Biosafety Regulations of Asian Countries 2013

06-08-2013

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

Biosafety Regulations of Asian Countries

FAO Regional Workshop on Strengthening Regional Cooperation and National Capacity Building on Biosafety in Asia - 17-20 June 2013

Diversity of Asian region

! 26 countries! Southeast Asia ! South and Southwest Asia! North & Central Asia! East Asia

Diverse economies andexperiences in adoption ofbiotechnology in agriculture

Source: FAO-RAP (2012) Selected Indicators of Food and Agricultural Development in the Asia-pacific Region 2001-2011

Agriculture is important to Asian region

SoutheastAsia

South &Southwest

North &Central

Japan World

Regions

Agricultural population

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”.

GM crops approved and under cultivation

Country Approved for

food/feed*

Approved for

cultivation*

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

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.

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Kavita Gupta

SoutheastAsia

South &Southwest

North &Central

Japan World

Regions

food/feed*

Approved for

cultivation*

China 7 8

pepper 4.0

Japan 9 8 -- --

Korea 6 3 -- ---

Thailand 2 ---- --- ---

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Kavita Gupta

SoutheastAsia

South &Southwest

North &Central

Japan World

Regions

food/feed*

Approved for

cultivation*

China 7 8

pepper 4.0

Japan 9 8 -- --

Korea 6 3 -- ---

Thailand 2 ---- --- ---

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Kavita Gupta

SoutheastAsia

South &Southwest

North &Central

Japan World

Regions

food/feed*

Approved for

cultivation*

China 7 8

pepper 4.0

Japan 9 8 -- --

Korea 6 3 -- ---

Thailand 2 ---- --- ---

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Kavita Gupta

SoutheastAsia

South &Southwest

North &Central

Japan World

Regions

food/feed*

Approved for

cultivation*

China 7 8

pepper 4.0

Japan 9 8 -- --

Korea 6 3 -- ---

Thailand 2 ---- --- ---

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Kavita Gupta

SoutheastAsia

South &Southwest

North &Central

Japan World

Regions

food/feed*

Approved for

cultivation*

China 7 8

pepper 4.0

Japan 9 8 -- --

Korea 6 3 -- ---

Thailand 2 ---- --- ---

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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

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 thatcontains a considerable quantity and variety of products that may becommercialized in developing countries within the next five years. Asnoted in the conference, whether or when they actually will becommercialized depends to a large extent on the GMO regulatoryframework in the country.

International Landmarks in the Development of Biosafety Regulations

1973- Gordon Conference led to a moratorium on recombinant research and led USNational Academy of Sciences (NAS) to study safety of certain laboratoryprojects.

1975- First NIH guidelines prepared.

1982- Revision of NIH guidelines and exemption granted for rDNA research; andexperiments previously prohibited, were to be reviewed for approval.

1986- OECD International Safety Guidelines for application of biotechnology based onrisk 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 toinclude risks posed by LMOs under its standard on Pest risk analysis

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

Status of Regulatory Preparedness in Asia*

! Countries that have enforced National Biosafety Regulations

! Bangladesh, China, India, Indonesia, Iran, Japan, Malaysia, Myanmar Pakistan, Philippines, Republic ofKorea,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/

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Bt cotton in India

unintended effects

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Bt cotton in India

unintended effects

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Bt cotton in India

unintended effects

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Bt cotton in India

unintended effects

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Bt cotton in India

unintended effects

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National Biosafety PolicyA stand-alone policy on biosafety/ part of policy(ies) on

o Biotechnologyo Agricultureo Biosecurity and/or quarantineo Biodiversity/ Environmental protection…

Regulatory Regime Legislation/ laws/ acts/ decrees/ guidelines

General ProvisionsOperational Provisions

AdministrativeSystem

• Competent Authority/ies

• System(s) for Risk assessment

• Meeting obligations under BCH and national participation in BCH

Mechanisms forpublic

awareness,education andparticipation

• 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) 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

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 riskassessment and management

! A system for monitoring and inspection to ensuretransparency and accountability

! Information sharing as an important component for regionalcooperation in risk assessment, evaluation and management

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 onenvironment, human and animal health

! Korea- two separate systems for obtaining food safety approvals and forconducting environmental risk assessments for biotech crops

! Bangladesh, India, Pakistan, Philippines- the risk assessment on case-by-casebasis 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.

Monitoring and Inspection System

! China- regulations stipulate authorities, coordination mechanisms, emergencyhandling system for monitoring of GMOs.

! India, Philippines- monitoring system with specific committees defined undervarious Ministries for effective monitoring and inspection.

! Thailand, Pakistan- institutional arrangements for monitoring and control similarto India, with several organizations involved

! Indonesia- Biosafety Commission monitors the biosafety testing and assessmentand 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.

Trade Policies concerning GM plants

! China- GMOs require permission for trade and transit

! India, Thailand- Import and export of GM plants or products allowed forresearch

! 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

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• BCH

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• BCH

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• BCH

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• BCH

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• BCH

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Bt eggplant (Brinjal)

Global distribution of eggplant fruit and shoot borer

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

On the 14th October 2009, GEAC concluded that Bt brinjal is safe for environmental release

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

EFSA proactive response to emerging issues

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 Authorityfood 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)

Workshop onBiosafety Regulations in the Asia-Pacific Region

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1. RCGM

Ministry decision

months

Draft decision

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1. RCGM

Ministry decision

months

Draft decision

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1. RCGM

Ministry decision

months

Draft decision

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1. RCGM

Ministry decision

months

Draft decision

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1. RCGM

Ministry decision

months

Draft decision

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! 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?

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! 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.

Biosafety Regulations of Asia-Pacific countries

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

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 Public Awareness• Regional Cooperation for Biosafety Management

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 developing Asia-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.

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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

! 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.

Collaborative Strengthening Biosafety Systems

! Resources sharing ! technical ! material ! expertise

! Experience sharing ! methodologies ! materials

! Information sharing ! Regional capacity building

! Regional Centers of Excellence

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Recommendations

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Recommendations

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Recommendations

Biosafety Regulations of Asian Countries 2013

Food

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