basics of national regulatory mechanism

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NATIONAL REGULATORY MECHANISM AND CERTIFICATION SYSTEM INCLUDING SEED CERTIFICATION S. K. AGGARWAL BHAGAT SACHIN SATYAWAN (Ph.D. STUDENTS) Course Title-: Principles and Procedures of Certification Plant Path. 603 DEPARTMENT OF PLANT PATHOLOGY PUNJAB AGRICULTURAL UNIVERSITY LUDHIANA

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Page 1: BASICS OF NATIONAL REGULATORY MECHANISM

NATIONAL REGULATORY MECHANISM AND CERTIFICATION SYSTEM INCLUDING SEED CERTIFICATION

S. K. AGGARWALBHAGAT SACHIN SATYAWAN

(Ph.D. STUDENTS)

Course Title-: Principles and Procedures of CertificationPlant Path. 603

DEPARTMENT OF PLANT PATHOLOGYPUNJAB AGRICULTURAL UNIVERSITY

LUDHIANA

Page 2: BASICS OF NATIONAL REGULATORY MECHANISM

INTRODUCTIONMeaning-: Regulation refers to “controlling human or social behaviour by rules or

alternatively a rule or order issued by an executive authority or regulatory agency

of a government and having the force of law”.

Regulation Mechanisms-

These are the methods or techniques that will be used to ensure that policy

principles are applied and action is taken to reach specified objectives.

OBJECTIVES OF REGULATION-

1. TO PREVENT MARKET FAILURE-

Market failure is a condition in which the market mechanism fails to allocate

resources efficiently to maximize social welfare to protect the monopoly.

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2. TO CHECK ANTI COMPETITIVE PRACTICES-

Firms may resort to anti competitive practices such as price fixing, market

sharing or abuse of dominant or monopoly power.

3.TO PROMOTE THE PUBLIC INTEREST-

The promotion of public interest which is an important policy objective for

governments. Support pricing i.e. government offering to buy wheat or rice from

farmers at a price which is higher than the market price.

Typology of regulation in India-

Three broad categories

1.Economic regulation

2.Regulation in the public interest

3.Environmental regulation

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National Regulatory Mechanism: (specifically related to Agriculture)

Government of India legislated the Destructive Insects and Pests (DIP) Act in 1914

With a view to restrict the entry of exotic pest, pathogens and weeds through

regulation of imports.

Later it also restricted the movement of certain planting material from one state

to another state within the country through the domestic quarantine in 1984.

A notification was issued under this Act, namely Plants, Fruits and Seeds

(Regulation of Imports in to India) order popularly known as PFS Order.

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Destructive Insects and Pests (DIP) Act 1914

Enacted as the first quarantine law in India after the British ordered compulsory

fumigation of imported cotton bales to prevent Mexican cotton boll weevil

(Anthonomus grandis) ordered in 1906.

Prohibit or regulate the import into India or any part thereof or any specific place

therein or any article or class of articles specified therein.

Prohibit or regulate the export from a State or the transport from one State to

another State in India of any plants and plant materials, diseases or insects, likely

to cause infection or infestation.

Authorizes the State Govt. to make rules for detention, inspection,

disinfection/disinfestations or destruction of any pest or class of pests or of any

article or class of articles for which center has issued notifications.

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Seeds Act(1966)

Act was passed by the parliament in 1966 and Seed Rules were framed under it

in 1968. Legislative measures promulgated to ensure high quality of seed in the

market place.

Act provides for a system of notification of kinds or varieties of seeds. Seed

(Control) Order, 1983 seeks to control and regulate seed production and

distribution as seed declared as an essential commodity under the Essential

Commodities Act, 1955.

Insecticides Act (1968)Regulates import, manufacture, sale, distribution and use of insecticides with a

view to prevent risk to human beings or animals and promotes safety measures.

Registration committee registers insecticides after verifying claims regarding

efficacy and safety.

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Environmental Protection Act (1986)

Aims to protect and improve quality of environment.

Provides for management and handling of hazardous wastes, use, import/export and

hazardous micro-organisms, genetically engineered organisms or cells.

New Policy on Seed Development (1988)Came into force with an objective to provide the Indian farmers with the best genetic

material available anywhere in the world to increase agricultural productivity, farm

income and export earnings.

Aimed at liberalization of imports along with streamlining of plant quarantine

procedures and encouragement to domestic seed industry through incentives.

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SALIENT FEATURE OF REVISED PFS ORDER (1989)

No consignment can be imported unless accompanied by an official

Phytosanitary Certificate issued by an official agency of the exporting

country

Seeds/planting material requiring isolation growing under detention, to be

grown in an approved post-entry quarantine facility.

Import of soil, earth, sand compost, plant debris accompanying seeds/

planting materials is not permitted. Hay, Straw or any other material of

plant origin would not be used as packing material.

Special conditions for imports of plants, seeds for sowing, planting and

consumption have also been mentioned under Schedule II (Clause 4) of

the Order.

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Protection of Plant Varieties and Farmers’ Rights Act (2001)

Has set up a Plant Varieties and Farmers’ Right Protection Authority.

Allows the registration of new plant varieties within a specific list of genera and

species as well as farmers’ varieties. Accords specific privileges to researchers/

breeders while respecting quarantine regulations.

Biodiversity Act (2002)

Addresses access to genetic resources, associated knowledge and equitable sharing

of benefits arising there from to the country.

To safeguard the interest of people of India.

Free access to the Indian citizens to use within the country for research.

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National Seed Policy (2002)

• The Seeds Act, 1966, Seeds Control Order 1988 promote and regulate the seed

industry.

• Encompasses quality assurance mechanisms along with facilitation of seed industry.

• Thrust areas include quarantine of imported seeds and planting material and

compliance to bio-safety. A specified quantity of imported seeds to be sent to Gene

Bank, NBPGR.

Export-Import Policy (2002-07) Import permitted without any compromise on plant quarantine procedures.

Restricts export of all cultivated seeds varieties – breeder/foundation/wild.

Quantitative restrictions for export of all other types of seeds/planting material

removed w.e.f. April 1, 2002.

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Plant Quarantine (Regulation for Import into India) Order (2003)

Notified in compliance to the Sanitary and Phytosanitary Agreement of WTO.

Pest risk analysis made a precondition for all imports.

Gives various schedules for import of various plants and planting materials.Pest Risk Analysis

Pest Risk Analysis is mandatory before any plant or plant materials being permitted

to be imported into the country.

The Import Permit issuing authorities shall issue import permits for commodities

specified in Schedule-V,Schedule-VI and Schedule-VII of PQ Order, 2003 for which

Pest Risk Analysis has already been done.

Export inspection and phytosanitary certification of plants and plant products is

carried out in accordance with article IV of International Plant Protection Convention

(IPPC) to meet the legal obligations of the member countries.

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Mechanism of plant quarantine-

Embargoes- an embargo prohibits any movement of susceptible or affected plant

materials from a quarantined area into protected areas. Example US does not impart

cotton and rice from any country.

Inspection and certification- many plants propagating material entering any region are

inspected Regularly at the point of entry(land, sea and airport) and allowed entry only

after having been declared free of injurious insects and diseases and done at both point of

origin and point of destination.

Disinfection of imported material- the plant materials entering new area may require

disinfection treatments, either at the point of origin or point of entry.

Special permit for imports- plants and plant products for scientific work e.g. exotic

plant material may be brought after obtaining special permit, even though quarantine

prevents commercial Shipments of the product.

Unrestricted shipment- when no potential pest is involved, plant materials of importance

in world trade may be shipped from one country to another without disinfections, or other

restrictions, although they are subject to occasional inspection.

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Directorate of Plant Protection, Quarantine  & StorageDepartment of Agriculture & Cooperation

Central Insecticides Board & Registration Committee (CIB&RC) Addl. Plant Protection Advisor(APPA) Plant Protection Advisor (PPA) Chief Administrative Officer (CAO) Locust Division (LD) Vigilance Officer (VO) Official Language(OL) Planning & Coordination Division(P&C) Under Secretary(US) Locust Warning Organization (LWO) Joint director (JD) LCO( locust control order) DD (Deputy director) CIPMC (Central integrated pest management centre)

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CERTIFICATION SYSTEM

It is a procedure for verifying that products conform to certain standards, either mandatory/compulsory or voluntarily.

What is Certification?

Basic types of certification

Mandatory or Compulsory (public)When products are sold to mainstream domestic market or exported,

national governments & exporting countries normally require standards & certification as part of food safety regulations.Voluntary (private)

Decision to adhere to standards & apply for certification is mainly a decision of the producing group for environmental, social, cultural, food safety purposes.

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EXAMPLES OF CERTIFICATION SYSTEM TYPES(BIS)

ISO 9001 Certification-:It is a quality management system that demonstrates its ability to consistently provide a product or a service that matches the applicable statutory and regulatory standards.

ISO 27001 Certification-:It is a standard that defines the requirements for an information security management system to ensure the right security controls are taken to protect critical data of an organization. ISO 14001 Certification In simplest terms, it is the criteria followed by a company that stipulates the standards

to identify and control its environmental impact and with this they can constantly improve on their performance on the environmental front.

ISO 22000 Certification It is a certification that explains the requirements from an organization to

demonstrate its ability to control food safety hazards. ISO 28000 Certification It is a certification that specifies the needs of a security management system that

has a critical view towards the supply chain of your business.

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ISO TS 16949 Certification It is a certification that specifies the quality requirements for the development or design, production or installation and servicing of automotive related products.OHSAS 18001 Certification

An occupational health and safety management system will place the basic requirements for a safe and secure environment.ISO 50001 Certification

It is a quality system model that aims at continuous improvement that is focused towards the energy management of a companyISO 30000 Certification

It is a quality standard explains the requirements for a system to enable a ship recycling facility. ISO 29001 Certification

It is a quality management system that discusses and ensures the right procedures that has to be in place for a company in Petroleum, petrochemical and natural gas industries.ISO 9000 Certification

Having an ISO 9000 certification is a certain way to improve the quality of process and improve efficiency in the system.

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SEED CERTIFICATIONSeed certification is a quality assurance process. Seed intended for domestic or

International markets is controlled and inspected by official sources in order to

guarantee consistent high quality for consumers

HISTORY OF SEE CERTIFICATION IN INDIA-:In india the field evaluation of the seed crop and its certification started with

the establishment of national seed corporation in 1963.

A legal status was given to seed certification with the enactment of first Indian

seed act in the year 1966 and formulation of seed rules in 1968.

The seed act of 1966 provided the required impetus for the establishment of

official seed certification agencies by the states.

Maharashtra was the first state to establish an official seed certification agency

during 1970 as part of department of agriculture

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OBJECTIVES OF SEED CERTIFICATION

Systematic increase of superior varieties.

Identification of new varieties and their rapid increase under appropriate and

genetically accepted names.

Provision for continuous supply of comparable material by careful maintenance.

PRINCIPLES OF SEED CERTIFICATION

Secure a basic seed from a recognized source.

Maintain genetic identity of a variety with respect to DUS.

High degree of genetic purity, no mechanical /genetic contamination.

High standard of germinability.

Multiply seed free from designated seed borne diseases.

Seed must qualify the minimum standards under field and laboratory conditions.

To make available quality of seed to farmers.

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Eligibility for certification of crop varieties

Seeds of only those varieties which are notified under section 5 of the Seeds

Act, 1966 shall be eligible for Certification.

Breeder seed is exempted from Certification. Foundation and Certified class

seeds come under Certification.

Breeder seed is produced by the plant breeder which is inspected by a

monitoring team consisting of the breeder, representative of seed certification

agency , representative of NSC (Deputy Manager) & nominee of crop

coordinator.

Phases of seed certification –

Receipt and scrutiny of application including eligibility of the variety,

verification and establishment of seed source and other requirements

Verification of seed source as well as class and other requirements of the seed

used for raising the seeds crop

Field inspections to verify conformity to the prescribed field standards

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Supervision at post harvest stages including processing and packing

Seed sampling and analysis for genetic purity, seed health etc. in order to verify

conformity to the prescribed standards

Grant of certificate and certification tags, tagging and sealing

1. Receipt & Scrutiny of application a. Application for registration

Any person, who wants to produce certified seed shall register his name with the concerned Assistant Director (AD) of seed certification by remitting Rs. 25/- per crop, per season. There are 3 seasons under certification viz., kharif (June-Sep), Rabi (Oct. – Jan.) & Summer (Feb-May). b. Sowing report: (Application for the registration of seed farm)

The seed producer who wants to produce certified seeds shall apply to the AD S.C. in the prescribed sowing report form in quadriplicate with prescribed certification fees along with other documents such as tags to establish the seed source. 2. Verification of seed source

During his first inspection of seed farm the S.C officer, will verify whether the seed used to raise the seed crop is from an approved source.

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3. Field Inspection Objective

The objective in conducting field inspection is to verify the factors which can cause irreversible damage to the genetic purity or seed health. Inspection Authority

The seed certification officer authorized by the registering authority shall attend to field inspections. Crop stages for inspection

The number of field inspections and the stages of crop growth at which the field inspections should be conducted vary from crop to crop. It depends upon duration, and nature of pollination of the seed crop. Field Counts

The purpose of field inspection is to find out field standards of various factors in the seed farm. It is impossible to examine all the plants in the seed farm. Hence, to assess the field standards of various factors random counting is followed.Sources of contamination or factors to be observed 1. Physical contaminants 2. Genetical contaminants

Physical contaminants are inseparable other crop plants, objectionable weed plants and diseased plants.

Genetical contaminants consist of off-types, pollen shedders and shedding tassels.

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a. Off Type Plant that differs in morphological characters from the rest of the population

of a crop variety. b. Volunteer Plant

Volunteer plants are the plants of the same kind growing naturally from seed that remains in the fields from a previous crop. c. Pollen Shedders

In hybrid seed production involving male sterility, the plants of ‘B’ line present in ‘A’ line are called Pollen shedders.e. Inseparable Crop Plants

These are plants of different crops which have seeds similar to seed crop.f. Objectionable Weed Plants These are weeds 1. Whose seeds are difficult to be separated once mixed

2. Which are poisonous g. Designated Diseases The diseases which may reduce the yield and quality of seeds are termed as Designated diseases. Inspection Report

The seed certification officer after taking field counts and comparing them with the minimum field standards, the observations made on the seed farm field should be

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reported in the prescribed Performa to 1. Deputy Director of S.C 2. To the Seed producer 3. AD, S.C 4. Retained with him. Assessment of seed crop yield It is necessary to avoid malpractices at the final stage during harvest operation.

L.F.R REPORT (Liable For Rejection Report) If the seed crop fails to meet with any one factor as per the standards,

L.F.R report is prepared & the signature of the producer is obtained & sent to D.DSC within 24 hrs. RE-Inspection

For the factors which can be removed without hampering the seed quality, the producer can apply for re-inspection to the concerned D.D,S.C within 7 days from the date of F.I rejection order 4. Post Harvest Supervision Of Seed Crop

The post harvest inspection of a seed crop covers the operations carried out at the threshing floor, transport of the raw seed produce to the processing plant, pre-cleaning, drying, cleaning, grading, seed treatment, bagging & post processing storage of the seed lot.

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5. Seed Sampling & Testing During packaging S.C office will draw samples according to ISTA

Procedure & send the sample to ADSC( Agricultural Diagnostic Service Centre) concerned within a day of sampling.

The ADSC will inturn send the sample to the STL within 3 days of receipt of the sample for testing seed standards viz. physical purity, germination, moisture content & seed health as prescribed. 6. Labelling, tagging, sealing and grant of certificate After receiving the seed analytical report, the SCO( Seed certification officer) will get the tag from the ADSC & affixes labels (producer’s label) and tags (Blue for C.S & White for F.S) to the containers & sealed to prevent tampering and grant certificate fixing a validity period for 9 months. Tagging should be done within 60 days of testing.  Resampling & Reprocessing When a seed lot does not meet the prescribed seed standards in initial test, on request of the producer SCO may take resample. If the difference in germination analysed & required is within 10 days, then straight away re-sampling can be done. If it is > 10, reprocessing & resampling may be done.

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TAG No. ................. CA's* EMBLEM Certified SeedKIND ..................... Class of seed ..............Variety.................... Name and

address of Certification Agency

Certificate No. ..............

Lot No ...................Date of issue of certificate..............Date of test..............

"Use of the seed after expiery of the validity period by any person is entirely at his risk and the holder of the certificate shall not be responsible for any damage to the buyer of seed. No one sould purchase the seed if seal or the certification tag has been tampered with".

Certificate to valid up to..........................(Provided seed is stored under cool and dry environment)

Name and full address of the Certified seed producer.............................

Validity of certificate further extended up to ............................................

Specification of the Certification TagSize, quality, colour, layout and contents of the certification tag shall be as given hereunder : Length:15cmBreadth:7.5cmQuality- It shall be made of durable material such as thick paper, paper with cloth lining, wax coated paper, plastic coated paper etc.Colour- Both sides shall be white for Foundation class and blue(ISI No. 104-Azure blue) for Certified class.Contents and LayoutIf tag is to be affixed on a smaller container then the size of the tag may be reduced proportionately. However, length and breadth ratio and contents would remain the same.  *(CA's: Certification Agency)

TAG No. .................CA's* EMBLEM

Certified SeedKIND ..................... Class of seed ..............Variety....................

Name and address of Certification Agency

Certificate No. ..............

Lot No ...................Date of issue of certificate..............Date of test..............

"Use of the seed after expiry of the validity period by any person is entirely at his risk and the holder of the certificate shall not be responsible for any damage to the buyer of seed. No one should purchase the seed if seal or the certification tag has been tampered with".

Certificate to valid up to..........................(Provided seed is stored under cool and dry environment)

Name and full address of the Certified seed producer.............................

Validity of certificate further extended up to ............................................

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Refusal for Certification

The certification Agency shall have the authority to refuse certification of

any seed production field or any seed lot that does not conform to the Minimum

standards prescribed for that particular crop, either for field or for seed or for both

Such refusal will be subject to any appeal made to the Appellate Authority

constituted under section 11(1) of the Seeds act, 1966. Validity Period of the Certificate

The validity period shall be nine months from the date of test at the time

of initial certification. The validity period could be further extended for six months

provided on retesting seed conforms to the prescribed standards in respect of

physical purity, germination and insect damage for all seeds except vegetatively

propagating material for which lot shall be re-examined for seed standards

specified for respective crop. A seed lot will be eligible for extension of the validity period as long as it

conforms to the prescribed standards

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CONCLUSION

Regulation is one of the important aspect to establish harmony in markets of all

the commodities including Agriculture commodities.

Regulation on National level prevents monopoly as well as provide maximum

sources for a consumer in both economic and social way.

At the level of the central government, the progress is quite satisfactory but State

governments need to supplement it by taking similar initiatives.

In Agriculture quarantine is one of the most important type of regulation

including restriction or rules for export and import of a plant material or related

crop varieties.

Certification of anything is perfect authentication for satisfaction of a user or

consumer. Seed certification is must for authentication of genetic and physical

purity of a seed.

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