LEGAL AND ETHICAL

ISSUES
CBE686_SAFETY AND HEALTH
IN CHEMICAL AND
BIOPROCESS INDUSTRIES

Course Outline
8.1 Standards and legislation
8.2 Biosafety legal issues
8.3 Ethical and professionalism
problems
8.4 Cartagena Protocol on Biosafety
8.5 Case study

Introduction:
OSHA 1994

OSHA 1994
The Occupational Safety and Health Act (OSHA) is
an Act which provides the legislative framework
to secure the safety, health and welfare
among all Malaysian workforce and to protect
others against risks to safety or health in
connection with the activities of persons at work
This Act was gazetted on 24th February 1994
Contains 67 sections, divided into 15 parts and
appended by 3 schedules
The purpose of Occupational Safety and Health Act
1994 is to promote and encourage occupational
safety and health awareness among workers and
to create organization along with effective safety
and health measures.

Sectors covered by OSHA

1994

1. Manufacturing

2. Mining and Quarrying

3. Construction
4. Hotels and Restaurant
5. Agriculture, Forestry and Fishing
6. Transport, Storage and
Communication

OSHA not applicable in this sector

NOTES :
Not applicable to work on board ships
governed by the Merchant Shipping
Ordinance 1952, the Merchant
Shipping Ordinance 1960 of Sabah and
Sarawak

Not applicable to armed forces

Objectives Of OSHA 1994

1. To secure the safety, health and welfare of persons at work
against risks to safety or health arising out of the activities of
persons at work.
2. To protect persons at a place of work other than persons at work
against risks to safety or health arising out of the activities of
persons at work.
3. To promote a suitable occupational environment for persons at
work which is adapted to their physiological and psychological
needs.
4. To provide the means whereby the associated occupational safety
and health (OSH) legislations may be progressively replaced by a
system of regulations and approved industry codes of practice
operating in combination with the provisions of this Act
designed to maintain or improve the standards of safety and health.

OSHA REGULATIONS
i.
ii.
iii.
iv.
v.
vi.
vii.

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 1996SHC
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
OSH (Notification of Accident, Dangerous Occurrence,
Occupational Poisoning and Occupational Disease)
Regulations 2004-NADOOPOD

OCCUPATIONAL SAFETY AND HEALTH (EMPLOYERS

SAFETY AND HEALTH GENERAL POLICY
STATEMENTS) (EXCEPTION) REGULATIONS 1995

ESHGPS 1995
Citation and commencement

These regulation may be cited as Occupational Safety and

Health (Employers Safety and Health General Policy
Statements) (Exception) Regulations 1995 and shall be
deemed to have come info force on the 25th February 1994

Exception

Section 16 (duty to formulate safety and health policy) of the

Act shall apply to every employer and every self-employed
person except those who carry on an undertaking with not
more than five employees

OCCUPATIONAL SAFETY AND

HEALTH
(CONTROL OF INDUSTRIAL
MAJOR ACCIDENT HAZARDS)
REGULATIONS 1996

APPLICATION OF CIMAH
1996
Come into force on 1 February 1996
These Regulations shall apply to ALL industrial
activities EXCEPT:
A nuclear installation
An installation under the armed forces
A vehicle or vessel transporting hazardous
substance to or from the site of an industrial
activity
An industrial in which there is involved or likely
to be involved a quantity of hazardous
substance or a category or categories of
substance which is or are equal or less than ten
per cent (10%)of the threshold quantity of the

CIMAH 1996
Section

1. Introduction
2. Identification and announcement of industrial
activities
3. Demonstration of safety operation for non
major hazard industries
4. Report on industrial actvities dan emergency
plan preparation for major hazard industries
5. Announcement of major accident
6. Penalty

Objectives:
To prevent major accident
To limit the consequences to people, property and
the environment
major accident means an occurrence

Including a major emission, fire or explosion

Resulting from uncontrolled developments
Leading to a serious danger to persons
Leading to a serious danger to the environment
Involving one or more hazardous substance

SCOPE
General need:
Section I: Introduction
Section II:
Identification and announcement of industrial
activities
Section V:
Announcement of major accident
Section VI:
Penalty
Non
Major
Major
Hazard
Industry Hazard
Industry
Section IV:
Industrial activities
Report on industrial
actvities and
emercency plan
preparation for major
hazard installation

Section III:
Demonstration of
safety operation for
non major hazard
installation

Interpretation
major hazard Installation means an industrial
activity which

Produces, processes, handles, uses, disposes of or

stores, either permanently or temporarily, one or more
hazardous substances in quantities which is equal to or
exceed the threshold quantity or

Determined by the Director General in accordance with

subregulation 7(2)
3

Some example of major hazard installations:

Petrochemical works and refineries

Chemical works and chemical production plants

LPG storage and terminal

Stores and distribution centers for chemical

Fertilizer plants

Explosive factories

Water treatment plants

Interpretation
non major hazard Installation An industrial
activity which

Produces, processes, handles, uses, disposes of or stores,

either permanently or temporarily, one or more hazardous
substances in quantities which is exceed 10 % of the
threshold quantity and less than the threshold
quantities

Determined by the Director General in accordance with

subregulation 7(2)
3

OBLIGATION OF MANUFACTURER UNDER

MHI

Notify to DOSH of an industrial activity

Prepare and submit Safety Report and On-Site
Emergency Response Plan to DOSH
Keep up to date report and plan
Inform to the local authority
Help local authority to prepare off-site ERP
Inform to the public
Inform DOSH of any major accident
3

OCCUPATIONAL SAFETY AND

HEALTH
(SAFETY AND HEALTH
COMMITTEE)
REGULATIONS 1997

COMPOSITION OF SHC
1996
A SHC shall consist of:1. A chairman
2. A secretary (Safety and Health Officer)
3. Representative of employer
4. Representative of employees

df

22

Functions of a safety and health

committee / officer

Assist in the development of safety and health rules and

safe systems of work

Review the effectiveness of safety and health programmes

Carry out studies on the trends of accident, near-miss

accident, dangerous occurance which occurs at the
workplace

Report to the employer of any unsafe or unhealthy

condition or practices at the place of work, together with
recommendation of corrective actions

Review the safety and health policies at the place of work

and make recommendations to the employer for any
df

revision of such policies

23

Removal of member of committee:1. He fails to attend 3 consecutive meetings of the committee without
leave of the chairman
2. He has been found or declared to be of unsound mind
3. He becomes a bankrupt
4. As a representative of employees, he is no longer employed at the
place of work
5. There has been proved against him, or he has been convicted on, a
charge in respect of
I. An offence involving fraud, dishonesty or moral turpitude
II. An offence under a law relating to occupational safety and health;
or
III. Any other criminal offence; or
6. He is otherwise unable or incapable of discharging his duties as a
member of the committee

OCCUPATIONAL SAFETY AND

HEALTH
(SAFETY AND HEALTH
OFFICER)
REGULATIONS 1997

OBJECTIVES OF THE REGULATIONS

Control of high risk industries

Assist to improve the level of occupational
safety and health and high risk industries
Create an effective and systematic safety
management system at the workplace
Facilitates the employer to conduct all work
activities safely

INDUSTRIES REQUIRED TO
EMPLOY A SHO
a)

Building

operation

where the

contract price

exceeds RM20 million

b)

Work

of

engineering

construction

where

the

contract price exceeds RM20 million

c)

Any ship building employing at the peak of work

over 100 employers

d)

Any

gas

processing

activity

or

petrochemical

industries employing over 100 employees

27

INDUSTRIES REQUIRED TO
EMPLOY A SHO
h)

i)

j)

28

Any wood working industry where

there is
cutting or sawing or
planning or moulding or sanding or
peeling or any combination of the
above, and
employing over 100
employees
Any cement manufacturing activity
employing over 100 employees
Any
other manufacturing
activity
other than
specified in
f)

i),
employing
over
500

INDUSTRIES REQUIRED TO
EMPLOY A SHO
e)

Any chemical or allied industry employing

over 100 employees

f)

Any

boiler or pressure vessel activity

employing over 100 employees

g)

Any

metal industry where canning or

stamping

or

blanking

or

shearing

bending operations and employing

29

100 employees

or

over

QUALIFICATION FOR REGISTRATION

Diploma in Occupational Safety and Health or
equivalent, approved by the Minister
Successfully
completed training* in Occupational
Safety and Health and passed any examinations for
that course, or equivalent approved by the Minister
and has minimum three years experience in
Occupational Safety and Health
Has been working in the area of Occupational Safety
and Health at least for a period of ten years
Holds
other qualifications or has received training
as prescribed from time to time by the Minister
* Courses that are conducted by NIOSH or any other
approved course

OCCUPATIONAL SAFETY AND HEALTH

(USE AND STANDARDS OF EXPOSURE OF CHEMICALS
HAZARDOUS TO HEALTH)
REGULATIONS 2000

APPLICATION OF USECHH 2000

These Regulations shall apply to all places of work

which are within the jurisdiction of the Act where
chemicals hazardous to health are used except
chemicals which area) Defined as radioactive materials under the Atomic
Energy Licensing Act 1984 [Act 304];
b) Foodstuffs;
c) Hazardous to health solely by virtue of their explosive
or flammable properties, or solely because they are at
a high or low temperature or a high pressure; and
d) Pharmaceutical products.

Sections
PART I Preliminary
employer shall
PART II - Identification Of
identify and
record in a
Chemicals Hazardous To Health
register
ceiling limit , TWA,
PART III - Permissible Exposure
Compliance with
permissible exposure limit
Limit
using respirator
PART IV - Assessment Of Risk To conducted by assessor
Health
shall provide
PART V - Action To Control ExposeEmployer
control measure,
PART VI - Labelling And
Relabelling

 PART VII - Information,

Instruction And Training
PART VIII - Monitoring Of
Exposure At The Place Of Work
PART IX - Health Surveillance
PART X - Medical Removal
Protection
PART XI - Warning Sign
PART XII - Record Keeping

CSDS, training,
instruction by sv

monitoring of
exposure shall be
conducted by a
hygiene technician
whenever
necessary

OCCUPATIONAL SAFETY AND HEALTH

(NOTIFICATION OF ACCIDENT, DANGEROUS
OCCURRENCE, OCCUPATIONAL POISONING,
AND OCCUPATIONAL DISEASES)
REGULATIONS 2004

APPLICATION OF NADOOPOD 2004

Shall apply to all places of work
Nothing in these Regulations shall prejudice any
requirement imposed by or under any other written
law relating to reporting of accident, dangerous
occurrence, occupational poisoning or occupational
disease

Notification and reporting of accident and

dangerous occurrence
Whenever any accident arising out of or in
connection with work which caused any
person eitherdeath or
Serious bodily injury, which prevents the
person from following his normal
occupation for more than four calendar
day
or where a dangerous occurrence takes
place in any place of work

EXEMPTION
Reporting of any death, injury or condition of a
person shall not apply to a patient when
undergoing treatment in a hospital or surgery by
a doctor or dentist

OCCUPATIONAL SAFETY AND

HEALTH (CLASSIFICATION,
LABELLING AND SAFETY
DATA SHEET OF HAZARDOUS
CHEMICALS) REGULATIONS

Purpose of CLASS regulation

MODERN BIOTECHNOLOGY,
CARTAGENA PROTOCOL AND
BIOSAFETY ACT

What is Biotechnology?

Biotechnology uses biological systems, living

organisms, or derivatives thereof, to make or
modify products or processes for a specific use

Genetic engineering is a technique that allows

genes and DNA to be transferred from one source
to another. It leads to the production of living
modified organisms (LMOs).or GMOs

Modern biotechnology gives scientists molecular

tools for obtaining a better understanding of the
structure and function of genes in living organisms

Modern Biotechnology: Promises

New precision tools and diagnostics

To speed up breeding gains and efficiency
To develop pest- and disease-resistant crops
To combat salinity, drought problems of
agriculture
To enhance the nutritional quality of food
To increase crop varieties and choice
To reduce inputs and production costs
To increase profits

Producing a GM Crop

Some Available GM Products

Crop
Maize
Soybean
Cotton
Canola

Traits
Insect resistance, herbicide tolerance
Insect resistance, herbicide tolerance
Insect resistance, herbicide tolerance
Modified oil composition, herbicide
tolerance

Potato

Virus resistance, insect resistance, higher

starch content

Tomato
Papaya
Banana

Insect resistance, longer shelf life

Virus resistance
Virus resistance

GMOs: Potential Risks and

Concerns
Health:
Safety of food for humans and livestock
New allergens, toxins
Increased resistance to antibiotics
Environment: Impact on biodiversity
Changes in agricultural inputs
Gene-flow, gene introgression
Impact on centers of origin
Impact on ecosystem
Socio-economic:
Lack of access to proprietary
technologies
Food and consumer choice
Impact on seed sector and on resource-poor farmers

Biosafety and the Cartagena

Protocol: Objective & Scope
Biosafety: The need to protect human health and
environment from the possible adverse effects of
the products of modern biotechnology.
Protocol Objective: Adequate protection in the
safe transfer, handling and use of living modified
organisms (LMOs) resulting from modern
biotechnology that may have adverse effects on the
environment & human health
Scope: Transboundary movement, transit, handling
and use of LMOs that can affect sustainable use of
biological diversity. Pharmaceuticals are excluded.

Malaysia Institutional bodies

The main institutional bodies
responsible for handling biosafety in
Malaysia are
The Ministry of Natural Resources and
Environment (NRE)
The National Biosafety Board (NBB)
The Genetic Modification Advisory
Committee (GMAC)

NATIONAL BIOSAFETY
BOARD (NBB)
Secretary General of
NRE (Chairman)
Min. of Agriculture
and Agro-based
Industry
Ministry of Health
Min. of Plantation,
Industries &
Commodities
4 experts in
biosafety

DG Dept of Biosafety
(Secretary)

NB
B

Min. International
Trade & Industry
Min of Science,
Techology &
Innovation

Min. of Domestic Trade, Cooperatives & Consumerism

ADMINISTRATIVE SUPPORT FROM DEPARTMENT OF BIOSAFETY

FUNCTIONS OF THE NBB

To decide on all applications & to monitor
activities relating to LMOs and the products
To promote research, development, educational
and training activities relating to biosafety
To establish mechanism to facilitate the
collection, storage & dissemination of data
relating to LMOs and the products and biosafety
Where so directed by Minister, to perform or
provide for the performance of the obligation
raising from agreements, convention or treaties
relating to biosafety

GENETIC MODIFICATION ADVISORY

COMMITTEE (GMAC)
Provide scientific assessment of applications for
approval and notifications and gives
recommendations to the NBB
Provide scientific, technical and other relevant
advice to the NBB or to the Minister
GMACs Chairman is appointed by the Minister
and the members appointed by the NBB
Member of GMAC consist of experts from various
science-based disciplines (e.g genetic
engineering, molecular biology, microbiology,
genetics etc)

Products of LMO
Derived from LMOs or part of LMOs
Contains detectable recombinant
DNA
Profile, characteristic or properties of
the products is or are no longer
equivalent to its conventional
counterparts irrespective of the
recombinant DNA

NATIONAL POLICY ON BIOLOGICAL

DIVERSITY 1998
Includes biosafety considerations in the
development & application of biotechnology
in harnessing biodiversity resources.
Vision: To transform Malaysia into a worlds
centre of excellence in conservation,
research and utilization of tropical biological
diversity by the year 2020.
Minister of NRE is lead and focal agency for
all matters relating to biosafety.

NATIONAL BIOTECHNOLOGY POLICY

2005
The NBPs purpose is to create an
integrated platform for participation by
the scientific, business and funding
groups to ensure an eco-system that is
capable of sustaining Malaysias growth
and progress in biotechnology
9 policy thrust area
MOSTI is the lead agency

WHY BIOSAFETY?
To reduce and eliminate risks
resulting from the modern
biotechnology (LMOs) and its
products so that it is safe for human,
plant and animal health as well as
the environment

BIOSAFETY ACT 2007

Complement the implementation of the
National Policy on Biotechnology (2005) &
also the National Policy on Biodiversity (1998)
Fulfill Malaysia's obligation under the 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
Federal Act-applicable in all states of Malaysia

Biosafety in Malaysia
STRIKE A BALANCE- creating an
enabling environment to gain the
maximum benefit from modern
biotechnology but at the same time
minimizing risks to the environment
and health

CPB and Biosafety ActComplimentary legal instruments

Country
A

Malaysia
Country B

Transboundary
movement CPB

Domestic
Law
Biosafety Act
2007
LMO &
Product

Evolution of Biosafety
Year

Event

2000

Signed the Cartagena Protocol on Biosafety (CPB)

2004

NRE formed to handle Environment & Biosafety issues

2005

National Policy on Biotechnology

2006/2007

Biosafety Bill in Parliament

2007

Biosafety Act passed in Parliament

2008

Biosafety Core Team formed (April)

2009

Biosafety Act enforced 1st December 2009

2010

NBB formed & GMAC members appointment

2010

Department of Biosafety established (24th May)

2010

Biosafety Regulations enforced (1st November)

2011

Transition period ends (30th November)

OBJECTIVES OF THE ACT

To establish the National Biosafety Board (NBB)
To regulate the release, importation, exportation
and contained use of living modified organisms
(LMO) and the release of products of such
organisms with the objectives of protecting
human, plant and animal health the environment
and biological diversity
To establish GMAC, to give science based advice
and to assist NBB
To set out the regulatory procedures for release
of LMOs and contained use of LMOs

Scope of the Act

RELEASE
LMOs
IMPORT

MODERN
BIOTECHNOLOG
Y

EXPORT(LMO)
PRODUCTS

ALL
INSTITUES
&
PERSONS
INVOLVED

ALL
STAGES
OF R&D
AND
RELEASE

CONTAINED
USE

ALL TYPES
OF
ORGANISMS

ALL TYPES
ACTIVITIES

REGULATORY PROCESS
NOTIFICATION- PART
IV OF ACT

APPROVAL-PART III OF ACT

DEVELOPING LMO FROM BENCH TO MARKET

R&D
Contained use
Import for contained
use

R&D
Field Trial

Commercialization
Direct intro of LMO to the
environment
Placing in the market
Commercial planting

DIRECT COMMERCIAL USE-NO R&D

Export LMO
Contained use for
industrial production

Import LMO/product for placing in

the market for release

RELEASE ACTIVITIES
R&D purposes in all field experiments
Supply or offer to supply for sale or
placing on the market
Offer as gift, prize or free items
Disposal
Remediation purposes
Any other activity which does not
amount to contained use

CONTAINED USE
Any operation including R&D, production
or manufacturing operation involving
LMOs, undertaken within facility,
installation or other physical structures
such as it prevents contact and impact
of the LMOs on the external
environment.

PENALTY
Non compliance to get approval from NBB for
release & contained use activities involving
LMO/products
Where such person is an individual
A fine not exceeding RM250,000 or to imprisonment for
a term not exceeding 5 years or both
Continuing offence, further fine no exceeding RM10,000
for each day

Where such person is a body corporate

A fine not exceeding RM 500,000
Continuing offence, further fine no exceeding RM
20,000 for each day

INSTITUTIONAL
BIOSAFETY COMMITTEE

IBC
NBB

Formal expert committee of an

organisation undertaking
modern biotechnology (MB)
R&D which involves use of any
LMO/rDNA materials-to
monitor&ensure compliance
to the Biosafety Act 2007 at
the institutional level and safe
handling of modern
biotechnology activities

IBC
IBC Chair
BSO
IBC
members
PI
Laboratory
Personnel

RESPONSIBILITIES OF IBC
1. Provide guidance for safe use of Modern
Biotech
-Guidance-biosafety policies/issues, safety of lab
-Assist in development of procedures
-Notify PI of results of IBCs review

2. Monitoring activities relating to Modern Biotech

-Assess and monitor facilities, procedures, practices, training and
expertise of personnel
-Review and report to head/NBB of non-compliance and significant
related accidents/illness
-Recommend action to be taken for non-compliance

3. Establish/Monitor implementation of

Policies/Procedures
-Recommend approval for activities, periodic review of
projects (extension review, modifications)
-Assess field experiments
-Adopt and implement ERP-accident spills, personnel
contamination
-Ensure information provided in application form is complete
-Routinely review policies/procedures of IBC

4. Determine Biosafety Level (BSL)

-Set

or modify containment level (BSL) for activity

IBC Chair Responsibilities

Provides executive leadership,
dissemination and implementation of
biosafety policies, standards and
procedures applicable to BA
Maintain ultimate responsibility for safe
conduct of activities
Appoint IBC members, BSO and Rapid
Response Team
May appoint ad-hoc subcomm for
Exemption activities

IBC Chair Responsibilities

Have awareness of all requirements for
BA compliance
Provide leadership and support at
management level
Determine that facilities are appropriate
and safe for the research proposal
Ensure laboratory personnel receive
appropriate training prior to the
initiation of research projects

IBC Chair Responsibilities

Support the work/decisions of IBC in its
charge to protect the organization and staff,
reduce liability for the organization and
staff, reduce and be good stewards of public
trust in the products of biotechnology
Provide written notification of IBC decision
to PI
Ensure that related educational activities
are conducted to educate the PI prior to
initiation of research

Biological Safety Officer (BSO)

Appointed by Head of Organization
Member of IBC (voting member) and must be
affiliated with the organization
Recommended to be permanent BSO of the IBC
Contact person for NBB & other regulatory
agencies
Assists in assuring compliance to BA
Responsible for submitting all
applications/notification and annual report of
IBC on behalf organization

Biological Safety Officer (BSO)

Periodically inspect laboratories
Report significant problems/non
compliance/research-related accidents or
illness to IBC
Provide guidance in development of ERP
Make recommendations to IBC on the BSL for
activities
Work with RRT to rpovide technical advice on
research safety and laboratory security
procedures to PI, laboratory personnel and IBC

MOVEMENT AND
TRANSPORT OF LMO

FOCUS
Movement and transport LMO and
related materials
Storage of LMO and related materials

Movement and Transport of LMO &

Related Materials
Between one certified facility and
another certified facility
To/from certified facility during
shipment
From certified facility to a place
where it is to be destroyed or
disposed

Movement and Transport of LMO &

Related Materials
Does not apply to:
Movement within certified facility
Between labs, field trial sites, storage
facility, animal housing facility

Movement & transport

Regulatory authorities (IBC & NBB)
shall be notified
Packaged in secure containers
LMO kept separate from other
materials

Microorganism and Cell

Lines
Primary container secured close, watertight
and sift-proof
Primary container within sealed secondary
container:
Leak proof, resistant to breakage or water damage

Absorbent padding material between primary

& secondary containers:
To prevent breakage during transport
To absorb entire contents of primary containers in
case of breakage or leakage

Seeds, Propagules or Plant

Parts
Transported in durable bags, sealed
envelope or package constructed of
tear & moisture resistant material
Each container - plant material of
single type derived from 1 line of a
single event
Sealed in leak-proof secondary
container- resistant to breakage or
water damage

Seedlings and Plants

Transferred in non-breakable
containers
Within leak-proof secondary
container- resistant to breakage or
water damage
Sufficient packing material between
containers

Seedlings and Plants

GM plants 2 m in height and have not
started flowering, transported in fully
covered vehicle with floor layered with a
durable plastic
Plant bearing flowers or buds should not
be transported
Vehicle compartment sprayed with
pesticide before & after
transportation

Animals
Placed in primary containers
Of sturdy, crush-proof frame of wood,
metal or material of equivalent strength
Surrounded by escape-proof
mesh/netting of strength & mesh size
sufficient to prevent escape of
organisms

Animals
Edges & seams of mesh or netting sealed
to prevent escape of organisms
Primary container secured within a large
container of wood, metal or equivalent
strength material
Primary & secondary containers placed
securely within an outer shipping container
made of corrugated cardboard, wood or
other material of equivalent strength

Animals
Handling & treatment of animals
during transport should follow
requirements of Malaysian Guidelines
on the Principles and Guide to Ethical
use of Laboratory Animals (2000)
and Guidelines for Humane
Transportation of Research Animals
(2006)

Shipment to Foreign
Country
All plant materials & animals should adhere
to the Biosafety Act 2007 and also animal
quarantine regulations of Malaysian
Quarantine and Inspection Services (MAQIS)
and the recipient country
For air transport and shipment, the primary,
secondary and outer containers should
follow relevant International Transport
Association requirements

Labeling Requirements
Clear label outside of package:
Type & amount of materials
Biosafety level of containment
Contact details of person to contact in
event of an unintentional release

Transport Containers
Sanitized prior to filling & after
removal of LMO, if intended to be reused
Containers destroyed after use by
autoclaving or burning
Any residual materials recovered
during the
process of sanitization should be
rendered non-viable

Unintentional Release of
LMO
All attempts should be made to
recover as much of the materials as
possible
Location marked & treated in manner
that ensures no additional release

Unintentional Release of
LMO
Authorized party should:
Notify regulatory authorities
Document corrective actions taken
Review situation to identify cause(s)
Institute changes in practices
Provide additional training of personnel

Records of LMO Transport

Nature & purpose of transport
IBC should maintain adequate
records as LMO move between
research facilities, storage facilities &
field trial sites
Ensure an adequate system is in
place for tracking its movement

Shipment of LMO
Shipper should notify recipient of
date, kind & amount of material to
be sent before shipped
Upon receiving the material,
recipient should confirm that
shipment has arrived intact and no
material has been lost

Storage of LMO and Related

Materials
Stored in such a way that there is no
release into the environment
Storage of multiple samples of LMOeach stored separately in a sealed,
labeled container

Storage Area Access

Access limited to authorized
personnel only
All personnel who have access
should be adequately trained
Access for the purpose of inspection
should be provided to regulatory
officials upon request

Storage
Area
Access
Storage
Area
Maintenance
Clearly labeled at point of access as
containing LMO
Cleaned prior to & immediately following
period of storage
Appropriate pest control implemented
Storage area should be checked and
maintained at regular intervals
Any residue or other material
recovered should be rendered
non-viable

Storage Area Maintenance

Inventory of storage
Type of material stored
Quantity by description
Record of removal-date, individual,
purpose

The regulators and researchers need to work together to create

an enabling environment for modern biotechnology R&D but at
the same time ensuring that human plant and animal health
biological diversity and the environment is conserved