Biosafety & Biosecurity: What Researchers need to know

Dr. Venugopal BalakrishnanRegistered Biorisk Professional, Malaysia

IFBA, Registered Biorisk Professional

W e l e a dBiosafety definition

• All measures that prevent accidentallyexposure at biological agents (micro-organisms and toxins) and infections andtheir released in environment

See WHO Biosafety manual

biological agent (adapted from EU Directive 2000/54/EC)any microorganism including those which have been genetically modified,cell cultures and endoparasites, which may be able to provoke anyinfection, allergy or toxicity in humans, animals or plants

W e l e a dWHAT ARE THE CONCERNS?

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IMPACT TO ENVIRONMENTPotential to infect/ colonise animals and plantsInfect invertebrates/ vertebrate or domestic animals with economic importanceHigh survival and disseminate in environmentEtc.

IMPACT TO HUMAN HEALTHAllergenicityToxicityPathogenicityPossible alteration of route of infectionPossible survival outside of hostAntibiotic resistance Etc.

W e l e a dLABORATORY HAZARDS

• Biologicals• Animals • Chemicals• Radiation• Physical

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EXPOSURE TO LABORATORY HAZARDS

• Absorption• Ingestion• Inhalation• Injection

W e l e a dLABORATORY ACCIDENTS

HUMAN FACTOR• Lack of training, knowledge, or experience• Carelessness (not vigilant)• Fatigue• Taking short cuts• Not enough time; working too fast• Decided NOT to follow safe practices• Do not believe it’s hazardous

W e l e a dLABORATORY ACCIDENTS

OTHER CAUSES• Equipment/Systems failure• Inaccurate risk assessment

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Bacterial:76% from clinical labs8% from research labs

Exposure:60% acquired from inhalation

Other exposures include:digestion, sharps, splashes, direct and indirect contact

Laboratory Acquired Infections (LAI)

W e l e a dLaboratory acquired infection (LAI)

Viral• 16% from clinical labs • 70% from research labs

– 32% from animal related activities

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Protection, control and accountability forvaluable biological materials withinlaboratories, in order to prevent theirunauthorized access, loss, theft, misuse,diversion or intentional release

BIOSECURITY

W e l e a dBioterrorism in World

• In 1972 police in Chicago arrested two college students, Allen Schwander and Stephen Pera, who had planned to poison the city's water supply with typhoid and other bacteria. Schwander had founded a terrorist group, "R.I.S.E.", while Pera collected and grew cultures from the hospital where he worked

W e l e a dBioterrorism in World

• 1984 Rajneeshee bioterror attack• Oregon in 1984, followers of the Bhagwan Shree Rajneesh

attempted to control a local election by incapacitating the local population.

• This was done by infecting salad bars in 11 restaurants, produce in grocery stores, doorknobs, and other public domains with Salmonella typhimurium bacteria in the city of The Dalles, Oregon.

• The attack infected 751 people with severe food poisoning. There were no fatalities. This incident was the first known bioterrorist attack in the United States in the 20th century

W e l e a dBioterrorism in World

• Aum Shinrikyo anthrax release in Kameido, Japan.• In June 1993 the religious group Aum Shinrikyo released

anthrax in Tokyo. • Eyewitnesses reported a foul odor. The attack was a total

failure, infecting not a single person. • The reason for this, ironically, is that the group used the

vaccine strain of the bacterium. • The spores recovered from the attack showed that they were

identical to an anthrax vaccine strain given to animals at the time.

• These vaccine strains are missing the genes that cause a symptomatic response

W e l e a dBioterrorism in World

• In September and October 2001, several cases of anthrax broke out in the United States in the 2001 anthrax attacks.

• Letters laced with infectious anthrax were concurrently delivered to news media offices and the U.S Congress.

• The letters killed 5

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• 1g of botulinium can kill more than 100,000 people in 1KM radius.

• Most effective – botulinium• Most popular - Slamonella

W e l e a dBioterrorism in Malaysia

• Yazid Sufaat (born 20 January 1964 , in Johor) is a Malaysian member of the Islamist terrorist organisationJemaah Islamiyah from shortly after its foundation in 1993 until his arrest by Malaysian authorities in 2001.

• He graduated from California State University, Sacramento with a degree in biochemistry

• He then served in the Malaysian army as a medical technician, rising to the rank of Captain

• In 1993 Sufaat set up a pathology laboratory called Green Laboratory Medicine, at which he subsequently tried to weaponries anthrax on behalf of al-Qaeda.

• Released in 2008, he was again detained on terrorist charges in Malaysia in 2013.

W e l e a dPotential Bioterrorism

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LAWS INVOLVED IN BIOSAFETY

• BWTC DRAFT BILL, 2015• Strategic Trade Act 2010 (Act 708,2010)• Malaysian Quarantine and Inspection Services (MAQIS),Act 2011• Prevention and Control of Infectious Diseases Act (Act No. 342,

1988), Regulations 2006• Plant Quarantine Act (Act No.167,1976)• Biosafety Act (Act No.678, 2007)• Occupational Health and Safety Act (Act No. 514, 1994)• Destruction of Disease-Bearing Insects Act (Act No.154,1975)• Postal Services Act 2012 (Act No.741,2012)• Postal Services Act 1991(Act 465,1991)

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LAWS INVOLVED IN BIOSAFETY

• Emergency (Public Order and Prevention of Crime)Ordinance,1969• Emergency (Essential Powers) Act (Act No. 216,1979)• Public Order (Preservation) Act (Act No.296, 1958)• Aviation Offences Act (Act No.307,1984)• Animals Act (Act No.647, 1953) Revision of Laws (Rectification of Animals Act

1953) • Animal Walfare Act 2015• Environmental Quality Act (Act No.127,1974)• Environmental Quality (Prescribed Premises) (Scheduled Wastes Treatment

and Disposal Facilities) Regulations 1989 (P.U.(A) 294/2005) (as amended)• Waters Act (Act No. 418, 1920)• Food Act (Act No.261, 1983)• Fisheries Act 1985 (Revision 2012)• Human Tissues Act 1974• Wildlife Conservation Act 2010• Protection of New Plant Varieties Act 2004

W e l e a dRegulations

International

• United Nation Security Council Resolution 1540• International Health Regulations (2005) IHR Core

Capacity Monitoring Framework: Questionnaire for Monitoring Progress in the Implementation of IHR Core Capacities in Capacities in States Parties 2011 Questionnaire

• IATA Dangerous Goods Regulations• United Nations COETDG Model Regulations

W e l e a dRegulations

Malaysia

• Biosafety Regulations 2010• Prevention and Control of Infectious Diseases Regulation 2006• OSH (Employers Safety and Health General Policy Statements) (Exception) Regulations 1995• OSH (Control of Industrial Major Accident Hazards) Regulations 1996-CIMAH• OSH (Safety and Health Committee) Regulations 1996-SHC• OSH (Classification, Packaging and Labelling of Hazardous Chemicals) Regulations 1997-CPL• OSH (Safety and Health Officer) Regulations 1997-SHO• OSH (Use and Standards of Exposure of Chemicals Hazardous to Health) Regulations 2000-

USECHH• Occupational Safety and Health (Notification of Accident, Dangerous Occurrence,

Occupational Poisoning and Occupational Disease) Regulations 2004 (P.U.(A) 128/2004

W e l e a dPOLICY

International• Convention on Biodiversity• Cartagena Protocol on Biosafety• 1925 Geneva Protocol• Biological Toxin and weapon Convention• WHO Laboratory Biosafety Manual, 3rd Edition, 2003• WHO Laboratory Biosecurity Guidance, 2006• Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, 2009 • The Laboratory Biosafety Guidelines, 3rd Edition, 2004, Health Canada.• Canadian Biosafety Standards and Guideline, 1st Edition, 2013Malaysia• Malaysia Laboratory Biosafety and Biosecurity Policy and Guideline 2015• National Biodiversity Policy• National Biotechnology Policy

W e l e a dSTANDARDS

International• Laboratory Biorisk Management CWA 15793:2011

(ISO 35001)• ISO 15189:2007-Medical Laboratories• ISO 15190:2003 – Medical Laboratories – Requirements for

safety• ASNI/ASSE Z9.14-2014

Malaysia• Malaysian Standard MS 1042-3:2015 (Safety in

Laboratories-Code of Practice-Part 3: Biosafety and biocontainment in microbiology laboratories (First revision)

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GUIDELINESInternational• Laboratory Biosecurity Guidance, World Health Organization, September 2006• Laboratory Biosafety Manual, Third Edition, World Health Organization, Geneva

2004, ISBN 92 4154650• Guidance on Regulations for the Transport of Infectious Substances 2007-2008,

World Health Organization, Applicable as from 1 January 2007 • Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition, U.S.

Department of Health and Human Services, Public health Service Centres for Disease Control and Prevention, National Instituted of Health, HHS Publication No. (CDC) 21-1112, Revised December 2009

• The Laboratory Biosafety Guidelines-Health Canada• NIH Guidelines for Research Involving Recombinant DNA Molecules• Biosafety risk assessment methodologies-Sandia Report• Tuberculosis Laboratory Biosafety Manual, World Health Organization 2012 Malaysia• Guidelines on the Handling and Management of Clinical Wastes in Malaysia,

Department of Environment, Ministry of Natural Resources & Environment, Third Edition August 2010

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1• Approval must be obtained from the

National Biosafety Board for any modernbiotechnology activities

2• IBC is responsible to monitor and ensure

compliance at the institutional level

3• Guidance and more information is

available at www.biosafety.nre.gov.my

WHAT DO YOU NEED TO KNOW ABOUT THE BIOSAFETY ACT?

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BIOSAFETY ACT 2007

• Complement the implementation of the National Policy on Biotechnology (2005) and also the National Policy on Biological Diversity (1998).

• Fulfill Malaysia’s obligation under the Cartegena Protocol on Biosafety (CPB) to have a domestic regulatory framework.

• Boost the confidence of investors in modern biotechnology

• Give a clear direction on regulatory framework on modern biotechnology.

• Not intended to disrupt R&D

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OBJECTIVE OF THE ACTTo establish the National Biosafety Board;

to regulate the release, importation, exportation and contained use of living

modified organisms (LMO*) & the release of products of such organisms, with the

objectives of protecting human, plant and animal health, the environment

and biological diversity

BIOSAFETY ACT 2007

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*The term LMO is used interchangeably with GMO

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SCOPE OF THE ACT

LIMITED TO MODERN

BIOTECHNOLOGY

RELEASE

IMPORT FOR RELEASE

EXPORT

CONTAINED USE

ALL INSTITUTES & PERSONS INVOLVED

ALL STAGES OF R&D

AND RELEASE

ALL TYPES OF ORGANISM

ALL ACTIVITIES

IMPORT FOR CONTAINED USE

LMOs

PRODUCTS OF LMOs

*rDNA*Direct

injection*Cell fusion

beyond taxonomic

family*Etc.

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SCOPE LIMITED TO MODERN BIOTECHNOLOGY

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Application of:(a) In vitro nucleic acid techniques,

including recombinant DNA and direct injection of the nucleic acid into cells or

organelles; or(b) Fusion of cells beyond taxonomic

family, that overcome natural physiological reproductive or recombination barriers

and that are not techniques used in traditional breeding and selections

MODERN BIOTECHNOLOGY

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W e l e a dMLBBPG

W e l e a dSCOPE of MLBBPG

• This document consists of the basic concepts and approaches in the form of policy and guidelines that govern all activities involving the handling, manipulation working, using, storing and disposing of infectious and potentially infectious agents/ materials and microbial toxins in all forms and sizes of laboratories in Malaysia. This document serves as a reference for the development and establishment of the respective institutional code of practice for good microbiological technique (GMT), biosafety and biosecurity in a laboratory and defined containment zone.

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• GUIDELINES FOR WORKING WITH INFECTIOUS AND POTENTIALLY INFECTIOUS AGENTS/MATERIALS AND MICROBIAL TOXINS - Administrative Control - Engineering Control- Standard Operating Procedure - Personal Protection Controls

• Laboratory Checklist

Thank you

Presented byVenugopal Balakrishnan | Institute for Research in Molecular Medicine