Government of India's Task Force on "Applications of Biotechnology in Agriculture"

The Ministry of Agriculture, Government of India, constituted a Task Force on “APPLICATIONS OF BIOTECHNOLOGY IN AGRICULTURE”, with Dr M S Swaminathan as the Chairman.   The FBAE was invited to meet with the Task Force on November 18, 2003, at the Ministry, New Delhi, to present the FBAE’s views on the subject.   The following was submitted by the FBAE, to the Task Force

The background for the recommendations is given along.

TECHNOLOGY DEVELOPMENT

*Review the current efforts in different institutions engaged in research in agricultural 
  biotechnology in India
*Encourage institutional collaboration to pool up expertise and facilities
*Monitor funding by different agencies to avoid duplication/overlap of work

There is vast expertise in molecular biology and agricultural biotechnology in India.   A number of funding agencies such as the Department of Biotechnology (DBT), Department of Science and Technology (DST), Council of Scientific and Industrial Research (CSIR), Indian Council of Agricultural Research (ICAR), University Grants Commission (UGC), have succumbed to the charms of biotechnology and have been funding research in molecular biology and agricultural biotechnology.   There is no apparent co-ordination among these organizations, with the result there is an unnecessary and overlap in the genetic events and/or crops chosen, resulting in an avoidable waste of effort and funds.  

In a number of cases the infrastructure and expertise are well below the mark for the chosen task, where institutional collaboration would yield scientifically sound and speedier results.

If a directory of all projects funded by all the agencies is compiled, it would help both the researchers and the funding agencies to avoid duplication or overlap of projects.   Stakeholders also would know what to expect and when.

TECHNOLOGY TRANSFER

*For certain genetic events and crops transfer of technology is more expedient than
  indigenous development  
*Government should bear the costs of technology transfer and development of local 
  varieties, in such cases

A number of genetically engineered crop varieties, ready for commercialization on regulatory approval, are available from public and private institutions outside India.   Some examples are Bt rice, abiotic rice, rice with high iron, low phytate and  high phytase,  rice with human milk proteins, tobacco with functional human haemoglobin, and gene stacked Bt cotton.   These are of great interest to India and developing them indigenously will involve enormous amounts of money, manpower and time.   Technology transfer on the lines of Golden Rice would be a better option.   Technology transfer costs could be quite high and if not met by the Government of India or through some international mechanism, the farmer/consumer will end up paying high costs of the seed or the products and the benefits would be denied to many.

*An international aid/loan fund should be set up, with the help of the World Bank or a
  similar institutional mechanism, to help developing countries to meet with costs of
  transfer of technology

If an international mechanism is put in place, the Governments of the developing countries also would not find the costs of technology transfer burdensome.

PUBLIC AND PRIVATE SECTOR COLLABORATION

*Facilitate public and private sector collaborative efforts
*Establish new models of academy-industry partnerships to foster academic brilliance
  without losing focus on commercial application  

The public institutions have the expertise while the private sector units have the commercial temper and mind set to market viable products, and in some cases even money, all of which are needed to foster speedy delivery of technology to the target groups.   Public-private institution collaborations will meet this end and there would be more of public trust in the products so generated.   Governments and institutions occasionally declare their interest in encouraging such collaboration but in the end nothing tangible happens.   The Golden Rice project which is going on very slow, would have been better off, had a private organization (such as Avesthagen or Metahelix) also was involved in developing local varieties for different Indian States.

FOCUS SHIFT

*Current traits in transgenic crops are   
  beneficial, but a focus shift is needed to
*Abiotic stress (drought, flood and salinity) and to
*Dry land crops  (millets, pulses and oil seeds)
  to benefit small land holders     

Most of the currently available transgenic crops are farmer oriented.   Others benefit by them, but only indirectly.   Except in the case of Golden Rice, there is no direct consumer benefit.   Besides, the crops involved are not of direct consequence to the farmers or consumers in the poorer areas of developing countries.   What is more urgently needed for these areas is a shift of focus to develop varieties that can withstand abiotic stress.   Equally important is that crops of dry areas cultivated by the marginal and very poor farmers should be addressed.   In the past forty years or so, the cultivation of chickpea, groundnut and bajra has fallen down alarmingly, in preference to other crops such as wheat, rice and cotton, that are expected to fetch high financial returns.   This attraction resulted in an enormous increase of acreage under these crops.   The fall in the acreage under cultivation of the dry land crops has made it unattractive to consider the dry land crops for transgenic technology by the private sector.    Since the commercial establishment cannot be made to consider these crops and the relevant genetic events, it is for the Governments to focus on their development in the public agricultural research institutions.

ENCOURAGE ENTREPRENUERSHIP 
*Support budding entrepreneurs with scientifically sound and implementable ideas
  addressing real problems in Indian agriculture
*Support to early commercialization of ideas in agricultural biotechnology

There is a large number of young and enthusiastic entrepreneurs who are interested in deploying agricultural biotechnology in various contexts.   Some of them have very specific ideas of what should be done.   However, they are handicapped for want of both financial resources and infrastructure, to test their ideas.   The venture capital system is one option but time frame needed for a successful project is far beyond that acceptable to financiers.   If the mechanisms of processing projects and permits for commercialization are streamlined and speeded up, it would help these entrepreneurs.   

DISTURBING TRENDS

*Discourage premature announcements of release of  GEOs, by public institutions
*Discourage transgression of mandate by public institutions

In the face deferral of Bt cotton in 2001, the Deputy Director-General of the ICAR announced that we have a variety of GE cotton resistant to pests.   Scientists from some public cotton research centers did the same, soon after.   A couple of months ago, the Director of Directorate of Rice Research, Hyderabad, announced a pest resistant GE rice.   Now there is a repeated assertion by the DBT of the release of a protein rich GE potato.   While there is a lot of research effort is on to develop GE crops in the country, none of these would see the light of the day in this decade.   So far as publicizing on going research projects these announcements are in order.   But the tone, tenor and timing (intended or unintended) are misleading giving an impression that the products a ready for release in the near future.   These premature announcements sow doubts on the public mind and people would think that while we are having our own transgenic crops why do we need transferred technology.     The credibility of the scientific community also is damaged.   Premature announcements are not just misleading, they are unethical, as they raise false hopes.

Recently the National Botanical Research Institute, Lucknow, is reported to have entered into an agreement with some seed Indian companies to develop Bt cotton.   The Director General of the CSIR also announced that they have a Bt gene.   It was reported that the Bt variety would be available in three years.   Added, the three years or so of the regulatory process, this cotton variety will not be seen in this decade, even if everything goes as clockwork.   Besides being a premature announcement, the involvement of the NBRI in agricultural biotechnology is surprising, since the institute has no mandate in this area.    Plant molecular biology or even transgenic horticultural crops are in line with this CSIR institute’s mandate, but not agricultural biotechnology.   Institutions engaged in research in agriculture have the general background, scope for peer consultation within the institution and understand the crop better than one-mouse developers.

UNAUTHORIZED PRODUCTS

*Illegal deployment of approved or unapproved genetic events for private benefits must
  be stopped
*Such products serious risks to the farmers, environment and economy
*Damage the country’s reputation
*Legal & administrative mechanisms to check this menace effectively are urgently
  needed

No action has been evident against the illegal Navbharath 151 Bt cotton, being cultivated for the second crop season in Gujarat and northern Maharashtra.    This would encourage other misadventures.   Such a highly unethical practice causes damage of far reaching consequences, besides undermining the authority and intentions of the Government, in controlling regulatory transgressions.      

One seed company appears to have claimed that a cross between plants of a Bt cotton variety from a neighbouring field with some plants in their non-Bt cotton field has produced a chance hybrid with Bt potential, and applied to the DBT/RCGM for permission for controlled field trials.   Even if this unbelievable hybrid with Bt qualities did really happen by chance, it does not constitute the use approved by the patentee or the regulatory agencies.    It has to go through the normal regulatory process, particularly so because the variety did not at any previous stage underwent controlled studies for biosafety.    If this is not checked, we will be having more chance hybrids, than authentic products.

UNAUTHORIZED PRODUCTS

*A letter of authorization, from the registered holder of a genetic event, permitting its
  deployment it into a crop plant in India, should be mandatory, from the time of the first
  application, to prevent unauthorized commercialization  

A legally bound mandatory practice of the Government demanding for authorization to use a patented genetic event, at any point of time from the initial application to the commercial crop in the field, would discourage both sale of illegal GE varieties and unauthorized deployment of genetic events. 

REGULATORY PROCESS

*A statutory Apex Body (GEAC?), exclusively concerned with biosecurity,  
  commercialization and deregulation
*Should be independent of Ministries and Government departments
*Acts upon the advice of a scientific committee (RCGM?) or other committees
  constituted by it, to advice on  specific issues
*Conducts public hearings before final decisions
*An Authority to redress grievances against decisions of the Apex Body is needed

The Genetic Engineering Approval Committee invited a lot of criticism on its functioning that leaves a lot to be desired.   The GEAC or a similar Apex body should be protected from outside pressures, which is possible only when it is a statutory autonomous body, with precisely defined responsibilities.   It should act upon scientific advice given on biosafety and crop qualities, by competent committees.   It should involve the public and stakeholders in decision-making.   And there must be a provision to appeal against its decisions.   Currently, a Judge appointed by the Chief Justice of India, functions as an Appelate Authority and a few weeks ago has dismissed the petition against the GEAC on the issue of permitting commercialization of GE Bt cotton.

REGULATORY PROCESS

*A scientific committee (RCGM?)  responsible for biosecurity assessment
*ICAR institutions to evaluate crop benefits
*Concurrent evaluation to save time
*Need to establish/identify competent and credible independent institutions to provide
  data to the RCGM/ICAR, sharing work to save time
*An authority to redress grievances against decisions on biosecurity and crop benefits
  needed

It is necessary that the roles of the Review Committee for Genetic Modification and the ICAR that monitors field trials, are clearly defined.   It is also necessary to establish a mechanism to monitor biosafety data by independent institutions, in addition to the ICAR.   So long as this is not so, the data necessarily come from the product developers (which is also the practice in other countries), monitored by the ICAR.   Data cannot become suspect, simply because they come from a company.   We need to trust some one somewhere.   An appellate authority should be put in place to readdress grievances against the decisions of the RCGM/ICAR.   Currently, the DBT plays this role, but it would be better if a different independent body is entrusted with this responsibility.

REGULATORY PROCESS

*Biosecurity data from accredited international governmental agencies (USDA, FDA) or
  institutions (Universities/laboratories) for a particular  genetic event and crop should be
  considered to avoid duplication of efforts and to save money and time
*Limited closely monitored commercialization after two-years of controlled field trials
  should be considered

There is enormous amounts of biosecurity data on Cry 1Ac gene in cotton and several crops, gathered for over one and half decades, the world over.   Making similar studies for the same gene in the same crop in every country is a waste of time, manpower and money.   With the establishment of the Biosafety Clearing House under the Cartagena Protocol, a website for biosecurity data, a lot more of authentic data would be easily available.   Data can also be taken from credible international institutions such as the USDA and the FDA.   When such data are available and convincing, the time required for regulatory process within the country can be suitably reduced.

REGULATORY BODIES

*Must function in a transparent, responsive, responsible and expedient manner,
  respecting citizen’s right to information

The functioning of the regulatory bodies should be convincing and should clearly be above board.   Information requested by any one should be readily and freely available on the websites or in the form of hardcopies, which can be charged.

 
CONSTITUTING REGULATORY COMMITTEES
*ADOPT PROCEDURES OF US NATIONAL ACADEMIES
*NOMINEE’S KNOWLEDGE AND EXPERIENCE IS IMPORTANT AND NOT
  POSITION
*MEMBERS SERVE AS INDIVIDUALS AND NOT AS REPRESENTATIVES OF
  THEIR INSTITUTIONS
*CONSIDER POTENTIAL SOURCES OF BIAS AND CONFLICT OF INTEREST
  THROUGHOUT TENURE
*POST PROVISIONAL CONSTITUTION ON THE MINISTRY’S WEBSITE FOR
  PUBLIC COMMENTS, BEFORE FINALIZING

The procedure adopted to constitute regulatory committees is one of the most important issues that has an influence on the committee’s functioning and the trust the public would place in it.   The US National Academies have adopted a credible procedure to constitute committees, which should be followed.

 
AWARENESS AND EDUCATION

*All the stakeholders should be involved in decision-making on the basis of appropriate
  information on the benefits and safety of biotechnology, firmly based in science

Awareness and Education are the most important aspects that would garner public support for agricultural biotechnology.   It is the consumer and the farmer who should have a choice of technology adoption.   And this should happen on the basis of informed decision-making.

AWARENESS AND EDUCATION

*Public awareness of risks and benefits of biotechnology is very low and is largely based
  on misinformation and disinformation and not science
*Public acceptance of transgenic products needs vastly enhanced awareness of the
  benefits and safety of technology   

The anti-tech activists have indulged in a campaign that is not based in science and use information taken out of the context, misunderstood science or even deliberately twisted facts.   Educating the public on the benefits and safety of GE products should be based in science avoiding the emotional and ethical platform.   It is also necessary that social, economic and political issues are not mixed up with science.

  
AWARENESS AND EDUCATION

*Launch/support extensive awareness and education programmes involving the general
  Public, media, judiciary and Government departments that formulate, implement and
  monitor policy

In conducting awareness and education programmes, different stakeholders should be separately addressed.   It would be necessary to organize these programmes in different states, at the district level and in the concerned local language.   Farmer education should be an important component of this effort.

 GENERAL POLICY

*Synchronize and dovetail different acts to avoid conflict
*New Seed Act
*Plant Variety Protection Act        
*Environment Protection Act          
*Patent Act
*Organize/support open debates inviting scientists, industry, interest groups and the
   public  to evolve a consensus

Currently there is overlap and even contradiction between Acts relevant to GE technology.   These lacunae can be misused and abused by the interested.   It is necessary to examine these gray areas, bring about a consensus and incorporate it in the Acts.

GENERAL POLICY
*Resource poor farmers would directly benefit from a wider deployment of
  biotechnology in agriculture 
*Indian agriculture should be on an international technology base
*Agricultural biotechnology should receive full support and commitment of the  
  Government of India, as a part of the Agri Vision 2020 document of the Government 
*A clear policy document on GEOs in agriculture is needed

Biotechnology offers a high promise for improvement of Indian agriculture.   The Ministry of Agriculture has a very important role to play in the deployment of biotechnology in agriculture.   Along the way, somewhere, the Ministry lost the initiative in this regard and appears to an outsider, to be playing only a secondary role.   The Ministry should regain the total control of this important area of its responsibility, set policy and implement it with the rigour it deserves. 

Professor C Kameswara Rao, Executive Secretary, Foundation for Biotechnology
Awareness and Education, No 1, Gupta’s Layout, Southend Road, Bangalore 560 004