Full Text
2099 GI/202 4 (1)
EXTRAORDINARY
PART II —Section 3 —Sub-section ( ii)
PUBLISHED BY AUTHORITY
No. 1410] NEW DELHI, TUESDAY , MARCH 19, 2024 /PHALGUNA 29, 1945
CG-DL-E-20032024-253249
(1) (2) (3) (4) (5)
3. 90 22 से 28
4. 120 33 से 37
5. 150 42 से 48
6. 180 50 से 53
(1) (2) (3) (4) (5) (6)
3. 180 60 50 से 53
4. 360 60
5. 540 60
6. 720 60
7. 900 20
8. 1080 20
MINISTRY OF FISHERIES, ANIMAL HUSBANDRY AND DAIRYING
(Department of Fisheries )
NOTIFICATION
New Delhi, the 15th March , 2024
S.O. 1 479(E).—In pursuance of section 3 of the Coastal Aquaculture Authority Act, 2005 (24 of 2005), read
with clause (d) of rule 3 of the Coastal Aquaculture Authority Rules, 2024, the Central Government hereby notifies
the following guidelines, namely: -
1. Short title and commencement. – (1) These guidelines may be called the Guidelines for the health
monitoring, disease s urveillance and Specific Pathogen Free certification of coastal aquaculture units and stocks in
India.
(2) They shall come into force from the date of their publication in the Official Gazette.
Guidelines for the health monitoring, disease surveillance a nd Specific Pathogen Free certification of
coastal aquaculture units and stocks in India.
1. Introduction. - These guidelines are not limited to but outlines broader requirements for the health
monitoring, disease surveillance and specific pathogen free cert ification of coastal aquaculture units and stocks
in India for safeguarding of the sector from the impact of diseases and pests, through risk analysis, risk
mitigation measures, inspection and certification, and implementation of mitigation response arrang ements for
Indian aquaculture sector.
2. Application. – (1) These guidelines shall apply to the coastal aquaculture units for which specific pathogen
free certification is mandatory under the rule 19 of the Coastal Aquaculture Authority Rules, 2024:
Provided that these guidelines shall also apply to other coastal aquaculture units including hatcheries which are
not covered under rule 19, but voluntarily opt for the specific pathogen free certification.
3. Biosecurity .- (1) The coastal aquaculture units shall ha ve adequate biosecurity which shall be a strategic and
integrated approach that analyse and manage risks in the life and health of candidate species including
associated environmental risk and the prevention of diseases in aquaculture.
(2) The operator of the coastal aquaculture units shall implement biosecurity measures, specific for each unit,
culture system and sanitary zone which may include the physical, chemical and biological methods necessary
to protect the facilities from the consequences of al l diseases that represent a high risk.
(3) The priority areas of strict biosecurity measures include the following, namely: -
(i) site or location;
(ii) water intake;
(iii) source water treatment;
(iv) compartmentalisation, zonation and physical separation or isolation with different levels of
biosecurity;
(v) sanitation and personnel hygiene;
(vi) movement of personnel between compartments and zones;
(vii) live or fresh or frozen feed sources;
(viii) introduction of new aquaculture sources or genetic materials;
(ix) dispatch and loading;
(x) entry and exi t of vehicle, personnel and visitors within and into the coastal aquaculture unit;
and
(xi) others as may be specified by the Authority from time to time.
4. Continuous health monitoring and disease surveillance. - (1) Any coastal aquaculture unit or stock shall be
certified as specific pathogen free, if -
(i) it has bio -secure facilities with appropriate water treatment within enclose environment;
(ii) it follows bio -secure management including bio -secure feeds;
(iii) it has tested negative for specific pathog ens for a continuous period of at least two years through a
surveillance programme.
(2) Any coastal aquaculture unit applying for specific pathogen free certification shall, -
(i) undertake continuous health monitoring and disease surveillance, to ensure f reedom from specific
pathogens of the candidate species on a continuous basis;
(ii) put in place necessary contingency plan so that prompt action can be carried out in controlling disease
outbreak and for preventing further spreading of disease.
(3) The coastal aquaculture unit shall be equipped with a wet lab and microbial pathology laboratories for
undertaking routine screening of the coastal aquaculture unit, water, animal, algae and other feeds to assess
the health status.
(4) The Central Government shall in consultation with the Technical Advisory Committee of the National
Surveillance Programme for Aquatic Animal Diseases, specify the pathogens of concern which are not
listed by World Organisation for Animal Health for each candidate species, metho dology or procedure and
assay of testing of that pathogen or any other matter connected therewith, and Microbiological Index for
each species -specific coastal aquaculture unit.
(5) Health monitoring and disease surveillance and testing shall be done on t he basis of procedures laid down
in Chapter 1.4 in Article 1.4.6 of Aquatic Animal Health Code on Disease Surveillance of World
Organisation for Animal Health .
(6) The procedure laid down in the Manual of Diagnostic Tests for Aquatic Animal of the World Organisation
for Animal Health shall be followed in all the testing procedures.
(7) The continuous health monitoring and disease surveillance shall be in two stages, namely: -
(i) a robust in -house health monitoring and disease surveillance programme inclu ding a verifiable in -house
biosecurity audit conducted by the operator himself; and
(ii) a chain of custody sampling and testing by the empanelled agency.
5. Verifiable in -house biosecurity audit. - (1) The operator of coastal aquaculture units shall implement a verifiable
in-house biosecurity audit to examine, how well those biosecurity measures are executed in such coastal
aquaculture units.
(2) The operator of coastal aquaculture units shall employ various levels, zones, compartments and strategies
for bios ecurity at the coastal aquaculture unit depending on the size and design of the facilities and the
diseases of concern.
(3) The operator of the coastal aquaculture units shall undertake a quarterly in -house evaluation of the
biosecurity measures being imp lemented in the coastal aquaculture unit by an expert and take such
necessary corrective action based on the audit report, required to ensure the biosecurity of the coastal
aquaculture unit.
(4) The quarterly audit report shall be made available for verif ication by the authorised personnel during
inspection and chain of custody sampling of the coastal aquaculture unit.
(5) A record of the biosecurity audit and the vetting of the same by the authorised personnel shall be
maintained as proof for specific pa thogen free certification.
6. In-house health monitoring and disease surveillance. - (1) The respective facilities shall implement an in -house
health monitoring and disease surveillance programme to monitor the health status and quality of their stocks with
appropriate frequency for sampling and testing and the results of the in -house monitoring shall be maintained
appropriately at the respective coastal aquaculture unit.
(2) The in -house health monitoring and disease surveillance involves three levels of e xamination, namely: -
(a) examination of stock for general health condition, sex determination, staging of ovarian development,
moult staging, removal of sick or moribund individuals;
(b) examination of larval stages by microscope, checking bacterial flora of norm al or moribund animals; and
(c) disease screening of brood stock and Parent Post Larvae by Polymerase Chain Reaction, histopathology
and or any other relevant advanced technique.
(3) The screening shall be conducted by qualified and certified technologists u sing latest Polymerase Chain Reaction
(PCR) or Real -time Reverse Transcriptase Polymerase Chain Reaction (RT -PCR) technique in accordance with the
procedures laid down in the latest World Organisation for Animal Health - Manual of Diagnostic Tests for Aqua tic
Animals.
(4) The frequency of sampling and sample size for each candidate species shall be as declared by the Authority.
(5) The general guide on the frequency of sampling with a sample size of twenty samples each during every sampling
for the mainten ance of in house disease surveillance protocol shall be as given in the table below:
Table -1
Screening
Number Screening
frequency
(Days of
Operation) Probable
range of
Weight. (g) Parameters to be tested Confirmatory
screening
(1) (2) (3) (4) (5)
1st 30 2 to 3 All pathogens listed by World
Organisation for Animal Health
and non listed pathogens of
concern specified by the Central
Government for the candidate
species concerned shall be
screened . Confirmatory
screening shall be
through
Histopathology an d
sequencing of
Polymerase Chain
Reaction products
following detection. 2nd 60 13 to 15
3rd 90 22 to 28
4th 120 33 to 37
5th 150 42 to 48
6th 180 50 to 53
(6) In the event of occurrence of any disease or pathogen, the operator of the coast al aquaculture unit shall
immediately isolate and contain the operation of such compartments in such a way as not to contaminate the
other areas of the coastal aquaculture unit and report the same to the Authority immediately.
7. Chain of custody sampling and testing:
A. Empaneled agencies for chain of custody sampling and testing. - (1) The Authority shall for the purpose of
chain of custody sampling and testing for specific diseases or pathogens of concern empanel and authorise any
Government or semi - Gove rnment Organisations including Indian Council of Agricultural Research - Central
Institute of Brackishwater Aquaculture, National Bureau of Fish Genetic Resources, Rajiv Gandhi Centre for
Aquaculture, Fisheries Universities, and World Organisation for An imal Health referral laboratories and private
agencies, if –
(i) they are accredited by National Accreditation Board for Testing and Calibration Laboratories;
(ii) they are qualified at the national or international ring test for multiple pathogens screen ing;
(iii) fulfill the terms and conditions and other criteria specified by the Authority for such empanelment.
(2) The Authority shall authorise the empaneled and authorised agencies following a roaster system to collect
samples for testing at specified intervals from the concerned units provided such collection of sample and
testing by an empanelled agency for two consecutive times from any coastal aquaculture unit shall be
avoided to ensure the transparency in the sampling and testing.
(3) The empanel led and authorised agency for chain of custody sampling and testing shall report their test results
as soon as available to the Authority, maintaining the confidentiality of the same.
(4) The samples shall be drawn, stored and tested by the authorised per sonnel or laboratory of empanelled and
authorised agency and the operator shall not in any way draw the sample and submit for third -party testing
under this programme.
(5) The empanelled agencies shall also be authorised to verify the quarterly in -house b iosecurity audit, the in -
house disease screening and their reports.
(6) The Authority shall fix a fee for chain of custody sample collection and testing and pay the same to the
empanelled agencies.
B. Disease surveillance process. - (1) The general guide on the frequency of sampling, sample size and maintenance
of in chain of custody sampling and testing protocol shall be as given in the table below:
Table -2
Screening
Number Screening frequency
(Days of Operation) Sample
Sets Probable
range of
Weight. (g) Parameters to be
tested Confirmatory
screening
(1) (2) (3) (4) (5) (6)
1st 30 60 2 to 3 All pathogens listed
by World
Organisation for
Animal Health and
non listed
pathogens of
concern specified
by the Central
Government for
the candidate
species concer ned
shall be screened. Confirmatory
screening shall be
through
Histopathology and
sequencing of
Polymerase Chain
Reaction products
following detection. 2nd 90 60 22 to 28
3rd 180 60 50 to 53
4th 360 60
5th 540 60
6th 720 60
specific path ogen free accreditation
7th 900 20
8th 1080 20
(2) The new coastal aquaculture units or facilities shall be scheduled for sampling during the 1st , 3rd , 6th , 12th,
18th, and 24th months and the sample size of initial 3 samplings of the 1st, 3rd and 6th months shall be with
60 sample sets each during each sampling.
(3) Surveillance and testing shall be continued at the 12th, 18th, and 24th months with 60 sample sets during each
sampling to acquire specific pathogen free certification or as sp ecified in Manual of Diagnostic Tests for
Aquatic Animals laid down by the World Organisation for Animal Health or as specified by the Authority.
(4) The sample size, frequency of sampling, Standard Operating Procedure for collection of samples, type,
methodology or procedure and assay of testing shall be as specified in Manual of Diagnostic Tests for Aquatic
Animals laid down by the World Organisation for Animal Health, to be specified by the Authority for each
candidate species and such sampling regime shall include all life stages available at the coastal aquaculture
unit.
(5) Upon successful specific pathogen free accreditation of the coastal aquaculture unit and the stock following
the chain of custody surveillance and testing for a continuous peri od of two years, it shall be scheduled once
in every six months with 20 sample sets each during each sampling or as specified in the Manual of
Diagnostic Tests for Aquatic Animals laid down by the World Organisation for Animal Health or as specified
by th e Authority.
(6) In the event of occurrence of a disease, or on affirmative positive sample set reported by the empanelled
agency or by the operator, the referral laboratory shall be notified at the shortest time possible by the operator
or empanelled age ncy or the Authority to confirm the same and the operation of the unit shall be suspended by
the Authority pending confirmation by the referral laboratory.
(7) On confirmation of occurrence of any disease or of a confirmative positive sample set by the r eferral
laboratory, the Authority shall engage with the Technical Advisory Committee and shall subject the infected
coastal aquaculture unit for inspection by a sub -committee of experts to ensure the biosecurity arrangements
and shall cause the coastal aqu aculture unit to destroy the entire infected stock and incinerate the same in their
presence to contain the spread of the infection.
(8) In the event of occurrence of disease or of a confirmative positive sample set by the referral laboratory in a
particu lar compartment, the Authority shall decide on the vigorous chain of custody sampling and testing to
ensure that the other compartments in the coastal aquaculture unit are free from the said infection, provided
there are sufficient biosecurity measures in place to prevent such contamination and any additional fee or
charges as decided by the Authority for the same shall be collected from the operator of the coastal
aquaculture unit.
8. Manner of certification. - (1) The coastal aquaculture units or stocks sh all be subjected to the disease surveillance
for the purpose of specific pathogen free certification as illustrated in the Annexure to this Guidelines.
(2) The operator of any coastal aquaculture unit engaged in the production of specific pathogen free s tocks of
finfish or shellfish or any aquatic organisms shall apply for the specific pathogen free certification of the
coastal aquaculture unit and stocks contained in it.
(3) The fee or charge for health monitoring, disease surveillance and specific path ogen free certification shall be
fixed by the Authority and shall be paid in advance by the operator of the coastal aquaculture unit concerned
to the Authority.
(4) Candidate species used for stocking in this coastal aquaculture unit must originate from a certified specific
pathogen free coastal aquaculture unit.
(5) In the case of new coastal aquaculture unit or, as the case may be, a unit which resumes its operation after
stoppage due to infection, the coastal aquaculture unit shall be allowed to sell o r ship or export the candidate
species as high health stock with health documents on successful completion of three negative sample sets
during the 1st, 3rd and 6th months with 60 sample sets each but such stocks shall not be certified as specific
pathogen free stocks.
(6) On successful completion of the 12th, 18th and 24th months with 60 sample sets each, tested negative within a
continuous period of two years, the stock and the coastal aquaculture unit shall be accredited with specific
pathogen free sta tus.
(7) The accreditation of specific pathogen free status to the coastal aquaculture unit and authorisation to sell the
stocks as high health or specific pathogen free shall be issued by the Central Government.
(8) In the event of occurrence of a disea se or confirmatory positive sample set, the specific pathogen free status
of the coastal aquaculture unit and stocks shall automatically stands withdrawn.
(9) The coastal aquaculture unit with a confirmatory positive sample set shall shutdown the operatio n and follow
the disinfection and dry out process of the compartment or the entire coastal aquaculture unit, as the case may
be, for a period of one month and shall start the operation and the process of health monitoring and disease
surveillance for speci fic pathogen free certification afresh.
9. Monitoring and regulation :
(A). Coastal Aquaculture Authority .- The Authority shall be the competent authority for the following matters,
namely: -
(i) empanelment of agencies for the chain of custody sampling and testing;
(ii) terms and conditions of empanelment;
(iii) creation of roaster of empaneled agencies for chain of custody sampling and testing;
(iv) fixation of any fee or charges under this programme;
(v) the sample size, frequency of sampling, Standard Operating Procedures for collection of samples;
(vi) scrutiny of test reports and recommendation;
(vii) coordination and follow up measures in case of a disease occurrence or a positive sample set;
(viii) suspension of the activity of the coastal aquaculture unit in the event of a disease occur rence or confirmatory
positive sample set; and
(ix) any other administrative and operational matters.
(B). Referral laboratories. -
(1) The Central Government shall notify the list of referral laboratories from time to time.
(2) In order to qualify for participat ing in the specific pathogen free certification programme, the laboratory shall
be National Accreditation Board for Testing and Calibration Laboratories accredited and shall qualify in the
national or international ring test for multiple pathogen screening of fish and aquatic organisms, unless it is
exempted from such conditions by the Central Government.
(3) The cost of the travel by the authorised personnel of the referral laboratory for the sample collection and
testing shall be incurred by the respective in stitutions or organisation.
(C). Technical Advisory Committee. - (1) The Technical Advisory Committee constituted by the Central
Government under rule 19 of the Coastal Aquaculture Authority Rules, 2024 shall oversee the implementation
of the health monito ring, disease surveillance and specific pathogen free certification programme.
(2) The Technical Advisory Committee shall assist the Authority in deciding on the matters relating to fixation of
the sample size, frequency of sampling, Standard Operating Pro cedures for collection of samples, fixation of
fee or charges, constitution of sub -committees for inspection and culling of the infected stocks, suspension of
activity of a coastal aquaculture unit in part or full in the event of disease detection, grievan ce redressal and
dispute under this programme.
(3) Appeal, if any, on the decision of the Authority shall be made to the Central Government and the decision of
the Central Government shall be final.
[F. No. j-1903336/2/2024 -DOF (E -23648) ]
NEETU KUMARI PRAS AD, J t. Secy .
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