PowerPoint Presentation - Ministry of Environment and Forests

workkinkajouBiotechnology

Dec 5, 2012 (4 years and 6 months ago)

276 views

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


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 INDIA

1.
GOVERNMENT

RULES

FOR

GMOs

2.
RECOMBINANT

DNA

GUIDELINES,

1990

3.
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 23
RD

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 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 SURVEY

Stakeholders contacted through questionnaires/interaction
8
20
13
15
53
6
15
20
Central government
State government
Regulatory bodies
Industry
Research organizations
Social experts
Agriculture service providers
Others
PRIORITY RANKING OF AREAS

0
50
100
150
200
250
300
350
400
450
500
Risk assessment
Risk management
HRD & training
Regulatory capacity building
Institutional collaboration
Sustainable use of biodiversity
Public awareness
Technology transfer
Identification
Information exchange
Socio-economic considerations
Development of LMOs/GMOs
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


PROPOSED TRAINING MODULES


PUBLIC AWARENESS ACTIVITIES:



USE OF PRINT AND ELECTRONIC MEDIA


USE OF
E
XISTING 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.


Incorporated


:

1990



Promoter



:

DBT


Shareholders


:

All India FIs, Industry



Clients



:

Industry





RIs/Universities




Industrial promotional






agencies






International organisations



No. of Clients


:

> 150


BCIL : 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.