Implementing Biosecurity in a 100 Year Old Institution

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S E R U M I N S T I T U T

Implementing Biosecurity

in a 100 Year Old Institution

Vibeke Halkjær-Knudsen, PhD,

Director EHS,

Senior Biosafety and Biosecurity Officer

Statens Serum Institute

Denmark

A Case Study

Vibeke Halkjær-Knudsen, PhD,

Limited term Principal Member of Technical Staff

Sandia National Laboratories

Albuquerque, NM, USA

[email protected]

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This Presentation

The new Biosecurity legislation in DK

Historical background of Statens Serum Institute

The implementation

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This Presentation

The ”H W” s

How to start

What to expect

How to motivate

What was gained

How to proceed

What did we learn

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Biosecurity

Implementation in Denmark

Biosikringsloven lov nr. 474

af 17. Juni 2008

Bekendtgørelse nr. 981 af

15. Oktober 2009

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Biosecurity

Implementation in Denmark

Timeline

Temporary application -> 1. May 2010

Appointed Biosecurity Officers participate in a 2 day course.

Background check, chriminal record

3 months for full application

Vulnerability analysis, security plan, safe storage, inventory

lists, procedures, training, access to materials etc etc

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WHY?

EN 1540

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”Law about security of selected biological agents,

launching devices and related material”

VI MARGRETHE DEN ANDEN, af Guds Nåde Danmarks Dronning, gør vitterligt:

Folketinget har vedtaget og Vi ved Vort samtykke stadfæstet følgende lov:

§ 1. Ministeren for Sundhed og Forebyggelse kan fastsætte regler om besiddelse, fremstilling, anvendelse, opbevaring, køb, salg og anden form for overdragelse, distribution, transport og bortskaffelse af biologiske stoffer, fremføringsmidler og relateret materiale, der er omfattet af eksportkontrol efter forordning om fællesskabsodning for kontrol med udførslen af produkter og teknologi med dobbelt anvendelse, og som kan anvendes ved biologiske anslag rettet mod mennesker.

Stk. 2. Ministeren for Sundhed og Forebyggelse kan fastsætte regler om, at reglerne i denne lov og regler fastsat i medfør af denne lov også gælder for andre biologiske stoffer, fremføringsmidler og relaterede materialer, der ikke er omfattet af stk. 1, hvis de biologiske stoffer m.v. vurderes at kunne anvendes ved biologiske anslag rettet mod mennesker og dermed at kunne udgøre en fare for den offentlige sikkerhed.

§ 2. Ministeren for Sundhed og Forebyggelse kan meddele de forbud og påbud, der er nødvendige for overholdelse af § 5, stk. 4.

besiddelse, fremstilling, anvendelse,

opbevaring, køb, salg og anden form for

overdragelse, distribution, transport og

bortskaffelse af biologiske stoffer,

fremføringsmidler og relateret materiale

, at reglerne i denne lov og regler fastsat i medfør af denne lov også gælder for andre biologiske stoffer, fremføringsmidler og relaterede materialer, der ikke er omfattet af stk. 1, hvis de biologiske stoffer m.v. vurderes at kunne anvendes ved biologiske anslag rettet mod mennesker og dermed at kunne udgøre en fare for den offentlige sikkerhed.

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EN 1540

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EN 1540

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EN 1540

United Nations Security Council Resolution 1540

was adopted unanimously on April 28, 2004

regarding the non-proliferation of weapons of mass

destruction

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EN 1540

The resolution establishes the obligations under

Chapter VII of the United Nations Charter for all

Member States to develop and enforce appropriate

legal and regulatory measures against the

proliferation of chemical, biological, radiological

and nuclear weapons and their means of delivery,

in particular, to prevent the spread of weapons of

mass destruction to non-state actors.

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EN 1540

It is notable in that it recognizes non-state

proliferation as a threat to the peace under the

terms of Chapter VII of the United Nations Charter,

and creates an obligation for states to modify their

internal legislation.

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EN 1540

Furthermore, the resolution requires every state to

criminalize various forms of non-state actor

involvement in weapons of mass destruction and

its related activities in its domestic legislation and,

once in place, to enforce such legislation.

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EN 1540

By virtue of its universal scope and mandatory

nature, resolution 1540 marks a departure from

previous nonproliferation arrangements and adds a

novel layer to the nonproliferation regime.

Before the resolution was adopted, the non-

proliferation regime was based on many partly

overlapping arrangements, none of which

established universal mandatory obligations

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EN 1540, press release

Following last week’s public debate on weapons of

mass destruction (see Press Release SC/8070 of 22

April), the Security Council this afternoon adopted

a non-proliferation resolution by which it decided

that all States shall refrain from supporting by any

means non-State actors that attempt to acquire,

use or transfer nuclear, chemical or biological

weapons and their delivery systems.

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EN 1540, press release

Also by that text, the Council decided to establish,

for a period of no longer than two years, a

committee comprising all Council members, which

would report on the implementation of the present

resolution.

It called on States to present a first report to that

committee, no later than six months from the

adoption of the resolution, on steps they had taken

or intended to take in its implementation.

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“The Danish Ministry for Health &Prevention

…. has therefore decided”

To provide statutory authority for public

inspection

Possession, manufacture, use of substances that can be used for

biological attacks against humans

Means of Delivery

Related Materials

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The purpose of the regulation is…

To comply with the recommendations in the

national (Danish) terror action plan

Secure all mentioned assets

Ensure that Denmark is compliant with the

international obligations:

UN Security Council Resolution 1540 on non-

proliferation of WMD

The Convention on the Prohibition of the

Development, Production and Stockpiling of

biological weapons - and the destruction

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The regulation is a supplement to…

.. the already existing regulations for health and

safety

Purpose: To counteract deliberate attempts on

acquiring biological agents

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The regulation will attempt…

To secure all components that can be used for

biological weapons

Agents

Means of delivery

Related materials

Components with a dual use potential

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Biological agents

Human pathogens

Zoonoses

Toxins – or subunits thereof

Genetically modified organisms

Bacteria

Certain fungi

Certain genetical elements

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Means of Delivery

Spray systems

Missiles

Unmanned systems

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Examples of “Related Materials”

Material, equipment and technologies….

- which can be used for design, production or used as biological

weapons

o Fermentors above 20 l

o Bioreactors, chemostats, continous flow systems

o Larger centrifuges, Decanters, Filtrations systems

o Steam sterilazable equipment for freeze drying

o Isolators

o Flexible isolators, drying boxes, anerobe chambers, gloveboxes

o Inhalators and similar aerosol generating equipment

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“Catch all” clause

“Products” which can have connection to - or

potential for development of weapons of mass

destruction

Even if these are not listed specifically……

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§ 7: The law is becomes effective from 1. Juli 2008

1 year for implementation

If an institution is not in compliance – penalty

§ 8: …. The law does not apply for the Faeroe

islands and Greenland …………….

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SSI

The Casestudy

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SSI: Mission Statement

Prevention and Control of Infectious Diseases,

Biological Threats and Congenital Disorders;

Based on SSI’s Core Activities

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Ministry of Health Agency 1.600 Employees

Established in 1902

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25 Acres Campus ~ 50 Buildings

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SSI’s Main Responsibility

To maintain a national alert based on science in order

to prevent and control infectious diseases and

congenital disorders

Mortality

1900-1996

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Public Health

Education and training Clinical microbiology Hospital Hygiene Epidemiology

National centre for hospital hygiene Surveillance of hospital acquired infections Consultancy, control/validation of disinfection/sterilization

Reference functions, 7 WHO Centers Identification and typing of microorganisms

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Public Health

• Surveillance of infectious diseases • Person identifiable system • HIV • STD • Laboratory (food infections) • Sentinel (influenza)

Surveillance of antibiotic resistance

Surveillance of pediatric vaccination programmes • Coverage • Effectiveness

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Public Health

WHO collaborating centres for reference and research on… Gonococci Escherichia and Klebsiella Pneumococci Virus Toxoplasmoses Treponematosis

WHOCARE – distribution centre

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Research

A centre of excellence for research in microbiology, immunology and epidemiology in order to prevent and control infectious diseases and congenital disorders

200 scientists 200 international publications yearly Research financed by the Danish Government,

WHO, EU, national and international foundations

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Research Areas

General Research Areas Microbiology Immunology Epidemiology Biotechnology/molecular biology

Specific Research Areas Diagnosis and surveillance of infectious diseases

and antibiotic resistance o Gastrointestinal infections o Antibiotic resistance o HIV-resistance o Respiratory tract infections

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Research Areas

Surveillance and control of hospital infections

Vaccine research Combination vaccines DNA vaccines TB vaccines

Plasma products MBL Specific immunoglobulins

Surveillance, diagnosis, and prevention of congenital disorders

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SSI

History

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History

1902 Anti-diphtheria serum

Tests for typhoid and syphilis

1910 Anti-tetanus serum

Influenza pandemic

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History

1920 TB tests

Pertussis vaccine

Biological standardization

Please do not

spit on the

sidewalk !

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History

1930 Smallpox vaccine

Monitoring of

contagious diseases

Milk epidemic

TB epidemiology

BCG vaccine

Tuberculin

Blood type serology

Foot-and-mouth disease

Hormone analyses

Pneumococcus antiserum

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History

1940 Diphtheria vaccination

STD epidemic

Refugees

Screening of pregnant women for syphilis

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History

1950 International tuberculosis campaign

Production of plasma products

Children’s vaccination programs

(Difteri-Tetanus-BCG)

Polio vaccine (IPV)

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History

1960 Staphylococci resistent to antibiotics

Local clinical microbiological units

Radioimmunoassay

Pertussis vaccine

1970 Immunology

ELISA (enzyme immuno assays)

Hospital hygiene/sanitation

Virology

1980 Bioteknology/molecular biology

Neo-natal screening (PKU)

HIV/AIDS

MFR-vaccination (measles,

mumps, and German measles)

1990 HIB-vaccination Di-Te-aP-IPV vaccine Food-transmitted infections

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History

2000 Resistance to antibiotics

Eradication of Polio and measles

Influenza pandemic

Biological warfare

Genetic modified microorganisms

Zenotransplantation

Consequences of social, technological,

and environmental changes

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Conclusion

If anybody ever died of it…..

we will have a sample in storage

……. because …..

… You Never Know!

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The Implementation of the Biosecurity Law at SSI

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The Regulations

Agents

Means of Delivery

Related Materials

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Where Do We Have It?

The lists from the Tech Department

998

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UPS!

~ 20% of listed freezers and refrigerators ….were

not there

~ 32% were not listed

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The Corridors!

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And the Small Rooms in the Basement

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The Labels

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Labels

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Hope Somebody Will Take the Phone?

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Jubilæumsbog

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When You Open the Freezer…

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This way you are absolutely sure

that the inventory list will not disappear.

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Plan for Implementation

Create inventory lists of biological agents

Amounts?

o Countable units

WHERE?

o Go through refrigerators, freezers, coldstores, drawers,

cubboards, roof space, cryo containers

Secured against theft and malicious damage

Register and count relevant equipment

List contact persons for agents and equipment

Send inventory lists to Center for Biological Preparedness

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For each and every unit

All out

Count it

Verify with existing inventory list – if it exists

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WHAT!

External coldstore ??

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Coldstore

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Wonder What Is Behind?

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Ohh ! THAT Was Behind !

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10 Racks

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How Do We Start?

List of Employees

Start with the Directors that are close to retirement

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Dress Them Up In Ski Attire

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Some Labelling Techniques

Are More Durable Than Others

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After Several Boxes

a Labeling Pattern Begins to Show

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They Must Have Had a Reason for

Keeping This for Later Generations

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A Good Experience

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Well…………

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No Danger for Us

Not Having a Job in the Close Future

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None was found in this box

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Neither Here

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And in the Bottom of the Bag ….

A Handful of Labless

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Sometimes There Is Not

a Lot of Information on the Samples

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Thank You for the Warning

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A Cubboard Nobody had Opened

in the Last 20 Years

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Moving Old Samples

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Did we find a lot of agents that we did

not know we had?

Did we find a lot of agents

that we did not know we had?

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Were they amongst the

select agents

we were looking for?

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Could we have looked CBB straight

in the eyes and told them:

” WE KNOW !!! ”

without having gone through it all?

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Did we end up throwing out

a lot of stuff

we could do without?

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Did we intiate a new energy

reduction plan,

exchanging freezers

from the 60’íes

with new energy efficient ones?

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Before – and After

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Picture Courtesy Per Staugaard

Documents

Implementing Biosecurity in a 100 Year Old Institution