establishment and operation of Nucleus Breeding Centre and Broodstock Multiplication Centres in India

2071 GI/202 4 (1) EXTRAORDINARY PART II —Section 3 —Sub-section ( ii) PUBLISHED BY AUTHORITY No. 1393] NEW DELHI, SATURDAY , MARCH 1 6, 2024 /PHALGUNA 26, 1945 CG-DL-E-18032024-253180 1. MINISTRY OF FISHERIES, ANIMAL HUSBANDRY AND DAIRYING (Departmen t of Fisheries ) NOTIFICATION New Delhi, the 15th March , 2024 S.O. 1 459(E).—In pursuance of section 3 of the Coastal Aquaculture Authority Act, 2005 (24 of 2005), read with clause (f) of rule 3 of the Coastal Aquaculture Authority Rules, 2024, the Central G overnment hereby notifies the following guidelines, namely: - 1. Short title and commencement. – (1) These guidelines may be called the Guidelines for establishment and operation of Nucleus Breeding Centre and Broodstock Multiplication Centres in India. (2) They shall come into force from the date of their publication in the Official Gazette. Guidelines for establishment and operation of Nucleus Breeding Centre and Broodstock Multiplication Centres in India. 1. Application. - (1) These guidelines lay down norms and procedure to govern the establishment and operation of Nucleus Breeding Centres and Broodstock Multiplication Centres in the coastal areas for the production of disease free broodstocks . (2) The Nucleus Breeding Centres and Broodstock Multiplic ation Centres for any candidate species including Litopenaeus vannamei or Paneaus monodon or Paneaus indicus , finfishes such as Sea Bass or Cobia or Pompano or Grouper and Fresh water prawn Macrobrachium rosenbergii to establish the improvised specific pathogen free or specific pathogen tolerant or specific pathogen resistant brood bank to harness the potential of coastal aquaculture shall be considered under these guidelines with appropriate biosecurity, genetic improvement and sustainability measures inc luding environmental safeguards. 2. Eligibility. - (1) The Nucleus Breeding Centres and Broodstock Multiplication Centres shall be established for increasing production and productivity of the coastal aquaculture sector in India by any existing producers of specific pathogen free or specific pathogen tolerant or specific pathogen resistant broodstock as well those involved in domestication and breeding programmes of any potential candidate species for coastal aquaculture either from India or from overseas eith er independently or through a joint venture with the local partner from the India. (2) An applicant organization possesses the requisite experience and capabilities required for establishment and operation of Nucleus Breeding Centres or Broodstock Multipli cation Centres may apply in Form - F-1 either individually (as sole organisation) or as lead partner of a consortium of organisations (as lead partner) as per the extant rules, regulations and procedure in force. (3) The Applica nts shall individually or collectively possess the following technical capacity and experience, namely: - (i) have successfully designed and operated a Nucleus Breeding Centres or Broodstock Multiplication Centres for Litopenaeus vannamei or any such other fish or shrimp species which has developed and maintained a minimum of 5 generations; and (ii) have successfully developed and managed a minimum of 50 families of Litopenaeus vannamei or any such other fish or shrimp species, through its own research and development activities, in the last ten years. (4) The applicants must have been engaged in the establishment and operation of at least one Nucleus Breeding Centres or Broodstock Multiplication Centres assignment within the last five years preceding th e date of application and submit details thereof. (5) The Genetic Improvement Programs and Nucleus Breeding Centre under the Government shall be encouraged through Indian Council of Agricultural Research under the Department of Agricultural Research and E ducation on a convergence mode with the other Ministries and Department of Government of India including organization and other entities under them, the State or union territory Governments and private entrepreneurs. 3. Prior permission for establishing Nucle us Breeding Centres or Broodstock Multiplication Centres. - (1) The prior permission for establishing the Nucleus Breeding Centres or Broodstock Multiplication Centres upon an application made under rule,11 of the said rules, shal l be granted by the Central Government in the Department of Fisheries, Ministry of Fisheries Animal Husbandry and Dairying, based on the recommendations of a Project Screening Committee consisting of the following members, namely: - (i) Joint Secretary (Marine Fisheries), Department of Fisheries - Chairperson (ii) Secretary, Coastal Aquaculture Authority - Member (iii) Director, Indian Council of Agricultural Research - National Bureau of Fish Genetic Resources - Member (iv) Director, Indian Council of Agricultural Research - Central Institute of Brackishwater Aquaculture - Member (v) Director, Indian Council of Agricultural Research - Central Marine Fisheries Research Institute - Member (vi) Representative from Department of Ec onomic Affairs or Corporate Affairs - Member (vii) Project Director, Marine Product Export Development Authority - Rajiv Gandhi Centre for Aquaculture - Member (2) The application under rule,11 of said rules shall contain but not limited to the following, namely: - (i) general background and overview of the individual firm or consortium; (ii) statement of qualification; (iii) understanding of the assignment and scope; (iv) work methodology; (v) detailed mile stones; (vi) domestic and international experience in design and operation of a Nucleus Breeding Centre or a breeding programme (if any); (vii) professional and local partners (if any); (viii) technical team strength; (ix) details of technology; (x) valid certificates of freedom from disease from the comp etent authority of the Government issued in accordance with the World Organization for Animal Health Code, for the facilities operated by the applicants. (3) The Project Screening Committee shall be assisted by a Technical and Inspection Committee to be c onstituted by an order of the Central Government . (4) The Project Screening Committee shall scrutinize the applications received from time to time and subject project site for physical verification and on -site inspection by the Technical and Inspection Co mmittee. (5) The Technical and Inspection Committee shall conduct a physical verification and on -site inspection and submit its report on the suitability of the site proposed for establishment of Nucleus Breeding Centres or Broodstock Multiplication Centr es before the concept presentation by the applicant. (6) The Project Screening Committee shall scrutinize the applications received from time to time and evaluate them through a concept presentation made by the applicant on the scheme of development coveri ng the following aspects, namely: - (i) brief background of the applicants and the details of Nucleus Breeding Centres or Broodstock Multiplication Centres being operated by the applicants, as well as experience, if any, of having provided services in any other project; (ii) conceptual plans of the project including preliminary lay out and site plan, floor plans, elevations, sections wherever necessary; (iii) indicative area allocation for the different zones of the Nucleus Breeding Centres or Broodstock Multiplication Centres ; (iv) expected features and functionalities of the proposed Nucleus Breeding Centres or Broodstock Multiplication Centres ; (v) preliminary cost estimates for the development of project; (vi) proposed selective breeding strategy that the applicant seeks to implement including physical growth, freedom from disease with disease tolerance characteristics and reproductive performance; (vii) analysis of the historical outcomes of the research & development undertaken by the applicants; (viii) presentation of the Standard Operating Procedure and manuals to be prepared for the project by the applicants and the procedure to be adopted for developing distinct families with least inbreeding. (ix) advantages of the technology and bio -security bein g provided by the applicants and the rationale and benefits of such an approach. (7) The Project Screening Committee shall make its recommendation based on the report of the Technical and Inspection Committee and the concept presentation to the Department of Fisheries for grant of prior permission or otherwise by the competent authority to establish Nucleus Breeding Centres or Broodstock Multiplication Centres . (8) The decision of the competent authority shall be conveyed to the applicant within ninety da ys from the date of receipt of application. 4. General requirements. - (1) There shall be no aquaculture activities or Fish Landing Centres or any other source of direct contamination within a radius of 1000 meters (one kilometer) from the site selected for th e establishment of the Nucleus Breeding Centres or the Broodstock Multiplication Centres . (2) The Nucleus Breeding Centres and Broodstock Multiplication Centres shall be in separate locations and in case there is substantial cause, they may coexist wit hin the same site with adequate physical separation and isolation from each other with independent water supply and discharge. (3) There shall be adequate biosecurity measures to analyze and manage risks in the life and health of candidate species includi ng associated environmental risk for the prevention of diseases in aquaculture. (4) The Nucleus Breeding Centres and Broodstock Multiplication Centres shall comply with the requirements for biosecurity, in -house biosecurity audit, in house health monitori ng and disease surveillance and chain of custody sampling and testing as specified in the Guidelines for the Health Monitoring, Disease Surveillance and Specific Pathogen Free Certification of Coastal Aquaculture Units and Stocks in India and Aquatic Anima l Health Code of World Organisation for Animal Health. 5. Infrastructure requirement . - The Nucleus Breeding Centres or Broodstock Multiplication Centres shall have sufficient infrastructure including the following for ensuring complete biosecurity, namely: - (i) the basic infrastructure including indoor rearing tanks in accordance with the annual broodstock production of the Broodstock Multiplication Centres or with the minimum number of founder families to be maintained at the Nucleus Breeding Centres ; (ii) in-house primary and secondary quarantine, with dedicated water supply, aeration and drainage system to avoid any cross contamination; (iii) a completely bio -secure production area with compound wall on the perimeter, shower and change room for entry, disinfection for men, materials and vehicles, isolation of entry and exit to avoid crisscrossing, compartmentalization of rearing units with adequate physical separation and packing facility; (iv) biosecured water supply and aeration system with double line; (v) completely covered the drainage system with provision for disinfection of the drainage water at each compartment; (vi) adequate temperature -controlled storage for biosecured feeds; (vii) intake water treatment facilities with sufficient capacity reser voirs, different types of filters and mandatory sterilisation of intake water using Ultra Violet or ozonization; (viii) an Effluent Treatment System with adequate capacity to ensure that no water is discharged without disinfection of the same; (ix) a fully equipped disease diagnostic laboratory with stock of all required primers as well as qualified and trained technicians; (x) capacity to carry out genomic analysis in the case of Nucleus Breeding Centres; (xi) a full - fledged facility for incineration of dead or diseased animals; (xii) a full fledged Specific Pathogen Free algal culture system. 6. Source material or germplasm and selective breeding programme. - (1) The Nucleus Breeding Centres facility shall implement its own scientifically documented selective breeding programme to develop a robust candidate species with a high level of genetic diversity, whilst maintaining high growth potential freedom from disease with disease tolerance characteristics and reproductive performance. (2) The founder families of highly genetically diverse breeders shall either be obtained from another breeding programme or wild or farmed stocks covering a range of environmental conditions. The new population from the wild shall be cleaned up through multiple quarantine and scre ening process. (3) The Nucleus Breeding Centres shall implement genetic improvement programs including family and within family breeding program, combined family and within -family selection scheme with the founder families which shall focus on improving size at harvest, survival rate and freedom or tolerance or resistance to listed diseases. (4) Appropriate measures including pedigree analysis shall be implemented to contain the accumulation of inbreeding whilst maintaining genetic integrity and variabil ity. (5) The Nucleus Breeding Centres shall to the extent possible trace the genetic relationships among breeding candidates and test animals by Deoxyribonucleic acid based parental assignment to have a Deoxyribonucleic acid profile of the populations. (6) With parental assignment by Deoxyribonucleic acid, animals belonging to different families shall be pooled shortly after tagging. (7) Candidate species used for stocking in any Broodstock Multiplication Centres shall originate from a certified Speci fic Pathogen Free coastal aquaculture unit. (8) The Broodstock Multiplication Centres shall have a reliable supply of Specific Pathogen Free parent post larvae from an established Nucleus Breeding Centre located in India or overseas. (9) In the case of Indigenous Domesticated Broodstock of wild type or which has or not undergoes genetic improvement, the Nucleus Breeding Centre must maintain the disease free, tested and clean broodstock which should be source of supply to Broodstock Multiplication Centr e. Broodstock Multiplication Centre must maintain the clean broodstock status for the seed supply down the line for aquaculture. 7. Import of source material and Quarantine. -(1) The Nucleus Breeding Centre or Broodstock Multiplication Centre may import th e source material either Broodstock or parent post larvae as the case may be, including those required for sentinel trials, as the case may be from the designated empaneled supplier of the respective Nucleus Breeding Centre or Broodstock Multiplication Centre every month subject to the availability of quarantine space at the aquatic quarantine facility. (2) In case of any change of designated supplier, the matter shall be referred to the Authority for consideration: Provided that the Broodstock Multipli cation Centre shall operate with the source material imported from one single designated empanelled supplier at any given point in time. (3) The imported source material shall be subjected to quarantine at the aquatic quarantine facility for a period as may be specified by the Authority or the Central Government, for such source material. (4) The imported source material shall undergo the required quarantine process at the in -house quarantine facility of the Nucleus Breeding Centres or Broodstock Multip lication Centres for period not less than one month to avoid any possible external contamination. (5) The imported source material shall be screened for all World Organisation for Animal Health listed pathogens for the candidate species concerned in addit ion to the pathogens of concern if any specified by the Authority or the Central Government. (6) The Central Government may from time to time specify the pathogens of concern, methodology or procedure and assay of testing of that pathogen or any other mat ter connected therewith, Microbiological Index for each species -specific coastal aquaculture unit, in consultation with the technical advisory committee constituted for the purpose. 8. Monitoring and regulation of Nucleus Breeding Centre or Broodstock Multip lication Centre. - (1) The Nucleus Breeding Centre or Broodstock Multiplication Centre shall comply with provisions of the Guidelines for the Health Monitoring, Disease Surveillance and specific pathogen free certification of coastal aquaculture units and s tocks in India. (2) The Nucleus Breeding Centres shall keep the average rate of inbreeding per generation in the target lines selected for specific traits to suit the environment where they will be grown at low ranging between from 0.25 to 0.50 percent. (3) The Nucleus Breeding Centres shall ensure that genetic gain per generation for growth or any other selected parameter is increased substantially. (4) The Nucleus Breeding Centres shall maintain the records of performance analysis including the follow ing namely: (i) completed generations of selection based on performance data from full -sib families; (ii) heritability estimates such as harvest weight, general survival, freedom from specific disease, resistance or tolerance to specific disease etc.; (iii) genetics trend analyses for average selection response per generation. (5) The Nucleus Breeding Centres or Broodstock Multiplication Centres shall supply certified High Health or specific pathogen free broodstock or source material alone to the coasta l aquaculture units registered with the Authority or States, in a fair and transparent manner and the Broodstock Multiplication Centre shall maintain a record of such sales. (6) The Broodstock Multiplication Centre operator shall maintain a detailed recor d of the growth, survival, disease occurrence of the shrimp population during rearing. (7) The approved Nucleus Breeding Centres or Broodstock Multiplication Centres shall pay monitoring fee as prescribed by the Authority and shall deposit a performance b ank guarantee for rupees five lakh in favour of the Costal Aquaculture Authority to ensure compliance of the guidelines by them and in the event of any violation the Bank Guarantee shall be invoked. (8) The non -compliance, if any, on the part of the Nucl eus Breeding Centres or Broodstock Multiplication Centres or its operator, the performance Bank Guarantee shall be invoked and shall be liable for suspension or cancellation of the registration in accordance with the provisions of section 14 of the said Act. Form - F-1 Application for prior permission to establish Nucleus Breeding Centre or Broodstock Multiplication Centre I. Name of the candidate species II Prior permission sought to establish Nucleus Breeding Centre or Broodstock Multiplication Centr e III. Details of the proposing firm or consortium: 1. Name of the applicant (s) or firm (s) (Separate sheet may be attached for each member in case of consortium) 2. Address 3. Date of incorporation and registration details 4. Field of opera tion 6. Details of Board of Directors and Managing Director with copy of Memorandum of Association or Memorandum of Article 7. Certified a Audited financial statement of the firm for the last three years IV. Statement of qu alification 1. Number of years of experience in the operation of Nucleus Breeding Centre or Broodstock Multiplication Centre 2. Number of Nucleus Breeding Centre or Broodstock Multiplication Centre designed or operated, candidate species and Number o f families developed and maintained in the last ten years (attach separate sheet) 3. Number of families developed and maintained through own research and development activities in the last ten years V. Details of source material: 1. Name of the overs eas Specific Pathogen Free Facility 2. Address (including email ID) 3. Details of the firm: 4. Country of registration 5. Location of the facility 6. Terms and conditions of agreement with the Indian firms 7. Details of extent of commercial supply of Specific Pathogen Free broodstock 8. Details of any other Nucleus Breeding Centre or Broodstock Multiplication Centre operated in any other country 9. Reproductive performance of Specific Pathogen Free broodstock of the firm in terms of Size at maturity, latency period for maturation, fecundity, Number of spawning per female, hatching rate and survival rate at different stages 10. Performance of the stock in commercial culture for growth and disease 11. Copy of the Memorandum of Understand ing or agreement indicating a firm commitment for the supply of source material as per the requirement is to be enclosed. VI. Detailed infrastructure and personnel of overseas Specific Pathogen Free facility 1. Lay-out plan of the Specific Pathogen Free facility (attach diagram with explanation) 2. Water treatment and supply 3. Rearing facilities 4. Laboratory facilities 5. Biosecurity (disinfection protocol, shower room, fencing, etc.) 6. Number of technical staff and details of their expe rtise (Attach biodata) 7. Financial status for last three years alongwith audited statement VII. Disease surveillance at the Specific Pathogen Free facility 1. List of pathogens excluded in the facility 2. Methodology followed for the diagnosis (or diagnostic protocols followed) 3. Certificate (issued by Government) of disease free nature of the facility for the last two years to be enclosed 4. Frequency of surveillance 5. Details of the diagnostic reports during the recent surveillance from a Government authorised or World Organisation for Animal Health referral laboratory VIII. Details of selective breeding programme 1. Source of Founder population (Number of geographic location or number of Specific Pathogen Free facilities sourced) 2. Genetic divergence of the population (Number of families from each location or each Specific Pathogen Free facility. 3. Frequency of introduction of further families into founder population 4. Type of selection programme followed 5. Number of lines and Number of families maintained 6. Number of generations raised 7. Minimum effective population size over the generations 8. Traits considered for selection 9. Genetic gain over the generations 10. Name and brief bio-data of the geneticist involved in drafting the breeding plan 11. Breeding plan indicating the specific details to avoid inbreeding IX. Details of Indian Broodstock Multiplication Centre facility 1. Annual capacity proposed (Number of broodstock per year) 2. Requirements of Specific Pathogen Free Post Larvae and the frequency of import 3. Number of months of rearing proposed 4. Survival anticipated during rearing from Post Larvae to broodstock X. Infrastructure facilities proposed 1. Land area 2. Location 3. Whe ther any existing facility is being remodeled as Broodstock Multiplication Centre ? If so, indicate its prior use and the present condition 4. Distance between the nearest hatchery or farm 5. Lay-out plan of the posed facility indicating the quarantine , water intake and treatment; rearing tanks under closed conditions, biosecurity features, Effluent Treatment System, etc., indicate the capacity and number of tanks (attach diagram with explanation) 6. Details of the diagnostic laboratory facility 7. Brief cost estimates and source of funding 8. Technical staff proposed to be involved in the operation of Broodstock Multiplication Centre and their brief bio-data indicating their area of expertise 9. List of pathogens proposed to be tested in the Broodstock Multiplication Centre and the surveillance protocol to be followed 10. Sampling details 11. Frequency of sampling and testing XI. Any other particulars or details [F. No. j-1903336/2/2024 -DOF (E -23648) ] NEETU KUMARI PRASAD, J t. Secy. Uploaded by Dte. of Printing at Government of India Press, Ring R oad, Mayapuri, New Delhi -110064 and Published by the Controller of Publications, Delhi -110054.