effectiveness of the physical security plan. The evaluation shall include equipment, policies, procedures and people with respect to performance.

  • 7.1 The Performance Test Plan shall be based on a comprehensive security plan that incorporates all the policies, procedures and hardware components of the physical security plan.

SECTION

D

PERSONNEL MANAGEMENT OF THE BIOSECURITY PROGRAM

Introduction

Personnel management intends to keep biological agents and toxins out of the possession of individuals who might intend to misuse them. It is in the best interest of every facility working with biological agents and toxins to have a complete biosecurity plan, including policies and procedures to screen and evaluate individuals. Personnel reliability control measures for biological facilities must consider both insider and outsider threats. These factors should be considered as part of a comprehensive biosecurity risk assessment process when developing a biosecurity plan. Insider threats occur when a person who has gained legitimate access to biological agents and toxins for research chooses to misuse his/her access for nefarious purposes.

Personnel management includes identifying the roles and responsibilities for employees who handle, use, store and transport dangerous pathogens and/or other important assets. The effectiveness of a biosecurity program against identified threats depends, first and foremost, on the integrity of those individuals who have access to pathogens, toxins, sensitive information and/or other assets. Employee screening policies and procedures are used to help evaluate these individuals. Policies should be developed for personnel and visitor identification, visitor management, access procedures, and reporting of security incidents.

Aside from periodic orientation, and regular training, it is important to instill to the laboratory personnel a security culture that includes a heightened awareness of the bioterrorism threat and vigilance in complying with biosecurity regulations.

• Standard 1. There shall be special/additional screening procedures for staff who shall be assigned in a restricted, sensitive or secure data and laboratory work areas.

  • 1.1 There shall be policies for personnel and visitor identification, visitor management, access procedures, and reporting of security incidents or breaches of security.

• 1.2 Degree of security shall be commensurate with the level of risk associated with the position, nature of work, type of assets dealt with.

• 1.3 There shall be a mechanism to verify and validate credentials, personal references, criminal history, psychological test, and indepth background information.

• Standard 2. There shall be an established personnel management procedure.

  • 2.1 The management shall define the roles, responsibilities and authority of laboratory personnel.
  • 2.2 A mechanism shall be developed to ensure the smooth flow of operations of the facility to include succession planning for management, scientific, technical and administrative personnel.

• Standard 3. There shall be appropriate identification requirements that will ensure only authorized personnel can access identified VBM.

  • 3.1 The management shall be provided with a list/directory of personnel who are authorized access to VBM.
  • 3.2 The facility administrators will develop a system of easily recognizable marks/codes on the identification tags/badges.
  • 3.3 Non-compliance of personnel with identification requirements shall be refused to enter in restricted areas.

• Standard 4. The management shall provide incentives, morale and welfare (awards) for BSL-3 personnel.

  • 4.1 The plan shall include provision of capacity building, medical, financial and legal assistance.
  • 4.2 Personnel considered to have a significant risk of exposure shall be identified and their healthcare needs assessed and managed.

SECTION

E

INFORMATION AND NETWORK SECURITY

Introduction

Information security, also known as cybersecurity or data security, is another component of a laboratory biosecurity plan. The objective of an information security program is to protect information from unauthorized release and ensure that the appropriate level of confidentiality is preserved. It is critical to the security of laboratory equipment and materials. Loss of data and computer systems from sabotage, viruses, or other means can be harmful to the laboratory. Policies should be established for handling sensitive information associated with the biosecurity program.

"Sensitive information" relates to the security of pathogens and toxins, or other critical infrastructure information. Sensitive information may also include personnel names, identifying information, and any Personally Identifiable Information on patients or the origin of samples held by the laboratory. Examples of sensitive information may include facility security plans, access control codes, agent inventories and storage locations.

Facilities should develop policies that govern the identification, marking and handling of sensitive information. The information security program should be tailored to meet the needs of the business environment, support the mission of the organization, and mitigate the identified threats. It is critical that access to sensitive information be controlled.

• Standard 1. There shall be policies on properly securing sensitive information, including electronic files and removable electronic media, that govern the identification, making and handling of sensitive information (e.g., CDs, computer drives, etc.).

  • 1.1 The policies shall ensure that the required and appropriate level of confidentiality is observed and maintained.
  • 1.2 The policies shall effectively prevent unauthorized acquisition and release of sensitive information.

• 1.3 The policies shall cover laboratory security plans, inventories, and storage locations of VBM.

• 1.4 Facilities shall develop policies that govern the identification, marking and handling of sensitive information.

• Standard 2. There shall be an appropriate system to acquire, store, handle and manage information in the laboratory.

  • 2.1 The system shall include documentation and accurate description of VBM.
  • 2.2 The documentation process shall be confidential, but available and useful to future generations. Accessibility to confidential documents and information shall be well-defined and controlled, as security concerns change over time.
  • 2.3 Documentation shall be updated as necessary.
  • 2.4 Protection of information shall be consistent with the level of risk it poses in terms of potentially compromising a VBM.

• Standard 3. There shall be policies on marking and handling of information.

  • 3.1 There shall be a system of coding, marking and storage, as well as a process to secure and control the manner of disseminating information.
  • 3.2 Codes or symbols, marking and storage labels shall be complete, visible, and easily understood by concerned persons.

Standard 4. There shall be a policy on network security.

• 4.1 A plan of action on network security shall be developed and implemented.
• 4.2 Manner of checking on network policies shall be conducted periodically.
• 4.3 The corresponding sanctions on specific violations shall be formulated.

SECTION

F

MATERIAL CONTROL, ACCOUNTABILITY AND INVENTORY

Introduction

The material control and accountability (MC&A) component of laboratory biosecurity addresses an insider threat. It is a measure to protect legitimate stocks of dangerous pathogens and toxins from being acquired by individuals with malicious intent. MC&A directly involves the personnel who work with pathogens and toxins that could be attractive to bioterrorists. Control of material comprises both procedural and physical measures for both material and MC&A-relevant information. Accountability requires a one-to-one correspondence between materials and people, together with a system of records, reporting and audit. Key elements of MC&A should be understood intellectually, rather than being applied simply as a prescriptive list of security measures. MC&A measures reflect an additional stewardship responsibility that technical people accept in working with material that could harm others if used improperly.

If applied correctly, the MC&A component of laboratory biosecurity can help mitigate the insider threat. The possibility of malicious intent, however small, does exist. The object of MC&A measures is to create an environment that discourages such misbehavior. MC&A seeks to establish practices and culture that systematically prevent and deter misuse scenarios, rather than relying exclusively on individual ethics and behavior.

• Standard 1. There shall be an established system of material control, accountability and inventory of VBM.

  • 1.1 There shall be an established procedure to document, control and maintain an accurate and updated inventory of toxins, agents in long storage, and other VBM used in researches or experiment in progress.
  • 1.2 There shall be inventory and records of VBM location, quantity, manner of use or manipulation, storage, internal and external transfer, further distribution, and destruction methods.

• 1.3 There shall be a simple and user-friendly inventory system with restricted and limited access to laboratory notebooks or computer software, preferably with an appropriate bar coding system.

• 1.4 There shall be an established procedure to maintain accurate and updated record of authorization for entry into limited access areas. It will include a current list of persons who possess door/electronic keys, and those who have knowledge of keypad access numbers or the security system.

• 1.5 There shall be internal and/or external audits conducted routinely or randomly to verify the stocks of VBM.

• Standard 2. There shall be documentation for Material Control and Accountability (MC&A) procedures.

  • 2.1 Information shall be required to characterize and classify the materials into Low Risk Pathogen and Toxin (LRPT), Moderate Risk Pathogen and Toxin (MRPT), High Risk Pathogen and Toxin (HRPT), Extreme Risk Pathogen and Toxin (ERPT).
  • 2.2 Information shall include the agent/strain's possible origin, date acquired, source history, quantity, various measure data, and other relevant information.
  • 2.3 Inventory list of materials shall be submitted to the National Registry of Pathogens at the Research Institute for Tropical Medicine (RITM) - Department of Health (DOH).
  • 2.4 Written report of the abovementioned shall be submitted by the principal investigator or researcher to the head of the facility who will then review, summarize, and submit the report to the DOH.

• Standard 3. There shall be control implementation to ensure that material will be stored, or in case of transport, delivered, where it is intended and used for the stated purpose by the authorized person.

  • 3.1 There shall be an engineered or physical control of preventing unauthorized access such as locking of a freezer, strengthening of network security system, or using an interlock that requires a laboratory be kept of all operations.
  • 3.2 There shall be an effective monitoring system for both normal and abnormal control conditions. Normal conditions are material

storage used in typical day-to-day conditions, including changes, creation, modification or destruction of materials. Abnormal conditions are inventory discrepancies (e.g. something appears to be missing, something was not booked right, a freezer left unlocked, occurrence of anomalies or accidents, etc.).

Standard 4. There shall be restricted areas where materials shall be stored and used in a routine manner.

• 4.1 There shall be a designated area where inventory of pathogens and toxins are identified.
• 4.2 There shall be established procedures at each location to deactivate and dispose of materials.
• 4.3 There shall be periodic inventory of agents/strains including inventory of the dates, methods of disposition of materials, and records retained for archiving purposes.
• 4.4 Historical records shall be kept for dangerous pathogens and toxins for at least ten (10) years after the date of final disposition.

Standard 5. There shall be accountability measures for restricted information and materials.

• 5.1 There shall be a designated point person knowledgeable on the restricted pathogens/control materials, their uses and storage.
• 5.2 The designated point person shall be in charge of accountability/discrepancy of book inventories and facility inventory of repository materials, and shall be responsible for submission of the inventory to RITM-DOH.
• 5.3 The management shall designate a point person who is knowledgeable and responsible for the security of materials under his or her control.

SECTION

MATERIAL TRANSFER AND TRANSPORT SECURITY

Introduction

Material transport policies should include accountability measures for the movement of materials within an institution (e.g. between laboratories, during shipping and receiving activities, etc.) and outside of the facility (e.g. between institutions or locations). Transport policies should address the need for appropriate documentation and material accountability and control procedures for pathogens in transit between locations. Transport security measures should be instituted to ensure that appropriate authorizations have been received, and that adequate communication between facilities has occurred before, during and after the transport of pathogens or other potentially hazardous biological materials. Personnel should be adequately trained and familiar with regulatory and institutional procedures for proper containment, packaging, labeling, documentation and transport of biological materials.

Transport of toxic and potentially infectious materials are subject to strict national and international regulations. These regulations describe the proper ways of transporting, as well as requirements in shipping. These requirements will protect VBM or high-consequence microbial agents and toxins, or critical relevant information from loss, theft, and release of intentional misuse.

• Standard 1. There shall be an adequate document scheme in classifying VBM for transport security.

  • 1.1 Classifications of VBM shall be in accordance to existing national and international guidelines.
  • 1.2 The classification scheme of VBM shall be kept complete, updated, and available/accessible to authorized personnel/staff.

• Standard 2. There shall be a documented chain of custody during pre-transport, transport, in-transit, en-route, and receipt of VBM.

  • 2.1 There shall be a well-defined system for material transport within and outside the laboratory/institution premises.

• 2.2 A material transfer agreement between the sender and the recipient shall be formulated, implemented and monitored.

• Standard 3. There shall be documented control procedures and records during transit between locations of VBM, and when they are moving around the protected areas within a facility.

  • 3.1 Institutional policies in the transport of VBM shall comply with existing national and international codes.
  • 3.2 For pathogen transport, documents such as transport permit, import/export permit, shipping and authorization forms shall be secured.

• Standard 4. There shall be an authorized person (qualified, reliable, competent, and trustworthy), who shall handle the packaging, labeling and controlling access to transport facilities, docks and vehicles.

  • 4.1 The person who handles the packaging for transport has appropriate written permit to become authorized to transport the VBM.
  • 4.2 All designated and authorized personnel within the chain of custody of VBM shall have adequate education, training and updates on Material Transfer Security.

• Standard 5. There shall be a system for tracking the shipping progress to ensure security of the package.

  • 5.1 There shall be adequate documentation and communication between facilities before and during the shipping of the package.

• Standard 6. There shall be a contingency plan, in case of untoward incidents in relation to the transport/transfer of VBM within and outside the facility.

  • 6.1 The contingency plan shall be comprehensive, fast, feasible, and properly coordinated.

• Standard 7. There shall be a provision in the regulatory framework applying to the exchange and supply of microorganisms, biological agents and toxins classified as VBM.

  • 7.1 There shall be an export control system on VBM, which may also be relevant in (or responsive to) issues related to "Bioprospecting,

Dual-use dilemma," and in accordance with Republic Act No. 10697, also known as Strategic Trade Management Act (An act preventing the proliferation of weapons of mass destruction by managing the trade in strategic goods, the provision of related services, and for other purposes), and other related export control regulation and initiatives.

• 7.2 Documents for export permits area shall be available and secured by transporting personnel.
• 7.3 Export permits shall bear distinct markings/seals and signatures for added security.
• 7.4 The importation of VBM shall comply with existing national and international laws and regulations.

SECTION

BIOSECURITY RESPONSE

Introduction

Incident reporting and response plan must be in place to ensure rapid response to any untoward event. Laboratory security policies shall consider situations that may require public safety personnel to enter the facility in response to an accident injury or other safety issues or security threats. The preservation of human life, the safety and health of laboratory employees and the surrounding community must take precedence in an emergency over biosecurity concerns.

• Standard 1. There shall be an established Biosecurity Response Team in each institution.

  • 1.1 The team shall be properly trained and equipped to handle emergencies.
  • 1.2 The team shall manage and guide the institutional responders to emergencies associated with VBM.
  • 1.3 The team in coordination with other government agencies shall establish public health and agriculture surveillance and reporting system with respect to VBM.
  • 1.4 The team shall ensure effectiveness of public emergency risk communication.

• Standard 2. The institution shall comply with local and/or national requirements needed in the agencies concerning the establishment/operation, evaluation and monitoring of the Pathogen Emergency Response System (PERS).

  • 2.1 The PERS shall be based on biosecurity risk assessment.
  • 2.2 Restricted and controlled areas shall be identified and provided.
  • 2.3 There shall be a monitoring and access of alarms by electronic intrusion detection system.

• Standard 3. There shall be an established system of coordination with the medical team, fire, police and other emergency officials when preparing emergency and security breach response plans.

  • 3.1 Laboratory emergency response plans shall be integrated with relevant facility-wide or site-specific security plans.
  • 3.2 The plans shall also consider adverse events, such as bomb threats, natural and deliberate outbreaks/disasters and severe weather, power outages, and other facility emergencies, that may introduce security threats.
  • 3.3 There shall be a plan for identification and countering potential adversaries.
  • 3.4 The system shall include chain of command both inside and outside the facility (i.e. emergency response personnel, local law enforcement, etc.)
  • 3.5 Monitoring, review, evaluation of emergency response plan and systems shall be performed periodically to serve as basis for continual improvement.

SECTION

I

BIOSECURITY UPDATES AND RE-EVALUATION

Introduction

The Biosecurity Management Program (BMP), headed by the BSO and external partners from concerned stakeholders of the institution, shall develop and conduct program audits to ensure that the policies and procedures are properly implemented, and the biosecurity measures in place are still relevant and applicable. Likewise, the Biosecurity Risk Assessment and Program should be reviewed, revised and updated routinely, and any biosecurity-related incidents should be followed up.

• Standard 1. There shall be an audit/evaluation design to accurately identify deficiencies, irregularities or potential concerns in the established and existing biosecurity program.

  • 1.1 Performance survey shall be conducted to reflect the stakeholders' expectations/reactions on the existing biosecurity system, and to make recommendations if changes or improvements have to be instituted.
  • 1.2 Audit and re-evaluation/audit results shall be properly documented.
  • 1.3 Regular coordination and meetings shall be conducted with the DOH biosecurity inspection officials/inspectors to discuss the findings.

• Standard 2. There shall be a provision for the regular periodic review, audit and revision of the biosecurity program to include procedures and the efficacy of security equipment.

  • 2.1 The BSO formulates a plan for the effective audit and reevaluation of the program.
  • 2.2 The audit and re-evaluation plan also cover measures for physical, personnel, transport, information/data security, and material control.

• 2.3 The audit and re-evaluation plan shall include the review of security measures, standard operating procedures, incident response plans, and regulation on the use, possession and transfer of VBM.

• 2.4 The institution's risk status and security objectives shall be reviewed regularly, including the risk statement and risk assessment processes.

• Standard 3. There shall be possible action to address the audits and re-evaluation findings/results.

  • 3.1 The BSO Officer develops a plan of action/corrective measures for each type or nature of problem identified.
  • 3.2 The appropriateness/applicability of the course of action approved by the management shall be discussed by the BSO with the appropriate government personnel.
  • 3.3 Any updates (e.g., those published in journals, or presented in conferences), improvements, or modifications in the biosecurity program shall be appropriately monitored and communicated to personnel concerned.
  • 3.4 Facility management shall be responsive to concerns raised by its employees.

SECTION

J

REPORTING AND COMMUNICATION

Introduction

Reporting and communication are important aspects of a biosecurity program. A "chain-of-notification" shall be established in advance of an actual event. This chain shall include laboratory officials, institution management, and any relevant regulatory or public authorities.

Sub-Section 1. Reporting

• Standard 1. There shall be an established system of reporting on all biosecurity activities.
  • 1.1 All laboratory facilities shall submit inventory list of VBM and names of personnel handling dangerous and unknown pathogens and toxins to the Research Institute for Tropical Medicine (RITM).
  • 1.2 Reports for disclosure information shall be classified as highly confidential and sensitive data.
• Standard 2. There shall be policies on reporting security breaches (e.g. missing biological agents, unusual or threatening phone calls, unauthorized personnel in restricted areas, etc.).
  • 2.1 The laboratory shall notify the BSO when a security breach occurs, and a written incident report shall be submitted to the management.
• Standard 3. There shall be coordination between government health authorities, institution investigators and biosecurity personnel.
  • 3.1 The head of institution shall notify the local government and concerned health agencies on notifiable diseases.
  • 3.2 An effective surveillance and timely response for illnesses suspected to be laboratory-acquired shall be in place.

3.3 Investigations of laboratory-acquired illnesses shall be made, and its findings and recommendations shall be reported.

Sub-Section 2. Communication

• Standard 1. There shall be prompt and accurate communication and public awareness-raising on the deleterious effects of pathogens and reportable disease incidents, as such situations arise.
  • 1.1 The general public shall be properly informed about potential pathogens in order to promote and maintain public trust, and reduce suspicion, fear and anxiety. Information shall include names of pathogens, signs and symptoms of diseases, risks to human health, and contact points for further information.
  • 1.2 There shall be designated person/s in charge of making statements and advisories, building talking points, addressing questions, and issuing/providing fact sheets and other relevant information materials related to the situation through tri-media.

SECTION

TRAINING AND PRACTICE DRILLS

Introduction

Training and practice drills are essential for the successful implementation of the biosecurity program. Discussion of the roles, responsibilities and authorities of staff, including maintenance and cleaning personnel, external first responders, and other responsible staff involved in ensuring the security of the laboratory facility shall be included in the training program. The training shall help the staff understand the need to protect VBM, equipment, and documents, the rationale for the laboratory biosecurity measures being adopted, and the relevant national policies and institutionspecific procedures. Protocols and guidelines to be implemented in the event of emergencies and security breaches shall also be part of the training design.

Sub-Section K.1. Training

Standard 1. There shall be a comprehensive Biosecurity Training Program.

• 1.1 The Biosecurity Officer shall have a Training Team responsible for the management of the training program.
• 1.2 A Training Development Needs Analysis (TDNA) shall be conducted to guide the Training Officer in the preparation of the training design.
• 1.3 Assessment of the training needs of the staff either through interviews or use of questionnaires/ tools shall be conducted prior to the development of the training design.

Standard 2. A comprehensive Biosecurity Training Module shall be developed.

2.1 All employees shall be required to have annual comprehensive training that would address topics like statutory laboratory biosecurity requirements, physical security measures, personnel management measures, information security measures, laboratory biosecurity incident reporting, laboratory biosecurity violations, and media or public requests.

• 2.2 All supervisors shall have annual supervisory training that covers training, reporting responsibility, monitoring the physical and mental health of personnel handling dangerous pathogens, and managing property. Supervisory training shall also include the conduct of background checks on staff and personnel.
• 2.3 Selected personnel shall have annual Biosecurity Response Training that develops and maintains competencies needed to perform effectively, and fulfill efficiently the required tasks at onsite response force missions.
• Standard 3. There shall be periodic review and evaluation of the training program to ensure its effectiveness.
  • 3.1 The level of knowledge and skills gained from the training shall be assessed through written evaluation or actual demonstration.
  • 3.2 Interventions such as retraining shall be instituted to supplement or correct deficiencies found in the assessment.

Sub-Section K.2. Practicum/Practice Drills

• Standard 1. Biosecurity practice drills and exercises shall assess the participants' effectiveness of the training program. Strengthening teamwork shall be one of the objectives of the practice drills.
  • 1.1 Trained staff and personnel, including external partners (police, fire, brigade, and medical emergency staff) shall participate in practice drills.
  • 1.2 Proper documentation of the assessment of the performance of the trained staff and personnel in the practice drills shall be the basis for maintaining or revising the training design.
  • 1.3 Practice drills shall address a variety of scenarios, such as, loss or theft of materials, emergency response to accidents and injuries, natural disasters, incident reporting and identification of and response to security threats.

Sub-Section K.3. Awareness-raising

Standard 1. There shall be a program on topics in biosafety and biosecurity intended for schools, universities and other institutions.

• 1.1 Biosafety and biosecurity in the school curriculum shall be introduced to concerned stakeholders.
• 1.2 The conduct of forums, symposia and workshops shall be encouraged to increase public awareness on biosafety and biosecurity.
• Standard 2. An awareness/advocacy-raising campaign for specific target audience shall be conducted in light of the possible implications of researches and studies related to biosafety and biosecurity.
  • 2.1 Proper coordination or networking with other agencies or institutions shall be done for possible funding and other resources for the campaign.

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