Issues Related to Biosafety and registration of transgenic

agricultural organisms

PP 603: Molecular Approaches for Improving Physiological Traits

Presented ByEkatpure Sachin

Dept. of Plant Biotechnology

Biosafety Guidelines

Biosafety

Protecting human & animal health and environment from the possible adverse effects of the products of modern

biotechnology

BIOSAFETY CONCERNS

• ENVIRONMENTAL SAFETY• FOOD SAFETY TO HUMAN AND ANIMAL HEALTH• RISK MANAGEMENT

STUDIES ON ENVIRONMENTAL SAFETY

Direct effects on non-target organisms

• In May 1999, it was reported that pollen from Bacillus thuringiensis (Bt) insect resistant corn had a negative impact on Monarch butterfly larvae

• This report raised concerns and questions about potential risks to Monarchs and perhaps other non-target organisms

Development of insect resistance• The use of Bt crops is that it will lead to the

development of insect resistance to Bt

• Insect resistance management plans have been developed by government, industry, and scientists to address this issue

– These plans include a requirement that every field of insect-resistant crops must have an associated refuge of non-GM crops in order for the insects to develop without selection to the insect resistant varieties.

Gene flow

• Accidental cross breeding between GMO plants and traditional varieties through pollen transfer can contaminate the traditional local varieties with GMO genes resulting in the loss of traditional varieties of the farmers

Increased weediness• Weediness means the tendency of the plant to spread

beyond the field where it was first planted.

• There are apprehensions about GM crops becoming weeds.

• For example, a salt tolerant GM crop if escapes into marine areas could become a potent weed there

• There is also fear about the development of superweeds i.e. a weed that has acquired the herbicide tolerant gene due to genetic contamination

• With a herbicide tolerance GMO through in field cross breeding to related species or through horizontal gene transfer

Loss of Biodiversity/reduction of cultivars:

• There have been concerns about reduction in the genetic diversity in cropping systems by the development and global spread of improved crop varieties to the green revolution.

• This genetic erosion will occurred with monocultures.

Changes in the soil ecology • Many plants leak chemical compounds into

the soil through their roots

• There are concerns that transgenic plants may leak different compounds than conventional plants, As and unintended sequence of their changed DNA

• The interaction between plants and solid microorganisms is very complex, with the microorganisms living around plant roots also secreting chemical compounds into the soil

Impossibility of Follow-up• Once the GMOs have been introduced

into the environment and some problems arise, it is impossible to eliminate them.

• Many of these risks are identical to those incurred with regards to the introduction of naturally or conventionally bred species.

• But still this does not suggest that GMOs are safe or benefitial nor that they should be less scrutinized

Competition with Natural Species

• Faster growth of GMOs can enable them to have a competitive advantage over the native organisms.

• This may allow them to become invasive, to spread into new habitats, and cause ecological and economic damage.

Increased Selection Pressure on Target and Non target Organisms

• Pressure may increase on target and non target species to adapt to the introduced changes as if to a geological change or a natural selection pressure causing them to evolve distinct resistant populations

Genetic Contamination/Interbreeding• Introduced GMOs may interbreed with

the wild-type or sexually compatible relatives.

• The novel trait may disappear in wild

types unless it confers a selective advantage to the recipient.

• However, tolerance abilities of wild

types may also develop, thus altering the native species’ ecological relationship and behavior.

FOOD BIOSAFETY TO ANIMAL HEALTH

Toxicity

• Any compound entering the food supply is subject to specific scrutiny for food safety.

• For example, a potentially toxic transgenic product, such as Bt toxin, must pass the same standards for safety that are applied to any biochemical pesticide products.

Allergenicity• Another concern related to food safety is

the potential for genetically modified food to introduce allergens into the food supply

• If the gene product is a known allergen, then it will also be an allergen in a transgenic plant. As an example, when a Brazil nut albumin was expressed in soybean to boost methionine content

• It was found that serum from Brazil nut allergic subjects reacted with the transgenic soybean extracts

RISK MANAGEMENTPest population exposed to Bt crops continuously for several years may develop resistance to the

Bt toxins through natural selection mutation, and selection

– To prevent resistance build up it is recommended to plant sufficient non Bt cotton (20%) to serve as a refuge for Bt susceptibility in seeds

– The refuge strategy is designed to ensure that Bt susceptible insects will be available to mate with Bt resistant insects, should they arise.

– Available genetic data indicates that susceptibility is dominant over resistance.

– Therefore, the offspring of these mating would most likely be Bt susceptible, thus mitigating the spread of resistance in the populations

Registration of transgenic agricultural organisms

Biosafety Framework Government Commitment

• The Genetically Modified Organisms (GMOs) and products thereof are regulated articles in India in view of potential risks to human health and environment by indiscriminate use under “Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically engineered organisms or cells, 1989 under the EPA (1986)”.

• India has ratified the Biosafety Protocol in January 2003

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity has been ratified and signed by 167 countries (March 2014).

Regulatory and Approval system for release of GM plant

According to the Cartagena Protocol, field trials and all other activities involving genetically modified organisms must be regulated and approved by national governments.

Government of India

Department of Biotechnology

RDAC RCGM

Ministry of Environment, Forest and Climate Change

GEAC

Institutional Biosafety Committee

State Biotechnology Coordination Committee

District level Committee

Indian biosafety regulatory framework

Elements of assessment

24

234

56789

10

11

1Laboratory researchGrowth chamber and green houseApplication for Confined field trials

Confined field trials Application for environmental release

Application for food safety assessmentEvent approval for cultivation and food/ feed useVariety/ hybrid releaseSeed/plant multiplicationSeed/plant marketing or distribution

Cultivation

Process followed by the applicant for regulatory approval

Procedure for GEAC approval for field trials and environmental release of transgenic crops.

Thank you