Policy Imperatives for the Regulatory Oversight of GMOs
Shivramiah "Shanthu" Shantharam,
Biologistics International,
Ellicott City, MD, USA.

“Whoever could make two ears of corn or two blades to grow where only one grew before, would deserve better of mankind and do more essential service to his country.”

                                                                                                -Jonathan Swift

The Premise for biotechnology regulatory policy:

Genetically Modified Organisms (GMOs) and other products of recombinant DNA (rDNA) technology are going to be regulated is now a universal fact.  No one expects either a free or an easy ride for biotechnology products, although enough arguments have been put forward as to whether one should regulate the product or the process of biotechnology or gene splicing technology is also a moot point.  First and foremost GMOs are regulated because they are genetically engineered.  Secondly, the biotechnology regulations are a response to the negative public perception of GMOs that is to a large extent orchestrated.  The argument is mostly about what kind of a regulatory review system is appropriate, and what should be the basic tenets of such a regulatory review process. 

The biotech controversy:

Agricultural biotechnologies of the Genetically Modified Organisms (GMOs) kind have attracted too much opprobrium from around the world so much so that its transfer to farmers fields and ultimately to consumers have stalled if not completely stopped.  The pace of adoption of GMOs has slowed down in Asia and Africa.  The raging public debate about the safety and utility of GMOs has really polarized the world.  If there is a single most critical factor that is holding up the transfer of GMOs to the farmer’s field, it must be the treacherous process of regulatory approvals in many parts of the world.  Most countries in the world have either put in place one or the other kind of biosafety rules and regulations to provide regulatory oversight of GMOs or in the process of doing so.  But, what is vexing is the contriving processes and methods used, and the kinds of data and issues required to evaluate GMOs.  Opinions vary to the extent that there is hardly any movement in many countries to clear GMOs through their regulatory review process in a timely and efficient manner.  The most important underlying cause for this non-functional or dysfunctional regulatory system is the lack of a sound biotechnology policy in which clear goals and objectives of a regulatory oversight mechanism are articulated.  Another important reason is the lack of appropriate skills and expertise in biosafety reviews and environmental risk assessments within a proper institutional framework.  This presentation will attempt to address some of the policy imperatives needed to develop an appropriate regulatory review system that would inspire public confidence in biotechnology by taking into account the views and opinions of all stakeholders.  It will also attempt to shed light on the potential for biotechnology to be a part of the solution of addressing the food security problem in the developing world.

The fundamentals of biotechnology:

It is important to understand the fundamentals of modern biotechnology, to put it in the perspective of making a public policy.  Modern biotechnology is an outgrowth of enormous strides made in the basic understanding of biological sciences in the last century (some refer it to as the golden age of biotechnology) combined with the knowledge of physics, chemistry, mathematics and informatics.  Biotechnology is one of the frontier technologies along with information technology that is altering our lives.  Protagonists of biotechnology would like everyone to believe that it is going to change life for the better, but a large body of critics and opponents disagree.  Biotechnology is a toolbox containing some of the most ingenious and creative tools to manipulate living organisms in any desired fashion.  To put it simply, drafting living organisms or its components to harness their potential for the benefit of mankind.  This is precisely what has been done with older and familiar technology like fermentation.  Biotechnology is an enabling technology that is the most recent to come on the scene.  There is no doubt that biotechnology has immense potential to solve some of the most egregious problems in health, the environment and agriculture.  Biotechnology is neither a panacea nor a silver bullet.  Biotechnology, per se, is no unsafe than any other technology used so far in agriculture.  In fact, modern biotechnology is by far the most precise of any technology known to biological sciences to date.  In relatively short history of GMOs (less than a decade of commercialization), there is not a single proven instance of it being harmful.  Yet, there is a clear danger of the benefits of biotechnology eluding the poorest people in the world like health care, water, food, energy and the green revolution tolls like improved seeds, chemical pesticides, herbicides and fertilizers because of world wide public controversy and lack of sound public policy framework and institutions for technology stewardship.

The drivers for biotechnology policy:

First and foremost, public policy must benefit the public at large, fairly and equitably.  Public policy must be developed by process of public consultation that promotes public consensus.  If the general public has a say right from the beginning the pace of technology transfer could be achieved much faster.  Stakeholders’ views are equally important in developing practical strategies for useful technology transfer.  Public perception is clearly going to be harbinger of any large-scale commercialization of biotechnology for sometime to come.  A technology policy that strives to inspire public confidence is the only one that is going to succeed in delivering the benefits of technology.  In today’s world, information travels faster and people come to know what is happening around the world and their views get influenced by them, and they have started to demand a say in the decision making process.

Biotechnology and food security:

The food security issue is a multi-dimensional problem that continues to defy solutions and baffle those who are trying to address it.  Women and children are the most vulnerable as a result of acute poverty and hunger.  According to a definition of the Biotechnology Commission of the European Commission (August, 2003), food security is the availability of food for the local population including production, access, affordability, and nutritional quality.  Poverty and hunger are the root causes of food and nutritional insecurity.  Out of the estimated 800 million undernourished people, about 525 million live in Asia alone, and India has the largest share of 204 million. (UN-FAO, 2003).  The causes of poverty and hunger include demographic changes (urbanization), lack of economic prosperity (growth in GDP), environmental degradation, lack of infrastructure and illiteracy, and not to mention war and strife.  World food security is not essentially a technical or a technological problem.  It is foremost a matter of grossly inadequate means of production of the world’s poorest peasant farmers who cannot meet their own needs locally, and lack of purchasing power of both rural and urban poor (Mazoyer, 2000).  Under such circumstances it is untenable to think that any one approach or technology can solve the problem singularly. Biotechnology cannot be an exception to the rule.  But, biotechnology can be a part of the solution, and that has been amply demonstrated in terms of improving yields on ever decreasing arable land and decreasing the costs of inputs.  For biotechnology to be an effective means of being a part of the solution, a sound public policy to steward biotechnology is a prerequisite.  Simulation models have shown that delays in the diffusion of modern biotechnology to solve “local food crisis” in developing countries will exacerbate local food crises (Evenson, 1999).  A recent discussion paper by the Nuffield Council on Bioethics (2003), on the use of GM crops in developing countries, clearly recommends that GM crops should be adopted in developing country agriculture by undertaking a case-by-case review of each GM crop.  The discussion paper, further argues GM crops have demonstrated capabilities to solve many of the agricultural production problems, and as such should not be discounted as one of the viable options.  Therefore, it follows that biotechnology policy development is given top priority by the developing nations of the world to bring about appropriate biotech intervention.

The challenges to policy makers:

The critical need under the present circumstances is, effective policy instruments and an institutional framework that can inspire confidence in biotechnology and its products against the onslaught of some valid and some not so valid criticisms and anti-biotechnology campaign.  The emerging world scenario of fears about social, economic and ethical impacts of modern biotechnology cannot be overlooked, and must be addressed by involving all the stakeholders.  In effect, the critical public is demanding a comprehensive evaluation of biotechnology that takes into account not only safety issues and concerns, but also socio-economic impact issues as well.  A successful biotechnology policy is one that can bridge the divide between just science based risk issues and just social impact issues and forges broad consensus toward biotechnology acceptance.

The problem of developing a public biotech policy seems to be more acute in developing countries.  In spite if many developing countries having bio9safety laws they are not being used to take effective decisions because of uncertainty and fear of political backlash.  As much as there are hundreds of international projects to develop regulatory capacity building, there seems to be increasing conflicts on obtaining a consensus toward the approach one need to take.  Some of the basic differences in regulatory approaches stem from the socio-economic conditions of the countries involved, and also as detractive tactics of those who oppose the introduction of GMOs.  That is presenting a real challenge to the international harmonization of biotech regulatory policies.  Most of the negative perception of GMOs in Asia and Africa are a reflection of the anti-GMO sentiments in Europe, and not something of indigenous origin.  Lack of public confidence in their own countries regulatory systems in which there are some serious defectives in the risk assessment skills.

The public perception problems of agricultural biotechnology:

Commercialization of agricultural biotechnology is largely driven by the private sector like the green revolution technologies that were developed by the public sector, as it ought to be.  Conversely, the green revolution technologies were developed by the public sector and were released to the poor farmers in certain developing countries free of cost.  This intervention of private sector in the biotechnology sector in and by itself strikes fear of some kind of sinister plot to take complete private control of food supply in the minds of many people.  This fear is compounded by decreasingly less public investment in agricultural research for the so-called “public goods”, and particularly in the developing countries, the fear is even amplified because public sector lags behind in research and development (R&D).  Although some great efforts are underway to apply the new biotechnologies for the improvement of orphan crops and crops of sustenance farmers, those efforts are still decades away from making any meaningful impact.  There are no doubts that the first generation GM crops like corn, cotton and soybean have made significant economic impacts on the farmers not only in the developed countries, but also in developing countries like Brazil, and South Africa.  The intellectual property rights over the new biotechnologies are also a cause for concern for technology transfer to the developing countries.  A large section of the opponents of modern biotechnology argue that it will be too expensive for the poor countries of the world to afford it.  There seems to be no empirical evidence for this concern so far.  There are many efforts by the private sector and philanthropic organizations trying to negotiate deals for biotechnology transfer to less developed countries and other developing countries on a case-by-case basis.  These efforts are still not reassuring to the critics to whom the very idea of patenting of living organisms which they consider to be a part world heritage distasteful, and have made it into a serious ethical issue.  These negotiations are excruciatingly slow.  Another important constraint is the knowledge, skills and expertise required by developing countries to negotiate technology transfer and licensing agreements and forge public-private partnerships.  It is for these reasons that there is a critical need for developing a comprehensive biotechnology policy in the developing countries.  Differing opinions on the need for a biotech policy is also causing considerable confusion among scientists, administrators, media, and the public.  This confusion and conflict continuously keeps the controversy always boiling and does not allow opportunities for the resolution of the issue.  Facing up to the public perception challenges will continue to be a dominating factor in convincing the general public of the safety and benefits of biotechnology for some more time to come.

Whither Biotech Policy

There are various causes for lack of a public policy on biotechnology in most developing countries.  Of them, lack of awareness about biotechnology, fear of the unknown, lack of transparency and accountability, inability to handle public consultation process all make biotechnology transfer a gigantic task.  A biotechnology regulatory policy must strive to assure public of the safety of biotechnology and its products, and their impact on plants, animals and the environment (biodiversity) through a rigorous scientific risk assessment process.  The objectives of the policy must be to allow for meaningful public participation, be transparent and clear, fair and equitable, not unduly burdensome (suitable or appropriate regulations to meet the level of risk determined by a scientific risk assessment process), and should be timely and efficient.  The policy should also encourage a high standard of regulatory compliance, and harmonize with other national and international standards instruments.  A sound regulatory framework must be based on a sound legislation (law), should determine whether it is the process or the product that needs to be regulated, and should allow for risk/benefit and cost/benefit analysis including the cost of delayed or lost opportunities.

Conclusions:

Agricultural biotechnology is a valuable technology that should not be denied to any individual or groups based on misconceptions and anti-biotechnology sentiments.  At the same time, the purveyors of biotechnology need to do some serious introspection about some genuine public fears and partner with like-minded organizations and stakeholders to assure them risks and benefits in an impartial way.  If agricultural biotechnology has to be accepted in the developing world, it must demonstrate that it is economically beneficial to growers and consumers.  It is in this context, developing countries cannot do without comprehensive public policies that promote comprehensive technology assessment and institute a scientifically sound regulatory system.  The public policy must be a visionary document that frames the issues in a proper perspective and also helps in the steward the technology for the benefit of all.  Biotechnology has a lot to offer, but should not be allowed to become a victim of polarized public wrangling forever.  If the public policy succeeds in forging a broad consensus by providing for checks and balances, then it would have served the public ably.