APPLICATION OF BIORISK MANAGEMENT FOR TRAINING AND RESEARCH ON ANIMALS

Abiodun A. Denloye, PhD, mesn, IFBA-CP, FSEAN

Dept of Zoology and Environmental BiologyLagos State University, Nigeria.

Thursday 16th February 2017www.denloye.com

www.slideshare.net/abiodundenloyetwitter@AbiodunDenloye

OUTLINE• What is Biorisk?• Meaning and Scope of Biosafety• Biosafety and Biosecurity• Working with Animals and Associated Risks• Biosafety Levels and Criteria• Where is LASU?• The Future is AMP: Laboratory Biorisk

Management. • Regulations - CWA15793 • Where do I Fit in as a Zoologist?

What is Biorisk?Risk associated with biological materials.

Biorisk = Biosafety + Biosecurity Risks

Slide 3

Meaning and Scope of Biosafety • (1) Biosafety is “the discipline addressing the safe handling and

containment of infectious microorganisms and hazardous biological materials” (CDC, 2010).

– This recognizes the subject with respect to microorganisms and hazardous biological materials.

• (2) Biosafety is a concept that refers to the need to protect human health and the environment from the possible adverse effects of the products of modern biotechnology (Convention on Biological Diversity, 1992).

This is one of the issues addressed by the CBD

Biosafety refers to safe handling, containment, release and utilization of infectious microorganisms and actually or potentially hazardous biological materials including Genetically Modified Organisms (GMOs) with a view to protecting human health, plants and the environment from possible adverse effects.

Biosecurity • Protection, control, and accountability for valuable biological materials in order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release.

• A valuable biological material is a laboratory material that requires administrative oversight, control, accountability, and specific protective and monitoring measures in the laboratory. Examples include pathogens, toxins, non-pathogenic organisms, vaccine strains, foods, GMOs, cell components, genetic elements etc.

Biosafety and Biosecurity

Like

lihoo

d

Very High

Consequences

Very Low

Low

Moderate

High

RISK

Risk

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You are at the zoo observing a mellow, tiger cub located behind a strong glass window.

Working with Animals and Associated Risks• Protozoans -

• Plasmodium (Malaria Parasite) • Trypanosomes (Sleeping Sickness Parasite)• Cryptosporidum etc• Trichomona

• Arthropods – • Insects eg. Mosquitoes, Sandflies, Black flies, • Spiders (Poisonous bites)• Scorpions (Poisonous stings)

• Birds – • Chickens (Avian Influenza), wild birds etc

• Mammals – • Bats (Ebola Virus Disease) • Rodents (Lassa Fever) • Monkeys (Ebola Virus Disease), • Cats (Crypto)• Dogs (Rabies)

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Biosafety Levels and Criteria• There are four Biosafety levels (BSL) designated according to the degree of

protection provided for the personnel, the environment and community.

• BSL 1 – For work with agents not known to cause diseases to immunocompetent individuals.

• BSL 2 – Builds on BSL 1. Suitable for work with agents that pose moderate hazards to personnel and Environment.

• BSL 3 - For clinical, diagnostic, teaching, research, or production facilities working with indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure.

• BSL 4 - For work involving dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease frequently fatal, for which there are no vaccines or treatments, or a related agent with unknown risk of transmission.

More details on this can be found here www.abdenloye/blogspot.com

Where is LASU?• All laboratories are BSL 1 , even research labs.

• The available BSL 1 labs are substandard; no conformity with specify standards for BSL 1s.

• Biorisk Management Introduced to LASU Senate in 2016.

• Biosafety and Biosecurity incorporated into GNS 301 (Logic and Science). Being taught for the first time this session (2016/2017).

•

Future Outlook – The Future is AMP

• What is AMP?• This is a universally accepted Model for Biorisk

Management System.

• A = Assessment• M = Mitigation• P = Performance

Risk Assessment Strategy:

Source: CWA 15793:2011

Biorisk Management = Assessment, Mitigation, Performance

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Slide 13

Laboratory Biorisk ManagementSystem or process to control safety and security risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities

CWA 15793 – International Approach

• Derived from the current WHO Biosafety and Biosecurity Guidelines

• Consistent with other international standards such as– ISO 9001/14001 and OSHAS18001

• Not country specific – Local solutions possible– Compliance with national and

local regulations mandatory

Slide 14

CWA 15793 – Major Sections

• Assessment– Hazard Identification– Risk Assessment

• Mitigation– Good microbiological

technique– Waste management– Physical security

• Performance– Performance measurement

and analysis of data– Management review

Slide 15

CWA 15793 is Performance-Oriented

• Describes what needs to be achieved

• Allows organizations to determine how best to achieve those objectives

• Not a technical document.

• Example:

Slide 16

4.4.4.5.3Waste ManagementThe organization shall establish and maintain an appropriate waste management policy for biological agents and toxins

• The lab worker/trainer/supervisor etc could be using animals bearing pathogens. He must be fully protected and has to train his students from getting infected.

• The zoology and Environmental biologist must key into the provisions of CWA 15793-2011 and operate with the standard for safe and secure work with AMP Model.

Where do I fit in as a Zoologist?

• Researcher/Lecturer - Entomologist, ornithologist,

Parasitologist, Geneticist, mammalogist etc.

• Project supervisor/Consultant • Animal Care Manager/Officer (CWA

15793 pp 23)• Training in biosafety and biosecurity

through Seminars and Workshops (CWA 15793 – 2011 section 4.4.2

• Project Assessment Experts • Institutional Biosafety Committee

Member/Officer

•THANK YOU