Branch: Fisheries Management  
Chief Directorate: Aquaculture & Economic Development  
Directorate: Sustainable Aquaculture Management  
 
 
 
 
SOUTH AFRICAN LIVE MOLLUSCAN SHELLFISH  
MONITORING AND  CONTROL PROGRAMME  
 
Issue  6: January 2016 
 
 
 
 
 
 
 
 
 
 
DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
1 CONTENTS  
1. BACKGROUND  ................................ ................................ ................................ ................................ .........................  3 
2. SCOPE AND AUTHORIZATION ................................ ................................ ................................ ................................ .. 4 
3. DOCUMENT CONTROL  ................................ ................................ ................................ ................................ .............  5 
4. RULES  ................................ ................................ ................................ ................................ ................................ ...... 6 
5. CLASSIFICATION OF SHELLFISH PRODUCTION AREAS  ................................ ................................ .............................  8 
5.1. Compliance  ................................ ................................ ................................ ................................ ................................ ....... 8 
5.2. Sanitary Survey  ................................ ................................ ................................ ................................ ................................ . 8 
5.3. Approved areas (Class A)  ................................ ................................ ................................ ................................ ...............  10 
5.4. Restricted areas (Class B)  ................................ ................................ ................................ ................................ ...............  10 
5.5. Prohibited areas  (Class C)  ................................ ................................ ................................ ................................ ..............  10 
5.6. Conditional areas (Temporarily Class A or B)  ................................ ................................ ................................ ................  10 
5.7. Toxic and other hazardous substances parameters for shellfish products  ................................ ................................ .. 11 
6. MONITORING OF SHELLFISH PRODUCTION AREAS AFTER CLASSIFCATION  ................................ ..........................  12 
6.1. Background  ................................ ................................ ................................ ................................ ................................ .... 12 
6.2. Microbiological monitoring  ................................ ................................ ................................ ................................ ...........  12 
6.3. Monitoring of environmental contaminants  ................................ ................................ ................................ ................  14 
6.4. Biotoxin monitoring  ................................ ................................ ................................ ................................ .......................  14 
7. REQUIREMENTS FOR HARVESTIN G AND TRANSPORT OF LIVE SHELLFISH TO A DISPATCH CENTRE, DEPURATION 
FACILITY OR AREA, OR PROCESSING PLANT  ................................ ................................ ................................ ..........  18 
7.1. Harvesting requirements  ................................ ................................ ................................ ................................ ...............  18 
7.2. Transport and Vessels  ................................ ................................ ................................ ................................ ....................  18 
7.3. Documentation and records  ................................ ................................ ................................ ................................ ..........  18 
8. REQUIREMENTS FOR RELAYING SHELLFISH  ................................ ................................ ................................ ...........  20 
8.1. Conditions  ................................ ................................ ................................ ................................ ................................ ...... 20 
8.2. Source of shellfish  ................................ ................................ ................................ ................................ ..........................  20 
8.3. Relaying areas  ................................ ................................ ................................ ................................ ................................  20 
8.4. Operating procedures  ................................ ................................ ................................ ................................ ....................  20 
8.5. Records  ................................ ................................ ................................ ................................ ................................ ...........  21 
9. DEPURATION  ................................ ................................ ................................ ................................ .........................  22 
9.1. Conditions  ................................ ................................ ................................ ................................ ................................ ...... 22 
9.2. Process verification  ................................ ................................ ................................ ................................ ........................  22 
9.3. Source of shellfish  ................................ ................................ ................................ ................................ ..........................  22 
9.4. Structural requirements ................................ ................................ ................................ ................................ .................  23 
9.5. Process water quality and operation ................................ ................................ ................................ .............................  23 
9.6. Cleaning and Sanitizing of facilities, utensils and equipment  ................................ ................................ .......................  23 
9.7. Quality assurance  ................................ ................................ ................................ ................................ ...........................  24 
9.8. Records  ................................ ................................ ................................ ................................ ................................ ...........  24 
10. WET STORAGE  ................................ ................................ ................................ ................................ .......................  25 
10.1.  Conditions  ................................ ................................ ................................ ................................ ................................ ...... 25 
10.2.  Source of shellfish  ................................ ................................ ................................ ................................ ..........................  25 
10.3.  Structural and design requirements  ................................ ................................ ................................ ..............................  25 DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
2 10.4.  Water quality  ................................ ................................ ................................ ................................ ................................ .. 25 
10.5.  Records  ................................ ................................ ................................ ................................ ................................ ...........  26 
11. REQUIREMENTS FOR DISPATCH CENTRES  ................................ ................................ ................................ .............  27 
11.1.  Receiving  and storage  ................................ ................................ ................................ ................................ ....................  27 
11.2.  Marking of consignments and records  ................................ ................................ ................................ ..........................  27 
11.3.  Transport from a dispatch centre  ................................ ................................ ................................ ................................ .. 28 
11.4.  Export  ................................ ................................ ................................ ................................ ................................ .............  28 
12. Feed management and monitoring  ................................ ................................ ................................ .......................  29 
12.1.  Farmer responsibility  ................................ ................................ ................................ ................................ .....................  29 
12.2.  Feed producer responsibility  ................................ ................................ ................................ ................................ .........  29 
13. Drug management ................................ ................................ ................................ ................................ .................  31 
14. DEFINITIONS  ................................ ................................ ................................ ................................ ..........................  32 
15. REFERENCES  ................................ ................................ ................................ ................................ ..........................  34 
16. SOUTH AFRICAN LEGISLATION  ................................ ................................ ................................ ..............................  35 
 
TABLES  
Table 1: Maximum allow able time between biotoxin test and shellfish harvesting  ................................ ................................ ... 16 
 
APPENDICES  
APPENDIX I: MINIMUM REQUIREMENTS OF THE SANITARY SURVEY REPORT  ................................ ................................ ........  36 
APPENDIX II: SAMPLING OF SHELLFISH AND WATER  ................................ ................................ ................................ .................  39 
APPENDIX III: STANDARDS AND METHODS FOR THE ANALYSES OF BIOTOXINS AND MICROBIAL CONTAMINANTS  ...........  41 
APPENDIX IV: MICROBIOLOGICAL REGULATORY LIMITS  ................................ ................................ ................................ ...........  42 
APPENDIX V: THRESHOLDS THAT TRIGGER INTENSIVE BIOTOXIN TESTING  ................................ ................................ .............  43 
APPENDIX VI: MICROBIOLOGICAL AND HAZARDOUS SUBSTANCE CONTINGENC Y MEASURES ................................ ..............  44 
APPENDIX VII: BIOTOXIN CONTINGENCY MEASURES  ................................ ................................ ................................ ................  45 
APPENDIX VIII : DOCUMENTATION AND LABELLING REQUIREMENTS DURING TRANSPORT OF LIVE SHELLFISH  ..................  46 
APPENDIX IX: HARMFUL ALGAL SPECIES FOUND IN SOUTH AFRICAN MARINE ENVIRONMENT  ................................ ............  47 
APPENDIX X: PROHIBITED DRUGS ................................ ................................ ................................ ................................ ................  47 
 DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
3 1. BACKGROUND  
 Food safety laws throughout the world give special consideration to molluscan shellfish for a number of reasons 
(summarized below):  
 Some of them are filter feeding she llfish that accumulate hazardous levels of biotoxins and other toxins and 
pathogenic micro -organisms (viruses, protozoa, bacteria and helminths) in their flesh causing them to 
become naturally contaminated.  
 While filter feeding bivalve molluscs pose by far  the greater public health threat from biotoxins, predatory, 
grazing and scavenging gastropods may accumulate toxins from their prey (e.g. toxic bivalve molluscs), food 
or if they grow in sea water containing toxin -producing phytoplankton. Often the source  of intoxication is not 
clear for gastropods.  
 In many cases no thermal process is applied to shellfish prior to sale to eliminate pathogens and therefore, 
further microbiological multiplication is likely to occur.  The presence of marine biotoxins is also not 
eliminated by cooking.  
 Raw molluscan shellfish receive the second highest hazard rating for all foods by the International 
Commission on Microbial Specification for Foods.  
 An increasing number of studies worldwide are showing the presence of pathogens  in near shore waters and 
shellfish when faecal coliforms are either absent or present in low numbers.  Pathogenic viruses and vibrio species 
may be present suggesting that the risk of disease may sometimes be underestimated by relying on densities of 
faecal coliforms alone.  In addition, the distribution of biotoxin producing phytoplankton appears to be spreading 
worldwide either as a result of increased monitoring efforts or new introductions.  For these reasons, shellfish 
quality assurance programmes sho uld be reviewed whenever new information becomes available.  
 This Manual has been prepared by the Department of Agriculture, Forestry and Fisheries (DAFF) and the 
Department of Food and Associated Industries of the National Regulator for Compulsory Specifi cations (NRCS), 
with the purpose of developing an official manual for South African operators which will provide the necessary 
guarantees to foreign buyers and Governments as well as to local consumers that the risk of disease and poisoning 
through consumi ng molluscan shellfish is adequately managed and minimised.  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
4 2. SCOPE AND AUTHORIZATION  
2.1. This manual addresses the public health concerns of live molluscan shellfish harvested from marine aquaculture 
production areas and intended for immediate human consumptio n or for further processing before consumption.  
The system of controls and sanitary checks covered in this manual can be extended to include wild -harvested 
shellfish in the future.  
2.2. Hatcheries and nurseries are not subject to public health requirements pr ovided the product is more than 6 
months from minimum market size.  
2.3. The manual applies to molluscan shellfish (hereafter referred to as shellfish) as defined under Section 14 
2.4. The manual addresses all activities r elated to the commercial farming of molluscan shellfish prior to placing on 
the market, including the producing, harvesting, wet storage, relaying, depuration, packaging, dispatch, 
transporting, labelling and storing of live molluscan shellfish.  The freez ing and canning of molluscan shellfish is 
controlled by the relevant Compulsory Specifications  published under the NRCS Act, 2008 (Act No. 5 of 2008)  
2.5. The manual includes the monitoring activities required for audit of production areas and establishments in  the 
interests of public health.  These activities will be managed and controlled by DAFF under the Marine Living 
Resources Act, 1998 (Act No. 18 of 1998) and the relevant municipal health authorities  under the National Health 
Act, 2003 (Act No. 61 of 2003 ) and the Municipal Structures Act, 1998 (Act No. 117 of 1998); in cooperation with 
the NRCS (the appointed body for administering the various Compulsory Standard Specifications for fishery 
products in South Africa and the recognised competent authority by  certain countries for the trade and export of 
fisher y products).  
2.6. The manual addresses the requirements for the certification and/or issue of permits for the production, 
harvesting, relaying, wet storage, depuration, transport and handling of live mollusc an shellfish.  
 DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
5 3. DOCUMENT CONTROL  
3.1. This manual was comp iled by DAFF in cooperation with the NRCS and the molluscan shellfish farming industry. 
The manual will be reviewed as pertinent new information becomes available.  The review process will involve 
consu ltation with representatives from DAFF, NRCS, industry, and the Dep artmen t of Health , (including provincial 
and/or municipal health authorities where applicable),  who collectively shall comprise the Shellfish Management 
Committee.  
3.2. Suggestions for alterati ons that would significantly improve the document are welcomed.  These should be 
forwarded to the co -ordinator of this document, explaining the reasons for the suggested changes.  
 Co-ordinator:  Dr Trevor Probyn (TrevorP@daff.gov.za)  
 Department of Agricult ure, Forestry and Fisheries  
 Private Bag X2  
 Roggebaai 8012  
 Cape Town  
 South Africa  
3.3. A detailed record of all amendments shall be maintained and amended pages dated accordingly.  
3.4. The latest version will be made available on the DAFF website and at NRCS .  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
6 4. RULES  
4.1. The definitions in Section 14 apply in this manual unless the context requires otherwise.  
4.2. DAFF is the Regulatory Authority authorising the aquaculture, harvesting, transport of molluscan shellfish for 
whol esale trading in terms of the Marine Living Resources Act, 1998 (Act No. 18 of 1998) and associated 
Regulations.  Authorisations are administered through the issue of a marine aquaculture (mariculture) right and 
permit.  Associated activities such as relay ing, depuration and wet storage will require special authorisation from 
DAFF in conjunction with the relevant local health authority.  Land -based wet storage facilities and depuration 
plants must obtain a Certificate of Acceptability for food premises from  the local health authority as required by 
Regulation 962 published under the Foodstuffs , Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972) . 
4.3. Establishments packing or processing molluscs must also be licensed by DAFF in cooperation with the NRCS 
(canned or frozen products) and/or local Health authorities (live and chilled products) as is relevant.  Such 
establishments will be licensed only when the operator can produce a Certificate of Acceptability in terms of 
Regulation 962 published under the F oodstuffs , Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972)  for 
the establishment which is not older than 3 months.  Each establishment must be  licensed annually.  
4.4. DAFF, the NRCS or relevant local h ealth authority may appoint official inspectors (e.g. NRCS inspectors, DAFF 
Compliance Officers, Environmental Health Practitioners) or other appropriately trained personnel to assist with 
the official survey and sampling activities, and for the inspection of compliance of operators with the 
requirement s of this manual.  A written appointment is required that defines the responsibilities of the 
inspector/officer so appointed.  
4.5. Where inter -government guarantees are sought (health certificate), the competent authority officially authorised 
by DAFF  must have  free access to records kept by DAFF.  
4.6. To enable proper liaison between DAFF and other governmental departments /authorities  in regard to Paragraphs 
4.2 - 4.4 above, a Memorandum of Understanding must be prepared and signed by all parties  concerned . 
4.7. DAFF shall keep and maintain a central file containing copies of the records and documents required by this 
manual including:  
 Copies of permits and other approvals.  
 Copies o f Certificates of Acceptability as referred to in Paragraphs 4.2 and 4.3. 
 Official laboratory certificates.  
 Movement documents.  
 Individual production area reports (e. g. maps of production areas, surveillance records, sanitary surveys, 
management plans, transport, closure, harvesting criteria adjustments, reclassification of areas and annual 
evaluation reports).  
 Details regarding marine aquaculture operations including reconstruction and remodelling plans.  
 Summaries of shellfish food -borne illness reports, where available (from Department of Health).  
 Marine biotoxin monitoring data and notices.  
 Enforcement action reports.  
 Evaluation reports generated by foreign governmen ts or local authorities.  
 All data, criteria and protocols relating to the operation of a restricted area such as relaying reports, 
depuration reports, harvesting permits and harvesting control records.  
 All data, procedures and reports on wet storage.  
 All approved documentation for licensing of dispatch and processing establishments.  
 Correspondence with farmers.  
4.8. The officially approved inspector servicing an establishment where molluscan shellfish are landed for relaying, 
wet storage, depuration, preparation , processing and final packaging or repacking must also keep a file containing 
copies of the relevant records, documents and reports described in Paragraph 4.7. DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
7 4.9. Industry shall keep complete, accurate and legible  shellfish transaction records for at least 5 year s in a 
permanently bound ledger book (or other approved method).  This pertains to each authorised marine farmer 
including relayer, depuration plant, wet storage unit and establishment packing and/or proces sing shellfish.  Such 
records shall include:  
 All information necessary to trace all purchases and sales of molluscan shellfish back to their production area 
source.  
 Dates of harvesting of molluscan shellfish and of their arrival at the licensed premises f or the intended 
process, including dates of shucking, packing and dispatch.  
 Results of laboratory analyses instigated by industry.  
 Permanent records of relaying and depuration activities where applicable.  
4.10. Permits to cultivate and harvest shellfish for dire ct human consumption or further processing shall be issued by 
DAFF subject to a satisfactory classification of the production or relaying area following a sanitary survey.  An area 
shall be classified as suitable for production and harvesting shellfish if it meets the requirements for approved 
(Class A) or restricted (Class B) areas as specified in Paragraphs 5.3 and 5.4. 
4.11. The development of new marine aquaculture operations in waters meeting the approved criteria  is to be 
promoted .  In view of the extra demands for the management and control and the greater risk of contamination 
for shellfish products originating from waters of lesser microbiological status than approved areas, cultiva ting 
shellfish in such areas is discouraged.  Approval for cultivation in waters with limited microbial pollution will 
require detailed motivation.  
4.12. Once a production area has been shown to conform to the approved area requirements (Paragraph 5.3) or that it 
may be utilized under certain conditions (Paragraph 5.4), a permit may be issued to the operator stating the 
conditions for operation, harvesting, transport, relaying and marketing  as may be applicable.  All marine 
aquaculture facilities must provide access and assistance to official staff for monitoring purposes as specified in 
Section 6. 
4.13. Harvesting, handling and transport of molluscan s hellfish by licensed operators shall be regulated as given in 
Section 6. 
4.14. Relaying and depuration are intended to reduce the number of pathogenic organisms that may be present in 
shellfish from moderately pollute d waters and, in the case of relaying, to reduce biotoxins to safe levels.  These 
different depuration approaches are not intended for heavily microbiologically contaminated shellfish or to 
reduce the levels of other accumulated toxic substances.  
4.15. Depuratio n of shellfish in relaying areas or in depuration plants may only take place with a permit obtained from 
DAFF.  The permit shall be specific for the particular depuration plant or relaying area.  The requirements for the 
relaying of shellfish are given in Section 8.  The layout and water quality required of depuration facilities must 
comply with the requirements given in Section 9. 
4.16. Each sea -based wet storage site for s hellfish shall be approved as above (Paragraph 4.10 ).  The general 
requirements for wet storage, both sea -based and land -based are given in Section 10. 
4.17. Requirements f or dispatch centres are given in Sections 11. DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
8 5. CLASSIFICATION OF SHELLFISH PRODUCTION AREAS  
5.1. Compliance  
 Compliance with classification objectives shall satisfy the conditions listed below.  
5.1.1.  A sanitary survey shal l be conducted  of each new production area prior to its approval as a source of 
shellfish for direct human consumption or for shellfish to be used in a relaying or depuration facility.  The 
sanitary survey shall be completed according to the guidelines giv en in Appendix I.  
5.1.2.  The requirements for a sanitary survey apply to both sea -based and shore -based marine aquaculture 
operations.  
5.1.3.  Existing production areas that have not been classified will be assessed on the basis of existing data on 
shellfish quality and related public health information.  Based on this review DAFF shall decide on the 
sanitary classification of the area.  
5.1.4.  Production areas are classified primarily according to their microbiological quality .  Othe r health risks such 
as contamination by heavy metals and pesticides, and occurrence of biotoxin -producing algae, may also  be 
considered.  Monitoring actions must take into account the risks that were established for a particular area 
and species.   
5.1.5.  Microbiological classification of production areas is  based on analyses of shellfish flesh.  Where the culture 
species is not available in a new production area an alternative species may be used as advised by DAFF.  In 
the case of bivalves, it may be necessary to place bags containing the culture species in  the production area 
to provide flesh for testing.  
5.1.6.  Shellfish shall not be harvested for the market from a production area until the sanitary survey has been 
completed and the sanitary survey report containing the recommended classification and harvesting c riteria 
has been officially established.  Results of microbiological testing of shellfish samples taken during a period 
of one year from stations (indicated on a map or plan of the production area) are used for the classification 
of production areas.  
5.1.7.  The s anitary classification status of production areas shall be reviewed annually taking into account new 
potential pollution sources and other developments that could affect water quality.  
5.1.8.  DAFF shall maintain a current list of individual farm health status for  distribution to the NRCS and  relevant  
local h ealth authorit y. 
5.2. Sanitary Survey  
 The sanitary survey is of critical importance in distinguishing acceptable and unacceptable areas for shellfish 
production.  This section sets forth the survey procedures, the classification scheme, and standards to be applied 
to those waters suitable for harvest for direct human consumption, those waters containing shellfish that require 
depuration or further processing, and those waters where harvesting is prohibited.  
5.2.1.  Establis hing sampling stations  
 Officials as specified in Paragraph 4.4 may be appointed by DAFF to assist with sampling activities.  
5.2.1.1.  For shore -based aquaculture systems, shellfish samples are to be taken from either wit hin the 
culture units or, if the farm is not established, from the source coastal waters at the position of the 
proposed intake and 500m on either side of this point parallel to the coastline. Should the culture 
species not be present an alternative indica tor Molluscan shellfish species may be used under 
advisement of DAFF.  
5.2.1.2.  Water abstracted for onshore cultivation must comply with the requirements for an approved area 
(Paragraph 5.3).  If water is to be treated to conform to th ese requirements the microbiological 
quality of source water, prior to disinfection, and recirculated water shall meet, at a minimum, the 
restricted production area standards (Paragraph 5.4).  Water that is exce ssively contaminated may 
not be used for marine aquaculture.  
5.2.1.3.  The production area survey in open waters shall take into account the proposed positioning of 
cultivation structures and potential pollution sources.  Where a possible point source of pollution i s 
indicated, a sampling station should be positioned on the boundary of the production area nearest to 
this point taking the predominant circulation patterns into account.  The positioning of other non -DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
9 pollution point microbiological sampling stations shal l also be dictated by the local hydrodynamics.  
All sampling points must be fixed and indicated on a chart of the production area.  Samples should be 
collected as close as possible to the nominal positions.  
5.2.1.4.  Where relevant, sampling should address possible water column gradients that may affect the 
candidate species (e.g. if culture species is to be grown on ropes or poles) and growth habit (e.g. 
attached to rock or rope, living in or on the sediment).  
5.2.1.5.  Water sampling positions for phytoplankton identificatio n must take local hydrodynamics into 
account.  A single key station may suffice for a particular production area.  
5.2.1.6.  Shellfish flesh may be composited from a number of sampling points for analysis of other toxic and 
hazardous substances.  However, sampling po ints considered to be near point sources of such 
contamination must be analysed separately.  
5.2.2.  Frequency of Sampling Required for Classification  
5.2.2.1.  A sample or sampling batch for a particular production area is considered to include all points that 
were establis hed as sampling stations by DAFF.  
5.2.2.2.  Microbiological samples shall be taken every two weeks from each sampling point for classification of 
a production area.  
5.2.2.3.  The samples are to be taken by DAFF sanctioned personnel (Paragraph 4.4) at a fixed frequency 
(determined by DAFF) under sufficiently broad environmental conditions to identify possible adverse 
scenarios.  It is expected the collection of this information will cover a period of at least 12 months 
for full class ification of an area.  All data collected during this period will be used for classification 
purposes.  
5.2.2.4.  If samples cannot be taken on a fixed date (e.g. due to bad weather conditions, problems in getting 
samples to the laboratory within the prescribed time,  etc.), they must be taken as close as possible to 
the stated date.  The reason for shifting the date must be depicted in the sampler’s report.  
5.2.2.5.  An initial period of no shorter than 3 months may be used for provisional classification.  Harvesting 
for the m arket may be permitted following provisional classification, providing results to date 
indicate conformance with microbiological, heavy metal, and other hazardous substances standards.  
Microbiological sampling shall b e conducted weekly in this case .  
5.2.2.6.  Shou ld a new farm be developed in the same production area as existing farms producing the same 
shellfish type i.e. mussels, oysters or abalone, the new farm is only required to show conformance 
with the microbiological standards for the provisional classifica tion, provided that the other farms in 
the same growing water conforms to heavy metal and other hazardous substances standards.  
5.2.2.7.  If at any stage during the sampling regime the test results fall outside specifications, weekly sampling 
shall either be initiat ed until such time as the problem is identified.  More frequent sampling may 
also be required when environmental conditions indicate a high potential for faecal contamination.  
5.2.2.8.  Shellfish flesh shall be sampled twice during the classification period for anal yses of heavy metals and 
other hazardous substances.  One sample shall be taken for radionuclides during this period.  Where 
the culture species is absent from the production area under investigation, an alternative indicator 
species may be used as recomme nded by DAFF.  
5.2.2.9.  Water samples for phytoplankton identification by DAFF sanctioned personnel are to be taken at 
least monthly . 
5.2.3.  Sampling and analytical protocols for microbiological parameters  
5.2.3.1.  Live shellstock, including intravalvular fluids is sampled from ea ch station as summarized in Appendix 
II and submitted to an accredited or officially approved microbiology laboratory.   
5.2.3.2.  The five -tube, three -dilution MPN method of Donovan et al. (1998) is required for enumeration of E. 
coli (Appendix III).  Alternative m ethods for E. coli , including other MPN methods, should be validated 
against the reference method following an internationally accepted protocol (e.g. ISO 16140).  
  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
10 5.3. Approved areas (Class A)  
5.3.1.  Shellfish harvested from an approved area shall comply with the fo llowing conditions:  
 The E. coli  MPN may not exceed 230 E. coli  per 100 g of flesh and intravalvular liquid in 80% of the 
samples. No sample may exceed 700 E. coli  per 100  g of flesh and intravalvular liquid .  
 Shall not contain hazardous concentrations of t oxic substances that exceed the regulatory limits 
referred to in Paragraph 5.7. 
5.3.2.  Harvesting for direct human consumption may take place at any time in an approved area provided a 
temporary closure is not in effect due to adverse  pollution or biotoxin events.  
5.4. Restricted areas (Class B)  
5.4.1.  A restricted area is one in which the sanitary survey indicates a limited degree of microbial pollution. Limited 
pollution is defined as:  
 The E. coli  MPN may not exceed 4 600 E. coli per 100 g of fle sh and intravalvular liquid in 90% of the 
samples. No sample may exceed 14 000 E. coli  per 100  g of flesh and intravalvular liquid.  
5.4.2.  No shellfish may be harvested for direct human consumption from restricted areas at any time.  Shellfish 
from restricted are as can only be harvested for depuration or relaying.  However, DAFF may consider the 
issuing of a special permit to harvest shellfish of which the E. coli  count of the flesh and intravalvular fluids 
are below 4  600/100g flesh, on condition that it is steri lised in hermetically sealed containers or subject to 
an approved heat treatment and frozen in compliance with Paragraph  2.4. 
5.5. Prohibited areas (Class C)  
5.5.1.  Shellfish shall not be harvested from prohibited areas for  direct human consumption, depuration, relaying 
or further processing.  An area will be classified as Prohibited when any of the following conditions exist:  
 There is no current sanitary survey or annual evaluation report.  
 The sanitary survey indicates leve ls of microbiological pollution exceeding the restricted area limits 
referred to in Paragraph 5.4.1 . 
 The sanitary survey or other data indicate contamination of shellfish with heavy metals, 
radionuclides, pestic ides or other hazardous chemicals that exceed the regulatory limits.  
Petrochemical contamination is also considered a food hazard.  
 Pollution sources may unpredictably contaminate the shellfish.  
5.5.2.  Areas adjacent to sewage outfalls and other waste discharges of public health significance shall be classified 
as prohibited.  The size of the prohibited zone shall take account of the pollution source loading, dispersion 
characteristics of the receiving waters and decay (die -off) rate of the pollutant.  
5.5.3.  Seed may be taken for on -growing from prohibited areas provided it is cultured in an approved or restricted 
area for a minimum of 6 months prior to harvesting for human consumption or relaying/depuration.  
5.6. Conditional areas (Temporarily Class A or B)  
5.6.1.  Conditional areas are subject to intermittent microbiological pollution events but may be classified as 
conditionally approved or conditionally restricted if they meet the relevant criteria for a reasonable and 
predictable period.  
5.6.2.  The conditional category allows for a chang e in classification status of a growing area in response to a 
clearly established set of criteria that can be timeously implemented.  For example, opening/closure criteria 
might be based on performance standards of sewage treatment plants, seasonal activit ies affecting water 
quality, meteorological events, etc.  
5.6.3.  A management plan shall be developed for Conditional areas that are centred  on the predictability of the 
pollution events (See Appendix I, Paragraph 9).  
  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
11 5.7. Toxic and other hazardous substances paramet ers for shellfish products  
5.7.1.  Limits for environmental contaminants  
 The limits for contaminants  such as heavy metals, radio -active substances (Caesium 134 and 137), polychlorinated 
biphenyls and pesticides will be those  included in  the relevant  regulations  published under the Foodstuffs 
Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972).  These limits apply to the fresh weight, edible portion 
of the shellfish . 
5.7.2.  Limits for biotoxins  
5.7.2.1.  No shellfish shall be harvested for direct human consumption if the  regulatory limits included in the 
relevant regulations published under the Foodstuffs Cosmetics and Disinfectants Act, 1972 (Act No. 
54 of 1972) and APPENDIX III are exceeded.  
5.7.2.2.  The recognised methods for shellfish to xicity tests are given in APPENDIX III.  Alternatives to 
biological methods such as the mouse bioassay may be employed on condition that they can be 
shown to provide an equivalent level of public health protection according to an internationally 
acceptable validation protocol.  
5.7.2.3.  Should there be conflicting results from two or more methods employed on a test;  the test result 
from the reference method as indicated in APPENDIX III will supersede the test results from the other 
methods.  
5.7.2.4.  Given the appropriate analytical capability, separate limits may be applied to the various sub -groups 
of lipophilic toxins ( formerly diarrhetic shellfish toxins).  
5.7.3.  Limits for veterinary drugs  
The lim its for veterinary drugs  will be those included  in the relevant regulations published under the 
Foodstuffs Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972).  
5.7.4.  Export  
Where shellfish are intended for export, the official limits applicable to the des tination country shall be 
adhered to . DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
12 6. MONITORING OF SHELLFISH PRODUCTION AREAS AFTER CLASSIFCATION  
6.1. Background  
6.1.1.  A system of sanitary checks will be initiated under the guidance of DAFF for each production area (including 
both natural and artificial areas us ed for marine aquaculture or relaying and depuration) to promote public 
safety for both local and international markets.  The functions of this programme are to:  
 Establish compliance with the requirements of this manual concerning microbiological quality ( Paragraph 
5.3 and 5.4), toxic and hazardous substances (Paragraph 5.7.1 ) and biotoxins (Paragraph 5.7.2 ) in 
shellfish intended for direct human consumption or for further processing prior to consumption.  
 Provide data for the annual review of the classification status of the production area, i.e. Approved (Class 
A), Restricted (Class B) etc.  
 Prov ide an early warning system for biotoxin control, where relevant, in the interest of public health (and 
shellfish health and survival in certain cases).  
6.1.2.  Trained and approved personnel shall assist with sample collection and delivery to accredited or offici ally 
approved laboratories for analyses.  A system of sample coding will be implemented.  
6.1.3.  It will be the responsibility of DAFF to co -ordinate the monitoring actions, provide a system of record 
keeping for the monitoring data, and enforce closures/dictate r e-opening of harvesting areas subject to 
public health considerations.  
6.1.4.  DAFF must maintain an updated list of farms indicating its classification and current harvesting status  i.e. 
either open or closed to harvest.  
6.2. Microbiological monitoring  
6.2.1.  Sampling will b e dictated to a certain extent by the findings of the sanitary survey.  For instance, sampling 
should take into account any meteorological, hydrological or other conditions that may result in a greater 
risk of faecal and pathogen contamination.  Future dev elopments in the area that may impact on water 
quality should be addressed as the need arises.  
6.2.2.  Approved (Class A) and Restricted production areas shall be tested at least monthly for microbial 
contamination viz. E. coli .  Conditional production areas shall  be tested at least weekly for microbial 
contamination  during  harvesting .  A composite sample of shellstock under harvest or intended for next 
harvest shall be taken.  
6.2.3.  If the initial sanitary survey indicated a production area could potentially be affected b y point sources of 
faecal contamination, additional, fixed pollution -point sampling station(s) shall be established (Paragraph 
5.2.1.3 ).  Pollution -point sampling stations shall be located to provide adequate wa rning of a potential 
threat to a production area.  
6.2.4.  Abalone production facilities classified as Approved are exempt from the requirements of paragraph 6.2.2  
and need only be monitored for microbial contamination d uring official surveillance of end -of-line product.   
If, however, the end -of-line product is not monitored on a routine basis, the Paragraph 6.2.2 still applies . 
6.2.5.  Should the results from end -product testing above indicate non -compliance of an abalon e produc tion 
facility, testing shall be conducted in accordance with Paragraphs 5.2.2.5  and 5.2.2.7  to ascertain whether  
re-classification is necessary.   Should the test resu lts af ter 3 months indicate that the c lassification status of 
the abalone production facility remains Approved Paragraph 6.2.4 shall apply.  
6.2.6.  A minimum of 12 samples must be collected from each station over a 12 month period in approved and 
restricted areas.   These results will be evaluated by adding the samples to the pre -existing bacteriological 
results that accurately reflect the current situation.  The annual evaluation shall address at least the last 20 
samples for Approved and Restricted areas and at le ast the last 30 samples for Conditional areas.  The 
period evaluated should not be  less than the last 12 months.  
6.2.7.  Production areas must be sampled for shellfish flesh microbiological parameters at least monthly for annual 
classification purposes, even if no t harvesting.  
6.2.8.  Where a production area at any time does not comply with the sanitary requirements of its designated 
classification (Paragraph 5.3 or 5.4) in terms of the E. coli  stand ards stipulated in Appendix III, the following DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
13 actions must be undertaken by DAFF in collaboration with the relevant Health authorities and/or the NRCS 
(see flow diagram, Appendix IV):  
 Review all necessary documentation to trace and recall potentially cont aminated shellfish products 
that are in the distribution system.  
 Effect an immediate temporary closure to harvest from the production area  being monitored . 
 Where E. coli  concentrations exceed the regulatory limit, conduct confirmatory E. coli  tests on 
representative flesh samples taken from at least 5 sampling points (n=5) for farms in an open water 
system e.g. bays, spread  out over the production area to be monitored  or in the case of  land based  
tanks systems , from 5  baskets of the next  batch to be markete d. 
 Re-open to harvest if the results are within regulatory limits (i.e. E. coli  n=5, C=1, m=230/100g and 
M=700/100g (see CODEX STAN 292 -2008) as in paragraph 5 .4). If the confirmatory test  results are not 
within the regulatory limits , the farm is closed un til at least 3 different batches of 5 samples each, taken 
over a minimum period of 3 consecutive days are within regulatory limits.    
 Should the E. coli  concentration in the shellfish exceed the initial trigger limit of <230/100g and fall 
within the regula tory limit n=5, C=1, m=230/100g and M=700/100g the shellfish may be marketed if 
pasteurized at 70°C for 2 minutes (Codex Code of Practice for Fish and Fishery Products No. 53 of 
2003).  
 Where the E. coli  regulatory limit, n=5, C=1, m=230/100g and M=700/100g  has been exceeded but 
remains below the E. coli  MPN value of 6000/ 100g in all raw samples tested , the product may be 
canned or cooked to a core temperature of 90°C held for at least 90 seconds . 
 Furthermore the shellfish shall be tested for Salmonella  and pathogenic Vibrio  contamination (see GNR 
692 in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972)).  
 Where  Salmonella  or Vibrio cholera  (or other pathogenic Vibrio ) positives are encountered, conduct 
confirmatory tests  for that organism on representative flesh samples taken from at least 5 sampling 
points (n=5) for farms in an open water system e.g. bays, spread  out over the production area to be 
monitored, or from 5 baskets in case of tanks systems of the next batch to b e marketed.  
 Re-open to harvest if the results are within regulatory limits (absence of Salmonella  or pathogenic 
Vibrio  in all 5 samples  (see CODEX STAN 292 -2008) ).  If the confirmatory test results are not within the 
regulatory limits, the farm is closed u ntil the test results of at least 3 different batches of 5 samples 
each, taken over a minimum period of 3 consecutive days are within regulatory limits.  
 Review the classification assigned to the production area when sampling indicates an area continues to 
exceed its current classification limits.  
6.2.9.  When an end of the line product fails to satisfy the microbiological criteria for human consumption, the 
following actions must be undertaken by the relevant Health authority, in consultation with the NRCS and 
DAFF  (see flow diagram, Appendix IV):  
 Investigate the possibility of a problem with handling, distribution and labelling and instigate 
appropriate corrective actions as required.  
 Instigate the course of actions given in Paragraph 6.2.8  for the implicated production area if the 
problem is not identified as related to handling, distribution and labelling.  
6.2.10.  When an epidemiologically confirmed shellfish -borne illness is reported involving two or more persons 
and implicati ng a shellfish production area, the Health authority responsible for the particular area, in 
consultation with DAFF and the NRCS, shall promptly:  
 Place a temporary ban on harvest from the implicated production area.  
 Detain and recall any remaining shellfi sh that are in the distribution system.  
 Investigate the possibility of a problem with handling, distribution and labelling and instigate 
appropriate corrective actions as required.  
 Remove the ban on harvesting and re -instate the original classification cat egory if it is determined that 
the production area is not the source of the outbreak, i.e. problem caused in handling or distribution,  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
14  Review the classification of the production area and re -classify if necessary.  
6.2.11.  Microbiologically contaminated shellfish m ay be canned or cooked and frozen as per requirements in 
Paragraph  2.4, provided the microbial status meets the Restricted criteria as a minimum (Paragraph 5.4) or 
the criteria stipulated in Paragraph 6.2.8 .  Such shellfish may also be harvested for relaying or depuration 
until the animals show compliance with Approved microbial limits (Paragraph 5.3).  This option may only be 
exercised in accordance with special permit conditions issued by DAFF.  
6.3. Monitoring of environmental contaminants  
6.3.1.  Sampling will address variation within a production area and will be conducted annually for heavy metals, 
polyc hlorinated biphenyls (PCBs) and pesticides.  Tests for radionuclides should be conducted every three 
years or more frequently if there is reason to suspect contamination.  Sampling for specific contaminants is 
recommended only when the sanitary survey reve als a potential problem, or if there is concern due to a 
paucity of data.  
6.3.2.  The test sample shall comprise that portion of the shellfish generally recognised as the edible portion, i.e. 
the whole animal for oysters and mussels, the muscular foot for abalone and the adductor muscle 
(including roe) for scallops.  Test specimens of marketable size and condition should be used for these 
analyses.  
6.3.3.  Non-compliance at any sampling point will require retesting. If the retest fails, sampling should be 
expanded to trace  the source of contamination.  Production areas face long -term or permanent closure if 
the situation cannot be restored.  
6.4. Biotoxin monitoring  
6.4.1.  Background  
 Historical data collected by DAFF around the South African coastline indicate that harmful algal blooms , some of 
which may be toxic, are clearly more prevalent in the west coast upwelling system with relatively few events 
recorded east of Cape Agulhas.  The most likely candidate toxic species are Alexandrium catenella , which is 
responsible for paralytic she llfish poisoning on the west coast and the diarrhetic shellfish poisoning species, 
Dinophysis acuminata  and D. fortii  around the coastline .  Other species of Dinophysis namely; D. hastata, D. 
rotundata and D. tripos also occur in the region.  Alexandrium c atenella  has not been recorded east of Cape Point 
but another species of Alexandrium  has been isolated from the Western Agulhas Bank.  However, substantial 
blooms have not been observed to date and the cell toxin quota is low; thus it does not appear to re nder shellfish 
toxic.  In both D. fortii  and D. acuminata , cell toxin quota data indicate that they are only moderately toxic with 
okadaic acid the primary toxin.   Protoceratium reticulatum  has been implicated in the accumulation of yessotoxins 
in black mu ssels on the west coast.  Cysts of another species associated with yessotoxins, Lingulodinium 
polyedrum,  have been found in low numbers in sediments on the west coast.  Pseudonitzschia  spp are frequently 
encountered, in particular, P. australis .  Although a known producer of domoic acid from other parts of the world, 
results to date indicate that blooms of P. australis  on the west coast of South Africa are not associated with 
amnesic shellfish poisoning events.  A number of Karenia spp (formerly Gymnodinium  spp) are found around the 
coast though none have been implicated in shellfish poisoning to date.  One species, K. cristata , appears to release 
an aerosol toxin responsible for skin and respiratory disorders of bathers, similar to K. brevis and K. brevisul cata .  
(NOTE: Considering the apparent global trend of expanding distributions of toxic algal species, DAFF personnel are 
actively involved in research on phytoplankton distribution and ecology and attempt to investigate all reported 
incidences of blooms).  
 Biotoxins and biotoxin -producing algae shall be monitored in each production area in accordance with a Biotoxin 
Management Plan.  The management plan serves to clearly identify the agencies responsible for and the 
procedures necessary to undertake the ac tions listed below:  
 Monitor toxin producing plankton and the geographical distribution thereof on a routine basis.  For the 
plankton component to act as an early warning system of impending shellfish toxicity, it is essential that a 
database be constructed  relating toxic organism concentration or thresholds to shellfish toxicity.  For this 
reason it is desirable to perform shellfish toxicity tests in conjunction with plankton monitoring, at least until 
there is sufficient confidence in using plankton as a p roxy.  
 Develop a contingency plan that provides an emergency response when a potential problem is detected.  The 
plan defines those administrative procedures and resources necessary to:  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
15 o Initiate emergency shellfish and water sampling.  
o Close areas and embarg o shellfish.  
o Prevent commercial harvesting from closed areas.  
o Recall shellfish.  
o Define criteria for re -opening closed areas.  
 Provide assurance that certain shellfish species, or products, can be safely excluded from the contingency 
plan.  This will require  collection of sufficient supporting data and will be reviewed on an annual basis by 
DAFF.  
6.4.2.  Biotoxin Management Plan  (See APPENDIX VII) 
 Biotoxin monitoring is mandatory during harvesting periods.  Farm managers mus t inform DAFF of extended 
periods of no harvest and dates when harvesting is to be resumed.  Failure to comply will result in temporary 
closure until testing is reinstated.  
 Abalone farms that are closed for the marketing of live abalone due to PSP toxin l evels are required to test the 
abalone  on the farm  for PSP on a monthly basis.  Each batch of processed product, however, shall be tested to 
ensure compliance with the regulatory limits.  
 Each production area management plan shall include a map showing the  sampling positions which are to be 
determined on the basis of “key stations” and “critical species”.  
 In open -water systems, sampling should be undertaken at sites where present knowledge indicates biotoxins are 
most likely to appear first.  
 Filter -feedin g shellfish most susceptible to rapid biotoxin accumulation (e.g. black mussels) may be used as 
sentinel species as advised by DAFF.  
 Toxin levels in the edible portions of shellfish provide the present basis for regulatory action.  This shall constitute 
the whole animal except for scallops when the final product is the adductor muscle (with or without roe) and 
abalone that are cleaned and eviscerated prior to placing on the market.  
 Under certain circumstances, as determined by DAFF, joint biotoxin monitor ing programmes may be established 
for farms in close proximity to each other.  A farm selected by DAFF shall be used to monitor the biotoxin status.  
Should the selected farm be closed due to regulatory limits being exceeded, all the farms that are part of  the 
programme will also be closed.  Each farm would then be required to carry out its own tests for each species 
farmed to be reopened in accordance with Section 6.2.8  for biotoxins, unless otherwise stated in a joint biotoxin 
agreement signed by the programme manager.  
 When testing indicates certain shellfish species do not constitute a biotoxin risk, harvest closures may be applied 
selectively to some species and not others from the same production area.  
 Sam pling at production areas shall be conducted at differing levels of intensity as determined by the shellfish 
species of concern, the history of contamination with the biotoxin under consideration, geographic position, 
presence of biotoxin producing phytopl ankton and level of contamination of shellfish flesh.  
6.4.2.1.  Routine monitoring phase  
The routine monitoring phase is to be conducted year round as described below:  
 In open water systems, a composite sample of the upper water column will be taken from DAFF select ed sites 
daily, where poss ible, or at least 3 days a week and delivered to DAFF for phytoplankton identification and 
enumeration.  
 In land -based systems, a water sample representative of the broad hydrographic regime from which intake 
water is drawn will b e used for phytoplankton analyses. Where this is not feasible, a sample of the inflow 
prior to screening or filtration shall suffice.  
 These water samples will be composited on a weekly basis for microscope counting.  
 Shellfish samples for biotoxin analyses will be collected in accordance with Table 1. 
 A composite sample of shellstock currently being harvested or intended for next harvest is to be taken.  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
16  The sampling schedule given in Table 1 provides the m inimum sampling requirements for shellfish flesh.   
 Routine testing for biotoxins may be required to be performed more frequently than specified in Table 1 for 
certain production areas regarded as high risk.  
Table 1: Maximum allowable time between biotoxin test and shellfish harvesting  
Biotoxin group  West of Cape Point  East of Cape Point  
Filter feeders  Non -filter feeders  Filter feeders  Non -filter feeders  
Paralytic shellfish 
poisons (PSP)  48h or twice a 
week for multiple 
harvesting  2 weeks*  1 month  1 month  
Lipophilic shellfish 
poisons (LSP)  1 week  1 month  2 weeks  1 month  
Amnesic shellfish 
poison (ASP)  1 month  N/A 1 month  N/A 
* Farms that are closed for live marketing, due to PSP toxins concentrations exc eeding the regulatory limit, shall 
test the shellfish on the farm once a month and each processed batch shall be tested for PSP toxins.  Should  
an abalone farm to the west of Cape Point that has been temporarily closed for the marketing of live abalone , 
due to PSP  toxin concentrations exceeding the regulatory limit,  be reopened in accordance with Paragraph 
6.4.2.2 , the farm is required to test for PSP weekly for 6 months after re -opening.  
 Should an abalone farm t o the west of Cape Point be temporarily closed for the marketing of live abalone due 
to PSP for a period of more than three months, the maximum time between biotoxin tests for PSP in live 
abalone can extend to 1 month if an exemption is issued to process t he abalone in such a way that the PSP is 
reduced to below the regulatory limit.  Each batch of processed abalone shall be tested for PSP.  
6.4.2.2.  Intensive sampling phase  
The intensive sampling phase is to be initiated following detection of biotoxins in shellfish  meats in excess of the 
trigger limits given in  APPENDIX V, though still below regulatory limits (Paragraph 5.7.2 ).  Intensive sampling may 
also be initiated when toxic phytoplankton are present in the absence of shellfish intoxication.  DAFF is in the 
process of investigating whether threshold concentrations for certain toxic phytoplankton species can be 
correlated with shellfish toxicity and hence used to trigger intens ive sampling.   
Should a test result exceed the regulatory limit the farm will be temporarily closed for harvesting (Section 6.4.2 ) 
and a retest undertaken .   
Should the retest result exceed the regulatory limit  the farm will be temporarily closed for harvesting and the 
procedure outlined below in this Section  shall be initiated.  
In the event that more sample is required for a confirmatory test, the procedure outlined below in this section  
shall be initiated.  
The intensive sampling phase shall  be carried out as described below:  
 Daily testing of filter -feeder shellfish and weekly testing of non -filter feeders for the relevant biotoxin(s) will 
be initiated - at an increased number of sampling points, as deemed nece ssary.  
 Should the presence of toxic algae be indicated in the water or in shellfish flesh, the individual daily 
phytoplankton samples around the event will be counted.   
 Supplementary phytoplankton samples may be collected from the implicated production are a. 
Routine sampling will be re -instated once the biotoxin concentration has returned to non -detectable levels for 3 
consecutive samples. A maximum of one sample per day may be submitted for testing.  
6.4.2.3.  Quarantine phase  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
17 The quarantine phase is to be brought in to effect immediately following detection of biotoxins in shellfish meats at 
a level sufficient to cause a public health hazard.  The limits for the various groups of biotoxins are given in 
Paragraph 5.7.2 . The quarantine phase is to be carried out as described below:  
 DAFF will place a ban on harvesting in the area.  
 DAFF Compliance Officers will ensure the embargo is maintained.  
 The closed status of the area will be communicated to Industry, the NRCS, the relevan t Health authority and 
other affected parties in writing, with confirmation of receipt.  
 The producer shall ensure that any stock marketed from the day that a representative sample of the stock 
was taken, and the biotoxin concentration in the sample was sho wn to exceed the regulatory limit, is recalled.  
 The producer shall ensure that any operator (packer, processor , retailer) , holding stock/s supplied by the farm  
that ha s been closed for bio toxins that has  not been tested between the particular date that a f arm exceeded 
the regulatory limit and the last date at which the farm tested below the regulatory limit, shall test such 
stock /s in their possession to ensure compliance with the biotoxin regulatory limits.  
 Contaminated products will be recalled, embargoed  and destroyed under the supervision of the local Health 
authority or NRCS inspector responsible for the area.  Shellfish that are still alive may be placed back into the 
production facility.  
 The frequency of testing of shellfish will be at the farm manager s’ discretion in consultation with DAFF.  A 
maximum of one sample per day may be submitted for testing.  
6.4.2.4.  Re-opening phase  
 During the re -opening phase a shellfish production area closed due to biotoxins will only be re -opened to 
harvesting when DAFF has det ermined that the criteria justifying this action are met.  Areas will only be re -opened 
when biotoxin levels are below the regulatory limit for 3 consecutive samples taken over a period not exceeding 
two weeks.  Information regarding detoxification curves will assist in adjusting these criteria in the future. The re -
opening phase is to be carried out as described below:  
 The re -opened status will be communicated to all relevant parties.  
 Sampling intensity following re -opening to harvest will be dictated by s hellfish toxin levels.  This would involve 
intensive sampling in the continued presence of biotoxins in the flesh even though the shellfish have attained 
sub-quarantine levels of biotoxins.  
 Routine sampling will be re -instated once the biotoxin concentrati on has returned to non -detectable levels 
for 3 consecutive samples.  
 DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
18 7. REQUIREMENTS FOR HARVESTING AND TRANSPORT OF LIVE SHELLFISH TO A DISPATCH CENTRE, DEPURATION 
FACILITY OR AREA, OR PROCESSING PLANT  
7.1. Harvesting requirements  
7.1.1.  No person shall harvest, handle  or transport shellfish for human consumption except according to the 
requirements of this manual under conditions stated in an official permit issued by DAFF.  
Harvesting techniques must not cause excessive damage to the shells or tissues of live shellfish .   
 Shellfish harvested and transported on a vessel for more than 6 hours must be shaded  from the sun, 
sprayed with clean seawater, chilled with clean ice , or covered with clean wet sacks.  
 Shellfish not intended for relaying, wet storage or depuration sh all be placed under temperature control at 
7C or less within 20 hours of harvesting.  Clean ice may be used for this purpose.  Temperature control 
shall be continuously maintained until final sale of the product to the consumer or until processing – excep t 
for a maximum period of 2 hours at points of transfer.  
7.1.2.  Where necessary, shellstock shall be washed using clean seawater or potable water under pressure to 
remove mud, bottom sediments or attached biota as soon as practicable after harvesting.  Wash water  may 
not be recycled.  
Containers for the transport or storage of shellstock must be clean and made from impervious, easily 
cleanable materials.  
 Bags or sacks may not be re -used for shellfish unless they are made from impervious material that can be 
washed  and disinfected prior to re -use. 
7.2. Transport and Vessels  
7.2.1.  All harvesting vessels and road transport vehicles must be inspected at least once annually and approved by 
the NRCS or relevant Health authority.  
7.2.2.  Decks and storage areas on vessels shall be designed and constructed to prevent bilge water or polluted 
water from coming into contact with shellfish.  
7.2.3.  Where the vessel or vehicle deck is not channelled, graded or adequately drained, the shellstock shall be 
stored at a minimum height of 100 mm off the deck.  
7.2.4.  Where toilets are provided on a harvest vessel, hand -washing facilities  must also be provided.  Toilets and 
hand -washing facilities shall be designed, located and operated to prevent the contamination of production 
areas and adjacent waters and be of the ty pe approved by the official inspector.  
7.2.5.  Human body wastes shall not be discharged from harvest vessels while in, or adjacent to, production areas.  
7.2.6.  All land and water transport vehicles used for shellstock transport shall be constructed, operated, cleaned 
and maintained so as to prevent contamination, deterioration or decomposition of the shellstock 
transported and the transporter must be in possession of a valid transport permit.  
7.2.7.  Refrigerated and frozen transport units must have calibrated thermostats and a ccurate indicating 
thermometers. Refrigerated units must be capable of holding the temp at 7 C or less.  
7.3. Documentation and records  
7.3.1.  A movement document issued by DAFF shall accompany each batch of live shellfish during transport from 
the production area up t o, and including, arrival of the batch at a dispatch centre or processing 
establishment.  The movement document must be completed in full and contain the following information:  
 Document number  
 Identity of h arvester, address and signature  
 Date of harvesting  
 Harvest site and official registr ation number of production area  
 Classification of production  area (e.g. Approved – Class A)  
 Shellfish identity (common and  scientific names) and quantity  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
19  Destination and,  if applicable, approval number  
 Date and place of re ceipt  
7.3.2.  The original (white copy) of the movement document shall be kept by the Permit Holder at their registered 
office. The duplicate (pink copy) of the movement document shall be kept by the authorised Fish Processing 
Establishment (FPE) and the duplicate  (blue copy) of the movement document shall be submitted to the 
Department within 30 days.  
7.3.3.  In the case of a batch of live shellfish that have been subject to a depuration process, the movement 
document must include, in addition to the above, the location/a ddress of the relaying area or depuration 
plant and the duration and dates of purging.  
7.3.4.  If harvesting is carried out by the same staff that operate the dispatch centre, processing plant, relaying 
area, depuration plant or wet storage facility of destination , DAFF may, if satisfied that the requirements 
concerning gathering and handling are complied with, issue a permanent authorization absolving the 
harvester from the requirement to use movement documents.  
7.3.5.  The facility receiving a movement document must keep  it available for inspection for a period of at least 5 
years . 
7.3.6.  The harvester must keep a copy on file of all movement documents issued recording all the information 
contained in the document for a period of not less than 5 years.  
7.3.7.  DAFF shall keep a copy on file of all completed movement documents issued indefinitely . DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
20 8. REQUIREMENTS FOR RELAYING SHELLFISH  
 At present no production areas are being utilized for relaying shellfish in South African coastal waters. The 
guidelines presented below are recommendations  for the management and control of relaying operations and are 
based on international recommendations.  
8.1. Conditions  
8.1.1.  Relaying refers to the transfer of shellfish with limited levels of pollution to approved areas where the 
ambient environment provides the me dium for biological depuration.  Relaying may be applied to reduce 
microbial and biotoxin contamination to acceptable levels.  Relaying is not recommended for the reduction 
of other toxic or hazardous substances unless studies are conducted that verify dep letion of the 
contaminant(s) of concern to acceptable levels.  
8.1.2.  Relaying operations must be supervised by a DAFF Compliance Officer or duly authorised official inspector.  
8.1.3.  Relaying areas must be authorised by DAFF as for a marine aquaculture operation.  Harve sting of shellfish 
for relaying may only be undertaken with authorisation from DAFF.  
8.1.4.  Permits for relaying shall be subject to the development of an approved operating procedure.  
8.1.5.  Relaying areas shall be monitored as for other approved production areas.  
8.1.6.  Caut ion must be exercised in relaying of shellfish from marine aquaculture operations to prevent the 
potential spread of animal diseases.  
8.2. Source of shellfish  
8.2.1.  No shellfish that exceed the contaminant levels for restricted areas (Paragraph 5.4) may be relayed.  
Shellfish must not be contaminated with biotoxins to the extent that safe levels cannot be achieved at the 
end of the relaying period.  
8.2.2.  Live shellfish must be gathered and transported in accordance with Section 7. 
8.2.3.  Shellfish intended for relaying must be accompanied by a movement document (Paragraph 7.3.1 ).  The 
conditions of Paragraph 7.3.4  apply.  
8.3. Relaying areas  
8.3.1.  Relayed shellfish shall be held in the approved or conditionally approved areas (when open) for sufficient 
time under suitable environmental conditions to complete depuration.  
8.3.2.  Sites within a relaying area must be well marked  and separated to prevent mixing of batches.  
8.4. Operating procedures  
8.4.1.  Each relayer must develop in consultation with DAFF, written standard operating procedures that provide 
assurance of end -product safety.  The procedures shall address the following:  
 Source a nd species of shellfish.  
 Contaminant levels of source shellfish and after depuration.  
 Methods of transport to the relaying site.  
 Relevant information regarding the use of a conditionally approved area for relaying.  
 Information on the water quality and qual ity of shellfish indigenous to the relaying area.  
 Method of holding shellfish at the relaying site and maintaining identity of individual source lots.  
8.4.2.  Studies shall be undertaken by the relayer to determine the effectiveness of contaminant reduction with 
due consideration to species and initial shellfish degree of contamination.  Water temperature and other 
critical parameters for effective depuration should be determined for each species where possible.  These 
environmental variables should be recorded by the relayer when it is known that limiting values may be 
approached.  
8.4.3.  The microbiological concentrations in the shellfish shall meet the approved criteria (Paragraph 5.3), and 
biotoxins limits given in Paragraph 8.4.2 , at the end of the relaying process.  
8.4.4.  A minimum period of 14 days is recommended when conditions are suitable at the relay site.  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
21 8.4.5.  Batches of shellfish may only be harvested from a relaying area following laboratory confirma tion of 
successful purification.  
8.4.6.  The harvester of relayed shellfish shall sign a declaration of compliance with operating procedures prior to 
harvesting, specifying details pertaining to permits, source production area, relay area and relay operations.  
8.4.7.  Batches of live shellfish harvested in a relaying area must be accompanied by a movement document 
(Paragraph 7.3.1 ) during transport to a dispatch centre or processing plant.  The conditions of Paragraph 
7.3.4  apply.  
8.5. Records  
8.5.1.  Relayers shall be required to keep complete and accurate records for inspection by DAFF for at least 5 
years.  This should include the following:  
 The source and species of batches of shellfish.  
 Resul ts of microbiological and/or biotoxicity tests of each lot of shellfish before and during relaying.  
 The date of harvest and quantity of shellfish harvested.  
 The dates and duration of relay.  
 Records of critical environmental parameters during relaying.  
 The purchaser and quantity purchased.  
 Movement documents and other records necessary to trace individual batches of shellfish.  
8.5.2.   DAFF shall maintain records of the following:  
 The sanitary survey reports and monitoring data for the relaying area  
 Approved procedu res for operation of the relaying area  
 Results of product sampling and environmental monitoring by the relayer  
 Movement documents  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
22 9. DEPURATION  
 The guidelines presented below are recommendations for the management and control of depuration centres and 
are b ased on international experience.  
9.1. Conditions  
9.1.1.  Depuration is the process whereby filter -feeding shellfish are biologically cleansed in a purified and 
controlled seawater environment.  Depuration is intended to reduce the number of pathogenic organisms 
that m ay be present in shellfish from moderately polluted areas.  Depuration is neither intended to reduce 
contamination in shellfish from heavily polluted areas nor to reduce the levels of accumulated toxic 
substances.  
9.1.2.  All operations harvesting shellfish for de livery to a depuration plant must be issued with a separate permit 
by DAFF.  
9.1.3.  The premises and hygienic standards must comply with the Regulations Governing the General Hygiene  
Requirements for Food Premises and the Transport of Food, Regulation 962 publish ed under the Foodstuffs 
, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972) .  Certification of depuration plants shall 
require:  
 Approval of plant design, construction and operation including remodelling.  
9.1.4.  The operator shall be responsible for verif ying the depuration process.  
9.1.5.  Certified depuration plants are to be inspected at least monthly to ensure compliance with Regulation 962 
published under the Foodstuffs , Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972) . 
9.1.6.  DAFF shall analyse plant pro cessing data and other records at least monthly to verify if the process and 
controls are sufficient to meet the end product criteria.  
9.2. Process verification  
9.2.1.  Each depuration plant shall develop an approved depuration process (ADP), drawing on outside experti se as 
necessary, prior to certification.  A comprehensive set of trials shall be conducted on the effectiveness of 
plant operations.  The development of the ADP shall take the following critical variables into account:  
 Shellfish species and source  
 Maximum pre-depuration level of faecal contamination to ensure that end point criteria are consistently 
achieved during normal operations (not to exceed limits given in paragraph 5.4.1 ). 
 Design construction and operatio n of the plant with regard to flow rates, loading rates, tank dimensions 
and spacing of shellfish  
 Water quality variables such as temperature, salinity, dissolved oxygen and turbidity.  Any seasonal 
effect must be addressed  
 Depuration times  
 End point crite ria 
 Process monitoring  
 Plant sanitation  
9.3. Source of shellfish  
9.3.1.  Only shellfish that meet the requirements for restricted areas (paragraph 5.4.1 ), at a minimum, may be 
harvested for depuration.  The acceptable pre -depuration levels of faecal contamination shall be 
established as part of the ADP.  
9.3.2.  Shellfish must be protected from contamination and physiological stress during harvesting and storage.  
9.3.3.  The identity of each harvest lot must be maintained and tagged to indica te it is from a restricted area.  
9.3.4.  Shellfish intended for depuration must be accompanied by a movement document (Paragraph 7.3.1 ) unless 
the conditions of Paragraph 7.3.3 apply.  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
23 9.3.5.  Shellfish should be culled of dead or damaged individuals and washed with clean seawater or potable water 
prior to depuration.  
9.4. Structural requirements  
9.4.1.  The construction of floors, walls, ceilings (where provided) and installation of lighting, plumbing and sewage 
disposal systems must comply with the provisions of the Regulation 962 published under the Foodstuffs , 
Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972) . 
9.4.2.  Vermin control shall be implemented in accordance with Regulation 962 published under the Foodstuffs , 
Cosmetics and Disi nfectants Act, 1972 (Act No. 54 of 1972) .  Effective barriers shall be provided to prevent 
the entry of vermin, animals and birds into the area and above the storage tanks.  
9.4.3.  Storage tanks and related plumbing shall be fabricated of non -toxic materials and s hall be easily cleanable.  
The construction of tanks shall allow for easy access for cleaning and inspection and for self -drainage.  The 
design and installation of plumbing shall allow for regular cleaning and  sanitising , to prevent contamination 
of the ta nks and water.  
9.4.4.  Shellfish containers (where used) shall have an impervious mesh -type construction that allows adequate 
flow of water to all shellfish in the containers.  They must be placed in tanks in such a manner that sufficient 
clearance is provided be tween the shellfish containers and bottoms and sides of the tanks.  
9.4.5.  The site, facility and plant shall be evaluated and approved annually by DAFF in conjunction with the NRCS 
and relevant  local h ealth authority, taking into account the records of water off icially tested.  
9.5. Process water quality and operation  
9.5.1.  Source water may be drawn from an approved or restricted production area prior to treatment.  Prohibited 
growing areas may not be used as source waters.  
9.5.2.  Process water must meet the requirements for sani tary quality and normal physiological activity of the 
shellfish species.  Critical parameters are given below:  
 Treated water on entry to a depuration unit shall contain no detectable E. coli.  Water must be sampled 
as described in the latest version of SAN S 241 and analysed according to SANS 5221.  Water treatment 
must not leave residues that will interfere with the depuration process or product quality.  
 pH must be in the range 7.0 – 8.4. 
 Temperature, salinity, turbidity and dissolved oxygen limits for norm al physiology of the particular 
species are to be established for the ADP.  Dissolved oxygen must always be greater than 50% saturation 
and turbidity less than 20 nephelometric turbidity units  when UV disinfection is employed . 
9.5.3.  Operational procedures shall promote water quality uniformity within depuration units.  Consideration 
must be given to flow rates, tank loading rates and shellfish spacing as established in the process 
verification study.  A minimum flow rate of 107 l/min/m3 of shellfish is recommende d. 
9.5.4.  Only shellfish of the same species are to undergo depuration in the same depuration unit.  Different harvest 
lots of shellfish must not be mixed and shall be maintained as identifiable batches throughout the 
depuration process and final packaging.  
9.5.5.  The m inimum depuration time is based on the batch in a depuration tank requiring the longest period of 
depuration and should be no shorter than 48 hours.  
9.5.6.  After completion of depuration, the shells of the live shellfish must be washed with clean seawater or 
pota ble water and damaged individuals culled.  
9.6. Cleaning and Sanit izing  of facilities, utensils and equipment  
9.6.1.  All facilities utensils and equipment on the premises shall be kept clean and sanitized in accordance with 
Regulation 962 published under the Foodstuffs  , Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972) . 
9.6.2.  All shellfish and sea water contacting surfaces must be cleaned and sanitised after each use as indicated 
below:  
 Process units, trays, containers and racks shall be cleaned, sanitised and rinse d before each depuration 
operation.  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
24  The process unit including the system piping network shall be cleaned, and where possible, sanitised 
after each batch.  
 The seawater storage tanks shall be cleaned and sanitised on a regular basis.  
 The washing, culling, s orting and pre -process storage areas shall be thoroughly washed and sanitised 
after each use.  
9.7. Quality assurance  
9.7.1.  Depuration plants must have their own laboratories or secure the services of an approved outside 
laboratory to assess the effectiveness of the p rocess and to establish that the end product meets the 
approved criteria.  
9.7.2.  Shellfish from single process batches may not be released to market unless laboratory results confirm that 
the end product meets the microbiological standards for approved areas (Par agraph 5.3). 
9.7.3.  Water disinfection systems should be sampled frequently to monitor effectiveness of the treatment units.  
9.7.4.  In the event of a process batch failing to meet the release criteria, the operator shall notify DAFF and an 
investigation shall be conducted into the cause for failure.  The following actions may be required through 
consultation with the local Health authority or the NRCS as relevant:  
 Destruction of the shellfish  
 Non-food use of the shellfish  
 An additional depura tion cycle  
 Modification of the ADP  
9.7.5.  Every package of purified shellfish must be provided with a label certifying that all of its contents have been 
purified.  The following minimal information shall be included:  
 Name of depuration plant and identity of oper ator 
 Depuration cycle number and date  
 Identity of production area  
 Type and quantity of shellfish  
9.7.6.  Batches of depurated shellfish must be accompanied by a movement document during transport to a 
dispatch centre or processing plant (Paragraphs 7.3.1  and 7.3.4 ). 
9.8. Records  
9.8.1.  Operators shall be required to keep the following complete and accurate records for at least 5 years:  
 Information that will allow a package of depurated sh ellstock to be traced back to the process batch, 
production area, harvest date and harvester and corresponding movement documents.  
 Results of product sampling and critical parameters (maintained for at least 5 years).  
 Current copy of the plant operating pr ocedures.  
 Dispatch details of consignments after depuration.  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
25 10. WET STORAGE  
10.1. Conditions  
10.1.1.  Wet storage refers to the holding of live shellfish in near -shore waters or onshore tanks for temporary 
storage or conditioning purposes prior to processing/packaging for sale.  Wet storage is not intended for 
depuration therefore all controls pertaining to shellfish for direct human consumption should be applied.  
10.1.2.  The premises and hygienic standards must comply with Regulation 962 published under the Foodstuffs, 
Cosmetics a nd Disinfectants Act, 1972 (Act No. 54 of 1972) .  Wet storage sites or facilities must undergo 
an annual evaluation by the relevant local h ealth authority in co -operation with DAFF.  This evaluation 
shall consider the following:  
 The sanitary survey of the near -shore site  and monitoring records.  
 The design and operating procedures for the onshore storage facility including the quality of source 
water and details of any water treatment system.  
 Plans for remodelling.  
10.1.3.  No other marine species may be stored in th e same tank with shellfish.  
10.1.4.  Caution must be exercised in wet storing shellfish from marine aquaculture operations to prevent the 
potential spread of animal diseases.  
10.1.5.  Filtration may be used to mitigate against contamination from biotoxin producing phytopla nkton in 
shore -based wet storage systems  
10.1.6.  Shellfish can be sold from onshore wet storage that has filtration in place to prevent the entry of 
phytoplankton on the following conditions:  
 Should a production area supplying the wet storage be closed due to the biotoxin concentration in 
the shellfish exceeding the regulatory limit, the last batch to enter the wet storage shall be tested for 
the implicated biotoxin.  Should the test result for the last batch be below the regulatory limit, the 
last batch and any pr ior batches contained in the wet storage may be placed on the market.  
 The water quality requirements stipulated in Section 10.4.8  are met.  
10.1.7.  The following conditions apply to wet storage that has no filtration in place to pre vent the entry of 
phytoplankton:  
 Should the production area  from which the wet storage plant draws its water be closed for biotoxins , 
the wet storage facility shall also be closed.  
 Should there not be a biotoxin monitoring programme for the source waters of the wet storage plant , 
the shellfish shall be tested as stipulated  in Table 1 
10.2. Source of shellfish  
10.2.1.  Shellfish for wet storage shall be harvested only from approved or conditionally approved production 
areas in open sta tus or taken fro m a certified depuration plant.  
10.2.2.  Shellfish delivered to a wet storage facility must have been handled, transported and held in such a 
manner as to prevent deterioration and contamination.  
10.2.3.  Shellfish from different harvest areas shall be wet s tored separately.  If multiple harvest lots are wet 
stored simultaneously, the identity of each lot shall be maintained throughout the process.  
10.2.4.  Shellfish intended for wet storage must be accompanied by a movement document (Paragraph 7.3.1 ) 
unless the conditions of Paragraph 7.3.4  apply.  
10.3. Structural and design requirements  
As for depuration (Paragraph 9.4). 
10.4. Water quality  
10.4.1.  Shell fish shall be washed with clean seawater or potable water and culled of dead or damaged animals 
prior to wet storage.  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
26 10.4.2.  Process water in onshore systems must not negatively affect the sanitary quality of the stored shellfish or 
result in physiological stress  that may lead to death.  
10.4.3.  Near -shore areas for wet storage must meet the approved or conditionally approved criteria (Paragraphs 
0 or 5.6). 
10.4.4.  Water of approved productio n area status may be used in an onshore facility without disinfection 
provided the system operates on a continuous flow -through basis and the near -shore source water 
meets the approved area bacterial criteria at all times shellfish are being held for direc t marketing.  
10.4.5.  In-water or land -based wet storage facilities that meet the approved criteria must conduct monthly 
microbiological testing or secure the services of an outside laboratory to provide confirmation of 
approved water status. Wet storage facilities  for abalone are  exempt from this provision.  
10.4.6.  Re-circulating systems or systems using water of a quality inferior to the approved water criteria must be 
treated.  Treated water entering wet storage tanks shall have no detectable levels E. coli , as for 
depur ation (Paragraph 9.5.2 ) The following conditions apply:  
 The operator of the facility shall conduct a study on the effectiveness of the disinfection process as 
assurance that the system will consistently supply w ater free of E. coli  under normal operation.  
Samples of treated water entering the storage system shall be taken at a minimum frequency of 
3/day over a period of 5 days.  Additional samples shall be taken daily of untreated source water.  
Any positive sam ple for E. coli  in treated water shall require corrective procedures and re -evaluation 
of treatment effectiveness  
 The treatment process shall not leave any residues that are not Generally Recognised As Safe or that 
may interfere with the process  
 The operat or shall have routine microbial testing conducted at least weekly for systems using treated 
water.  In the event that a single sample contains detectable E. coli , daily testing shall be immediately 
initiated until the problem is identified and rectified  
 Turbidity shall not exceed 20 nephelometric turbidity units where UV light is used for disinfection.  
Treatment effectiveness shall be confirmed whenever new UV lamps are installed  
10.4.7.  Salt added to increase salinity or produce synthetic seawater must be food -grade salt  as defined under 
the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972)  
10.4.8.  The following requirement is applicable to wet storage that has a filtration system to remove  
phytoplankton species:  
 The operator of the facility shall con duct a study on the effectiveness of the filtration system as 
assurance that the no toxic phytoplankton  (see APPENDIX IX) cells shall be found in the facility except 
for Pseudo -nitzchia  species  for which the concen tration in the incoming water shall be less than 10 0 
cells/litre. Samples of filtered water entering the storage system shall be taken at a minimum 
frequency of 3/day over a period of 5 days for analysis.  
 Should any production areas in the vicinity be clos ed for biotoxins, the incoming filtered water shall 
be analysed once a week for phytoplankton until all production areas are re -opened.  
10.5. Records   
10.5.1.  The following records shall be maintained by the operator:  
 Information that will enable each lot of shellstock to be traced to the wet storage facility and 
classified production area  
 Records of water sampling and other tests as may be required (minimum of 2 years)  
 Movement documents  
10.5.2.  Live shellfish shall be labelled as described in Paragraph 11.2.1  during transport and distribution until 
retail sale.  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
27 11. REQUIREMENTS FOR DISPATCH CENTRES  
11.1. Receiving and storage  
11.1.1.  A dispatch centre is any installation for the reception, handling and packaging of live shellfish fit for 
human consum ption.  
11.1.2.  The premises and hygienic standards must comply with the Regulation 962 published under the 
Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972)  and must be inspected at least 
once annually and approved by an NRCS inspector or rele vant local h ealth authority.  Dispatch centres 
must be issued with a permit as for a processing establishment in terms of the Marine Living Resources 
Act, 1998 (Act No. 18 of 1998).  
11.1.3.  Live shellfish accepted at a dispatch centre must have originated from an approved or conditionally 
approved production area, a relaying area, a depuration plant, or another dispatch centre.  A record 
should be kept of the condition of each batch received and accepted.  
11.1.4.  Only batches of live shellfish accompanied by a movement doc ument (Paragraph 7.3.1 ) shall be accepted 
at a dispatch centre unless the conditions of Paragraph 7.3.4  apply.  Shellfish must have been harvested 
and transported acc ording to the requirements of this manual (Section 7). 
11.1.5.  In any sorting or dry storage area, live shellfish must be kept at a temperature that does not adversely 
affect their quality and viability.  Live shellfish  intended for the market in a live chilled state must be 
stored and transported at a temperature of 7 C or colder, though not so cold as to affect viability.  
Temperature control must be put in place within 20 hours of harvest.  
11.1.6.  The room must be vermin proo f and have impermeable floors. Shellstock should be held in a protected 
location away from direct contact with the floor or from foot splash.  
11.1.7.  No chemicals that may contaminate the live shellfish may be present in the room used for sorting or 
storing.  
11.1.8.  Shell fish from different production areas must be kept sorted and packed separately to maintain 
identity.  
11.1.9.  Before dispatch, the shells of live shellfish must be washed thoroughly with clean seawater or potable 
water.  
11.2. Marking of consignments and records  
All parce ls in a consignment of live shellfish shall bear a label so that the original dispatch centre may be identified 
at all times during transport and distribution until retail sale.  The label shall contain the following information in 
addition to other labell ing requirements specified in the relevant regulations published under the Foodstuffs, 
Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972) , where applicable , Trade Metrology Act, 1973 (Act 
No77 of 1973), Compulsory Technical Standards as applied in terms of the National Regulator for Compulsory 
Specifications Act, 2008 (No. 5 of 2008), or importing country regulations:  
 Dispatch establishment number, name and address.  
 Date of harvest (day, month, year)  
 Date of packaging (day, month, year) and batch c ode reflecting origin of product.  
 Production method, commercial designation and species name (e.g. cultivated  abalone – Haliotis midae ). 
 Requirements for storage prior to use by consumer (on main panel) and the warning: These animals must be 
alive when sol d (or date of durability).  
 Net mass in kilograms.  
 Product of the Republic of South Africa.  
11.2.1.  The label must be durable and waterproof and the information presented must be legible and indelible.  
11.2.2.  A person operating the dispatch centre must keep a record of ea ch consignment for a period of not less 
than 5 years  to enable products to be traced and recalled if necessary.  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
28 11.2.3.  If shellfish are unwrapped and subsequently re -wrapped, handled or further processed in another 
establishment, the latter establishment must app ly its own label to the product and maintain adequate 
records of origin and destination for 5 years .  The label must include, in addition to that set out in 
Paragraph 11.2.1 , details of the original dispatch cen tre and re -packaging details.  
11.3. Transport from a dispatch centre  
11.3.1.  The transport of live shellfish intended for human consumption must comply with the relevant provisions 
of Regulation 962 published under the Foodstuffs , Cosmetics and Disinfectants Act, 1972  (Act No. 54 of 
1972) . Consignments of live shellfish intended for human consumption must be transported wrapped in 
sealed parcels until offered for sale to the consumer or  retailer.  
11.3.2.  Individual consumer -size packages of live shellfish must remain sealed af ter leaving the dispatch centre 
until presented for sale to the end consumer.  
11.3.3.  Live shellfish must be transported and distributed using closed vehicles or containers which maintain the 
product at a temperature that does not adversely affect quality and viab ility.  Live shellfish intended for 
the market in a live, chilled state must be brought to a temperature of 7 C or less before leaving the 
centre.  This temperature shall not be so cold as to affect the viability of the shellfish.  This temperature 
shall b e maintained during transport and storage.  
11.3.4.  Packages containing live shellfish must not come into direct contact with the vehicle floor and must not 
be transported with other products that might contaminate them.  
11.3.5.  Ice used for temperature control must have b een made from potable water or clean seawater.  
11.4. Export  
11.4.1.  Health guarantees are issued by the relevant authorities officially authorised by DAFF  in accordance with  
the requirements of the country of destination.  As required, finally prepared and packaged live  shellfish 
will be monitored on the basis of a random testing and surveillance programme, in addition to the 
sampling of live product prior to dispatch.  
11.4.2.  Exporters are to copy their request for health certification from the issuing office to their area NRCS  
inspector (for sampling purposes)  
  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
29 12. Feed management and monitoring  
Feed that is compounded industrially or at the aquaculture facility shall contain only such additives, growth promoting 
substances, flesh colouring agents; anti -oxidizing agents, caking ag ents or veterinary drugs that are permitted for 
shell fish by DAFF.  
Storage and transportation conditions shall conform to the specifications on the label.  
12.1. Farmer responsibility  
12.1.1.  Feed and feed ingredients shall be supplied by feed manufacturers which are reg istered with the 
regulatory body.  
12.1.2.  Ingredients shall meet acceptable, and where applicable, statutory standards for levels of undesirable 
substances that may give rise to human health hazards.  
12.1.3.  Medicated feed shall be stored separately, in order to avoid err ors. 
12.1.4.  Farmers shall follow manufacturer instructions on the use of medicated feeds.  
12.1.5.  The feed and the ingredients of the feed shall be fully traceable to source and product tracing of all feed 
ingredients shall be assured by proper record -keeping.  
12.1.6.  Feed shall  be registered with DAFF and sourced from a supplier approved by DAFF.  
12.1.7.  Each batch procured shall be recorded on Feed Batch Register, which is to be filed and be available for 
inspection.  The register shall include at least:  
 Brand name  
 Batch Date (Date of manufacture)  
 Date In  
 Date Out of last bag  
 Period in storage  
 Supplier  
12.1.8.  Feed shall be handled on a first -in-first-out basis and each batch shall be kept separately and used by the 
expiry date.  If the expiry date is exceeded the producer shall ensure that the  feed is safe for intended 
use. 
12.1.9.  Dry feeds shall be stored in cool and dry areas to prevent spoilage, mould growth and contamination. 
Moist feed shall be properly refrigerated according to manufacturer instructions.  
12.1.10.  The feed shall be kept off the ground to allow for ventilation to reduce contamination.  
12.1.11.  The store room shall be dry, well ventilated and kept clean.  
12.1.12.  Regarding the control of pests refer to Section  9.4.2 . 
12.1.13.  There shall be no chemicals stored in the same s tore room or substances that are harmful to shell fish or 
humans.  
12.2. Feed producer responsibility  
12.2.1.  Feeds and feed ingredients shall be properly labelled with an expiry date and production date.  Their 
composition must fit the declaration on the label.  
12.2.2.  Labelling  shall comply with relevant legislation.  
12.2.3.  Feed shall comply with the relevant legislation in terms of hazardous substances and shall be safe for fish 
consumption.  
12.2.4.  Only approved additives and approved flesh colouring agents of the correct concentration shall  be 
included in the feed.  
12.2.5.  Moist feed or feed ingredients shall be fresh and of adequate chemical and microbiological quality.  
12.2.6.  Fish silage and offal from fish, if used, shall be properly cooked or treated to eliminate potential hazards 
to human health.  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
30 12.2.7.  Vete rinary drug and other chemical treatments shall be authorised for use by the medicines control 
council and shall be administered in accordance with recommended practices and comply with national 
regulations.  
12.2.8.  Medicated feeds shall be clearly identified on t he package.  
  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
31 13. Drug management  
13.1. Prior to administering veterinary drugs, a system shall be in place to monitor the application of the drug to 
ensure that the withdrawal time for the batch of treated shell fish can be verified.  
13.2. Products registered under Fertil izers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 
36 of 1947) and Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) shall only be 
administered by veterinarians registered with the South African Veterinary  Council, (SAVC) and / or on 
prescription by such a veterinarian.   
13.3. Drugs listed in APPENDIX X shall not be used and shall be monitored for in the shell fish. 
13.4. All chemicals used for the treatment of shell fish or pro duction water shall be adequately labelled.  
13.5. Storage and transportation conditions shall conform to the specifications on the label.  
13.6. Control of diseases with drugs shall be carried out only on the basis of an accurate diagnosis by a registered vet.  
13.7. If aquac ultured shell fish are monitored for drug residues and drug residue concentrations are found to be above 
the maximum residue limit (MRL)  or the withdrawal limits have not been observed as indicated on the drug 
label , harvest of the batch shall be postponed until the batch complies with the MRL. After an assessment of the 
better management practices (BMP) regarding pre -harvest measures, appropriate steps shall be taken to 
modify the drug residue control system.  
13.8. A post harvest control shall reject all shell fish that do not comply with the requirements set for MRL.  
13.9. Products registered under Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (act No. 
36 of 1947) and Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965) shall only be 
procured from a registered veterinarian.  
13.10.  The Drug Procurement Register shall contain at least the following information:  
 Date purchased  
 Suppliers name and contact details  
 Name of drug  
 Quantity purchased  
 Batch number  
 Expiry date  
 Withholding pe riod 
13.11.  The treatment of shell fish or production water shall only be undertaken under the supervision of a registered 
vet. 
13.12.  Records shall be maintained for the use of veterinary drugs in aquaculture production.  A Treatment Register 
shall be maintained and sha ll include at least the following information:  
 Date administered  
 Batch of shell fish treated  
 Name of the drug  
 Amount used  
 Withholding period  
 Date shell fish safe for harvest  
 Who administered the drug  
 Reason for treatment  
13.13.  Withdrawal times shall be observed be fore shell fish is harvested for human consumption.  
13.14.  The Treatment Register shall be properly filed and available for inspection.  
 DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
32 14. DEFINITIONS  
“Acceptable ” means acceptable to the competent authority for the approval and licensing of molluscan shellfish pr oduction 
and harvesting waters and for the competent authority inspecting and certifying such product for export.  
“Adverse pollution conditions ” means conditions determined by changes in meteorological, hydrographic, seasonal and 
point source pollution con ditions that have been historically  demonstrated to unfavourably impact on a particular 
production area.  Examples are unusual climatic conditions, long periods without rain, unusually hot temperatures, 
consecutive days of light rainfall, heavy rainfall, t idal effects, salinity and wind effects.  
“Approved areas (Class A) ” means the classification by DAFF of a production area where shellfish may be harvested for sale 
for direct human consumption at any time outside of temporary closures.  An approved area mu st meet the microbiological 
requirements set out in Paragraph 5.3.  An approved area may be temporarily closed to harvesting, e.g. when a flood, storm 
or marine biotoxin event occurs.  
“Central file ” means the file system mainta ined by the persons responsible for management of this programme at DAFF.  
“Clean ice ” means ice made from potable water or clean seawater and that has been stored hygienically prior to use.  
“Clean seawater ” means water that meets the approved area microbia l requirements and does not contain toxic or 
objectionable substances at levels that pose a public health risk or impair the taste of the shellfish.  
“Closed area ” means a production area where the harvesting of shellfish is temporarily or permanently not p ermitted.  
“Compliance Officer ” means any person appointed as such in terms of the Marine Living Resources Act, 1998 (Act No. 18 of 
1998).  
“Conditional areas ” means the classification by DAFF of a production area that meets either the approved or restricted  area 
criteria for a predictable period.  The period is conditional upon established performance standards specified in a 
management plan.  
“Conditioning ” means the storage in clean seawater of live shellfish meeting the approved area criteria for the purpo se of 
improving palatability and/or vitality.  
“Depuration plant ” means a licensed establishment comprising one or more depuration units that are used for purifying 
shellfish according to an approved depuration process.  A depuration unit is a tank or serie s of tanks fed by a single process 
water system.  
“Depuration ” means the process of using a controlled clean sea water system to reduce to levels of microbial contaminants 
in live shellfish.  
“Direct human consumption ” means live shellfish intended for direc t human consumption are regarded as ready to eat at 
the point sale, i.e. safe in the live, fresh state, if so desired.  Also referred to as immediate human consumption.  
“Dispatch centre ” means any installation for the reception, conditioning, washing, clea ning, grading and packaging of live 
shellfish fit for human consumption.  
“Establishment number ” means refers to the official approval number for a production or harvesting area and packaging or 
processing facility.  The establishment number for packaging a nd processing is obtained from the Food Standards Division of 
the NRCS in Cape Town.  This number may also refer to a permit number issued by DAFF for a specific cultivation area, 
relaying area, depuration plant or harvester.  
“Harvester ” means a person who  takes shellfish by any means from a production area.  
“Health authority ” means the relevant local authorities responsible for municipal health services as defined in the National 
Health Act, 2003 (Act No. 61 of 2003)  as amended , read in conjunction with th e Municipal Structures Act, 1998 (Act No. 117 
of 1998 ). 
“Intensive sampling ” means the taking of samples at a greater frequency, as prescribed by DAFF, than required for routine 
sampling.  
“Lot of shellfish (or batch) ” means shellfish harvested from a parti cular identifiable area at a particular time (i.e. no more 
than one day).  
“Marine aquaculture ” means for the purposes of this manual, the controlled production of molluscan shellfish in natural 
and artificial seawater systems destined for the market as a f oodstuff.  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
33 “Marine biotoxins ” means poisonous compounds that accumulate in shellfish generally by feeding on toxin -producing 
dinoflagellates or diatoms, though other means of toxification could occur.  
“Molluscan Shellfish ” means for the purposes of this man ual, applies to all bivalve molluscs and including Pectinidae and 
marine gastropods but excluding octopus and squid.  (“shellfish” in the text refers to molluscan shellfish).  
“Official Inspector ” means any Compliance Officer, Inspector, Environmental Healt h Practitioner or Health Officer 
appointed in terms of the Marine Living Resources Act, (Act No. 18 of 1998), National Regulator for Compulsory 
Specifications Act, 2008 (Act No. 5 of 2008) or National Health Act, 1998 (Act No.61 of 2003) and regulations pr omulgated 
under these Acts.  
“Person ” means an individual, partnership, corporation, association or other legal entity.  
“Point source  (of pollution)” means a discernible single source such as any pipe, ditch, channel, tunnel or conduit that 
carries pollutio n. 
“Potable water ” means water that is safe for human consumption and that complies with the requirements of SANS 241 
(NRCS 241).  
“Process batch ” means a quantity of shellfish used to fill each separate depuration unit.  
“Process water ” means seawater in de puration tanks during the time that the shellfish are being depurated, or the water 
used in a tank system where molluscan shellfish are cultivated, or the water in wet storage tanks during the time the 
shellfish are being wet stored.  
“Processing ” means the  physical or chemical treatment of shellfish that substantially alters the initial product.  Shucking, 
packing and repacking are also regarded as processing.   
“Processor ” means a person who processes shellfish.  
“Production area ” means an artificial or natu ral seawater or estuarine system that supports or could support the 
propagation of live shellfish.  
“Prohibited area ” means a production area where there is no current sanitary survey or where the sanitary survey or other 
monitoring programme indicates tha t faecal material ( E. coli ), pathogens or toxic substances may reach the area in 
excessive concentrations.  Any taking of shellfish for human consumption from such area is prohibited.  
“Relaying ” means the transfer of live molluscs to a production area of a pproved status to facilitate the natural biological 
cleansing of microbiological contaminants and/or biotoxins.  The transfer of shellfish to a different area for further growth  
or fattening is not included.  
“Restricted area (Class B)”  means a production a rea classified by DAFF as an area from which shellfish may be harvested 
only by special permit.  A restricted area must comply with the microbiological requirements set out in Paragraph 5.4.  
Shellfish from rest ricted areas may be processed (e.g. canning, cooking and freezing) or subjected to an approved 
depuration process such as relaying or depuration.  
“Sanitary Survey ” means the evaluation, in accordance with the requirements of Paragraph 5.2 of this manual, by a DAFF 
approved party, of all actual and potential pollution sources and environmental factors that may affect shellfish production 
water quality.  
“Shellfish Management Committee ” means the board of management  of the DAFF, in co -operation with the Department of 
Health, NRCS, and Industry, whose primary role it is to review the management actions proposed in this manual with regard 
to public health on an annual or more frequent basis.  
“Shellstock ” means shellfis h in the shell.  
“Shoreline Survey ” means a survey of the shoreline of the production area catchment conducted by an officer authorised 
by DAFF according to requirements in Appendix I.  
“Transaction Record ” means a form used to document each purchase or sale  of shellfish at the wholesale level.  
“Treated water ” means seawater used in a depuration or wet storage facility that has been disinfected by either UV, ozone, 
chlorine/hypochlorite, iodophor, or other appropriate treatment.  Treated water must contain no  detectable E. coli  after 
treatment.  
“Wet Storage ” means the temporary storage of shellfish harvested from Approved or Conditional production areas open to 
harvesting.  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
34 15. REFERENCES  
1. AOAC 1990. Paralytic shellfish poisoning. Biological method. Final action. In: Hellrich, K. (Ed).  Official Methods of 
Analysis. 15th Edition, pp 881 -882, sec 959.08. Association of Official Analytical Chemists, Arlington, Virginia, USA.  
2. Canadian Shellfish Sanitation Program. Manual of Operations. 1992.  
3. Codex 2008. Standard for Li ve and Raw Bivalve Molluscs. CODEX STAN 292 P1 -7 
4. Commission Decision of 11 December 1992. Approving certain treatments to inhibit the development of 
pathogenic micro -organisms in bivalve molluscs and  marine gastropods (93/25/EEC).  
5. Commission Decision of 3 May 1996. Establishing health certification of live bivalve molluscs, echinoderms, 
tunicates and marine gastropods from third countries which are not covered by a specific decision (96/333/EC).  
6. Commission Regulation (EC) No 1021/2008. Controls on products of animal origin intended for human 
consumption  
7. Commission Regulation (EC) No 1441/2007. Microbiological criteria for foodstuffs amendment.  
8. Commission Regulation (EC) No 15/2011. Detection methods for marine biotoxins.  
9. Commission Regulation (EC) No 1664/20 06. Implementing measures for certain products amendment  
10. Commission Regulation (EC) No 1881/2006. Contaminant limits in foodstuffs  
11. Commission Regulation (EC) No 2065/2001. Laying down detailed rules for the application of Council Regulation 
(EC) No 104/200 0 as regards informing consumers about fishery and aquaculture products.  
12. Commission Regulation (EC) No 2073/2005. Microbiological criteria for foodstuff  
13. Commission Regulation (EC) No 2074/2005. Implementing measures for certain products  
14. Commission Regulat ion (EC) No 420/2011. Contaminant limits in foodstuffs amendment.  
15. Commission Regulation (EC) No 558/2010. Hygiene rules for food of animal origin  
16. Commission Regulation (EC) No 852/2004. On the hygiene of foodstuffs.  
17. Commission Regulation (EC) No 853/2004. Laying down specific hygiene rules for food of animal origin.  
18. Commission Regulation (EC) No 854/2004. Laying down specific rules for the organisation of official controls on 
products of animal origin intended for human consumption.  
19. Donovan TJ, Gallacher s,  Andrews NJ, Greenwood MH, Graham j, Russel JE and R Lee (1998) Modification of the 
standard method used in the United Kingdom for counting Escherichia coli  in live bivalve molluscs. Communicable 
Disease and Public Health 1: 188 -196.  
20. Food Safety (fishery Products and Live Shellfish) (Hygiene) Regulations 1998. Statutory Instrument 1998 No. 994.  
21. Guide to regulatory requirements and examination procedures for fish and fish products exported from Canada to 
the European Union. Canadian Food Inspection Agency, Fish Seafood and Production Division. Sept 25, 2000.  
22. Hannah DJ, Till DG, Deverall T, Jones PD and JM Fry 1995 Extraction of lipid -soluble marine toxins. Journal of AOAC 
International 78: 480 -483.  
23. ISO 16140 (2004) Microbiology of food and animal feeding st uffs – Protocol for the validation of alternative 
methods.  
24. ISO 6579 (2002) Microbiology of food and animal feeding stuffs – Horizontal method for the detection of 
Salmonella spp.  
25. ISO/TS 16649 -3 (2005) Microbiology of food and animal feeding stuffs – Horizo ntal method for the enumeration of 
beta -glucuronidase -positive Escherichia coli Part 3. Most probable number technique using 5 -bromo -4-chloro -3-
indolyl -D-glucuronide.  
26. Issue 1 of the New Zealand Fishing Industry Agreed Implementation Standards IAIA 001,1 : Shellfish Quality 
Assurance Circular 1995.  
27. National Shellfish Sanitation Program. Manual of Operations. Part 1. Sanitation of Shellfish Growing Areas. 1995 
Revision. US -FDA.  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
35 28. National Shellfish Sanitation Program. Manual of Operations. Part 2. Sanitation of the Harvesting, Processing and 
Distribution of Shellfish. 1995 Revision. US -FDA.  
29. NRCS Manual 570 MAN 005. Basic Requirements for Inspection Purposes Pertaining to the Implementation of 
HACCP Principles for Fishery Products. 2009.  
30. Operations Manual of the Australian Shellfish Sanitation and Control Program. First Edition 1997.  
31. Quilliam MA, Xie M and WR Hardstaff 1995 Rapid extraction and clean up for liquid chromatographic 
determination of domoic acid in unsalted food, Journal of AOAC International 78: 534-554.  
32. SANS 241:2001 (NRCS 241:2001) Drinking Water.  
33. SANS 5221:2001 (NRCS SM 221:2001) Microbial analysis of water – General test methods.  
34. Sanz, I. 1999. Imports of fishery products into the EC: Sanitary approval for third countries. EC Fisheries 6 
Coop eration Bulletin 12: 4 -6.  
35. Yasumoto T, Murata M, Oshima, Y, Matsumoto K and J Cardy 1984. Diarrhetic shellfish poisoning. In: EP Ragelis 
(ed.), Seafood Toxins, ACS Symposium Series, 262, 207 -214. American Chemical Society, Washington, DC.  
 
16. SOUTH AFRICAN LE GISLATION  
The following South African legislation is applicable to the South African Molluscan Shellfish Monitoring and Control 
Programme:  
 Marine Living Resources Act, 1998 (Act No. 18 of 1998)  
 Foodstuffs, Disinfectants and Cosmetics Act, 1972 (Act No. 54 of 1972) and relevant regulations  
 National Regulator for Compulsory Specifications Act, 2008 (Act No. 5 of 2008)  
o Compulsory Specification for the Manufacture, Production, Processing and Treatment of Canned Fish, 
Canned Marine Molluscs and Canned Crustacean s. Regulation 790, 1 9 July 2004, in terms of the NRCS Act 
(Act No. 5 of 2008).  
o Compulsory Specification for Frozen Fish, Frozen Marine Molluscs and Frozen Products derived there from. 
Regulation 979, 4 July 2003, in terms of the NRCS Act, 2008 (Act No. 5 of 2008).  
 Municipal Structures Act, 1998 (Act No.117 of 1998)  
 Trade Metrology Act, 1973 (Act No. 77 of 1973)  
 Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies, 1947 (Act No. 36 of 1947)  
 Medicines & Related Substances Control Act, 1965 (Act No. 101 of 1965)  
 Veterinary and Para - veterinary Professions Act, 1982 (Act No. 19 of 1982)  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
36 APPENDIX I: MINIMUM REQUIREMENTS OF THE SANITARY SURVEY REPORT  
 The following provides an outline of the many factors to be considered in  performing and reporting on the sanitary 
survey as required in Section 5.2.  These guidelines act as a checklist and provide a model for the structure of the 
report.  
1. Summary  
 Provide a synopsis of the result s of the sanitary survey and recommendations for the particular production area 
under investigation.  
2. Background information  
2.1 Motivation for the study.  
2.2 General description of production area – including maps and, where available, aerial photograph s. 
2.3 Resources to be harvested – specifying shellfish species, location within the production area and abundances.  
2.4 Harvest practices – methods, seasonality, landings (previous and projected) and intended use of harvested 
shellstock, i.e. direct human  consumption, processing, depuration or wet storage.  
2.5 History of production area classification:  
 Summary of sanitary survey history  
 Previous classification – including maps and photographs, where appropriate.  
3. Pollution source (shore line) survey  
3.1 Personnel and procedures – description of plan for shoreline pollution source survey and methods of data 
collection.  
3.2 Summary of pollution sources and location – including maps of major sources of actual or potential pollution.  
3.3 Identification and ev aluation of pollution sources.  All actual sources of pollution must be classified as either a 
direct impact (discharges directly into production area) or indirect impact (discharge which is advected or mixed 
into the production area from a distant source) .  The volumes of the different discharges should be quantified 
where possible.  
 Domestic wastes – include maps and discussion on use of septic tanks in the catchment area and sewage 
treatment facilities and outfalls  
 Stormwater  – information on the nature (combined) and conduiting (drainage ditches, pipes and runoff)  
 Agricultural waste from farms, feedlots and slaughterhouses  
 Industrial wastes  
 Wildlife areas – unfenced access of animals to production areas  
 Radionuclides  
 Marinas  
 Minor sources such as boats, birds and seals  
4. Hydrographic and meteorological characteristics  
4.1 Physiography – physical description of water body including chart of depth contours.  
4.2 Tides – full description of type, range and tidal exchange rates.  
4.3 Currents – type of current s (tidal, wind driven etc.) and dispersion characteristics.  
4.4 Waves – heights, frequency of storms and role in sediment re -suspension.  
4.5 Rainfall – provide a summary of last 5 – 10 years rainfall figures, showing seasonal variation and frequency of 
significant rainfalls.  
4.6 Winds – provide summary wind data for the last 5 – 10 years on strength, direction and seasonality.  
4.7 River discharges – volumes and seasonality . DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
37 4.8 Summary discussion on actual or potential effects of transport (water borne or a ir borne) of pollutants to the 
production area.  Include discussion on physical dispersion and dilution of pollutants.  
5. Water quality studies  
5.1 Sampling plan, taking potential pollution sources into account.   
5.2 Map showing sampling stations.  
5.3 Desc ription of sample collection and analytical procedures.  
5.4 Microbiological data analysis and presentation.  Present data and statistical analyses in table form indicating 
compliance with criteria given in Section 6 and classification of individual sample stations where applicable.  
5.5 Assessment of levels of toxic and hazardous substances in shellfish.  
5.6 Assessment of risk imposed by biotoxin producing phytoplankton.  
5.7 Inter -relationship with physical forcin g factors.  Discuss how meteorological and hydrodynamic conditions affect 
actual or potential pollution sources and their impact on water quality.  The discussion must address the following:  
 Effects of meteorological and hydrodynamic  factors on pollution s ources.  
 Causes of adverse pollution conditions.  
 Potential pollution associated with seasonal events such as holidays, festivals etc.  
 Explanation for the variability in the data.  
6. Recommended classification.  
 Classification of the production area indicat ed on a chart/map showing closure lines and separation of various 
classifications where applicable.  
7. Recommendations.  
7.1 Details of monitoring schedule for microbiological indicators and toxic and hazardous substances that will be used 
in the annual re -assessment of production area classification.  
7.2 Monitoring actions for biotoxins.  
7.3 Provide suggestions for future work and improvements in the above programmes from previous years.  
8. Enforcement action reports  
 Provide details of enforced closure to harvest for public health reasons during the re -classification period.  This 
should include (see also Paragraphs 9.3 and 9.4 of this Appendix):  
 Reasons for closure and duration (dates)  
 Management actions taken (harvest closures, recall, embargo, policing) and response times from sampling to 
the specific responses.   
 Details regarding the roles of the different agencies involved in the emergency response,  
 Re-opening criteria and re -classification status if applicable.  
 Information relevant to cooperation rece ived from the affected harvester(s) or farmer(s).  
9. Management plans  
9.1 Management plans for areas classified as conditionally approved or conditionally restricted shall be included in the 
initial sanitary survey and updated as necessary during the annua l evaluations.  Because of the burden on the 
public resource, a conditional classification option should only be considered in special cases.  
9.2 The plan shall include a description of predictable pollution events that cause closure.  Information on waste water 
treatment, environmental effects and other events shall be included as relevant:  
9.2.1  Wastewater treatment facility - performance standards based on:  
 Peak effluent flow  
 Bacteriological, chemical and physical quality of the effluent  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
38  Bypasses  
 Design, construction and maintenance to minimise mechanical failure or overloading  
 Monitoring of wastewater treatment efficacy and feedback system in the case of inadequate treatment  
9.2.2  Meteorological and hydrodynamic  events - discussion of the specific events that cause closure, their predictability 
and frequency of occurrence.  
9.2.3  Other events - marina openings and closures, bird migrations, holiday seasons etc.  
9.3 Implementation of conditional area closures.  
9.3.1  Notification of management plan violations .  Identify agency or agencies responsible for notifying an inspector of 
such violations, the procedures for prompt notification, and response time between violation and notification.  
9.3.2  Implementation of a closure.  Identify the response time between n otification of a management plan violation and 
legal closure.  Detail means by which Industry and surveillance personnel are notified.  
9.3.3  Enforcement of closure.  Identify agency responsible and response time between legal closure and patrol agency 
notification.  
9.4 Criteria for reopening a conditional area after a pollution event.  DAFF shall establish the following control 
elements to define re -opening criteria:  
 Procedures to determine that the pollution event has ended  
 Physical flushing time, i.e., ti me for area to exchange a sufficient volume of water to disperse/assimilate the 
pollutant load  
 Shellfish feeding activity is sufficient to promote natural cleansing  
 Time after flushing required for shellfish to naturally cleanse themselves  
9.5 Synopsis of the effectiveness of closure and policing procedures and details of the co -operation between different 
agencies.  
 DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
39 APPENDIX II: SAMPLING OF SHELLFISH AND WATER  
In situations where a localized production area in open waters (e.g. S mall Bay, Saldanha) is utilized for harvest by a 
number of different permit holders, some monitoring (sampling) efforts may be combined as advised by DAFF.  
 Shellfish samples for microbiological and biotoxin analyses should comprise shellstock close to mar ket size.  
Juvenile shellfish should not be used as a proxy.  
1 Shore -based marine aquaculture systems  
1.1 Filter feeders - samples for microbiological examination are to be taken of shellstock within the grow -out units.  
1.2 Non-filter feeders - samples for  microbiological examination are to be taken of shellstock within the grow -out 
units, as well as the intake water to the farm.  
1.3 The daily seawater samples for algal identification are to be taken from a position representative of the intake 
water.  
1.4 A composite shellfish sample from the grow -out tanks/ponds will be required for tests on other hazardous and 
deleterious substances.  
2 Production (cultivation) areas in the open -water environment  
2.1  Filter feeders - samples for microbiological examinatio n are to be taken from shellstock within the production 
area.  
2.2 Non-filter feeders - samples for microbiological examination are to be taken of shellstock within the production 
area, as well as ambient water.  
2.3 Water samples for algal identification sh all be taken from positions that provide adequate early warning of the 
presence of harmful algal species.  DAFF will advise on sample station positioning and method of collection.  
Where feasible, an integrated sample of the upper water column shall be tak en using a Lund tube.  
2.4 A composite shellfish sample will be required for tests on other hazardous and deleterious substances.  Where 
contamination may be expected from an identifiable point source, an additional sample or samples shall be taken 
in proxi mity to the source.  
3 Shellfish samples  
3.1 A representative and sufficient sample of shellfish including intravalvular fluids and free of open or cracked shells 
are collected.  The following sample sizes are recommended:  
 Mussels:   15 – 30 
 Oysters and cla ms: 10 – 15 
 Abalone and scallops:  5 – 10 
3.2 Shellstock is collected in clean, waterproof, puncture resistant containers.  Sample containers for microbiological 
analyses must be sterile.  
3.3 Separate samples are to be collected for biotoxin and microbiolog ical analyses.  
3.4 Shellfish should be cleaned of dirt, sediment and other organisms, and then rinsed in clean seawater and drained 
before being placed in storage containers.  
3.5 The sample is labelled with the collector’s name, type of shellfish, the sour ce or production area code, station 
position or other identifier as relevant, time and date, and intended analysis (e.g. E. coli , PSP etc.).  An official 
sample submission form should be used for this purpose.  
3.6 Samples for microbial testing are maintain ed in dry storage between 0  and 7C until examined - as soon as 
possible after collection but not exceeding 24 hours.  Coolers containing ice packs, not in direct contact with the 
sample, offer a convenient system.  Samples should not be frozen.  
3.7 Sampl es for biotoxin testing should be kept chilled during same -day delivery to the analytical laboratory.  Samples 
should be frozen for longer -term storage.  
3.8 Samples for analysis of radionuclides and metals are to be frozen for delivery to the laboratory.  
4.  Seawater samples for microbial examination  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
40 4.1 Samples are collected in clean, sterile, watertight glass or polypropylene containers of sufficient size to hold a 
minimum of 100ml with a head -space for shaking.  
4.2 Samples are identified with the collect or’s name, source or production area identifier, position, time and date of 
collection, and intended analysis.  An official laboratory submission form should be used for this purpose.  
4.3 Samples shall be maintained at 0  - 7C until examined - as soon as possible after collection but not exceeding 24 
hours.  
5. Seawater samples for algal identification  
5.1 Samples are collected in clean, watertight containers of sufficient size to hold 100 ml with a headspace for shaking.  
5.2 Samples are identified with the  collector’s name, production area or other identifier, position, and time and date.  
Supplementary environmental data should be supplied as requested by DAFF  
5.3 Samples are preserved with buffered formalin to a final concentration of 2.5%.  
6 Receipt of s amples by the laboratory  
6.1 Samples should be accompanied by an official submission form.  
6.2 For microbiological analyses, the receiving laboratory must record:  
 the condition and number of individuals in the sample  
 sample temperature  
 time of sample colle ction and receipt at the laboratory  
6.3 Shellfish intended for microbiological analysis must be alive on receipt by the laboratory and stored at between 0 
and 7C prior to analysis.  
6.4 For biotoxin analyses, the receiving laboratory must record the condit ion (freshness) and number of individuals in 
the sample.  
 DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
41 APPENDIX III: STANDARDS AND METHODS FOR THE ANALYSES OF BIOTOXINS AND MICROBIAL CONTAMINANTS  
 
BIOTOXIN  TEST METHODS  STANDARDS  
Paralytic Shellfish Poisons (PSP)  
Saxitoxin  Mouse bioassay (AOAC official method 
959.08 1990) (Commission Regulation (EC) 
2074/2005).  
Lawrence method (AOAC Official Method 
2005.06) (Commission Regulation (EC) No 
1664/2006).  ≤ 0.8 mg total PSP / kg edible flesh 
(Regulation (EC) No 853/2004).  
Lipophilic Shellfish Poisons (LSP)  
Okadaic acid, dinophysistoxins, 
azaspiracids, pectenotoxins and 
yessotoxins  Mouse bioassay (Yasumoto et al.  1984) 
using acetone extraction and liquid -liquid 
partitioning with dichloromethane 
(Hannah et al. 1995) (Commission 
Regulation (EC) No 15/2011).  Death of 2 out of 3 mice in 24 hours is 
considered a positive result 
(Regulation (EC) No 2074/2005).  
Okadaic acid group toxins: OA, 
DTX 1, DTX 2 & DTX 3 and 
Pectenotoxins group toxins: PTX  1 
& PTX  2  ^Liquid Chromatography Mass 
Spectrometry (EU -RL* LC -MS/MS method) 
(Commission Regulation (EC) No 15/2011)  ≤ 0.16 mg okadaic acid equivalents / kg 
edible flesh (Commission Regulation 
(EC) No 853/2004).  
Yessotoxins group toxins: YTX, 45 
OH YTX, homo YTX, and 45 OH 
homo YTX  ^Liquid Chromatography Mass 
Spectrometry (EU -RL LC -MS/MS method) 
(Commission Regulation ( EC) No 15/2011)  ≤ 8 mg yessotoxin equivalents / kg edible 
flesh (Codex).  
Azaspiracids group toxins: AZA1, 
AZA2 and AZA3.  ^Liquid Chromatography Mass 
Spectrometry (EU -RL LC -MS/MS method) 
(Commission Regulation (EC) No 15/2011)  ≤ 0.16 mg azaspiracid equival ents / kg 
edible flesh (Commission Regulation 
(EC) No 853/2004).  
Amnesic Shellfish Poisons (ASP)  
Domoic acid  ^High Performance Liquid 
Chromatography with UV detection after 
methanolic extraction and SAX -cleanup 
(Quilliam et al.  1995) (Commission 
Regulati on (EC) No 2074/2005).  
Liquid Chromatography Mass 
Spectrometry (LC -MS/MS method)  ≤ 20 mg domoic acid eq / kg edible 
flesh (Commission Regulation (EC) No 
853/2004).  
*European Union Reference Laboratory  
^ Reference Method  
 
  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
42 APPENDIX IV: MICROBIOLOGICAL REGULATORY LIMITS  
MICROBIAL AGENTS  TEST METHOD  STANDARDS  
Escherichia coli  SANS 16649 -3:2008/ISO/TS 16649 -3:2005  
(Donovan et al . 1998)  <230/100 g edible flesh (Class A).  
<4 600/100 g edible flesh (Class B).  
Salmonella  SANS 6579:2003/ISO 6579:2002  Absence in 2 5 g 
Vibrio cholerae  & 
V. parahaemolyticus  SANS 6196:2 006 Absence in 25 g  
 
Analytical laboratories should strive to provide results  to DAFF in as short a time as possible from receipt of samples.  This 
period should not exceed 3 days for PSP , 3 days for DSP, and 3 days for E. coli  in the majority of cases.  As ASP is only tested 
on a monthly basis  due to low risk  the requirement  for reporting of test  results is less critical.  Should the biotoxin or 
microbiological concentrations exceed the regulatory limit, the laboratory is to inform DAFF via a Red Alert imm ediately 
after the results are obtained.  
 
Relevant legislation  
Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972) - Regulation 692 of 1997: Regulations governing 
microbiological standards for foodstuffs and related matters  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
43 APPENDIX V: THRESHOLDS THAT TRIGGER INTENSIVE BIOTOXIN TESTING  
The following biotoxin concentration thresholds shall trigger daily testing for the implicated toxin in filter feeders and 
weekly testing in abalone if the production area is not temporarily closed for harvesting:  
 
Biotoxin  Threshold  
Total Saxitoxin  0.4 mg saxitoxin equivalents / kg edible flesh  
Sum of OA, DTX 1, DTX 2, DTX 3, PTX  1 & PTX  2 0.08 mg okadaic acid equivalents / kg edible flesh  
Sum of YTX, 45 OH YTX, homo YTX, and 4 5 OH homo YTX  4 mg yessotoxin equivalents / kg edible flesh  
Sum of AZA 1, AZA 2 & AZA 3  0.08 mg azaspiracid equivalents / kg edible flesh  
Total Domoic acid  5 mg domoic acid eq / kg edible flesh  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
44 APPENDIX VI: MICROBIOLOGICAL AND  HAZARDOUS SUBSTANCE CONTINGENCY MEASURES  
 
 
DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
45 APPENDIX VII: BIOTOXIN CONTINGENCY MEASURES  
 
 
DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
46 APPENDIX VIII: DOCUMENTATION AND LABELLING REQUIREMENTS DURING TRANSPORT OF LIVE SHELLFISH  
1 A movement docume nt (Paragraph 6.3.1) must accompany batches of live shellfish transported prior to placing on 
the market unless the same staff operates the facility, relaying site or depuration plant of destination (Paragraph 
6.3.2).  A movement document identifies the pr oduction area where the shellfish were harvested, the sanitary 
classification of the area, and destination of the batch.  
2 A label is required for all batches of live shellfish where the destination is a retailer or consumer.  This label allows 
the dispatc h centre of origin to be identified.  
3 Depurated shellfish must be provided with a label certifying that all live shellfish have been purified (Paragraph 
8.7.5).  
 
4 When exporting live shellfish the requirement for supporting documentation can b e extensive (e.g. air waybill, 
certificate of origin, commercial invoice, shippers export declaration, shippers certification for live animals (IATA), 
insurance certificate, veterinary certificate and CITES certificate).  From a public health perspective, some 
countries (e.g. Commission Decision 96/333/EC) may require that each shipment of seafood products is 
accompanied by a numbered sanitary/health certificate certifying the product meets certain standards.  Such 
requirements generally exist where a speci fic decision has not yet been adopted by the destination country.  A 
single certificate may be issued for several containers of the same product considered to be a single lot.  
 
Depuration
PlantRelaying 
AreaHarvest MarketMovement 
DocumentDispatch Centre
Processing Plant
Wet Storage
Label
(Live product )Movement 
Document
Purification
CertificateDAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
47 APPENDIX IX: HARMFUL ALGAL SPECIES FOUND IN SOUTH AF RICAN MARINE ENVIRONMENT  
The following list includes those phytoplankton species reported to form blooms  and/ or to be toxic  or potentially toxic : 
 
Dinophyceae  
Alexandrium catenella+*  
Alexandrium minutum  
Ceratium dens+  
Ceratium furca+  
Ceratium lineatum+  
Dinophysis acuta*  
Dinophysis acuminat a* 
Dinophysis fortii*  
Dinophysis hastat a* 
Dinophysis tripos*  
Dinophysis rotundata # 
Protoceratium reticulatum +* 
Gonyaulax polygramma+  
Gonyaulax spinifera+  
Karenia cristata +* 
Gymnodinium sanguineum+  
Heterocapsa triqueta+  
Noctiluca scintillas+  
Prorocentrum balticum+  
Prorocentrum micans+  
Prorocentrum rostratum  
Prorocentrum triestinum+  
Polykrikos schwartzii+  
Scrippsiella trochoidea+  
 
 
 Bacillariophyceae  
Chaetoceros convolutus#  
Pseudo -nitzschia spp # 
 
Raphidophyceae  
Chattonell a spp# 
Heterosigma akashiwo+#  
 
Pelagophyceae  
Aureococcus anophagefferens+  
 
Haptophyceae  
Chrysochromulina spp# 
Emiliania huxley+  
Gephyrocapsa oceanica+  
Phaeoc ystis pouchetii#  
Syracosphaera pulchra+  
 
Euglenophyceae  
Eutreptiella sp+ 
 
Ciliates  
Mesodinium rubru m+ 
 
+ Bloom  
*Toxic  
# Potentially harmful or toxic  
  DAFF:  South African Molluscan Shellfish Moni toring and Control Programme ( Issue 6) January 201 6 
 
47 APPENDIX X: PROHIBITED DRUGS  
List of pharmacologically active substances for which no maximum levels can be fixed:  
 Stilbenes, stilbene derivatives, and their salts and esters  
 Steroids  
 Aristolochia spp. and preparations thereof  
 Chloramphenicol  
 Chloroform  
 Chlorpromazine  
 Colchicine  
 Dapsone  
 Dimetridazole  
 Metronidazole  
 Nitrofurans (including furazolidone)  
 Ronidazole