Uganda has got a good Biotechnology law that will allow the development of safe GMOs

By Clet Wandui Masiga

On Wednesday October 4th 2017, the 10th parliament of Uganda adopted the National Biotechnology and Biosafety Bill 2012 into Law. I was in parliament listening to all the issues debated and agreed upon. Henry Lutaaya of the Sunrise news paper interviewed me shortly after the passing of the Bill into Law. On overall Uganda has got a good law that will allow the development and commercialization of GMOs that are safe to the humans, biodiversity and environment. His article titled “What next after passing of the biosafety law?” is available at http://www.sunrise.ug/news/201710/what-next-after-passing-of-the-biosafety-law.html

Petition to the 9th parliament of Uganda to Adopt the National Biotechnology and Biosafety Bill 2012 into Law

By Clet Wandui Masiga, Tropical Institute of Development Innovations (TRIDI)

Summary

Technology and innovations are critical to addressing some of the key challenges constraining agricultural production in Uganda. Biotechnology is one of the innovative tools that are used to increase production of agriculture. However in Uganda, there is no law that regulates its use, which is a requirement for countries signatories to Cartagena protocol on biosafety. The Uganda farmers and global community are requesting the Uganda’s 9th parliament to adopt the National Biotechnology and Biosafety Bill 2012 into Law. This petition http://bit.ly/1UxKCJd is sponsored by the Tropical Institute of Development Innovations (TRIDI) on behalf of Uganda Alliance for Science and all stakeholders involved in promoting the application of biotechnology. We are urging the members of 9th Parliament of Uganda to quickly pass this bill into Law before their end of term in May 2016. This will be the greatest gift the 9th Parliament will offer its voters before their term end. Sign petition available at http://bit.ly/1UxKCJd

Introduction

This petition is written to The Right Honorable Speaker of Parliament of Ugandawith copies to the President of Uganda; the Vice President; the Rt. Hon. Deputy Speaker; the Prime Minister; Minister of Education, Sport, Science & Technology; Minister of Agriculture, Animal Industry & Fisheries; Minister of Finance, Planning and Economic Development; State Minister of Finance for Planning; Minister of Water & Environment; State Minister for Higher Education & Technology; and all other ministers of Uganda.

The purpose of the petition is to request the Government of Uganda to adopt “The National Biotechnology and Biosafety Bill, 2012,” whose purpose is to ensure the safe development and use of modern biotechnology for national development. All the procedures to enact the Bill into law have been done.

The only step left is the final approval by Parliament. This law is needed to help farmers fight major challenges such as weeds, diseases, pests, drought, and nitrogen deficiency. 

The current issues agriculture biotech research is addressing in Uganda

In Uganda, farming is increasingly becoming non-competitive, expensive and unprofitable largely due to major challenges such as weeds, diseases, pests, drought and nitrogen deficiency. Modern agricultural practices will give farmers another and better option to control pests and diseases.

  • Weeds: Weeds are a major challenge to the production of staple food and cash crops such as maize, sorghum, soy beans, coffee etc. Responsible use of biotechnology, especially herbicide-tolerant crops, reduces backbreaking labor of farmers — especially women — who do most of the backbreaking work on farms such weeding using the hand-held hoe. Scientists have successfully developed herbicide-tolerant maize and soybeans. These have been grown for the last 20 years in many countries, and we only need the enabling law to regulate their development and deployment in Uganda.
  • Diseases: These are limiting production of both food and cash-crops in Uganda. For instance, Banana Bacterial Wilt (BBW), Fusarium Wilt, Black Sigatoka, Coffee Wilt, Cassava Brown Streak and Cassava Mosaic Diseases; Early/late Blight, Sweet Potato Weevils and Viruses, are continuously infecting all bananas, coffee, cassava, Irish and sweet potatoes respectively, across the country. These diseases cause huge income losses and food insecurity to the nation. NARO has used modern biotechnology to develop resistant/tolerant varieties of these affected crops, but these varieties are kept due to lack of an enabling law that will allow farmers to access these crops.
  • Drought: Every year, farmers experience losses in maize and other cereal crops production due to drought. Already scientists from NARO have used modern biotechnology to develop maize that is tolerant to drought using modern biotechnology. We will need this law if farmers are to benefit.
  • Pests: Weevils, nematodes, whiteflies, stem/stalk borers, coffee twig-borers, African cotton bollworms and fruit-flies are some of the key pests that are ravaging bananas, beans, cassava, maize, coffee, cotton, fruits—especially mangoes and pawpaws— respectively, in Uganda. We can use advanced scientific tools like modern biotechnology to develop resistant crops, fruits and trees to avoid using chemicals to spray pests which may also kill useful insects like bees, butterflies, as well. In turn, using less chemical sprays will help save our environment.
  • Climate Change: The increasing rise in temperatures due to Global Warming is affecting farming with unpredictable and prolonged dry spells, rainstorms and flooding. This is also negatively impacting on soils, rendering land unproductive due to massive erosions, and nutrient/fertility loss. NARO has used modern biotechnology to develop nitrogen-efficient, soil salinity-tolerant and water efficient crops like NEWEST-rice that grows in less fertile soils.

If farmers are to access the modern biotechnology crops named above, Uganda needs the National Biotechnology and Biosafety Bill passed into law to regulate and govern their deployment. This Bill is currently before Parliament and farmers call upon their legislators to pass the Bill for them to access these technologies and manage ever-growing farm challenges.

The President of Uganda has himself publicly urged members of Parliament to pass the Biosafety Bill.

Please sign the petition at http://bit.ly/1UxKCJd

and please help circulate widely within your networks.

 

African more than developed countries farmers to reap more economic and environmental benefits of Genetically Modified Organisms (GMOs)

By Clet Wandui MASIGA

Conservation Biologist, Geneticist and Farm Entrepreneur

Email: wmasiga@hotmail.com

African farmers are set to benefit more from genetically engineered organisms than developed countries partly due to non-functional rights laws. Here are the conclusions from four peer reviewed publications evaluating genetically modified organisms (GMOs) that have Bacillus thuringiensis (Bt)  and herbicide tolerant (HT)/round ready (RR) traits.

Widespread adoption of Bt cotton and insecticide decrease promotes biocontrol services (Lu et al 2012). This is because transgenic crops producing insecticidal proteins derived from Bacillus thuringiensis (Bt) have proved effective in controlling bollworm and reducing the need for pesticides. In USA, the net benefits, includes convenience of roundup ready (RR) soybeans, significant value on operator and worker safety, environmental benefits and market risks diminishes sharply as the percent of roundup ready soybean acres increases (Marra et al 2004).

Perhaps the most important thing that African leaders will need to know is a tradeoff between farmers getting out of farming to pave way for rich mechanized farms or adopt HT tolerant crops and keep more people in farming hence consumers have more choices on markets than having a few that will dictate the food prices (–a practice I personally support). The latter option will happen naturally as long as farming remains unprofitable in Africa. Farmers will either scale up or out of farming. We will see younger people selling off land to bigger farm entrepreneurs.

In Argentina GMOs particularly RR soybeans has increased total factor production by 10% on average with cost savings being more for smaller farms than larger farms (Qaim & Traxler, 2005). In terms of economics, the global value of biotech seeds was USD15.7 billion and farm gate prices of harvested end product was USD133.3 billion (James Clive, 2014). Note that it costs about USD135 million to develop and commercialize a GM variety. So if a company makes profit of a billion is worth the investment. But many other people across the value chain benefits. According to Qaim & Traxler (2005), the largest share of benefits from RR soybean went to consumers (53%), followed by seed and biotechnology firms (34%), and agricultural producers (13%).It’s also important to note that even when Africa rejects GMOs, private seed companies using conventional technologies still market seeds worth more than USD55 billion annually.

In Argentina due to comparatively weak intellectual property protection and because only small technology mark-ups in seed prices and widespread adoption, Argentine soybean growers receive 90% of the benefits in that country which demonstrates that farmers in developing countries can gain considerably when they obtain access to suitable foreign innovations through technology spill-overs (Qaim & Traxler, 2005). On average, GM technology adoption has reduced chemical pesticide use by 37%, increased crop yields by 22%, and increased farmer profits by 68%. Yield gains and pesticide reductions are larger for insect-resistant crops than for herbicide-tolerant crops. Yield and profit gains are higher in developing countries than in developed countries (Klumper & Qaim, 2014).

Africans and others who are fighting GMOs, will need to remember that in absence of Bt, there will be more sales from chemical companies most them are owned by Europeans and Asian entrepreneurs. Alternatively as GMOs are being fought, most of the seeds will continue to be provided by private seed companies and they will sale it as proprietary technology.

Because ignorance seems to be ruling the world, let me end by providing some factual data. The world top three seed companies include Monsanto, DuPont/pioneer and Syngenta. All combined make about USD28 billion annually. The top three agrochemical companies include Syngenta, Bayer and Basf and they make USD46 billion, the top three food processing companies include Nestle, Archer and unilever  and all together USD521 billion. And the top three food distribution companies include Walmat, Carrefour and Tesco and all together they make USD764 billion. So who is controlling the world or monopolizing world food?

I remain wondering if African leaders and others against GMOs have any of this data or have just been mislead with misinformation on subjects they do not understand. It’s therefore logical that African leaders need to make courageous and logical decision and support their farmers to have access to technology options for their development.

Reference

James, Clive. 2014. Global Status of Commercialized Biotech/GM Crops: 2014. ISAAA Brief  No. 49. ISAAA: Ithaca, NY.

Klümper W, Qaim M (2014). A meta-analysis of the impacts of genetically modified crops. PLoS One. 2014 Nov 3;9(11):e111629. doi: 10.1371/journal.pone.0111629. eCollection 2014.

Lu Yanhui, Kongming Wu, Yuying Jiang, Yuyuan Guo,  & Nicolas Desneux (2012). Widespread adoption of Bt cotton and insecticide decrease promotes biocontrol services. Nature 487, 362-365 doi:10.1038/nature11153

Marra Michele C., Nicholas E. Piggott, and Gerald A. Carlson (2004). The net benefits, including convenience, of roundup ready® soybeans: results from a national survey.  NSF Center for IPM Technical Bulletin 2004-3. 39pp. Raleigh, NC

Matin Qaim and Greg Traxler (2005). Roundup Ready soybeans in Argentina: farm level and aggregate welfare effects. Agricultural Economics. Volume 32, Issue 1, pages 73–86. DOI: 10.1111/j.0169-5150.2005.00006.x

 

 

 

 

 

 

Africa needs courageous leaders like the Catholic Priests to benefit from genetically modified Organisms (GMOs)

By Clet Wandui MASIGA

Conservation Biologist, Geneticist and Farm Entrepreneur

Email: wmasiga@hotmail.com

 

On Saturday December 5th, 2015 at the National Agricultural Research Laboratories (NARL) of the National Agricultural Research Organization (NARO), the Director CARITAS, Justice and peace, Archdiocese of Kampala Rev. Fr. Vicent Kisenyi Byansi together with Caritas farmers praised research on genetically modified organisms (GMOs). Rev. Fr. Vicent Kisenyi Byasi knelt down and openly apologized to his parishioners and participants who had attended a sensitization workshop on intensive livestock management, urban farming and biotechnology for having got duped/manipulated and misinformed about the science of genetic modification.

 

During the workshop, more than 70 farmer leaders and mobilisers from Caritas- Archdiocese of Kampala lauded the work GMOs and scientists in developing solutions to their farming challenges, including the use of genetic modification to address the dreadful banana bacteria wilt.

 

The catholic priest further urged the farmers and Ugandans to continue supporting the great work of scientists in finding solutions to some of their farming constraints. The leaders noted that a lot of mis-information had been spread by some people, including a few within Caritas, demonizing the work of the gallant scientists but they urged the scientists to continue the good work in championing the cause of farmers in the country. Fr Byansi particularly asked that those who led the mis-information to be forgiven by God. The workshop was organized by NARO in partnership with Caritas. The participants learnt of the available products of genetic modification in improving banana, cassava, maize, potato, sweet potato, and rice in Uganda. Participants also learnt on the potential risks with GM technology and how these risks are and must be managed using appropriate legislation as proposed in the National biotechnology and Biosafety Bill. Caritas farmer leaders, parishioners and its director pledged to fully support the need for the parliamentarians to adopt the bill.

 

He pledging his support for GMOs, Fr. Byasi re-echoed the words almost in almost exactly the same way as did Pope John Paul II in 2000 as part of the great jubilee celebrations. He stated that the famous words of Genesis entrust the earth to man’s use, not abuse.

 

Rev. Fr. Vicent Kisenyi Byasi is one of the first prominent leaders of the Catholic Church and Caritas Justice and Peace commission to openly declare support for GMOs. The Catholic-founded CARITAS is one of the key anti-GMO groups in Uganda and globally. This was a historic undertaking by our Catholic leadership and parishioners who also learnt DNA technology is used to create new crop varieties for the benefit of human kind.  They acknowledged that they had been misled by organic promoters and anti-GMO activists and expressed support for GMOs to solve some of challenges they face in their daily farming activities. They said that non of anti-GMO activists, soil scientists, organists or organic promoters, pseudo-scientists and some misled priests, are not solving nor even attempting to solve serious crop pests, diseases and abiotic stresses.

 

The participants disclosed that there is an organic promoter who works with anti-GMO activists and has been selling farmers a fake anti-chemical claiming it controls banana bacterial wilt disease. This crooked business man had in addition been very successful in misleading the Catholic Church in particular CARITAS to mobilize its members and farmers, to be trained on the use and adoption of his concoction which NARO recently discovered on testing to be a mere combination of fertilizers and some unknown formulation. The crook was even telling lies that he had gotten approval of NARO which was not true.

 

The Catholic priest asked the parishioners to be sharp-eyed not to be duped by anti-GMO activists who are not specialists in plant breeding, nor do not possess any scientific standing, as to oppose genetic engineering. He said he has a personal firm belief that GM-technology presents immense opportunities for farmers to benefit from.

 

I take this opportunity to thank Rev. Fr. Vicent Kisenyi Byasi and the Parishioners of the Archidiocese of Kampala for taking this courageous position in leading the church to adopt the GMOs whose safety and benefits has been proven over nearly the past two decades in countries with more than half of the world’s population. Other religious leaders and priests should emulate this catholic priest and help our people have access to this modern technology to make their farming competitive and profitable. This will also lead to increased productivity of farm products for food, fuel, fibre and feed.

 

According to Wikipedia, in 1999, after two years of discussions, the Vatican’s Pontifical Academy for Life stated that modifying the genes of plants and animals is theologically acceptable. The Guardian reported that “Bishop Elio Sgreccia, vice- president of the pontifical academy, said: ‘We are increasingly encouraged that the advantages of genetic engineering of plants and animals are greater than the risks. The risks should be carefully followed through openness, analysis and controls, but without a sense of alarm.’ Referring to genetically modified products such as corn and soya, Sgreccia added: ‘We give it a prudent ‘yes’ We cannot agree with the position of some groups that say it is against the will of God to meddle with the genetic make-up of plants and animals.'”

 

In 2000 as part of the Great Jubilee Pope John Paul II gave an address concerning agriculture, at which he said: The “famous words of Genesis entrust the earth to man’s use, not abuse. They do not make man the absolute arbiter of the earth’s governance, but the Creator’s “co-worker”: a stupendous mission, but one which is also marked by precise boundaries that can never be transgressed with impunity. This is a principle to be remembered in agricultural production itself, whenever there is a question of its advance through the application of biotechnologies, which cannot be evaluated solely on the basis of immediate economic interests. They must be submitted beforehand to rigorous scientific and ethical examination, to prevent them from becoming disastrous for human health and the future of the earth.

 

A 2002 meeting between bishops and scientists in the Philippines concluded that biotechnology could be an important stepping stone in the struggle against hunger and environmental pollution.

 

A 2003 symposium gathered by Cardinal Renato T. Martino has examined the use of GMOs in modern agriculture. The symposium’s study argued that the future of humanity is at stake and that there is no room for the ideological arguments advanced by environmentalists. Velasio De Paolis, a professor of canon law at the Pontifical Urban University, has said that it was “easy to say no to GM food if your stomach is full”.

A 2009 study on genetically modified organisms sponsored by the Pontifical Academy of Sciences came to a favorable conclusion on GMOs, viewing them as praiseworthy for improving the lives of the poor.

This year (2015), Pope Francis wrote and released the Encyclical Letter.  The letter suggests the need for a scientific-evidence-based decision-making in advancement of a modern agriculture that offers food, nutrition and income security.  He also seems to respects scientists’ right to protect their intellectual property [IP] from the works of their hands and brains, just as Arts-professionals or artisans do copy right their works (literary works, music, art, dance, drama, comedy, books e.t.c).

Quote: “If an artist cannot be stopped from using his or her creativity, neither should those who possess particular gifts for the advancement of science and technology be prevented from using their God-given talents for the service of others”

 

The detailed key excerpts are:

New biological technologies………..

 

  1. In the philosophical and theological vision of the human being and of creation which I have presented, it is clear that the human person, endowed with reason and knowledge, is not an external factor to be excluded. While human intervention on plants and animals is permissible when it pertains to the necessities of human life, the Catechism of the Catholic Church teaches that experimentation on animals is morally acceptable only “if it remains within reasonable limits [and] contributes to caring for or saving human lives”.[106]The Catechism firmly states that human power has limits and that “it is contrary to human dignity to cause animals to suffer or die needlessly”.[107]All such use and experimentation “requires a religious respect for the integrity of creation”.[108]

 

  1. Here I would recall the balanced position of Saint John Paul II, who stressed the benefits of scientific and technological progress as evidence of “the nobility of the human vocation to participate responsibly in God’s creative action”, while also noting that “we cannot interfere in one area of the ecosystem without paying due attention to the consequences of such interference in other areas”.[109]He made it clear that the Church values the benefits which result “from the study and applications of molecular biology, supplemented by other disciplines such as genetics, and its technological application in agriculture and industry”.[110]But he also pointed out that this should not lead to “indiscriminate genetic manipulation”[111] which ignores the negative effects of such interventions. Human creativity cannot be suppressed. If an artist cannot be stopped from using his or her creativity, neither should those who possess particular gifts for the advancement of science and technology be prevented from using their God-given talents for the service of others. We need constantly to rethink the goals, effects, overall context and ethical limits of this human activity, which is a form of power involving considerable risks.

 

  1. This, then, is the correct framework for any reflection concerning human intervention on plants and animals, which at present includes genetic manipulation by biotechnology for the sake of exploiting the potential present in material reality. The respect owed by faith to reason calls for close attention to what the biological sciences, through research uninfluenced by economic interests, can teach us about biological structures, their possibilities and their mutations. Any legitimate intervention will act on nature only in order “to favour its development in its own line, that of creation, as intended by God”.[112]

 

  1. It is difficult to make a general judgement about genetic modification (GM), whether vegetable or animal, medical or agricultural, since these vary greatly among themselves and call for specific considerations. The risks involved are not always due to the techniques used, but rather to their improper or excessive application. Genetic mutations, in fact, have often been, and continue to be, caused by nature itself. Nor are mutations caused by human intervention a modern phenomenon. The domestication of animals, the crossbreeding of species and other older and universally accepted practices can be mentioned as examples. We need but recall that scientific developments in GM cereals began with the observation of natural bacteria which spontaneously modified plant genomes. In nature, however, this process is slow and cannot be compared to the fast pace induced by contemporary technological advances, even when the latter build upon several centuries of scientific progress.

 

In conclusion, GMOs continue to benefit farmers in countries where half of the word population lives. However, there continues to be a lot of misinformation about GMOs. We need courageous leaders like Rev. Fr. Vicent Kisenyi Byasi to take broad decisions to support use of this GMOs to benefit humanity.

Improving sorghum productivity using innovative breeding approaches for African resource constrained farmers

By Clet Wandui Masiga, Conservation Biologist, Geneticist and Farm Entrepreneur
Email: wmasiga@hotmail.com
At the 2nd International Conference on Global Food Security 11-14 October 2015 | Cornell University, Ithaca, New York, USA  I will be presenting onImproving sorghum productivity using innovative breeding approaches for African resource constrained farmers.

 

Theme 6:  Technologies to  improve and  target  production 
Venue/Room: Room 423 – ILR  Conference  Center (KingShaw Hall) 
Date: Wednesday,14thOctober 2015
Time: 10:45‐11:05
Abstract:

Improving sorghum productivity using innovative breeding approaches for African resource constrained farmers

CletWandui Masiga1*, Nada BabikerHamza2, Damaris Odeny3, Tadesse Yohannes4, Steven Runo6, Rasha Ali7, Robert Olupot8,  , Yusuf B Byaruhanga10, Santie de Villiers11, Hai Chun Jing12, and Abdalla H.Mohamed13

 

1Tropical institute of development innovations (TRIDI), P O Box 493, Entebbe Uganda

2National Centre for Research, P.O.Box 2404, Khartoum, Sudan

3International Crops Research Institute for the Semi-Arid Tropics (ICRISAT), PO Box 39063-00623 Nairobi, Kenya

4National Agricultural Research Institute (NARI), PO Box 4627 Asmara- Eritrea

6Biochemistry and Biotechnology Department, Kenyatta University, P.O Box 43844-00100 GPO, Nairobi, Kenya

7Agricultural Research Council (ARC), P.O. Box 126, Wad-Medani, Sudan

8National Semi-Arid Resources Research Institute, Serere/National Agricultural Research Organization

10Department of Food  Technology & Nutrition, College of Agricultural and Environmental  Sciences, Makerere University, P O Box 7062, Kampala, Uganda

11Pwani University, PO Box 195-80108 Kilifi, Kenya

12Institute of Botany, Chinese Academy of Sciences, 20 Nanxincun, Xiangshan,  Beijing 100093, China

13International Crops Research Institute for the Semi-Arid Tropics (ICRISAT-Ethiopia Po.Box 5689, Adis Ababa Ethiopia

 

 

* Correspondingauthor. Email: wmasiga@hotmail.com; c.masiga@tridi.org

Tel: +256 772 457155

 

 

Abstract

Striga remains one of the key biotic constraints affecting cereal grain production in Africa, particularly in semi-arid areas.  The Striga weed parasitizes sorghum,maize, millet, teff, sugarcane, cowpea, and rice. The current solution for managing Striga is cultural, chemical orbiocontrol measures as well asusing resistant lines. Cultural measures include crop rotation, intercropping, trap-cropping and catch cropping. Chemical measures include fertilizers, herbicides and soil sanitation, while biocontrol measures include insects and fungus.  The resistant lines that have been developed and used by farmers frequently succumb again to infection probably due to attack by different ecotypes of Striga while the other management options have proven to be expensive and unaffordablefor most African farmers.  The option proposed now is to continue improving the current resistant and tolerant lines by introgressing a gene for Strigaimmunity that has been identified in wild sorghums. We will integratean array of biotechnological approaches to alleviate constraints due to drought and Striga parasitism in sorghum.  Marker assisted breeding was used to develop Striga and drought tolerant sorghum in Sudan and these lines have been adopted by the national agricultural research systems foradvance for commercial release in Rwanda, Uganda, Kenya, Tanzania, Sudan and Eritrea. The lines were developed at the Agricultural Research Corporation of Sudan. In addition to advancing these lines, we are also using a transcriptional profiling approach to identify and validate gene products in Striga and sorghum that are essential for early post-penetration development and subsequent growth and differentiation of Striga on susceptible sorghum.  This process will accelerateStriga resistance gene identification and allow a better understanding of the molecular mechanism of Striga parasitism on sorghum.  We are also using transgenic approaches to impart tolerance to drought as well as the knowledge of marker assisted breeding, Striga phenotyping and genetics to obtain novel sources of Striga resistance and drought tolerance genes from wild relatives of sorghum by mapping advanced backcross populations derived from wild relatives of sorghum and farmer preferred sorghum varieties (FPSV). Finally, we are characterizing the nutritional and industrial technological properties of Striga resistant and drought tolerant varieties. This article details the methodologies being used to develop Striga resistant and drought tolerant sorghum lines for Africa.

 

It costs $136 million to discover, develop and commercialize a GMO

By Clet Wandui Masiga, Conservation Biologist, Geneticist and Farm Entrepreneur

It costs $136 million to discover, develop and commercialize GMOs having any specific trait. This cost represents money spent on staff, equipment and laboratory supplies, and   the regulatory testing and registration process. The time taken is about 13 years. Much of this time which is about 5.5 years is regulatory and registration.

Below is information I obtained at crop life website on October 201 (https://croplife.org/plant-biotechnology/regulatory-2/cost-of-bringing-a-biotech-crop-to-market/).

Each year, millions of farmers around the world plant biotech crops for higher yields, improved crop quality and the ability to use sustainable farming practices such as no-till.  Getting these innovative new traits from the lab to their fields requires a tremendous investment – a new research survey reveals how it all adds up.

  • The cost of discovery, development and authorization of a new plant biotechnology trait introduced between 2008 and 2012 is US$136 million.
  • The time from the initiation of a discovery project to commercial launch is 13.1 years on average for all relevant crops.
  • The time associated with registration and regulatory affairs is increasing from a mean of 3.7 years for an event introduced before 2002, to the current (2011) estimated 5.5 years.
  • Regulatory science, registration and regulatory affairs account for the longest phase in product development, estimated at 36.7% of total time involved.
  • The trend in the number of units (candidate genes, constructs or genetic events) being screened in order to develop one trait is increasing.

From discovering new genetic traits, field testing and meeting intense regulatory requirements that ensure environmental and human safety, the overall plant biotech R&D process is costly and time-consuming. To determine the relative cost and duration of this process, Phillips McDougall conducted a research survey based on information provided by six of the industry’s largest biotech crop developers – BASF, Bayer CropScience, Dow AgroSciences, DuPont/Pioneer Hi-Bred, Monsanto and Syngenta AG.

The September 2011 survey entitled, “The cost and time involved in the discovery, development and authorization of a new plant biotechnology derived trait”, focused on biotech traits in large scale commodity crops that had received cultivation approval in two countries and import approvals from at least five countries.

Key findings of the survey included:

Overall Cost

The cost of discovery, development and authorization of a new plant biotechnology trait introduced between 2008 and 2012 is US$136 million

Overall Time to Commercialization

The time from the initiation of a discovery project to commercial launch is 13.1 years on average. This does not include the time required to develop and obtain regulatory approval for stacked trait varieties which are the final product in most crops today.

Number of Years Required to Discover, Develop and Authorize a new Plant Biotech Trait (Mean Values)

Canola

Corn

Cotton

Soybean

All crops

Number of years from discovery of trait to first commercial sale

11.7

12.0

12.7

16.3

13.1

 

Duration of Each Activity Stage

The time associated with the R&D stage involving registration and regulatory affairs (Stage VII) is increasing from a mean of 44.5 months (3.7 years) for an event introduced before 2002, to the current estimate of 65.5 months (5.5 years). Because various activity stages overlap in real time, these totals do not reflect the actual duration of the overall R&D process described above.

Duration of Each Activity Stage in the Trait R&D Process (mean number of months)

Activity Stage

Duration for an event sold before 2002

Duration for an event introduced between 2008 and 2012

Duration to complete each stage in 2011

I Early Discovery

38.0

33.9

25.8

II Late Discovery

17.3

20.0

20.9

III Construct Optimization

18.0

27.0

32.8

IV Commercial Event Production & Selection

24.0

30.0

34.0

V Introgression Breeding & Wide-Area Testing

40.0

37.2

42.0

VI Regulatory Science

50.5

37.2

47.0

VII Registration & Regulatory Affairs

44.5

48.8

65.5

Total Cumulative Time

232.3

234.1

268.0

Number of Units Evaluated

The trend in the number of units (candidate genes, constructs or genetic events) being subjected to screening in order to develop one trait is increasing from a mean of 1,638 for an event introduced before 2002, to 6,204 for an event introduced between 2008 and 2012. The survey also demonstrated increasing efficiency by the industry with fewer events in the production & selection stage (Stage IV) for the events commercialized in 2008-2012 compared to events introduced before 2002.

Activity Stage

Event introduced before 2002

Event introduced between 2008-2012

I Early Discovery

1,638

6,204

II Late Discovery

302

4,005

III Construct Optimization

135

511

IV Commercial Event Production & Selection

2,853

1,302

V Introgression Breeding & Wide-Area Testing

4

2

VI Regulatory Science

2

1

VII Registration & Regulatory Affairs

1

1