Module 1

Module 1: BIOSAFETY-REGULATORY
FRAMEWORK FOR GMO’s IN INDIA
Dr Ashwathanarayana R
Department of Genetics
Dayanand Sagar University, Bangalore
GMOs
GMOs
GMOs
• India has experienced Green Revolution in wheat and rice during 1970s which
makes us self-sufficient in food grains production. The situation has changed
significantly in 21st century due to climate change and increasing population
pressure. World hunger is on the rise again and eliminating hunger and
malnutrition by 2030 will be challenging and it will be achieved by sustainable
agriculture and collective efforts by all the stakeholders.
• The conventional technologies will not be able to meet the food and nutritional
demand. Advancement in modern biology, especially biotechnology and molecular
biology, offer many advantages when applied in conjunction with the traditional
plant breeding techniques.
• The scientific and technological advances in these areas have progressed at a
remarkable pace during the last decade at the global level. GM crops are produced
by transfer of genes between organisms for specific traits using laboratory
techniques. Plants derived from this method are called GMOs (Genetically
Modified Organisms) or genetically engineered or transgenic plants.
GMOs
• Researchers have attempted various approaches for preparing genetically
engineered crops in last three decades and the first transgenic fruit crop developed
and commercialized successfully was the well-known ‘Flavr Savr’ tomato.
Which had been modified to contain reduced levels of the cell wall softening
enzyme polygalacturonase.
• After this, several other GM food and non-food crops have been developed and
commercialized worldwide. These include pest resistant cotton, maize, canola
(mainly Bt or Bacillus thuringiensis), herbicide glyphosate resistant soybean,
cotton and viral disease resistant potatoes, papaya and squash.
• In addition to this many other GM crops are under development and field trials,
and not yet released commercially with the traits of phytoremediation,
biofortification and production of pharmaceutical.
• Development of genetically modified crops expressing a variety of novel traits
such as insect resistance, disease resistance, herbicide tolerance, improved
nutritional quality etc have led to large scale cultivation of GM crops.
GMOs
• GM crops that have been commercialized in the past twenty years include tomato,
corn, soybean, cotton, canola, rice, potato, squash, melon and papaya of
which soybean, corn, cotton, and canola are of major importance due to its wide
cultivation and integral part of agricultural economy in several countries.
• The United States of America, Argentina and Canada are the major producers
and exporters of GM crops and products. Argentina, Brazil, China and India are
the largest developing-country producers of transgenic crops.
• Most arguments for and against transgenic plants are about their outcomes and
impacts, whether on farmers, on health and the environment, or on economic
performance. Climate change and food crisis are some of the major issues
concerning scientists and policy makers worldwide.
• Food crisis is growing at an alarming rate as it is getting difficult to keep pace in
agriculture production with the rate of population growth; therefore, scientists
are looking for modern biotechnology to provide food security.
GMOs
• Huge debate is going on since its introduction and commercialization and faced
many demonstrations and protests by NGOs, farmers and general public, and
bans by many governments in worldwide. USA, Canada and Japan had
commercialized several food and non-food GMOs and accepted well by the
public largely except little sporadic opposition to some specific GM food.
• There is some confusion about GM foods, their safety and labelling of
genetically modified foods among Americans. Recently, the majority of
Americans supported strongly for the labelling of foods that have been genetically
modified. They want to know that what they are eating, GM or non-GM? and all
the food stuffs should be labelled properly about the presence of GMOs.
• There is a strong opposition of GM foods in UK and entire Europe but UK
Government is trying hard to convince the people about safety of GMOs and its
urgent need to feed about one billion hungry people in developing nations.
GMOs
STATUS OF GM CROPS IN INDIA
• Genetically engineered cotton (popularly known as Bt cotton) for insect
resistance has been released for commercial cultivation in India during 2002 by
GEAC (Genetic Engineering Approval Committee), Government of India (GOI)
and it has turn out to be a paradigm shift in Indian GM crop research, its
deregulation and even for cotton industry in India.
• Cultivation and production of Bt cotton has grown exponentially since then and
India has become second largest producer of cotton and leading exporter in the
world.
• The GEAC cleared Bt brinjal for commercialization in October 2009 but
following concerns raised by some farmers, anti-GM activists and scientists, the
Government of India officially announced moratorium on 9 February 2010.
• Recently, the GEAC (Genetic Engineering Appraisal Committee, since July 22,
2010) on July 18, 2014 has given approval for limited experimental field tribals
of GM rice, brinjal, mustard, cotton and chickpea for the sole purpose of
generating biosafety data.
GMOs
• Recently, the GEAC recommended for commercial cultivation of GM mustard
for clearance to Environment Minister. but final decision is still pending.
Present Indian Government is showing some interest to change the course on GM
field testing and allowed for field trials of few GM crops last year but several State
Governments are still not ready to embrace this technology.
• Substantial increase in cotton production and improved socio-economic
conditions of cotton growers in different states of India over the years after
deregulation of Bt cotton is telling entirely different story.
• As per an estimate, approximately 7.2 million farmers cultivated Bt cotton on
10.8 m ha equivalent to 93 per cent of India’s total 11.6 m ha cotton in the
season of 2012. Approximate 40 million bales of cotton was produced in 2014 in
India and becomes the world’s leading producer of cotton in 2014 after 13
years of deregulation and commercial release of Bt cotton in India.
GMOs
• A number of GM crops or transgenic crops carrying novel traits have been
developed and released for commercial agriculture production with the rapid
advances in biotechnology.
• More than 20 crops are under various stages of research and field trials for
genetic modification in India, namely Cotton, Rice, Wheat, Maize, Brinjal,
Potato, Sorghum, Mustard, Groundnut, Cauliflower, Okra, Chickpea, Pigeon
pea, Castor, Sugarcane etc. for the traits insect resistance, herbicide tolerance,
drought tolerance, salinity tolerance, virus resistance, quantitative traits
(yield increase), nutrition improvement etc.
• The increasing cultivation of transgenic crops has raised several issues with
respect to food safety, environmental effects, socio-economic issues and ethical
issues. From the food and health perspective, the main concerns are related to
possible toxicity and allergenicity of GM foods and products.
Regulatory framework in India governing GMOs
India has experienced Green Revolution in wheat and rice during 1970s which
makes us self-sufficient in food grains production. The situation has changed
significantly in 21st century due to climate change and increasing population
pressure. World hunger is on the rise again and eliminating hunger and
malnutrition by 2030 will be challenging and it will be achieved by sustainable
agriculture and collective efforts by all the stakeholders.
The conventional technologies will not be able to meet the food and nutrition
requirements. Advancement in modern biology, especially biotechnology and
molecular biology, offer many advantages when applied in conjunction with the
traditional plant breeding techniques.
• India is a signatory of Cartagena Protocol on Biosafety and established
Biosafety Clearing House (MoEF & CC 2017) and other institutions required
to assess biosafety issues associated with GM crops.
• Cartagena Protocol on Biosafety describes biosafety
regulations for Living Modified Organism (LMOs) in
detail and suggests the biosafety requirements for GM
crops research and its role during commercialization and
deregulation process.
• The Cartagena Protocol on Biosafety to the Convention
on Biological Diversity is an international agreement on
biosafety as a supplement to the Convention on
Biological Diversity (CBD) effective since 2003. The
Biosafety Protocol seeks to protect biological diversity
from the potential risks posed by genetically modified
organisms resulting from modern biotechnology. the
Protocol had 173 parties, which includes 170 United
Nations member states, the State of Palestine, Niue,
and the European Union.
• In India, regulation for biotechnology products was started in 1982 when The
National Biotechnology Board was established for forming biotechnology
safety guidelines to undertake biotech research in laboratory.
• Later on, National Biotechnology Board was converted into Department of
Biotechnology (DBT) under the Ministry of Science and Technology in 1986.
• Biodiversity conservation and environment protection comes under MoEF
by the Government of India (Allocation of Business) Rules 1961. MoEF
initiated the regulation of genetically modified organisms and their products
under the existing Environmental Protection Act 1986 (EPA 1986), which was
enacted by the Parliament of India in 1986.
• After this, MoEF drafted and notified ‘the rules for the manufacture, use,
import, export and storage of hazardous microorganisms, genetically
engineered organisms or cells in 1989ʹ referred as the EPA Rules 1989 under
‘hazardous substances’ section of the EPA 1986.
• The regulation of all activities related to GMOs and products derived from
GMOs in India is governed by Rules, 1989 under the provisions of the
Environment Protection Act (EPA), 1986 through the Ministry of
Environment, Forest and Climate Change.
• Multitiered regulatory framework to assess and ensure biosafety of GM
crops work under the MoEF&CC and Department of Biotechnology (DBT)
of Ministry of Science and Technology, Government of India through six
competent authorities: The Recombinant DNA Advisory Committee (RDAC),
The Review Committee on Genetic Manipulation (RCGM), The Genetic
Engineering Appraisal Committee (GEAC), Institutional Bio-safety Committees
(IBSC), State Biotechnology Coordination Committees (SBCC) and District
Level Committees (DLC).
• The roles and functions of each of these committees have been elaborated in the
Rules 1989.
Regulatory framework for GMO crops in India.

• The Genetic Engineering Appraisal Committee (GEAC) is the highest body
constituted development, environmental release and in the Ministry of
Environment, Forest and Climate Change under ‘Rules for Manufacture, Use,
Import, Export and Storage of Hazardous Microorganisms/ Genetically
Engineered Organisms or Cells 1989ʹ, under the Environment Protection Act,
1986.
• GEAC acts as a constitutional body in India for review and approval from
environmental angle of activities involving large scale use of GMOs and
their products in research and development, industrial production,
environmental release and field application.
• Three important legislations enacted by the Parliament of India for regulation
of GM crops development, environmental release and in the Ministry of
approval for commercialization.
• These included the Environment Protection Act 1986 administered by

MoEF&CC, the Seed Act 1966 & the Seeds (Control) Order by Ministry of
Agriculture and the Food Safety and Standard Act 2006 under the Ministry
of Health and Family Welfare.
• India has ratified the Cartagena Protocol in 2003 which requires a setting
up of a regulatory body. Currently, the GEAC under the Ministry of
Environment, Forests and Climate Change is responsible for approval of
genetically modified products in India.
• Government of India is in the process of establishing Biotechnology
Regulatory Authority of India (BRAI) for quicker realization of modern
biotechnology products to Indian farmers.
• This Biotechnology Regulatory Authority of India will be able to made
efficient single window system for GM crops research, safety issues and
regulatory measures. The Biotechnology Regulatory Authority of India
(BRAI) bill was introduced in Lok Sabha in 2013 to set up an independent
regulatory authority for regulation of organisms and products of modern
biotechnology including GMOs
• This BRAI will regulate the research, transport, import, containment,
environmental release, manufacture, and use of all biotechnology
products and all the approval will be granted through a multilevel process
of assessment undertaken by scientific experts. Presently, the BRAI bill has
been lapsed and expected to be produced again after substantial revisions
under current government.
Recombinant DNA Advisory committee (RDAC)
• This Committee constituted by the Department of Biotechnology
(DBT) of the Union Ministry of Science & Technology is to monitor the
developments in biotechnology at national and international levels.
• Review developments in biotechnology at national and international
level and recommend suitable and appropriate safety regulations for
India in r-DNA research, use and application.
• Was set up in 1990 and prepared recombinant DNA Safety Guidelines,
1990.
• The RDAC submits recommendations from time to time that are
suitable for implementation for upholding the safety regulations in
research and application of GMOs and products thereof.
Scope of the Guidelines
Research Environmental Risks
• Genetically Engineered organisms • Release of Engineered organisms in
• Genetically transformation of animals and Green Environment-serious Ecological
plants Consequences.
• rDNA technology in vaccine development • Guideline prescribed Criteria:
• Based on the principle of GLP-Good Laboratory assessment of ecological aspects on
Practices. a case by case basis.
Large scale operations • Planned introduction of rDNA
• Use of GMO in large scale fermentation processes organisms into the Environment.
or application of it in the environment. • Also covers quality control
• Based on the principle of GLSP-Good Large Scale methods as: safety, purity and
Practices. Efficacy of rDNA products.
• Involves-containment, quality control, Personnel
Protection and Medical surveillance.
Aim
• Take a note of developments at national and international levels in
Biotechnology
• Updating of the safety regulation for India on recombinant research use
and applications
• To evolve long term policy for research and development in
Recombinant DNA research.
• To formulate the safety guidelines for Recombinant DNA Research to be
followed in India.
• To recommended type of training program for technicians and research
fellows for making them adequately aware of hazards and risks involved
in recombinant DNA research and methods of avoiding it.
The RDAC is advisory in nature and expected to give
recommendations from time to time on safety regulations in research
and applications of GMOs and products thereof.
This Committee prepared the Recombinant DNA Biosafety Guidelines
in 1990, which were adopted by the Government for conducting
research and handling of GMOs in India.

Institutional Biosafety Committee (IBSC or IBC):
• This Committee is constituted by the organizations involved in research
with GMOs. The committee requires the approval of the DBT.
• IBSC also has a nominee from the DBT who oversees the activities to
ensure that safety aspects in accordance with the safety guidelines are
fully adhered to by the organization.
• Every R&D project using GMOs has to have an identified investigator
who is required to inform the IBSC about the status and results of the
experiments being conducted.
• Constituted in all centers engaged in genetic engineering research and
production activities.
• The Institutional Biosafety Committee shall be the nodal point for
interaction within institution for implementation of the guidelines. The
IBSCs comprise of the head of the organization, scientists engaged in
DNA work, a medical expert and a nominee of the DBT. The IBSC is the
nodal point for interaction within the institution for implementation of
the guidelines.
• Any research project which is likely to have biohazard during the
execution stage or which involve the production of either
microorganisms or biologically active molecules that might cause bio-
hazard should be notified to IBSC.
• Is mandatory for each organization involved in Recombinant DNA
(rDNA) activities.
• Comprises of the Head of institution, three or more scientists engaged in
rDNA work, a medical expert and a member nominated by DBT.
• Responsible for ensuring adherence to rDNA safety guidelines,
experimentation carried out at designated locations as per approved
protocols and prepare onsite emergency plans according to manuals/
guidelines of review committee on genetic manipulation (RCGM).
• Serve as nodal point for interfacing with other Regulatory Committees
regarding ongoing research within the institutions.
• Review experiments falling in risk category III or above and
recommend to RCGM.
The Review Committee on Genetic Manipulation (RCGM)
• The RCGM is constituted by the DBT to monitor the safety aspects of
ongoing research projects and activities involving genetically engineered
organisms.
• The committee is also mandated to bring out Manuals of Guidelines
specifying procedures for regulatory process with respect to activities
involving genetically, engineered organisms in research, use and
application including industry with a view to ensure environmental safety.
• All ongoing projects involving high risk category and controlled field
experiments shall be reviewed by the RCGM to ensure that adequate
precautions and containment conditions.
• The RCGM can lay down procedures restricting or prohibiting
production, sale, importation and use of GMOs.
AIM
• To establish procedural guidance manual-procedure for regulatory
process with respect to activity involving genetically engineered
organisms in research, production and applications related to
environmental safety.
• Recommend containment facility.
• To assist the Bureau of Indian Standards to evolve standards for
biologics produced by rDNA technology.
• To advise on intellectual property rights with respect to rDNA
technology on patents.
• Is a regulatory body functioning in DBT. Comprises of Members from DBT,
Indian Council of Medical Research, Indian Council of Agricultural Research,
Council of Scientific and Industrial Research and other experts from multi-
disciplinary fields in their individual capacity.
• Responsible for bringing out manuals/guidelines specifying procedures for
conduct of GMO research, use and industrial applications with a view to endure
environmental safety and lay down procedures restricting or prohibiting
production, sale, import and use of GMO as mentioned in the schedule of rules
1989.
• Authorized to review all ongoing rDNA projects and approve experiments
falling in risk category III and above with appropriate containment and permit
import of GMOs/ Transgene for research purpose.
• Authorized to recommend GM crop field experiments (Biosafety Research
Level I-BRLI) as multi locations in an area of up to 1 acre per site.
1. RCGM can approve applications for generating research
information on transgenic plants. RCGM can also direct the
generation of toxicity, allergenicity and any other relevant data on
transgenic materials in appropriate systems.
2. The RCGM can issue clearances for import/export of etiologic
agents and vectors, transgenic germplasms including transformed
calli, seed and plant parts for research use only.
3. The RCGM can put such conditions as would be required to
generate long term environmental safety data from the applicants
seeking release of transgenic plants into the open environment.
• The RCGM functions as a body under the DBT to monitor the safety
related aspects in respect of on-going research projects and activities
involving Genetically engineered organisms/hazardous
microorganisms.
• RCGM is also mandated to bring out manuals of guidelines specifying
procedure for regulatory process with respect to activities involving
GE organisms in research, use and applications with a view to ensure
environmental safety.
• The RCGM includes representatives of scientific
departments/organizations in the country viz. Indian Council of
Medical Research (ICMR), Indian Council of Agricultural Research
(ICAR), Council of Scientific and Industrial Research (CSIR) and other
experts in their individual capacity.
Genetic Engineering Approval Committee (GEAC):
• This Committee functions as a body in the Ministry of Environment &
Forests and is responsible for approval of activities involving large scale
use of GMOs in research, industrial production and applications. The
clearance of GEAC is only from environmental angle under the EPA.
• All other relevant laws would apply even though EPA clearance is
available for using GMOs and products thereof; for example, drugs
made through GMOs would require separate approval for manufacture
and use under the Indian Drugs Acts; production of GMOs is also
authorized under Indian Industries (Development, and Regulation)
Act, and therefore these, clearances are also mandatory. Now, this
committee is known as Genetic Engineering Appraisal Committee.
• Authorized body for review and approval of activities involving large
scale use of genetically engineered organisms and their products in
research and development, industrial production, environmental
release and field applications.
• Import, export, transport, manufacture, process, selling of any
microorganisms or genetically engineered substances
• Discharge of Genetically engineered/classified organisms/cells from
Laboratory, hospitals and related areas into environment.
• Large scale use of genetically engineered organisms/classified
microorganisms in industrial production and applications.
• GEAC is the apex committee functioning in MoEF and CC and has
representatives from concerned ministries/agencies and experts.
• GEAC is chaired by a senior officer of (special secretary/ additional
secretary) MoEF & CC and co-chaired by expert nominated by DBT
and comprises of members from Ministry of Industrial Development,
DBT, Department of Atomic energy, Member Secretary is an official of
MoEF & CC.
• Expert members also includes nominees of Director General, Indian
Council of Agricultural Research, Director General Health Services, Plant
Protection Adviser, Directorate of Plant Protection, Quarantine and
Storage, Chairman, Central Pollution Control Board and Three outside
experts in individual capacity. The committee may co-opt other members/
experts as necessary.
• GEAC is responsible for approval of activities involving large scale
use of hazardous microorganisms and recombinant products in
research and industrial production from the environment angle.
• Authorized to review, monitor and approve all activities involving
large scale use of hazardous micro-organisms and recombinant
research and industrial production including import, export, transport,
manufacture, use or sale of GMOs and products thereof from
environmental angle.
• Authorized to review, monitor and approve proposals relating to
release of genetically engineered organism and products into the
environment including experimenting field trials with specific
conditions for containment.
State Biotechnology Coordination Committee (SBCC):
• This Committee, headed by the Chief Secretary of the respective State
is constituted in each Indian state where research application of
GMOs are contemplated. The Committee has the powers to inspect,
investigate and take disciplinary actions in case of violations of the
statutory provisions.
• SBCC is constituted in each State where research and applications of
GMOs are underway. SBCC is headed by the Chief Secretary of the
State and has primarily monitoring responsibilities
• It is a regulatory committee set up in each state where research and
applications of GMOs are contemplated.
• The Committee is chaired by Chief Secretary of the state and comprises
of Secretaries from the State Department of environment and forest, State
Department of Health, State Department of Agriculture, State
Departments of Industries and Commerce, State Departments of Public
Works, Chairman, State Pollution Control Board and Experts in the field
of microbiology and pathology as Members. The Committee may co-opt
other experts/members as necessary.
• Empowered to inspect, investigate and to take punitive action in case of
violations of statutory provisions through the nodal Department and the
state Pollution Control Board or the Directorate of Health/ Medical
Services.
• Authorized to review periodically the safety and control measures in

various industries/ institutions handling genetically engineered/
hazardous organisms.
• Serve as a nodal point at State level for coordinating activities related
to GMOs in the State with the Central Ministries Including monitoring
of conditions stipulated by the Review committee on genetic manipulation
(RCGM) and Genetic Engineering Appraisal Committee (GEAC).
District Level Committee (DLC):
• This Committee is constituted at the district level to monitor the safety
regulations in installations engaged in the use of GMOs in research and
applications. The District Collector heads the Committee, who can induct
representatives from State agencies to enable the smooth functioning and
inspection of the installations with a view to ensure the implementation
of safety guidelines while handling GMOs under the Indian EPA.
• DLCs are constituted in districts, wherever required to monitor the safety
regulations in installation engaged in the use of GMOs/hazardous
microorganisms and its applications in the environment. Each DLC is
headed by the District Collector (officer responsible for administration of
a district) with officers concerned with public health, environment,
pollution control etc. at the district level.
• Is a Regulatory Committee set up in each District where research and
applications of GMOs are contemplated.
• The Committee is headed by District Collector of the District and
comprises of Factory Inspector, Representative of State Pollution
Control Board (SPCB), Chief Medical Officer, District Agriculture
Officer, Representative of Public Health Engineering Department,
Commissioner, Municipal Corporation and Technical Experts in the
field of microbiology and pathology as Members, the Committee may
co-opt other experts/ members as necessary.
• Authorized to monitor and inspect the safety regulations in
installations engaged in the use of genetically modified/ hazardous
organisms and its applications, formulate information chart, identify
hazards and risk associated with each of these installation and
coordinate activities with a view to meeting emergency.
• Serve as a nodal point at district level for coordinating activities
related to GMOs in the District with State Biotechnology Coordination
Committee (SBCC) and Genetic Engineering Approval Committee
(GEAC) including monitoring of conditions stipulated by the Review
committee on genetic manipulation (RCGM) and Genetic Engineering
Approval Committee (GEAC).
The interactive mechanism of the committees
• The interactive mechanisms between committees have also been provided in Rules,
1989. All Institutional Bio-Safety Committee (IBSCs) are required to review the
applications and submit their recommendations and reports to Review committee
on genetic manipulation (RCGM).
• RCGM review and gives its recommendation for large scale activities, field trials
and environmental release to Genetic Engineering Approval Committee (GEAC).
District Level Committee (DLCs) are also required to regularly submit its report to the
State Biotechnology Coordination Committee (SBCC) and Genetic Engineering
Approval Committee (GEAC).
• In addition to the above, various sub-committees and expert committees are
constituted by RCGM and GEAC on a case by case basis. Such committees comprise
of experts from various disciplines drawn from public sector institutions to prepare
and review various guidelines and biosafety data. Central Compliance Committees
are also set up for monitoring of confined field trials on case by case basis.
The interactive mechanism of the committees
Procedure for approval of confined field trials and environmental release of GE plants
Approval and prohibition under rule 1989
Rules, 1989 provide for compliance of the biosafety safeguards and any
violation and non-compliance in this area attracts punitive actions provided
under the EPA, 1986. The approvals and prohibitions under Rules 1989 are
summarized below:
• No person shall import, export, transport, manufacture, process, use or
sell any GMOs, substances or cells except with the approval of the
GEAC.
• Use of pathogenic organisms or GMOs or cells for research purpose shall
only be allowed in laboratories or inside laboratory areas notified for this
purpose under the EPA, 1986.
• Any person operating or using GMOs for scale up or pilot operations shall
have to obtain permission from GEAC.
Approval and prohibition under rule 1989
• Experiments for the purpose of education involving GMOs can be
undertaken with the oversight of IBSCs.
• Deliberate or unintentional release of GMOs not allowed.
• Production in which GMOs are generated or used shall not be
commenced except with the approval of GEAC All approvals shall be for
a period of 4 years at first instance renewable for 2 years at a time.
GEAC shall have powers to revoke approvals in case of:

i. Any new information on harmful effects of GMOs.
ii. GMOs cause such damage to the environment as could not be envisaged
when approval was given.
iii. Non-compliance of any conditions stipulated by GEAC.
Supervision and penalties
• GEAC supervises the implementation of the terms and conditions laid
down in connection with the approvals accorded by it.
• GEAC may carry out supervision through SBCC, DLC or any authorized
person.
• If orders are not complied with, there is provision for imposing penalties
including immediate intervention by the SBCC/DLC in order to prevent
damage to the environment, nature and health without issuing any orders
at the expense of the person responsible for such damages.
• The GEA may fix the fees to cover the expenses incurred by the
authorities in connection with approvals, examinations, supervision and
controls.
Supervision and penalties
• Various notifications have also issued under Rules, 1989 from time to
time to address issues such as empowering Seed Inspectors/Seed
Analyst/Laboratories notified under Seed Act under Environment
(Protection) Act, 1986, exempting certain categories of recombinant
pharmaceutical products, GM food stuffs, ingredients in food stuffs, and
additives from the purview of Rules, 1989.

Exemption
MoEF and CC has the authority to exempt an occupier handling a particular
GMO from the provisions of Rules 1989 (7-11). The following activities/
products are exempted from the purview of rules 1989.
• Indigenous product development, manufacture and marketing of
recombinant pharmaceuticals derived from organisms falling under Risk
Group I and II.
• Import and marketing of products derived from Living Modified
Organisms (LMOs) as drugs/pharmaceuticals in bulk and/ or finished
formulations (therapeutic proteins) where the end product is not LMO.
• Bt cotton hybrids containing approved events under the “Event Based
Approval Mechanism”.
Recombinant DNA Guidance 1990
• DBT had formulated rDNA guidelines in 1990 which were revised in
1994
• It include guidelines for R&D activities on GMOs, transgenic plants,
animals and products into the environment
• Four different biosafety levels have been recognized and containment
facilities for each level are recommended which have already been
explain.
Definition of recombinant DNA: Recombinant deoxyribonucleic acid
(rDNA) by definition involves in vitro introduction of different segments of
DNA (one being the vector and the others normally unrelated DNA
sequences) that are capable of replication in a host cell either autonomously
or as an integral part of host's genome and maintenance of their continued
propagation.
• This will include all types of cell fusion, microinjection of DNA or RNA
or parts or all of chromosomes, genetic engineering including self
cloning and deletion as well as cell hybridation, transformation and other
types of virus or pathogen introduction into unnatural hosts.
Classification of a pathogenic microorganisms: The classification of
infective microorganisms are drawn up under 4 risk groups in increasing
order of risk based on the following parameters:
• pathogenicity of the agent
• modes of transmission and host range of the agent
• availability of effective preventive treatments or curative medicines
• capability to cause diseases to humans/animals/plants
• epidemic causing strains in India
The above mentioned parameters may be influenced by levels of
immunity, density and movement of host population, presence of vectors
for transmission and standards of environmental hygiene.
Containment:
• Biological containment (BC): In consideration of biological
containment, the vector (plasmid, organelle, or virus) for the recombinant
DNA and the host (bacterial, plant, or animal cell) in which the vector is
propagated in the laboratory will be considered together.
• Physical Containment (PC): The objective of physical containment is

to confine recombinant organisms thereby preventing the exposure of the
researcher and the environment to the harmful agents. Physical
containment is achieved through the use of i) Laboratory Practice, ii)
Containment Equipment, and iii) Special Laboratory Design.
Containment:
Elements of Containment: The three elements of containment include laboratory
practice and technique, safety equipment and facility design.
i) Laboratory practice and technique: Strict adherence to standard
microbiological practices and techniques; Awareness of potential hazards;
Providing/arranging for appropriate training of personnel; Selection of safety
practices in addition to standard laboratory practices if required; Developing of
adopting a biosafety or operations manual which identifies the hazards
ii) Safety equipment (primary barriers): Safety equipment includes biological
safety cabinets and a variety of enclosed containers (e.g. safety centrifuge cup).
iii) Facility Design (Secondary barriers): The design of the facility is important
in providing a barrier to protect persons working in the facility but outside of the
laboratory and those in the community from infectious agents which may be
accidentally released from the laboratory.
Bio-safety levels:
It consists of a combination of laboratory practices and techniques, safety
equipment and laboratory facilities appropriate for the operations performed and
the hazard posed by the infectious agents. The guidelines for Microbiological and
Biomedical Laboratories suggest four Biosafety levels in incremental order
depending on the nature of work.
Biosafety Level 1: These practices, safety equipment and facilities are appropriate
for undergraduate and secondary educational training and teaching laboratories and
for other facilities in which work is done with defined and characterized strains of
viable microorganisms not known to cause disease in healthy adult human. No
special accommodation or equipment is required but the laboratory personnel are
required to have specific training and to be supervised by a scientist with general
training in microbiology or a related science.
Bio-safety levels:
Biosafety Level 2: These practices, safety equipment and facilities are applicable in clinical,
diagnostic, teaching and other facilities in which work is done with the broad spectrum of
indigenous moderate-risk agents present in the community and associated with human disease
of varying severity. Laboratory workers are required to have specific training in handling
pathogenic agents and to be supervised by competent scientists. Accommodation and facilities
including safety cabinets are prescribed, especially for handling large volume are high
concentrations of agents when aerosols are likely to be created. Access to the laboratory is
controlled.
Biosafety level 3: These practices, safety equipment and facilities are applicable to clinical,
diagnostic, teaching research or production facilities in which work is done with indigenous or
exotic agents where the potential for infection by aerosols is real and the disease may have
serious or lethal consequences. Personnel are required to have specific training in work with
these agents and to be supervised by scientists experienced in this kind of microbiology.
Specially designed laboratories and precautions including the use of safety cabinets are
prescribed and the access is strictly controlled.
Bio-safety levels:
Biosafety level 4: These practices, safety equipment and facilities are applicable to work with
dangerous and exotic agents which pose a high individual risk of life-threatening disease. Strict
training and supervision are required and the work is done in specially designed laboratories under
stringent safety conditions, including the use of safety cabinets and positive pressure personnel
suits . Access is strictly limited.
A specially designed suit area may be provided in the facility. Personnel who enter this area wear
a one-piece positive pressure suit that is ventilated by a life support system. The life support
system is provided with alarms and emergency break-up breathing air tanks. Entry to this area is
through an airlock fitted with air tight doors. A chemical shower is provided to decontaminate the
surface of the suit before the worker leaves the area. The exhaust air form the suit area is filtered
by two sets of HEPA filters installed in the series. A duplicate filtration unit, exhaust fan and an
automatically starting emergency power source are provide. The air pressure within the suit area
is lower than that of any adjacent area. Emergency lighting and communication systems are
provided. All penetrations into the inner shell of the suit area are sealed. A double door autoclave
is provided for decontamination of disposable waste materials from the suit area.
Guidelines for rDNA research activities:
The guidelines stipulate three categories of research activities, These are:
Category I: Which are exempt for the purpose of intimation and approval of
competent authority.
I. The experiments involving self cloning, using strains and also inter-species
cloning belonging to organism in the same exchanger group (Vide Chapter-V A4,
A5).
II. Organelle DNA including those from chloroplasts and mitochondria.
III. Host-vector systems consisting of cells in culture and vectors, either non-viral or
viral containing defective viral genomes
Category I:
It includes:
• Routing cloning of defined genes, defined non-coding stretches of DNA and open
reading frames in defined genes in E. coli or other bacterial host which are
generally considered safe to human, animals and plants.
• Transfer of defined clones genes into agrobacterium.
• Use of defined reporter genes to study transient expression in plant cells and to
study genetic transformation conditions.
• Molecular analysis of transgenic plants grown in vitro.
• The experiments need intimation to IBSC (Institutional Biosafety Committee) in
the prescribed proforma.
Category II:
• Experiments falling under containment levels II, III and IV.
• Experiment wherein DNA or RNA molecules derived from any source except for
eukaryotic viral genome may be transferred to any non-human vertebrate or any
invertebrate organisms and propagated under conditions of physical containment
PC1 and appropriate to organism under study.
• Experiments involving non pathogen DNA vector systems and regeneration from
single cells.
• Large scale use of recombinants made by self cloning in systems belonging to
exempt category (e.g. E.coli, Saccharomyces, and B. subtilis)
Category II:
• Experiment where in DNA or RNA molecules derived from any source except for
eukaryotic viral genome may be transferred to any non-human vertebrate or any
invertebrate organisms and propagated under conditions of physical containment
PC1 and appropriate to organism under study.
• Experiments involving non pathogen DNA vector systems and regeneration from
single cells.
• Permission to perform experiments will be provided by IBSC.
• It would be intimated to RCGM (Review Committee On Genetic Manipulation)
before execution of experiments
Category III:
• It includes experiments having high risk where the escape of transgenic traits into
the open environment could cause significant alteration in the biosphears, the
ecosystem, plants and animals by dispersing new genetic traits the effects of which
cannot e judged precisely.
• Further this is also includes experiment conducted in greenhouse and open field
condition not belonging to the above category II types. Such experiments could be
conducted only after clearance from RCGM and DBT.
Category III:
• It also includes experiments on toxic genes cloning such as B. subtilis and B. sphericus
toxin genes and B. thuringiensis crystal protein genes in E.coli K12. All toxin gene
cloning experiments producing LD50 less than 50 ug/kg of body weight of
vertebrates or large scale growing may be referred to Institutional Biosafety
Committee (IBSC) for clearance.
• Cloning of genes for vaccine production: e.g. Rinderpest and leprosy antigens is
listed under special category in the Centers for Disease Control & National Institute
of Health (CDC-NIH) system. The containment should be decided by Review
Committee on Genetic Manipulation (RCGM) on a case by case basis on experiment
utilizing DNA from non-defective genomes of organisms recognized as pathogen.
• Cloning of mosquito and tick DNA experiments should be prescribed on a case by
case basis since these are natural vectors for certain endemic viral and parasitic
diseases.
Category III:
• Genes coding for antibiotic resistance into pathogenic organisms which do not
naturally possess such resistance.
• Introduction into cultured human cells of recombinant DNA molecules containing
complete genes of potentially oncogenic viruses or transformed cellular genes.
• Introduction into animal cells of unidentified DNA molecules derived from cancer
cells or in vitro transformed cells.
• Experiments involving the use of infectious animal and plant viruses in tissue
culture systems. Experiments involving gene transfer to whole plants and animals
• Cell fusion experiments of Animal cells containing sequences from viral vectors if
the sequence lead to transmissible infection either directly or indirectly as a result of
complementation or recombination in the animals. For experiments involving
recombinant DNA of higher class organisms using whole animals will be approved
on case by case following IBSC review.
Category III:
• Transgenesis in animal experiments: Transgenesis method is used to transform
animal cells with foreign DNA by using viruses as vectors or by microinjection of
DNA into eggs and pre-embryos.
• All experiments involving the genetic manipulation of plant pathogens and the use
of such genetically manipulated plant pathogens would require approval of
competent authority (IBSC).
• Transfer of genes with known toxicity to plants using Agrobacterium tumefaciens or
other vectors. Attempts are under way using Ti-plasmid, A. tumefaciens and other
vectors to transfer toxin-encoding genes that enable plants to make their own
insecticide, resist infections or tolerate a variety of environmental stresses.
Category III:
• In case of plant viruses, permission may be obtained only when it is known that
there is a chance of non-species specific spread of infection to plants that could
produce changes in pathogenicity, host range or vector transmissibility..
• Experiments requiring field testing and release of rDNA engineered microorganisms
and plants
• Experiments involving engineered microbes with deletions and certain
rearrangements.
• Diagnostics: No major risk can be foreseen on diagnostics involving in vitro tests.
But for diagnostics involving in vivo tests, specific containment levels have to be
prescribed on case by case basis. For example, tuberculin moiety could be cloned and
used for in vivo hypersensitivity test as a diagnostic method.
• Gene therapy for hereditary diseases of genetic disorders.
Large scale experiments: In the guidelines, experiments beyond 20 litres capacity for
research as well as industrial purposes are included in the category of large scale
experimentation/operations
For such activities it is recommended that one should seek approval of the competent
authority. In order to seek approval it will be necessary to furnish the relevant details in a
prescribed format on the lines suggested by GEAC.
To keep work place and environment exposure to any physical, chemical or biological
agent to the lowest practicable level; to exercise engineering control measures at source
and to supplement these with appropriate personal protective clothing and equipment
when necessary; to test adequately and maintain control measures and equipment; to test
when necessary for the presence of viable process organisms outside the primary
physical containment; to provide training of personnel to formulate and implement local
code of practice for the safety of personnel.
Revised guidance for research in Transgenic plants (1998)
• Department of Biotechnology in January 1990 issued a compendium of
guidelines under the title “Recombinant DNA Safety Guidelines”. A
revision was made in 1994 under the title “Revised Guidelines for
Safety in Biotechnology”. The current guidelines have been developed
in the light of enormous progress that has been made in recombinant
DNA research and its widespread use in developing improved microbial
strains, cell lines and transgenic plants for commercial exploitation.
• This guidelines cover areas of recombinant DNA research on plants
including the development of transgenic plants and their growth in soil
for molecular and field evaluation. The guidelines also deal with import
and shipment of genetically modified plants for research use only.
• In accordance with the Notification No. GSIR 1037 (E) dated 5th
December, 1989 of the Ministry of Environment & Forests which
empowers the Review Committee on Genetic Manipulation
(RCGM) to bring out manuals of guidelines specifying procedure for
regulatory process with respect to activities involving genetically
engineered organisms in research use and applications including
industry with a view to ensuring environmental safety, the present
changes in the procedures are being made.
• These changes are made reiterating the powers conferred on the RCGM
to lay down procedures restricting or prohibiting production, sale,
importation and use of genetically engineered organisms or cells as
are mentioned in the attached schedule of the above mentioned
notifications.
Categories of genetic engineering experiments on plants and their
notifications
CATEGORY I, routine recombinant DNA experiments
• This category includes routine cloning of defined genes, defined non-
coding stretches of DNA and open reading frames in defined genes
in E. coli or other bacterial and fungal hosts which are GENERALLY
CONSIDERED AS SAFE (GRAS) to human, animals and plants.
• A list of such microorganisms will be prepared by the RCGM and
shall be made available to the P.I. on request.
notifications
CATEGORY I, routine recombinant DNA experiments
This category involves experiments in the lab in contained environment and
includes the following:
i. Routine cloning of defined DNA fragments of microbial, animal and
plant origin in GRAS organisms.
ii. Transfer of defined cloned genes into Agrobacterium;
iii. Use of defined reporter genes to study transient expression in plant
cells to study genetic transformation conditions;
iv. Molecular analysis of transgenic plants grown in-vitro.
Categories I experiment need only intimation to the IBSC in the prescribed
proforma (available with the RCGM secretariat).
notifications
CATEGORY II
This category includes lab and green house/net house experiments in
contained environment where defined DNA fragments non-pathogenic
to human and animals are used for genetic transformation of plants, both
model species and crop species and the plants are grown in the green
house/net house for molecular and phenotypic evaluation.
Permission for performing Category II experiments will be provided by
IBSC. The decision of the IBSC would be intimated to the RCGM before
execution of the experiments and RCGM would put this information on
record.
notifications
CATEGORY II
This category includes the experiments described below :
1. Transgenics with constitutive, tissue specific and chimeric promoters used
for experimenting expression of defined DNA fragments.
2. Marker genes extensively used in genetic transformation of plants in lab
and green house/net house experiments.
3. Lab and green house/net house experiments with plants with herbicide
resistance conferring genes;
4. Lab and green house/net house experiments with plants using heterologous
genes which confer resistance to biotic and abiotic stresses (i.e. genes like
chalcone synthase, heat shock proteins, chitinase, protease inhibitors
etc);
notifications
CATEGORY II
This category includes the experiments described below :
5. Lab and green house/net house experiments with genes from plants,
animals and microbial sources that would confer resistance to plant
pathogens.
6. and green house/net house experiments with transgenics with genes for
the production of antibodies (Neutraceuticals)
7. Green house/net house experiments with transgenics with transposable
elements for gene tagging in crop species.
notifications
CATEGORY III & ABOVE
This category pertains to high risk experiments where the escape of
transgenic traits into the open environment could cause significant
alterations in the biosphere, the ecosystem, the plants and animals by
dispersing new genetic traits, the effects of which can not be judged
precisely. All experiments conducted in green house and open field
conditions not belonging to the above Category II types, would fall under
Category III risks.
Such experiments could be conducted only after clearance from RCGM and
notified by the Department of Biotechnology.
CONTAINMENTS
Different levels of containment are prescribed for the three different categories of rDNA
experiments.
Category I experiment should be performed using routine good laboratory practices
For Category II experiments dealing with evaluation of transgenics in green house/net
house. The transgenic experiments of Category II risks will have to be carried out in green
house/net house, the specification of which is significantly stringent to ensure arrest of
transgenes within the contained facility.
For Category III experiments in green house/net house, the later needs to be designed as
indicated broadly in Appendix II. The specifications of the green house/net house have
been designed to ensure near complete isolation of the facilities from the open
environment; care has also been taken to prevent the entry of insects into the green
house/net house facility. For limited field experiments in the open environment, the RCGM
would provide for and/or would approve the design of the experimental field plots.
MONITORING AND EVALUATION MECHANISMS FOR GREEN HOUSE/ NET
HOUSE EXPERIMENTS AND LIMITED FIELD TRIALS IN THE OPEN
ENVIRONMENT
The RCGM can bring out manuals of Guidelines specifying procedures for
regulatory process with respect to activities involving genetically engineered
organisms in research and applications to ensure environmental safety. To monitor,
over a period of time, the impact of transgenic plants on the environment, a special
Monitoring cum Evaluation Committee of the following constitution will be set up
by the RCGM. The Committee shall have the following constitution.
MONITORING AND EVALUATION MECHANISMS FOR GREEN HOUSE/
NET HOUSE EXPERIMENTS AND LIMITED FIELD TRIALS IN THE OPEN
ENVIRONMENT
• This committee will undertake field visits at the experimental site/s. The
committee shall be guided by the RCGM on the design of field experiments
and on the preparation of formats for collecting scientific information on
plants in green house/net conditions as well as in limited field trials.
• Based on the on-the-spot situation the committee can suggest remedial
measures to adjust the original trial design and assist the RCGM in
collecting, consolidating and analyzing the field data for evaluating the
environmental risks emanating from the transgenic plants.
• This committee shall also collect or cause to collect the information on the
comparative agronomic advantages of the transgenic plants.
MONITORING AND EVALUATION MECHANISMS FOR GREEN HOUSE/ NET
HOUSE EXPERIMENTS AND LIMITED FIELD TRIALS IN THE OPEN
ENVIRONMENT
• From time to time, the committee shall advise the RCGM on the risks and
benefits from the use of the transgenic plants put into evaluation.
• Trials will be done for at least one year with minimum four replications and
ten locations in the agroecological zone for which the material is intended.
• The biological advantage of transgenic will have to be clearly enumerated by
the applicant, the Institution, the University or the Industry.
• The latter would recommend those transgenics, which would be found to be
environmentally safe and economically viably by the RCGM, to the Genetic
Engineering Approval Committee for consideration for release into the
environment.
BIOSAFETY ASPECTS OF THE TRANSGENIC PLANTS
Experiments are designed to systematically identify the hazards, to access to risks and
to take step to manage the risks by applying logically valid strategies, to systematically
identify the hazards and to assess the risks; the information on the following aspects
would be required to be generated.
Characteristics of the donor organisms providing the target nucleic acids. These
may include the following:
1. Name of the donor organism with its identification characteristics with relevant
reference to published information if any.
2. Pathogenically and toxicity characteristics to plants and animals.
3. Allergenicity characteristics to human along with of the allergenic substances,
wherever possible.
4. The geographical origin of the organisms, its distribution pattern and survival
mechanisms.
5. The method of transfer of its genetic materials to other organisms.
Characteristics of the vectors used : These may include the following :
1. The origin, identity and habitat of the vectors used.
2. The sequence, frequency of mobilization, specificity and marker genes if any,
present in the vectors.
3. The abilities of the vectors to get established in other hosts; the hosts are also to
be specified.
Characteristics of the transgenic inserts : These may include the following :
1. The specific functions coded by the inserted nucleic stretches including the
marker gene inserts.
2. The expression of the nucleic acid products and their activities/properties.
3. The toxicity of the expression products on the host plant, if any.
4. The toxicity and allergenicity of the nucleic acid products to human and
animals.
Characteristics of the transgenic plants : These may include the following:
1. Methods of detection of the transgenic plant in the environment.
2. Methods of detection and characterization of the escaped transgenic traits in
the environment.
3. Toxicity and pathogenicity of the transgenic plants and their fruits to other
plants in the ecosystem and the environment.
4. Possibility of and the extent of transgenic pollen escape and pollen transfer to
wild near relatives, and the consequences to the environment.
5. Pathogenicity, toxicity and allergenicity of the transgenic plants and their fruits
to human and animals.
For minimizing the risk arising from the limited release of transgenic plants, the
following may be taken into consideration :
1. Special separation for isolation, for preventing reproduction/fertilization and seed
setting.
2. Biological prevention of flowering by making use of sterility properties etc.
3. Human intervention for the removal of reproductive structures of flowers.
4. Controlling the reproductive structures of transgenic plants like the seeds and the plant
propagules from unaccounted spread.
5. Controlling and destroying volunteer plants from the experimental field.
6. To take into account the proximity to human activity in case the transgenic plants have
allergenic properties to human and animals.
7. Appropriate training of field personnel responsible for handling the transgenic plants.
8. Plans for handling unexpected events.
9. Documentation of previous published information, if any, including any documented
evidence of effects of release to ecosystem.
IMPORT AND SHIPMENT OF TRANSGENIC GERMPLASM FOR RESEARCH
PURPOSES:
• Clearance for import of transgenic material, for research purposes would
be provided by the Review committee on genetic manipulation . The
RCGM will issue an import certificate after looking into the documents
related to the safety of the material and the national need.
• The RCGM will take into consideration the facilities available with the
importer for in-soil tests on the transgenic material. The importer of a
transgenic material may import the material accompanied by an
appropriate phyto-sanitary certificate issued by the authority of the
country of export, and such import may be routed through the Director,
National Bureau of Plant Genetic Resources (NBPGR) on the basis of
the import permit issued by the DBT, based on the recommendations of
the RCGM.
IMPORT AND SHIPMENT OF TRANSGENIC GERMPLASM FOR RESEARCH
PURPOSES:
• The import certificate would be cancelled if NBPGR would not provide
the phyto-sanitory certificate. NBPGR will provide information on
the time that is required for phyto-sanitary evaluation.
• These evaluations will be done in a time-bound manner in presence of
the agents of the institutes or the commercial organizations that are
importing the material, if they so desire.
• Parts of the seed material will be kept at NBPGR in double lock
system in the presence of the importer. This lot of seed will act as a
source material in case of any legal dispute.
GOOD LABORATORY PRACTICES:
1. Use a pipettor for all the solution transfers. No mouth pipetting.
2. Plug pipettes with cotton.
3. Do not blow infectious material out of pippetes.
4. Do not prepare mixtures of infectious material by bubbling
expiratory air through the liquid with a pipette.
5. Before and after infecting an animal, swab the site of injection with a
disinfectant.
6. Sterilise discarded pipettes and syringes in pan where they were first
placed after use.
7. Before centrifuging, inspects tubes for cracks. Inspect the inside of
the Turin cup for rough walls caused by erosion or adhering matter.
Carefully remove all bits of glass from the rubber cushion.
GOOD LABORATORY PRACTICES:
8. Use of centrifuge trunnion cap with screw caps or equivalent.
9. Avoid decanting centrifuge tubes; if you must do so, wipe off the outer
rim with a disinfectant. Avoid filling the tube to the point that the rim
ever becomes wet with culture.
10. Sterilize all contaminated material before discarding.
11. Periodically, clean out deep-freeze and dry-ice chests in which cultures
are stored to remove broken ampules or tubes. Use rubber glovers and
respiratory protection during the cleaning.
12. Avoid smoking, eating and drinking in the laboratory.
13. Do not reuse plasticware that has been used for PCR, recombinant DNA
work and plant transformation work.
14. Sterilize all the plasticware before discarding it. Burn all the transgenic
material in an incinerator after observations have been taken.
MODEL PLAN FOR THE CONSTRUCTION OF A GREEN HOUSE/NET HOUSE
FOR EXPERIMENTS USING TRANSGENIC PLANTS
MODEL PLAN FOR THE CONSTRUCTION OF A GREEN
HOUSE/NET HOUSE FOR EXPERIMENTS USING
TRANSGENIC PLANTS
Frame Structure :
The structure should be made from galvanized mild steel
designed to with stand wind loading of not less than 100
km/hour.
The method of affixing the polythene film cover to the
frame should be strong enough to with stand similar wind
velocities.
The base may be constructed with bricks and cement or
with any durable structure up to a height of 1.5 to 2 feet
from the ground level so as to isolate the land inside the
framed structure from the outside land.
Revised guidance for research in
Transgenic plants (1998)
MODEL PLAN FOR THE CONSTRUCTION
OF A GREEN HOUSE/NET HOUSE FOR
EXPERIMENTS USING TRANSGENIC
PLANTS
Optimum size of unit :
The recommended minimum size of the unit would
be 1000 to 1500 cubic meters. In dimensions each
such unit may be 30 meters long 13 meters wide
and having and under the gutter height of about 3 to
4.5 meters from the base.
The plan view as well as the side view of a multi span unit with double door entry
recommended and the span of the area for the double door entry can be kept as 5 to 6
meters in length and about 3 meters in width along with height maintained commensurate
with the main structure of the unit.
The main entrance may be optionally be provided with an air curtain.
Optimum size of unit :
• The outer door shall be only one panel of flush door opening inside the buffer area
and the inside doors may be more than one
• In case sliding doors are not installed, the inside doors should be of one panel each,
opening inside the buffer area only.
• The entry wall can be utilised for housing the suction fans as shown in the drawing
while the opposite wall can be mounted with evaporation pads (shown in the drawing).
The optimum sized unit recommended above would provide a growing area of about
350 sq. meters, allowing 10% for path ways.
• This unit have a Volume of about 1100 - 1200 cubic meters. Such a unit would be able
to maintain a stable temperature, the desired humidity with adequate and ample air
circulation.
Plastic film covering :
• It is recommended that the area covering the frame should be of 200 micron (800
gauge) thickness, UV stabilised polymer film. Such materials are expected to have a
life span of 4 to 6 years.
• All coverings should be double film covering on all surfaces to give double UV
filtration and a more stable temperature control.
• The roof covers are likely to be inflated by the action of blower fans, thus maintaining
a cavity throughout the unit.
• In addition to its suggested that an internal separation wall can be constructed to
bifurcate the spans if there are more than one, which can be done by fixing the plastic
films to the securing rails.
• With in the whole unit facilities can thus be provided for separate crop studies.
Fan, Pad system and Filter screens :
An evaporative cooling system will be required to enable the maintenance of stable
temperature gradient from the site of evaporative pad to the suction end. The surface are
of the cooling unit will depend upon the overall all size of the structure. If the unit exceeds
30 meters in length then the temperature variation through out the length of unit may be
such than an even temperature may not be maintainable even with the introduction of
turbo circulation fans. The dimensions of the evaporation pad required to obtain a
temperature 15 degree centigrade below ambient for a give volume of green house can
be calculated from the following approximate equation.
The fans required for a unit of above dimensions, to be housed at the other end of the
unit should be about 61 centimeters (24 inch) in diameter with low noise and high
Cubic feet per minute (CFM) air circulation capacity, with four numbers to be
installed per unit.
It is recommended that motors with 1.5 H.P. with three phase may be installed which is
slightly over designed but which is expected to have more life span and there fore
substantial saving on replacements. Compromises can be made by installing 1 H.P.
three phase motors, but this may need more maintenance. The fan units should have
40 X 40 mesh durable plastic screen fitted to the out side of the external surface.
Each motor unit can be connected to one semi automatic temperature controlled
which should shut down the fan as and when the temperature drops below the
required levels. Such designs are available in the market.
Blower fans are required to be fitted on the each roof section which will inflate
the top roof sheet. These fans must also to be fitted with 40 X 40 mesh durable
plastic screen on the induction side to prevent any pollen evacuation.
As these fans are expected to be constantly in operation it is recommended that
these should be fitted with bearings and not with bust type.
It is essential to have circulation fans within the green house to ensure that a
uniform temperature is maintained though out the growing area. The number
and the positioning will however depend upon the external conditions and therefore
may vary from place to place. The manufacturer may be consulted for selecting
the correct number.
Irrigation :
• Full over head irrigation systems are installed. In smaller houses it
would be advisable to carryout the watering manually as regulation of
humidity is difficult to maintain through over head irrigation system
because any extra watering will increase the humidity level.
• In line feeding units can be installed to take care of the nutrient
requirements of the plants. A water tank needed to supply water to the
pads and irrigation may be installed slightly below the ground level to
avoid direct influence by sun or solar heat. The water will therefore
remain cool.
Proposed positioning :
• The location and the orientation of the unit is of significant importance. The
fans should not be positioned in a manner that they below directly to wards
the plants. Electricity and water are continuously required. Therefore these
must be positioned within a reasonable reach of the unit to keep costs down.
• The area selected for the unit must be flat, and as far as possible leveled to
accommodate the unit plus approximately 2 metros off around the outside.
It would be useful to provide a drainage system around the unit at suitable
lower levels to enable the drainage of extra water.
• A suitable drain off area is also recommended to enable the extra water
running off from the gutters; the drain off area may be more than 10 meters
away from the unit.
National seed policy (2002)
• Indian Agriculture has made enormous strides in the past 50 years, raising
food grains production from 50 million tones to over 200 million tones.
In the process, the country has progressed from a situation of food
shortages and imports to one of surpluses and exports. Having achieved
food sufficiency, the aim now is to achieve food and nutritional security at
the household level.
• The increase in agricultural production, however, has brought in its wake,
uneven development, across regions, crops, and also across different
sections of farming community. In the decade of the 'nineties', a marked
slackening in the pace of growth has occurred, pointing to the need for
infusing a new vitality in the agricultural sector.
• Seed is the most important determinant of agricultural production
potential, on which the efficacy of other agriculture inputs is dependent.
Seeds of appropriate characteristics are required to meet the demand of
diverse agro-climatic conditions and intensive cropping systems.
Sustained increase in agriculture production and productivity is
dependent, to a large extent, on development of new and improved
varieties of crops and an efficient system for timely supply of quality
seeds to farmers.
• The seed sector has made impressive progress over the last three decades.
The area under certified seeds has increased from less than 500 hectares in
1962-63 to over 5 lakh hectares in 1999-2000. The quantum of quality
seeds has crossed 100 lakh quintals.
• The Seeds Act, 1966 and Seeds Control Order promulgated thereunder, and
the New Policy on Seeds Development, 1988, form the basis of promotion and
regulation of the Seed Industry. Farreaching changes, however, have taken
place in the national economic and agricultural scenario and in the
international environment since the enactment of the existing seed legislation
and the announcement of the 1988 Policy.
• The Seed Act, 1966 , seed control order 1983 and New Policy on Seeds
Development, 1988, from the basis of promotion and regulation of the Indian
Seed Industry.
• The “New Seed Policy” of 1988 ushered in a new area of growth and
phenomenal development. Because, it allowed limited import of commercial
seed, remove curbs on imports of seeds of vegetables, flowers and ornamental
plants and even allowed import of seed of course cereals, pulses and oilseeds
for a period of two years.
The important constraints were
➢ Non existence of National Seed Policy
➢ IPR laws
➢ Restrictions and licenses on seed exports and imports
➢ Lack of incentives for the public and private seed sectors of the country
• India later developed the National Seed Policy in 2002. The main objectives
are the provision of an appropriate climate for the seed industry to utilize
available and prospective opportunities, safe guarding of the interests of
Indian farmers and the conservation of agro-biodiversity.
The National Seeds Policy will lay
the foundation for comprehensive
Thrust Areas
reforms in the seed sector.
1. Varietal Development and Plant Variety
Significant changes in the existing
Protection
legislative framework will be
2. Seed Production
effected accompanied by
3. Quality Assurance
programmatic interventions.
4. Seed Distribution and Marketing.
The Policy will also provide the
5. Infrastructure facilities
parameters for the development of
6. Transgenic Plant Varieties
the seed sector in the Tenth and
7. Import of seeds and planting material
subsequent Plans.
8. Export of seeds
The progress of implementation of
9. Promotion of Domestic Seed
the Policy will be monitored by a
10. Strengthening of monitoring system
High Level Review Committee.
1. Varietal Development and Plant Variety Protection:
Varietal Development and Plant Variety Protection To stimulate investment in research
and development (R&D) new varieties an effective sui generis system* for IPR will be
implemented.
• Establishment of Plant Varieties Protection and Farmers Rights Authority, to
implement PVPFR Act, 2001.
• Under this Act, Plant Varieties will be registered based on Novelty, Distinctness,
Uniformity and Stability (DUS) characters.
• Registration of all plant genera or species as notified by the Authority will be done in a
phased manner. The Plant Variety Protection Authority will develop
characterization and documentation of plant varieties registered under the PVP Act
and cataloguing facilities for all varieties of plants.
• Farmers/groups of farmers/village communities will be rewarded suitably for their
significant contribution in evolution
• Farmers Rights: Farmers can save, use, exchange, share or sell seeds of protected
variety but not under the brand name.
*sui generis system- creation of a new national law or the establishment of international norms that would afford protection to intellectual property dealing with genetic resources
1. Varietal Development and PVP:
• Researchers Rights: Seed / planting material of protected varieties can be used for
research and breeding new varieties.
• Breeders Rights: Benefit a rising out of use of varieties upon commercialization of
seeds of new variety, will be shared with the respective breeder.
• Community Rights: Benefit sharing with Farmers / Village communities will be
ensured for contributing in evaluation of plant variety upon registration. of a plant
variety subject to registration. The contribution of traditional knowledge in
agriculture needs to be highlighted through suitable mechanisms and incentives.
• Equitable sharing of benefit arising out of the use of plant genetic resources that may
accrue to a breeder from commercialisation of seeds/planting materials of a new
variety, will be provided.
• Regular interaction amongst the Private and Public Researchers, Seed
Companies/Organizations and Development Agencies will be fostered to develop and
promote growth of a healthy seed industry in the country.
2. Seed production:
• To meet the Nation's food security needs, it is important to make available to
Indian farmers a wide range of seeds of superior quality, in adequate quantity
on a timely basis. Public Sector Seed Institutions will be encouraged to
enhance production of seed towards meeting the objective of food and
nutritional security.
• The Indian seed program adheres to the limited three generation system of seed
multiplication, namely, breeder, foundation and certified seed. Breeder seed is
the progeny of nucleus seed.
• Nucleus seed is the seed produced by the breeder to develop the particular
variety and is directly used for multiplication as breeder seed.
• Breeder seed is the seed material directly controlled by the originating or the
sponsoring breeder or Institution for the initial and recurring production of
foundation seed.
2. Seed production:
• Foundation seed is the progeny of breeder seed. Foundation seed may also be
produced from foundation seed. Production of foundation seed stage-I and stage-II
may thus be permitted, if supervised and approved by the Certification Agency and if
the production process is so handled as to maintain specific genetic purity and
identity.
• Certified seed is the progeny of foundation seed or the progeny of certified seed. If
the certified seed is the progeny of certified seed, then this reproduction will not
exceed three generations beyond foundation stage-I and it will be ascertained by the
Certification Agency that genetic identity and genetic purity has not been
significantly altered.
• Public Sector Seed Production Agencies will continue to have free access to breeder
seed under the National Agriculture Research System. The State Farms
Corporation of India and National Seeds Corporation will be restructured to make
productive use of these organizations in the planned growth of the Seed Sector.
2. Seed production:
• Private Seed Production Agencies will also have access to breeder seed subject to
terms and conditions to be decided by Government of India.
• State Agriculture Universities/ICAR Institutes will have the primary
responsibility for production of breeder seed as per the requirements of the
respective States
• Special attention will be given to the need to upgrade the quality of farmers’ saved
seeds through interventions such as the Seed Village Scheme.
• Seed replacement rates will be raised progressively with the objective of expanding
the use of quality seeds.
• Department of Agriculture & Cooperation (DAC) in consultation with ICAR and
States, will prepare a National Seed Map to identify potential, alternative and
nontraditional areas for seed production of specific crops.
2. Seed production:
• To put in place an effective seed production program, each State will undertake
advance planning and prepare a perspective plan for seed production and
distribution over a rolling (five to six year) period. Seed Banks will be set up in
non-traditional areas to meet demands for seeds during natural calamities.
• The 'Seed Village Scheme' will be promoted to facilitate production and timely
availability of seed of desired crops/varieties at the local level. Special importance
will be given to seed multiplication for building adequate stocks of certified/quality
seeds by providing foundation seed to farmers.
• For popularizing newly developed varieties and promoting seed production of
these varieties, seed minikits of pioneering seed varieties will be supplied to farmers.
Seed exchange among farmers and seed producers will be encouraged to popularise
new/non-traditional varieties.
2. Seed production:
• Seeds of newly developed varieties must be made available to farmers with
minimum time gap. Seed producing agencies will be encouraged to tie up with
Research Institutions for popularization and commercialization of these varieties.
• As hybrids have the potential to improve plant vigour and increase yield, support for
production of hybrid seed will be provided.
• Seed production will be extended to agro-climatic zones which are outside the
traditional seed growing areas, in order to avoid unremunerative seed farming in
unsuitable areas.
• Seed Banks will be established for stocking specified quantities of seed of required
crops/varieties for ensuring timely and adequate supply of seeds to farmers during
adverse situations such as natural calamities, shortfalls in production,
unforeseen situations etc. Seed Banks will be suitably strengthened with cold
storage and pest control facilities.
2. Seed production:
• For the storage of seeds at farm level,
scientific storage structures will be
popularized and techniques of scientific
storage of seeds will be promoted among
farmers as an extension practice.
• Seed growers will be encouraged to avail of
Seed Crop Insurance to cover risk factors
involved in production of seeds.
• The Seed Crop Insurance Scheme will be
reviewed so as to provide effective risk
cover to seed producers and will be extended
to all traditional and non-traditional areas
covered under the seed production program.
Regulatory framework
in India governing GMOs
• National Seed Board will be established as apex body in place of existing Central Seed
Committee to implement New Seed Act.
• National Seeds Register will be maintained varieties will be registered based on
“Value for Cultivation and Usage”. (VCU).
• Farmers will retain rights to save, use, exchange, share or sell seeds of any variety but
not under the brand name.
• The NSB will accredit ICAR, state agricultural universities, public/private
organizations to conduct VCU trials of all varieties for the purpose of registration as
per prescribed standards.
• The NSB will maintain the National Seeds Register containing details of varieties that
are registered. This will help the Board to coordinate and assist activities of the States in
their efforts to provide quality seeds to farmers.
• The NSB will prescribe minimum standards (of germination, genetic characteristics,
physical purity, seed health, etc.) as well as suitable guidelines for registration of seed
and planting materials.
• Provisional registration would be granted on the basis of information filed by
the applicant relating to trials over one season to tide over the stipulation of
testing over three seasons before the grant of registration.
• Government will have the right to exclude certain kinds or varieties from
registration to protect public order or human, animal and plant life and health,
or to avoid serious prejudice to the environment.
• The NSB will have the power to cancel the registration granted to a variety if
the registration has been obtained by misrepresentation or covering-up of
essential data, the variety is outdated and has outlived its utility and if the
prevention of commercial exploitation of such variety is necessary in the public
interest.
• Registration of Seed Processing Units will be required if such Units meet the
prescribed minimum standards for processing the seed.
• Seed Certification will continue to be voluntary. The Certification tag/label will
provide an assurance of quality to the farmer.
• To meet quality assurance requirements for export of seeds, Seed Testing
facilities will be established in conformity with International Seed Testing
Association (ISTA) and Organization for Economic Co-operation and
Development (OECD) seed certification programs.
• The State Government, in conformity with guidelines and standards specified by
the Board, will establish one or more State Seed Testing Laboratories or declare
any Seed Testing Laboratory in the Government or non-Government Sector as
a State Seed Testing Laboratory where analysis of seeds will be carried out in the
prescribed manner.
• Farmers will be encouraged to use certified seeds to ensure improved
performance and output.
• Farmers will retain their right to save, use, exchange, share or sell their farm
seeds and planting materials without any restriction.
• Farmers also free to sell their seed on their own premises or in the local
market without any hindrance provided that the seed is not branded.
• Farmers’ right to continue using the varieties of their choice will not be
infringed by the system of compulsory registration.
• Strict measures would be taken to ensure the availability of high quality of
seeds and check the sale of spurious or misbranded seeds.
• The availability of high quality seeds to farmers through an improved
distribution system and efficient marketing set-up will be ensured to facilitate
greater security of seed supply.
• For promoting efficient and timely distribution and marketing of seed
throughout the country, a supportive environment will be provided to
encourage expansion of the role of the private seed sector. Efforts will be made
to achieve better coordination between State Governments to facilitate free
Inter-State movement of seed and planting material through exemption of
duties and taxes.
• Private Seed Sector will be encouraged and motivated to restructure and
reorient their activities to cater to nontraditional areas.
• A mechanism will be established for collection and dissemination of market
intelligence regarding preference of consumers and farmers.
• A National Seed Grid will be established as a data-base for monitoring of
information on requirement of seed, its production, distribution and preference
of farmers on a district-wise basis.
• Access to term finance from Commercial Banks will be facilitated for developing
efficient seed distribution and marketing facilities for growth of the seed sector.
• Distribution and marketing of seed of any variety, for the purpose of sowing and
planting will be allowed only if the said variety has been registered by the National
Seeds Board.
• National Seeds Board can direct a dealer to sell or distribute seeds in a specified
manner in a specified area if it is considered necessary to the public interest.
• Availability of high quality seed will be ensured through improved distribution
system and efficient marketing set up.
• To meet the enhanced requirement of quality/certified seeds, creation of new
infrastructure facilities along with strengthening of existing facilities, will be
promoted.
• National Seed Research and Training Center will be set up to impart training
and build a knowledge babse in various disciplines of the seed sector.
• The Central Seed Testing Laboratory will be established at the National Seed
Research and Training Center to perform referral and other functions as
required under the Seeds Act.
• Seed processing capacity will be increased to meet the enhanced requirement
of quality seed.
• Modernization of seed processing facilities will be encouraged in terms of
modern equipment and latest techniques, such as seed treatment for
enhancement of performance of seed, etc.
• Conditioned storage for breeder and foundation seed and aerated storage for
certified seed would be created in different regions.
• A computerized National Seeds Grid will be established to provide
information on availability of different varieties of seeds with production
agencies, their location, quality etc. This network will facilitate optimum
utilization of available seeds in every region.
• State Governments, or the National Seeds Board in consultation with the
concerned State Government, may establish Seed Certification Agencies.
• State Governments will establish appropriate systems for effective execution
and implementation of the objectives and provisions of the Seeds Act.
• National Seed Research and Training center (NSRTC) will be set up. Seed
processing and storage faculties will be amplified.
• Seeds of transgenic plant varieties for research purposes will be imported
only through the National Bureau of Plant Genetic Resources (NBPGR) as
per the EPA, 1986.
• All GM crops will be tested for environment and bio safety before
commercial release as per EPA (1986).
• Required infrastructure will be developed for testing, identification and
evaluation of transgenic planting material.
• Transgenic crops/varieties will be tested to determine their agronomic
value for at least two seasons under the All India Coordinated Project
Trials of ICAR, in coordination with the tests for environment and bio-
safety clearance as per the EPA before any variety is commercially
released in the market.
• After the transgenic plant variety is commercially released, its seed will be
registered and marketed in the country as per the provisions of the Seeds Act.
• After commercial release of a transgenic plant variety, its performance in the
field, will be monitored for at least 3 to 5 years by the Ministry of
Agriculture and State Departments of Agriculture.
• Transgenic varieties can be protected under the PVP legislation in the same
manner as non-transgenic varieties after their release for commercial
cultivation.
• All seeds imported into the country will be required to be accompanied by a
certificate from the Competent Authority of the exporting country regarding
their transgenic character or otherwise.
• If the seed or planting material is a product of transgenic
manipulation, it will be allowed to be imported only with
the approval of the Genetic Engineering Approval
Committee (GEAC), set up under the EPA, 1986.
• Packages containing transgenic seeds/planting materials, if
and when placed on sale, will carry a label indicating their
transgenic nature.
• The specific characteristics including the agronomic/yield
benefits, names of the transgenes and any relevant
information shall also be indicated on the label.
• Emphasis will be placed on the development of
infrastructure for the testing, identification and evaluation
of transgenic planting materials in the country.
• While importing seeds and planting material, care will be taken to ensure that
there is absolutely no compromise on the requirements under prevailing plant
quarantine procedures, so as to prevent entry into the country of exotic pests,
diseases and weeds detrimental to Indian agriculture.
• All imports of seeds will require a permit granted by the Plant Protection
Advisor to the Government of India, which will be issued within the
minimum possible time frame.
• All import of seeds and planting materials, etc. will be allowed freely subject
to Export Import Policy (EXIM Policy) guidelines and the requirements of
the Plants, Fruits and Seeds (Regulation of import into India) Order, 1989 as
amended from time to time. Import of parental lines of newly developed
varieties will also be encouraged.
• Seeds and planting materials imported for sale into the country will have to
meet minimum seed standards of seed health, germination, genetic and
physical purity as prescribed.
• All importers will make available a small sample of the imported seed to the Gene
Bank maintained by National Bureau of Plant Genetic Resources (NBPGR).
• The existing policy, which permits free import of seeds of vegetables, flowers
and ornamental plants, cuttings, saplings of flowers, tubers and bulbs of
flowers by certain specified categories of importers will continue. Tubers and
bulbs of flowers will be subjected to post-entry quarantine.
• After the arrival of consignments at the port of entry, quarantine checks would
be undertaken; which may include visual inspection, laboratory inspection,
fumigation and grow out tests. For the purpose of these checks, samples will be
drawn and the tests will be conducted concurrently.
8. Export of seeds
• Given the diversity of agro-climatic conditions, strong seed production
infrastructure and market opportunities, India holds significant promise
for export of seeds.
• Government will evolve a long term policy for export of seeds with a view
to raise India's share of global seed export from the present level of less
than 1% to 10% by the year 2020.
• The export policy will specifically encourage custom production of seeds
for export and will be based on long term perspective, dispensing with case
to case consideration of proposals.
• Establishment and strengthening of Seeds Export Promotion Zones with
special incentives from the Government will be facilitated.
Regulatory framework
in India governing GMOs
8. Export of seeds
• A data bank will be created to provide information on the International
Market and on export potential of Indian varieties in different parts of the
world.
• A data base on availability of seeds of different crops to assess impact of
exports on domestic availability of seeds will be created.
• Promotional programs to improve the quality of Indian seeds to enhance
its acceptability in the International Market will be taken up.
• Testing and certification facilities will be established in conformity with
international requirements.
9. Promotion of Domestic Seed Industry
• Incentives will be provided to the domestic seed industry to enable it to produce
seeds of high yielding varieties and hybrid seeds at a faster pace to meet the
challenges of domestic requirements.
• Seed Industry will be provided with a congenial and liberalized climate for
increasing seed production and marketing, both domestic and international.
• Membership to International Organisations and Seed Associations like International
Seed Testing Association (ISTA), Organisation for Economic Co-operation and
Development (OECD), The International Union for the Protection of New
Varieties of Plants (UPOV), International Association of Plant Breeders for the
Protection of Plant Varieties (ASSINSEL), World Intellectual Property
Organization (WIPO), at the National level or at the level of individual seed
producing agencies, will be encouraged.
• Emphasis will be given to improving the quality of seed produced and special efforts
will be directed towards improving the quality of farmers' saved seeds.
9. Promotion of Domestic Seed Industry
• Financial support for capital investment, working capital and infrastructure
strengthening will be facilitated through NABARD/ Commercial
Banks/Cooperative Banks.
• Tax rebate/concessions will be considered on the expenditure incurred on in-
house research and development of new varieties and other seed related research
aspects. In order to develop a competitive seed market, the States will be
encouraged to remove unnecessary local taxation on sales of seeds.
• To encourage seed production in non-traditional areas including backward
areas, special incentives such as transport subsidy will be provided to seed
producing agencies operating in these marginalised areas.
• Reduction of import duty will be considered on machines and equipment used
for seed production and processing which are otherwise not manufactured in
the country.
10. Strengthening of monitoring system
• The Department of Agriculture & Cooperation (DAC) will supervise the
overall implementation and monitoring of the National Seeds Policy.
• The physical infrastructure in terms of office automation,
communication facilities, etc., in DAC will be augmented in a time bound
manner.
• The technical capacity of DAC need to be augmented and strengthened to
undertake the additional work relating to implementation of National Seeds
Policy, implementation of PVP&FR Bill, Seeds Act, Import and Export
of Seeds, etc.
• Capacity building, including National and International training and
participation in Seminars/Workshops will be organized for concerned
officials.
Prevention Food Adulteration Act (1995)
Calcium carbide Ethylene

According to food safety officers, most green vegetables like peas, gourds and cucumbers are dipped in chemicals
such as copper sulphate which is crystalline blue in colour but gives the vegetables a fresh green look
Different Types of Food Adulteration
• Intentional: Sand, marble chips, stones, mud, other filth, talc, chalk
powder, water, mineral oil
• Incidental: Pesticide residues tin from can, droppings of rodents, larvae in
foods.
• Metallic contamination: Arsenic from pesticides, lead from water,
mercury from effluent, from chemical industries, tins from cans.
• Packaging Hazards: Polyethylene, polyvinyl chloride and allied
compounds are used to produce flexible packaging material.
Some other adulterants…
• Cream is adulterated with gelatin, and formaldehyde is employed as a
preservative for it.
• Butter is adulterated to an enormous extent with oleomargarine, a product
of beef fat.
• Brick dust in chilli powder, colored chalk powder in turmeric.
• In confectionery, dangerous colors, such as chrome yellow, prussian blue,
copper and arsenic compounds are employed.
• Pickles and canned vegetables are sometimes colored green with copper
salts.
Definitions Adulterated Food means:
(a) The food that is not of nature, quality or substance demanded by the purchaser.
(b) The food that contains a substance which effects injuriously the nature or quality of the food.
(c) Inferior or cheaper substance in place of authentic food affecting the quality of food.
(d) A food article which is wholly or in part abstracted affecting the quality of food.
(e) The food article obtained from diseased animal.
(f) The food article prepared, packed or kept under insanitary conditions.
(g) The food article which consist wholly or in part filthy, putrid, rotten, decomposed or diseased
animal or vegetable substance or is insect infested and unfit for human consumption.
(h) The food containing any colouring matter other than prescribed in the Act or if the amount of
this prescribed colouring matter is not within prescribing limits.
(i) A food article which contains prohibited preservative or permitted preservative in excess.
(j) A food article which falls below the prescribed standards.
(k) A food article which contains any poisonous or other ingredient rendering injurious effects to
human being.
Definitions Misbranded Food means:
(a) An imitation or a substitute resembling authentic food.
(b) An article which is falsely stated to be the product of any place or country.
(c) An article if sold by name which belongs to other article.
(d) An article wherein the damage is concealed by coating, polishing or other
operation.
(e) The article with false claims on label of the article.
(f) An article with false labeling in any manner i.e., in terms of content,
composition or even the owner.
(g) Any artificial flavoring, coloring or chemical preservation of an article without
declaration on the label.
• The Prevention of Food Adulteration Bill was passed by both the house of
Parliament and received the assent of the President on 29th September,
1954.
• It came into force on 1st June, 1955 as THE PREVENTION OF FOOD
ADULTERATION ACT, 1954 (37 of 1954).
In this Act unless the context otherwise requires,

i. "adulterant" means any material which is or could be employed for the
purposes of adulteration;
ii. "adulterated"—an article of food shall be deemed to be adulterated.
An Act to make provision for the prevention of adulteration of food.
Be it enacted by Parliament in the Fifth Year of the Republic of India as follows:
Short title, extent and commencement-
(1) This Act may be called the Prevention of Food Adulteration Act, 1954.
(2) It extends to the whole of India .
(3) It shall come into force on such date as the Central Government may, by
notification in the Official Gazette, appoint.

According to the act Food is said to be adulterated if…
• the article sold by a vendor is not of the nature, substance or quality
demanded by the purchaser; and is to his prejudice, or is not of the nature,
substance or quality which it purports or is represented to be.
• the article contains any other substance which affects the nature, substance or
quality;
• any inferior or cheaper substance has been substituted;
• the article had been prepared, packed or kept under insanitary conditions
whereby it has become contaminated or injurious to health;
• the article consists wholly or in part of any filthy, putrid, , rotten, decomposed
or diseased animal or vegetable substance or is insect-infested or is otherwise
unfit for human consumption;
• the article is obtained from a diseased animal;
According to the act Food is said to be adulterated if…
• the article contains any poisonous or other ingredient which renders it injurious
to health;
• the container of the article is composed of whether wholly or in part, of any
poisonous or deleterious substance which renders its contents injurious to health;
• any coloring matter other than that prescribed is present in the article;
• the article contains any prohibited preservative or permitted preservative in
excess of the prescribed limits;
• if the quality or purity of the article falls below the prescribed standard or its
constituents are present in quantities not within the prescribed limits of
variability, but which renders it injurious to health;
• if the quality or purity of the article falls below the prescribed standard or its
constituents are present in quantities not within the prescribed limits of
variability but which does not render it injurious to health:
Objective of Prevention Food Adulteration Act (1995)
• To make provision for the prevention of adulteration of food.
• preventing import, manufacture, sale or distribution of adulterated and
misbranded food
• To prevent all types of food adulterations
Administrative Bodies
1. Central Committee for food standards
2. Central Food Laboratory
3. Public Analyst
4. Food Inspector
1. Central Committee for food standards:
• It is constituted by the Central Government
• Functions: to advice Central or State Governments on all matters arising out
of administration of this Act and also for carrying out other functions.
• Chairman: The Director General of Medical and Health Services,
Government of India
• The total number of members of the Committee is not indicated.
• The Committee can frame by-laws, constitute committees and meet as and
when required.
2. Central Food Laboratories:
• Central Government has established four well equipped laboratories with
experienced personnel in food analysis at Kolkata, Ghaziabad, Mysore and Pune.
• Functions:
(i) analysis of samples sent by officers of Central Government
(ii) fixation of standards and quality control parameters for food articles; and
(iii) collaboration work with State laboratories for analysis and standardization.
• Many of the State Governments have their own laboratories for food analysis
manned by public analysts who work in collaboration with the Central
Laboratories.
• The Central Government prescribes procedure, fees to be paid for analysis,
proforma to be used, etc.
3. Public Analyst
• Central Government or State Government may appoint public analyst
• Different analysts for different articles can also be appointed:
• Public Analyst Qualifications:
➢ A person who holds degree in science with chemistry/ food technology/ food and
drugs/biochemistry or equivalent examination
➢ And not less than 5 years practical experience after graduation in analysis of food
articles or holds masters degree in chemistry/food technology/biochemistry/food
and drugs/microbiology
➢ or Associateship of Institution of Chemists (analysis of food) or any other
equivalent qualification with a minimum of 3 years practical experience after post
graduation in analysis of food.
➢ The person should have been declared qualified for appointment by the Board
appointed by Government.
3. Public Analyst
4. Food inspector
• appointed by the Central Government or State Government for Local Areas
identified
Qualification:
(a) A medical officer in charge of Health Administration of Local Area or
(b) A graduate in medicine with a minimum of one month training in inspection of
food sampling work in an institution approved by Central Government or State
Government or
(c) A graduate in science with chemistry/agriculture/pharmacy/ veterinary
science/food technology/dairy technology/public health/diploma holder in food
or dairy technology or equivalent qualification and a minimum of 3 months
satisfactory practical training in inspection of food and training approved by
Central Government or State Government.
4. Food inspector
Duties of Food Inspectors
1. To inspect establishment for license for manufacture, storage or sale of
food article and satisfy that the conditions and provisions of the Act are
complied with
2. To make enquiries on receipt of complaints about the quality of food and
conduct inspection accordingly
3. To procure the sample of food and send to public analyst as and when
required.
4. To investigate into matters of specific complaints given in writing.
5. To maintain the records of inspection properly and keep inform higher
authorities about inspection.
4. Food inspector
Powers of Food Inspectors
• The food inspector can prohibit sale of food article in public interest for a
specific period,
• can also stop the vehicles carrying adulterated or misbranded food
• seize the samples of food articles prepared in contravention with the
provisions of the Act,
• enter the premises within the reasonable time of business and seize the
sample or
• break open any package containing adulterated or misbranded food.
4. Food inspector
Powers of Food Inspectors
• The food inspector can prohibit sale of food article in public interest for a specific
period,
• can also stop the vehicles carrying adulterated or misbranded food
• seize the samples of food articles prepared in contravention with the provisions of
the Act,
• enter the premises within the reasonable time of business and seize the sample or
• break open any package containing adulterated or misbranded food.
Seizing of Sample
• For seizing the sample, a notice in writing has to be given to the owner.
• Three parts of the seized material are prepared in presence of witnesses, sealed, one
part is sent to public analyst and two parts to local authorities.
➢ Permitted Colours in Food
Chlorophyll, caramel, beta-carotene, annatto, coal-tar dyes, saffron and curcumin.
The colour content should not be more than 0.2 mg per kg of food material.
➢ Antioxidants Permitted in Food
Tocopherol, ascorbic acid, lecithin
➢ Preservatives Permitted in Food
❑ Class I: Common salt, sugar, dextrose, glucose, syrup, vinegar, honey and
edible vegetable oil.
❑ Class II: Benzoic acid and salts, sulphurous acids and salts, nitrates and
nitrites of sodium and potasium. Sorbic acid and salts, methyl diacetate,
sodium, potassium and calcium salts of lactic acid.
❑ Not more than one class II preservative is permitted.
❑ No nitrate or nitrite preservative to be added to infant food.
❑ The Food Inspector functioning beyond the scope of this Act is liable to the
penalty of Rs. Five hundred.
Explanation-Where two or more articles of primary food are mixed together and the resultant
article of food-
(a) is stored, sold or distributed under a name which denotes the ingredients thereof; and
(b) is not injurious to health, then, such resultant article shall not be deemed to be
adulterated within the meaning of this clause;
(ii) "Central Food Laboratory" means any laboratory or institute established or specified
under section 4;
(iii) "Committee" means the Central Committee for Food Standards constituted under section
3;
(iv) "Director of the Central Food Laboratory" means the person appointed by the Central
Government by notification in the Official Gazette as the Director of the Central Food
Laboratory and includes any person appointed by the Central Government in like manner to
perform all or any of the functions of the Director under this Act: Provided that no person
who has any financial interest in the manufacture, import or sale of any article of food shall
be appointed to be a Director under this clause
(v) "food" means any article used as food or drink for human consumption other than drugs
and water and includes—
(a) any article which ordinarily enters into, or is used in the composition or preparation of,
human food,
(b) any flavouring matter or condiments, and
(c) any other article which the Central Government may, having regard to its use, nature,
substance or quality, declare, by notification in the Official Gazette, as food for the
purposes of this Act;
(vi) "Food (Health) Authority" means the Director of Medical and Health Services or the
Chief Officer in-charge of Health administration in a State, by whatever designation he is
known, and includes any officer empowered by the Central Government or the State
Government, by notification in the Official Gazette, to exercise the powers and perform the
duties of the Food (Health) Authority under this Act with respect to such local area as may be
specified in the notification;
(vii) "local area" means any area, whether urban or rural, declared by the Central
Government or the State Government by notification in the Official Gazette, to be a local area
for the purposes of this Act;
(viii) "local authority" means in the case of :-
(1) a local area which is-
(a) a municipality, the municipal board or municipal corporation;
(b) a cantonment, the cantonment authority ;
(c) a notified area, the notified area committee;
(2) any other local area, such authority as may be prescribed by the Central Government or
the State Government under this Act;
(viiia) "Local (Health) Authority", in relation to a local area, means the officer appointed by
the Central Government or the State Government, by notification in the Official Gazette, to be
in-charge of Health administration in such area with such designation as may be specified
therein:
(viiib) "manufacture" includes any process incidental or ancillary to the manufacture of an
article of food;
(ix) "misbranded“-an article of food shall be deemed to be misbranded-
1. if it is an imitation of, or is a substitute for, or resembles in a manner likely to deceive,
another article of food under the name of which it is sold, and is not plainly and
conspicuously labelled so as to indicate its true character;
2. if it is falsely stated to be the product of any place or country;
3. if it is sold by a name which belongs to another article of food;
4. if it is so colored, flavored or coated, powdered or polished that the fact that the article is
damaged is concealed or if the article is made to appear better or of greater value than it
really is;
5. if false claims are made for it upon the label or otherwise;
6. if, when sold in packages which have been sealed or prepared by or at the instance of the
manufacturer or producer and which bear his name and address, the contents of each
package are not conspicuously and correctly stated on the outside thereof within the limits
of variability prescribed under this Act;
(ix) "misbranded“-an article of food shall be deemed to be misbranded-
7. if the package containing it, or the label on the package bears any statement, design or
device regarding the ingredients or the substances contained therein, which is false or
misleading in any material particular; or if the package is otherwise deceptive with respect
to its contents;
8. if the package containing it or the label on the package bears the name of a fictitious
individual or company as the manufacturer or producer of the article;
9. if it purports to be, or is represented as being, for special dietary uses, unless its label bears
such information as may be prescribed concerning its vitamin, mineral, or other dietary
properties in order sufficiently to inform its purchaser as to its value for such uses;
10. if it contains any artificial flavouring, artificial colouring or chemical preservative, without
a declaratory label stating that fact, or in contravention of the requirements of this Act or
rules made thereunder;
11. if it is not labelled in accordance with the requirements of this Act or rules made
thereunder
(x) "package" means a box, bottle, casket, tin, barrel, case, receptacle, sack, bag, wrapper or
other thing in which an article of food is placed or packed;
(xi) "premises" include any shop, stall, or place where any article of food is sold or
manufactured or stored for sale;
(xii) "prescribed" means prescribed by rules made under this Act;
(xiia) "primary food" means any article of food, being a produce of agriculture or horticulture
in its natural form;
(xiii) "sale" with its grammatical variations and cognate expressions, means the sale of any
article of food, whether for cash or on credit or by way of exchange and whether by wholesale
or retail, for human consumption or use, or for analysis, and includes an agreement for sale, an
offer for sale, the exposing for sale or having in possession for sale of any such article, and
includes also an attempt to sell any such article;
(xiv) "sample" means a sample of any article of food taken under the provisions of this Act or
of any rules made thereunder;
(xv) the word "unwholesome" and "noxious" when used in relation to an article of food
mean respectively that the article is harmful to health or repugnant to human use.
(i) Even mere addition of salt to chili powder makes it injurious to health as it was still
considered adulterated within the meaning of sub-clause (m) of clause (ia) of section 2 of the
Act on the ground that the quantity and purity of the article falls below the prescribed
standard ; Gauranga Aich v. State of Assam, 1990 (2) FAC 41.
(ii) Liquor (including country liquor) is an article used as a drink and is meant for human
consumption and for the purposes of the Prevention of Food Adulteration Act, 1954 is
included in the definition of "food" under clause (v) of section 2; State of Himachal Pradesh
v. Raja Ram, 1990 (2) FAC 231.
2A. Rule of construction —
Any reference in this Act to a law which is not in force in the State of Jammu and
Kashmir shall, in relation to that State, be construed as a reference to the corresponding law,
if any, in force in that State.

The Prevention of Food Adulteration Bill was passed by both the house of
Parliament and received the assent of the President on 29th September, 1954. It
came into force on Ist June, 1955 as THE PREVENTION OF FOOD
ADULTERATION ACT, 1954 (37 of 1954).
LIST OF ADAPTATION ORDER AND AMENDING ACTs

1. The Adaptation of Laws (No.3) Order, 1956.
2. The Prevention of Food Adulteration (Amendment) Act, 1964 (49 of 1964).
The Food Safety and Standards Bill (2005)
Laws on Food & Allied Items
1) Vegetable Oil Products (Control)
Order, 1947,
2) Prevention of Food Adulteration
Act, 1954 ,
3) Fruit Products Order , 1955, 4)
Solvent Extracted Oil, De- Oiled
Meal and Edible Flour (Control)
Order, 1967,
4) Meat Food Products Order , 1973,
5) Edible Oils Packaging (Regulation)
Order 1988,
6) Milk and Milk Products Order,
1992 ………repealed after
commencement of FSS Act, 2006.
Highlights of the bill
• The Food Safety and Standards Bill, 2005 consolidates eight laws governing the
food sector and establishes the Food Safety and Standards Authority (FSSA) to
regulate the sector.
• FSSA will be aided by several scientific panels and a central advisory committee
to lay down standards for food safety. These standards will include specifications
for ingredients, contaminants, pesticide residue, biological hazards and labels.
• The law will be enforced through State Commissioners of Food Safety and local
level officials.
• Everyone in the food sector is required to get a license or a registration which
would be issued by local authorities.
• Every distributor is required to be able to identify any food article to its
manufacturer, and every seller to its distributor. Anyone in the sector should be
able to initiate recall procedures if he finds that the food sold had violated
specified standards.
Key issues and analysis
• The organized as well as the unorganized food sectors are required to follow the
same food law. The unorganized sector, such as street vendors, might have
difficulty in adhering to the law, for example, with regard to specifications on
ingredients, traceability and recall procedures.
• The Bill does not require any specific standards for potable water (which is usually
provided by local authorities). It is the responsibility of the person preparing or
manufacturing food to ensure that he uses water of adequate quality even when tap
water does not meet the required safety standards.
• The Bill excludes plants prior to harvesting and animal feed from its purview. Thus,
it does not control the entry of pesticides and antibiotics into the food at its source.
• The power to suspend the license of any food operator is given to a local level
officer. This offers scope for harassment and corruption.
• It appears that state governments will have to bear the cost of implementing the
new law. However, the financial memorandum does not estimate these costs.
Objectives of the Bill
The main objectives of the Bill are:
(a) to introduce a single statute relating to food, and
(b) to provide for scientific development of the food processing industry. The Bill aims
to establish a single reference point for all matters relating to food safety and
standards, by moving from multi-level, multi-departmental control to a single line
of command. It incorporates the salient provisions of the Prevention of Food
Adulteration Act 1954 and is based on international legislations, instrumentalities
and Codex Alimentarius Commission
(c) An Act to consolidate the laws relating to food and
(d) to establish the Food Safety and Standards Authority of India for laying down
science based standards for articles of food and to regulate their manufacture,
storage, distribution, sale and import, to ensure availability of safe and wholesome
food for human consumption and for matters connected therewith or incidental
thereto. August 24, 2006 came into effect.
Some important terms
• Adulterant (Section 3(a))-can cause food unsafe/sub-standard/mis-branded
• Contaminant (Section 3(g))-present in food as a result of the production,
manufacture, processing, preparation, treatment, packing, transport.
• Food (Section 3(j))-extensively defined
• Food Additive (Section 3(k))-typical ingredients of the food
• Food Business (Section 3 (n))-for profit or not
• Food Business Operator (Section 3(o))-umbrella term
• Food Safety (Section 3(q))..accepted for human consumption
• Sub Standard (Section 3 (zx))-does not meet specified standard
• Unsafe Food (Section 3 (zz))-injurious to health
Section 4 :- Establishment of FSSAI
• Central Govt. will establish Food
Safety & Standards Authority of
India.
• Head Office at New Delhi.
• Food Authority may establish its
offices at any other places in India.
• A Chairperson, 22 members out of
which one third shall be women
(Section 5).
• Term for 3 years, eligible for re-
appointment (Section 7)
• CEO will see day to day activities of
• Food Safety and Standards Authority of India (FSSAI) is a statutory body
established under the Ministry of Health & Family Welfare, Government
of India. The FSSAI has been established under the Food Safety and
Standards Act, 2006, which is a consolidating statute related to food
safety and regulation in India. FSSAI is responsible for protecting and
promoting public health through the regulation and supervision of food
safety.
• The FSSAI has its headquarters at New Delhi. The authority also has 6
regional offices located in Delhi, Guwahati, Mumbai, Kolkata, Cochin,
and Chennai. 14 referral laboratories notified by FSSAI, 72 State/UT
laboratories located throughout India and 112 laboratories are NABL
accredited private laboratories notified by FSSAI.
• The following are the statutory powers that the FSS Act, 2006 gives to the
Food Safety and Standards Authority of India (FSSAI).
1. Framing of regulations to lay down food safety standards
2. Laying down guidelines for accreditation of laboratories for food testing
3. Providing scientific advice and technical support to the Central
Government
4. Contributing to the development of international technical standards in
food
5. Collecting and collating data regarding food consumption, contamination,
emerging risks, etc.
6. Disseminating information and promoting awareness about food safety and
nutrition in India.
• The FSSAI functions under the administrative control of the Ministry of
Health and Family Welfare. The main aim of FSSAI is to
1. Lay down science-based standards for articles on food
2. To regulate the manufacture, storage, distribution, import, and sale of food
3. To facilitate the safety of food
The FSS Act is a bucket for all the older laws, rules and regulations for food
safety. The FSS Act took 7 older acts into one umbrella.
• Prevention of Food Adulteration Act, 1954
• Fruit Products Order, 1955
• Meat Food Products Order, 1973
• Vegetable Oil Products (Control) Order, 1947
• Edible Oils Packaging (Regulation) Order 1988
• Solvent Extracted Oil, De- Oiled Meal and Edible Flour (Control) Order, 1967
• Milk and Milk Products Order, 1992
• The FSSAI would consist of a
Chairperson and 18 members. The
Chairperson would be either an eminent
food scientist or a civil servant not below
the rank of Secretary.
• Seven of the members would be ex-officio, not below the post of Joint
Secretary, from various ministries.
• Five members would be appointed by rotation every three years from the
states and Union Territories.
• The Authority would have two representatives each from the food
industry and consumer organizations, one food technologist, and one
member from a farmers' organization.
Section 16 :- Functions of Food Authority
• Food Authority to regulate and monitor the
manufacture, processing, distribution, sale
and import of food so as to ensure safe and
wholesome food.
• It will provide scientific advice and
technical support to the Central
Government and the State Governments in
matters of framing the policy and rules in
areas which have a direct or indirect
bearing on food safety and nutrition; Other
works as mentioned in the act.
Section 24 :- Restrictions of advt. & prohibition as to unfair trade
practice.
• No advertisement shall be made of any food which is misleading or
deceiving or contravenes the provisions of this Act, the rules and
regulations made thereunder.
• No person shall engage himself in any unfair trade practice for
purpose of promoting the sale, supply, use and consumption of articles
of food or adopt any unfair or deceptive practice including the practice
of making any statement, whether orally or in writing or by visible
representation.
• Provided that where a defense is raised to the effect that such guarantee
is based on adequate or scientific justification, the burden of proof of
such defense shall lie on the person raising such defense.
Section 26 :- Responsibilities of the Food Business Operator
Every food business operator shall ensure that the articles of food satisfy
the requirements of this Act and the rules and regulations made
thereunder at all stages of production, processing, import, distribution
and sale within the businesses under his control.
Section 27 :- Liability of manufacturer, packers, wholesalers,
distributors and sellers
Liabilities are mentioned separately for Manufacturer & Packers
Wholesalers, distributors Sellers.
Section 29 :- Authorities responsible for
enforcement of Act
The Food Authority and the State Food Safety
Authorities shall be responsible for the
enforcement of this Act.
They shall monitor and verify that the relevant
requirements of law are fulfilled by food
business operators at all stages of food
business.
Section 30:- Commissioner of the Food Safety
State Govt. shall appoint the commissioner of
Food Safety for the state for efficient
implementation of food safety and standards.
Section 31:- Licensing & Regi. Of food business
➢ No food business except under a license.
➢ Not applicable to *petty manufacturer but they will register themselves as
prescribed.
➢ If license is not issued in 2 months or application is not rejected, the applicant
may start his food business.
*Petty manufacturer means any food manufacturer, who
(a) manufactures or sells any article of food himself or a petty retailer, hawker, itinerant vendor or
temporary stall holder; or distributes foods including in any religious or social gathering except a caterer;
or
(b) such other food businesses including small scale or cottage or such other industries relating to food
business or tiny food businesses with an annual turnover not exceeding Rs 12 lakhs and/or whose
(i) production capacity of food (other than milk and milk products and meat and meat products) does not
exceed 100 kg / ltr per day or
(ii) procurement or handling and collection of milk is up to 500 litres of milk per day or
(iii) slaughtering capacity is 2 large animals or 10 small animals or 50 poultry birds per day or less.
Licensing Regulation 2011
Section 35:- Notification of food poisoning
The Food Authority may, by notification, require registered medical practitioners
carrying on their profession in any local area specified in the notification,
to report all occurrences of food poisoning coming to their notice to such officer as
may be specified.
Section 36:- Designated Officer
The Commissioner of Food Safety shall appoint Designated Officer for each
district. Functions
• It will issue or cancel license of food business operators.
• It will prohibit the sale of any article of food which is in contravention of the
provisions of this act.
• To make recommendation to the Commissioner of Food Safety for sanction to
launch prosecution in case of contraventions punishable with imprisonment.
• To maintain record of all inspections made by Food Safety Officers and
actions taken by them in the performance of their duty.
Section 37:- Food Safety Officer
The Commissioner of Food
Safety shall appoint Food Safety
Officers The State Govt. may
authorize any officer of the state
govt. to perform the functions of a
Food Safety Officer.
Powers (Section 38)
• Take sample of any food, seize
any article of food, enter in
premises of food operators and
inspect.
• FSO will follow the guidelines
issued by Commissioner of
Food Safety from time to time.
Section 39:- Liability of Food Safety Officer in certain cases
Any Food Safety Officer exercising powers under this Act or the rules and
regulations made thereunder who –
(a) vexatiously and without any reasonable ground seizes any article of food
or adulterant; or
(b) commits any other act to the injury of any person without having reason to
believe that such act is necessary for the execution of his duty and shall be
liable to a penalty which may extend to 1 lakh rupees:
(c) Any false complaint is made against a Food Safety Officer, the
complainant shall be punishable with fine which shall not be less than fifty
thousand rupees but may extend to 1 lakh rupees.
Section 40:- Purchaser may have food analyzed.
• Purchaser also can get food analyzed by food analyst on payment of
prescribed fees.
❖ Provided that such purchaser inform Food Business Operator at time of
purchase of his intention to have such article so analyzed.
• If food analyst found that food is not in compliance with the Act or rules or
regulations, the purchaser shall be entitled to get refund of the fees paid.
• Food Analyst find the sample in contravention of provisions of this act and
rules and regulations, the food analyst shall forward the report to the
Designated Officer for prosecution under Section 42.
Section 42:- Procedure for launching prosecution
• Food Safety Officer shall be responsible for
inspection of food business, drawing samples and
sending them to Food Analyst for analysis.
• Food Analyst will send report to Designated Officer
with a copy to Commissioner of Food Safety within
14 days.
• Designated Officer will decide the case after
analyzing the report with the consultation with
Commissioner of Food Safety.
Section 51:- Penalty for sub-standard food
Any person who whether by himself or by any other person on his behalf
manufactures for sale or stores or sells or distributes or imports any article of
food for human consumption which is sub-standard, shall be liable to a penalty
which may extend to 5 lakh rupees.
Section 53:- Penalty for misleading advertisement
Any person who publishes, or is a party to the
publication of an advertisement, which –
(a) falsely describes any food; or
(b) is likely to mislead as to the nature or substance or quality of any food or gives
false guarantee, shall be liable to a penalty which may extend to 10 lakh rupees.
Section 56:- Penalty for unhygienic or unsanitary processing or mfg. of food

Any person who, whether by himself or by any other person on his behalf,
manufactures or processes any article of food for human consumption under
unhygienic or unsanitary conditions, shall be liable to a penalty which may
extend to 1 lakh rupees.
Section 57:- Penalty for possessing adulterant
(1) Subject to the provisions of this chapter, if any person who whether by
himself or by any other person on his behalf, imports or manufactures for sale,
or stores, sells or distribute any adulterant shall be liable –
(i) where such adulterant is not injurious to health, to a penalty not exceeding 2
lakh rupees;
(ii) where such adulterant is injurious to health, to a penalty not exceeding 10
lakh rupees.
(2) In a proceeding under sub-section(1), it shall not be a defense that the accused
was holding such adulterant on behalf of any other person.
Section 59:- Punishment for unsafe food
➢ Does not result in injury:
❑ imprisonment upto 6 months & fine upto 1 lakh rupees.
➢ Non-grievous injury:
❑ imprisonment 1 year & fine upto 3 lakh rupees.
➢ Grievous injury:
❑ imprisonment 6 years & fine upto 5 lakh rupees.
➢ Death:
❑ not less than 7 years imprisonment may extend for life and fine not less
than 10 lakh rupees.
Section 64:- Punishment for subsequent offences
If any person, after having been previously convicted of an offence punishable
under this Act subsequently commits and is convicted of the same offence, he shall
be liable to-
(i) twice the punishment, which might have been imposed on a first conviction,
subject to the punishment being maximum provided for the same offence;
(ii) a further fine on daily basis which may extend up to 1 lakh rupees, where the
offence is a continuing one; and
(iii) his license shall be cancelled.

Section 74:- Special Courts & Public
Prosecutor.
Special Courts can be established for certain
cases and public prosecutor and additional
public prosecutors can be appointed
Section 75:- Power to transfer cases to regular
courts
Special Court will transfer the cases if it is of
the opinion that the offence is not triable by it.
Section 76:- Appeal
Appeal can be filed against the order of Special
Court to High Court within 45 days from the
date on which the order was served. Appeal shall
be disposed by the High Court by a bench of
not less than 2 judges.
Recent scenarios/ Cases/ News
• FSSAI allows up to 5% vegetable fats in chocolates Economics Times, May
25, 2017
• Milk adulteration more in North India: FSSAI Economics Times, April 17,
2017
• FSSAI to bring new regulations for organic foods Ecobnomics Times,
February 9, 2017
• FSSAI wants edible oil manufacturers to make small packs for rural India
Economics Times, April 18, 2017
• FSSAI ties up with US firm Decernis Ltd to get access to global standards.
Economics Times, April 12, 2017
• FSSAI ties up with Coca-Cola to train 50,000 food vendors. Economics Times,
March 27, 2017
• FSSAI bans 'Carcinogenic' additive potassium bromate in bread. Economics
Times, June 21, 2016
Recent scenarios/ Cases/ News
Regulation for the import of GM products Under Foreign trade policy
(2006-2007)
The new Foreign Trade Policy of the Union Government was unveiled by the
commerce Minister Shri. Kamal Nath on August 31, 2004. With foreign trade
largely freed and import duties falling progressively, the policy have necessarily
restricted itself to a facilitating role rather. This policy stated, “Trade is not an end
in itself , but a means to economic growth.
Objectives:
1. To double India’s percentage share of global merchandise trade by 2009.
2. To act as an effective instrument of economic growth by giving a thrust to
employment generation.
(2006-2007)
STRATEGY
These objectives are proposed to be achieved by adopting, among others, the
following strategies:
1. Unshackling of controls and creating an atmosphere of trust and transparency to
unleash the innate entrepreneurship of our businessmen, industrialists and traders.
2. Simplifying procedures and bringing down transaction costs.
3. Neutralizing incidence of all levies and duties on inputs used in export products,
based on the fundamental principle that duties and levies should not be exported.
4. Facilitating development of India as a global hub for manufacturing, trading
and services.
5. Identifying and nurturing special focus areas which would generate additional
employment opportunities, particularly in semi-urban and rural areas, and
developing a series of 'Initiatives' for each of these.
(2006-2007)
STRATEGY
(vi) Facilitating technological and infrastructural upgradation of all the sectors of the
Indian economy, especially through import of capital goods and equipment, thereby
increasing value addition and productivity, while attaining internationally accepted
standards of quality.
(vii) Avoiding inverted duty structures and ensuring that our domestic sectors are not
disadvantaged in the Free Trade Agreements/Regional Trade Agreements/Preferential
Trade Agreements that we enter into in order to enhance our exports.
(viii) Upgrading our infrastructural network, both physical and virtual, related to the entire
Foreign Trade chain, to international standards.
(ix) Revitalizing the Board of Trade by redefining its role, giving it due recognition and
inducting experts on Trade Policy.
(x) Activating our Embassies as key players in our export strategy and linking our
Commercial Wings abroad through an electronic platform for real time trade intelligence and
(2006-2007)
STRATEGY
(vi) Facilitating technological and infrastructural upgradation of all the sectors of the
Indian economy, especially through import of capital goods and equipment, thereby
increasing value addition and productivity, while attaining internationally accepted
standards of quality.
(vii) Avoiding inverted duty structures and ensuring that our domestic sectors are not
disadvantaged in the Free Trade Agreements/Regional Trade Agreements/Preferential
Trade Agreements that we enter into in order to enhance our exports.
(viii) Upgrading our infrastructural network, both physical and virtual, related to the entire
Foreign Trade chain, to international standards.
(ix) Revitalising the Board of Trade by redefining its role, giving it due recognition and
inducting experts on Trade Policy.
(x) Activating our Embassies as key players in our export strategy and linking our
Commercial Wings abroad through an electronic platform for real time trade intelligence and
(2006-2007)
Import on GM products
Import of plants or planting material is defined as an act of bringing into the
country any kind of seed, plant or other planting material from a place outside India
either by sea, land, air or across any customs frontiers. Similarly, export of plants or
planting material is the act of taking out of the country any kind of seed, plant or other
planting material outside India either by sea, land, air or across any customs frontiers.
The import and export of genetically modified organisms (GMOs)/ living modified
organisms (LMOs) (hereinafter referred to as GMOs) and their products is regulated
under the Environment Protection Act (1986), The Destructive Insects and Pests Act,
1949, and the Foreign Trade (Development & Regulation) Act, 1992 No. 22 of 1992.
Under these Acts import and export of GMOs will be allowed only with the approval
of Genetic Engineering Approval (now Appraisal) Committee.
Regulation for the import of GM products Under Foreign trade policy (2006-2007)
Import on GM products (According to The Environment Protection Act (1986))
Rules for the manufacture, use/import/export and storage of hazardous
microorganisms/ genetically engineered organisms or cells (1989)
• No person shall import, export, transport, manufacture, process, use or sell any
hazardous microorganisms or genetically engineered organisms/substances or
cells except with the approval of the Genetic Engineering Approval Committee.
• Use of pathogenic microorganism or any genetically engineered organisms or cell
for the purpose of research shall only be allowed in laboratories or inside laboratory
areas notified by the Ministry of Environment and Forests for this purpose under
the Environment (Protection) Act, 1986.
• The Genetic Engineering Approval Committee shall give directions to the
occupier to determine or take measures concerning the discharge of micro-
organisms/genetically engineered organisms or cells mentioned in the schedule
from the laboratories, hospitals and other areas including prohibition of such
discharges and laying down measures to be taken to prevent such discharges.
Import on GM products (According to The Environment Protection Act
(1986))
Rules for the manufacture, use/import/export and storage of hazardous
microorganisms/ genetically engineered organisms or cells (1989)
• Any person operating or using genetically engineered organisms/
microorganisms mentioned in the schedule for scale up or pilot operations
shall have to obtain license issued by the Genetic Engineering Approval
Committee for any such activity. The possessor shall have to apply for
license in prescribed proforma.
• Substances and products, which contain genetically engineered
organisms or cells or microorganisms shall not be produced, sold,
imported or used except with the approval of Genetic Engineering
Approval Committee.
Import on GM products ( According to The Foreign Trade (Development &
Regulation) Act, 1992 No.22 of 1992)
It is an Act to provide for the development and regulation of foreign trade
by facilitating imports into, and augmenting exports from India and for
matters connected therewith or Incidental thereto.
Section 18 of the Rules under this Act deals with the Import of Genetically
Modified Food, Feed, Genetically Modified Organism (GMOs) and
Living Modified Organisms (LMOs) subject to the following conditions:
• The import of GMOs/LMOs for the purpose of (i) R&D; (ii) Food; (iii)
Feed; (iv) Processing in Bulk and (v) For Environment release will be
governed by the provisions of the Environment Protection Act, 1986
and Rules 1989.
Import on GM products ( According to The Foreign Trade (Development &
• The import of any Food, Feed, raw or processed or any ingredient of
food, food additives or any food product that contains GM material
and is being used either for Industrial production, Environmental
release, or field application will be allowed only with the approval of the
Genetic Engineering Approval Committee (GEAC).
• Institutes/Companies who wish to import Genetically Modified material
for R&D purposes will submit their proposal to the Review Committee
for Genetic Modification (RCGM) under the Department of
Biotechnology. In case the Companies/Institutes use these Genetically
Modified material for commercial purposes, approval of GEAC is also
required.
Import on GM products (According to The Foreign Trade (Development &
• At the time of import all consignments containing products which
have been subjected to Genetic Modification will carry a declaration
stating that the product is Genetically Modified. In case a
consignment does not carry such a declaration and is later found to
contain Genetically Modified material, the importer is liable to penal
action under the Foreign Trade (Development and Regulation) Act,
1992.
Import on GM products (The Destructive Insects and Pests Act, 1914)
Enacted to make provision for preventing the introduction into India of any
insect, fungus or other pest, which is or may be destructive to crops.
Plant Quarantine (Regulation of import into India) Order, 2003 Permits
required for import of Germplasm, Transgenic or Genetically Modified.
Organisms
• No consignment of germplasm/transgenics/Genetically Modified
Organisms (GMOs) shall be imported into India for research/ experimental
purpose without valid permit issued by the Director, National Bureau of
Plant Genetic Resources, New Delhi -110012.
• No imported consignments of plant germplasm/ transgenics/ genetically
modified pests shall be opened at the point of entry and it shall be
forwarded to the Director, National Bureau of Plant Genetic Resources,
New Delhi.
Import on GM products (The Destructive Insects and Pests Act, 1914)
• Every application for import of plant germplasm/ transgenics/
genetically modified organisms for research/experimental purpose by
the public/private organizations will be made to the Director, National
Bureau of Plant Genetic Resources, New Delhi in form PQ 08 and the
permit shall be issued in form PQ 09 in triplicate and a red/ green tag
in PQ 10 for germplasm and a red/white tag in PQ 11 for
transgenic/Genetically Modified Organisms.
• Such permits for import of transgenic/Genetically Modified
Organisms shall be issued subject to the approval of Review
Committee on Genetic Manipulation (RCGM) setup by Department
of Biotechnology.
Import Procedure
• Import of GM plants and planting material has so far remained confined
to that meant for research or experimentation.
• The Plant Quarantine Order (2003) under the Destructive Insects and Pests
Act, 1914 prohibits or restricts the import of some plants species or plants
from some countries, irrespective of GMO or non-GMO.
• This order also regulates the import of GM plants for the purpose of
research or experimentation. Such an import requires a permit to be issued
by the Director, National Bureau of Plant Genetic Resources, New Delhi
(NBPGR) of the Indian Council of Agricultural Research. The permit is
issued subject to the issue of Import Clearance by the Review Committee
on Genetic Manipulation (RCGM) of the Department of Biotechnology,
Government of India (DBT).
Import Procedure
• Importer who wishes to import a GM plant or planting material for
research or experimental purposes must have in place, (i) Institute
Biosafety Committee (IBSC), and (ii) post-entry quarantine facility
certified by DBT.
• The importer submits the proposal for import to RCGM through the IBSC.
• RCGM assesses the import application and examines the desirability of
import from biosafety point of view. When satisfied, RCGM issues Permit
letter valid for one year.
• Importer applies to NBPGR along with RCGM Permit letter for issue of
Import Permit.
• The exporter sends the consignment addressed to Director, NBPGR
enclosing a copy of the Import Permit along with the documents as above.
The port of entry is Delhi airport only.
Import Procedure
• NBPGR assesses the application also taking note of RCGM Permit letter
and requirements laid out comprising the type of permit and instructions for
use, conditions of issuance, and handling and packaging instructions.
NBPGR issues the Import Permit sending copies to the importer and the
exporter along with instructions for other documentation needed for import
(Phytosanitary Certificate, Supplier Declaration that the GM material
does not contain any embryogenesis deactivator gene sequence).
• Since the material is meant for research purposes, only a small quantity of
seed/planting material sufficient enough to establish the plant is
considered optimum and permitted for import. The quantity is specified by
DBT in its Permit letter
• At the airport customs, the consignment without opening is examined for
the required documentation.
Import Procedure
• NBPGR verifies the contents and the accompanying documents (Import
permit, Phytosanitary Certificate, Supplier Declaration that the GM
material does not contain any embryogenesis deactivator gene sequence).
• At NBPGR, the material is tested for the absence of diseases, pests and
other undesirable material and also for absence of embryogenesis
deactivator gene sequence. The material is also tested for the presence of
the declared transgene.
• The material is released to the importer under the condition that it would
be grown in the post-entry quarantine facility certified by DBT and under
prescribed supervision.
• The importer informs NBPGR within one month of sowing. NBPGR carries
out field examination and required laboratory tests for absence of
quarantine pests and diseases.
Import Procedure
• The material is released for experimentation if free of quarantine pests
and diseases. Otherwise, it is destroyed in presence of Plant Quarantine
Officer.
• The persons who shall be required to take the approval of the National
Biodiversity Authority under sub section (1) are the following, namely: (a) a
person who is not a citizen of India; (b) a citizen of India, who is a non
resident as defined in clause (30) of section 2 of the Income tax Act, 1961;
(c) a body corporate, association or organization-
(i) not incorporated or registered in India; or
(ii) incorporated or registered in India under any law for the time being in
force which has any non-Indian participation in its share capital or
management.
National environmental policy (2006)
WHAT IS ENVIRONMENTAL SAFETY AND WHY IS IT REQUIRED?
Environmental safety has become a high priority issue around the world.
Ensuring the safety of an environment is key to productivity and function in a work
or research setting.
Environmental safety is the practice of policies and procedures that ensure that a
surrounding environment, including work areas, laboratories or facilities, is free of
dangers that could cause harm to a person working in those areas. The need of
environmental safety brings into the picture the need of “ENVIRONMENTAL
PLANNING”.
WHAT IS ENVIRONMENTAL PLANNING?
It is the process of facilitating the decision making to carryout the land development
with the emphasis given on natural environment, social, political, economic and
governance factors, so as to provide a holistic framework to achieve sustainable
outcome.
WHAT IS ENVIRONMENTAL SAFETY AND WHY IS IT REQUIRED?
Environmental safety has become a high priority issue around the world.
Ensuring the safety of an environment is key to productivity and function in a
work or research setting.
Environmental safety is the practice of policies and procedures that ensure that a
surrounding environment, including work areas, laboratories or facilities, is
free of dangers that could cause harm to a person working in those areas. The
need of environmental safety brings into the picture the need of
“ENVIRONMENTAL PLANNING”.
WHAT IS ENVIRONMENTAL PLANNING?
It is the process of facilitating the decision making to carryout the land
development with the emphasis given on natural environment, social, political,
economic and governance factors, so as to provide a holistic framework to
achieve sustainable outcome.
Earlier Policies on Environment
The National Environment Policy (NEP), 2006 was
an effort towards India’s commitment to clean
environment and making positive contribution to
international efforts. The NEP builds on the various
earlier policies which had addressed the challenges of
environment and need of sustainable development
prior to this policy. Some of them were:
• National Forest Policy, 1988
• National Conservation Strategy and Policy
Statement on Environment and Development, 1992
• Policy Statement on Abatement of Pollution,1992
• National Agriculture Policy, 2000
• National Population Policy, 2000
• National Water Policy, 2002
INTRODUCTION TO NATIONAL ENVIRONMENTAL
POLICY,2006
• The NATIONAL ENVIRONMENTAL POLICY was first
formulated in 2006, by Government of India, Ministry of
Environment and Forest.
• The National Environment Policy seeks to extend the coverage, and fill in
gaps that still exist, in light of present knowledge and accumulated
experience. It does not displace, but builds on the earlier policies.
• The dominant theme of this policy is that while conservation of
environmental resources is necessary to secure livelihoods and well being of
all the most secure basis of conservation is to ensure that people depend on
particular resources to obtain better livelihoods from the fact of conservation
rather than the degradation of the resources.
INTRODUCTION TO NATIONAL ENVIRONMENTAL POLICY,2006
• The dominant theme of this policy is that while conservation of
environmental resources is necessary to secure livelihoods and well-being of
all, the most secure basis for conservation is to ensure that people dependent
on particular resources obtain better livelihoods from the fact of conservation,
than from degradation of the resource
• The policy also seeks to stimulate partnerships of different stakeholders, i.e.
public agencies, local communities, academic and scientific institutions, the
investment community, and international development partners, in
harnessing their respective resources and strengths for environmental
management
• Involvement of Panchayati Raj Institutions and urban local bodies has been
highlighted.
INTRODUCTION TO NATIONAL ENVIRONMENTAL POLICY,2006
• It also seeks to revisit the Coastal Regulation Zone notifications to make the
approach to coastal environmental regulation more holistic and, thereby, ensure
protection to coastal ecological systems, waters and the vulnerability of some
coastal areas to extreme natural events and potential sea level rise.
• Environmental Impact Assessment will continue to be the principal
methodology for appraisal and review of new projects.
• To achieve sustainable development, environmental protection shall
constitute an integral part of the development process and cannot be
considered in isolation from it
Objectives of National Environment Policy, 2006
• CONSERVATION OF CRITICAL ENVIRONMENTAL RESOURCES: To
protect and conserve critical ecological systems and resources, and invaluable
natural and man-made heritage, which are essential for life support,
livelihoods, economic growth, and a broad conception of human well-being.
• INTRA-GENERATIONAL EQUITY: LIVELIHOOD SECURITY FOR
THE POOR: To ensure equitable access to environmental resources and
quality for all sections of society, and in particular, to ensure that poor
communities, which are most dependent on environmental resources for their
livelihoods, are assured secure access to these resources.
• INTER-GENERATIONAL EQUITY: To ensure judicious use of
environmental resources to meet the needs and aspirations of the present and
future generations.
• INTEGRATION OF ENVIRONMENTAL CONCERNS IN ECONOMIC

AND SOCIAL DEVELOPMENT: To integrate environmental concerns
into policies, plans, programs, and projects for economic and social
development.
• EFFICIENCY IN ENVIRONMENTAL RESOURCE USE: To ensure
efficient use of environmental resources in the sense of reduction in their use
per unit of economic output, to minimize adverse environmental impacts.
• ENVIRONMENTAL GOVERNANCE: To apply the principles of good
governance (transparency, rationality, accountability, reduction in time
and costs, participation, and regulatory independence) to the management
and regulation of use of environmental resources.
• ENHANCEMENT OF RESOURCES FOR ENVIRONMENTAL
CONSERVATION: To ensure higher resource flows, comprising finance,
technology, management skills, traditional knowledge, and social capital,
for environmental conservation through mutually beneficial multi-
stakeholder partnerships between local communities, public agencies, the
academic and research community, investors, and multilateral and
bilateral development partners.
PRINCIPLES OF NATIONAL ENVIRONMENTAL POLICY,2006
1. Human Beings are at the Centre of Sustainable Development Concerns
2. The Right to Development-
3. Environmental Protection is an Integral part of the Development Process
4. The Precautionary Approach
5. Economic Efficiency- Polluters pay and Cost minimization
6. Entitles with incomparable value
7. Equity
8. Legal liability
9. Public trust Doctrine
10. Decentralization
11. Integration
12. Environmental standard setting
13. Perspective action
14. Environmental offsetting
STRATEGIES AND ACTION OF NATIONAL ENVIRONMENTAL POLICY,2006
1. Human Beings are at the Centre of Sustainable Development Concerns
2. The Right to Development- Equitably meet developmental and environmental
needs of present and future generations
3. Environmental Protection is an Integral part of the Development Process- In
order to achieve sustainable development, environmental protection
4. The Precautionary Approach
5. Economic Efficiency- Polluters pay : Impacts of acts of production and
consumption of one party may be visited on third parties who do not have a
direct economic nexus with the original act. Such impacts are termed
“externalities” Cost minimization: Efficiency of resource use may also be
accomplished by the use of policy instruments that create incentives to
minimize wasteful use and consumption of natural resources
6. Entities with “Incomparable” Values: The Environmentally Sensitive Zones
are the areas with identified environmental resources having “Incomparable
Values” which require special attention for their conservation. In order to
conserve and enhance these resources, without impeding legitimate socio-
economic development of these areas, the National Environment policy aims
to identify and give legal status to Environmentally Sensitive Zones in the
country having environmental entities with “Incomparable values” requiring
special conservation efforts. The policy also envisages formulating area
development plans for these zones on a scientific basis, with adequate
participation by the local communities.
7. Equity: Equity, in the context of this policy refers to both equity in
entitlements to, and participation of, the relevant publics, in processes of
decision-making over use of environmental resources.
8. Legal Liability
The environmental redressal mechanism based on doctrines of criminal liability,
have not proved sufficiently effective, and need to be supplemented. The policy
adopts the civil liability for environmental damage that would deter
environmentally harmful actions, and compensate the victims of environmental
damage.
The alternatives to Civil Liability may also apply viz. Fault Based liability and
Strict Liability.
• In Fault Based Liability a party is held liable if it breaches a preexisting legal
duty, for example, an environmental standard.
• Strict liability imposes an obligation to compensate the victim for harm
resulting from actions or failure to take action, which may not necessarily
constitute a breach of any law or duty of care.
9. Public Trust Doctrine
As per this doctrine, the State is not an absolute owner, but a trustee of all natural
resources, which are by nature meant for public use and enjoyment, subject to
reasonable conditions, necessary to protect the legitimate interest of a large
number of people, or for matters of strategic national interest.
10. Decentralization Legislative Reforms
A judicious mix of civil and criminal processes and sanctions will be employed in
the legal regime for enforcement, through a review of the existing legislation. The
policy calls for identification of the emerging areas for new legislation, due to
better scientific understanding, economic and social development, and
development of multilateral environmental regimes, in line with the National
Environment Policy. It also calls for review the body of existing legislation in
order to develop synergies among relevant statutes and regulations.
11. Environment Impact Assessment
The policy focuses on encouraging the regulatory authorities, Central and State,
to institutionalize regional and cumulative environmental impact assessments
(R/CEIAs) to ensure that environmental concerns are identified and addressed at
the planning stage itself.
• Environmental Impact Assessment (EIA) will continue to be the principal
methodology for appraising and reviewing new projects.
• The assessment processes are under major revision in line with the
Govindarajan Committee recommendations.
• Under the new arrangements, there would be significant devolution of powers
to the State/UT level.
• However, such devolution, to be effective, needs to be accompanied by
adequate development of human and institutional capacities
12. Coastal Regulation Zone (CRZ) notifications to make the approach to coastal
environmental regulation more holistic, and thereby ensure protection to coastal
ecological systems, coastal waters, and the vulnerability of some coastal areas to
extreme natural events and potential sea level rise. In pursuance with the Policy CRZ
Notification 2011 was released recently.
• Development activities in the coastal areas are regulated by means of the Coastal
Regulation Zone notifications and Integrated Coastal Zone Management
(ICZM) plans made under them.
• The ICZM plans should be reviewed at pre-determined intervals to take account
of changes in geomorphology, economic activities, settlement patterns, coastal
and marine environmental conditions.
• Decentralize, to the extent feasible, the clearance of specific projects to State
level environmental authorities, exempting activities, which do not cause
significant environmental impacts, and are consistent with approved ICZM plans.
13. Environmental Standard Setting such as : risks to human health, risk to other
environmental entities, technical feasibilities, cost of compliance, and strategic
consideration.
14. The Problem of LMOs
• LMO refers to the Living Modified Organisms. Living modified organisms (known
as LMOs) result from modern biotechnology is broadly equivalent to genetically
modified organisms.
• The difference between an LMO and a GMO is that a Living Modified Organism is
capable of growing, and typically refers to agricultural crops. Genetically
Modified Organisms include both LMOs and organisms which are not capable of
growing, i.e. are dead.
• The National Environment Policy says that Genetically Modified Organisms
require evaluation of their potential benefits and risks as part of relevant regulatory
processes.
• The subset of LMOs, may, however, owing to their potential for replication,
involve environmental concerns in addition.
• LMOs may pose significant risks to ecological resources, and perhaps,
human and animal health.
• In order to ensure that development of biotechnology does not lead to
unforeseen adverse impacts, the policy aims to review the regulatory
processes for LMOs so that all relevant scientific knowledge is taken into
account, and ecological, health, and economic concerns are adequately
addressed.
• The use of Genetically modified plants and animals are very helpful for
progress, but can also pose significant risks to ecological resources, and
perhaps, human and animal health.
STRATEGIES AND ACTION OF NATIONAL ENVIRONMENTAL
POLICY,2006
These risks can be reduced by:
• Review the regulatory processes for LMOs so that all relevant scientific
knowledge is taken into account, and ecological, health, and economic
concerns are adequately addressed.
• Periodically review the National Bio-safety Guidelines, and Bio-safety
Operations Manual to ensure that these are based on current scientific
knowledge.
• Ensure the conservation of bio-diversity and human health when dealing
with LMOs in transboundary movement in a manner consistent with the
multilateral Bio-safety Protocol.
15. Environmentally Sensitive Zones are the areas with identified environmental
resources having “Incomparable Values” which require special attention for their
conservation.
In order to conserve and enhance these resources, without impeding legitimate socio-
economic development of these areas, the National Environment policy aims to
• Identify and give legal status to Environmentally Sensitive Zones in the country
having environmental entities with “Incomparable values” requiring special
conservation efforts.
• Formulate area development plans for these zones on a scientific basis, with
adequate participation by the local communities.
• Create local institutions with adequate participation for the environmental
management of such areas, to ensure adherence to the approved area development
plans, which should be prepared in consultation with the local communities.
16. Desert Habitats
The arid and semi-arid region of India covers 127.3 mha (38.8%) of India’s
geographical area and spreads over 10 states.
The Indian desert fauna is extremely rich in species diversity of mammals
and winter migratory birds. However the pressures of a rapidly increasing
population on the natural resource base necessitate adoption of innovative
and integrated measures for conservation of desert ecosystems.
The policy aims at measures such as Intensive water and moisture
conservation through practices based on traditional and science based
knowledge, and relying on traditional infrastructure.
STRATEGIES AND ACTION OF NATIONAL ENVIRONMENTAL
POLICY,2006
17. Panchayats & Women Participation
The policy aims at working towards giving the legal recognition of the
traditional entitlements of forest dependent communities taking into
consideration the provisions of the (PESA).
This would remedy a serious historical injustice, secure their livelihoods,
reduce possibilities of conflict with the Forest Departments, and provide
long-termincentives to these communities to conserve the forests.
18. Wild life
The policy aims to expand the Protected Area (PA) network of the country,
including Conservation and Community Reserves, to give fair representation to
all bio-geographic zones of the country. In doing so, develop norms for
delineation of PAs in terms of the Objectives and Principles of the National
Environment Policy, in particular, participation of local communities,
concerned public agencies, and other stakeholders, who have a direct and
tangible stake in protection and conservation of wildlife, to harmonize
ecological and physical features with needs of socio-economic development.
19. Wetlands
The Ramsar Convention defines wetlands as, ‘areas of marsh, fen, peat land or
water, whether natural or artificial, permanent or temporary, with water that is
static or flowing, fresh, brackish or salt, including areas of marine water the
depth of which at low tide does not exceed six meters’, thereby giving a wide
scope to the term.
Wetlands are under threat from drainage and conversion for agriculture and
human settlements, besides pollution.
The policy aims at setting up a legally enforceable regulatory mechanism for
identified valuable wetlands, to prevent their degradation and enhance their
conservation. Develop a national inventory of such wetlands.
20. Monitoring of Compliance: Even after proper planning, if the execution of
the plan is not successful, it can make the whole project to fail its objectives. To
avoid such failure, the following methods are used:
• Take measures, including capacity development initiatives to enable
Panchayati Raj Institutions and urban local bodies to undertake monitoring
of compliance with environmental management plans. Measures will also be
taken to encourage municipalities to annually report their environmental
performance to their governing bodies.
• Develop feasible models of public-private partnerships to leverage financial,
technical, and management resources of the private sector in setting up and
operating infrastructure for monitoring of environmental compliance, with
ironclad safeguards against possible conflict of interest or collusion with the
monitored entities.
21. Use of Economic Principles in Environmental Decision-making
• It is important to understand the Financial aspects of the works done for the
environmental conservation to keep it in check with respect to the country’s
economic conditions.
• Use of existing policy instruments, such as the fiscal regime, may
significantly reduce or eliminate the need for enhanced institutional
capacities to administer the incentive based instruments.
• In future, accordingly, a judicious mix of incentives and fiats based
regulatory instruments would be considered for each specific regulatory
situation.
STRATEGIES USED FOR ENVIRONMENTAL REFORM
Land Degradation:
• Adoption of science based and traditional sustainable land use practices through research and
development.
• Pilot scale demonstrations and farmers’ training.
• Promote reclamation of wasteland and degraded forest land
• To reduce desertification through action plans.
Forests:
• To formulate an innovative strategy for increase of forest.
• Afforestation of degraded forest land, wasteland and tree cover on private or revenue land.
Wildlife:
• Expanding the Protected Area Network
• Paralleling multi-stakeholder partnerships for afforestation
• Encouraging eco-tourism at wildlife sites.
• Implementing measures for captive breeding and release into the wild identified endangered
species.
STRATEGIES USED FOR ENVIRONMENTAL REFORM
•Environmentally Sensitive Zones :
• Identify ESZs.
• Formulate area development plans
• Create local institutions for the environmental management of such areas.
Sustainable Mountain Development :
• Norms for infrastructure construction in mountain regions
• Promotion of organic farming
• Sustainable tourism
Sustainable Coastal Resources :
• Sustainable management of mangroves
• Protection to coastal environment
Conservation of Freshwater Resources:
• River Management
• Groundwater
Pollution Abatement
Climate Change
ENVIRONMENTAL REFORM
Environmental Management Systems, Eco labeling and
Certification:
• Encourage industry associations to promote the adoption of ISO
14000
• Encourage adoption of EMS through purchase preference for
ISO14000 good sand services for Government procurement, except
for items reserved for the small-scale sector at any given time
• Formulate “Good Practice Guidelines” for ecolabels
• Promote “good practices” norms in all relevant sectors
Clean Technologies and Innovation:
• Financial capacity building for cleaning technology.
• Public and private co operation
• Adoption of cleaning technology
Capacity Building
• Review the present institutional capacities
• Continuous Upgradation of Knowledge And Skills
ENVIRONMENTAL REFORM
Environmental Awareness, Education, and
Information:
• Develop and operate an online, real time, Research and Development :
publicly accessible environmental information • Periodically identify and prioritize areas for
system research.
• Use Of Remote Sensing Data • Encourage research in priority areas
• Adult Education, Special Midcareer Training •International Cooperation
Programmes • Avail of multi lateral and bilateral
• Environmental Awareness cooperation programs.
Partnerships and Stakeholder Involvement: Review of the Policy:
• Public-Community Partnerships • Three-year Reviews
• Public-Private Partnerships • Redefine The Objectives And Principles,
• Public-Community-Private Partnerships And Recast The Strategic Themes For
• Public-Voluntary Organization Partnerships Action.
• Public-Private-Voluntary Organization • Review Of Implementation:
Partnerships
PROCESS OF FORMULATION OF NATIONAL ENVIRONMENTAL
POLICY,2006
• The preparation of this Policy has involved inputs and consultations with diverse
experts, and stakeholders.
• A draft of the National Environment Policy was prepared through an intensive
process of consultation within the Government and inputs from experts.
• The draft, in English and Hindi was posted on the website of the Ministry of
Environment and Forests and responses were invited from individuals and
organizations, through advertisements in national and regional newspapers.
• The draft was open for public consultation from 21 August, 2004 to 31 December,
2004. Consultations were held with concerned Ministries of the Central
Government, and all State/UT governments at meetings of the State Environment
Ministers and senior officials.
PROCESS OF FORMULATION OF NATIONAL ENVIRONMENTAL
POLICY,2006
• The latter were encouraged to undertake local level public consultations. The draft
was also provided to the Members of Parliament and their views and suggestions
were invited.
• The Ministry of Environment and Forests also held consultations with
representatives of major academic and research institutions, and key Industry
Associations, Voluntary Organizations, and individuals who are well known in
the field.
• Detailed summaries of responses were prepared and the various concerns
expressed by the respondents were addressed. Many of the suggestions received
have been incorporated in the Policy.
Ministry of Environmental and Forest Notification (1989)
The Ministry of Environment and Forests
(MoEF) is the nodal agency in the
administrative structure of the Central
Government for planning, promotion, co-
ordination and overseeing the
implementation of India's environmental and
forestry policies and programs.
Which is established on 5th December, 1989
in turn of Environment (Protection) Act,
1986 to pollution, environmental protection,
wildlife etc. is provided and actions and
reports related to climate change and
biodiversity conservation.
Rules for the Manufacture, use, import, export and storage of hazardous
micro organisms, genetically engineered organisms or cells.
With a view to protecting the environment, nature and health, in connection
with the application of gene-technology and micro-organisms, the Central
Government hereby makes the following rules, namely
1. Short title, extent and commencement:
These rules may be called the Rules for The Manufacture, Use, Import,
Export and Storage of Hazardous micro-organisms Genetically engineered
organisms or cells.
These rules shall come into operation on the date to be notified for this
purpose in the Official Gazette.
2. Application:
• These rules are applicable to the manufacture import and storage of
micro-organisms and Gene-Technological products.
• These shall apply to genetically engineered organisms, microorganisms
and cells and correspondingly to any substances and products and food
stuffs, etc. of which such cells, organisms or tissues hereof form part
• These rules shall also apply to new gene-technologies apart from those
referred to in clauses (ii) and (iv) of rule 3 and these rules shall apply to
organisms/micro-organisms and cells generated by the utilization of such
other gene-technologies and to substances and products of which such
organisms and cells form part.
2. Application:
These rules shall be applicable in the following specific cases:
(a) sale, offers for sale, storage for the purpose of sales, offers and any kind of
handling over with or without a consideration;
(b) exportation and importation of genetically engineered cells or organisms;
(c) production, manufacturing, processing, storage, import, drawing off,
packaging and repacking of the Genetically Engineered Products;
(d) Production, manufacture etc. of drugs and pharmaceuticals and food
stuffs distilleries and tanneries, etc. which make use of micro-organisms
genetically engineered micro-organisms one way or the other.
(e) These rules shall be applicable to the whole of India.
3. Definitions:
“Biotechnology” means the application of scientific and engineering principles
to the processing of materials by biological agents to produce goods and
services.
“Cell hybridization” means the formation of live cells with new combinations
of genetic material through the fusion of two or more cells by means of
methods which do not occur naturally
“Genetic engineering” means the formation of new combinations of genetic
material by incorporation of a cell into a host cell, where they occur naturally
(self cloning) as well as modification of an organism or in a cell by deletion
and removal of parts of the heritable material.
4. Competent Authorities:
(1) Recombinant DNA Advisory Committee (RDAC)
(2) Review Committee on Genetic Manipulation (RCGM)
(3) Institutional Biosafety Committee (IBSC)
(4) Genetic Engineering Approval Committee (GEAC)
(5) State Biotechnology Co-ordination Committee (SBCC)
(6) District Level Committee (DLC)
Rules for the Manufacture, use, import, export and storage of
hazardous micro organisms, genetically engineered organisms or cells.
5. Classification of micro-organisms or genetically engineered product:
(1) For the purpose of these rules, microorganisms or genetically
engineered organisms, products or cells shall be dealt with under two
major heads; animal, pathogens and plant pests and these shall be
classified in the manner specified in the Schedule.
(2) If any of the microorganisms, genetically engineered organism or cell
falls within the limits of more than one risk class as specified in the
Schedule, it shall be deemed to belong exclusively to the last in number
of such classes.
6. Microorganisms laid down in the Schedule are divided into the
following:
(1) Bacterial Agents;
(2) Fungal Agents;
(3) Parasitic Agents;
(4) Viral,
(5) Rickettsial
(6) Chlamydial Agents
(7) Special Category.
7. Approval and Prohibitions, etc:
1. No person shall import, export, transport, manufacture, process, use
or sell any hazardous microorganisms of genetically engineered
organisms/substances or cells except with the approval of the Genetic
Engineering Approval Committee.
2. Use of pathogenic microorganisms or any genetically engineered
organisms or cells for the purpose of research shall only be allowed in
laboratories or inside laboratory area notified by the Ministry of
Environment and Forests for this purpose under the Environment
(Protection) Act, 1986.
Rules for the Manufacture, use, import, export and storage of hazardous micro
organisms, genetically engineered organisms or cells.
7. Approval and Prohibitions, etc.:
3. The Genetic Engineering Approval Committee shall give directions to the occupier to
determine or take measures concerning the discharge of microorganisms/genetically
engineered organisms or cells mentioned in the Schedule from the laboratories,
hospitals and other areas including prohibition of such discharges and laying down
measures to be taken to prevent such discharges.
4. Any person operating or using genetically engineered organisms/microorganisms
mentioned in the schedule for scale up or pilot operations shall have to obtain license
issued by the Genetic Engineering Approval Committee for any such activity. The
possessor shall have to apply for license in prescribed proforma.
5. Certain experiments for the purpose of education within the field of gene technology
or microorganism may be carried out outside the laboratories and laboratory areas
and will be looked after by the Institutional Bio-safety Committee
8. Production:
• Production in which genetically engineered organisms or cells or
micro-organisms are generated or used shall not be commenced
except with the consent of Genetic Engineering Approval Committee
with respect of discharge of genetically engineered organisms or cells
into the environment.
• This shall also apply to production taking place in connection with
development, testing and experiments where such production.
9. Deliberate or unintentional release:
• Deliberate or unintentional release of genetically engineered
organisms/hazardous microorganisms or cells, including deliberate
release for the purpose of experiment shall not be allowed.
• Deliberate release shall mean any intentional transfer of genetically
engineered organisms/hazardous, microorganisms or cells to the
environment or nature, irrespective of the way in which it is done.
• The Genetic Engineering Approval Committee may in special cases
give approval of deliberate release.
10. Permission and approval for certain substances:
• Substances and products, which contain genetically engineered
organisms or cells or microorganisms shall not be produced, sold,
imported or used except with the approval of Genetic Engineering
Approval Committee.
11. Permission and approval for food stuffs.
• Food stuffs, ingredients in food stuffs and additives including
processing and containing or consisting of genetically engineered
organisms or cells, shall not be produced, sold, imported or used
except with the approval of the Genetic Engineering Approval
Committee.
12. Guidelines:
• Any person who applies for approval as determined by the Genetic
Engineering Approval Committee submit information and make
examinations or cause examinations to be made to eradicate the case,
including examinations according to specific directions and at specific
laboratories also make available an on-site emergency plan to GEAC
before obtaining the approval.
• Any person to whom an approval has been granted under rules 8-11
above shall notify the Genetic Engineering Approval Committee of any
change in or addition to the information already submitted.
13. Grant of approval:
1) In connection with the granting of approval under rules 8 to 11 above,
terms and conditions shall be stipulated, including terms and conditions
as to the control to be exercised by the applicant, supervision, restriction
on use, the layout of the enterprise and as to the submission of
information to the State Bio-technology Co-ordination Committee or to
the District Level Committee.
2) All approvals of the Genetic Engineering Approval Committee shall be
for a specific period not exceeding four year at the first instance
renewable for 2 years at a time.
13. Grant of approval:
The Genetic Engineering Approval Committee shall have powers to revoke
such approval in the following situations:-
(a) If there is any new information as to the harmful effects of the
genetically engineered organisms or cells.
(b) If the genetically engineered organisms or cells cause such damage to
the environment, nature or health as could not be envisaged when the
approval was given, or
(c) Non compliance of any condition stipulated by Genetic Engineering
Approval Committee.
14. Supervision:
(1) The Genetic Engineering Approval Committee may supervise the
implementation of the terms and conditions laid down in connection
with the approvals accorded by it.
(2) The Genetic Engineering Approval Committee may carry out this
supervision through the State Biotechnology Coordination Committee
or the State Pollution Control Boards/District Level Committee or
through any person authorized in this behalf.
15. Penalties:
(1) If an order is not complied with, the District Level Committee or State
Biotechnology Co-ordination Committee may take measures at the
expense of the person who is responsible.
(2) In case where immediate intervention is required in order to prevent any
damage to the environment, nature or health, the District Level
Committee, or State Biotechnology Coordination Committee may take
the necessary steps without issuing any order or notice. The expenses
incurred for this purpose will be repayable by the person responsible for
such damage.
15. Penalties:
3. The State Bio-technology Co-ordination Committee/District Level Committee
may take samples for a more detailed examination of organisms and cells.
4. The State Bio-technology Co-ordination Committee/District Level Committee
shall be competent to ask for assistance from any other government authority to
carry out its instructions.
16. Responsibility to notify interruptions or accidents
District Level Committee/State Biotechnology Co-ordination Committee and the
state medical officer of any interruption of operations or accidents that may lead to
discharges of genetically engineered organisms or cells which may be harmful to
the environment, nature or health or involve any danger thereto
17. Preparation of Off-site emergency Plan by the DLC:
1. It shall be the duty of the DLC to prepare an off-site emergency plan detailing
how emergencies relating to a possible major accident at a site will be dealt
with and in preparing the plan, the DLC shall consult the occupier and such
other person as it may deem necessary.
2. For the purpose of enabling the DLC to prepare the emergency plan required
under sub-rule (1), the occupier shall provide the DLC with such inforbmation
relating to the handling of hazardous microorganisms/genetically engineered
organisms under his control as the DLC may required including the nature,
extent and likely off-site effects of a possible major accident and the DLC shall
provide the occupier with any information from the off-site emergency plan
Rules for the Manufacture, use, import, export and storage of hazardous micro
organisms, genetically engineered organisms or cells.
18. Inspections and information regarding finance:
The State Biotechnology Co-ordination Committee or the Genetic Engineering Approval
Committee/the DLC or any person with special knowledge duly authorised by the State
Biotechnology Co-ordination Committee or the Genetic Engineering Approval
Committee or the DLC where it is deemed necessary, at any time on due production of
identity be admitted to public as well as to private premises and localities for the purpose
of carrying out supervision
• Any person who is responsible for activitibes subject to rules 7-11 above shall at the request of District
Level Committee or State Bio-technology Co-ordination Committee or the GEAC submit all such
information including information relating to financial conditions and accounts, as is essential to the
authority's administration under these rules.
• The Genetic Engineering Approval Committee may fix fees to cover, in whole or in part, the expenses
incurred by the authorities in connection with approvals, examinations, supervisions and control.
19. Appeal:
Any person aggrieved by a decision made by Genetic Engineering Approval
Committee/State Biotechnology Co-ordination Committee in pursuance of these
rules may within thirty days from the date on which the decision is communicated
to him, prefer an appeal to such authority as may be appointed by Ministry of
Environment and Forests provided that the appellate authority may entertain the
appeal after the expiry of the said period of thirty days if such authority is satisfied
that the appellant was prevented by sufficient cause from filing the appeal in time.
20. Exemption: The Ministry of Environment and Forests shall, wherever
necessary, exempt an occupier handling a particular microorganism genetically
engineered organism
Animal and human pathogens (Bacteria)
Animal and human pathogens
Fungi Parasites
Animal and human pathogens
Virus
also unclassified organism and/or organisms whose classification is unknown, and all other
organisms associated with plant and insect disease.

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Module 1: BIOSAFETY-REGULATORY

FRAMEWORK FOR GMO’s IN INDIA

Regulatory framework for GMO crops in India.

• These included the Environment Protection Act 1986 administered by

The RDAC is advisory in nature and expected to give

recommendations from time to time on safety regulations in research

and applications of GMOs and products thereof.

This Committee prepared the Recombinant DNA Biosafety Guidelines

in 1990, which were adopted by the Government for conducting

research and handling of GMOs in India.

• Authorized to review periodically the safety and control measures in

GEAC shall have powers to revoke approvals in case of:

time to address issues such as empowering Seed Inspectors/Seed

Analyst/Laboratories notified under Seed Act under Environment

(Protection) Act, 1986, exempting certain categories of recombinant

pharmaceutical products, GM food stuffs, ingredients in food stuffs, and

additives from the purview of Rules, 1989.

• Physical Containment (PC): The objective of physical containment is

Calcium carbide Ethylene

In this Act unless the context otherwise requires,

(2) It extends to the whole of India .

notification in the Official Gazette, appoint.

if any, in force in that State.

LIST OF ADAPTATION ORDER AND AMENDING ACTs

Section 56:- Penalty for unhygienic or unsanitary processing or mfg. of food

offence is a continuing one; and

(iii) his license shall be cancelled.

• INTEGRATION OF ENVIRONMENTAL CONCERNS IN ECONOMIC

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