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(2)They shall come into force on the date of their publication in the Official Gazette.
2. Definitions.—(1) In these rules, unless the context otherwise requires,—
(a) "Act" means the Atomic Energy Act, 1962 (33 of 1962);
(b) "applicant" means the person making an application for grant of licence under rule 3;
(c) "certificate of radiation processing" means a certificate issued by the licensee to the effect that the food and allied products have been processed by radiation;
(d) "dosimetry" means a system adopted to measure the absorbed radiation dose by the food and allied products;
(c) "facility" means the radiation processing facility for food and allied products; t-Tocidlnd allied products" means any food and allied products that could be processed by radiation and as notified by the Central Government;
(g) "licence" means the licence issued under rule 3;
(h) "radiation processing" means processing of food and allied products by radiation.
(2) Words and expressions used in these rules and not defined but defined in the Act shall have the meanings assigned to them in the Act, 3, Ciondition for operating a facility.—No person shall operate a facility without obtaining a licence for radiation processing of food and allied products under these rules.
4. Application far licence.--(I) An application for licence to operate a facility shall be made to the Central t ov anon: rit in Fonn-1.
(2) Fvcry application under sub-rule (1) shall be accompanied by -
(a) a licence fee of rupees ten thousand payable by bank draft; and
(b) a certified copy of the licence issued under rule 3 of the Atomic litergy (Radiation Protection) Rules,
2004. S. lieenee.--(1) Where the Central Government, is satisfied that
(i) the application is complete in all respects; and
(1) requirements of rule 4 are complied with; shall, within a period of one month from the date of receipt and subject to the terms and conditions specified in rule 6, grant licence to Ole applicant.
(2) Where the Central Government is not satisfied, it may, after giving the applicant a reasonable opportunity of being heard. refuse to grant the licence by an order in writing setting forth the reasons for its refusal.
(3) Every order under sub-rule (I) or sub-rule (2) shall be communicated to the applicant within a period nforic month from the date of order by sending a copy of such order by registered post on the address mentioned in the application.
(4) The licence issued under sub-rule ( 1 ) shall be valid for a period of five years from the date of issue.
6. Terms and conditions of licence.---The licensee shall - -
(a) operate the facility using one of the following sources;
(i) Gamma radiation;
(ii) Electron beams from a machine operated at or below ten million electron volts:
(iii) X-rays generated from a machine operated at or below seven and half mill ion electron volts;
(b) process food and allied products within the absorbed dose limits as specified in Schedule land Schedule II, It) use packaging material suitable for radiation processing of food and allied products as specified in Schedule III; 0/3 70i1Eit2.-3
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(d) carry out dosimetry as specified in Schedule IV.
(e) affix the following label on the package to indicate the product processed by radiation :— PROCESSED BY RADIATION NAME OF THE PRODUCT : PURPOSE OF RADIATION PROCESSING OPERATING LICENCE NO. BATCH ID tt CATION NO. (BIN) (as provided by facility) DATE OF PROCESSING appoint personnel having such qualification and have undergone such training as may be recognised by the Atomic Energy Regulatory Board for operation of the facility;
(g) maintain product processing record in Form II for a period of five years and issue a certificate of radiation processing; (10 provide security to the.facility at all times;
(i) hold a valid licence under Atomic Energy (Radiation Protection) Rules, 2(144, and
(j) hold a valid licence under the Prevention of Food Adulteration Act, 1954.
7. Inspection.--(1) Any person duly authorised under sub•section (4) of section 17 of the Act may, for the purposes of enforcement of these rules, inspect the facility.
(2) For the purpose of carrying out inspection, the person authorised under sub-rule (1) shall have access to any place within the facility and to all documents and records relating to the radiation processing of food and allied products.
(3) The person authorised under sub-rule (1) shall have powers to verify that the—
(a) facility is operated using sources specified under clause (a) rule 6;
(b) competent personnel are appointed by the licencee for the operation, quality control, safety and security of the facility;
(c) specified packaging material is being used;
(d) specified dosimetry system is used;
(c) specified radiation doses are applied; (0 specified label is affixed; and
(g) documents and records are properly maintained.
(4) The Central Government shall have power to issue, to the licencee, such directions as it may deem fit, fix taking corrective actions.
8. Cancellation of licence.—The Central Government may cancel the licence granted under rule 5 if the licencee has failed to comply with—
(a) any of the terms and conditions of licence specified in rule 6; or
(b) the directions issued under sub-rule (4) of rule 7 :
Provided that no licence shall be so cancelled, unless a reasonable opportunity of being heard has been afforded to the licencee. i) Farm `I' (see rule 4) APPLICATION FORM FOR LICENCE/RENEWAL OF LICENCE I. Naine of the applicant in full (in capital letters) Designation of the applicant Telephone No. (0) (R) Fax No. Mobile No. Email Address of the Applicant :
2. Detail of the facility :
(a) Name and address of the facility with pin code: Telephone Nos. (including Control Room) : Fax No
(b) Identification (ID) number of the facility: [issued under Atomic Energy (Radiation Protection) Rules, 2004)
(c) Proposed date of commissioning of the facility:
(d) Categoryof the facility:
(e) Purpose for which Class of food and allied product the facility will be used: (I) Radiation source details: . Name of source Maximum designed activity (P&)/Energy (MeV)/Power (kW)
(g) Name and address of the source supplier : Telephone No. Fax No. E-mail
3. Details of the payment of application fee: Demand DraftNo- Date of issuance: Issuing bank and branch: Amount: Rs.
4. 1/We hereby undertake that-
(i) No operations shall be carried out for purposes other than those specified under item 2(c) above
(ii) All applicable provisions of the Atomic Energy Act, 1962 and the rules made thereunder shall be complied with,
(iii) The radiation processing facility shall not be transferred/decommissioned without the prior permission of the authority issuing a license,
(iv) All directions that may be made from time to time by the authority issuing license shall be complied with,
(v) Any change in the information furnished above shall be communicated to the authority issuing license within 30 days from the date of its occurrence,
(vi) In case of any unforeseen circumstances resulting in threat to safety and security of the gamma radiation source, I will arrange to return the source to the supplier at my cost. It is hereby declared that all statements made above are correct to the best of my knowledge and belief. Place: Signature: Date: Name and designation of the applicant:
(12) Fenn [sec clause (g) of rule 61 Product Processing Record Name of the facility : Identification Number : Sr. No. Particulars Name of the product
2. Date and time o freceipt
3. Quantity (Metric ion)
4. Mode of transport (Vehicle Registration Number)
5. Packaging material () Primary
(a) Secondary
6. Ilateh/lot Number 7, Remarks on quality of received product & Name and Address of the customer
(i) Food and Drug Administration/ I .oan licence number
(ii) Issuing authority for loan licence (ifapplicablc)
(iii) Date of issue
(iv) Period of validity
9. Purpose of radiation processing IQ Dose (0 Dose desired by customer
(ii) Whether this dose is within the range notified by the Government of India
(iii) If 'NO' then provide country of destination
(iv) Customer has provided information that the dose desired by him is acceptable as per the legal provisions in the country mentioned (iii)
11. Date and time of processing
12. Dosimeter used
13. Dose delivered 1) /D. ma RIM .14. Labelling details
15. Serial number of ccrti (Icate trf radiation processing
16. Remarks on processed product
17. Date and time of delivery to the customer
18. Destination
(1) Shipping dctails/date of dispatch
(ti) Mode of transport (vehicle Registration Number)
19. General remarks, ifany; and signature of
(i) Quality Control Officer
(ii) Authorized signatory (Licensee or his authorized nominee) Schedule - I sce clause (b) of rule 6J Classes of Food Products and Dose I,imits for Radiation Processing lass Food t 1 Bulbs, stem and root tubers and rhizomes ('lass 2 Fresh fruits and vegetables (other than Class I) (lass 3 Cereals and their milled products, pulses and their milled products, nuts, oil seeds, dried fruits and their products ('lass 4 Fish, aquaculturc, seafood and their products (fresh or frozen) and crustaceans Clas's 5 Meat and meat products including poultry (fresh and frozen) and eggs Class 6 Dry vegetables, seasonings, spices, condiments, dry herbs and their products, tea, coffee, cocoa and plant products Class 7 Dried foods o f animal origin and their products ('lass a Ethnic foods, military rations, space foods, ready-to-cat, readyto-cook/minimally processed foods Purpose Dose limit (KiloGray) Minimum Maximum Inhibit sprouting 0.02 02 Delay ripening 0.2 ' 10 Insect disinfestation 0.2 1.0 Shelf-life extension 1.0 23 Quarantine application 0.1 ID Insect disinfcstation 0.25 1.0 Reduction of microbial load
1.5 5.0 Elimination of 1.0 7.0 pathogenic microorganisms 1 Shelf-life extension 1.0 30 Control of human parasites
0.3 2.0 Elimination of pathogenic microorganisms
1.0 7.0 Shelf-life cxtensinn 1.0 30 Control ofhuman parasites
0.3 213 Microbial decontamination
6.0 140 Insect disin festation 0.3 1,0 Insect disinfestation 0.3 1.0 Control of moulds 1,0 3.0 Elimination of pathogenic microorganisms
2.0 7.0 Quarantine application
0.25 I Reduction of microorganisms 2 10 Sterilization 5 25 ; 23 70191/12-4
(14)
SCHEDULE• [see clause (b) of rule 61 Dose Limits for Radiation Processing of Allied Products Sr.No. Allied product Purpose Dose limits (KiloGray) 1%Gnimum Maximum 2 3 4 5
1. Animal food and feed Insect disinfestation 0.25 Microbial decontamination 5.0 10.0
2. Ayurvedie herbs and Insect disinfcstation 0.25 1.0 their products, and Microbial decontamination 5.0 10.0 medicines Sterilization 10 -is
3. Packaging materials for Microbial dcconta tion 5.0 foodiallied products Sterilization 10
4. Food additives insect disinfcstation 0.25 1.0 Microbial decontamination 5.0 10.0 Sterilization 10 25
5. Health foods, dietary Insect disinfcstation 025 1.0 supplement and Microbial decontamination 5.0 10.0 nutraceuticals Sterilization 10 -Ps b. Bodyeare and cleansing Microbial decontamination 5.0 10.0 products Sterilization 10
7. Cut flowers Quarantine application 0.25 IA) Shelf-life extension 0.25 1.0
SCHEDULE-Ill One clause (c) of rule 61 Packaging Material for Radiation Processing of Food and Allied Products Sr. No. Packaging material Maximum tolerable dose KiloGray 2 3
0.5 Kraft paper (flour packaging only)
2. Iliaxially oriented polypropylene (BOPP) 10
3. Cardboard cartons with polyethylene liners 10 4 Cardboard kegs 10 5, Glassine paper 10
6. 1 lessain sacks 10
7. Multiply paper sacks 10 11, Multiply paper sacks with polyethylene liners 10 9, Nitrocellulose coated cellophane 10
10. Nylon-11 10
11. Polycthylcnc tcrephthal ate film cantaining coatings comprising a vinylidinc chloride co-polymer with one or more of the following co. monomers : 10 acrylic acid, aerylonitrile, itaeonic acid, methyl acrylate, and methyl mcthacrylale
12. Polyethylene tercphthalatc film cantaining coatings of polyethylene 10
13. Polyolcfm film (e.g. Polyethylene. BOPP) 10
(15) 1 3 I 4. Polyolefin film containing coatings comprising a vinylidinc chloride co-polymer with one or more of the following co-monomers : acrylic acid, acrylonitrile, itaconic acid, methyl acrylate, and methyl methacrylate 10
15. Polystyrene film 10
16. Rubber hydrochloride film 10 7, Vinylidcnc chloride copolymer-coated cellophane 10
18. Vinylidene chloride-vinyl chloride co-polymer 10
19. Wax-coated paperboard 10
20. Woven polypropylene sacks 10
21. Polyethylene coated multiply paper sacks 10
22. Ethylene vinyl acetate co-polymer film 30 21 Polyethylene polyester laminates 30
24. Nylon-6 film 60
25. Polyethylene film CO
26. Polyethylene tercplithalatc film 03
27. Vegetable parchment CO n. Vinyl chloride-vinyl acetate co-polymer 60
29. A eryloniirile copolymers
SCHEDULE-1V (sec clause (d) rule 61 Dosimetry for Food andAllied Products Usable absorbed dose range Gray Dosimeter Readout system Manioc Electron Paramagnetic Resonance spectrometer Spectrophotometer Spectrophotometer Spectrophotometer Therrooluminescenee reader Spectrophotometer Spectrophotometer Spectrophotometer or potentiometer Spectrophotometer Spectrophotometer Spectrophotometer Spectrophotometer, colour titration. high frequency conductivity Lyolurnineseenee reader Voltmeter 1 - 1W -1W - 10" 10 1 -4x 10' 10' 1W - Kr 1 - 1W 10'-1W 20-4x ID' 101 - ur 10-1 - 5 x 10' 10 -2 x 10" 10'- 1W 1 - 10' Dyed polymethyl methacrylate Clear polymethyl methacrylate Cellulose acetate Lithium borate, lithium fluoride Li thium fluoride ( optical grade) Radiochrornic dye solution, mical wave guide ('eric serous sulfate solution rous sulfate solution I 'otassium/Silvcr dichromate 1 ous cupric, sulfate solution 1 t chi orobenzenc solution Amino acids Metal Oxide Semiconductor Field liliect Transistor [17. No. AliA/17/1,2006-111.1 RAHUL.KULS11R1 ,..4.ilrtn. Jt.Sivy. MG1P141.1ND 2370 AIVV, 100 Copies, Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15