THE GAZETTE OF INDIA: EXTRAORDINARY

I PAR i II—SEC. Mitt

MTN1STRY OF COMMERCE AND INDUSTRY

(Department of Com merce)

ORDER

New Delhi, the 1st October, 2002

S.O. K)54(E).— Whereas, in exercise of the powers conferred by section 6 of the Export

(Quality Control and Inspection) Act, 1963 (22 of 1963), the Central Government is of

the opinion that it is necessary and expedient to do so for the development of the export

trade of India that 'bivalve molluscs' should be subject to quality control and inspection

for export.

And, whereas it is necessary to maintain the highest quality standards and stipulated

health requirements that would encompass the standards prescribed by the European

Union in its Council Directive No 91/492/EEC dated 15^th July, 1991 and subsequent

related Directives;

And whereas, bivalve molluscs freshly caught are in principle, free of contamination and

micro-organisms but contamination and subsequent decomposition may occur when

handled and treated unhygienically;

And, therefore, the essential requirements should be laid down for correct hygienic

handling of fresh bivalve molluscs at all stages of production and during harvesting,

handling, storage, transport.

And whereas, it is the responsibility primarily of the fisheries industry to ensure that

bivalve molluscs meet the health requirements laid down in these proposals;

And whereas, it is expedient that the proposed control measures shall be introduced to

guarantee the uniform application and to ensure smooth operation of the said proposals,

such measures shall apply in an identical manner;

And whereas, provision shall therefore be made for a procedure for monitoring and to

ensure that the above based conditions of equivalence;

And whereas, the competent authority nominated by the Central Government shall ensure

the effective compliance of the quality standards in the country;

And whereas, the Central Government has formulated proposals specified below for the

said purpose and has forwarded the same to the Export Inspection Council as required by

sub-rule (2) of rule 11 of the Export (Quality Control and Inspection) Rules, 1964;

Now, therefore, in pursuance of the said sub-rule (2), the Central Government hereby

publishes the said proposals for information of the general public likely to be affected

thereby, and notice is hereby given that any person who desires to make any objection or

suggestion with respect to the said proposals may forward the same within i, irty days of

the date of publication of this Order in the Official Gazette to the Export Inspection

Council of India, 3^rd Floor, New Delhi YMCA Cultural Centre Building, 1, Jtu J ^ h

Road, New Delhi-110001

PROPOSALS

To notify that bivalve molluscs shall be subject to quality control and inspection

prior to export;

To specify the type of quality control and inspection in accordance with the draft

Export of bivalve molluscs (Quality Control, Inspection and Monitoring) Rules,

2002 set out in the Annexure appended to this Order;

To recognise the specifications as set out in the Schedule as appended to this

Order as the standard specification for bivalve molluscs; and

To prohibit the export of bivalve molluscs in the course of international trade

unless they are produced and manufactured in a unit approved by the export

inspection agency established under sub-5erfroo(l) of section 7 of the Export

(Quality Control and Inspection) Act, 1963.

SCHEDULE

Specification for bivalve molluscs recognised as per section 6 of the Export (Quality

Control and Inspection) Act, 1963 shall be -

National standards of the importing countries; or

Contractual specifications agreed to between the foreign buyer and the exporters

provided the same is satisfying the health requirements of the importing countries;

In the case of any bivalve molluscs for which no standard is available at (a) and

(b) above, the standard formulated by an Expert Committee consisting of the

following members shall be made applicable -

Representative from Export Inspection Agency - Convener

Representative from the Marine Products Export Development Authority.

(MPEDA) - Member;

Representative from the Central Institute of Fisheries Technology - Cochin

(CIFT)-Member;

Representative from the trade - Member

[F No. ()/3/2(K)2-EI&EPJ

MV.P.C. SASTRY. Jt. Secv.

THE GAZETTE OF INDIA. EXTRAORDIN ARY

I PART 11—SKC. 3(ii)]

Annexure

DRAFT RULES PROPOSED TO BE MADE UNDER SECTION 17 OF THE

EXPORT (QUALITY CONTROL AND INSPECTION) ACT 1963

Short Title and commencement - (1) These rules may be called the Export of

Bivalve Molluscs (Quality Control, Inspection and Monitoring) Rules, 2002.

(2)

They shall come into force on the date of their final publication in the

Official Gazette;

In these rules, unless the context otherwise requires -

(a)

"Act" means the Export (Quality Control and Inspection) Act 1963 (22 of

1963);

(b)

"Agency" means any one of the Export Inspection Agency established at

Bombay, Calcutta, Cochin, Delhi and Madras established under section 7 (1) of the

Act;

(c)

"Council" means Export Inspection Council established under section 3 of the

Export (Quality Control and Inspection) Act 1963;

(d)

"bivalve molluscs" means filter-feeding lamellibranch molluscs;

(e)

"batch" means a quantity of live bivalve molluscs collected from a production

area and subsequently intended for delivery to an approved dispatch centre,

purification centre, relaying area or processing plant as appropriate;

(f)

"clean sea water" means sea water or brackish water which is to be used under

the conditions laid down in these rules and which is free from microbiological

contamination and toxic and objectionable substances.

(g)

"conditioning" means the storage of live bivalve molluscs, whose quality does

not indicate the need for relaying or treatment in a purification plant, in tanks or any

other installation containing clean sea water or in natural sites to remove sand mud

or slime

(h)

"competent authority' means the Export Inspection Council of India (EIC)

and the Export Inspection Agencies (ElAs) established at Bombay, Calcutta, Cochin

and Madras competent to carry out veterinary checks or any authority to which it has

delegated that competence.

(i)

"consignment" means a quantity of live bivalve molluscs handled in a dispatch

centre or treated in a purification centre and subsequently intended for one or more

customers;

(j)

"dispatch centre" means any approved on-shore or off-shore installation for

the reception, conditioning, washing, cleaning, grading and wrapping of live bivalve

molluscs fit for human consumption;

(k)

"e.coli" means faecal coliforms which also form indole from tryptophan at

44°C +/- 0. 2°C within 24 hours.

(1)

"faecal coUform" means facultative, aerobic, gram-negative, non spore

forming, cytochrome oxidase negative, rod shaped bacteria that are able to ferment

lactose with gas production in the presence of bile salts, or other surface active

agents with similar growth-inhabiting properties, at 44°C +/- 0. 2°C within 24 hours

at least;

(m) "gatherer" means any natural or legal person who collects live bivalve

molluscs by any means from a harvesting area for the purpose of handling and

placing on the market;

(n)

"marine biotoxins" means poisonous substances accumulated by bivalve

molluscs feeding on plankton containing toxin;

(o)

"means of transport" means those parts set aside for goods in automobile

vehicles, rail vehicles and aircraft, the holds of vessels and containers for transport

by land, sea or air;

(p)

"placing on market' means the holding or displaying for sale, offering for

sale, selling, delivering or any other form of placing on the market of live bivalve

molluscs for human consumption either raw or for the purpose of processing.

(q)

"production area" means any sea, estuarine or lagoon area containing natural

deposits of bivalve molluscs or sites used for cultivation of bivalve molluscs from

which live bivalve molluscs are taken;

(r)

"purification centre" means an approved establishment with tanks fed by

naturally clean sea water or sea water that has been cleaned by appropriate treatment,

in which live bivalve molluscs are placed for the time necessary to remove

microbiological contamination, so making them fit for human consumption;

(s)

"relaying area" means any sea, estuarine brackish water or lagoon area

approved by the competent authority and used exclusively for the natural purification

of live bivalve molluscs;

(t)

"relaying" means an operation whereby live bivalve molluscs arc transferred

to approved sea or lagoon areas or approved estuarine, brackish water areas under the

supervision of the competent authority for the time necessary to remove

contamination, which does not include the specific operation of transferring bivalve

molluscs to areas more suitable for further growth or fattening;

(u)

"wrapping' means an operation whereby live bivalve molluscs are placed i:,

packing material adequate for the purpose;

3085 G1/2002—5

THE GAZETTE OF INDIA: EXTRAORDINARY

[PAKIII—SEC. 3(ii)]

Basis of Compliance - It shall be the primary responsibility of the industry to

ensure that the fresh and processed fishery product bivalve mollscus intended for

export are handled, processed at all stages of production, storage and transport

under proper hygienic conditions so as to meet the health requirements laid down

under these rules and that the product conforms to the specifications prescribed by

the Central Government under section 6 of the Act and the same shall be further

ensured by the recognised competent authority that the producers and

manufacturers comply with, the requirements, by regular monitoring of the

establishments as per the control measures by the Council from time to time.

Provisions for production - The placing on the market of live bivalve molluscs

for human consumption shall be subject to the conditions that they -

(a) originate from production areas which comply with the requirements laid

down in chapter I of these rules.

(b) have been harvested and transported from the production area to a

dispatch centre, purification centre, relaying area or processing plant

under the conditions laid down in Chapter II of these rules;

and complying with the conditions laid down in Chapter III of these rules;

(d) have been handled hygienically, and where appropriate, have been

purified in establishments approved for that purpose and complying with

the requirements of chapter IV of these rules;

(e) comply with the criteria set out in Chapter V of these rules;

(f) have been subjected to health controls in accordance with Chapter VI of

these rules;

(g) have been appropriately wrapped in accordance with Chapter VII of these

rules;

(h) have been stored and transported under satisfactory conditions of hygiene

in accordance with Chapters VIII and IX of these rules;

(i) bear a health mark as provided for in Chapter X of these rules;

(j) comply with the relevant requirements of these rules and be processed in

accordance with the requirements of these rules.

Handing and processing - It shall be ensured that persons handling live bivalve

molluscs during their production and placing on the market shall adopt all measures

necessary to comply with the requirements of this standard. The persons responsible for

dispatch and purification centre shall in particular ensure that representative numbers of

samples for laboratory examination are regularly taken and analysed in order to establish

an historical record on the basis of the areas where batches come from and of the health

quality of the live bivalve molluscs both before and after handling at a dispatch centre or

purification centre. A register shall be kept for the permanent record of the results of the

various checks and kept for presentation to the competent authority.

Functions of competent authority -(1) The competent authority shall approve

dispatch centres and purification centres once it is satisfied that they meet the

requirements of this standard. The competent authority shall take the necessary measures

if the requirements cease to be met.

(2)

The Competent Authority shall draw up a list of approved dispatch centres and

purification centres, each of which shall have an official number.

(3)

The list of approved dispatch centres and purification centres, and any subsequent

amendments thereto, shall be communicated by the competent authority to the

Commission.

(4) The inspection and monitoring of these shall be carried out regularly under the

responsibility of the competent authority, which shall have free access to all parts of the

centre, in order to ensure compliance with the provision of this standard.

(5)

If such inspection and monitoring reveal that the requirements of these standards

are not being met, the competent authority shall take appropriate action.

(6)

The competent authority shall establish a list of production and relaying areas,

with an indication of their location and boundaries, from which live bivalve molluscs may

be taken in accordance with the requirements of the standards and, in particular, with

Chapter I of the Annexure of these rules.

(7)

This list shall be communicated to those affected by the standards, such as

gatherers and operators of purification centres and dispatch centres

(8) The monitoring of the production and relaying areas shall be carried out under the

responsibility of the competent authority in accordance with the requirements of the

standards.

(9)

If such monitoring reveals that the requirements of the standards are no longer

being met, the competent authority shall close the production or relaying area concerned

until the situation has been restored to normal.

(10)

The competent authority may prohibit any production and harvesting of bivalve

molluscs in area considered unsuitable for these activities for health reasons.

(11)

Having satisfied that the establishment or factory vessel meet the requirements

with regard to the nature of the activities they carry out, the competent authority shall

accord approval to such establishments or factory vessel. If the establishment or factory

vessel decides to carry out activities other than those for which it has received approval,

specific approval from competent authority shall be obtained for that purpose.

(12)

The competent authority may seek the advice of the experts from Marine Products

Export Development Authority (MPEDA) and Central Institute of Fishery Technology

(CIFT) in the manner of approval of establishment.

(13)

Recognised competent authority shall take necessary measures including

withdrawal of approval, if the requirements cease to be met.

(14)

The inspection and monitoring of establishments or factory vessels shall be

carried out regularly under the responsibility of the recognized competent authority which

shall at all times have a free access to all parts of the establishments or factory vessels and

records pertaining application of these rules to ensure compliance with the requirements

under the rules.

(15)

If such inspections and monitoring reveal that the requirements oi thcrt mJey arc

not being met the recognised competent authority shall take appropriate action

THE GAZETTE OF INDIA: EXTRAORDINARY

[PART II—SEc.3(ii)l

Functions of the Industry-(1)

The industry shall ensure that persons

responsible for the establishment take all necessary measures so that at all stages of

production of bivalve molluscs the specifications are complied with and to that end the

said persons shall carry out their own checks based on the following principles namely :-

(a)

identification of critical points in their establishment on the basis of the

manufacturing process used.

(b)

establishment and implementation of methods for monitoring and checking such

critical points.

(c)

taking samples for analysis in an approved laboratory by the recognised

competent authority for the purpose of checking the cleaning and disinfection methods

and for the purpose of checking compliance with the standards established in this

notification.

(d)

keeping a written record or decord registered in indelible manner of the preceding

points with a view to submitting them to the competent authority. The results of the

different checks and tests shall in particular be kept for a period of at least two years.

(e)

The establishment shall have competent and qualified technologists duly approved

by the competent authority to conduct own checks and tests.

(f)

The technologists shall posses one of the qualifications and experience or training,

as the case may be.

i) Graduation/Post Graduation in Fishery Science, Fishery Management,

Industrial Fishery or Fish Processing, or.

ii) Graduation/Post Graduation in Marine Biology, Fishery Biology,

Microbiology,

Chemistry,

Biochemistry,

Bioscience

Food

Processing Technology; Degree in Pharmacy and Agricultural Science

(B.Sc. Agriculture /M.Sc. Agriculture)

and

iii) One year experience in Fish Processing and Quality Control or

Training for minimum six months duration in a

Government

recognised institute in Fish Processing and Quality Control

(2)

If the results of own checks or any information at the disposal of the technologists

retencd to above reveal the risk of health or suggest that one might exist, appropriate

measures shall be taken under the official supervision of the recognised competent

authority.

Certification - (1)

On request from the processors or exporter the competent

authority shall issue Health or Veterinary Certificate in the prescribed proforma after

satisfying that the bivalve molluscs are processed in approved establishment or factory

vessels having valid approval number and after satisfying that the consignments comply

with the requirements of these rules.

(2)

The competent authority may also issue such other certificates on request after

satisfying that the requirements of the relevant standards are met.

Inspection Fee - (1) A fee of Rs. 2000/- shall be paid by the processor along

with the application for approval of the establishment or factory vessel as per these rules.

(2)

A monitoring fee @ 0.2 percent of FOB value shall be paid by the processor or the

exporters to the concerned Export inspection Agency.

10.

Appeal-(1) Any person aggrieved by a-

decision of the competent authority not to accord approval under sub-rule

(Il)ofrule6;or

ii) decision of the competent authority to withdraw the approval under sub-

rule (13) of rule 6; or

iii) refusal of the competent authority to issue Health or Veterinary Certificate

under sub-rule (1) of rule 8;

may prefer an appeal within ten days of receipt of such communication to

an Appellate Authority appointed by the Central Government.

(2)

At least two-thirds of the total membership of the Appellate Authority

shall consist of non-officials.

(3)

The quorum of Panel of the Appellate Authority shall be three.

(4)

The appeal shall be disposed of within fifteen days of receipt.

™

THE GAZETTE OF INDIA: EXTRAORDINARY

[PARTII—SEC.3(ii)]

CHAPTER-I

CONDITIONS FOR PRODUCTION AREAS

The location and the boundaries of production areas must be fixed by the competent

authority in such a way as to identify the areas from which live bivalve molluscs;

can be collected for human consumption. Live bivalve molluscs taken from these

areas must meet the requirements set out in Chapter V of this Order;

can be collected but only placed on the market for human consumption after

treatment in a purification centre. Live bivalve molluscs from these areas must not

exceed the limits of a five-tube, three-dilution MPN-test of 6000 faecal coliforms per

lOOg of flesh or 4600 E.Coli per lOOg of flesh in 90% of samples. After purification,

all the requirements set out in Chapter V of this Order must be met;

can be collected but placed on the market only after relaying over a long period (at

least two months), whether or not combined with purification, or after intensive

purification for a period to be fixed, so as to meet the requirements under (a).

Any change in the demarcation of production areas and the temporary or definitive

closure thereof must be immediately announced by the competent authority to those

affected by this Standard and in particular to producers and operators of purification and

dispatch centres.

CHAPTER-II

REQUIREMENTS

FOR

HARVESTING

AND

TRANSPORTATION

BATCHES TO A DISPATCH OR PURIFICATION CENTRE, RELAYING AREA

OR PROCESSING PLANT.

1. Harvesting techniques must not cause excessive damage to the shells or tissues of live

bivalve molluscs

2. Live bivalve molluscs must be adequately protected from crushing, abrasion or

vibration after harvesting and must not be exposed to extremes of hot or cold

temperature.

3. Techniques for harvesting, transporting, landing and handling live bivalve molluscs

must not result in additional contamination of the product, nor in a significant

reduction in the quality of the product, nor in an changes significantly affecting their

ability to be treated by purification, processing or relaying.

4. Live bivalve molluscs must not be reimmersed in water which could cause additional

contamination between harvesting and landing.

5. The means of transport used for transporting live bivalve molluscs must be used under

condition which protect the latter from additional contamination and crushing of

shells. They must permit adequate drainage and cleaning. In the event of bulk

transport over long distances of live bivalve molluscs to a dispatch centre, purification

centre, relaying area or processing plant, the means of transport must be equipped in

such a way as to ensure the best survival conditions possible, and in particular must

comply with the requirements laid down in Chapter IX, Section 2 of this Order.

6. A registration document for the identification of batches of live bivalve molluscs

during transport from the production area to a dispatch centre, purification centre

Relaying area or processing plant must be issued by the competent authority upon

request by the gatherer. For each batch, the gatherer must complete legibly and

indelibly the relevant sections of the registration document which must contain the

following information :

the gatherer's identity and address,

the date of harvesting,

the location of the production area described in as precise detail as is practicable

or by a code number,

the health status of the production area as referred to in Chapter I,

the shellfish species and quantity indicated in as precise detail as is practicable,

the approval number and place of destination for wrapping, relaying, purification

or processing.

The registration document must be dated and signed by the gatherer.

•10

THE GAZETTE OF INDIA: EXTRAORDINARY

[PARTII—SKc.3(ii)|

The registration documents must be numbered regularly and in sequence.

The competent authority must keep a register indicating numbers of registration

documents together with the names of the persons collecting live bivalve molluscs to

whom the documents were issued. The registration document for each batch of live

bivalve molluscs must be date-stamped upon delivery of a batch to a dispatch centre,

purification centre, relaying area or processing plant and must be kept by operators of

such centres, areas or plants for at least twelve months. In addition, the gatherer is also

obliged to keep it for the same period.

However, if gathering is carried out by the same staff operating the dispatch centre,

purification centre, relaying area or processing plant of destination, the registration

document may be replaced by a permanent transport authorization granted by the

competent authority. A Standard registration document, containing a reference to the

various requirements which are to be included in it, will be introduced by the competent

authority

7. If a production or relaying area is closed temporarily, the competent authority must

refrain from issuing registration documents for that area and immediately suspend the

validity of all registration documents already issued.

CHAPTER-III

CONDITION FOR RELAYING LIVE BIVALVE MOLLUSCS

Live bivalve molluscs must be gathered and transported in accordance with the

requirements of Chapter II of this Order;

Techniques for handling live bivalve molluscs intended for relaying must permit the

resumption of filter feeding activity after immersion in natural waters;

Live bivalve molluscs must not be relaid at a density which does not permit

purification;

Live bivalve molluscs must be immersed is seawater at the relaying area for an

appropriate period which must exceed the time taken for levels of faecal bacteria to

become reduced to the levels permitted by this Order taking accounts of the fact that

the Standards of Chapter V of this Order must be met;

The minimum water temperature for effective relaying must, where necessary, be

determined and announced by the competent authority for each species of live

bivalve molluscs and approved relaying area;

Areas for relaying live bivalve molluscs must be approved by the competent

authority. The boundaries of the sites must be clearly identified by buoys or other

fixed means; there must be a minimum distance of 300 metres between relaying

areas, and also between relaying areas and production areas;

Sites within a relaying area must be well separated to prevent mixing of batches; the

'all in, all out' system must be used, so that a new batch cannot be brought in before

the whole of the previous batch has been removed;

Permanent record of the source of livt bivalve molluscs, relaying periods, relaying

areas and subsequent destination of the batch after relaying must be kept by the

operators of relaying areas for- inspection by the competent authority;

After harvesting from the relaying area, batches must, during transport from the

relaying area to the approved dispatch centre, purification centre or processing plant,

be accompanied by a registration document, setting out , in addition to the

information specified in point 6 of Chapter II of this Order, inter alia the location and

approval number of the relaying area and the duration of relaying, together with any

other information needed to identify and trace the product. However, the above shall

not be required where the same staff operate both in the relaying area and in the

dispatch centre, purification centre or processing plant.

THE GAZETTE OF INDIA: EXTRAORDIN ARY

|PARI II—SEC. 3(ii)|

CHAPTER-IV

CONDITIONS FOR THE APPROVAL OF DISPATCH OR PURIFICATION

CENTRES

General conditions relating to premises and equipment

Centres must not be located in areas which are close to objectionable odours, smoke, dust

and other contaminants. The location must not be subject to flooding by ordinary high

tides or run of from surrounding areas.

Centres must have at least:

On premises where live bivalve molluscs are handled or stored :

building or facilities of sound construction, designed and maintained

adequately for the purpose of preventing contamination of live bivalve

molluscs by any type of waste, dirty water, fumes, dirt or by the presence of

rodents or other animals;

flooring which is easy to keep clean and is laid in such a way as to facilitate

drainage;

adequate working space to allow for satisfactory performance of all

operations;

durable walls which are easy to clean;

adequate natural or artificial lighting;

access to an appropriate number of changing rooms, wash basins and lavatories;

there must be a sufficient number of wash basins close to the lavatories;

Adequate equipment for washing tools, containers and equipment;

Facilities for the supply and, where appropriate, storage of exclusively potable water

within the meaning of Council Standard 80/778/EEC of 15 July 1980 relating to the

quality of water intended for human consumption or facilities for the supply of clean

sea water.

facilities supplying non-potable water may be authorised. The water concerned may not

ome into direct contact with live bivalve molluscs or be used for cleaning or disinfecting

containers, plant or equipment which come into contact with live bivalve molluscs. Pipes

, tnd outlets carrying non-potable water must be clearly distinguished from those carrying

potable water;

Equipment and instruments or their surfaces which are intended to come into

contact with live bivalve molluscs must be made of corrosion-resistant material

which is easy to wash and clean repeatedly.

General Hygiene Requirements

A high degree of cleanliness and hygiene must be required of staff, premises, equipment's

and working conditions :

Staff who treat or handled live bivalve molluscs must in particular wear clean

working clothes and, where appropriate, gloves which are suitable for work in

which the person is engaged;

Staff are obliged to refrain from personal behavior, such as spitting, which could

result in contamination of live bivalve molluscs; any person suffering from an

illness which can be transmitted by live bivalve molluscs must be temporarily

prohibited, until recovery, from working with or handling these products;

Any rodents, insects or other vermin found must be destroyed and further infestation

prevented. Domestic animals must not enter the facilities;

Premises, equipment and instruments used for handling live bivalve molluscs must

be kept clean and in good state of repair; equipment and instruments must be

thoroughly cleaned at the end of the day's work and at such times as may be

appropriate;

Premises, instruments and equipment must not be used for purpose other than the

handling of live bivalve molluscs without authorization by the competent authority.

Waste products must be stored hygienically in a separate area and, where

appropriate, in covered containers suitable for the purpose intended. Waste material

must be removed from the vicinity of the establishment at appropriate intervals;

The finished product must be stored under cover and must be kept away from the

areas where animals other than live bivalve molluscs, such as curstaceans, are

handfet

III

Requirements for purification centres

In addition to the requirements under Sections I and II, the following conditions must be

met;

The floors and walls of the purification tanks and any water storage containers must

have a smooth, hard and impermeable surface and be easy to clean scrubbing or use

of pressurized water. The base of the purification tanks must be sufficiently sloped

and equipped with drainage sufficient for the volume of work;

Live bivalve molluscs must be washed free of mud with pressurized clean sea water

or potable water before purification. The initial washing may also be carried out in

the purification tanks before purification commences, the drainage pipes being kept

open during the entire initial washing and sufficient time being allowed thereafter

for the system to be flushed clean before the purification process begins;

The purification tanks must be supplied with a sufficient flow of sea water per hour

and per tonne of live bivalve molluscs treated;

-1-1

THKGA/hlTb.OriNUlA LM RA( WHINAin

|PARI 11 — Si-c. 3(ii)|

Clean sea water or sea water cleaned by treatment must he used for purifying live

bivalve molluscs; the distance between the sea water intake point.and the waste

water outlets must be sufficient to avoid contamination; if treatment of the sea water

is necessary, the process shall be authorised once its effectiveness has been verified

by the competent authority; potable water used to prepare sea water from its major

constituent chemicals must comply with the requirements laid down in Standard

80/778/EEC;

Operation of the purification system must allow live bivalve molluscs to rapidly

resume filter feeding activity, remove sewage contamination, not to become re-

contaminated and able to transport before being placed on the market;

The quantity of live bivalve molluscs to be purified must not exceed the capacity of

the purification centres; the live bivalve molluscs must be continuously purified for

a period sufficient to allow the microbiological Standards laid down in Chapter V of

this Order to be met. This period starts from the moment at which the live bivalve

molluscs in the purification tanks are adequately covered by the water until the

moment when they are removed. The purification centre must take account of the

data relating to the raw materials (the type of bivalve molluscs, its area of origin,

microbe content, etc.) in case it is necessary to extend the purification period so as

to ensure that the live bivalve molluscs meet the bacteriological requirements of

Chapter V of this Order;

Should a purification tank contain several batches of molluscs, they must be of the

same species and come from the same production area or different areas conforming

to the same health conditions. The length of the treatment must be based on the time

required by the batch needing the longest period of purification;

Containers used to hold live bivalve molluscs in purification systems must have a

construction which allows sea water to flow through; the depth of layer of live

bivalve molluscs should not impede the opening of shells during purification;

No crustaceans, fish or other marine species must be kept in a purification tank in

which live bivalve molluscs are undergoing purification;

10. After completion of purification, the shell of live bivalve molluscs must be washed

thoroughly by hosing with potable water or clean sea water; this may take place in

the purification tank if necessary; the washing water must not be recirculated;

11.

Purification centres must have their own laboratories or secure the services of a

laboratory equipped with the necessary facilities for checking the efficiency of

purification by use of microbiological specifications. Laboratory facilities outside

the centres must be recognised by the competent authority;

12. Purification centres must regularly keep a record of the following data :

results of microbiological tests on purification system water entering the

purification tanks;

results of microbiological tests on unpurified live bivalve molluscs;

results of microbiological tests on purified live bivalve molluscs;

dates and quantities of live bivalve molluscs delivered to the purification

centre and corresponding registration document numbers;

the times of filling and emptying of purification systems (purification

times);

dispatch details of consignments after purification.

These records must be complete and accurate, legible and recorded in a permanent

ledger book which must be available for inspection by the competent authority;

13. Purification centres must accept only those batches of live molluscs \\]

Ji ;^;rc

accompanied by the registration document referred to in Chapter II of this Order;

Purification centres dispatching batches of live bivalve molluscs to dispatch centres must

provide a registration document, as per the specimen drawn up by the competent

authority, setting out, in addition to the information specified in point 6 of Chapter II of

this Order, inter alia the approval number and address of the purification plant and the

duration of purification, the dates of entering and leaving the purification centre, together

with any other information needed to identify and trace the product.

14. Every package containing purified live bivalve molluscs must be provided with a

label certifying that all molluscs have been purified.

Requirements for dispatch centres

In addition to the requirements under Section I and II, the following conditions must

be met:

a) conditioning must not cause any contamination of the product; conditioning

facilities must be used in accordance with procedure recognized by the

competent authorities, with special regard to the bacteriological and chemical

quality of the sea water used in those facilities;

b) equipment and containers in the conditioning facilities must not constitute a

source of contamination;

c) procedures for calibration of live bivalve molluscs must not result in additional

contamination of the product or in any changes affecting the ability of the

product to be transported and stored after wrapping;

d) any washing or cleaning of live bivalve molluscs must be carried out using

pressurized clean sea water or potable water; cleaning water may not be

recycled.

Dispatch centres must accept only those batches of live bivalve molluscs which arc

accompanied by the registration document referred to in Chapter II, section 6 of this

Order and coming from an approved production area, relaying area or purification

centre.

3085 GI/?002—7

THE GAZETTE OF INDIA: EXTRAORDINARY

[PARTII—SEC, 3(ii)l

Dispatch centres must have their own laboratories or secure the services of a

laboratory equipped with nessary facilities for checking, inter alia, whether the

molluscs comply with the micro-biological Standards of Chapter V of this Annex.

Laboratory facilities outside the centres must be recognised by the competent

authority. However, these requirements do not apply to dispatch centres obtaining

their molluscs exclusively and directly from a purification centre where they have

been examined after purification.

Dispatch centres must keep the following at the disposal of the competent authority

the results of microbiological tests on live bivalve molluscs from an

approved production area or relaying area or from a purification plant,

the dates and quantities of live bivalve molluscs delivered to the dispatch

centre, together with the corresponding registration documents, dispatch

details including the names and addresses of consignees, the dates and

quantities of live bivalve molluscs dispatched, together with the

corresponding entry registration document numbers).

These data must be classified chronologically and prewnvfcd for A period of twelve

months.

CHAPTER-V

REQUIREMENTS CONCERNING LIVE BIVALVE MOLLUSCS

Live bivalve molluscs intended for immediate human consumption must comply with the

following requirements :

The possession of visual characteristics associated with freshness and viability,

including shells free of dirt, an adequate response to percussion, and normal amounts

of intravalvular liquid.

They must contain less than 300 faecal coliforms or less than 230 E.Coli per 100 g of

mollusc flesh and intravalvular liquid based on a fivetube, threedilution MPN-test or

any other bacteriological procedure shown to be equivalent accuracy.

They must not contain salmonella in 25 g of mollusc flesh.

They must not contain toxic or objectionable compounds occurring naturally or

added to the environment. The competent authority shall determine the testing

methods for checking the chemical criteria and the limit values applicable.

The upper limits as regards the radionuclide contents must not exceed the limits for

foodstuffs.

The total Paralytic Shellfish Poison (PSP) content in the edible parts of molluscs (the

whole body or any part edible separately) must not exceed 80 microgrammes per 100

g of mollusc flesh in accordance with the biological testing method - in association if

necessary with a chemical method for detection of Saxitoxin or any other reconised

method.

If the results are challenged, the reference method shall be the biological method.

The customary biological testing methods must not give a positive result to the

presence of Diarrhetic Shellfish Poison (DSP) in the edible parts of molluscs (the

whole body or any part edible separately).

The total Amnesic Shellfsh Poison (ASP) content in the edible parts of molluscs (the

entire body or any part edible separately) must not exceed 20 micrograms of domoic

acid per gramme using the HPLC method.

In the absence of routine virus testing procedures and the establishment of

virological Standards, health checks must be based on faecal bacteria counts.

L^awiinution for checking compliance with the requirements of this Chapter must be

carried out in accordance with proven methods which are scientifically recognised.

For the uniform application of this Standard sampling plans as well as the methods and

analytical tolerance to be applied in order to check compliance with the requirements of

this chapter will be established by the competent authority.

The effectiveness of the faecal indicator bacteria and their numerical limhs as well as the

other parameters laid down in this Chapter must be kept under constant review and,

where scientific evidence proves the need to do so, that will be revised.

THE GAZETTE OF INDIA .EXTRAORDINARY

1 PART 11— SEC.3(U)]

When there is scientific evidence indicating the need to introduce other health checks or

to amend the parameters in this Chapter for the purpose of protecting public health, such

measures will be adopted by the competent authority.

CHAPTER-VI

PUBLIC HEALTH CONTROL AND MONITORING OF PRODUCTION

A public health control system must be established by the competent authority in order to

verify whether the requirements laid down in this Standard are complied with. This

control system must include :

Periodic monitoring of live bivalve molluscs relaying and production areas in

order to

avoid any malpractice with regard to the origin and destination of the live bivalve

molluscs;

check the microbiological quality of the live bivalve molluscs in relation to the

production and relaying areas;

check the possible presence of toxin producing plankton in production and

relaying water and biotoxins in live bivalve molluscs;

check the possible presence of chemical contaminants.

For the purpose of points (c) and (d), sampling plans must be established by the

competent authority.

Sampling plans as provided :

Must in particular take account of:

likely variations in faecal contamination at each production and relaying areas;

possible variation in production at relaying areas in the presence of plankton

containing marine biotoxins. The sampling must be carried out as follows :

i) monitoring : periodic sampling organised to detect changes in the

composition of the plankton containing toxins and the geographical

distribution thereof. Information leading to a suspicion of accumulation of

toxins in mollusc flesh must be followed by intensive sampling,

ii) intensive sr mpling : monitoring plankton in the growing and fishing water by

increasing the number of sampling point and the number of samples, and

toxicity tes s using the mollusks from the affected area which are most

susceptible to contamination. Placing on the market of molluscs from that area

may not be reauthorised until new sampling has provided satisfactory toxicity

test results;

possible contamination of the molluscs in the production and relaying area;

If the result of a sampling plan shows that placing on the market of live bivalve

molluscs may constitute a hazard to human health, the competent authority must

close the production area, as regards molluscs concerned, until the situation has

been restored.

Laboratory tests in order to check compliance with the requirements for the end

product as laid down in Chapter V of this Order. A control system must be

established to verify that the level of marine biotoxins does not exceed safety limits.

An inspection of establishment at regular intervals. These inspections must include

in particular checks :

To verify whether the approval conditions are still being complied with;

On the cleanliness of the premises, facilities, equipment and on staff hygiene;

To verify whether the live bivalve molluscs are handled and treated correctly;

On the correct application and functioning of purification or conditioning

systems;

On the records referred to in Chapter IV section III, 12 of this Order,

On the correct use of health marks.

This checks shall include the taking of samples for laboratory tests; the result of

these tests are notified to the persons responsible for the establishments.

Checks on the storage and transport conditions for consignments of live bivalve

molluscs.

CHAPTER-VII

WRAPPING

Live bivalve molluscs must be wrapped under satisfactory conditions of hygiene.

The wrapping material or container must not impair the organoleptic characteristics

of the live bivalve molluscs, not be capable of transmitting substances harmful to

human health to the live bivalve molluscs, be strong enough to give adequate

protection to the live bivalve molluscs.

Oysters must be wrapped with the concave shell downwads.

All wrappings of live bivalve molluscs must be sealed and remain sealed from the

dispatch centre until delivery to the consumer or retailer.

THE GAZETTE OF INDIA: EXTRAORDINARY

[PART II—SEC. 3(ii)1

CHAPTER-VIII

PRESERVATION AND STORAGE

In any storing rooms, live bivalve molluscs must be kept at a temperature which

does not adversely affect their quality and viability; the wrapping must not come

into contact with the floor of the store room, but must be placed on a clean, raised

surface,

Reimmersion in or spraying with water of live bivalve molluscs must not take place

after they have been wrapped and have left the dispatch centre except in the case of

retail sale at the dispatch centre.

CHAPTER-IX

TRANSPORT FROM THE DISPATCH CENTRE

Consignment of live bivalve molluscs intended for human consumption must be

transported, wrapped as sealed parcels from the dispatch centre until offered for sale

to the consumer or retailer.

The means of transport used for consignments of live bivalve molluscs must have

the following characteristics :

a) their interior walls and any other pars which might pome into contact with the

live bivalve molluscs must be made of corrosion - resistant material; the walls

must be smooth and easy to clean;

b) they must be suitably equipped to provide efficient protection of the live bivalve

molluscs against extremes of hot and cold, contamination with dirt or dust, and

damage to the shells from vibration and abrasion;

c) the live bivalve molluscs must not be transported with other products which

might contaminate them.

Live bivalve molluscs must be transported and distributed using closed vehicles or

containers which maintain the product at a temperature which does not adversely

affect their quality and viability.

The parcels containing live bivalve molluscs must not be transported in direct contact

with the floor of the vehicle or container but must be supported on raised surface or by

some other means which prevent contact. Where ice is used transporting consignments of

live bivalve molluscs, it must have been made from potable water or clean sea water.

CHAPTER-X

MARKING OF CONSIGNMENTS

All parcels in a consignment of live bivalve molluscs must be provided with a

health mark so that the original dispatch centre may be identified at all times during

transport and distribution until retain sale. The mark must contain the following

information :

the country of dispatch,

the species of bivalve molluscs (common name and scientific name),

the identification of the dispatch centre by the approval number issued by

the competent authority,

the date of wrapping, comprising at least the day and the month,

by way of derogation from Standard 79/112/EEC the date of durability

may be replaceiby the entry 'these animals must be alive when sold'.

The health mark may be printed on the wrapping material or be put on a separate

label which is then affixed to the wrapping material or put inside the wrapping. It

may also be a twist-tie or staple design; self-adhesive health marks must not be

used, unless they are not detachable. All types of health mark must be for single use

only and may not be transferred.

The health mark must be durable and waterproof, and the information presented

must be legible, indelible and in easily decipherable characters.

The health mark attached to consignments of live bivalve molluscs which are not

wrapped in individual consumer-size parcels must be kept for at least 60 days by the

retailer after splitting up the contents of the consignment.

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