BIOSAFETY, BIOSECURITY AND BIORISK MANAGEMENT TRAINING | MODULE 1.

International and Local Policies, Guidelines and Standards

Biorisk Management Academy | 18 April 2024

OUTLINE → Laboratory Biosecurity Program and Training

I. Main Heading E. Appendix
A. Subheading F. Footer D. BIOSAFETY IN MICROBIOLOGICAL AND
B. Subheading Font G. Summary of Font BIOMEDICAL LABORATORIES (BMBL) 6TH ED
and Sub-subheading Size ● Serves as
II. Content Formatting III. Review Questions ● The core principle of the BMBL is a protocol-driven risk
A. General Formatting IV. APA Format (7th ed) assessment. It is recommended to use thos document as
B. Figure V. References a tool in the post medication steps in biomedical and
C. Tables clinical laboratories.
D. Important/Nice To
Know Information E. ISO BIORISK MANAGEMENT FOR LABORATORIES
LEARNING OBJECTIVES AND OTHER RELATED ORGANIZATIONS
● ISO 35001: 2019
✔ Identify the international guidelines and standards on ● A document that defines the process to identify, assess,
biosafety; and and monitor the risk associated with hazardous biological
✔ Identify local guideline and standards on biosafety. materials. It is intended to complement the international
standards for laboratories.
I. INTERNATIONAL GUIDELINES AND STANDARDS
A. THE GLOBAL CHALLENGE F. FOOD AGRICULTURE ORGANIZATION
● Global challenges are made up of 15 questions that BIOSECURITY TOOLKIT
provide a framework to assess the global prospects of ●
humanity. ● FAO Biosecurity toolkit is divided into 3 parts
● Global challenges are transnational in nature, → Biosecurity principles and components
transinstitutional in solution. → Guide to assess biosecurity capacity
● “How can the threat of new and reemerging diseases and → An overview and framework ….
immune microorganisms be reduced?” is the 8th of the 15
questions directed towards the implementation and
programs of biorisk, biosafety and biosecurity G. CARTAGENA PROTOCOL ON BIOSAFETY
management. ● Intend to contribute in ensuring an adequate level of
● Identification of needs and gaps, and recommendations to protection in the field of the safe transfer, handling, and use
optimize biosafety, biosecurity, oversight, and Inventory of living modified organisms resulting from modern
Management and Control are essential key points to foster biotechnology that may have adverse effects on the
the development and sustain the culture of biosafety and conservation and sustainable use of biological diversity.
biosecurity culture in the Philippines and beyond our → focusing on transboundary movements.
borders. ● In the UN Security Council Resolution 1540 (2004), the
council decided that all states shall refrain from
B. WHO LABORATORY BIOSAFETY MANUAL providing any form of support to non-state actors that
● encourage countries to accept and implement the basic attempt to develop, acquire, manufacture, possess,
concepts in biosafety and to develop national cultive transport, transfer, or use nuclear, chemical or biological
practice for the safe handling of biological agents in weapons and their means of delivery, in particular, for
laboratory facilities within their geographical borders. terrorist purposes.
● First edition was published in 1983. →
● 4th edition focuses on risk and evidence-based approach
allowing facilities safety practices and safety equipment be
locally available and relevant. II. LOCAL/ NATIONAL POLICIES, GUIDELINES AND
● But, the actual risk is influenced by many factors: STANDARDS
→ the infectious agent A.
→ the procedure ● During the term of Cory Aquino, the National Committee on
→ the staff and their experience Biosafety was developed.
C. LABORATORY BIOSECURITY GUIDANCE ● Executive Order 514 (2006)
● Aims to expand the biosecurity concepts introduced in the → established the national biosecurity framework,
WHO lab biosafety manual 3rd edition balancing the long prescribing guidelines for its implementation,
known biosafety procedures and practices and the recently strengthening the national committee on biosafety of the
introduced biosecurity concepts. Philippines, and for other purposes.
● Composed of 7 major parts: ● aims to strengthen the science based .. biosafety to ensure
→ Introduction to Biosecurity the safe and responsible use of modern biotechnology and
→ Biosecurity as a compliment to laboratory biosafety enhance the decision making system ..
→ Biorisk management approach ● Executive Order 430 of 1990
→ Biorisk management → constituted the National Committee on Biosafety of
→ Countering Biorisk the Philippines (NCBP)

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 → NCBP is the lead body to coordinate interagency in ● Licensure of COVID-19 testing laboratories performing
multisectoral effort to develop biosafety policies in the NAAT
country where such are not yet stipulated by law and
said scientific and technical procedural standards and
actions by agencies and other sectors to promote
biosafety in the Philippines.
→ The NCBP are composed of competent national
authorities and associated department and agencies:
▪ DOST - secretariat
▪ DOA
▪ DENR
▪ DOH
▪ DFA
▪ DTI
▪ National Commission on Indigenous Peoples
▪ DILG
●
PHILIPPINE BIOSAFETY GUIDELINES 1991
● covers genetic engineering, and activities requiring the
importation, introduction, field release and breeding of non
indigenous or exotic organisms even though these are not
genetically modified.
● its contents include the organizational structure for
biosafety; procedures for evaluations of proposals with
biosafety concerns; procedures and guidelines on the
introduction, movement and field release of regulated
materials and physico-chemical and biological containment
and procedures.
DOH LABORATORY BIOSAFETY AND BIOSECURITY
STANDARDS
● aims to provide specific biorisk principle and practices that
are applicable to the Philippines.
● Local Health Authority
→ The DOH through the Health Facility Services
Regulatory Buereau (HFSRB) released guidelines and
rules regulating COVID-19 testing laboratories and
Clinical Laboratories in the Philippines.
→ These essential components of biorisk management
are required to obtain a license to operate.

REPUBLIC ACT NO. 4688 (1966)

● The Clinical Laboratory Law of the Philippines
→ act regulating the operation and maintenance of clinical
laboratories and requiring the registration of the same
with the Department of Health, providing penalty for the
violation thereof, and for other purposes.
DOH AO No. 2021 - 0037
● The New rules and regulations governing the
regulation of Clinical Laboratories in the Philippines
→ RA 1123 - Universal Healthcare Act
→ Policy on guidelines on laboratory biosafety and biosecurity,
Section E under Physical Plant, “there shall be policy guidelines
on laboratory biosafety and biosecurity which includes risk
assessment that will serve as the basis of biosafety level
required for the specific clinical laboratory”
→ Section B: Lead or head (CMT)
→ Section E of part VIII: emphasizes need for policy for biosafety
and biosecurity.

DOH AO No. 2020 - 0014

● LTO for COVID - 19 Testing Laboratory
● 0014 - A (May 20, 2020)
● 0014 - B (September 8, 2020)
DOH AO No. 2023 - 0004

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