CHAPTER 3:

SAFETY ASPECTS OF TRANSGENIC CROPS

3.1 Introduction

In the past several years, literature has been coming out rapidly to examine the

impact of GMOs on human health, environmental health, and economic health.1 This

topic has generated severe public debate in many parts of the world. Though, it is widely

claimed that transgenic crops offers dramatic promise for meeting some of greatest

challenges but like all new technologies, it also poses certain risks, because of the fact

that transgenic crops can bring together new gene combinations which are not found in

nature having possible harmful effects on health, environmental and non-target species.

But results of different researches vary from country to country, depending on its

geographic location, strength and resilience of the farm sector, attitudes of people

towards food and so on. Some regions, such as the European Union, have established

highly restrictive regulations in an effort to stop the spread of transgenic crops. While

The United States market is more open for transgenic crops. America who have got most

stringent food safety standard in the world have been promoting it at an impressive rate

and continues to be the lead producer of transgenic crops globally and has not

experienced the same type of consumer criticism as has occurred in Europe.

3.2 Public Perceptions towards Transgenic Food

The Genetically modified technology having a dispute over the relative

advantages and disadvantages of food derived from genetically modified organisms. The

dispute involves consumers, biotechnology companies, governmental regulators, non-

governmental organizations and scientists. The key areas of controversy related to

genetically modified (GM) food are: risk of harm from transgenic food, whether

transgenic food should be labeled, the role of government regulators, the effect of

transgenic crops on the environment, the impact of transgenic crops for farmers, the role

of transgenic crops in feeding the growing world population and transgenic crops as part

of the industrial agriculture system.

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There is broad scientific consensus that food on the market derived from GM

crops poses no greater risk than conventional food.2,3,4,5,6 Supporters of GMOs hold that

food is as safe as other foods. They trust that regulators and the regulatory process are

sufficiently objective and rigorous. They trust that GM technology is a key to feeding a

growing world population, and view GM technology as a continuation of the

manipulation of plants that humans have conducted for millennia. Advocacy groups such

as Greenpeace and World Wildlife Fund have concerns that risks of GM food have not

been adequately identified and managed, and have questioned the objectivity of

regulatory authorities. Opponents of GM food are concerned about the safety of the food

itself and wish it banned or at least labeled. In 2006, the Pew Initiative on Food and

Biotechnology made public a review of U.S. survey results from 2001-2006.7 The review

showed that Americans' knowledge of genetically modified foods and animals was low

through the period. During this period there were protests against Calgene's FlavrSavr

transgenic tomato that described the GM tomato as being made with fish genes,

confusing it with DNA Plant Technology's Fish tomato experimental transgenic

organism, which was never commercialized.8,9 The Pew survey also showed that despite

continuing concerns about GM foods, American consumers do not support banning new

uses of the technology but rather seek an dynamic role from regulators to ensure that new

products are safe.10 A 2010 Deloitte survey found that 34% of U.S. consumers were

extremely concerned about GM food, a 3% reduction from 2008.10 A 2009 review article

of European consumer polls concluded that opposition to GMOs in Europe has been

gradually decreasing.11 Approximately half of European consumers accepted gene

technology particularly when benefits for consumers and for the environment could be

linked to GMO products. 80% of respondents did not cite the application of GMOs in

agriculture as a significant environmental problem. Many consumers seem unafraid of

health risks from GMO products and most European consumers did not actively avoid

GMO products while shopping. A 2007 survey by the Food Standards Australia and New

Zealand found that in Australia where labeling is mandatory,12 27% of Australians

looked at the label to see if it contained GM material when purchasing a grocery product

for the first time.13

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There is a concerted and organized effort from many environmental and other

advocacy groups to impose moratoriums or ban GMO products from being

commercialized. International organizations like Greenpeace14 and Friends of the Earth15

include genetic engineering as part of their environmental and political concerns. Other

groups like GM Watch and The Institute of Science in Society concentrate mostly or

solely on opposing genetically modified crops.16, 17

Too much of hue and cry has been made about safety aspect of transgenic crops in

India. Despite impressive growth and substantial potential of transgenic crops, Indian

policy towards it has not been encouraging. Bt brinjal has passed all the regulatory

procedure that is formed by government of India and yet Government imposed a ban. It

has put a question mark on future of GM foods in India .18

To observe the situation we have to determine that, are transgenic crops really

dangerous for human health and food safety? Are they risky for our environment and the

biological diversity? How can they help attain sustainability? What about the economics

of transgenic crops? We also have to investigate that what scientific approach can be used

to monitor and assess possible long-term health effects or unintended/unexpected adverse

effects? What are the Principles of GM food safety assessment and regulatory system?

Do we have safety mechanism in place and how authentic is our apprehension about

safety? In short, we must consider several key points when assessing the safety of

transgenic crops for production and commercialization. With the help of literature, first

we will try to know the impacts of transgenic crops on health and environment.

3.3 Health

Governments worldwide assess and manage the risks associated with transgenic

crops. Regulators examine the genetic modification, its protein products, and any

intended changes that those proteins make to the food.20 Regulators also check to see

whether the food derived from a GMO is "substantially equivalent" to its non-GM-

derived counterpart.19 If the newly included protein is not similar to that of other proteins

found in food or if difference arise in the substantial equivalence comparison, further

toxicological testing is required.19

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In 2012, the American Association for the Advancement of Science stated "Foods

containing ingredients from genetically modified (GM) crops pose no greater risk than

the same foods made from crops modified by conventional plant breeding techniques".21

The American Medical Association, the National Academies of Sciences and the Royal

Society of Medicine have stated that no adverse health effects on the human population

related to GM food have been reported and substantiated in peer-reviewed literature to

date.6 The European Commission Directorate-General for Research and Innovation 2010

report on GMOs noted that "The main conclusion to be drawn from the efforts of more

than 130 research projects covering a period of more than 25 years of research and

involving more than 500 independent research groups is that biotechnology, and in

particular GMOs are not per se more risky than e.g. conventional plant breeding

technologies".22

3.3.1 Approaches to Safety Evaluation

The introduction of transgenic crops need a high level safety standard for the

new crops by setting up guidance for evaluation and development of pre-market

approval systems that include extensive documentation, analysis and test. The argument

for this high safety level which seems to be much higher than the safety level for

traditional plants is the present limitation of experience (lack of history of safe intake)

with transgenic crops. Concerted efforts have been made internationally to harmonize the

risk assessment of transgenic crops as articulated in two important documents published

in 2003 by the Codex Alimentarius Commission (CAC) “Principles for the Risk Analysis

of Foods Derived from Modern Biotechnology” (“Codex Principles”) and “Guideline for

the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA

Plants”. Several international organizations have already addressed the issues associated

with the safety assessment of transgenic crops.23,24,25,26 The current approach of food

safety assessment of transgenic crops is based on the concept of substantial equivalence.

It is a key step in the safety assessment process. Although it does not characterize hazard,

rather it is used to determine whether the genetically modified food is as safe as it’s a

conventional counterpart.

 

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3.3.2 Substantial Equivalence

The starting point for the safety assessment of transgenic food products by

regulatory bodies is to assess if the food is "substantially equivalent" to their

counterparts, which themselves are the products of genetic manipulation via traditional

methods of cross-breeding and hybridization.27 Substantial equivalence is a concept, first

described in an OECD (Organization for Economic Co-operation and Development)

publication in 1993. It follows a stepwise process and factors taken into account in the

safety assessment include identity, source, composition, effects of processing/cooking,

transformation process, the recombinant DNA (e.g. stability of insertion, potential for

gene transfer), protein expression product of the novel DNA, potential toxicity, potential

allergenicity, possible secondary effects from gene expression or the disruption of the

host DNA or metabolic pathways, including composition of critical macro, micro

nutrients, anti-nutrients, endogenous toxicants and physiologically active substances and

potential intake and dietary impact of the introduction of the genetically modified crops.

The above factors are the assessment of foods derived from genetically modified plants.

The safety assessment of GM foods has been based on the principle that these factors can

be compared with traditional foods that have an established history of safe use. The

concept of substantial equivalence was further endorsed by an FAO/WHO (Food and

Agriculture Organization/World Health Organization) joint expert consultation in 1996. It

recognized that the establishment of substantial equivalence is not a safety assessment

per se, but that establishing the characteristics and composition of the GM food as

equivalent to those of a familiar, conventional food with a history of safe consumption

means that the new product will be no less safe under similar consumption patterns and

processing practices. The concept of substantial equivalence also recognizes the fact that

existing foods often contain toxic components (usually called anti nutrients) and are still

able to be consumed safely for example the cassava root is quite toxic, but proper

processing converts it into a nutritious and widely consumed food. Soybeans and Lima

beans, among other crops, contain anti-nutrients (e.g., soybean trypsin inhibitor and

lectins) and require proper processing. Potatoes and tomatoes can contain toxic levels of

the glycoalkaloids solanine and alpha-tomatine, respectively. Thus, the presence of a

toxicant in a plant variety does not necessarily eliminate its use as a food source. In

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considering the safety of the GM food, it is therefore important to examine the range of

possible toxicants, critical nutrients or other relevant factors, as well as its processing,

intended use and exposure.28 The proposed indirect measurements using the substantial

equivalence approach therefore do not result in 100% certainty on the absence of any

toxicologically unwanted effects, but in a strong reduction of the likelihood that such

unwanted effects have occurred. The fact that such effects can also occur in

conventionally bred crops, makes that if no substantial differences are found, the

modified crop is considered to be (at least) as safe as the conventionally bred varieties.

The application of substantial equivalence has been criticized by Erik Millstone,

Eric Brunner and Sue Mayer argued in a commentary in Nature that the substantial

equivalence standard was pseudo-scientific and was the product of politics and business

lobbying. They claimed it was created primarily to reassure consumers and to aid

biotechnology companies in avoiding the time and cost of more rigorous safety testing.

They suggested that all GM foods should have extensive biological, toxicological and

immunological tests and that the concept of substantial equivalence should be

abandoned.29 This commentary was criticized for providing a misleading presentation of

history,30 for distorting existing data and applying bad logic.31 This process was

examined further in a review published by Harry Kuiper in 2002 in the journal

Toxicology. It stated that substantial equivalence does not measure risks, but instead

identifies differences between existing products and new foods, which might pose

dangers to health. If differences do exist, identifying these differences is a starting point

for a full safety assessment, rather than an end point.32 It concluded that "The concept of

substantial equivalence is an adequate tool in order to identify safety issues related to

genetically modified products that have a traditional counterpart".

3.3.3 Non-Substantial Equivalence

If the GM plant or one of its components is not similar to its conventional

varieties then the following unexpected differences could arise:

(i) Pleiotropy: The transgene not only result in the expected new trait, but also results in

another unexpected change in the plant. Like the transgene product can interact

unexpectedly with other components in the plant. The pathway in which the transgene

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product has its function is (unexpectedly) cross linked with other pathways. Changed

expression level of an enzyme may trigger other pathways or a down regulation response.

(ii) Insertion: The transgene has landed somewhere in a gene thereby disrupting this

gene’s function and resulting in changes in the plant’s constituents.

(iii) Somaclonal Variation: In the in-vitro regeneration of the transgenic plants, due to

chromosomal instability, changes have appeared in the plant resulting in changes in

morphology, behavior, or macro- or micro constituents. But these unexpected effects are

not yet understood totally and these non-substantial equivalence results in a need for

further analysis.

In certain countries, the regulatory authority for GM foods is the same authority

that is responsible for administering food safety law(s). Like The United States looks at

GMOs as being substantially equivalent to conventional crops and fall under Generally

Recognized As Safe (GRAS) labeling and regulations. This recognizes that the safety

assessment of GM foods is part of, and not separate from programs that address the

broader context of ensuring the safety of the foods that the public consumes. In India,

FSSAI (Food Safety and Standards Authority of India) as the statutory body for ‘laying

down science based standards for articles of food and regulating manufacturing,

processing, distribution, sale and import of food so as to ensure safe and wholesome

food for human consumption.33 FSSAI is the agency responsible for administering or

determining the substantial equivalence of GM crop.

3.3.4 Allergen-city

Some environmental organizations such as the European Green Party and

Greenpeace have suggested that GM food might trigger food allergies.34 A 2005 review

in the journal Allergy of the results from allergen testing of current GM foods stated that

"no biotech proteins in foods have been documented to cause allergic reactions".35 The

development of GM products which have been found to cause allergic reactions have

been halted by the companies developing them before they were brought to market. In the

early 1990s, Pioneer Hi-Bred attempted to improve the nutrition content of soybeans

intended for animal feed by adding a gene from the Brazil nut. Their studies showed that

the modified strain produced immune reactions in people with Brazil nut allergies36 and

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Pioneer Hi-Bred discontinued further development.37,38 In 2005, a pest-resistant field pea

developed by the Australian Commonwealth Scientific and Industrial Research

Organization for use as a pasture crop was shown to cause an allergic reaction in mice.39

Work on this variety was immediately halted.

Toxicologists note that "conventional food is not risk-free; allergies occur with

many known and even new conventional foods. For example, the kiwi fruit was

introduced in the U.S. and the European markets in the 1960s with no known human

allergies; however, today there are people allergic to this fruit".40 Genetic modification

can also be used to remove allergens from foods, potentially reducing the risk of food

allergies.41 In ryegrass, a pollen that is a major cause of hay fever but a fertile GM grass

was produced that lacked the main pollen allergen, demonstrating that the production of

hypoallergenic grass is also possible.42

3.3.5 Horizontal Gene Transfer

One concern raised, has been the possibility of the transgenes transferring to

different species. Of particular concern is that the antibiotic resistance gene commonly

used as genetic markers in transgenic crops could be transferred to harmful bacteria,

creating superbugs that are resistant to multiple antibiotics.43 In 2004 a study involving

human volunteers was conducted to see if the transgene from GM soybean would

transfer to the bacterium that naturally lives in the human gut. The transgene was only

detected in three volunteers, part of seven who had previously had their large intestines

removed for medical reasons. As this gene transfer did not increase after the consumption

of GM soy, the researchers concluded that gene transfer did not occur during the

experiment. In volunteers with complete digestive tracts, the transgene did not survive

passage through intact gastrointestinal tract.44 The antibiotic genes used in genetic

engineering are already found in many natural pathogens,45 commonly used during

animal husbandry 45 and not widely used prescribed.46 The risk of horizontal gene

transfer between plants and animals is very low.47

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3.3.6 Animal Feeding Studies

A 2012 review of more than 24 long-term animal feeding studies conducted by

public research laboratories concluded that none of these studies discovered any safety

problem linked to long-term consumption of GM food. Gerhard Flachowsky concluded in

a 2005 review that the current GM food with only a single gene modification are similar

in nutrition and safety, to non-GM foods, but noted that food with multiple gene

modifications would be more difficult to test and would require further animal studies.48

A 2004 review of animal feeding trials by Aumaitre et al. found no differences among

animals eating genetically modified plants.49 In 2007, Jose L. Domingo searched the

PubMed database using 12 search terms and found 68 papers showing animal studies

involving GM food. He concluded that the "number of references" on the safety of

GM/transgenic crops was "surprisingly limited" and questioned whether the safety of

genetically modified food has been demonstrated; the review also remarked that its

conclusions were in agreement with three earlier reviews.50 In contrast, Philippe Vain

found 692 research studies in 2007 that focused on GM crop and food safety and

identified a strong increase in the publication of such articles in recent years.51,52 Vain

commented that the multidisciplinary nature of GM research complicates the retrieval of

GM studies and requires using many search terms (he used more than 300) and multiple

databases. Domingo again reviewed the literature in 2011 and said that although there

had been a substantial increase in the number of studies since 2006, most were conducted

by the biotechnology companies responsible for commercializing the plants.53

3.3.7 Human Studies and Obstacles

While some groups and individuals have called for more human testing of GM

food, 54 there are several obstacles to such studies. There are strong ethics that guide the

conduct of research on human subjects, which mandate that the intervention being tested

must have a potential benefit for the human subjects such as treatment for a disease or

nutritional benefit (ruling out toxicity testing on humans).55 In this context, scientists and

regulators discussed clinical studies of GM food have written that the "ethical and

technical constraints of conducting human trials, and the necessity of doing so, is a

subject that requires considerable attention".56 Golden rice has been tested in humans to

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see if the rice provides a nutritional benefit, namely, increased levels of Vitamin A.57,58

However the authors of a study in Chinese Children published in 2012 have come under

fire for not obtaining the consent of the parents of the children nor the Chinese

government.59

3.3.8 Individual Studies

3.3.8.1 The Pusztai Affair

There have been some individual studies published in journals that have

suggested negative impacts of GM food. The first such peer reviewed paper was

published in 1999 and covered research conducted by Arpad Pusztai in 1998. Pusztai had

fed rats with GM potatoes transformed with the Galanthus Nivalis Agglutinin (GNA)

gene from the Galanthus (snowdrop) plant, allowing the GNA lectin protein to be

synthesized.60 Pusztai said that rats fed the potatoes had stunted growth and a repressed

immune system.61 A media frenzy resulted and Pusztai was suspended from the Rowett

Institute with misconduct procedures used to seize his data and ban him from speaking

publicly.62 The Rowett Institute and the Royal Society reviewed Pusztai's work and

concluded that the data did not support his conclusions.63,64 When his work was

eventually published in The Lancet it reported significant differences in the thickness of

the gut epithelium of rats fed with genetically modified potatoes (compared to those fed

the control diet), but no differences in growth or immune system function were

suggested.65 The published paper was criticized on the grounds that the unmodified

potatoes were not a fair control diet and that any rats fed only on potatoes will suffer

from a protein deficiency.66 Pusztai responded to these criticisms by stating that all the

diets had the same protein and energy content and that the food intake of all rats was the

same.66 The incident became known as the Pusztai affair.67

3.3.8.2 The Monarch Butterfly Controversy

A paper published in Nature by Cornell researcher John E. Losey regarding the

interaction between Monarch butterflies and the pollen released by GMO maize which

expressed the Bt toxin .68 The paper described a lab study which indicated that Monarch

larvae which consumed pollen from Bt maize that had been dusted on milkweed leaves

subsequently died. Although Losey had urged caution in the interpretation of his results

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in subsequent press conferences, the media latched on to the notion of a charismatic

species such as the Monarch Butterfly being potentially wiped out by GM crops. So

many papers were published in contradiction of Losey’s result. The main stated

drawbacks, acknowledged by Losey, were that the samples sizes were small and

performed in the lab, not in the natural environment. Effectively Losey’s study simply

showed that Bt toxin, a known insecticide, was toxic to specific by-stander insect species

when expressed in pollen. Other studies 70,71,72 showed that though the result was not

unexpected, it was also not likely to occur in the field. Several key points were brought

up demonstrating the weaknesses in Loseys methodology like the pollen density

necessary to negatively affect Monarch larvae is rarely ever achieved in the open

environment. This was confirmed both in studies of natural environments and in the

laboratory as well. The period in which Monarch larvae occur and are feeding on

milkweed leaves has a very little overlapping with the period in which Bt maize is

actively shedding pollen, reducing the exposure time frame. Milkweed is not a preferred

food supply of Monarch larvae and only a portion of the larvae is consuming this species.

Other butterfly and moth species showed no evidence of elevated toxicity or mortality in

real-world experiments. These showed that laboratory testing for these effects failed to

take into account the complex interactions of real world agricultural activity and that

Loseys paper represent a worst case scenario in terms of environmental interaction. At

the same time Trewavas & Leaver (2001) also showed that not only were general

populations of Monarch butterflies not adversely affected by Bt crops in 1999 but their

populations increased by 30% during that time frame, likely due to the reduced overall

use of pesticides in GMO maize crops, which represented nearly 50% of the US maize

harvest that year. A 2002 review of the scientific literature concluded that "the

commercial large-scale cultivation of current Bt–maize hybrids did not pose a significant

risk to the monarch population" and noted that despite large-scale planting of GM crops,

the butterfly's population is increasing.73 In 2007, 2009, and 2011 Gilles-Eric Seralini

published re-analysis studies that used data from Monsanto rat feeding experiments for

three GM maize varieties (insect resistant MON 863 and MON 810, and the glyphosate

resistance NK603. He concluded that they had actually caused liver, kidney, and heart

damage in the rats.74,75,76 The European Food Safety Authority (EFSA) reviewed the data

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and concluded that the small differences were all within the normal range for control

rats.77 The EFSA review also stated that the statistical methods used were incorrect.78,79

The EFSA conclusions were supported by Food Standards Australia New Zealand

(FSANZ),80 a panel of independent toxicologists funded by Monsanto81 and the French

High Council of Biotechnologies Scientific Committee (HCB).82 In 2012 the Seralini lab

published a paper that looked at the long term effects of feeding rats various levels of GM

roundup resistance maize, maize spiked with the roundup chemical and a mixture of the

two.83 The paper concluded that rats fed GM maize had an increased incidence of

cancer.83 Once published, there was widespread criticism of the study. Many claimed that

Seralini's conclusions were impossible to justify given the statistical power of the study

and that Sprague-Dawley rats were not appropriate for a lifetime study (as opposed to a

shorter toxicity study) because these rats have a high tendency to get cancer over their

lifespan (one study found over 80% got cancer under normal conditions).84,85,86

3.4 Environment

Genetically modified crops are planted in fields much like regular crops. There

they interact directly with organisms that feed on the crops and indirectly with other

organisms in the wider food chain. The pollen from the plants behaves like the pollen of

any other crop. This has led to concerns about effects of genetically-engineered crops on

non-target species. Some supporters of GM crops see these crops as providing benefits to

the environment through a reduction in the use of pesticides  87 and a reduction in

greenhouse gas emissions.88

3.4.1 Non Target Organisms

One of the major uses of GM crops is in insect pest control though the expression

of cry genes from Bacillus thuringiensis (Bt). There are concerns that the Cry toxin could

target predatory and other beneficial or harmless insects as well as the targeted pest

insect. The proteins produced by Bt have been used as organic sprays for insect control in

France since 1938 and the USA since 1958 with no ill effects on the environment

reported.89 The toxicity of each Bt type is limited to one or two insect orders; it is

nontoxic to vertebrates and many beneficial arthropods because Bt works by binding to

the appropriate receptor on the surface of midgut epithelial cells. Any organism that lacks

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the appropriate receptors in its gut cannot be affected by Bt.90,91 Regulatory agencies

assess the potential for the transgenic plant to impact non-target organisms before

approving their commercial release.92

3.4.2 Gene Flow

Genes from a genetically modified organism will pass to another organism just

like an endogenous gene. There are concerns that the spread of genes from modified

organisms to unmodified relatives could produce species of weeds resistant to

herbicides93,94 or could disrupt the ecosystem.95,96 This is primarily a concern if the

transgenic organism has a significant survival capacity and can increase in frequency and

endure in natural populations.97

In 2009 the government of Mexico created a regulatory pathway for approval of

genetically modified maize,98 but because Mexico is the center of diversity for maize,

concerns have been raised about the effect that genetically modified maize could have on

local strains.99,100 A 2001 report in Nature presented evidence that Bt maize was cross-

breed with unmodified maize in Mexico,101 although the data in this paper was later

described as originating from an artifact and Nature stated that "the evidence available is

not sufficient to justify the publication of the original paper".102 A subsequent large-scale

study, in 2005, failed to find any evidence of contamination in Oaxaca.103

3.4.3 Chemical Use

One of the major environmental benefits from using GM crops is the reduction in

the use of pesticides. Insect-resistant Bt-expressing crops will reduce the number of pest

insects feeding on these plants without the farmers having to apply as much

insecticides.104,105 A study published by the UK consultancy PG Economics, concluded

that globally pesticide spraying was reduced by 286,000 tons in 2006, decreasing the

environmental impact of herbicides and pesticides by 15%.69 A survey of small Indian

farms between 2002 and 2008 concluded that Bt cotton adoption has led to higher yields

and lower pesticide use.106 One study concluded insecticide use on cotton and corn during

the years 1996 to 2005 fell by 35.6 million kg of insecticide active ingredient, which is

roughly equal to the amount of pesticide applied to arable crops in the EU in one year.107

A study on the effects of using Bt cotton in six northern provinces of China from 1990 to

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2010 concluded that Bt cotton halved the use of pesticides and doubled the level of

ladybirds, lacewings and spiders, with the environmental benefits extended to

neighboring crops of maize, peanuts and soybeans.108,109

3.4.4 Resistant Insect Pests

Resistance evolves naturally after a population has been subjected to intense

selection pressure in the form of repeated use of a single herbicide or insecticide.110 In

November 2009, Monsanto scientists found the pink bollworm had become resistant to

the first generation Bt cotton in parts of Gujarat, India - that generation expresses one Bt

gene, Cry1Ac. This was the first instance of Bt resistance confirmed by Monsanto

anywhere in the world.111,112 Bollworm resistance to first generation Bt cotton has also

been identified in the Australia, China, Spain and the United States.113 The strategy to

delay the emergence of Bt resistant pests has been to have non-GM refuges within the

GM crops to dilute any resistant genes that may arise or more recently to develop GM

crops that have multiple Bt genes that target different receptors within the insect.114

3.5 Regulations

3.5.1 Labeling

While some groups advocate the complete prohibition of GMOs, some call for

mandatory labeling of genetically modified food or other products, while others call for

no labeling of GM food. The European Union, Australia, China, and other countries

require GMO labeling, while others make GMO labeling voluntary or have plans to

introduce labeling.115 The American Medical Association116 (AMA) and the American

Association for the Advancement of Science117(AAAS) oppose mandatory labeling of

GM food because there is no scientific evidence of harm. The AMA believes that even

voluntary labeling is misleading unless accompanied by focused consumer education.

The AAAS argues that mandatory labeling "can only serve to mislead and falsely alarm

consumers". There are several arguments put forward in favor of and against mandatory

labeling of GM foods. Supporters say that consumers have a right to know what is in

their food, especially concerning products for which health and environmental concerns

have been raised.118 While opponent say that labels on GM food imply a warning about

health effects, whereas no significant differences between GM and conventional foods

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have been detected. Labeling of GM foods to fulfill the desires of some consumers would

impose a cost on all consumers. Experience with mandatory labeling in the European

Union, Japan, and New Zealand has not resulted in consumer choice. Rather, retailers

have eliminated GM products from their shelves due to supposed consumer dislike to

GM products.119 Consumers who want to buy non-GM food already have an option: to

purchase certified organic foods that are labeled "100% Organic," which by definition

cannot be produced with non-organic ingredients.120

3.6 Protests

Within the UK, European countries and India also many trial crops have been

destroyed by protesters. Though, the primary concern of the campaigners is

contamination of existing crops could destroy existing markets. Scientists take many

precautions to minimize the risks as much as possible and admit the risk of contamination

is small. However, campaigners counter with examples of widespread contamination that

has already occurred despite assurances and promises from scientists. The scientists give

several reasons for the need of trials - climate change, a growing global population and

reduced use of chemicals. The campaigners draw attention to natural and organic

solutions to reduce chemical use and question the usefulness of the trials (e.g. field trials

in the UK for a crop designed for Africa).121

3.7 Safety Protocol in India for Transgenic Crops

In India the path of transgenic crops from the laboratory to the market involves

five main stages: laboratory test, greenhouse test, contained field tests, large-scale field

trials and approval by the bio-safety and other regulatory authorities for varietal tests and

commercialization.122 In 1989 India established this regulatory system for the import,

testing and commercialization of genetically test engineered material.123 It is based on the

bio-safety guidelines first developed and implemented in some of the leading

Organizations for Economic Co-operation and Development (OECD) countries.

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They covered the health safety of humans and livestock, environmental safety

(ecology and biodiversity) and economic impact.124 It comprised of the following

committees (Figure 3.1).

1-The Review Committee on Genetic Manipulation (RCGM) under the Ministry of

Science and Technology (MoST).

2-The Genetic Engineering Approval Committee (GEAC) under the Ministry of

Environment and Forestry (MoEF).

3-The Monitoring and Evaluation Committee (MEC) under DBT/MoST.125,126,127

The regulations classify activities involving GMOs into four risk categories;

provide lists of bacterial, fungal, parasitic and viral agents that fall into each category.

1-Category I comprises routine recombinant DNA experiments conducted inside a

laboratory.

2-Category II consists of both laboratory and greenhouse experiments involving

transgenes that combat biotic stresses through resistance to herbicides and pesticides.

3-Categories III and IV comprise experiments and field trials where the effect of

transgenic traits into the open environment could cause significant alterations in the

ecosystem.128

Until 2012, many crops had completed the laboratory and greenhouse stages.

Fourteen of them have been put through contained field tests which include Brinjal,

Cabbage, Cauliflower, Chickpea, Cotton, Groundnut, Maize, Mustered, Okra, Papaya,

Potato, Rice, Sorghum, Tomato, Watermelon. However, only transgenic cotton has

passed the stage of commercialization as yet. 129

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Figure 3.1: Safety Protocol in India for Transgenic Crops

Applicant/Investigator

SBCC 

RCGM

Main functions of GEAC 1-To approve for large scale use. 2-To approve for open release to environment. 3-Inform decision to administrative ministry and applicant/investigators to follow pvp/ seeds Act.

GEAC

Main function of IBSC 1-To approve. 2-To recommend & to seek approval of RCGM.

MEC

ICAR

Main function of RCGM 1-To note. 2-To approve. 3-To recommend generation of appropriate Biosafety and agronomic data. Applicant/

Investigator 

Release for Commercial agriculture

State Government Permission

Main functions of ICAR

1-To generate complete agronomic data on transgene. 2-To recommended suitable transgene for commercial release.

IBSC

Main function of MEC 1- Visit trial site. 2-Analyze data. 3-Inspect facilities. Recommend safe and ergonomically viable transgenic.

DLC

Source: Sharma, M. (2003)130

For commercialization of transgenic crops every applicant has to take approval

first from Institutional Bio-safety Committee (IBSC). It is composed of scientists of

rDNA, medical officers and nominee of department of biotechnology. Its main function is

to oversee rDNA research activity. It seeks RCGM approval for category III and informs

the District level Committee (DLC), State Biotechnology Coordination Committee

(SBCC) & Genetic Engineering Appraisal Committee (GEAC) about relevant

experiments. DLC composed of District collector, factory inspectors, pollution control

board and other experts in individual capacity. It monitors safety regulation in installation

and report violations to SBCC or GEAC. SBCC consists of chief secretary, Department

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of Environment, State Pollution Control Board, microbiologists, pathologist and other

experts in individual capacity. Its main function is to periodically review the safety and

control measures in institution handling GMOs. It inspects and takes punitive action in

case of violations through the State Pollution Control Board. SBCC acts as a nodal

agency to assess damage and take of site control measures also.

At second stage of commercialization of transgenic crops, RCGM comes into

picture. It works under the Department of Biotechnology (DBT) of the Ministry of

Science and Technology (MoST). The main function of RCGM is to issue guidelines for

GMO research and authorize rDNA project in high risk category III. It also authorizes

controlled field experiments and permits the import of GMO for research. At this stage

RCGM’s mandate is to assess and decide on the applications submitted by institutions

and companies for conducting R&D work, greenhouse tests and contained field tests on

plots of less than one acre in size (0.4 hectare). RCGM also cooperate with Monitoring

and Evaluation committee (MEC). It does monitoring work and its reports are expected to

cover all the main aspects of bio-safety, i.e. the impact of the GM-crop on the

environment (ecology and biodiversity), the agronomy (crop production science and

farm-level economy), the health of humans and livestock and the livelihoods of the

farming community. It collects information on comparative agronomic advantages of

transgenic plants and assists RCGM in collecting and analyzing field data at experiment

side.

After these two stages, towards general release and commercialization of

transgenic crops, large scale and multi location field trials are mandatory under the bio-

safety regulation. At this stage GEAC has the sole responsibility and power to authorize

large-scale and multi-location field trials, and assess the output of the trials. On the basis

of that assessment GEAC decide to approve, reject or put on hold the applicant’s request

for general release of the GM-crop for commercial planting. GEAC may request ICAR to

check and validate the ‘output’ of field trials submitted by the applicant, if necessary by

conducting its own field trials. Indian Council for Agricultural Research (ICAR) is an

autonomous body under the Department of Agricultural Research and Education of the

Ministry of Agriculture. After investigation of the applicant, State government provides

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permission for commercialization of crops.127,131,132 Details of Committees Involved in

Indian Regulatory Framework are given below.

3.7.1 Recombinant DNA Advisory Committee (RDAC)

This committee is constituted by DBT to monitor the developments in

biotechnology at national and international levels. RDAC submits recommendations from

time to time that are suitable for implementation for upholding the safety regulations in

research and applications of GMOs and products thereof. This committee prepared the

first Indian recombinant DNA biosafety guidelines in 1990, which were adopted by the

Government for handling of GMOs and conducting research on them.

3.7.2 Institutional Biosafety Committee (IBSC)

It is composed of scientists engaged in rDNA work, biosafety or medical officer,

nominee department of biotechnology. Its main function is to oversee rDNA research

activities, to seek RCGM approval for category, to inform DLC, SBCC and GEAC about

relevant experiment. This committee is constituted by organizations involved in

recombinant DNA (r-DNA) research. It has the mandate to approve low-risk (Category I

and II) experiments and to ensure adherence to r-DNA safety guidelines. IBSC

recommends category III or above experiments to Review Committee on Genetic

Manipulation (RCGM) for approval. It also acts as a nodal agency for interaction with

various statutory bodies.

3.7.3 Review Committee on Genetic Manipulation (RCGM)

It comes under the Department of Biotechnology (DBT) of the Ministry of

Science and Technology (MoST). Its composition includes department of biotechnology,

Indian Council of Agricultural Research, And Council of Scientific and Industrial

Research. Its main function is to issue guidelines for GMO research, to authorized rDNA

projects in high risk category, to authorized controlled field experiments, to permit import

of GMOs for research. This committee is constituted by DBT to review all ongoing

projects involving high-risk (Category III and above) and controlled field experiments.

These small experimental field trials, also called Biosafety Research Level I (BRL I), are

limited to a total area of 20 acres in multi-locations in one crop season. In one location

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where the experiment is conducted with transgenic plants, the land used should not be

more than 1 acre. RCGM approval is granted for one season and applicant must provide

entire details of the experimentation to the committee. Monitoring of field trials is carried

out by Monitoring cum Evaluation Committee of RCGM. RCGM can lay down

procedures restricting or prohibiting production, sale, importation and use of GMOs. It

also issues clearances for import/export of etiologic agents and vectors, transgenic

germplasm including transformed calli, seed and plant parts for research use only.

3.7.4 Genetic Engineering Approval Committee (GEAC)

It comes under the Ministry of Environment and Forestry (MoEF). Its

composition includes Chairman, additional secretary Ministry of Environment and

Forests, Co chair Department of Biotechnology and Atomic Energy, Indian Council of

Medical Research, Council of Scientific and Industrial Research, Directorate of Plant

Protection, Central Pollution Control Board and other in individual capacity. Its main

function is to authorize commercial use (including imports) of GMO or their products. To

authorized large-scale production and release of GMOs and their products into the

environment to mandate restrictions and prohibitions on production, sale, and import of

GMOs, if necessary. This committee functions as a body in the Ministry of Environment

and Forests and is responsible for environmental approval of activities involving large-

scale use of GMOs in research, industrial production and applications. Large-scale

experiments conducted in an area of 2.5 acres per location also known as Biosafety

Research Level II (BRL II) beyond the limits specified within the authority of RCGM are

authorized by GEAC. The GEAC can authorize approval and prohibition of any GMO for

import, export, transport, manufacture, processing use or sale.

3.7.5 State Biotechnology Coordination Committee (SBCC)

Its composition includes Chief Secretary (state government), secretaries,

(department of environment) health, agriculture, commerce, forest, public work, public

health, State Pollution Control Board, State Microbiologist and Pathologists, other

experts in individual capacity. Its main Function is to periodically review safety and

control measures in institutions handling GMOs, to inspect and take punitive action in

case of violations through the state pollution control board or the directorate of health, to

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act as nodal agency at the state level to assess damage, if any, from release of GMOs and

to take of site control measures. The Committee is also nominates state government

representatives for field inspection of GM crops.

3.7.6 District Level Committee (DLC)

Its Composition includes District Collector, factory inspector, pollution control

board, representative chief medical officer, district agricultural officers, public health

department representative, district microbiologist/pathologist, Municipal Corporation,

commissioner, other experts in individual capacity. Its main Function is to monitor safety

regulation in installation, to investigate compliance with rDNA guidelines and report

violations to SBCC or GEAC, to act as nodal agency at district level, to assess damage, if

any from release of GMOs and to take on site control measures. The District Collector

heads the committee who can induct representative from state agencies to enable smooth

functioning and inspection.

3.7.7 Monitoring and Evaluation Committee (MEC)

This committee comes under DBT/MoST.DBT provides the secretariat for RCGM and MEC. Its Composition includes Chairman, jointly elected by secretary (Department of Biotechnology) and secretary (Department of Agricultural Research and Education), plant breeders (nominated by RCGM or ICAR) and the National Bureau of Plant Genetic Resources (NBPGR) nominee, a MoEF nominee and the member secretary of the RCGM. Its main Function is to undertake field visits at experiment sites, to suggest remedial measures, to adjust original trial design, to assist RCGM in collecting and analyzing field data to collect comparative agronomic advantages of transgenic plants.

This system has some deficiencies. Current protocols focus largely on screening for toxic effects of chemicals, rather than biological impacts. A striking feature of the composition of RCGM, GEAC and MEC is the absence of the representatives of other crucial stakeholders e.g. civil society organizations (CSOs, including NGOs), private sector companies and institutions, and the central government funded Indian Council for Social Science Research (ICSSR). While the regulations say that the RCGM, the GEAC, the SBCCs and the DLCs may co-opt other members/experts as necessary, they do not include representatives of CSOs /NGOs and the private sector. In practice, however, these non-governmental stakeholders have been excluded 133. In 2007 the Government of

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India approved the National Biotechnology Development Strategy which promoted the establishment of a National Biotechnology Regulatory Authority that would act as an ‘independent, autonomous and professionally led body to provide a single window mechanism for bio-safety clearance of genetically modified products and processes’. Now Department of Biotechnology (DBT) has been given the responsibility to establish and operationalize this new regulatory authority, the Biotechnology Regulatory Authority of India (BRAI). Biotechnology regulation will continue under the existing regulatory framework until the BRAI is fully functional. In India only a single transgenic crop, transgenic cotton is commercialized by following the above regulatory procedure successfully. Its details are given in the table3.1.

Table 3.1: Regulatory Processes Followed by Transgenic Cotton

Years Regulatory processes / Studies undertaken Oversight Committees

1995-1996

Permit for importation of transgenic cotton seed containing the Cry1Ac gene.

DBT

1996-2000

Greenhouse breeding for integration of the Cry1Ac gene into Indian germplasm, seed purification, and stock increase.

DBT

1996-2000

Limited field studies for potential of pollen escape, aggressiveness and persistence.

RCGM

1998-2001

Biochemical and toxicology studies. RCGM, GEAC

1998-2000

Multi-location field trials: Agronomic and entomology performance of first-generation transgenic cotton hybrids conducted by Mahyco and state agriculture universities.

RCGM, MEC

2000-2001

Soil rhizosphere evaluations and protein expression analyses from multi location field trials.

RCGM, GEAC

2001 Advanced stage multi location field performance trials of first-generation transgenic cotton hybrids conducted by ICAR.

GEAC, ICAR, DBT, MEC

2002 Submission of final biosafety, environmental safety, gene efficacy & performance documentation to GEAC; commercial release of first-generation transgenic cotton hybrids by GEAC.

GEAC

2002 Continued field performance trials of second-generation transgenic cotton hybrids for, ongoing regulatory approval.

RCGM, GEAC, ICAR, MEC

Source: Barwale, R. B et al 2004 134

Though Bt cotton is commercialized in India but decision on commercialization

of Bt brinjal is still pending. Various studies based on the concept of substantial

equivalence point that cooked Bt Brinjal is safe for human consumption,135 safe and non-

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toxic on rats, 136 and non irritant to rabbit skin.137 The alkaloid profile from power

samples of fruit and roots of Bt and non Bt Brinjal were the same with no significant

variation in their relative abundances.138 There was no significant difference on health

and growth found between the rabbit and goat group who fed with Bt Brinjal and non Bt

Brinjal fruit.139 On comparison of different parameters like moisture, protein, oil, Ash,

Carbohydrate and calorie value of Bt and non Bt Brinjal in table 3.2, it was found that

both type of food having same properties.

Table 3.2: Substantial Equivalence: Composition of Fruit Tissue

of Bt and Non-Bt Brinjal entries *

Crops Moisture % Protein % Oil % Ash % Carbohydrate % K cal/

100g

Bt brinjal 88.4 2.2 0.2 0.9 8.3 43.6

Non Bt brinjal 88.4 2.0 0.3 0.8 8.6 44.4

* All values are expressed on fresh weight basis and mean of four replications. Source: Study conducted at Kallakal.140

Thus, Studies have confirmed that first Indian GM food Bt. brinjal completely

fulfill international norms of Substantial equivalence and safe as natural brinjal. Bt and

non-Bt brinjal show similar results and no significant differences were noted for leaf,

stem and root tissues also. Studies on food and feed safety, including toxicity and

allergenicity tests, have been conducted on rats, rabbits and goats; and findings have

confirmed that Bt brinjal is as safe as its non- Bt counterpart. Further, EC-II concluded

development and safety assessment of Bt Brinjal event EE-I is in accordance with the

prevailing bio-safety guidelines and is fully compliant with the conditions stipulated by

GEAC, while according approval for large scale trials. The EC-II also noted that the data

requirements for safety assessment of GM crops in India are comparable to the

internationally accepted norms in different countries and by international agencies and

therefore no additional studies need to be prescribed for safety assessment.141 Bt Brinjal

has undergone rigorous scientific evaluation to assess its food safety, environmental

safety, human and animal health safety and biodiversity. It has successfully passed

laboratory stages, green house trial stages, confined trial stages, multi location research

trial, large stage field trial, seed production stage. Genetic Engineering Approval

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Committee (GEAC) has recommended the environmental release of Bt Brinjal in India

based on the recommendations of the Review Committee on Genetic Manipulation

(RCGM), a statutory body and two expert committees constituted by the GEAC between

2006 and 2009.142 But commercial release is still pending in India.

3.8 Indian Policies

Yet most of India’s actual policies toward GM crops are far from promotional.

Precautionary bio-safety policies are keeping these crops out of the hands of farmers. By

filing law suits against RCGM (Review Committee on Genetic Manipulation) for

authorizing Bt. cotton field trials in 1998, and by sponsoring physical attacks against

those field trials, anti-GM activist groups in India have transformed the bio-safety

approval process into a highly politicized and at times paralyzed policy struggle. RCGM

and GEAC (Genetic Engineering Appraisal Committee) have moved slowly on bio-safety

approvals, fearing criticism from anti-GM NGOs. Impact of all this has been

precautionary approach towards GM crops. On the other hand, our neighbor China has

embraced a more permissive bio-safety policy toward GM crops. One reason has been its

greater insulation from the international influences that seem elsewhere to be promoting

caution.

However, by 2011 88% of Indian cotton was GM.143 Though disputed 144,145 the

economic and environmental benefits of GM cotton in India to the individual farmer have

been documented.146,147 A long-term study (2002 through 2008) on the economic impacts

of Bt cotton in India, published in the Journal PNAS in 2012, showed that Bt cotton

increased yields, profits, and living standards of smallholder farmers.148 Indian regulators

cleared the Bt brinjal, a genetically modified eggplant, for commercialization in October

2009. Following opposition from some scientists, farmers and environmental groups a

moratorium was imposed on its release in February 2010 "for as long as it is needed to

establish public trust and confidence".149, 150

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3.9 Conclusion

Man has learned by trial and error to avoid poisonous plants. A relatively recent

example on how man learned about the toxicity of food by trial and error is the

introduction of potato in Europe. People died as a result of eating the poisonous berries of

the potato plant. Later they found that the tuber could be safely eaten after being cooked.

Now it is a major source of carbohydrates. Our current food still contains toxic

substances. Some plants even have to be cooked before they can be eaten safely.

Conventional foods consumed in small quantities, such as peanuts, can pose a great risk

to individuals who are allergic. A complete analysis of food can be difficult, as many

complex compounds are being consumed and individuals vary in their responses. It is,

however, widely agreed that current GM crops intended for human consumption pose no

greater risk to human health than do their non-modified counterparts.

Transgenic crops are superior to conventional crops because conventional

breeding shuffles thousands of genes randomly and with largely unpredictable results. It

take many years of careful breeding, back crossing, and balancing negative traits for

getting required results. Herbicide-resistance crops reduce the application of harmful

chemicals, reducing human exposure and subsequent health complications. Herbicides

are applied to kill almost all plants whether the plants are harmful weeds or not, but

herbicide-resistant crops are target specific.151 Bt crops are the most well known

genetically modified insecticidal crops. Bt is highly selective against certain classes of

insects. The action of one particular Bt protein can be against one or a few insects and the

possibility exists that the Bt crops hits sensitive insects that live in or around the crop.

The insect-resistant cotton can protect non-target pests such as predators. According to a

scientific research, predator insect density in Bt cotton is much higher than that in

conventional cotton with chemical use. In addition, due to decreases insecticide use,

farmers’ health was improved.152

No new technology comes without risk and GM plants have proved to be

comparable to conventional crops in terms of safety.153 The ability for GM plants to

hybridize with non-modified strains, related crops, and wild relatives is neither new nor

unexpected.154,155 However, many factors must come together simultaneously for gene

76  

transfer to actually occur and many of these variables can be controlled at the crop-

management level to prevent incidences of cross contamination. Having accurate

information regarding development cycles, pollination and flowering periods and overall

sexual compatibility of local wild varieties can help minimize risks of cross

contamination.156 Further, proper rotation of crop varieties and the use of buffer zones,

methods which have traditionally been used to prevent unwanted crosses of crop varieties

and reduce crop-specific pests can be used effectively to reduce cross breeding with non-

GMO species. Even when cross fertilization does occur, there is no certainty of fertility

or stability of the novel gene in the offspring.156 In human being DNA consumed in the

diet is very unlikely to survive intact beyond the stomach and into the gastrointestinal

tract. That DNA which remains after digestion consists of very small fragments which do

not contain whole genes. However, some experiments have shown that these fragments

may enter the blood stream and that small amounts may even enter cells and attach to

cellular DNA. Such DNA fragments would not function in the human or animal because

of their small size. Furthermore, no evidence of active ingested genes, even those

designed to work in human cells, has been found.

A number of plants produce toxins as a protection against insect and fungal pests

and it is for this reason that we cook many foods such as potatoes. These are parts of their

innate defense systems. These are generally present at such low levels that humans and

animals are able to tolerate them. Plant breeding, with genetic modification used to

remove toxins or allergens in existing food crops. Such toxins are almost always bred out

during development of commercial varieties. As of 2002, over 50 varieties of GM crops

were approved for commercialization in various parts of the world and in 2012, that

number has increased to 144, all of which have been tested for direct, short term health

implications and have been shown to be safe for consumption.157 Some comparative

studies regarding GM crops, such as rice, have shown the GM variety to be nutritionally

and functionally identical to their conventional varieties.158

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