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S.O.668(E) In exercise of the powers conferred by section 17 of the
Export (Quality Control and Inspection) Act, 1963 (22 of 1963), the Central
Government hereby makes the following rules, namely:-
1.
Short Title and commencement –
(1) These rules may be called the Export
of Bivalve Molluscs (Quality Control, Inspection and Monitoring) Rules, 2003.
(2)They shall come into force on the date of their final publication in the
Official Gazette;
2.
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 the Act;
(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 this
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 (EIAs) 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)
“despatch center”
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
440C +/- 0. 20C within 24 hours.
(l)
“faecal coliform”
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 440C +/- 0. 20C
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 center”
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 are 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 are placed in packing material adequate for the purpose;
3. 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 this 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 recognized 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.
4.
Approval- Live bivalve molluscs shall be exported subject to the approval by the
competent authority or all or any of the following conditions, namely:-
(a) Originate from production areas which comply with the requirements laid
down in chapter I.
(b) Have been harvested and transported from the production area to a
dispatch centre,
purification centre, relaying area or processing plant under
the requirements laid down in
Chapter II.
(c) Have been relaid in suitable areas as approved for the purpose of
standards and complying
with the
conditions laid down in Chapter III.
(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.
(e) Comply with the criteria set out in Chapter V.
(f) Have been subjected to health controls in accordance with Chapter VI.
(g) Have been appropriately wrapped in accordance with Chapter VII.
(h) Have
been stored and transported under satisfactory conditions of hygiene in accordance
with
Chapters VIII and IX.
(i)
Bear a health mark as
provided for in Chapter X
5. 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 center.
A register shall be kept for the permanent record of the
results of the
various checks and kept for presentation to the competent authority.
6.
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 despatch 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 despatch 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) The 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 of these rules are not being
met, the
competent
authority shall take appropriate action.
7.
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 recognized
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 rules;.
(d) Keeping a written record or record 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:-
(1)
Graduation/Post Graduation in Fishery Science, Fishery Management,
Industrial Fishery or Fish Processing, or. graduation/Post Graduation
in Marine Biology, Fishery
Biology,
Microbiology, Chemistry, Biochemistry,
Bioscience
or Food Processing
Technology;
Degree in Pharmacy and
Agricultural Science (B.Sc. Agriculture /M.Sc. Agriculture)
and
one year
experience in Fish Processing and Quality Control or
Training
for minimum
six
months duration in a Government
recognized institute in Fish
Processing and Quality Control
(2) If the results of own checks or any information at the disposal of the
technologists
referred 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.
8.
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.
9.
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 –
i) Decision of the
competent authority not to accord approval under
sub-rule (11) of rule 6; 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 shall be three.
(4) The
appeal shall be disposed of within fifteen days of receipt.
Chapter
– I
requirements
for Production Areas
1.
The location and the
boundaries of production areas shall be fixed by the competent authority in such
a
way as to identify the areas from awhich live bivalve
molluscs:-
a)
Can be collected for human
consumption. Live bivalve molluscs taken from these areas shall meet
the requirements set out in Chapter V aof the rules;
b) Can
be collected but only placed on the market for human consumption after treatment
in a
purification
centre. Live bivalve molluscs
from
these areas shall not exceed the limits of a five-tube,
three-dilution MPN-test
of 6000 faecal coliforms per 100g of flesh or 4600 E.Coli
per 100g of flesh in
90% of samples. After
purification, all the requirements
set out in Chapter V of this rule shall be met;
c) 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).
2.
Any change in the demarcation of production areas and the temporary or
definitive closure thereof
shall be immediately announced by the competent authority to
those affected by this standard and in
particular, to producers and operators of
purification and despatch centres.
Chapter – II
Requirements for Harvesting and Transportation of Batches to a dispatch or
purification centre, relaying area or processing plant.
1.
Harvesting techniques shall
not cause excessive damage to the shells or tissues of live bivalve molluscs.
2.
Live bivalve molluscs shall
be adequately protected from crushing, abrasion or vibration after harvesting
and shall not be exposed to extremes of hot or cold temperature.
3.
Techniques for harvesting,
transporting, landing and handling live bivalve molluscs shall 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 shall
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 shall be used under condition which
protect the latter from additional contamination and crushing of
shells. They shall permit adequate
drainage and cleaning. In the event of bulk
transport over long distances of live bivalve molluscs to a
despatch centre, purification centre,
relaying area or processing plant, the means of transport shall be
equipped in such a way as to ensure the
best survival conditions possible, and in particular shall comply
with the
requirements laid down in Chapter IX.
6.
(1) A traceability document
for the identification of batches of live bivalve molluscs during transport
from the production area to a despatch centre, purification centre
relaying area or processing plant
must be issued by the competent authority upon
request by the gatherer. The traceability
document shall
contain the following information, namely:-
(a) The
gatherer’s identity and address,
(b) The
date of harvesting,
(c)
The location of the production area described in as precise detail as is
practicable or by a
code number,
(d)
The shellfish species and quantity indicated in as precise detail as is
practicable,
(e)
The approval number and place of destination for wrapping, relaying,
purification or
processing,
(f)
The traceability document shall be dated and signed by the gatherer,
(2) The traceability
documents shall be numbered regularly and in sequence.
(3) The competent authority shall keep a register indicating numbers of
traceability documents together
with the names of the persons collecting live bivalve
molluscs and to whom the documents have
been issued. The traceability document
for each batch of live bivalve molluscs shall be date-stamped
upon delivery of a batch to a despatch centre, purification centre, relaying
area or processing plant
and shall be kept by the operators of
such centres, areas or plants and the gatherer, if any, for at
least twelve
months.
Chapter – III
Requirements
for Relaying Live Bivalve Molluscs
1
Live bivalve molluscs shall
be gathered and transported in accordance with the requirements of Chapter II of
these rules;
2
Techniques for handling live
bivalve molluscs intended for relaying shall permit the resumption of filter
feeding activity after immersion in natural waters;
3
Live bivalve molluscs shall
not be re-laid at a density which does not permit purification;
4
Live bivalve molluscs shall
be immersed in seawater at the relaying area for an appropriate period which
shall exceed the time taken for levels of faecal bacteria to become reduced to
the levels permitted by this rule taking into account of the fact that the
Standards of Chapter V shall be met;
5
The minimum water
temperature for effective relaying shall, where necessary, be determined and
announced by the competent authority for each species of live bivalve molluscs
and approved relaying area;
6
Areas for relaying live
bivalve molluscs shall be approved by the competent authority. The boundaries of
the sites must be clearly identified by buoys or other fixed means; there shall
be a minimum distance of three hundred between relaying areas, and also between
relaying areas and production areas;
7
Sites within a relaying area
shall be well separated to prevent mixing of batches; the ‘all in, all out’
system shall be used, so that a new batch cannot be brought in before the whole
of the previous batch has been removed;
8
Permanent record of the
source of live bivalve molluscs, relaying periods, relaying areas and subsequent
destination of the batch after relaying shall be kept by the operators of
relaying areas for inspection by the competent authority;
9
After harvesting from the
relaying area, batches shall, during transport from the relaying area to the
approved despatch centre, purification centre or processing plant, be
accompanied by a traceability document, setting out, in addition to the
information specified in point 6 of Chapter II, 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.
Chapter
– IV
Requirements for the Approval of DEspatch or
Purification Centres
I.
General
conditions relating to premises and equipment- The
despatch or purification centres shall not be located in areas which are close
to objectionable odours, smoke, dust and other contaminants. The location shall
not be subject to flooding by ordinary high tides or run off from surrounding
areas.
The
premises of the despatch or purification centers shall have-
a)
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;
b)
Flooring, which is easy to
keep clean and is laid in such a way as to facilitate drainage;
c)
Adequate working space to
allow for satisfactory performance of all operations;
d)
Durable walls, which are
easy to clean;
e)
Adequate natural or
artificial lighting;
f)
An appropriate number of
changing rooms, wash basins and lavatories for the workers;
g)
Adequate equipment for
washing tools, containers and equipment;
h)
Facilities for the supply
and, where appropriate, storage of exclusively potable water within the
meaning
of EC Directive 778/80/EEC of
15 July 1980 relating to the quality of water intended for
human consumption or
facilities for the supply of clean sea water;
i)
Facilities
for supplying non-potable water may be authorized. The water concerned shall not
come
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
and outlets carrying
non-potable water shall be clearly distinguished from those
carrying potable water;
j)
Equipment and instruments
made of corrosion-resistant material, which come into contact with
the live
bivalve moullsucs;
II
General Hygiene
Requirements-A high degree of
cleanliness and hygiene shall
be required of staff, premises, equipments and working conditions namely:-
1.
Staff, who treat or handled
live bivalve molluscs, shall in particular wear clean working clothes and,
where appropriate, gloves, which are suitable for work in which the person, is
engaged;
2.
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, shall be temporarily prohibited, until
recovery, from working with or handling
these products;
3.
Any rodents, insects or
other vermin found shall be destroyed and further infestation prevented.
Domestic animals shall not be permitted to enter the facilities;
4.
Premises, equipment and
instruments used for handling live bivalve molluscs shall be kept clean and in
good state of repair; equipment and instruments shall be thoroughly cleaned at
the end of the day’s
work and at such times as may be appropriate;
5.
Premises, instruments and
equipment shall not be used for purpose other than the
handling of live
bivalve molluscs without authorization by the competent
authority.
6.
Waste products shall be
stored hygienically in a separate area and, where appropriate, in covered
containers suitable for the purpose intended. Waste material shall be removed
from the vicinity of the
establishment at appropriate intervals;
7.
The finished product shall be stored under cover and shall be kept away
from the areas, where animals
other than live bivalve molluscs, such as
curstaceans, are handed.
III
Special requirements for
purification centers-
(a) The purification centers shall have the following special requirements
namely:-
1.
The floors and walls of the
purification tanks and any water storage containers shall have a smooth,
hard
and impermeable surface and be easy to clean scrubbing or use of pressurized
water. The base
of the purification tanks shall be sufficiently sloped and
equipped with drainage sufficient for
the volume of work;
2.
Live bivalve molluscs shall
be washed free of mud with pressurized clean sea water or potable water
before
purification. The initial washing shall 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;
3.
The purification tanks shall
be supplied with a sufficient flow of sea water per hour and per tonne of
live bivalve molluscs treated;
4.
Clean sea water or sea water
cleaned by treatment shall be used for purifying live bivalve molluscs; the
distance between the sea water intake point and the waste water outlets shall be
sufficient to avoid
contamination; if treatment of the sea water is necessary,
the process shall be authorized 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 EC
Directive
778/80/EEC;
5.
Operation of the
purification system shall 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;
6.
The quantity of live bivalve
molluscs to be purified shall not exceed the capacity of the purification
centres; the live bivalve molluscs shall be continuously purified for a this
rule 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 shall 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.
7.
A purification tank
contained several batches of molluscs, shall 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 shall be based on the time required by
the batch needing the longest period of
purification;
8.
Containers used to hold live
bivalve molluscs in purification systems shall have a construction which
allows sea water to flow through; the depth of layers of live bivalve molluscs should
not impede the
opening of shells during purification;
9.
No crustaceans, fish or
other marine species shall 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 shall be washed thoroughly by
hosing
with potable water or clean sea water; this shall take place in the
purification tank if necessary; the
washing water shall not be re-circulated;
11.
Purification centres shall
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 shall
be recognized by the competent
authority;
(b) Purification centres shall regularly keep a record of the
following data, namely:-
§
results of microbiological
tests on 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
traceability document numbers;
§
the times of filling and
emptying of purification systems (purification times);
§
despatch details of
consignments after purification.
The
above records shall be complete and accurate and recorded in a permanent ledger
book, which shall be
available for inspection by the competent authority;
(c
) 1. Purification centres shall accept only those batches of live molluscs,
which are accompanied by the traceability document referred to in Chapter II.
2. Purification centres despatching batches of live bivalve molluscs to
dispatch centres shall provide a
traceability 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, 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.
3. Every package containing
purified live bivalve molluscs shall be provided with a
label certifying that
all molluscs have been purified.
IV Special requirements for
despatch centers -
(a)
The
despatch centers shall have the following special requirements, namely:-
1.
Conditioning shall not
cause any contamination of the product; conditioning facilities shall 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;
2.
Equipment and containers in
the conditioning facilities shall not constitute a source of
contamination;
3.
Procedures for calibration of live bivalve molluscs shall 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;
4.
Any washing or cleaning of live bivalve molluscs shall be carried out
using pressurized clean
sea water
or potable water; cleaning water may not be recycled.
(b) 1. Despatch
centres shall accept only
those batches of live bivalve molluscs, which are
accompanied by
the traceability document referred
to in section 6 of Chapter II
and
coming from an approved
production area, relaying area or
purification centre.
2. Despatch centres shall have their own laboratories or secure the
services of a laboratory
equipped
with necessary facilities for checking, inter
alia, whether the molluscs
comply
with the micro-biological standards of Chapter V. Laboratory facilities
outside the centres
shall be recognized by the competent authority. These requirements do
not apply to
despatch centres obtaining their molluscs exclusively and directly from a purification
centre
,
where they have been examined after purification.
(c)
Despatch centres shall keep
the following at the disposal of the competent authority
1. The results of microbiological
tests on live bivalve molluscs from an approved production area or
relaying area
or from a purification plant;
2. The dates and quantities of live bivalve molluscs delivered to the despatch
centre, together with
the corresponding traceability documents, despatch details including the names and addresses of
consignees, the dates and quantities of live bivalve molluscs despatched, together with the
corresponding entry traceability document
number(s).
3. The data shall be classified
chronologically and preserved for a period of twelve months.
Chapter – V
Requirements
of live bivalve molluscs
Live bivalve molluscs intended for immediate human consumption shall comply
with the following requirements
namely:-
1.
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.
2.
They shall contain less than
300 faecal coliforms or less than 230 E.Coli per 100 g of mollusc flesh and
intravalvular liquid based on a five-tube, three-dilution Most Probable Numbwe-test
or any other
bacteriological procedure shown to be equivalent accuracy.
3.
They shall not contain
salmonella in 25 g of mollusc flesh.
4.
They shall 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.
5.
The upper limits as regards
the radionuclide contents shall not exceed the specified limits for foodstuffs.
6.
The total Paralytic
Shellfish Poison (PSP) content in the edible parts of molluscs (the whole body
or any
part edible separately) shall not exceed 80 micrograms per 100 g of
molluscs flesh in accordance with
the biological
testing method.
7.
The customary biological
testing methods shall 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).
8.
The total Amnesic Shellfsh
Poison (ASP) content in the edible parts of molluscs (the entire body or any
part edible separately) shall not exceed 20 micrograms of domoic acid per gram
using the High
Performance Liquid Chromatography method.
9.
In the absence of routine virus testing procedures and the establishment
of virological Standards,
health checks shall be based on faecal bacteria
counts.
Note:
(a) Examination for checking compliance with the requirements of this
Chapter shall be carried
out in accordance with proven methods, which are
scientifically recognized.
(b) 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 shall be established by the
competent authority.
(c ) The effectiveness of
the faecal indicator bacteria and their numerical limits as well as the other
parameters laid down in this Chapter shall be kept under constant review and,
where scientific
evidence proves the need to do so, that shall be revised.
(d) 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
shall be adopted by the competent
authority.
Chapter
– VI
Public Health Control and monitoring of
Production
The competent authority shall establish a public health control and monitoring
of production which shall include:-
a)
Periodic monitoring of live
bivalve molluscs relaying and production areas in order to
i.
Avoid any malpractice with regard to the origin and destination of the
live bivalve molluscs;
ii.
Check the microbiological
quality of the live bivalve molluscs in relation to the production and relaying
areas;
iii.
Check the possible presence of toxin producing plankton in production and
relaying water and biotoxins
in live bivalve molluscs;
iv.
Check the possible presence of chemical contaminants.
b) For the purpose of clauses (iii)
and (iv), sampling plans shall be established by the competent
authority.
c) The competent authority shall provide for the following sampling methods,
namely:-
1.
a) where variations in
faecal contamination, at each production and relaying areas;
b) where variations in production at relaying areas, in the presence of
plankton containing
marine
biotoxins. The sampling shall be
carried out as follows:-
i)
Monitoring
: periodic sampling organized 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
sampling : monitoring plankton
in the growing and fishing water by
increasing the
number of sampling point and
the number of samples, and toxicity
tests using the molluscs from the affected
area which are most susceptible to
contamination. Placing on the market of molluscs from that area may not be
reauthorized until new sampling has provided
satisfactory toxicity test results;
2.
If the result of a sampling
plan shows that export of live bivalve molluscs shall constitute
a hazard to
human health, the competent authority shall close the production area, as
regards molluscs concerned, until the situation has been restored.
3.
Laboratory tests in order to
check compliance with the requirements for the end product
as laid down in
Chapter V. A control system must be established to verify that the level
of
marine biotoxins does not
exceed safety limits.
4.
An inspection of
establishment at regular intervals. These inspections shall include in
particular, checks,
namely:-
a)
To verify whether the
approval conditions are still being complied with;
b)
On the cleanliness of the
premises, facilities, equipment and on staff hygiene;
c)
To verify whether the live
bivalve molluscs are handled and treated correctly;
d)
On the correct application
and functioning of purification or conditioning systems;
e)
On the correct use of health
marks.
These checks shall include the taking of samples for laboratory tests;
the result of these
tests are
notified to the persons responsible for the establishments.
5. Checks on the storage and transport conditions for consignments of live
bivalve molluscs.
Chapter
– VII
WRAPPING
1.
Live bivalve molluscs must
be wrapped under satisfactory conditions of hygiene. The wrapping material
or container shall 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.
2. Oysters shall be wrapped
with the concave shell downwards.
3. All wrappings of live
bivalve molluscs for export shall be sealed and remained sealed from the
despatch
centre.
Chapter – VIII
Preservation
and Storage
1.
In any storing rooms, live
bivalve molluscs shall be kept at a temperature which does not adversely
affect their quality and viability; the wrapping shall not come into contact with thee
floor of the store
room, but shall be placed on a clean, raised surface.
2.
Reimmersion in water or
spraying water on live bivalve molluscs shall not take place after they have
been wrapped and have left the despatch centre for export.
Chapter – IX
Transport
from the dEspatch centre
1.
Consignment of live bivalve
molluscs intended for human consumption shall be transported, wrapped as sealed
parcels from the despatch centre for export.
2.
The means of transport used
for consignments of live bivalve molluscs shall have the following
characteristics :
a)
Their interior walls and any other parts which might come into contact
with the live bivalve
molluscs shall be
made of corrosion – resistant
material; the walls shall be smooth and easy to
clean;
b) They
shall 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 shall not be transported with other products
which might contaminate them.
d)
Live bivalve molluscs shall 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.
e)
The parcels containing live bivalve molluscs shall not be transported in
direct contact with the
floor of the
vehicle or container but shall be
supported on raised surface or by some other means
which prevent
contact with
the floor. Where ice is used in transporting consignments of live
bivalve
molluscs, it shall
have been made from potable water or clean sea water.
Chapter – X
Marking of Consignments
1.
All parcels in a consignment
of live bivalve molluscs for export shall be provided with a health mark so
that
the original despatch centre may be identified at
all times during transport. The mark shall contain
the following information :
a) The
country of despatch,
b)
The species of bivalve
molluscs (common name and scientific name),
c) The
identification of the despatch centre by the approval number issued by the
competent
authority,
d)
The date of wrapping,
comprising at least the day and the month,
e) By
way of
expressing durability, it shall be mentioned that these animals shall be
alive when
exported.
2.
The health mark shall 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 shall also be a
twist-tie or staple design; self-adhesive health marks shall not be used, unless
they are not detachable. All types of health mark must be for single use only
and shall not be transferred.
3.
The health mark shall be
durable and waterproof, and the information presented shall be legible,
indelible and in easily decipherable characters.
(F.No.6/3/2002-EI&EP)
M.V.P.C.SASTRY,
Jt.Secy.
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