This guidance document “Guidelines for the Establishment of Containment

Facilities: Biosafety Level 2 (BSL-2) & 3 (BSL-3) and Certification of BSL-3

facility” with subsequent additional information on technical standards for
engineering controls, major tests to be conducted during installation, and
methodology for validation of BSL-3 facility, after detailed deliberations from the
experts was approved in the 184th and 191st meetings of the Review Committee
on Genetic Manipulation (RCGM) held on 04th June 2020 and 15th October
2020, respectively.

It is important to mention that while the guidelines notified here provide

specifications for BSL-2 facility, those for the BSL-3 facility are essential
components of compliance required for the Certification of the BSL-3 facility.
 CONTENTS

ABBREVIATIONS

INTRODUCTION 1

CHAPTER 1: PRINCIPLE AND COMPONENTS OF CONTAINMENT 4-5

1.1. PRINCIPLE 5
1.2. CONTAINMENT 6
1.3. FACTORS IN CONTAINMENT 6

CHAPTER 2: ESTABLISHMENT OF BIOSAFETY LEVEL 2(BSL-2)FACILITY

12-13
2.1. Laboratory design and facilities 14
2.2. Procedures 18
2.3. Laboratory Monitoring 19
2.4. Health and Medical Surveillance 19
2.5. Emergency Procedures 20
2.6. Fire Safety 20

CHAPTER 3: ESTABLISHMENT AND CERTIFICATION OF BIOSAFETY

LEVEL 3 (BSL-3)FACILITY 22-23
3.1. Code of practice 24
3.2. Laboratory design and facilities 25
3.3. Laboratory equipment 26
3.4. Procedures 27
3.5. Laboratory Monitoring & Information network 27
3.6. Health and medical surveillance 28
3.7. Emergency Procedures 28
3.8. Fire and Natural Disasters 30
3.9. Statutory approvals 31
3.10. Testing, Commissioning and Validation of facility 31

ANNEXURE
Annexure I: Technical standards for Engineering controls for the BSL-3 laboratory
33
Annexure II: Essential tests during the installation of BSL-3 laboratory 47
Annexure III: Validation procedure for BSL-3 laboratory 51
Annexure IV: Standard Operating Procedures (SOPs) for specific considerations for
working in the BSL-3 facility 56
Annexure V: Certification of BSL-3 Facility 62
GLOSSARY 71

REFERENCES 73

ACKNOWLEDGEMENTS 74
 ABBREVIATIONS

ACH Air Changes per Hour

ACR Air Change Rates
BAS Building Automation System
BMS Building Management System
BC Biological Containment
BIBO Bag-In-Bag-Out
BSC Biosafety Cabinet
BSL Biosafety Level
CCTV Closed-Circuit TeleVision
CDC Centers for Disease Control and Prevention
CPCB Central Pollution Control Board
DBT Department Of Biotechnology
DDC Direct Digital Control
DG Diesel Generator
DLC District Level Committee
DST Department Of Science & Technology
ECBC Energy Conservation Building Code
EPA Environment (Protection) Act
ETP Effluent Treatment Plant
GE Genetically Engineered
GEAC Genetic Engineering Appraisal Committee
HEPA High Efficiency Particulate Air
HVAC Heating, Ventilation and Air Conditioning
IATA International Air Transport Association
IBSC Institutional Biosafety Committee
ICAR Indian Council Of Agricultural Research
ICMR Indian Council Of Medical Research
ISO/IEC 17025 Accreditation based on standards entitled "general requirements for
the competence of testing and calibration laboratories", published
by the International Organization for Standardization
LAN Local Area Network
MoEF&CC Ministry Of Environment, Forest and Climate Change
NSF/ ANSI 49 American National Standard, which apply to Class II Biosafety
Cabinets
PLC Programmable Logic Controller
PPE Personal Protective Equipment
RCGM Review Committee On Genetic Manipulation
RDAC Recombinant DNA Advisory Committee
rDNA Recombinant DNA
RG Risk Group
SBCC State Biotechnology Coordination Committee
SOP Standard Operating Procedures
SS-304 Stainless Steel - Grade 304 (Standard "18/8")
ULPA Ultra Low Particulate Air
UPS Uninterrupted Power Supply
WHO World Health Organization
 INTRODUCTION

Globally, biotechnology applications have seen a phenomenal advancement over the last
few decades. Accordingly, biosafety and biosecurity practices pertaining to the safe
handling and containment of infectious pathogens, emerging and re-emerging
microorganisms along with hazardous biological materials are of utmost concern, as
inadvertent or deliberate usage in addition to laboratory associated infections may have
fatal consequences. This necessitates the institution of code of conduct, ethics and
biosafety practices and adherence to globally harmonized regulations and guidelines,
ultimately for ensuring the protection of public health and the environment.

In India, all activities related to Genetically Engineered organisms (GE organisms) or

cells and hazardous microorganisms and products thereof are regulated as per the
“Manufacture, Use/Import/Export and Storage of Hazardous Microorganisms/
Genetically Engineered Organisms or Cells, Rules, 1989” (Rules, 1989) notified by the
Ministry of Environment, Forest and Climate Change (MoEF & CC), Government of
India under the Environment (Protection) Act, 1986 (EPA 1986). The Six Competent
Authorities and their mandate & functions as defined under Rules, 1989 are:
Competent Authorities Mandate & Functions
Recombinant DNA The RDAC functions in the Department of Biotechnology
Advisory Committee (DBT) and reviews developments in biotechnology at
national and international levels and recommends suitable
(RDAC)
and appropriate safety regulations for India in recombinant
research, use and applications from time to time.
Institutional Biosafety The IBSC is constituted by an occupier or any person
Committee including research institutions, handling hazardous
microorganisms/genetically engineered organism(s) [at
(IBSC)
Research & Development (R&D) level]. The occupier or
any person including research institutions prepares, with the
assistance of the IBSC, an up-to-date on the site emergency
plan according to the manuals/guidelines of the RCGM and
makes available copies to the DLC/SBCC and
RCGM/GEAC.
Review Committee on RCGM functions in the DBT to monitor the safety-related
Genetic aspects in respect of on-going research projects and
Manipulation(RCGM) activities involving genetically engineered
organisms/hazardous microorganisms. RCGM brings out
Manuals of Guidelines specifying the procedure for
regulatory process with respect to activities involving
genetically engineered organisms in research use and
applications including industry with a view to ensure
environmental safety. All ongoing projects involving high
risk category and controlled field experiments need to be
reviewed to ensure that adequate precautions and
containment conditions are followed as per the guidelines.

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