Canadian Audit of the Chilean Bivalve Mollusc Sanitation Program Final Report - 2018
On this page
- Executive summary
- Abbreviations and special terms used in the report
- 1. Introduction
- 2. Audit objective, scope and methodology
- 3. Legal basis for the audit
- 4. Background
- 5. Findings
- 5.1 Regulatory foundation
- 5.2 Government oversight
- 5.3 Shellfish inspection and control program
- 5.4 Food related illness and outbreak investigation
- 5.5 Laboratory controls
- 6. Closing meeting
- 7. Conclusions and recommendations
- Annex 1: Summary of the Canadian Food Inspection Agency (CFIA) recommendations/findings from the Canadian Audit of the Chilean Bivalve Mollusc Sanitation Program Draft Report – 2018
Abbreviations and special terms used in the report
- Canadian Food Inspection Agency
- Canadian Shellfish Sanitation Program
- Hazard Analysis Critical Control Points
- Instituto National de Normalizacion
- International Standards Organization
- Ministry of Health
- Programa de Sanidad de Moluscos Bivalvos
- Planta de tratamiento de aguas servidas (wastewater treatment plant)
- Quality Assurance Program
- Quality Management Program
- Extraction and Transport Register for Bivalve Mollusks
- Servicio Nacional de Pesca y Acuicultura (National Fisheries and Aquaculture Service)
- Undersecretariat for Fisheries and Aquaculture
This report describes the outcome of an audit of the Chilean Shellfish Sanitation Program (Programa de Sanidad de Moluscos Bivalvos - PSMB) conducted by the Government of Canada from March 5 to March 15, 2018.
The main objective of the audit was to determine if the PSMB provides an equivalent level of health protection to that provided by the Canadian Shellfish Sanitation Program (CSSP) and the Quality Management Program (QMP). This was the first audit of the PSMB by the Government of Canada.
The scope of the audit included evaluating whether the PSMB was implemented as documented and whether there were any significant differences between the PSMB and Canadian systems in the areas of; growing area classification and monitoring, harvesting controls, laboratories, and inspection systems for vessels, conveyances and processing establishments. The audit included site visits to:
- the Servicio Nacional de Pesca y Acuicultura - National Fisheries and Aquaculture Service (SERNAPESCA) in Valparaiso and Puerto Montt
- 3 laboratories in the Puerto Montt/Puerto Varas area and on Chiloé Island
- 5 shellfish processing establishments and 4 harvesting areas in the Puerto Mont area and on Chiloé Island
Overall, the PSMB is being implemented by a well-trained and dedicated team of professionals. The SERNAPESCA establishment inspection and oversight of PSMB activities at the national and regional level is commendable.
The audit showed that the PSMB is implemented as intended and is effective at managing food safety risks associated with bivalve shellfish. Recommendations for consideration for enhancing the PSMB were noted in the following areas:
- response to adverse weather events and discharges from sanitary waste systems
- education of harvesters on the risks associated with overboard discharge from vessels
Currently, roe-on scallops are the only bivalve shellfish Chile is permitted to export to Canada. The Chilean government has requested that the scope of the species eligible for export be expanded to include all bivalve shellfish.
The Government of Canada conducted an audit of the Chilean shellfish sanitation program at the request the Chilean Government from March 5 to 15, 2018. The audit was led by the Canadian Food Inspection Agency and included team members from Fisheries and Oceans Canada and Environment and Climate Change Canada. Harvest area controls and harvest area classification elements were assessed by specialists from Fisheries and Oceans Canada and Environment and Climate Change Canada respectively. The remaining shellfish program elements were assessed by Canadian Food Inspection Agency specialists.
The audit began with an opening meeting held in Valparaiso, with the participation of representatives from Chilean competent authorities including; SERNAPESCA, Ministry of Health (MINSAL), and the auditors from the Government of Canada. The field portion of the audit was conducted in the Los Lagos region where the majority of the export growing areas and processing establishments are located.
The official title of the Chilean shellfish program is the PSMB and will be referred to as PSMB hereafter. This is the first audit of the Chilean PSMB by the Government of Canada.
2. Audit objective, scope and methodology
The objective of this audit was to determine if the Chilean bivalve mollusc sanitation program provides an equivalent level of health protection to that provided by the CSSP and the Canadian QMP.
The scope of the audit included the whole bivalve mollusc production chain for products intended to be exported to Canada, in particular:
- growing area classification
- harvesting controls
- vessel controls
- landing areas
- processing establishments
The process included a review of relevant regulations, methods of implementation, site inspections, observation of establishment conditions, Chilean verification activities, general level of operator compliance with Chilean food safety requirements, and subsequent corrective and follow-up actions.
The audit was conducted by assessing the implementation of the Chilean PSMB and inspection of Quality Assurance Programs (QAP) by the SERNAPESCA as described in their Food Safety and Certification Manual (English only). In addition, the auditors noted any areas where the Chilean program differed from the CSSP and the QMP. If there were significant differences, an assessment was made to determine if the Chilean program provides the same level of public health protection as that provided by the CSSP and the QMP. The audit was conducted using standard audit techniques of document review, interview and observation. The Chilean Food Safety and Certification Manual was the primary document used to conduct the audit.
|Competent authority visits||No.||Locations and/or comments|
|Competent authorities - National||1||Valparaiso, Santiago (closing meeting)|
|Competent authorities - State/regional||1||Puerto Montt|
|Laboratories||3||Puerto Montt/Puerto Varas area, Chiloé Island|
|Harvest areas||4||Puerto Montt area, Chiloé Island|
|Processing establishments||5||Puerto Montt area, Chiloé Island|
3. Legal basis for the audit
The audit was conducted under the authority of:
- the Canadian Fish Inspection Act and Regulations, specifically the requirements in section 6(1) (b) which states:
No person shall import, export or process for export or attempt to import, export or process for export live oysters, clams, mussels or other molluscs (except scallops) or raw products derived therefrom, whether frozen or unfrozen, unless the President of the Agency is satisfied on the basis of information submitted to him that the waters from which such shellfish are taken and the premises in which they are handled and processed are of such a nature as will ensure that the shellfish are wholesome.
- the Canadian Food and Drugs Act section 4(1) which prohibits the sale of food that:
(a) has in or on it any poisonous or harmful substance
(b) is unfit for human consumption
(c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance
(d) is adulterated
(e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions
4.1 Program design
Chile's shellfish sanitation program requirements are outlined in the SERNAPESCA's Food Safety and Certification Manual. The manual is divided in 4 parts with the majority of the requirements for the PSMB found in part II – Standards and Procedures. Shellfish classification and monitoring of harvest area requirements are contained in section I (Control of Harvesting) while processing requirements are contained in section II (Process Control). Other requirements with respect to authorized samplers, laboratories, inspection, and export certification can also be found in the manual.
Classification of shellfish harvest areas is based on the European Union model which classifies areas into category A, B or C depending on results of E. coli testing in bivalve mollusc flesh and shoreline sanitary surveys. This approach is different than the Canadian model which classifies shellfish harvest areas as approved, conditionally approved, restricted, conditionally restricted or prohibited depending on the results of fecal coliform levels in water samples and shoreline sanitary surveys.
Processing establishments that export must have a QAP which is based on Hazard Analysis Critical Control Points (HACCP) principles. The SERNAPESCA approves theoretical establishment QAP programs based on a satisfactory independent evaluation. The initial on-site certification audit is conducted by an independent evaluator in conjunction with a SERNAPESCA inspector.
Control of export is maintained through a rigorous certification program administered by the SERNAPESCA. Details of the requirements for certification are described in part II; section III (Export and Certification Control) of the Food Safety and Certification Manual.
4.2 Production and trade information
Chile has approximately 800 shellfish concessions (leases) located in 129 shellfish areas which are covered under the PSMB. The majority of the shellfish areas and aquaculture production are located in the Los Lagos Region. Chile exports over 77,000 tons of various forms of cooked mussels (Mytilus chilensis). Product forms include fully cooked and frozen; mussel meats, whole in shell mussels and, half shell mussels. Products cooked in shell or on the half shell may have different sauces included depending on the product line. Top export markets include the European Union, Russia and many Asian countries. Currently, only a small fraction of the total production is exported to Canada.
There are 55 shelfish processing establishments that operate under the PSMB program.
- 5. Findings
- 5.1 Regulatory foundation
- 5.2 Government oversight
- 5.3 Shellfish inspection and control program
- 5.4 Food related illness and outbreak investigation
- 5.5 Laboratory controls
5.1 Regulatory foundation
Chile's legal framework for food safety is based on the Health Code of 1967, the Sanitary Regulation of Foods (August 6, 1996) and the decree with force of law of 2005. The MINSAL is responsible for overall public health in Chile through monitoring of domestic and imported foods. This is achieved by national surveillance programs to detect any microbiological, chemical or physical hazards present in foods.
The SERNAPESCA's mission is to provide regulatory oversight and promote compliance to Chilean laws and export market requirements. The legal framework to control the harvest of wild and aquaculture shellfish and export area controls are found in the General Law on Fisheries and Aquaculture and associated regulations. The licensing of fisheries and Aquaculture Concessions is carried out by the Undersecretariat for Fisheries and Aquaculture (SUBPESCA) under this legislation.
5.2 Government oversight
- 5.2.1 Organizational structure
- 5.2.2 Program resources
- 5.2.3 Training
- 5.2.4 Program assessment/audit
- 5.2.5 Industry, community, and international relations
5.2.1 Organizational structure
Chile's oversight of food safety is divided amongst 3 ministries depending on the commodity and whether the food is produced and consumed domestically, imported or exported. The MINSAL is responsible for oversight of imported food and food produced for domestic consumption. For bivalve molluscs, the MINSAL maintains a domestic biotoxin surveillance programs and works closely with the Ministry of Economy, Development and Tourism (through the SERNAPESCA) to share biotoxin results obtained by PSMB monitoring activities. The Ministry of Navy has oversight of all activities in marine waters including illegal harvesting activities and enforcement of emergency harvest closures. The Chilean National Police, the Carabineros, assist with enforcement activities on land. The SERNAPESCA works collaboratively with both the Navy and Carabineros to achieve compliance and enforcement objectives where required.
Responsibility for oversight of export of bivalve molluscs lies within SERNAPESCA. Three sub-directorates of the SERNAPESCA (Aquaculture, Fisheries and Foreign Trade) participate in principal oversight activities which include:
- authorization and inspection of processing establishments
- administration of the PSMB
- maintenance and distribution of PSMB growing areas activities and status
- oversight of laboratories providing services for the PSMB in conjunction with Instituto National de Normalizacion (INN)
- training and oversight of authorized PSMB samplers
- export certification
- compliance inspections of wild and aquaculture fisheries
5.2.2 Program resources
The SERNAPESCA has nearly 1000 employees of which 150 are official inspectors. There are 20 inspectors directly involved in the PSMB activities on a regular basis.
Sampling to support implementation of the PSMB is conducted by authorized trained samplers. As of January 15, 2018, there were 35 authorized samplers of which 14 are active.
Analytical support for the PSMB is delivered by International Standards Organization (ISO)-17025 accredited laboratories that are authorized by the SERNAPESCA to perform testing under the program. The SERNAPESCA employees audit these laboratories on a yearly basis to determine compliance to the requirements found in Part II: Section IV of the Food Safety and Certification Manual. Through this control program the SERNAPESCA has access to a network of private, university and state laboratories that comply with program requirements. There are approximately 25 laboratories in this network that are authorized and included on the list of analytical entities.
The National Direction of the Civil Service has an online portal of public jobs which are open and allow public servants and citizens to apply for employment. The SERNAPESCA uses this website to publicize its vacancies and job opportunities. A current posting for an inspector position was reviewed. It stated that the educational requirements for the position were a Professional Title of Doctor of Veterinary Medicine, Food Engineer or related professional degree of at least 10 semesters of duration (Fisheries Engineer, Chemist, Biochemist, Environmental Engineer).
The inspectors interviewed possessed a degree in either Food Engineering or Veterinary Medicine. After the hiring process new SERNAPESCA inspection personnel receive basic training for a period of 3 to 6 months. The 120 hours of training cover all aspects of food safety related to the shellfish program including:
- act and regulations
- soft skills
- comprehensive audit model
- organoleptic evaluation
An inspector in training also shadows a senior inspector in the establishment during inspections. The basic training must be completed prior to performing inspections independently. The trainee is authorized to conduct inspections independently when basic training is complete.
Continuing training is provided when required by the nature of the inspection task assigned to the inspector (for example, HACCP/QAP, sampling, and commodity/process specific training). Continuing training needs are discussed between the supervisor and the inspector during regular meetings. In-class training can be given by the SERNAPESCA or by a third-party company.
All training records are kept in the regional office. These records included the nature of training and the signature of the employee and director. The training file for a randomly-selected inspector was reviewed. The file showed the training activity, the date, whether it was completed successfully, and the signature of the director and trainee. The training records for all inspectors are available for public viewing online.
Observation and interviews of the SERNAPESCA inspectors indicate that the training program adequately prepares them to perform their duties in the processing facilities.
184.108.40.206 Authorized samplers
Authorized PSMB samplers are required to take a SERNAPESCA training course which consists of 32 hours of classroom and practical training. At the end of the course, participants are administered a test. They are required to achieve a score of at least 60% in order to be recognized as a PSMB sampler. Samplers are certified for a period of 10 years and are required to carry their sampling identification at all times when conducting sampling activities. The SERNAPESCA inspectors accompany authorized samplers once a month to confirm samples are being collected according to PSMB procedures.
220.127.116.11 Laboratory staff
Laboratory staff training is performed in order to comply with the requirements of Section 5.2 Personnel of the ISO 17025 Standard. Subsections 5.2.1 to 5.2.5 cover various aspects related to the training of laboratory staff. In summary, laboratory management is responsible for the supervision and competence of staff. They demonstrate this by ensuring:
- staff performing specific tasks are qualified
- staff qualifications are based on education, training, experience and skills
- goals with respect to education, training and skills are set for staff
- the laboratory has policies and procedures to identify training needs and provide training to staff
- the effectiveness of training is evaluated
- any person working in the laboratory does so in accordance to the laboratory's management system
- current job descriptions of staff are maintained
- specific personnel are authorized to perform specific tasks.
- records for all of the aforementioned requirements are maintained and readily available and include the date on which the authorization/competence is confirmed
Laboratory staff is supervised and receives internal training as well as external training as determined by the laboratory's specific needs. These training records are verified by both the accrediting body of Chile, the INN and the SERNAPESCA on a yearly basis during their respective audits.
5.2.4 Program assessment/audit
The Chilean PSMB was assessed by audit teams from the European Union in 2010 and 2013. Since 2010, 8 internal PSMB audits have been conducted, 7 of which were at regional/local offices and 1 at the central office in Valparaiso.
The PSMB laboratories are assessed and accredited by the INN for compliance to the ISO 17025:2005 standard. The PSMB laboratories are also assessed by the SERNAPESCA inspectors on annual basis for compliance to the PSMB requirements.
5.2.5 Industry, community, and international relations
The SERNAPESCA's Foreign Trade Sub-directorate participates in the Codex Committee on Fish and Fishery Products. This committee is responsible for the maintenance and updating of the Standard for Live and Raw Bivalve Molluscs (CODEX STAN 292-2008). The SERNAPESCA also participates on the Codex Committee on Methods of Analysis and Sampling and the Committee on Food Import and Export Inspection and Certification Systems.
The SERNAPESCA participated in the International Conference on Molluscan Shellfish Safety 2015 in Puerto Varas, Chile, and also in the International Conference on Molluscan Shellfish Safety 2017 in Galway, Ireland, from May 14 to 18, 2017.
On a national, regional and local level multiple efforts are made to ensure continued education and awareness of shellfish sanitation issues.
At the national level, the PSMB professionals participate in an inter-sectorial working group which is comprised of staff from the SERNAPESCA, the SUBPESCA and the MINSAL. There is also a public red tide contingency working group comprised of the SUBPESCA, the MINSAL, the SERNAPESCA, the maritime authority (General Directorate of Maritime Territory and Merchant Marine of Chile), and the Superintendent of Environment.
At the regional level meetings and working groups are held upon request. A regional red tide contingency working group is formed when necessary which has the same structure as the central working group.
At the local level, multiple meetings have been held in 2018 with interested stakeholders to keep them advised of the PSMB activities and requirements.
5.3 Shellfish inspection and control program
- 5.3.1 Harvest area classification
- 5.3.2 Harvest area controls
- 5.3.3 Processing establishment controls (HACCP)
- 5.3.4 Microbiological testing programs
- 5.3.5 Marine biotoxin and chemical testing programs
5.3.1 Harvest area classification
The PSMB requires that extraction (harvest) areas are classified based on an assessment of sanitary risks posed by sources in the adjacent watershed, complemented by a rigorous sampling of shellfish from the extraction area. The results of the sanitary survey and the initial sampling inform the classification decision.
Upon application for a new harvest site, a classification program must be implemented within 16 weeks. This includes a comprehensive sanitary survey of the area and weekly sampling of shellfish in the area for microbiological contaminants, marine biotoxins and phytoplankton. Sampling for chemical analysis is conducted once during the initial 16 week classification period. Sampling and the coastline survey is conducted by certified independent sampling entities, under the oversight of the SERNAPESCA.
The survey report documents the meteorological, hydrological and tidal conditions at the time of survey, the estimation of drainage flow at each source and, and where applicable, the microbiological results of surface water samples collected of the source.
Extraction areas are classified as A, B or C:
Minimal contamination risk; live bivalve molluscs may enter the market for direct human consumption or exported live, fresh chilled or processed.
Marginal contamination risk; live bivalve molluscs must be purified, relayed or thermally treated prior to consumption.
Significant contamination risk; live bivalve molluscs must be subjected to extended relay periods or approved thermal processes
Once classified, the extraction area is routinely monitored as outlined in table 2. Each classification type includes a number of microbiological, biotoxin and chemical standards as detailed in table 3.
|E. coli and Salmonella||X|
|Norovirus (oyster areas only)||X|
|Chemicals and pesticides||X|
|Dissolved oxygen and salinity||X|
|Bacteria, virus, biotoxin or chemical||Standard|
|E. coli (type A areas)||230/100g|
|Salmonella||absent in 25g|
|Vibrio parahaemolyticus||absent in 25g|
|Norovirus (oysters only)||absent in 15g of hepatopancreas|
|Paralytic shellfish poison||80ug/100g|
|Amnesic shellfish poison||20ug/g|
|Lipophilic toxins (diarrhetic shellfish poison) -
okadaic acid, dinophysistoxins and pectenotoxin
|Lipophilic toxins (diarrhetic shellfish poison) -
|Lipophilic toxins (diarrhetic shellfish poison) -
|Pesticides - halogenated organic Compounds||none detected|
18.104.22.168 Sanitary surveys
The growing area classification component involves sanitary surveys and routine monitoring in the extraction (harvest) areas. The objectives of the sanitary survey include:
- identify and evaluate actual and potential sources of pollution along the coastline adjacent to the extraction area
- determine the distance between the pollution source and the extraction area
- identify the presence of animals, both domestic and wild, resident and migratory, as well as human populations along the adjacent coastline
- document and evaluate any other additional sources of information relevant to the sanitary conditions of the harvest area
Shoreline inspection reports were provided for the coastline adjacent to the 4 extraction areas visited. Each survey was performed by an authorized sampling entity. Surveys were conducted of Bahía Huelmo in 2013 and 2017, and Bahía Huenquillahue in 2013 and 2016. Survey updates of La Planchada (Isla Quinchao) and Punta Pullao was conducted in 2013, while re-evaluation surveys of these same 2 sites was completed in 2017.
With the exception of the very brief 2013 update inspection reports for La Planchata and Pullao, the reports produced were thorough and detailed. The most recent reports for these areas produced in 2017 were very comprehensive. Each survey identified direct and indirect, and actual and potential sources of sanitary contamination along the shoreline and within the immediately-adjacent watershed. Key sites were photographed, samples from freshwater streams were collected and surface water flows were measured. E. coli results were documented and provided an indication of sites of greatest contamination risk. The location of E. coli sampling sites on the aquaculture concessions were determined as being in closest proximity to the sites of greatest sanitary risk on the adjacent shoreline.
Sanitary surveys were conducted during specific periods ranging from 1 to 6 weeks, depending on the area. As noted earlier, subsequent classification sampling of the extraction areas is conducted over an extended period. It did not appear that the shoreline source sampling was repeated over various environmental conditions in all areas, particularly after periods of significant rainfall. It is suggested that as a best practice, the SERNAPESCA consider developing an alert system for harvesters where extraction areas are particularly susceptible to increased sanitary contamination following periods of heavy rainfall or significant weather events (for example, once-in-two-year storm recurrence). As an alternative to closure of the potentially-impacted concessions, companies would be encouraged to postpone harvesting for a short period until the contamination risk has passed.
22.214.171.124 Authorized samplers
As of January 15, 2018, 35 SERNAPESCA certified samplers work for 8 recognized sampling entities. Samplers are trained by the SERNAPESCA staff according to established training and examination programs, and all must carry identification cards. Certification is valid for a period of 10 years. To ensure continuity and chain of custody, the ID cards are presented for inspection to obtain a daily sampling requisition from the SERNAPESCA, to the company providing transport to the sampling site(s) and at the receiving laboratory. Samplers are usually transported to the sampling site by the operator and may be accompanied by a SERNAPESCA officer for auditing purposes.
For microbiological sampling, the routine location is established by the SERNAPESCA as the highest risk in terms of proximity and magnitude of potential contamination from land-based sources. Biotoxin and phytoplankton may also be collected at this site or at another location within 100 metres. On mussel production sites, the company employee lifts the mussel lines for sample collection by the certified sampler. Shellfish samples are collected from the upper, mid and lower portions of the mussel line to a minimum quantity of 200g of flesh. All samples are labelled with the registration number, date, time and location.
Samples are transported to the laboratory within prescribed time limits; otherwise they are rejected by the lab and reported to the SERNAPESCA.
The authorized sampler program appears to be robust and well-implemented. Effective controls are in place to ensure the integrity of the sampling program and chain of custody of the samples. The SERNAPESCA maintains effective oversight of the program through regimented training programs, sampler certification and routine on-site observation of the sampling activities, usually on a monthly basis.
126.96.36.199 Wastewater systems
The risk of contamination of bivalve shellfish from enteric viruses in human sewage is a significant food safety concern. Common sources of contamination include untreated sanitary discharges from vessels, non-existent or failing on-site septic systems of shoreline residences, and municipal wastewater treatment and collection systems. To gain familiarity with the nature of urban wastewater systems that discharge to marine areas, the Canadian audit team visited a local wastewater treatment plant serving Castro, Chiloé.
The Castro wastewater treatment plant (Planta de tratamiento de aguas servidas - PTAS), like all municipal wastewater systems in the Los Lagos Region, is managed and operated by a private company, under the oversight of the Superintendencia de Servicios Sanitarios (the federal regulatory agency responsible for sanitary wastewater facilities for Chile), who set requirements for system operation and regulatory limits for effluent quality. Any occasion when specified effluent quality limits are exceeded are noted as infractions and subject to fines. Under the transparency policy of the Chilean government, all conformance data is publicly available.
The Castro PTAS serves a population of approximately 55,000 persons, collecting combined sewage as well as industrial waste from a nearby salmon feed facility. The average flow is 6,000 m3/day with a peak flow of 160 litres/second. The PTAS provides secondary-level treatment through an extended aeration, activated sludge process. Influent is screened and greases and oils removed. Sludge separation in post-bioreactor effluent is clarified and separated. The final effluent is disinfected using monitored ultra-violet light. All key stages of the wastewater process are monitored on-site and remotely by staff of the private company managing treatment system. The facility is equipped with a backup power system in the event of a power failure which ensures continuity in operation. Wastewater pumping stations (plantas elevadoras de aguas servidas) on the collection system are also equipped with on-site backup power and redundant pumps to mitigate the risk of overflows of untreated sanitary sewage. The Castro PTAS discharges to Estero Chacra which is not an active shellfish growing area. Overall, the wastewater collection and treatment system in Castro was reliable, well-operated, and produced a high quality effluent. Monthly records provided by the Superintendencia de Servicios Sanitarios for 2017 indicated only 1 non-compliance in February.
The Canadian audit team understands that extraction areas used for exported product are remote from the influence of PTAS. Nevertheless, given the enteric virus contamination risk from partially-treated or untreated sewage, it is suggested that as a best practice, the SERNAPESCA, Superintendencia de Servicios Sanitarios and the wastewater system operators work together to develop an alert system to advise harvesters of planned or unplanned discharges of untreated or partially-treated sanitary waste. This is particularly important in oyster extraction areas that are susceptible to contamination by sewage.
5.3.2 Harvest area controls
188.8.131.52 Licensing and regulatory compliance
Licences are issued for aquaculture and wild fisheries by the SUBPESCA. These licenses allow aquaculture operators to grow and harvest farmed bivalves and wild harvesters to harvest from wild 'banks' of naturally growing bivalves. The harvested bivalve shellfish is authorized to be sold through processing establishments, which are in turn regulated to process shellfish for export markets.
Chilean laws, regulations and associated regulatory instruments appear to be comprehensive and allow for the effective management and oversight by the SERNAPESCA of all activities relating to the control of the harvest areas. Chilean laws and regulations are similar to Canadian ones for managing fisheries and aquaculture. The SERNAPESCA has different programs that conduct regulatory compliance activities (that is, foreign export, aquaculture, domestic fisheries), with comparable compliance and management outcomes to fisheries and aquaculture management in Canada.
Shellfish closures are administered by the MINSAL. Extensive communication processes are in place to ensure the public is aware of health risk associated with eating contaminated shellfish, especially marine biotoxins. For commercial aquaculture export areas, control is maintained by conducting rigorous sampling programs and, communicating the results to processing establishments via the official list of PSMB extraction areas. The official list includes information on the status of the area. Processing establishments are required through HACCP plans to monitor status of areas by reviewing the PSMB extraction area list on a regular basis.
In the event of an emergency closure for bivalve shellfish harvest due to biotoxins or other contaminants, SERNAPESCA works in collaboration with the MINSAL, the Navy and Carabineros to ensure harvest closures are enforced and unsafe shellfish does not enter the export process.
Legal consequences for regulatory non-compliance exist in the form of criminal penalties, fines and losing status as an export harvest area or processor. Industry representatives appeared to be very familiar with their regulatory and compliance requirements, indicating that the SERNAPESCA is effective in educating industry and in conducting compliance activities that hold industry accountable.
Traceability was evaluated through observation during harvest area and processing establishment visits, interviews and document reviews. There are 2 main means to achieve traceability of harvested shellfish. When harvesting is conducted by independent companies, they must first obtain a record of extraction and transport (Extraction and Transport Register for Bivalve Mollusks - RET) form from the SERNAPESCA that authorizes the extraction of the shellfish from the harvest area and the subsequent transport to the processing establishment. The RET is present at the harvest site and accompanies the product to the plant. Prior to the shellfish being accepted at the plant for processing, the RET is examined and verified, and is ultimately retained with the records at the processing establishment.
When harvesting is conducted by the processing establishment company as part of an integrated harvest-processing supply chain, a document similar to the RET is used called a Guia de dispatcho or Dispatch Guide. The accompanying SIVAXFootnote 1 system sticker provides additional assurances on traceability as it ensures that the document it is affixed to is the original. Tags and labels were also observed to be affixed to totes containing harvested mussels. The record keeping system was found to be very comprehensive from the harvest areas to reception at processing establishments.
184.108.40.206 Sanitary and chemical containment on vessels and work platforms
Chile has strict laws concerning the discharge of waste or contaminants to water and aquaculture areas. During visits to the harvest areas, the industry representatives present were fully aware of pollution prevention and legal requirements and were able to explain the mitigation measures in place to prevent pollution of the water and contamination of the shellfish. At the harvest areas observed, there were systems in place to allow employees to get to shore in order to use the washroom or in case of sickness. Larger harvest vessels were equipped with washroom facilities and contained non-discharging toilet systems. Fuel and hydraulic machinery on work platforms were equipped with spill containment to prevent contamination of the water. Although the risk of illness associated with fully cooked mussels is lower, the risk for partially cooked or products consumed raw (such as oysters) is higher. It is recommended that an education program be developed for harvest vessel workers in oyster extraction areas inform them of the risks associated with overboard waste discharge of infectious wastes (for example, sewage and vomitus).
5.3.3 Processing establishment controls (HACCP)
As described in the Chile Food Safety and Certification Manual Part II: Section II Processes Control, the QAP is based on the concept of HACCP. QAP is mandatory for all plants whose products are destined for export markets that require the production under the HACCP system as required by Canada. The SERNAPESCA is responsible for the evaluation of the application, document review, on-site verification and establishment certification. After certification, the SERNAPESCA continues to verify the on-site implementation of the QAP and HACCP controls every 2 months during visits to the establishment.
At each visit, the inspector prioritizes the verification of 1 production line and the corrective actions put in place since the last visit. The findings are recorded in a hardcopy checklist which includes sections on supervision of the QAP, Sanitation, and Pre-Requisite Programs. The checklist gives suggested items to review and provides guidance on classifying the severity of deficiencies. Currently, no IT system is used by the inspector to record the findings but the CCA plans to implement one in the future. The inspector notes the deficiencies and ranks their severity as minor, major, serious or critical in the checklist and a notebook. The number and severity of the deficiencies allows the inspector to decide if the establishment's QAP is approved or rejected. The checklist remains in the possession of the inspector and the notebook stays in the establishment. The notebook and the checklist contain the status of the corrective actions for the deficiencies from the previous visit and the deficiencies identified during the current visit. The notebook content is discussed and signed by the establishment representative and the inspector after every visit.
During the audit, shellfish processing activities were observed in all 5 establishments. All the establishments received live mussels from PSMB harvesting areas categorized as A and B. The establishments were QAP-certified and produced only ready-to-eat frozen fully cooked chorito products (blue mussels). No live or raw molluscs were produced and exported from these establishments at the time of the audit. The on-site visit, interview with the employees and review of the records related to the critical control point shows adequate controls over the HACCP and pre-requisites components. Logbooks at the establishments showed that inspections were conducted by the SERNAPESCA at the required minimum frequency of every 2 months. During the walkthroughs and record reviews the SERNAPESCA inspectors demonstrated a good knowledge of program requirements and the logbooks indicated that deficiencies were being identified and corrective actions followed up on as necessary.
5.3.4 Microbiological testing programs
220.127.116.11 Harvesting areas
The PSMB requires microbiological sampling and testing of shellfish flesh either as part of the initial classification of harvesting areas or as routine ongoing monitoring. For the initial classification, shellfish samples are analyzed for Escherichia coli (E. coli), Salmonella, and Norovirus (oysters only) for 16 consecutive weeks and Vibrio parahemolyticus every second week. Subsequent ongoing monitoring requires monthly sampling for E. coli and Salmonella in category A areas, monthly sampling for E. coli in category B areas, biweekly sampling for Vibrio parahaemolyticus in category A areas and weekly sampling for Norovirus in category A areas where oyster harvesting is occurring.
During this audit, microbiological data from 2015, 2016 and 2017 was reviewed for 4 harvesting areas in the Los Lagos region; Bahia Huelmo, Bahia Huenquillahue, La Planchada and Pullao. The data indicates that testing is being conducted at program design frequencies. It was noted that some shellfish growers will choose a downgrade in classification from A to B to avoid costs associated with conducting additional microbiological tests.
Bahia Huelmo and Bahia Huenquillahue are classified as category B areas and E. coli test results were within program norms. La Planchada and Pullao are classified as category A areas. For La Planchada, E. coli, Salmonella and Vibrio parahaemolyticus test results were with PSMB norms. For Pullao, test results for Salmonella and Vibrio parahaemolyticus were within PSMB norms, however, E. coli results exceeded program norms on 2 occasions. Follow up consecutive contingency sample results showed no ongoing contamination concerns.
18.104.22.168 Processing establishments
The microbiological, chemical and physical standards for each product in Chile are described Part II: Section II and III of the Food Safety and Certification Manual.
As audited, the operator must take monitoring samples of the finished product and the food contact surface each 15 days of production. The SERNAPESCA official microbiological testing program is performed on the finished products. When an official sample is scheduled to be taken, it's the responsibility of the operator to notify to the regional or local SERNAPESCA office of the date in which the sample must be sent to the verification laboratory, in accordance with the production days. The official sample is taken under the SERNAPESCA supervision and submitted to official laboratory for analysis.
One out of 4 operator monitoring samples become an official SERNAPESCA sample for frozen crustaceans, frozen-cooked molluscs, smoked fishery products, and ready-made meals. One out of 6operator monitoring samples become the SERNAPESCA official sample for chilled refrigerated-frozen fish, canned, salted, dried and dried-salted fishery products, frozen and preserved raw molluscs intended for human consumption.
For exportation, standards have to meet to obtain the SERNAPESCA authorization of shipment and sanitary certification for export products intended for human consumption. As an example, frozen cooked shellfish products has to be tested for marine toxins, total count, E. coli, Salmonella, Staphylococcus aureus and Listeria monocytogenes and the standards are specified by type of classification category of the harvesting area. In the processing establishments, all the raw primary material comes from harvesting areas included in the PSMB.
5.3.5 Marine biotoxin and chemical testing programs
22.214.171.124 Marine biotoxins
The PSMB requires weekly shellfish testing for marine biotoxins as well as water samples for phytoplankton analysis under routine conditions. Shellfish is tested for paralytic shellfish poison, amnesic shellfish poison and diarrhetic shellfish poison. The diarrhetic shellfish poison toxin group includes analysis for okadaic acid, dinophysistoxins, pectenotoxins, yessotoxins and azaspiracids. Water samples are examined for the presence of marine biotoxin producing phytoplankton such as Alexandrium catenella, Pseudonitzchia australis and Dinophysis acuta.
When the results of the monitoring programs detect the presence of Alexandrium catenella in qualitative water samples at a relative abundance level of 2 or higher and there is no evidence of the presence of toxins in the flesh samples, an intensive sampling process is applied. If the results of the monitoring programs show evidence of Pseudonitzchia australis levels with an abundance over 65% of all the species present in the phytoplankton sample, an intensive sampling is applied. If Dinophisis acuta is detected in the results of the monitoring program, without detecting toxins in flesh samples collected on the same date, an intensive sampling procedure is applied. Intensive sampling requires phytoplankton and marine toxin analysis every 2 days from the affected area.
For marine biotoxins, intensive sampling is applied when the results indicate the presence of paralytic shellfish poison at levels equal to or lower than 80 ug/100g, amnesic shellfish poison equal to or less than 20 ug/g, and/or some of the toxins of the lipophilic group below the limits. The intensive sampling will continue until obtaining 2 consecutive results where the presence of the biotoxin is not detected in the shellfish and of the causal agents in the water samples.
During this audit, marine biotoxin and phytoplankton data from 2015, 2016 and 2017 was reviewed for 4 harvesting areas in the Los Lagos region; Bahia Huelmo, Bahia Huenquillahue, La Planchada and Pullao. It was noted that water and shellfish sampling is not conducted if there is no harvesting occurring.
Shellfish samples were taken in all 4 areas at the program design frequency. Contingency sampling was initiated in all 4 areas several times in response elevated biotoxin and/or phytoplankton levels. The only time the biotoxin levels exceed program standards was in December of 2015 when yessotoxins reached 667 mg/kg in Bahia Huenquillahue.
126.96.36.199 Chemical testing
Pesticides and heavy metal data from 2015, 2016 and 2017 were reviewed for the same 4 harvesting areas as the marine toxins. The PSMB is required to monitor for heavy metals (Cadmium, Lead, and Mercury) and halogenated organic compound pesticides at a rate of 2 samples per year. Documentary evidence for the 4 growing areas reviewed indicates that samples are being collected at the planned frequency except for Bahia Huelmo in 2017 and Bahia Huenquillahue in 2016 which were only sampled once in those years. All results were negative for pesticides. The heavy metals results were low and below Chilean norms. In conclusion, the sample results for pesticides and heavy metals do not indicate any food safety concerns.
5.4 Food related illness and outbreak investigation
The MINSAL responsible for ensuring food safety and, for regulating international trade of food products. The MINSAL is also responsible for performing epidemiological investigations of disease outbreaks of food origin in accordance with the Regulations on Compelling Declaration of Transmissible Diseases.
Notification of noticeable diseases must be made to the Ministerial Regional Secretariat of Health of the corresponding jurisdiction or the corresponding Provincial Office, in accordance with the provisions of the Regulation or, as directed by the MINSAL's Department of Epidemiology. The Department of Epidemiology conducts an epidemiological investigation and informs other MINSAL departments and the health care network of the outcome. The MINSAL uses these findings to develop prevention and control measures which are implemented by the Ministerial Regional Secretariat of Health of the corresponding jurisdictions. For example, public communication of the food safety risk through the press, monitoring of regional epidemiological data, and product recall. The MINSAL oversees product recalls.
The MINSAL staff stated that they recalled 1 case where illness had been linked to exported product. In that case the product was recalled and subsequently destroyed.
Interviews with the SERNAPESCA staff revealed that they are knowledgeable of the MINSAL's role and they stated that any illness complaints received by an establishment must be immediately reported to the SERNAPESCA which would then report to the MINSAL through established channels. The QAP system of each establishment includes a traceability system, and requirements for distribution information to be provided within 48 hours if requested by the SERNAPESCA.
No specific cases of food borne illness were available for review, but interviews and program review indicate there is a structured system in place to detect and follow up on food borne illnesses.
5.5 Laboratory controls
The standards and procedures used to manage the system of laboratories authorized by the SERNAPESCA are described in their Food Safety and Certification Manual. Both Spanish and English versions of the manual are available online for consultation. The laboratory component of the PSMB is described mainly in Part II: Section IV: Authorization and Control of Analysis and Sampling Entities and Samplers.
Laboratories that are part of the Export Fishery Certification System of the SERNAPESCA are accredited to the ISO 17025 standard by the INN and are recognized by the Public Health Institute. The INN produces certificates of accreditation and performs scheduled audits to ensure laboratories are meeting the requirements of the ISO 17025 Standard. The SERNAPESCA also performs laboratory audits to verify that program requirements/elements are being met.
Under the PSMB program, authorized laboratories perform the following analyses:
- microbiological testing for classifying and monitoring of production areas
- marine biotoxin testing for product destined for human consumption
- phytoplankton testing for classifying and monitoring extraction areas
Three laboratories, each representing 1 type of testing area as indicated above, were visited and assessed for compliance to PSMB requirements. The following program elements were verified:
- the accreditation status of each laboratory
- the recognition as Public Health Food Science Laboratories
- the educational and experience requirements for personnel directing the laboratories
- the proficiency testing requirements
- requirements for reports of analysis
- usage of required marine biotoxin, phytoplankton and microbiological analysis methods
The accreditation certificate and scope of methods of each laboratory was found to be valid. The official letter was also available and presented as evidence of recognition as a Public Health Food Science Laboratory. Personnel directing laboratories had university degrees (BSc, MSc, PhD) with significant years of experience. The laboratories participated in proficiency testing schemes and all elements required on the reports of analyses were present. The methods on the scopes of each laboratory conducting marine biotoxin, phytoplankton or microbiological analysis were the official methods recognized by the SERNAPESCA.
In addition, the following ISO 17025 accreditation requirements were verified at each of the 3 laboratories visited:
- laboratory quality manual
- audit reports from the accrediting body (INN)
- audit reports from SERNAPASCA
- internal audit reports
- management review reports
- control of non-conforming work
- document control
- staff training program and records
- testing facilities and environmental conditions
- analytical methods and records
- equipment verification and usage records
- proficiency testing results
- reporting of results
As required by the 17025 Standard, all laboratories have a quality manual and certain elements within the manual were chosen at random for verification during the visit. Audit checklists and final reports from both the INN and the SERNAPESCA were reviewed and determined to contain all the necessary elements of the standard and program requirements. In other words, there is evidence that all aspects of the management as well as the technical requirements of the standard and the program are being audited through established processes and at a scheduled frequency.
The respective laboratories are performing internal audits, management reviews and have staff training programs. Evidence of these elements, related to management requirements, was verified and confirmed through the on-site revision of associated documents (standards of procedure, policies) and records (completed checklists, forms).
Procedures and records associated with participation in proficiency testing schemes, handling of testing equipment, verification of environmental testing conditions and facilities were also verified on-site and provided sufficient evidence that these aspects were under the laboratories' control and taking place within the respective quality system of each laboratory.
A technical evaluation of several testing methods was also conducted. This consisted of ensuring the required methods were being used, document control policies/procedures were being respected and laboratory staff could adequately describe and/or demonstrate certain steps of the methods.
A traceback activity which consisted of reviewing records associated with the analysis of a sample from start to finish was conducted. The traceback included looking at sample reception, handling, analysis as well as the equipment and media used, the reporting and authorization of results and ended with sample disposal. The records reviewed provided sufficient information to get a clear idea of all laboratory processes related to the treatment of a sample from start to finish.
Based on the evidence collected and reviewed prior to and during the on-site visit, the following can be concluded about the laboratory controls:
- the SERNAPESCA provides program and laboratory oversight as described in the Food Safety and Certification Manual, Part II, Section IV
- the INN is the Chilean accreditation body that has established policies and practices to competently oversee laboratory accreditations to the ISO 17025, General requirements for the competence of testing and calibration laboratories
- the laboratories are following the program and accreditation requirements to assure the quality of testing results
In addition, the following observations were made during the visit:
- There appears to be good communication and interaction between the SERNAPESCA and authorized testing laboratories
- All of the SERNAPESCA and laboratory staff were very cooperative, patient and willing to engage in open discussion on program and laboratory requirements, processes and practices
6. Closing meeting
The closing meeting was held in Santiago on March 15, 2018 at the SERNAPESCA. It was attended by the Government of Canada audit team and representatives of the SERNAPESCA. The audit team thanked the staff of the SERNAPESCA for their efforts in logistical planning, responsiveness to requests, provision of translators, and professionalism during the audit process. The findings and recommendations were presented by the audit team. The team indicated that the draft audit report would be available approximately 60 days after the closing meeting.
7. Conclusions and recommendations
Overall, the Chilean PSMB is delivered by a highly qualified professional team in a comprehensive manner. Regional and local SERNAPESCA staff were very capable and knowledgeable of the program operations in their geographic areas of responsibility. There are many examples where the program is delivered at an exceptional level. The most notable are:
- the amount of samples collected and analysed for the program
- the level of oversight by the SERNAPESCA
The growing area classification component of the CSSP is a water quality-based program whereas the PSMB relies on testing of shellfish. However, the 2 programs share a common approach for sanitary surveys, including coastline inspection and assessment of contamination sources. Overall, it is apparent that the integrity of the PSMB classification program provides an equivalent level of food safety assurance of product extracted from the harvest areas.
The audit team made 3 audit recommendations for consideration by the SERNAPESCA. These include:
1. Develop an alert system for harvesters where extraction areas are particularly susceptible to increased sanitary contamination following periods of heavy rainfall or significant weather events (for example, once-in-two-year storm recurrence). As an alternative to closure of the potentially-impacted concessions, companies would be encouraged to postpone harvesting for a short period until the contamination risk has passed.
2. Develop an alert system to advise harvesters of planned or unplanned discharges of untreated or partially-treated sanitary waste where extraction areas are located in the vicinity of sanitary wastewater treatment and collection systems. This is particularly important in oyster extraction areas that are susceptible to contamination by enteric viruses in sewage.
Harvest area controls – waste containment
3. Develop an education program for harvest vessel workers in extraction areas (notably oyster extraction areas) to inform them of the risks associated with overboard waste discharge of infectious wastes (for example, sewage and vomitus).
Annex 1: Summary of the Canadian Food Inspection Agency (CFIA) recommendations/findings from the Canadian Audit of the Chilean Bivalve Mollusc Sanitation Program Final Report - 2018
|No.||Canadian recommendations||SERNAPESCA action plans / comments|
|1.||Develop an alert system for harvesters where extraction areas are particularly susceptible to increased sanitary contamination following periods of heavy rainfall or significant weather events (for example, once-in-two-year storm recurrence). As an alternative to closure of the potentially-impacted concessions, companies would be encouraged to postpone harvesting for a short period until the contamination risk has passed.||An alert system for accidental contamination or natural phenomena is being developed including, among others, significant abnormal climatic events for the region, floods, discharges of domestic wastewater or from sewage treatment plants, spills or discharges of oil, petroleum or chemical products. The notification of said events will be made through the list of extraction areas published on the website of the Service. The procedure will include an evaluation of the event and possible contingency measures. During the last week of September a workshop will be held in the city of Castro with the inspectors of the Regional Directions of SERNAPESCA in order to agree on the procedures and protocols. The Food Safety and Certification Manual will be updated accordingly on October 2018.|
|2.||Develop an alert system to advise harvesters of planned or unplanned discharges of untreated or partially-treated sanitary waste where extraction areas are located in the vicinity of sanitary wastewater treatment and collection systems. This is particularly important in oyster extraction areas that are susceptible to contamination by enteric viruses in sewage.||An alert system for accidental contamination or natural phenomena is being developed including, among others, significant abnormal climatic events for the region, floods, discharges of domestic wastewater or from sewage treatment plants, spills or discharges of oil, petroleum or chemical products. The notification of said events will be made through the list of extraction areas published on the website of the Service. The procedure will include an evaluation of the event and possible contingency measures. During the last week of September a workshop will be held in the city of Castro with the inspectors of the Regional Directions of SERNAPESCA in order to agree on the procedures and protocols. The Food Safety and Certification Manual will be updated accordingly on October 2018.|
|3.||Develop an education program for harvest vessel workers in extraction areas (notably oyster extraction areas) to inform them of the risks associated with overboard waste discharge of infectious wastes (for example, sewage and vomitus).||
3. A chapter on good practices in harvesting operations will be included in the Food Safety and Certification Manual, considering the risks associated with the discharge of waste and biological material.
The trainings carried out to the operators of the PSMB areas will be audited through the checklist applied to the inspection of the area.
Easy to understand material for dissemination and downloadable documents will be published on SERNAPESCA's website, and relevant information will be included in the Manual in order to strengthen the training activities of the operators working in the extraction areas. This material will be available in October 2018.
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