seed act 2000

Question 1

CHAPTER II

Answer 1

RULES AND PROCEDURES
Powers to notify kinds or varieties of seeds
Powers to specify minimum limits of germination and purity

Question 2

CHAPTER III

Answer 2

REGULATION OF SEEDS SALE
Regulation of sale of seeds of notified kinds or varieties

Question 3

CHAPTER IV

Answer 3

CERTIFICATION
Seed Certification Agency
Grant of Certificate
Revocation of certificates
Appeal
Recognition of Foreign Seed Certification Agencies

Question 4

CHAPTER V

Answer 4

CENTRAL SEED TESTING LABORATORY
Central Seed Testing Laboratory
Referee Seed Testing Laboratory

Question 5

CHAPTER VI

Answer 5

ENFORCEMENT AND PENALTIES
Seed Inspectors
Powers of Seed Inspectors
Procedures of seed inspection
Reports of Seed Testing laboratory
Penalty
Forfeiture of Property
Liability of Seed Inspector

Question 6

CHAPTER VII :

Answer 6

MISCELLENOUS
General powers sanctioned to Ministry of Agriculture
Genetic resources

Question 7

BIOSAFETY CONCERNS OF GMOs

Answer 7

The application of genetic modification allows genetic material to be transferred from any species into plants or other organisms
The introduction of a gene into different cells can result in different outcomes, and the overall pattern of gene expression can be altered
Copies of a gene may be integrated and gene sequences rearranged and deleted—which may result in lack of operation of the genes instability or interference with other gene functions possibly cause some potential risks
Therefore, there could be a number of predictable and unpredictable risks related to release of GMOs in the open environment

Question 8

BIOSAFETY CONCERNS OF GMOs

Answer 8

1. 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 behaviour.
2. 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.
3. 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
4. Ecosystem Impacts
   The effects of changes in a single species may extend well beyond to the ecosystem
   Single impacts are always joined by the risk of ecosystem damage and destruction.
5. Impossibility of Followup
   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 beneficial, nor that they should be less scrutinized
6. Horizontal Transfer of Recombinant Genes to Other Microorganisms
   One risk of particular concern relating to GMOs is the risk of horizontal gene transfer (HGT)
   HGT is the acquisition of foreign genes by organisms in a variety of environmental situations
   It occurs especially in response to changing environments and provides organisms with access to genes other than those that can be inherited
   HGT of an introduced gene from a GMO may confer a novel trait in another organism, which could be a source of potential harm to the health of people or the environment
7. Ethical Concerns
   Various ethical issues associated with HGT from GMOs have been raised including perceived threats to the integrity and intrinsic value of the organisms involved, to the concept of natural order and integrity of species, and to the integrity of the ecosystems in which the genetically modified organism occurs

Question 9

BIOSAFETY CONCERNS ASIA

Answer 9

1. In Asia, the only major GM crops approved for commercial release are Bt cotton, which is grown commercially in China, India and Indonesia, and GM corn recently approved in the Philippines
   To date, no Asian government has given official permission to plant GM soybeans or rice
2. While China had initially moved quickly on the approval of GM crops for environmental and commercial releases, the approval process has slowed considerably since 2000 and strict regulations have been implemented for GMO imports

Question 10

BIOSAFETY CONCERNS JAPAN

Answer 10

3. Japan requires all recombinant DNA (rDNA) organisms to which new properties have been introduced using rDNA technology to undergo a safety evaluation, which should be submitted to the Ministry for Agriculture, Forestry and Fishery for approval
   In addition, certain GMO agricultural products need to be labelled.

Question 11

BIOSAFETY CONCERNS KOREA

Answer 11

Korea’s Ministry of Agriculture & Forestry requires mandatory labelling for certain GM “raw materials”, including GM soybean, corn and beans sprouts
In April 2002, the Philippines adopted regulations for GMOs, which will require importers of GM plants for environmental release, and GMOs for food, feed and processing to acquire a permit

Question 12

THAILAND

Answer 12

In 2001, Thailand banned all GM field experiments and has restricted GM imports
Malaysia, while investing heavily in the development of GM crops since the 1980s, is also holding back on the commercial release of GM crops.

Question 13

SRI LANKA

Answer 13

In 2001, Sri Lanka’s Health Ministry imposed import restrictions requiring 21 categories of food imports to be free of GM products
The ban was later suspended following a request by the WTO that the country should give its trading partners 60 days to prepare for the restrictions, before it was finally postponed indefinitely.

Question 14

INDIA

Answer 14

India had not approved the commercial planting of any GM crops until March 2002 when the Indian Genetic Engineering Approval Committee finally approved the commercial production of three varieties of GM cotton amid widespread protests by anti-GM activists.

Question 15

BHUTAN

Answer 15

Bhutan bans import, research, cultivation or consumption of all GM crops and products under the Biosafety Act, 2015.

Question 16

RISK ASSESSMENT OF GMOs

Answer 16

Risk assessment intends to quantify risks and evaluate the probabilities of possible outcomes on the basis of data
Because of the potential human and environmental risks, real or perceived, posed by GMOs, it is widely recognized that there is a need for each country to establish a regulatory regime specifically to assess the safety of products of modern biotechnology

Question 17

A biosafety framework

Answer 17

A biosafety framework typically includes four important elements: a national biosafety policy instrument (e.g law, act or decree), a regulatory system, a system for monitoring and compliance and procedures for ensuring transparency, public participation and accountability.

Question 18

The Cartagena Protocol on Biosafety (CPB),

Answer 18

The Cartagena Protocol on Biosafety (CPB), an international multilateral agreement on biosafety, was adopted in 2000 and came into force in 2002
It has been signed by more than 100 countries in recognition of the need to ensure biosafety through national systems of risk assessment
Its main objectives are: to set up the procedures for the safe transboundary movement of living modified organism, harmonize principles and methodology for risk assessment and establish a mechanism for information sharing through the Biosafety Clearing House (BCH)

Question 19

Biological Risk

Answer 19

Biological risk refers to naturally occurring or human made risk caused by exposure to biological agent or microorganism.
Risk - likelihood that under particular conditions of exposure an intrinsic hazard will represent a threat or harm
Risk is a function of hazard and exposure.

Hazard – intrinsic (it is there or it is not) potential of a material to cause harm to human health and/or the environment

Also synonymous to threat
Exposure – the extent and the duration of or the frequency with which one is exposed to the hazard

Question 20

Naturally occurring biological risks

Answer 20

Naturally occurring biological risks – includes the emergence of antibiotic resistant bacterial infections (tuberculosis, pneumonia); naturally emerging pathogens attributed to deforestation (monkey pox, Ebola); spreading of a zoonosis i.e. infected animal population conveying the disease to humans via direct contact, vector or water/foodstuffs; toxins arising from certain molds and fungi (aflatoxins) parasitic infection outbreaks in humans

Question 21

Human caused or related biological risks

Answer 21

can be further classified into: (1) deliberately induced risks such as the use of harmful biological agents through warfare or terrorism; and (2) biotechnological risks such as products of cross breeding and selection, mutation and modern biotechnology.

Question 22

Risk analysis is in its broadest sense is an integrated process consisting of three major components:

Answer 22

risk assessment
risk management
risk communication
The individual components are distinct, but are linked to achieve a well-functioning risk analysis process that forms the basis for decision making

Question 23

Risk assessment

Answer 23

Risk assessment is the first and the scientific component of risk analysis
It is a rigorous science-driven process used to identify a hazard and obtain qualitative or quantitative estimate of the levels of risk posed by a hazard including possible adverse effects to human health and the environment
It typically consists of four steps: hazard analysis (identification and characterization), likelihood estimation, consequence evaluation; and risk estimation.

Hazard analysis (identification and characterization) - An identification of any novel genotypic and phenotypic characteristics associated with GMO that may have adverse effects on biological diversity in environment, taking also into account risks to human health
Hazard identification establishes the intrinsic or ‘built-in’ potential of the biological agent (e.g. GMO or GM foods) to cause harm
Hazard characterization aims to evaluate in qualitative and quantitative terms the nature of the identified intrinsic hazard

Likelihood estimation- An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the receiving environment to the living modified organism
Likelihood is the probability that the harm will occur
It is expressed as relative measure of frequency (the number of occurrences per unit time) and probability

Consequence evaluation- An evaluation of the consequences should these adverse effects be realized
Consequence evaluation involves characterizing the significance of the adverse outcome if the hazard occurs.

Risk estimation - An estimation of the risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized
Risk estimation combines the information on likelihood and consequence of the identified hazard to come up with the risk estimate matrix
As a general rule, risks with moderate and high estimates will invoke the corresponding risk management treatments or control measures

Question 24

Risk management

Answer 24

Risk management is the second and decision-making component of the process of risk analysis
It is primarily supported by risk assessment but is informed by other risk considerations
Risk management is concerned with evaluating whether the risks identified by the risk assessment process are acceptable and manageable, then selecting and implementing the control measures as appropriate to ensure that risks are minimized or controlled.

Question 25

Key Steps in Risk Management

Answer 25

Risk management is a step-by-step process which consists of:
Risk evaluation: This step decides whether the identified risk is manageable i.e. a consideration of appropriate risk management strategies
Risk mitigation: It determines the options and plans to reduce or avoid the risks and decides whether the proposed risk management strategies sufficiently reduce the likelihood or the consequence

Question 26

Risk communication

Answer 26

Risk communication is recognized as the third component that underpins the risk assessment and risk management processes
It is the process of exchange of information and opinions concerning risk and risk-related factors among various stakeholders concerned with risk
It strengthens the over-all process of risk analysis by helping to define the issues and providing the link and the feedback mechanism that informs the two processes.

CPB explains risk communication as:
Promote and facilitate public awareness, education and participation concerning the safe transfer, handling and use of living modified organisms
Endeavour to ensure that public awareness and education encompass access to information on living modified organisms.
In accordance with respective laws and regulations, consult the public in the decision-making process regarding living modified organisms and make the results of such decisions available to the public
Endeavour to inform public about the means of public access to the Biosafety Clearing-House.