Capacity Building in Biosafety  

Short term orientation course on Biosafety and Biotech regulations, TERI, New Delhi

February 7, 2006

By

Dr. Vibha AhujaDeputy General Manager

Biotech Consortium India LimitedNew Delhi

NEED FOR BIOSAFETY NEED FOR BIOSAFETY REGULATIONSREGULATIONS

NATIONAL BIOSAFETY FRAMEWORK ESSENTIAL TO REGULATE PRODUCTION AND RELEASE OF GMOs IN ANY COUNTRY WITH A BIOTECHNOLOGY PROGRAMME

ENSURES SAFE ACCESS TO NEW PRODUCTS AND TECHNOLOGIES DEVELOPED IN THE COUNTRY OR ELSEWHERE.

PROVIDES A LEVEL OF PUBLIC CONFIDENCE THAT PRODUCTS PLACED ON THE MARKET HAVE BEEN ASSESSED AS SAFE

EMERGENCE OF REGULATIONSEMERGENCE OF REGULATIONS

FIRST SET OF RECOMMENDATIONS FORMULATED AT ASILOMAR IN 1975

THESE FORMED THE BASIS OF SUBSEQUENT REGULATIONS IN USA AND OTHER COUNTRIES

INITIALLY THE FOCUS WAS MORE ON USE OF TECHNOLOGY AND THUS SAFETY WITHIN THE LABORATORY AND HUMAN HEALTH IN GENERAL

THE FOCUS SHIFTED TO THE END PRODUCTS IN ADDITION TO THE TECHNOLOGY WITH RELEASE OF COMMERCIAL PRODUCTS

STATUS OF GMOs IN STATUS OF GMOs IN AGRICULTUREAGRICULTURE

SO FAR 17 CROPS APPROVED FOR COMMERCIAL CULTIVATION

MAJOR CHARACTERISTICS ARE INSECT RESISTANCE, HERBICIDE TOLERANCE, VIRUS RESISTANCE AND IMPROVED PRODUCT QUALITY

MAJOR COUNTRIES INCLUDE USA, CANADA, JAPAN, CHINA, EU, ARGENTINA, SOUTH AFRICA

ONLY FOUR CROPS BEING MARKETED COMMERCIALLY I.E., CORN, COTTON, SOYBEAN AND CANOLA

COMMERCIAL PRODUCTION INITIATED FOR PAPAYA, SQUASH AND TOBACCO IN USA

RESEARCH & DEVELOPMENT STATUS

63 COUNTRIES INVOLVED AT VARIOUS STAGES 57 PLANTS IDENTIFIED FOR DEVELOPMENT SECOND GENERATION OF TRAITS INCLUDE

MODIFICATIONS SUCH AS NUTRITIONAL ENHANCEMENT, DISEASE TOLERANCE, STRESS TOLERANCE AND PRODUCTION OF PHARMACEUTICALS

INDIAN STATUS

ONLY ONE CROP APPROVED 14 CROPS UNDER VARIOUS STAGES OF

CONTAINED FIELD TRIALS INCLUDE BRINJAL, COTTON, CABBAGE,

GROUNDNUT, PIGEON PEA, MUSTARD, POTATO, SORGHUM, TOMATO, TOBACCO, RICE, OKRA AND CAULIFLOWER

TRAITS INCLUDE INSECT RESISTANCE, HERBICIDE TOLERANCE, VIRUS RESISTANCE, NUTRITIONAL ENHANCEMENT, SALT TOLERANCE, FUNGAL RESISTANCE

REGULATORY FRAMEWORK IN INDIAREGULATORY FRAMEWORK IN INDIA

1. GOVERNMENT RULES FOR GMOs2. RECOMBINANT DNA GUIDELINES, 19903. GUIDELINES FOR RESEARCH IN TRANSGENIC PLANTS,

19984. SEED POLICY, 20025. PREVENTION OF FOOD ADULTERATION ACT6. THE FOOD SAFETY AND STANDARDS BILL, 20057. PLANT QUARANTINE ORDER 20038. TASK FORCE ON APPLICATION OF AGRICULTURAL 9. BIOTECHNOLOGY10. DRAFT NATIONAL ENVIRONMENT POLICY, 200411. DRAFT NATIONAL BIOTECHNOLOGY STRATEGY 2005

CARTAGENA PROTOCOL: STATUS OF COMPLIANCE IN INDIA

1. INDIA RATIFIED THE PROTOCOL ON 23RD JANUARY 2003 AND IT CAME INTO FORCE IN SEPTEMBER 2003

2. MAJOR ELEMENTS THAT MERIT ATTENTION INCLUDE AIA PROCEDURE, SIMPLIFIED SYSTEM FOR AGRICULTURAL COMMODITIES, RISK ASSESSMENTS, RISK MANAGEMENT AND EMERGENCY PROCEDURES, EXPORT DOCUMENTATION, BCH, CAPACITY BUILDING, PUBLIC AWARENESS AND PARTICIPATION AND ISSUE OF NON PARTIES

3. COMPETENT AUTHORITY AND CONTACT POINTS NOTIFIED

4. RULES IN PLACE BUT HARMONIZATION REQUIRED WITH THE PROCEDURES FOR TRANSBOUNDARY MOVEMENTS

Contd/-

3. DBT GUIDELINES FOR RESEARCH IN PLANTS BUT ENVIORNMENTAL RISK ASSESMENT PROCEDURES TO BE STREAMLINED INCLUDING THE BASELINE INFORMATION

4. DETAILED GUIDELINES REQUIRED FOR HANDLING, TRANSPORT, PACKAGING AND IDENTIFICATION

5. INFORMATION SHARING NEEDS TO BE STRENGTHENED

6. METHODS AND MECHANISMS FOR DETECTING UNINTENTIONAL OR ILLEGAL MOVEMENTS

7. MECHANIMS FOR DETERMINING VALUE ADDITION TO SPECIFIC SOCIO ECONOMIC GROUPS

8. NATIONAL CONSULTATION ON L&R REGIME

OBJECTIVE:

To identify the training needs of agricultural biotechnology stakeholders in the public and private sectors as regards genetically engineered crops, livestock, and the products derived from these (including foods).

TRAINING NEEDS ASSESSMENT SURVEY

AREAS FOR TRAININGAREAS FOR TRAINING

Development of LMOs/GMOs; Risk assessment (impact on human health and environment); Risk management; Identification of LMOs/GMOs; Regulatory capacity building; Human resource development and training; Public awareness, education and participation; Information exchange and data management; Scientific and institutional collaborations; Technology transfer; Socio-economic considerations; Sustainable use and conservation of biodiversity

FINDINGS OF THE FIELD SURVEYFINDINGS OF THE FIELD SURVEY

Stakeholders contacted through questionnaires/interaction

820

13

15

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6

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20Central government

State government

Regulatory bodies

Industry

Research organizations

Social experts

Agriculture service providers

Others

PRIORITY RANKING OF AREASPRIORITY RANKING OF AREAS

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STAKEHOLDERSSTAKEHOLDERS Senior government officials (policy/decision makers); Regulators (e.g. application reviewers/assessors, advisors,

administrators); Enforcement officials (e.g. field inspectors health, food and agriculture

departments, custom and plant quarantine officers); Scientists/technical personnel who review or prepare applications (public

and private sector); Legal experts; Economists; Information managers including IT specialists; Graduate and undergraduate students; Interest groups (e.g. consumer groups, farmer associations, professional

associations, NGOs); Mass media and outreach/extension workers (e.g. journalists and

agricultural extensionists) and General public and political leadership

PROPOSED TRAINING MODULESPROPOSED TRAINING MODULES PUBLIC AWARENESS ACTIVITIES:

• USE OF PRINT AND ELECTRONIC MEDIA • USE OF EXISTING NETWORKS AND CHANNELS SUCH AS

AGRICULTURAL EXTENSION OFFICES AND DEPARTMENTS, NUTRITION EDUCATION DEPARTMENTS, HEALTH EDUCATION PROGRAMMES ETC.

• NETWORK OF SCIENTIFIC COMMUNICATORS • RISK COMMUNICATION STRATEGIES FOR REGULATORS • DEVELOPMENT OF TV/RADIO EDUCATIONAL PROGRAMMES• PRIMERS/BROCHURES/BOOKLETS/FAQS/GLOSSARY OF

TERMS • USE OF LOCAL LANGUAGES • INTERACTION WITH MEDIA

Contd../-

NATIONAL WORKSHOPS: • SERIES OF EVENTS FOR BORDER CONTROL

AUTHORITIES, SCIENTISTS OF SAUs, RESEARCH INSTITUTIONS, SCIENTISTS OF HEALTH AND NUTRITION ORGANIZATIONS, HEALTH AND FOOD INSPECTORS

• CONSULTATIONS/WORKSHOPS ON POST RELEASE MONITORING PROCEDURES

• NATIONAL CONSULTATIONS ON VARIOUS ARTICLES OF CARTAGENA PROTOCOL

• WORKSHOPS ON VARIOUS CROPS UNDER DEVELOPMENT

• SUGGESTED APPROACH TO HAVE COORDINATING AGENCIES AT THE CENTRAL LEVEL WHICH CAN INTERACT WITH THE LOCAL/REGIONAL ORGANIZATIONS TO HAVE UNIFORMITY AND COMPLIMENTARITY WITH THE NATIONAL APPROACH.

Contd../-

LABORATORY TRAINING: • TRAINING PROGRAMMES ON GOOD

LABORATORY PRACTICES FOR RESEARCHERS• SERIES OF SEMINARS ON SPECIFIC AREAS

PERTINENT TO GMO BIOSAFETY IN BOTH FOOD AND FEED SAFETY EVALUATION AND ENVIRONMENTAL RISK ASSESSMENTS

• SHORT TERM TRAINING ON DETECTION METHODS

Contd../-

UPDATION OF RULES/GUIDELINES: • REVIEW AND UPDATE THE PROVISIONS OF

NATIONAL RULES AND GUIDELINES AS WELL AS NOTIFY ADDITIONAL POLICIES/RULES/ GUIDELINES

• GUIDELINES TO BE DEVELOPED FOR HANDLING, PACKAGING AND TRANSPORT OF GMOS

• GUIDELINES TO BE DEVELOPED FOR NEW GMOS AND PRODUCTS AND NEWER APPLICATIONS OF EXISTING GMOS E.G. TRANSGENIC ANIMALS INCLUDING LIVESTOCK AND FISH, USE OF PLANTS AND ANIMALS FOR PRODUCTION OF PHARMACEUTICALS/ BIOCHEMICALS

Contd../-

STUDIES AND SURVEYS:• REVIEW OF GUIDELINES FOR TRANSPORT OF

LMOS IN VARIOUS COUNTRIES • STUDY ON GLOBAL STATUS, IMPACT AND

COST IMPLICATIONS OF LABELING• BASELINE SURVEYS FOR DEVELOPING

PROTOCOLS FOR RISK ASSESSMENT PARTICULARLY ECOLOGICAL ISSUES

• BASELINE SURVEYS FOR ASSESSMENT OF AWARENESS AMONG THE USER SEGMENTS

Contd../-

PUBLICATION/DOCUMENTS/WEBSITES/ VIDEO FILMS: • HANDBOOKS FOR VARIOUS REGULATORY

BODIES.• RESOURCE MATERIAL ON BIOSAFETY ISSUES

FOR SPECIFIC STAKEHOLDERS.• MANUALS ON RISK ASSESSMENT AND

MANAGEMENT PROCEDURES, AIA PROCEDURE, METHODS AND APPROACHES FOR LMO DETECTION.

• NEWSLETTERS/BULLETINS• VIDEO FILMS ON SUCCESSFUL CASE STUDIES• CDS/VIDEOS ON REGULATORY

REQUIREMENTS • DEDICATED BIOSAFETY WEBSITE ETC.

Contd../-

INTERNATIONAL CONFERENCES FOR CAPACITY BUILDING REQUIREMENTS:

• LMOs TESTING METHODS, FACILITIES AND EQUIPMENTS INCLUDING BOTH PRIVATE AND PUBLIC SECTOR

• RISK ASSESSMENT AND MANAGEMENT PROCEDURES INCLUDING CASE STUDIES BY DIFFERENT COUNTRIES

• REGIONAL CONFERENCE (ASIA OR ASIA PACIFIC) ON UNDERSTANDING AND HARMONIZATION OF BIOSAFETY RULES, GUIDELINES AND PRIORITIES/APPROACH FOR EFFECTIVE IMPLEMENTATION OF CARTAGENA PROTOCOL.

STUDY TOURS:• PARTICIPATION IN THE INTERNATIONAL

CONFERENCES BY LEADING SCIENTISTS FROM BOTH PUBLIC AND PRIVATE SECTOR.

• STUDY TOURS/EXCHANGE PROGRAMMES

DIRECTORY OF RESOURCE PERSONS

COMPENDIUM OF BIOSAFETY TRAINING PROGRAMMES

LONG-TERM TRAINING PROGRAMMES

BIOTECH CONSORTIUM INDIA LTD.BIOTECH CONSORTIUM INDIA LTD.

Incorporated : 1990 Promoter : DBT Shareholders : All India FIs, Industry Clients : Industry

RIs/Universities Industrial promotional agencies

International organisations

No. of Clients : > 150

BCIL : ACTIVITIESBCIL : ACTIVITIES

TECHNOLOGY TRANSFER

- Facilitation of Industry/ Research

CONSULTANCY

- PFR / DPR, market surveys, sectoral studies SYNDICATION OF FUNDS INFORMATION DISSEMINATION

- Biotech club, publication, seminar and workshop MANPOWER TRAINING

- BITP and placement

(Won National Award 2001 for Biotechnology Commercialization)

BIOSAFETY: KEY AREA OF OPERATION OF BCIL

Working since 1998 with the two regulatory bodies i.e. Ministry of Environment & Forests and Department of Biotechnology, Govt. of India on biosafety issues related to genetically modified organisms (GMOs)

Activities include organizing workshops/ consultations/ conferences for various stakeholders, preparation of documents, setting up of websites etc.

Contd../-

INTERNATIONAL EVENTS: Two regional workshops sponsored by UNEP/GEF on

Biosafety for the Asia-Pacific Region at New Delhi (1998)

Workshop on biotechnology for environmental protection and sustainable development, in cooperation with MOEF and the Department of Environment, Government of Canada at New Delhi (2003)

Biotec India International 2003, Hyderabad, an international conference organized to deliberate on the latest developments in biotechnology (2003) – A separate section on biosafety

International Conference on Foods derived from GM Crops (2005)

Contd../-

NATIONAL SERIES OF WORKSHOPS/ CONSULTATIONS Five workshops on biosafety aspects of genetically

modified organisms (1998) Six workshops on biosafety aspects of genetically

modified organisms (2002) Workshops on “Biosafety issues related to transgenic

crops” in six Bt cotton growing states (2004) Six workshops on “Biosafety issues related to

transgenic crops with special focus on Bt cotton” covering nine Bt cotton states (2005)

Six National Consultation on biosafety aspects related to Genetically Modified Organisms for members and nominees of DBT on Institutional Biosafety Committees (IBSCs) (2004)

Four workshops on Safety assessment of GM foods (2005)

Contd../-

 NATIONAL WORKSHOPS/CONSULTATIONS

Workshop on Capacity Building on Biosafety (2005) National Consultation on Liability and Redress in the

Context of Cartagena Protocol on Biosafety (2005) National Workshop on Management of Field trials of

GM Crops in India (2005)

STUDIES/SURVEYS Studies on recombinant therapeutics, transgenic

animal models and recombinant companies for both government and industry (2000 – 2004) 

Contd../-

 WEBSITES/NEWSLETTERS Establishment and maintenance of India’s Biosafety

Clearing House Establishment and maintenance of Website on

Capacity building on biosafety, a project funded by World Bank/GEF

Establishment and maintenance of a web based database on Indian GMO Research Information System.

Biosafety Newsletter

INTERACTION WITH STATE LEVEL AGENCIES

  Facilitated interaction amongst state government

officials (particularly agricultural departments, members of SBCCs and other related departments) with scientists, experts from central government, industry and farmers in Bt cotton growing state)

Arranged demonstration of Bt cotton detection kits for all the stakeholders.

Provided opportunity for feedback from all the stakeholders including the scientists from institutions, state government, farmers and NGOs.

SUGGESTIONS FOR THE STATE GOVERNMENTS

Extensive capacity building efforts required at all levels starting from policy makers, research scientists, implementing officers at state level, media, farmers etc.

Specific workshops to be planned for various categories

Regular participation of various stakeholders in the national level events.

Contd../-

Information dissemination through preparation and circulation of documents/brochures catering to specific requirements of various category of stakeholders (in English, Hindi and local languages).

Use of internet by creating a specific website or a component of some existing websites to provide authenticated information from the government on various biosafety issues.

Mass awareness programmes could be channeled through state agricultural universities and other education institutions traditionally trusted by farmers and consumers.

AREAS OF ASSISTANCE BY BCIL TO STATE GOVERNMENT

Preparation of various documents with updated information such as primers, handbooks, brochures, leaflets, newsletters, background documents for workshops etc.

Planning the workshops in terms of identification of topics, programmes, speakers/faculty etc. for SBCCs, DLCs, media, farmers, etc.

Capacity building of SAUs and their field stations for effective management and monitoring of field trials.

Assisting in establishment and maintenance of website Regular information about the national/international

developments including the rules and regulations, events etc.