Transcript Infectious substances

2016 NCTU Laboratory Biosafety Training Program
Regulations and Management
of Infectious Biological Materials
Chia-Chen Chang Ph.D
University of Edinburgh, Institute of Cell Biology
University of Manchester, Institute of inflammation and Repair
Outline
Regulations of Infectious Biological Materials
Laboratory biosecurity
Transport of Infectious Substances
Practical process
Outline
Regulations of Infectious Biological Materials
Laboratory biosecurity
Transport of Infectious Substances
Practical process
Regulations of Infectious Biological Materials
Home > Acts and Regulations > Regulations > Category of Communicable Disease Control
Download : Regulations Governing Management of Infectious Biological Materials
http://www.cdc.gov.tw/english/index.aspx
Risk assessment
Identify
hazards
Evaluate
risks
Biological agents
Infectious substances
Determine
necessary control
Evaluate effectiveness
of controls
Four risk groups of microorganisms
Enforcement Rules of the Communicable Disease Control Act :
Infectious substances are substances which are known or are reasonably
expected to contain pathogens. Pathogens are defined as micro-organisms
(including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such
as prions, which can cause disease in humans or animals
Factors of the classification system
• Pathogenicity of the organism
• Mode of transmission and host range
• Stability in the environment
• Availability of effective preventive measures (e.g., vaccines)
• Availability of effective treatment (e.g., antibiotics)
• Other factors
Risk assessment
Identify
hazards
Evaluate
risks
Determine
necessary control
Evaluate effectiveness
of controls
• Risk groups
• Other substances associated with pathogens
• Clinical samples
Four risk groups of microorganisms
Classification
Assessment
Examples
Not associated with disease in
healthy adult humans or animals
Bacillus subtilis,
Escherichia coli-K12,
adeno-associated virus Type 1-4
RG2
associated with disease which is
rarely serious and for which
preventative or therapeutics is
often available
Measles virus,
Salmonellae
Toxoplasma spp.,
Hepatitis B virus
RG3
associated with serious or lethal
human disease for which
preventative or therapeutics may
be available
M. tuberculosis
SARS-associated Coronaviruses
Hantaan virus
RG4
associated with lethal human
disease for which preventative or
therapeutics are not readily
available
Ebola virus
Marburg virus
RG1
感染性生物材料管理辦法
Pathogen Safety Data Sheets (PSDSs)
http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/index-eng.php
Infectious substances - biotoxin
Classification
Biotoxin
例子
Assessment
a poisonous
Toxins can be small molecules, peptides, or proteins
substance produced that are capable of causing disease on contact with or
by a living organism. absorption by body tissues interacting with biological
macromolecules such as enzymes or cellular receptors.
Control of biotoxin
Level
Examples
General
biotoxin
Cholera toxin霍亂毒素、Clostridium perfringens toxins產氣莢膜梭狀芽孢桿菌
毒素、Corynebacterium diphtheriae toxin白喉桿菌毒素、 Pertussis toxin百日
咳毒素、Shiga toxin；shiga-like toxins志賀氏毒素；類志賀氏毒素、
Staphylococcus aureus toxins金黃色葡萄球菌毒素、Tetanus toxin破傷風毒素、
mycotoxin黴菌毒素、Verruculogen疣孢青黴菌毒素、Verotoxin綠猴腎細胞毒
素(VT)
Restricted
biotoxin
Botulinum neurotoxins肉毒桿菌神經毒素 (0.5 mg)、Diacetoxyscirpenol DAS蛇
型毒素 (1000 mg)、Staphylococcal enterotoxins(Subtypes：A、B、C、D 及 E)
葡萄球菌腸毒素 (5 mg)、T-2 toxin T-2黴菌毒素(1000 mg)
持有、保存或處分感染性生物材料之核備流程
感染性生物材料管理辦法
Risk assessment
Identify
hazards
Evaluate
risks
Determine
necessary control
Evaluate effectiveness
of controls
• Biological safety level (BSL) of the laboratory
• Biosafety committee
• Management of biological research units
Biological safety level (BSL) of the laboratory
Biosafety management of biological research units
Biosafety management of labs with RG2, RG3, RG4 pathogens or other biotoxins
≧5
people
Biosafety Committee
lab leader
manager
technician
Register and
inform your
institute in 1
month
＜5
people
Biosafety Manager
professional knowledge
16 h biosafety training
more than 3 year lab experience
•
•
•
•
•
•
•
•
•
Using and preservation
Transport
Examination of biosafety level
Containment plan
Lab construction
Biosafety controversy dispute
Biosafety audit
Biosafety training
Biosafety accident
感染性生物材料管理辦法
Biosecurity risk assessment process
Laboratory biosecurity
 Physical security of materials preservation
Restricted area I:
RG2
• Limited access





Restricted area II:
RG3
• Documentation:
limited access
equipment
lab construction
Restricted area III:
RG4
•
•
•
•
Restricted area to individuals
Proper authorization
Physical security
Monitoring System
Personal management: ID with photo, visitors control
Risk assessment: incident plan, biosafety control
Biosafety training: annual training and improvement
Securing lab equipment : equipment maintenance, lab construction
Information security: electronic files, programming system
WHO Laboratory biosecurity guidance
Biosafety management system
Control of RG3 and RG4 pathogen – purchasing, cleaning, subculture and deposit
操作步驟可參照: 第三級以上危險群微生物之感染性生物材料異動之線上核備
及維護操作說明 (102.10.01 修訂)
衛生福利部疾病管制署生物材料分讓作業規範
https://biobank.cdc.gov.tw/
持有、保存或處分感染性生物材料之核備流程
Risk assessment
Identify
hazards
Evaluate
risks
Determine
necessary control
Evaluate effectiveness
of controls
• Containment plan
Organized management of bio-materials in lab
• SOP
• Renew
• Remove
• Protocol
• Publication
• Patent
Biological
materials
preservation
Experience
heritage
Database
access
• Research details
• Data record
• References
Record
control
• Personal access
• Information
• Bioinformatics
Outline
Regulations of Infectious Biological Materials
Laboratory biosecurity
Transport of Infectious Substances
Practical process
Transport of Infectious Substances
Category
United Nations
number
Definition
Category A
UN2814
Infectious substances cause disease in humans or
both in humans and animals.
Category A
UN2900
Infectious substances cause disease in animals.
Category B
UN3373
Infectious substance which does not meet the
criteria for inclusion in Category A
Exemptions -
Substances that do not contain infectious
substances or that are unlikely to cause disease in
humans or animals are not subject to dangerous
goods regulations, unless they meet the criteria for
inclusion in another class
WHO 2015-2016 Guidance on regulations for the Transport of Infectious Substances
Examples of Category A -- UN2814
Examples of Category A -- UN2900
WHO 2015-2016 Guidance on regulations for the Transport of Infectious Substances
Transport of Infectious Substances
Materials not subject to dangerous goods regulations :
• Human or animal specimens (patient specimens) for which there is
minimal likelihood that pathogens are present
• Environmental samples (including food and water samples)
• Dried blood spots, collected by applying a drop of blood onto
absorbent material
• Faecal occult blood screening samples
• Medical equipment which has been drained of free liquid
• Blood or blood components, any tissues or organs which have been
collected for the purposes of transfusion or for the preparation of
blood products to be used for transfusion or transplantation
WHO 2015-2016 Guidance on regulations for the Transport of Infectious Substances
Packing instruction
Classification
Category A
Category B
Packing restriction P620
P650
Hand carriage
No
No
Sent by post
No
Yes
Road transport
No weight restriction
No weight restriction
Air transport
1. Passenger aircraft :
50 ml or 50 g
2. Cargo aircraft :
4 litres or 4 kg for
No primary receptacle shall exceed
1 litre and the outer packaging must
not contain more than 4 litres (for
liquids) , except for packages
containing body parts, organs or
whole bodies
Other rules
Any primary receptacle with a capacity of more than 50
ml shall be oriented in the
outer packaging so that the
closures are upwards.
WHO 2015-2016 Guidance on regulations for the Transport of Infectious Substances
Packing instruction – basic triple packing system
P620
P650
WHO 2015-2016 Guidance on regulations for the Transport of Infectious Substances
Packing instruction – Category A marking
Packing instruction – Category B marking
Packing instruction - labelling
WHO 2015-2016 Guidance on regulations for the Transport of Infectious Substances
Packing instruction - labelling
WHO 2015-2016 Guidance on regulations for the Transport of Infectious Substances
Spill clean-up procedure
1. Wear gloves and protecting clothing, including face and eye protection if indicated.
2. Cover the spill with a cloth or paper towels to contain it.
3. Pour an appropriate disinfectant over the cloth or paper towels and the
immediately surrounding area (5% bleach solutions are generally appropriate, but
for spills on aircraft, quaternary ammonium disinfectants should be used).
4. Apply the disinfectant concentrically beginning at the outer margin of the spill area,
working towards the centre.
5. After about 30 min, clear away the materials. If there is broken glass or other
sharps are involved, use a dustpan or a piece of stiff cardboard to collect the
materials and deposit them into a puncture-resistant container for disposal.
6. Clean and disinfect the area of the spillage (if necessary, repeat steps 2–5).
7. Dispose of contaminated materials into a leak-proof, puncture-resistant waste
disposal container.
8. After successful disinfection, report the incident to the competent authority and
inform them that the site has been decontaminated (see Incident reporting below)
WHO 2015-2016 Guidance on regulations for the Transport of Infectious Substances
Laboratory Biosafety Manual – 3rd Edition
http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LYO_2004_11/en/
Outline
Regulations of Infectious Biological Materials
Laboratory biosecurity
Transport of Infectious Substances
Practical process
Practical process of infectious substances transport
Obtains the necessary
authorization(s) from
national authorities
The shipper
Obtains the necessary
authorization(s) from
national authorities
The carrier
• Makes advance arrangements with the
receiver including investigating the need for
import/export permits
• Notifies the receiver of transportation
arrangements once these have been made,
well in advance of the expected arrival time.
The receiver
• Provides the sender with the
required import permit(s),
letter(s) of authorization
• Arranges for the most timely
and efficient collection on
arrival
Practical process of infectious substances transport
Make sure the right authorities
Humans
pathogen?
X
O
O
Animals
pathogen?
X
Other
pathogen?
Check Category A list
Guidance on regulations for the
Transport of Infectious
Substances
X
O
Centers for disease control
O
Category A :
UN2900
Ask for authorities
Category B : UN3373
O
The Bureau of Animal and Plant Health
Inspection and Quarantine (BAPHIQ)
X
Other authorities
X
Animal or plant
material?
Category A : UN2814
Centers for disease control
Home > Acts and Regulations > Regulations > Category of Communicable Disease Control
Download : Regulations Governing Management of Infectious Biological Materials
http://www.cdc.gov.tw/english/index.aspx
The Bureau of Animal and Plant Health Inspection and Quarantine
• Cell line, antibodies, genetic transgenic materials, DNA, RNA or plasmids from animals
• Microorganisms, animal tissue, tissue fluid, excreta and other material contained
pathogens
• Blood or serum samples from animals
https://www.baphiq.gov.tw/en/view.php?catid=5767
Ministry of Health and Welfare
• Blood or blood components, any tissues or organs which have been collected for the
purposes of transfusion or for the preparation of blood products to be used for
transfusion or transplantation
http://www.mohw.gov.tw/EN/Ministry/Index.aspx
Food and drug administration (FDA)
• Patient specimens, materials for medicine, medical device…
http://www.fda.gov.tw/EN/index.aspx
感染性生物材料、傳染病檢體及相關生物材料輸出（入）管理規定
有關人類血液；已調製動物血液供治療、預防疾病或診斷用；毒素、微生物培養體
（酵母除外）和類似品等相關品項，如涉及自大陸地區輸入或輸出至北韓、伊朗者，
應另依經濟部國際貿易局相關申請規定辦理。
感染性生物材料、傳染病檢體及相關生物材料輸出（入）管理規定
Practical process of other substances transport
Make sure the right authorities
System for transport of
infectious substance
疾病管制署全球資訊 (http://www.cdc.gov.tw)
>>專業版項下之出入境健康管理>國際檢>感
染性生物材料輸出入申請>感染性生物材料
簽審通關系統
Practical process of other substances transport
https://bioaudit.cdc.gov.tw/cdc_doh/login.aspx
Practical process of other substances transport
Make sure the right authorities
System for transport of
infectious substance
Apply for lab account
• Use a lab or an organization for account
owner
• About 3 working days
Practical process of other substances transport
Make sure the right authorities
System for transport of
infectious substance
Apply for lab account
Fill online forms and sign
• Ask Tax number of your agency for the
online application
Practical process of other substances transport
Make sure the right authorities
System for transport of
infectious substance
Apply for lab account
Fill online forms and sign
Send application to center
for disease control
• Different materials require different
documents: Guidance on regulations for the
Transport of Infectious Substances
• Deactivated materials require declaration.
• Contracts have to be attached for deposit of
microorganisms for the purposes of patent
procedure.
Practical process of other substances transport
Make sure the right authorities
System for transport of
infectious substance
Apply for lab account
Fill online forms and sign
Send application to center
for disease control
Note:
1. The consistency of numbers
2. The sending quantity can not be more
than the applied quantity
Send documents to your
customs broker
Practical process of other substances transport
Make sure the right authorities
System for transport of
infectious substance
Apply for lab account
Fill online forms and sign
Contact shipping company
and prepare documents
Send application to center
for disease control
Send documents to your
customs broker
Documentation
1. the shipper’s Declaration for Dangerous
Goods
2. a packing list/proforma invoice that
includes the receiver’s address, the
number of packages, detail of contents,
weight, value (Note: for international
transport, a minimal value shall be
indicated, for customs purposes, if the
items are supplied free of charge)
3. an import and/or export permit and/or
declaration if required
Practical process of other substances transport
Make sure the right authorities
System for transport of
infectious substance
Apply for lab account
Pack and deliver
Fill online forms and sign
Contact shipping company
and prepare documents
Send application to center
for disease control
Send documents to your
customs broker
Contacts
National Chiao Tung University
Environmental Protection and Safety Center
http://esc.nctu.edu.tw/index.php/2016-01-31-20-35-55/dept
National Tsing Hua University
Environment protection and Occupational safety and Sanitation center
http://nesh.web.nthu.edu.tw/files/11-1021-9081.php?Lang=en