Indian Experience in Environmental safety Assessment of GM cropsAssessment of GM crops

– lessons learnt and future outlook

Regulatory Frame work

S R RAOPUBLIC 

S.R.RAO,Advisor,Department of Biotechnology .

POLICY

Science of risk 

assessment

Public concerns

Ministry of Science & TechnologyGovernment of Indiasrrao@dbt.nic.in

assessment

srrao@dbt.nic.in

Recombinant DNA SafetyIBSC

Indian Regulatory System

EPA Act 1986

Recombinant DNA Safety Guidelines, 1990

Revised guidelines for research

s

1986g

in transgenic plants & guidelines for toxicity and allergenicity evaluation of

transgenic seeds, plants and plant parts 1998M

Rules Standard Operating

Procedures for confined field trials 2008

plant parts, 1998

RC

GM

1989field trials 2008

Guidelines for the conduct of confined field trials of

regulated GE crops 2008

R

Guidelines and protocols for food and feed safety

regulated, GE crops, 2008

assessment of GE crops, 2008GEAC

Constitution of GEAC ( 31 members)Chairman : Environment and forests

Scientific agencies/institutions 1 CCMB

Regulatory agencies6Director General of Health services

Chairman : Environment and forests Member convener : Environment and forests

1.CCMB2.CSIR 3.ICAR4 DBT

6Director General of Health services7Central pollution control board8Directorate of plant protection9Food safety & standards Authority4.DBT

5.BARC6.ICMR

9Food safety & standards Authority of India

Ministries Independent Members 11Ministries10. Environment & Forests11. Industry12. Agriculture

Independent Members - 1117-20 Universities21-23 CSIR Institutes 24 ICAR Institutes12. Agriculture

13. Commerce14. External affairs15.Health & Family welfare

24 ICAR Institutes 25 Consumer 26 Social science 27 Lawy

16. food processing industry ----------------------------------------------------28-29 Supreme Court - Observers

VARIOUS GENES/EVENTS OF Bt COTTON UNDER CULTIVATION AND EVALUATION IN INDIA

Approved Events AS PER OLD GUIDLINESMON 531(cry1Ac gene)

CULTIVATION AND EVALUATION IN INDIA

MON 531(cry1Ac gene),

• MON 15985 (cry1Ac & cry2Ab genes),

• GFM Cry 1A (cry1Ab –cry1Ac), y ( y y )

• JK-1 (cry1Ac)

• CICR (cry1Ac)

Events Under Biosafety Evaluation AS NEW GUIDLINESRound-up Ready Flex (RRF) cry1Ac & cry2Ab genes (Event MON15985) & CP4 EPSPS genes (Event MON 88913)) g ( )

WideStrike™ (cry1Ac & cry1F genes) Event 3006-210-23 and Event 281-24-236)

JK Stack cry1Ac (Event 1) and cry1EC (Event 24)JK Stack- cry1Ac (Event -1) and cry1EC (Event-24)

cry1C (Event 9124)

Post release conditions of Bt cotton approval

Period of validity of approval -three years

Post release conditions of Bt cotton approval

Period of validity of approval three years

To look for the incidence of sucking pests on thesehybrids and carry out artificial screening for CLCVhybrids and carry out artificial screening for CLCVresistance and submit its report to the GEAC. (only fornorth zone)

Planting of refugia (20%) for which each packet ofseeds of the approved varieties should also contain aseeds of the approved varieties should also contain aseparate packet of the seeds of the same non-Bt cottonvariety, which is sufficient for planting in the refugedefined abovedefined above.

Commercialization of Bt cotton boosted its growth However slow in several key other crops, However  slow in several key other crops, 

230

Yields of select crops in India, 1991-2008

(Indexed : 1991 yields = 100) CAGR

170

190

210

230 (Indexed : 1991 yields 100) CAGR

4.38%

110

130

1501.40%1.18%0.60%

70

90

1991 1995 1999 2003 2007

0.19%

Source: Ministry of agriculture website : http://dacnet.nic.in/eands/At_Glance_2008/pcrops_new.html

Wheat Rice Pulses Soybeans Sugar cane Cotton

• Wheat, rice, pulses etc. are largely varietal crops (non hybrid)

6

Wheat, rice, pulses etc. are largely varietal crops (non hybrid)• No existing business models for private sector work in non -hybrid crops

• Strong R&D, supported by PPP led business models needed to encourage private R&D

Population of sucking pests, bollworms and natural enemies

Mean number of pests/natural enemies over the season

IPM Non-IPM Insect pest Standard week# Bt MECH-162 Non- Bt MECH-162 CC CC

Sucking pests*

Whiteflies 30-42 0.15ª 0.15ª 0.24b 0.29b

Jassids 30-42 0.07ª 0.07ª 0.14b 1.97c

Thrips 30-42 4.88ª 4.56ª 5.98b 12.62c

Aphids 30-42 3.96ª 3.50ª 20.56b 44.34c

Bollworms**

American bollworm eggs 31-49 0.12ª 0.12ª 0.08b 0.17c

American bollworm larvae 31-49 0.03ª 0.06b 0.05b 0.09c

Spotted bollworm larvae 31-49 0.00ª 0.01ª 0.03b 0.06c

Natural enemies **bGreen lacewign eggs 31-49 0.37ª 0.37ª 0.61b 0.26c

Ladybird beetle adults 31-49 1.33ª 1.23ª 2.06b 0.69c

M ith t l t l tt t i ifi tl diff tMeans with at least one letter common are not significantly different.

# Standard week 30 corresponds to 23-29 July.

8 Number of insects/three leaves, ** Number of insects/plant. Bambawale( 2006)

Story of Bt brinjal debacle ithi l t f k d fwithin same regulatory framework and for same gene

Bt

Non‐Bt

Non‐Bt

Cash benefit of Rs 64,800 per ha and 

Non Bt

Rs 3,000 crore to our nation

Biosafety evaluation of Bt brinjal - the first food crop

2002‐2004 : Confined field trials to study pollen flowand growth , aggressiveness andweediness Biochemical properties toxicity andweediness, Biochemical properties, toxicity andallergenicity

2004‐2005: Data on the effect of Bt brinjal on soilmicroflora efficacy against FSB , pollen flow andchemical Composition

Environmental Safety Approach for Bi t h l CBiotechnology Crops

EnvironmentalIntroduced Trait(s) Modified Plant

EnvironmentalSafety

l Ecological impact of the trait(s)– Similarity to proteins or

traits in conventional

l Ecological impact of the plant– Similarity to conventional

varietiestraits in conventional varieties

– Potential non-target toxicity– Potential for resistance

varieties– Potential weediness– Expression profile

Potential ecologicalPotential for resistance– Outcrossing impacts

– Potential ecological impacts

Carefully evaluate the “new” and y

confirm no unintended adverse effects

Some concerns in public consultationsSome concerns in public consultations for Commercial release of Bt Brinjal

Resistance development and its management areResistance development and its management areserious concerns

There is a need for a consolidated report onecology, biology genetics and population dynamics

d i l i d l b d l d fand simulation models are to be developed for postrelease risk management

3/06/2010 Hyderabad

In the context of Section 45 Codex onlocation and conduct of field trials ----It wasconcluded current standards formulated doconcluded current standards formulated donot match global standards

Rich agri-biodiversity of brinjal should be conserved and

preserved before we permit the extinction of the giftsof thousands of years of naturalevolution and human selection

Th F lThe Final diagnosis

Lessons learnt…..

RegulatoryRegulatory Frame work

PUBLIC POLICY

Science of risk

assessmentPublic

concerns

Strategic  risk management  requires :For an integrated action :

Id tif i i t l ff t f d ti• Identifying environmental effects of proposed actions•Considering alternatives, including the best practicable environmental option

• Specifying appropriate mitigation measures

To contribute to environmentally sustainable development by:• Anticipating and preventing environmental impacts at source

• Early warning of cumulative effects and global risksE t bli hi f d b d i i l f t i bl d l t• Establishing safeguards based on principles of sustainable development

Achieve environmental protection and sustainable development by:• Consideration of environmental effects of proposed strategic actions Consideration of environmental effects of proposed strategic actions

• Identification of the best practicable environmental option• Early warning of cumulative effects and large-scale changes

T i t t th i t i t t ifi d i i ki bTo integrate the environment into sector-specific decision making by:• Promoting environmentally sound and sustainable proposals

• Changing the way decisions are made

Source: Adapted from Abaza et al [2009] .

The adoption of a variety of new regulatory approaches andconcepts, decision making processes and educational frames over the lastconcepts, decision making processes and educational frames over the lastthree decades can be interpreted as an attempt to improve socialacceptability of the process of science and technology governance.Based on this comparative However, neither the introduction of non-standard scientific methodologyand precautionary policy, nor participatory decision making, norincreased scientific–technological education are likely to significantly

research, it is argued that models of public acceptance of

controversial science-based increased scientific–technological education are likely to significantlyimprove social acceptance of science and technology governance. Suchreforms may shift the focus of ongoing policy debates, but do not lead toclosure

products must also take into account the state’s ability to

define the range of public debateclosure.

In consequence, more research is needed on the complexl ti hi b t t t t i f ti d

define the range of public debate as a key overall parameter of

public attitude formationrelationship between acceptance, trust, information andparticipation, the implications of non-standard methodology inregulatory decision making, as well as the different interpretationsg y g, pthat stakeholders may give to key regulatory concepts.

Way forward

Effective regulation is an Effective regulation is an essential component of any

innovation processBiology documents Human resources with skills R l t iRegulatory science Modeling agro-ecosystems Roster and network of ERA

Serious re-evaluation of the existing regulatory framework

in the light of accumulated evidence and experience

experts

POLICY INTERVENTION–GOVERNMENT OF INDIA

Two specific expert groups i.e. M. S. Swaminathan Task Forceon Agriculture Biotechnology and Mashelkar Task Force on

GOVERNMENT OF INDIA

on Agriculture Biotechnology and Mashelkar Task Force onRecombinant Pharma constituted by the Ministry ofAgriculture and the Ministry of Environment and Forestsrecommended the establishment of an “autonomous statutoryrecommended the establishment of an autonomous, statutoryand professionally led National Biotechnology RegulatoryAuthority.

Setting up NBRA will require the promulgation of newlegislation, namely the: Biotechnology Regulatory Authority ofIndia Act 2011” or the BRAI ActIndia Act , 2011” or the BRAI Act.Existing mechanisms may continue till a full-fledged body

is created with the required infrastructure and fully functional autonomy.

METHODOL0GY ADOPTED BY DBT FOR ESTABLISHMENT OF BRAIESTABLISHMENT OF BRAI

Step 1

Review of the structure and

governance of other

Review of international

models for the

Review of India’s international obligations Step 1 governance of other

autonomous agencies in India

models for the regulation of

biotechnology

obligations pertinent to the BRAI’s mandate

Step 2Development of a model for the BRAI that addresses:1. Scope of the regulatory mandate of the BRAI2. Structure of the BRAI: programs and operations3. Legal framework and other issues

Step 3Preparation of a preliminary establishment plan for the BRAI.Stakeholder interviews to obtain feedback on the preliminary plan.Preparation of a revised, draft plan incorporating stakeholder feedback.

Step 4

p p p g

Preparation of draft legislation for establishing the BRAI

St 5Step 5 Consultative process with various stakeholders

PROCESS OF TAKING FORWARD BRAI BILLPROCESS OF TAKING FORWARD BRAI BILL

⌧ Preparation of draft Bill and establishment plan through a consultative process.

⌧ High level advisory committee to review and recommend. ⌧ Placing on the DBT’s websites and advertisements in

leading newspapers for comments.⌧ Consultation with state governments for consensus and ⌧ Consultation with state governments for consensus and

feed back⌧ Six countrywide consultation meetings with various

stakeholders in D lhi Ch i B l H d b d M b i d Delhi, Chennai, Bangalore, Hyderabad, Mumbai and Kolkata.

⌧ Special consultation with Media & legal experts.⌧ Finalization of the draft Bill and establishment plan.⌧ Finalization of the draft Bill and establishment plan.⌧ Inter-ministerial consultation ⌧ Roundtable with international regulators

(USA, Canada, Australia, Philippines).⌧ ---- the bill is now ready for introduction in parliament

KEY FEATURES OF BRAI BILL 2011KEY FEATURES OF BRAI BILL, 2011

The proposed statutory independent regulator that isthe Biotechnology Regulatory Authority of India (BRAI)the Biotechnology Regulatory Authority of India (BRAI)would be a nodal agency of the Government of India toensure comprehensive safety assessment oforganisms and products of modern biotechnologyorganisms and products of modern biotechnology.Commercialization of biotechnology products inagriculture and healthcare would be subject to allg jother laws whether Central or State, for the time beingin force and rules and regulations made thereunder.The organizational plan of the Authority also providesThe organizational plan of the Authority also providescollaborative arrangements, co-ordination andmechanisms with other existing regulatory agencies.

MANDATE AND STRUCTURE OF BRAI

BRAI shall be anindependent autonomous statutory agency toindependent, autonomous, statutory agency toregulate theresearch, transport, import, manufacture and useof organisms and products of biotechnology.of organisms and products of biotechnology.

BRAI shall consist of a Chairperson, two wholetime members and two part time members to beappointed by the Central Government.

The members shall have expertise in the fields ofmolecular biology, healthcare, agriculture andenvironment biotechnologyenvironment biotechnology.

Elements ofBiotech regulatory

Legislation

R l & d SystemRules & procedures

ISOPs

NotifiedCGuidelines People

NFR

TestingLabs

COMM

Biosafety ReviewProcess

RAST Monitoring

MUN Process T

RU

MonitoringCellsI

CA

CTU

ATIO U

REMULTIDISCIPLINARY HUMAN RESOURCE

Field sitesON

ORGANIZATION STRUCTURE OF BRAI

Chairperson, BRAI  and  two whole time and two part time 

membersInter-Ministerial Governing

BoardBoard

Environment Appraisal Panel

Economic Analysis Unit

Challenges

Human resource for risk assessmentreview , management and communicationat all levels

State of art Laboratories ( new or Existing )to meet future challenges of technologycomplexities

Continual education and researchresources for regulation

Consult Our Web sitewww.dbtindia.nic.in

For more informationFor more information