Transcript Document

Capacity Building in Biosafety
Short term orientation course on
Biosafety and Biotech regulations, TERI, New Delhi
February 7, 2006
By
Dr. Vibha Ahuja
Deputy General Manager
Biotech Consortium India Limited
New Delhi
NEED FOR BIOSAFETY
REGULATIONS
 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 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
AGRICULTURE
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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
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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
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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 INDIA
1.
2.
3.
GOVERNMENT RULES FOR GMOs
RECOMBINANT DNA GUIDELINES, 1990
GUIDELINES FOR RESEARCH IN TRANSGENIC
PLANTS, 1998
4. SEED POLICY, 2002
5. PREVENTION OF FOOD ADULTERATION ACT
6. THE FOOD SAFETY AND STANDARDS BILL, 2005
7. PLANT QUARANTINE ORDER 2003
8. TASK
FORCE
ON
APPLICATION
OF
AGRICULTURAL
9. BIOTECHNOLOGY
10. DRAFT NATIONAL ENVIRONMENT POLICY, 2004
11. 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
TRAINING NEEDS ASSESSMENT
SURVEY
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).
AREAS FOR TRAINING
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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 SURVEY
Stakeholders contacted through questionnaires/interaction
20
8
20
Central government
State government
15
Regulatory bodies
13
6
Industry
Research organizations
Social experts
15
Agriculture service providers
Others
53
0
Development of LMOs/GMOs
Socio-economic considerations
Information exchange
Identification
Technology transfer
Public awareness
Sustainable use of biodiversity
Institutional collaboration
Regulatory capacity building
HRD & training
Risk management
Risk assessment
PRIORITY RANKING OF AREAS
500
450
400
350
300
250
200
150
100
50
STAKEHOLDERS
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
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PROPOSED TRAINING MODULES
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PUBLIC AWARENESS ACTIVITIES:
• USE OF PRINT AND ELECTRONIC MEDIA
• USE OF EXISTING NETWORKS AND CHANNELS
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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
Contd../INTERACTION WITH MEDIA
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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../-
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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../-
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UPDATION OF RULES/GUIDELINES:
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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../-
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STUDIES AND SURVEYS:
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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../-
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PUBLICATION/DOCUMENTS/WEBSITES/
VIDEO FILMS:
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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../-
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INTERNATIONAL CONFERENCES FOR
CAPACITY BUILDING REQUIREMENTS:
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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.
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STUDY TOURS:
• PARTICIPATION IN THE INTERNATIONAL
CONFERENCES BY LEADING SCIENTISTS FROM
BOTH PUBLIC AND PRIVATE SECTOR.
• STUDY TOURS/EXCHANGE PROGRAMMES
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DIRECTORY OF RESOURCE PERSONS
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COMPENDIUM OF BIOSAFETY TRAINING
PROGRAMMES
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LONG-TERM TRAINING PROGRAMMES
BIOTECH CONSORTIUM INDIA LTD.
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Incorporated
 Promoter
 Shareholders
 Clients
:
:
:
:
1990
DBT
All India FIs, Industry
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:
> 150
No. of Clients
Industry
RIs/Universities
Industrial promotional
agencies
International organisations
BCIL : ACTIVITIES
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TECHNOLOGY TRANSFER
- Facilitation of Industry/ Research
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CONSULTANCY
- PFR / DPR, market surveys, sectoral studies
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SYNDICATION OF FUNDS
 INFORMATION DISSEMINATION
- Biotech club, publication, seminar and workshop
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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)
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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../-
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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
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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
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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)
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Arranged demonstration of Bt cotton detection kits
for all the stakeholders.
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Provided opportunity for feedback from all the
stakeholders including the scientists from
institutions, state government, farmers and NGOs.
SUGGESTIONS FOR THE STATE
GOVERNMENTS
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Extensive capacity building efforts required at all
levels starting from policy makers, research
scientists, implementing officers at state level, media,
farmers etc.
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Specific workshops to be planned for various
categories
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Regular participation of various stakeholders in the
national level events.
Contd../-
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Information dissemination through preparation and
circulation of documents/brochures catering to specific
requirements of various category of stakeholders (in
English, Hindi and local languages).
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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.
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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
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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.