1. Jawahir L. Karihaloo
Coordinator, Asia-Pacific Consortium on Agricultural Biotechnology
(APCoAB), APAARI, New Delhi, India
Kavita Gupta
National Bureau of Plant Genetic Resources, New Delhi, India
1
Biosafety Regulations of Asian
Countries
FAO Regional Workshop on Strengthening Regional Cooperation and National
Capacity Building on Biosafety in Asia - 17-20 June 2013

2. Diversity of Asian region
! 26 countries
! Southeast Asia
! South and Southwest Asia
! North & CentralAsia
! East Asia
Diverse economies and
experiences in adoption of
biotechnology in agriculture
Source: FAO-RAP (2012) Selected Indicators of Food and Agricultural Development
in the Asia-pacific Region 2001-2011

3. Agriculture is important to
Asian region
0
5
10
15
20
25
30
35
40
45
50
Southeast
Asia
South &
Southwest
Asia
North &
Central
Asia
Japan World
Percent
Regions
Agricultural population
Source: FAO-RAP (2012) Selected Indicators of Food andAgricultural Development in the Asia-
pacific Region 2001-2011

4. Policy support to biotechnology
INDIA: “The strategy will lay a strong foundation
for discovery and innovation, effectively utilizing
novel technology platform with potential to
contribute to long term benefits in agriculture,
animal productivity, human health,
environmental security and sustainable industrial
growth”.

5. GM crops approved and
under cultivation
Country Approved
for
food
/feed*
Approved
for
cultivat
ion*
Under cultivation* Area (Mha)
(2013)
China 7 8
cotton, papaya,
tomato, sweet
pepper 4.0
India 1 1 cotton 10.8
Japan 9 8 -- --
Korea 6 3 -- ---
Malaysia 2 -- -- ---
Myanmar 1 1 cotton 0.3
Pakistan 1 1 cotton 2.8
Philippines 7 1 Maize 0.8
Thailand 2 ---- --- ---
Source: htpp://bch.cbd.int/database/decisions;ISAAA* As on 14.06.2013

6. GM crops - some successes
! GM crops are under commercial cultivation in China, India,
Pakistan, Philippines and Myanmar.
! China, Japan, Korea, the Philippines and Thailand have
approved GM crops for food and livestock feed.
! In India the area under Bt cotton reached 10.8 million
hectares in 2012, which constitutes nearly 90% of the total
cotton area of the country.
! In Pakistan, Bt cotton covers 2.8 million ha.
! In Philippines, GM corn covers 45% of 1.2 million ha
potential yellow corn area.

7. Bt cotton in India
• Yield increase by 40%
• Pesticide spray reduction from
4.2 kg/ac to 2.6 kg/ac
• Farmer made net cost saving of
USD 20-24/ha
• Profitability USD 82-365/ha
• Raw cotton export increase
from USD16.5 million (2002-03)
to USD 2.6 billion (2009-10)
Sources: Cotton Corporation of India; Brookes G, Barfoot P
(2012) GM crops: global socio-economic and environmental
impacts 1996-2010. PG Economics Ltd, UK;ISAAA

9. GM Crops in pipeline
Ruane, J. 2013. An FAO e-mail conference on GMOs in the pipeline in
developing countries:The moderator’s summary. FAO.
http://www.fao.org/biotech/biotech-forum/
From the email conference a picture emerged of a GMO pipeline that
contains a considerable quantity and variety of products that may be
commercialized in developing countries within the next five years. As
noted in the conference, whether or when they actually will be
commercialized depends to a large extent on the GMO regulatory
framework in the country.

10. International Landmarks in the
Development of Biosafety Regulations
1973- Gordon Conference led to a moratorium on recombinant research and led US
National Academy of Sciences (NAS) to study safety of certain laboratory
projects.
1975- First NIH guidelines prepared.
1982- Revision of NIH guidelines and exemption granted for rDNA research; and
experiments previously prohibited, were to be reviewed for approval.
1986- OECD International Safety Guidelines for application of biotechnology based on
risk assessment and management of GMOs
2000- Cartagena Protocol adopted in Montreal after >1year of inception
2003- Codex Guidelines for GM foods including the analysis of
unintended effects
2004- IPPC- International Standards for Phytosanitary Measures (ISPM)-11 revised to
include risks posed by LMOs under its standard on Pest risk analysis

11. Landmarks in the Development
of Biosafety Regulations in the Asian Region
India – 1990 (Recombinant DNA safety Guidelines);1998; 1999; 2008
Philippines – 1991(Biosafety Guidelines on genetic engineering);1998; 2002; 2004;
Thailand – 1992 (Biosafety Guidelines on genetic engineering and field release);
Malaysia - 1997 (National Guidelines for the Release of GMOs); 2007; 2010
China - 2001 (Regulation on Administration of Agricultural Transgenic Biosafety); 2002;
2007
Japan - 2003 (Law on conservation and sustainable use of LMOs); 2011
Bangladesh - 2005 (Biosafety Guidelines);2010
Pakistan -2005 (Biosafety Rules)
Cambodia - 2008 (Law on Biosafety), 2010
Iran - 2009 (National Biosafety Act)
Vietnam – 2010 (Decree on biosafety management of GMOs)
Indonesia 2011(Decree No. 61/2011 on evaluating, release of GM crops); 2012

12. Status of Regulatory
Preparedness in Asia*
! Countries that have enforced National Biosafety Regulations
! Bangladesh, China, India, Indonesia, Iran, Japan, Malaysia, Myanmar Pakistan, Philippines, Republic of
Korea,Thailand andVietnam
! Countries that have Biosafety Regulations at various stages of development
! Bhutan, Cambodia, DPR Korea, Laos Republic and Nepal
! Parties to Protocol:
! Afghanistan, Bhutan, Cambodia, China, Iran, India, Indonesia, Japan, DR Korea, R Korea,
Myanmar, Bangladesh, Pakistan, Malaysia, Sri Lanka, Thailand, Philippines, Lao PDR,
Kazakhstan, Mongolia, Maldives,Vietnam (22)
! Protocol ratified:
! Iran, India, Indonesia, DR Korea, R Korea, Myanmar, Bangladesh, Pakistan, Malaysia, Sri Lanka,
Philippines, Lao PDR
* as on 14 June 2013
Source: http://bch.cbd.int/protocol/

13. National Biosafety Policy
A stand-alone policy on biosafety/ part of policy(ies) on
o Biotechnology
o Agriculture
o Biosecurity and/or quarantine
o Biodiversity/ Environmental protection…
Regulatory Regime
Legislation/ laws/ acts/
decrees/ guidelines
General Provisions
Operational Provisions
Administrative
System
• Competent
Authority/ies
• System(s) for
Risk assessment
• Meeting
obligations
under BCH and
national
participation in
BCH
Mechanisms for
public
awareness,
education and
participation
• Public access to
information
• Public involvement
in decision-making
• Awareness and
Education
• BCH
Systems for follow up
• Monitoring for
environmental and effects
on human, animal, plant
• Enforcement
• Offences and Penalties
Components of a National Biosafety Framework
(UNEP-GEF)

14. UNEP-GEF Support for NBF
Status of Countries in Asia
! Countries with National
Biosafety Framework (NBF)
! Countries with NBF and
draft Biosafety Regulations
! Countries with NBF and
notified Biosafety Laws
! Bhutan, Mongolia, Nepal
! DPR Korea, Kazakhstan,
Laos, Sri Lanka, Syria,
Thailand
! Bangladesh, Cambodia,
Indonesia, Iran, Philippines,
Republic of Korea

15. A Typical Regulation on GMOs
A typical National Biosafety Framework includes
! A national policy for biosafety as a stand alone document or
a part of larger biotechnology/ biosecurity strategy
! The regulatory system including mechanisms for risk
assessment and management
! A system for monitoring and inspection to ensure
transparency and accountability
! Information sharing as an important component for regional
cooperation in risk assessment,evaluation and management

16. Provisions for Risk Assessment
and Risk Management
! China- risk assessment called “safety assessment system”, risk management system
“safety system” with clear-cut implementation bodies
! Indonesia- mechanism outlined in GM regulation defines risk assessment on
environment, human and animal health
! Korea- two separate systems for obtaining food safety approvals and for
conducting environmental risk assessments for biotech crops
! Bangladesh, India, Pakistan, Philippines- the risk assessment on case-by-case
basis based on level of risk and end use and several ministries/ committees notified
! Japan- details of risk assessment modalities???
! Thailand- risk assessment of GMO categorized as (1) work bearing no risk; (2)
work bearing low risk; (3) work with high risk.

17. Monitoring and Inspection System
! China- regulations stipulate authorities, coordination mechanisms, emergency
handling system for monitoring of GMOs.
! India, Philippines- monitoring system with specific committees defined under
various Ministries for effective monitoring and inspection.
! Thailand, Pakistan- institutional arrangements for monitoring and control similar
to India, with several organizations involved
! Indonesia- Biosafety Commission monitors the biosafety testing and assessment
and results publicized by mass media for 60 days
! Korea- No crops using biotechnology commercialized to date
! Bangladesh- only reporting mechanism spelt out
! Japan- regulation is silent on mechanism for monitoring and inspection.

18. Trade Policies concerning GM plants
! China- GMOs require permission for trade and transit
! India, Thailand- Import and export of GM plants or products allowed for
research
! Philippines, Indonesia, Japan biosafety law allows import of GMOs
! Korea import of biotechnology crops and products permitted
! Bangladesh- Guidelines silent on exchange
! Pakistan - import, export of LMOs permitted

19. Bt eggplant (Brinjal)
Global distribution of
eggplant fruit and shoot borer

20. Review Bt brinjal safety
Three High level Technical Committees that reviewed the safety of Bt brinjal:
Committees constituted by GEAC
1. RCGM
2. Expert Committee of 13 members - 2006
3. Expert Committee of 15 members - 2009
On the 14th October 2009,GEAC concluded that Bt brinjal is safe for
environmental release

21. Ministry decision
! Post GEAC recommendation, Minister of E&F invited
comments on the Bt brinjal reports
! Seven Nationwide consultations conducted in Jan and Feb
2010
! On Feb, 9th 2010 – moratorium on the release of Bt brinjal
! Parliamentary Committee Report on GM Food Crops

22. EFSA proactive response
to emerging issues

23. Regional Collaboration in Regulatory
Management - EFSA
(one- door- one- key approach)
Applicant submits
to National Authority
European Food Safety Authority
• Use of GMOs for food and feed
• Deliberate release into Environment
EFSA informs EU
members and public
and establishes
“Opinion” within 6
months
National Food
Safety Authority
food safety or
environmental
risk assessment as
per EU Guidelines
“EFSA Opinion” to EU
Commission, Member
State and Applicant
European
Group on
Ethics in
Science and
New
Technology
Draft
decision
Standing
Committee on
Food Chain and
Animal Health
EU CouncilApproval of
GM product
(valid for 10 yrs)

24. Workshop on
Biosafety Regulations in the Asia-Pacific Region

25. ! Asia is too large and diverse (socially, ecologically,
economically, politically)
! Regional and sub-regional efforts may be initiated with
! Mutual understanding of regulatory systems
! Sharing of information including risk assessment dossiers
! Capacity strengthening for risk assessment, management, handling
and detection of LMO’s, communication systems
Is the EU set-up applicable to
Asian Region?

26. ! Biosafety and related acts, rules,
regulations and guidelines of 39
countries.
! Key features of the regulations.
! Status of national legislative
preparedness with respect to
Cartagena Protocol on Biosafety.
! Additional chapters on status of
biotechnology, biosafety issues
and international instruments
on biosafety.
26

27. Biosafety Regulations of
Asia-Pacific countries

28. http://www.apcoab.org/modules.php?name=Co
ntent&pa=showpage&pid=75

29. Stakeholders’ Dialogue on
Biosafety Regulations in the Asia-Pacific
Region, Bangkok, (16-17 April 2013)
• Prioritization of GM R&D for smallholders
• Enhancing Communication for PublicAwareness
• Regional Cooperation for Biosafety Management

30. Preamble and Justification
! Cooperation in biosafety management should be based on
basic and practical national cooperation before expanding it to
the sub-regional and regional levels
! The lack of appropriate science-based and cost effective
regulatory systems continues to be the major constraint to
adoption of modern biotechnology. Rigorous but not onerous
regulation management is needed for small and low income
developingAsia-pacific countries
! Asia Pacific countries are highly diversified in terms of R & D,
human resources development,basic infrastructure, facility etc.,
and capacity building mechanism which are urgently needed in
the whole region. Different A & P countries are also at
different stages of biotechnology and biosafety adoption.

31. Recommendations
! Cooperation, collaboration, linkages and networking in
modern biotechnology/ biosafety among the Asia Pacific
countries need to be initiated, implemented and
strengthened.
! There is a need on the alignment and synergies of the
existing policies under different national component
authorities in each Asia Pacific country and sub-regional
or regional economic/ political associations

32. ! There exists an acceptable resolution on the co-existence
issues among conventional agriculture, organic farming
and biotech crop cultivation.A settlement is urgently
needed in each and other Asia Pacific countries
concerned.
! In order to accomplish these aims and make them
sustainable there is a need of an effective financial
mechanism and assistance such as financial mechanism
under GEF.

33. Collaborative Strengthening
Biosafety Systems
! Resources sharing
! technical
! material
! expertise
! Experience sharing
! methodologies
! materials
! Information sharing
! Regional capacity building
! Regional Centers of Excellence