Report of the Canadian assessment of Indonesia's Fish and Seafood Control Program - 2018
On this page
- Abbreviations and special terms used in the report
- Executive summary
- 1. Introduction
- 2. Audit objective, scope and methods
- 3. Legal basis for the audit
- 4. Background
- 5. Findings
- 5.1 Regulatory foundation
- 5.2 Government oversight
- 5.3 Export 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 Indonesia's Fish and Seafood Program draft report - 2018
Abbreviations and special terms used in the report
- Best Aquaculture Practices
- Badan Pengawas Obat dan Makanan (National Agency of Food and Drug Control)
- Competent Authority
- Canadian Food Inspection Agency
- Directorate General
- Fish Quarantine and Inspection Agency
- FQI SEL
- Fish Quarantine and Inspection Standard Examination Laboratory
- Foreign Verification Office
- Good Manufacturing Practice
- Hazard Analysis Critical Control Points
- Health Certificate
- International Standards Organization
- Komite Akreditasi Nasional (National Accreditation Committee)
- Listeria monocytogenes
- Ministry of Marine Affairs and Fisheries
- Proficiency test
- Quality Assurance
- Quality Control
- South East Asian Fishery Development Centre
- Technical Implementation Unit
- Unit handling and processing fish
- United States
- Vibrio vulnificus
This report describes an assessment of Indonesia's food safety system for fish and seafood. The Canadian Food Inspection Agency (CFIA) conducted the assessment in Java and Sumatra, Indonesia from November 25 to December 7, 2018.
The main goals of the assessment were to verify how the Indonesian competent authority's (CA) food safety controls:
- were applied to the production and export of fish and seafood products
- achieved outcomes to meet:
- Canadian import requirements
- Canadian public health expectations
The assessment included visits to:
- 2 national CA offices
- 2 regional CA offices
- 6 processing establishments
- 1 aquaculture site
- 1 port authority
- 1 regulated landing site
- 2 laboratories (1 national government and 1 private)
The assessment found that Indonesia has a system for the safe production and export of fish and seafood products in place. The system is generally being carried out as written by well-trained and skilled professionals at both the state and federal level.
The CFIA made several recommendations to enhance the existing program and how it's carried out. Including:
- consider making the health certificate (HC) process mandatory for all exports over time
- confirm authorities and processes to make sure traceback activities are conducted to find the root cause of food safety issues where possible
- make sure that stakeholders have access to and consider all Canadian import requirements
The observations and recommendations contained in this report are based on information gathered by the assessment team through the Canadian Assessment Standards tool, personal interviews, and on-site observation. They represent the collective understanding of the members of the assessment team.
The CFIA has a broad mandate that encompasses food safety, animal health, plant protection and international market access. The CFIA's main priority is preserving the health and safety of Canadians. The CFIA periodically conducts audits and assessments of the food control systems of Canada's foreign trading partners. This verifies that these countries have controls for the safe production of the foods they export to Canada. Such activities form part of developing and keeping relations to enhance food safety, where trade between Canada and an exporting country is ongoing.
In September of 2017, the CFIA's Foreign Verification Office (FVO) visited Indonesian fish and seafood establishments. During that visit, they identified several systemic food safety issues. These findings triggered the assessment of Indonesia's food safety controls for fish and seafood by the CFIA's Food Systems Evaluation unit.
The assessment was conducted in various locations in Java and Sumatra, Indonesia from November 26 to December 7, 2018. The assessment team consisted of a lead from Food Systems Evaluation and a Technical Specialist from the FVO.
2. Audit objective, scope and methodology
The objective of the assessment was to verify how the food safety controls:
- are applied to the production and export of fish and seafood products by the Indonesian CA
- achieve proper outcomes that meet Canadian
- import requirements
- public health expectations
The scope of the audit included:
- relevant national laws and provisions
- organisation of the official system of controls
- controls for the production of ready-to-eat (RTE) and non-RTE products
- shrimp/prawn, king fish, barracuda, tilapia, squid, red snapper, canned tuna and surimi
- controls for the exports of RTE and non-RTE products
- shrimp/prawn, king fish, barracuda, tilapia, squid and red snapper
The process included a review of information on the relevant laws, and the design of the food safety control program. The review was given to the CFIA by the Ministry of Marine Affairs and Fisheries (MMAF). An on-site visit was then conducted to verify the assessment team's understanding of the laws and program design. The on-site visit also checked how they were carried out by observing:
- verification activities conducted by the national and regional CAs
- establishment conditions
- general level of operator compliance with the program requirements
- corrective and follow-up actions
Information was collected at:
- 6 processing facilities (Unit Handling and Processing Fish; UPIs)
- 1 government laboratory
- 1 private laboratory
- a regulated landing site
- an aquaculture site
- presentations and interviews with representatives of the CA
(see Table 1)
|CA visits||Number of visits||Locations or comments or both|
|National representatives of the CA||2||MMAF and National Agency of Food and Drug Control (BPOM)|
|State/regional representatives of the CA||2||Technical Implementation Unit (TIUs) (Jakarta and Medan)|
|Port authority||1||Port authority for Jakarta|
|Laboratories||2||The National Reference Laboratory and 1 private laboratory|
|Landing site||1||Certified landing site for unloading fish|
|Processing establishments||6||Establishments of varying complexity and size|
|Aquaculture sites||1||Aquaculture site raising freshwater finfish|
3. Legal basis for the audit
This assessment was carried out in agreement with the Indonesian authorities. It was also carried out under the CFIA's legislative requirements for fish inspection as outlined in the Fish Inspection RegulationsFootnote 1 and the Food and Drugs Act. In particular:
- Section 6 (1) (a) of the Fish Inspection Regulations:
"No person shall import, export or process for export or attempt to import, export or process for export any fish that is tainted, decomposed or unwholesome or otherwise fails to meet the requirements of these Regulations."
- Section 4(1) of the Food and Drugs Act:
"No person shall sell an article of food that
- has in or on it any poisonous or harmful substance;
- is unfit for human consumption;
- consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance;
- is adulterated; or
- was manufactured, prepared, preserved, packaged or stored under unsanitary conditions."
Indonesia is a large country consisting of more than 17,000 islands. It has a total coastal length of more than 81,000 km. Fisheries resources represented 12.5 million tonnes in 2017. Aquaculture contributes 75% of the overall catch volume. In 2016, 16.67 million tonnes of aquaculture was harvested compared to 6.35 million tonnes for wild capture.
The establishments visited have modern and highly sophisticated systems for the safe production of the products exported. They range from small to medium family-owned operations, to very large multi-national operations that produce multiple tonnes of product per day. All establishments visited (referred to hereafter as a UPI) have at least 1, if not multiple, third party certifications. These certifications include:
- food safety
- British Retail Council
- Best Aquaculture Practices (BAP)
- social responsibility
- Business Social Compliance Initiative
- Initiative Clause Sociale
- quality management certifications
- International Standards Organization ISO 9002:2008, ISO 22000:2005
At the time of the assessment there were about 750 certified UPIs located across 34 provinces. MMAF regulated 102 UPIs on Java and 72 on Sumatra.
While the domestic market consumes 90% of total production, Indonesia is actively working to expand their export markets. Indonesia exports both RTE and non-RTE fish and seafood products to Canada. The top products imported are: shrimps, fish meat, tilapia fillets and crab. Products exported to Canada are from aquaculture and wild capture sources (both marine and freshwater). Data available at the time of planning the on-site audit indicated that Indonesia was the 13th largest exporter of fish and seafood products to Canada. In 2017, Canada imported 3,745,648 kg of Indonesian fish and seafood products valued at $47.4 million CAD (Statistics Canada).
Many issues were associated with fish and seafood products exported from Indonesia to Canada from 2014 to 2018. These included issues related to:
- the presence of:
- chemical additives
- microbiological hazards
- various other regulatory violations
5.1 Regulatory foundation
Indonesia's legal framework and foundation consists of:
- Food Law No. 18/2012
- regulations (governmental, presidential, ministerial and partner country)
- Government Regulation No. 69/1999 on Food Labelling and Advertisement (now under revision)
- Government Regulation No. 28/2004 on Food Quality, Safety and Nutrition (now under revision)
- decrees (ministerial, head of the Fish Quarantine and Inspection Agency (FQIA) of the MMAF)
- standard operating procedures
(see Table 2)
Government Regulation Number 28/2004 assigns the responsibility for the control and supervision of food safety (at various points in the food chain) to specific agencies. For example, the Ministry of Agriculture and MMAF are responsible for agricultural products and post-harvest products. The Ministry of Industry, Ministry of Trade, MMAF and BPOM are responsible for manufactured and processed foods. Products in distribution are overseen (depending on the point of distribution) by the:
- Ministry of Industry
- Ministry of Agriculture
- Ministry of Health
- Provincial or District government
The Ministry of Industry decrees establish Good Manufacturing Practices (GMP) requirements and licenses operators.
Fisheries Law No. 31/2004 (amended by Law no. 45/2009) gives MMAF the responsibility for the management of the fisheries resource base. Government Regulation 57/2015 sets out the Quality and Safety Assurance System. Government Regulation 28/2017 assigns authorities for aquaculture.
The National Agency of Drug and Food Control BPOM Decree No. 22/2017 gives BPOM authority for:
- the safety of processed foods
- food and drug safety investigations
- related to medium and large enterprises handling high risk foods
- the Ministry of Health is responsible for small and medium ones who handle low risk foods
- related to medium and large enterprises handling high risk foods
|Fisheries Law No. 31/2004 (amended by Law no. 45/2009)||Management of fisheries
|Law of The Republic of Indonesia No. 16/1992||Animal, fish and plant quarantine|
|Health Law No. 36/2009||Management of health|
|Food Law 18/2012||Regulation of food|
|Civil Law 31||Authority to destroy product|
|Criminal Act 80||Authority to destroy product|
|Government Regulation No. 28/2004||Food safety, quality, and nutrition
|Government Regulation No. 57/2015||System of quality assurance and safety of fishery products, and enhancement added value of fishery products
|Government Regulation No. 28/2017||Aquaculture|
|Government Regulation No. 69/1999||Food labelling and advertisement|
|MMAF Regulation PER 19/MEN/2010||Official Control on System of Quality Assurance and Safety of Fisheries Product
|MMAF Regulation No. 39/PERMEN-KP/2015||Residue control of fish medicines, chemical and contaminants in edible fish aquaculture|
|Ministerial Decree No. KEP 52A/MEN/2013||Requirements for quality and safety assurance system of fishery products during production, processing and distribution|
|Decree of the Director General of FQIA No 59/KEP-BKIPM/2016||Assigns duties to regional FQIA staff related to HCs (including sampling, surveillance and issuance)
Conducted using procedures outlined in a series of Technical Guidelines (has country-specific requirements)
|Ministerial Regulation No. 54/PERMEN-KP/2017||Authorities for service units (TIUs) to conduct activities for:
|Ministerial Regulation 74/2016||National import control policy|
|Regulation 3/2011 Attachment 3||Requirements for quality inspectors|
|Decree 12/KEP-BKIPM/2017||Appointment of fish inspectors|
|Decree of the Ministry of Industries||GMPs|
|Head of BPOM decree No. 22/2017||Product recall|
The Arrangement on the Mutual Recognition of Fish and Fishery Products Inspection and Control Systems Between the Canadian Food Inspection Agency and the Directorate General of Capture Fisheries of the Department of Marine Affairs and Fisheries of the Republic of Indonesia gives the MMAF the authority to require establishments exporting to Canada to:
- be registered under a Hazard Analysis Critical Control Points (HACCP)-based integrated quality management program
- comply with Canadian product standards and labelling requirements
Indonesia has a legal framework that lets regulatory authorities carry out and oversee a national food safety control program for fish and seafood products destined for Canada.
5.2 Government oversight
5.2.1 Organizational structure
The MMAF is the key CA responsible for the safety of fish and fishery products. MMAF directorates with responsibilities for fish and seafood safety include:
- Directorate General (DG) FQIA
- Centre for Fish Quarantine
- Centre for Quality and Safety Control
- Harmonization and Investigation
- Surveillance and Product Certification
- Inspection and Traceability
- Centre for System Standardization and Compliance
- Capture Fisheries (DG Capture)
- Aquaculture (DG Aquaculture)
- Product Competitiveness (DG Product Competitiveness)
In general, the FQIA carries out the QC systems related to fish processing for export. This is achieved through mandatory HACCP implementation (as required by Government Regulation No. 57/2015) and licensing of all steps of the:
- export process
- certification and surveillance of HACCP implementation
- issuing HCs
FQIA's operational arm is located across 46 regional TIUs, plus a national reference laboratory (Balai Uji Standar Karantina Ikan Pengendallan Mutu Dan Keamanan Hasil Perikanan; The Fish Quarantine and Inspection Standard Examination Laboratory (FQI SEL)). The FQI SEL is considered to be a separate TIU. TIUs are responsible for controlling the quality and safety of fish for both import and export. Each TIU has an on-site microbiology and chemistry lab. These labs are accredited for a variety of analyses, mostly fish pathogens, plus some microbiology, chemistry and sensory parameters. They're accredited by the national accreditation authority - Komite Akreditasi Nasional (National Accreditation Committee (KAN)). There were 320 TIU inspectors across Indonesia at the time of the visit.
DG Capture is responsible for:
- registering fishing vessels larger than 30 tonnes
- oversight of Good Handling Practices on fishing vessels
- certifying catches
DG Aquaculture is responsible for:
- certifying Good Aquaculture Practices
- including hatcheries
- oversight of the national chemical residue monitoring plan
- registration of veterinary drugs and fish feed
DG Product Competitiveness issues import recommendations.
BPOM has more authorities and activities in food safety investigation and recall. BPOM's inspectorate also conducts GMP and labelling inspections of food establishments. This includes distributors, importers and exporters. In 2018, the inspectorate was located across 34 provincial and 40 new regional offices. They are supported by a central laboratory and 26 regional laboratories.
The MMAF is the key ministry responsible for Indonesia's fish and seafood safety program. Its organizations (at both the national and regional levels) are responsible for the design, start and delivery of the program. BPOM has a role in food safety and recall.
5.2.2 Program resources
The MMAF appears to have enough inspectors, auditors, and laboratory staff to meet the inspection frequencies needed under their HACCP system. This makes sure export certificates are issued as needed and samples are promptly processed.
Every TIU has at least 1 delegated investigator who is trained and authorized under the Indonesian Penal Code (Civil Law 80). They conduct investigations and issue enforcement measures.
In contrast, BPOM isn't as well resourced. With about 500 inspectors, they are challenged to meet their inspection targets. They are considering other models of delivery, including third party inspectors.
The MMAF's fish inspection and certification program appears to be generally well-resourced. BPOM would benefit from more program resources to support food safety investigations and recalls.
Quality inspectors and HACCP auditors
Attachment 3 of Regulation 3/2011 outlines the requirements for quality inspectors. Candidates must be a government employee. They are usually recommended by local TIUs. Candidates with relevant background and education are approved by national headquarters (HQ). They must also pass basic HACCP training and inspector-specific training. The approved candidates are assigned an inspector number, and appointed for 1 year by the Minister via Ministerial Decree. HQ can also end an appointment. Inspector profiles are accessible in an online system called HONEST - HACCP Online System. This system manages everything related to HACCP certification. Quality inspectors who issue HCs need more training in foreign country requirements and the certification process.
To become a certified HACCP auditor, an inspector must:
- complete the designated training modules
- pass a standardized test
- take part as an observer in 3 audits
The candidate then becomes a team member. A senior auditor observes the candidate lead 3 audits before they can become an independent auditor. Senior auditors also review audit reports on a scheduled basis to make sure the program is carried out consistently. The assessment team was informed that HACCP auditors are also trained in private standards such as BRC Global Standards. This is so they can give technical support to UPIs who need to fulfill the requirements of private schemes.
TIUs receive training from HQ in inspection, traceability and investigation. Technical training is delivered by:
- experts from the Indonesian government
- agricultural universities
- other third party providers
- for example, the South East Asia Fishery Development Centre
Technical training can include pasteurization or canning. TIUs have standardized in-house training for inspectors. TIUs also give technical training to establishments within their respective areas. An example of this is foreign country requirements and regulatory changes.
Each TIU has at least 1 enforcement officer who is:
- trained by the police
- designated under the Indonesian penal code
- wears a police badge
Only these officers can issue sanctions. Some TIU officers interviewed weren't familiar with the full range of enforcement tools available. The assessment team didn't see how, or under what circumstances, the enforcement officers would be engaged. Nor did they see what the role of non-enforcement TIU officers might be in such cases.
BPOM inspectors must hold a bachelor's degree. The degree can be in pharmacology, food technology, or other related disciplines. BPOM inspectors are trained through a comprehensive, graduated training program. The program includes both standardized and technical work competencies. Trainees move through this graduated program through a series of on-the-job and formal training. They start as a basic, become intermediate, and then finish as senior inspectors. Inspectors are assigned to specific inspections by their local office. This is guided by risk priorities from BPOM and according to an annual inspection plan.
All government laboratory analysts must have a degree or diploma in food microbiology, food chemistry or laboratory methods from an agricultural college. The assessment team was informed that analysts at the FQI SEL might also hold a degree in fisheries. The staff responsible for developing methods must have a master's degree.
Training of FQI SEL staff is ongoing. Training is decided by needs such as the purchase of new equipment, or the development of new methods. The FQI SEL has a budget to train staff in technical skills through in-house training by internal or third party experts. FQI SEL also sends candidates to take part in other organized training. Candidates are selected by section heads and confirmed by HQ.
FQI SEL gives technical training to TIU and provincial laboratory staff. Training needs are identified in consultation with FQIA. For example, annual training is given on new methods, as well as reviews of methods and procedures. The assessment team observed a fish disease training session being delivered to regional officers.
TIU heads review inspector needs and find candidates for further specialized training. Also, FQIA HQ staff reviews the results of all inspections to confirm consistency in delivery and the quality of documentation. An annual summary report isn't prepared. The report would show more widespread trends and gaps which could signal the need for regional or national training.
Similarly, staff at the private laboratory visited held bachelors and master's degrees. Training needs are identified through an annual performance evaluation. The evaluation consists of observing tasks and proficiency testing (PT) results.
Quality assurance (QA) staff from each UPI receive initial QC training from FQIA HQ and or local TIUs. Training is held as needed to accommodate demand. For instance, 2 QC training sessions were held in 2018 (1 at HQ and 1 in the region). One (1) TIU had recently delivered HACCP training to industry QC staff. UPIs also take external training as needed. Company QA staff must hold internal training in their UPIs at least once per year.
Training programs are in place for the various parties involved in the delivery of the program.
5.2.4 Program assessment/audit
The national program:
- works under ISO 9001:2015
- both national and regional offices
- is maintained through:
- a system of internal audits
- conducted by the Centre of Quality Management
- third party certification
- conducted by QAI Global Services
- a system of internal audits
Other ISO certifications were seen at the TIUs visited depending on their area of expertise and assigned duties. For example, ISO 17025:2008 and ISO 17020:2012.
A technical team of senior auditors at FQIA HQ oversee the quality of work conducted by TIU inspectors. The technical team does scheduled and random reviews of inspection results and audit findings. Inconsistencies, errors or omissions are addressed through an internal feedback loop and more inspector-specific training. TIU inspectors who need re-training might not be allowed to conduct inspections until they are re-trained.
In the least, government and private laboratories are accredited by KAN. KAN is in turn accredited by the International Laboratory Accreditation Cooperation. KAN audits each laboratory as part of the process of keeping their accreditation. After each 4 year accreditation period, laboratories reapply to be reaccredited. KAN's accreditation process includes management of non-conformities and corrective action plans. The process may be managed by their new Integrated Management System. This would depend on a laboratory's ability to access the internet.
FQIA is responsible for the oversight of regional government laboratories via audits. FQI SEL staff helps with these audits when asked by FQIA.
The MMAF has started a series of internal QC systems to help with the consistent delivery of their fish inspection and audit program. The assessment team recommended an annual review of national inspection delivery by MMAF HQ. The review would help find regional or national or both training needs as opposed to inspector-specific needs.
5.2.5 Industry, community, and international relations
MMAF is a member of the South East Asian Fishery Development Centre (SEAFDC) in Thailand. The SEAFDC helps in planning and co-operation between member countries. Officials from the European Union helped in the development and launch of Indonesia's HACCP program. MMAF staff were trained by Canada on sensory analysis. Indonesia is developing a FVO to make sure that imported commodities meet their legislative requirements.
FQIA receives notification of product rejections from other countries. This triggers an investigation by the regional TIU. Investigation findings and corrective actions are reported back to the originating country.
The FQIA website can be accessed by the public to view laws, national standards, prosecutions and procedures. In TIU offices visited, facility representatives were seen accessing the export certificate system on computer terminals given by FQIA.
Local TIU offices and national FQIA HQ appear to have well-established and co-operative relationships with each other and with the regulated establishments. Facility management welcomed FQIA inspectors and MMAF staff. They actively engaged in constructive conversation. Facility management accepted all observations, or requests for corrective actions, as an opportunity to improve:
- efficiency in their plants
The FQI SEL is a member of the Indonesian Food Laboratory Testing Network (Jejaring Laboratorium Pengujian Pangan Indonesia).
The FQI SEL routinely collaborates with other laboratories such as:
- the laboratory for DG Aquaculture
- on topics related to marine toxin monitoring and fish diseases
- provincial laboratories
- about formaldehyde testing
The FQI SEL collaborates with both private and governmental organizations in several countries. They collaborate on topics such as marine toxin monitoring. An example of this work was a 5 year (2013 to 2018) monitoring project funded by Japan. The project was to find the species of phytoplankton present in both wild and non-seeded aquaculture locations. Results and next steps were being discussed by delegates including MMAF (FQIA and DG Aquaculture) at the time of the CFIA visit. FQI SEL also collaborates on various topics with Singapore, Australia, New Zealand, Japan, China, the United Kingdom, France and the United States (US).
Laboratory staff regularly receive training from one of the following:
- SEAFDC staff in Thailand
- trainers who come to Indonesia to deliver training on site
BPOM offers basic food safety information to the local community (schools, villages, social media campaigns) and receives consumer complaints.
BPOM is working with other government departments to develop a rapid alert system for food safety threats and recalls. At the time of the assessment, it was still in the development phase. When food safety investigations were initiated in Canada related to Indonesia products, the information was passed through the designated channels. The result was follow up activities at the manufacturing plant.
BPOM takes part in the Asian Rapid Alert System for Food and Feed. This aims to investigate rejection of Indonesian products in other countries, find the root cause and the solution. This system wasn't discussed in depth during this visit.
Indonesia is a member of the Codex Alimentarius Commission and the World Trade Organization. BPOM actively takes part in:
- Codex committees
- International Food Safety Authorities Network – PDF (2.15 MB)
- Association of South East Asian Nations
- other regional South East Asian organizations
Indonesia has established channels for co-operation and communication with other Indonesian institutions involved in food safety and, with other countries.
5.3 Export control program
The foundation of the export control program includes:
- HACCP certification
- ongoing surveillance activities
- a HC for every shipment transported directly from Indonesia to Canada (for countries requiring an export certificate)
The authority for these controls typically stems from agreements between Indonesia and an importing country.
5.3.1 Hazard Analysis Critical Control Points certificates
All fish processing facilities that ship products to countries that need an export certificate (including Canada) need an MMAF license. Fish Law 31 requires establishments regulated by MMAF to carry out a HACCP plan certified by FQIA. In practice, UPIs apply for a HACCP certificate via the HONEST - HACCP Online System. FQIA HQ reviews the request. They also select quality inspectors (usually teams of at least 2 inspectors) to inspect the UPI. The inspectors are chosen based on their qualifications and the complexity of the process. The date of the inspection and the names of the inspectors are shared with the UPI via a delegation letter. The designation letter delegates authority to the inspector to conduct the activity.
Inspectors conduct initial and surveillance activities according to procedure. The procedures are outlined in the Technical Guidelines Surveillance (2016) and the Sampling Technical Guide (2016). Samples taken by inspectors according to these procedures are cost recovered via an online Ministry of Finance platform called SIMPONI. Following the inspection, the inspector(s) issue(s) a receipt for any samples taken as well as corrective actions and the operator gives evidence of how they're carried out. This information is given to DG FQIA where an Approvals Commission recommends whether or not to issue a HACCP certificate. Once issued, the HACCP certificate is shared with the local TIU responsible for that operator.
HACCP certification must be renewed annually. UPIs are rated in terms of non-compliance instead of product/process risk. The HACCP rating of a UPI (A equals high, B, or C equals low) is decided using a system of minor, major, serious and critical non-compliances (see Table 3). The classification criteria for each rating are not well-defined. Inspectors can use their own discretion to decide risk and classify non-compliance. This may lead to inconsistency in the assigning non-compliances.
The HACCP rating also dictates the frequency of surveillance audits (see Table 3).
|Rating||Critical||Serious||Major||Minor||Frequency of surveillance|
|B||0||2||10||7||Every 2 months|
All of the UPIs visited during the CFIA assessment were rated A. Indonesian authorities stated that only A-rated and select B-rated facilities are allowed to ship to:
- the European Union
B-rated UPI's may ship to non-A countries. C-rated UPIs can only ship within Asia. The basis for this and the potential implications were not clear.
FQIA HQ staff in the Centre for Quality and Safety Control generally conducts the HACCP certification process for new UPIs. TIU staff typically manage the annual HACCP renewal process. The assessment team found that FQIA HQ often accompanies the TIU team during annual HACCP visits. DG FQIA gains assurance that HACCP is being carried out continuously via an annual surveillance program. This program consists of announced annual inspections no later than 3 months before the expiry of the current HACCP certificate.
Surveillance inspections are scheduled according to an annual surveillance plan which is dictated by the HACCP rating of each UPI (see Table 3). Inspectors are selected based on competency requirements for a particular UPI, as well as availability.
UPIs must give corrective actions to the local TIU for any deviations noted during a HACCP inspection, or surveillance visit, within 2 weeks. If a UPI does not meet the requirements of their HACCP grade, the local officer recommends a grade change to the FQIA Surveillance at HQ.
In 1 region visited, all information about surveillance inspections is uploaded to and managed by a local online tool. Surveillance inspection information includes:
- the letter to tell of a pending inspection
- inspection results
- corrective actions needed
- corrective actions carried out
- the letter of closure of the activity
This local online tool manages everything related to UPI activities including:
- the HACCP and surveillance timelines
- inspection results
- current status
- blocking a UPI from applying for a HC in the online system if they:
- don't have a current surveillance certificate
- have outstanding surveillance non-conformities that exceed the tolerance for their HACCP level
The procedure and targeted timelines generally appeared to be met consistently in the areas visited. There was some variability due to production schedules, weather events, and changes in the list of active UPIs. It wasn't confirmed how this regional system links to the HONEST - HACCP Online System.
In the past, surveillance activities were conducted by FQIA HQ staff. Now, about 80% of this work is done by regional (TIU) inspectors. They are delegated this authority by HQ. HQ issues a designation letter which identifies the activity, inspector(s), location and date. Inspectors are rotated about every 4 years, if there is capacity in the region to do so. HQ staff will take part where:
- a new company is applying for HACCP certificate
- a UPI is upgrading their HACCP rating
- no qualified TIU inspectors are available
BPOM registers establishments that produce processed foods. Operators who apply and meet the requirements are awarded a 5 year registration. This process is administered using a web-based system. BPOM also has a national system to collect inspection reports and review industry compliance. Annual reports are shared with the Planning and Finance Bureau. They review trends and profit returns to inform the next planning cycle.
The foundation of the export control program includes HACCP certification. The MMAF has started a certification process and a system of ongoing surveillance activities to ensure its continuous implementation.
The classification criteria for each rating aren't well-defined. Inspectors can use their own discretion to decide risk and classify non-compliance. This may lead to inconsistency in the assigning non-compliances.
Also, the rationale and potential implications for allowing certain B-rated UPIs to export to Canada weren't clear.
5.3.2 Health Certificates
Some importing countries (like Canada) have negotiated for a mandatory export certificate with each shipment. The MMAF needs the export certificate (HACCP-based HC) to be issued before the shipment can be exported.
The HACCP-based HC offers assurance that the products shipped:
- were produced in an approved establishment
- which consistently works under HACCP
- meet the requirements of the importing country
The authority to issue a HC is delegated to the regional TIU office by Decree No 59/KEP-BKIPM/2016 of the Director General of FQIA. The process procedures are outlined in the guide: Technical Guideline Publishing HC (2016).
When preparing to load a shipment, establishments with a HACCP certificate apply to the local TIU for a HC for export. Establishments apply through an online national tool called PPK online (also known as Permohonan Pemeriksaan Karantina Ikan; SisterKaroline). An inspector is assigned to verify:
- conditions in the establishment
- including results of surveillance visits and other information
- the load to be shipped according to:
- the Technical Guidelines Surveillance (2016)
- the Sampling Technical Guide (2016)
Note: this is called a 'stuffing' inspection
If both the UPI and the load meet the requirements, including the foreign country requirements, a HC is issued for the shipment.
If an error is found on a HC for a shipment in transit, the reasons for the error are reviewed with the implicated UPI. When appropriate, the UPI will be allowed to apply for an amendment if the original certificate is returned. The HC is revised in PPK Online, reprinted and verified. A HC can't be issued by the system if there is an outstanding non-compliance.
It was noted that the language used in the documents that guide inspections can be vague and open to misinterpretation. For example, the following terms are unclear or not measureable or both:
- "cooled quickly"
- "cooled promptly"
- "held at ice's melting point"
This could be a misconception attributed to the quality of the translation given to the assessment team.
MMAF indicated that Indonesia and the US don't have an agreement on the certification of exports from Indonesia. Because of this, the US does not need the MMAF to certify exporting establishments or, individual shipments. Instead, Indonesian companies apply directly to the US Food and Drug Administration for an import license. Any products destined for Canada are then transhipped by the American broker through the US to Canada. This happens without foreign CA verification of the controls at the exporting establishment.
Some importing countries (like Canada) have negotiated for a mandatory export certificate with each shipment. The MMAF needs the export certificate (HACCP-based HC) to be issued before the shipment can be exported. The MMAF has started a process to manage this requirement.
5.3.3 Chemical and microbiological requirements
Indonesia's technical standards for chemistry and microbiology are in line with European Commission Directive 96/23/EU. These can differ from Canadian requirements in terms of both content and acceptable limits.
MMAF staff, TIU staff, and several (but not all) of the UPIs visited were aware of the Canadian requirements as published in the Sampling Technical Guide. The requirements in the guide were found to be incomplete. For example, the guide didn't contain information on:
- veterinary drugs
- banned drugs
- gentian violet and malachite green
- the suite of sulfa drug residues that Canada checks
As a result, industry does not test products destined for Canada for these parameters.
Also, the assessment team didn't see any evidence that products Canada would consider to be fully-cooked and RTE had been tested for Listeria monocytogenes (Lm). Despite the Sampling Technical Guide including the Canadian requirements for Lm in RTE foods. These products don't appear to be treated as RTE by Indonesia. They may not be subject to the same microbiological standards as in Canada. For example, Lm wasn't identified as a hazard for the production of cooked shrimp and so, there was no control for it. Since Indonesia does not routinely test for Lm in these products, they don't need it for products being exported to Canada. The MMAF stated that the shrimp are only considered to be blanched and need further cooking. Even though the internal temperature reached the Canadian requirement for cooked shrimp and, the product had the appearance of a fully-cooked product. Product was seen being shipped to South Korea labelled as fully-cooked. The assessment team was informed that similar products are typically exported to Canada.
These appear to be gaps in the control system for RTE products, such as cooked shrimp, being sent to Canada. The assessment team discussed these gaps with the MMAF. They expressed a commitment to update their guidance to show current Canadian requirements. MMAF also expressed a commitment to share both the changes and expectations to the parties involved (TIUs, industry and laboratories). Changes and expectations include which products should be routinely assessed for which parameters.
The MMAF confirmed that products for export are only tested for parameters for which each product is routinely tested in Indonesia. Canada expects that products being exported to Canada will routinely meet Canadian requirements. Products that are suspected to be, or have likely been, exposed to veterinary drugs or chemicals that could violate Canadian requirements, should be assessed before exporting. For products destined to Canada, Indonesia should use chemical residue analysis methods that are sensitive enough to test results against Canadian MRLs and other acceptability criteria.
There are cases when a fish product is sold by an Indonesian establishment to a buyer in one country, and then exported to Canada without the knowledge of the exporting establishment. The exporter can't be expected to prove that their product meets Canadian requirements in these cases. An exporter can only be expected to meet Indonesia's national requirements and those of the country that directly receives their product.
BPOM also has authority to sample and control foods in non-processed establishments. But because of their limited resources, they typically delegate this authority to the ministry(ies) who are generally responsible for those products. For example, they delegate the responsibility of fish product operators to the MMAF.
The assessment team noted that both MMAF (HQ and TIUs) and industry often respond to unacceptable microbiological or chemical results by re-testing. If the second or third sample does not yield the same unacceptable result, then no further action may be taken. This practice may allow unsafe food products to enter the marketplace due to the non-homogeneous nature of pathogens and chemicals in food.
Indonesia's technical standards for chemistry and microbiology are based on European Commission Directive 96/23/EU. These may differ from Canadian requirements. There was general awareness of Canadian requirements as published in the Sampling Technical Guide. The chemical requirements in this guide were found to be incomplete. As a result, industry isn't aware of the actual Canadian requirements. Industry does not consider them in their verification programs.
Also, discrepancies were noted between the Indonesian and Canadian definitions of RTE. So, products Canada would consider to be RTE aren't being tested for Lm.
The MMAF has expressed their commitment to closing these gaps to prevent future rejections in Canada.
5.3.4 Registration of fishing vessels
All fishing vessels operating in Indonesia with a gross tonnage over 30 tonnes must:
- have a license issued by the DG Capture Fisheries
- follow Good Handling Practices and sanitation practices
Vessels less than 30 tonnes are exempt from this requirement. They need only report basic information such as the location and type of fish caught. This leads to the possibility that fish entering establishments for export processing aren't being handled in a way that prevents contamination and temperature abuse.
The port visited is accredited to ISO 9001:2015 for 9 of 34 services they offer, including fish quality inspection.
- inspect fish before unloading
- issue an inspection certificate with a grade A, B, or C (which weren't defined)
- issue certificates to boats who comply with requirements
- issue certificates to fisherman who take part in free training on good fish processing practices
- training coordinated with the Ministry of Health
Other control activities conducted by the port include:
- monthly laboratory testing of fish
- monitoring of sanitation and hygiene
- in the freezer
- in processing facilities located on site
There is oversight of fishing vessels with a gross tonnage over 30 tonnes. The exemption of vessels less than 30 tonnes creates the possibility that fish entering establishments for export processing aren't being handled in a way that prevents contamination and temperature abuse.
5.3.5 Import controls
The National Import Control Policy is based on Ministerial regulation 74/2016 which was scheduled to be revised. Also, Ministerial decree 16/92 requires every import to meet custom, immigration, and quarantine requirements. It also assigns the TIUs authority to allow the port to allow entry of shipments that meet these requirements. In practice, licensed importers must tell their local TIU of imports. A local TIU officer then visits the location and takes samples to verify compliance. Product is released once laboratory results are satisfactory.
The assessment team was informed that the Ministry of Finance runs the Indonesian National Single Window which controls imports. Importers are given 3 days to return product which does not meet Indonesian requirements or, it will be destroyed. Importers with multiple issues may not be eligible to export.
Indonesia uses a single window-approach to control imports. This approach is carried out by the Ministry of Finance, in collaboration with TIUs and Ports.
5.3.6 Shellfish inspection and control program
Although Indonesia isn't eligible to ship live or raw shellfish to Canada, they can ship processed shellfish. Indonesia's microbiological and chemical shellfish inspection program isn't yet as robust as the Canadian inspection program. No evidence was shown to prove that an ongoing, statistically-valid, sampling program for microbiological or chemical hazards at shellfish harvest sites is being carried out. Also, no evidence was given that Indonesia has procedures in place to close shellfish harvest areas if unacceptable pathogen or toxin levels are found. There was no evidence that there were procedures to tell harvesters and processing facilities if unacceptable pathogen or toxin levels are identified. Levels are identified through surveillance activities at a processing facility or via complaint or illness.
It was noted that canning UPIs may rely on imports of certain primary products, for example, clams. The assessment team didn't see evidence of a routine program to verify the marine toxin status of shellfish, carnivorous gastropods or crustaceans (imported or domestic). Canada does not have evidence that processed shellfish from Indonesia is a health risk.
Local TIU's conduct monitoring sampling for microbiology and chemical toxins at the UPIs on an annual basis. TIU's also take annual samples from harvest sites. But, there is no ongoing shellfish toxin sampling or microbiological sampling at regular intervals during harvest. Local TIUs may tell their UPIs and ask them not to use certain imported products if an issue has been recognised. A case about imported clams was cited from 2017.
That said, DG Aquaculture routinely checks water quality for phytoplankton content. The FQI SEL conducts any associated marine toxin work. The assessment team was informed that there had been earlier findings of Paralytic Shellfish Poisoning toxin. But, these were in the range of 0.1 – 0.15 parts per million. The regulatory limit is 0.6 parts per million (the Canadian limit is 80ug/100g or 0.8 ppm). Sampling depends largely on funding which typically allows for 20 samples every 3 months. The assessment team was advised that FQIA has the authority to act on results exceeding 0.6 parts per million. That had never happened so they weren't familiar with a process to follow. Actions could include confirming the condition of the sample location and root cause analysis. FQI SEL has proposed developing and carrying out an early warning system to the Ministry of Administrative and Bureaucratic Reform.
Although there was evidence of a microbiological and chemical shellfish inspection program, it isn't as robust as the Canadian one. Harvest sites are checked for phytoplankton and marine toxins, but the program isn't run consistently due to funding constraints. Also, the assessment team didn't see evidence of a testing programme for toxins for shellfish, carnivorous gastropods or crustaceans (imported or domestic). Canada does not have evidence that processed shellfish from Indonesia is a health risk.
5.3.7 Ciguatera monitoring program
Indonesia is located in tropical waters where ciguatera toxin can be a hazard. Ciguatera toxin has not been officially confirmed in Indonesian waters, but there are anecdotal reports of illness. A limited sampling run conducted from 2002 to 2004 didn't confirm the presence of ciguatera toxin. Indonesia continues to check key areas using mussels and grouper fish. But there is no plan to start a more robust sampling plan. Unless evidence emerges that ciguatera illnesses are occurring from fish harvested in Indonesia, it seems that ciguatera toxin isn't a significant hazard in fish harvested from Indonesian waters.
Gaps in the controls for ciguatera were noted and discussed. Ciguatera toxin does not appear to represent a significant hazard in fish harvested from Indonesian waters.
5.4 Food related illness and outbreak investigation
At the time of the visit, Indonesia didn't have a written protocol that outlines outbreak investigation:
The assessment team was advised that one was being developed in collaboration with key ministries involved. In the interim, large scale investigations may be led by the Ministry of Health. FQIA or BPOM might take the lead for smaller issues. In general, BPOM takes the lead for pre-packaged RTE products, and MMAF leads for raw products (FQIA for exports). BPOM also leads investigations related to food safety issues identified by foreign countries on products originating from Indonesia. The Ministry of Trade and BPOM share responsibility on imports.
At the time of the CFIA visit, Indonesia didn't have a written protocol that outlines the procedures, roles and responsibilities for conducting an outbreak investigation. One is being developed. This should give clarity and consistency to the roles, responsibilities and authorities of those involved in conducting an outbreak investigation. In the meantime, investigation leads are on a case-by-case basis.
5.4.1 Traceability and recall
Head of BPOM Decree No. 22/2017 on product recall requires food industries to carry out traceability systems of one step back and one step forward. It also requires them to develop recall plans which are tested annually via mock recalls. Fishery products must be traceable to the harvest vessel.
Notifications of rejected shipments from other countries come to DG FQIA. They arrive either directly, or via BPOM, an embassy or, via UPIs (who are obliged to inform MMAF). They initiate a traceback and follow up to the establishment level with the help of the regional TIUs. The implicated UPI's HACCP certificate is suspended during this period. This prevents them from exporting until the issue is resolved.
The assessment team was informed of a case where Vibrio vulnificus (V.v.) was found in frozen wild giant tiger prawns from Indonesia that were exported to Europe in 2017. Although it did trigger a traceback investigation (and a temporary suspension of the UPI involved), a recall wasn't issued. The UPI identified all clients who had received the product. They were all deemed to have 'controls' for V.v. so no product action was taken. No warnings or directions to fully-cook any product still in distribution were given. This was possibly because all of the product had been distributed to 1 foreign country. Indonesia didn't feel they had authority to recall product. Furthermore, the first notification which came via the European Rapid Alert System for Feed and Food was only 'for your information'. It didn't ask for a response.
Back in Indonesia, it wasn't clear how the issue had been scoped within the UPI. Or whether a comprehensive risk assessment of the product had been conducted. MMAF referred to the literature which indicates that:
- V.v. isn't commonly found in subtropical waters
- there is no requirement to test for V.v.
- there is no standardized method
The UPI did test new product samples for V.v. at a private lab. V.v. wasn't detected, but it isn't known if, or how, the sample analysed was related to the product that tested positive.
Further, it wasn't clear whether the investigation went back to the harvest location to find the root cause to make sure that there was no ongoing issue. This could represent a health risk for more products. These products include those of:
- other lots from the same harvester
- other harvesters
- other processors
- the local community
- for example, a wastewater treatment breach
A shellfish harvest area control protocol may have helped in showing the need for a traceback investigation. There may be limitations to do so with current legal authorities. This is something for Indonesia to explore and consider as they develop a national outbreak response protocol.
UPIs must start a traceability system and to carry out recall plans which are tested annually via mock recalls. Upon notification of a rejected shipment, MMAF initiates a traceback investigation. One (1) example given exposed some potential gaps in legal authorities and investigation procedures. MMAF should confirm these authorities and review their existing procedures. This would make sure that, where possible, traceback investigations go all the way back to the source and attempt to find the root cause.
The enforcement authorities of the MMAF are outlined in Decree of the Director General of FQIA No 59/KEP-BKIPM/2016. Civil Law 80 and Law 31 offer more authorities. Some examples of enforcement tools include:
MMAF HQ suspends UPIs implicated in a food safety issue. They can also cancel a UPIs HACCP certification in the most severe cases.
Product recalled for food safety reasons is destroyed. If a UPI refuses to conduct a recall, the MMAF can suspend their HACCP certification. This would prevent further exports.
The MMAF can also decide sanctions as per the provisions in Law 31 when there is a potential health risk. For example, it is a criminal offense to export without a HC. It could result in a 1 year jail term plus a fine of 800 million rupiahs (about $75,578.48 CDN).
Ministerial decree 59 gives the authority to TIUs to temporarily suspend a UPI until corrective actions are started. The decree also gives authority to reject a request for imports and to reject imports. If a UPI does not take corrective actions within an agreed upon time frame, the head of the TIU sends the UPI a warning letter. If the UPI still does not take action, the head of the TIU has the authority to suspend their HACCP certification. This would make the UPI ineligible to export.
The assessment team observed a suspension letter issued by a local TIU. The letter was in response to notification from FQIA HQ of a rejected shipment in another country. The letter cited 3 deviations with the rejected product. It also asked the UPI to investigate, find the cause, and give evidence of corrective actions.
Civil law 80 gives TIU investigators the power to:
- suspend licenses
- order destruction of product
- ask for a court order to confiscate product
BPOM has the authority to:
- suspend or prohibit a license
- and then production
- issue public warnings and recalls
- mandatory and voluntary
- issue fines and prison sentences
As in Canada, Indonesia has 3 recall levels (see Table 4). In several cases, Indonesia's response plan is more stringent than in Canada.
|Recall class||Recalls based on the level of health risk associated with the food product being recalled or noncompliance to law or standards||Time to recall|
|1||May cause serious illness/health problems/death:
|2||Has no serious impact to health:
|3||Has no impact on human health or noncompliance to law:
Voluntary recalls must be reported to BPOM. The product recall law including the recall and traceability guideline for industry is available online.
An ad hoc committee at BPOM has the authority to asses and decide the right level of action. One (1) example was cited whereby a Class 2 recall of a low acid canned fish product was issued for the presence of Anisakis worms. The recall was issued in response to public pressure. In this case, the provincial inspectorate was mobilized to inspect and sample product to scope the issue. A joint audit of the implicated producer was conducted by BPOM and the Ministry of Industry to verify product handling.
The assessment team was informed that the local police can also temporarily hold product. But the circumstances under which this could happen weren't clear.
Both MMAF and BPOM have authorities to carry out enforcement measures about fish and seafood. These range from suspension or cancellation of certification, to public notification, recalls, destruction of product, fines and jail time. The police have more authorities which could be explored further on a future mission.
As in Canada, Indonesia has 3 recall levels. In several cases, Indonesia's response plan is more stringent than in Canada.
5.5 Laboratory controls
UPIs must have an in-house laboratory which can support analysis of some parameters. These are mostly driven by buyer demands such as BAP requirements. Although UPI laboratories don't need to be accredited by KAN, all of the UPI sites visited were accredited. UPIs may also contract external private laboratories for other testing needs.
Each of the 46 regional TIUs has an on-site microbiology and chemistry laboratory. These are accredited for a variety of analyses (mostly fish sensory, fish pathogens, some chemistry) by KAN. TIUs contract provincial government laboratories to conduct some analyses for which they aren't resourced. For example, food safety microbiological analyses.
The FQI SEL:
- is the reference laboratory to the FQIA
- is 1 of the 47 TIUs
- serves as the standard reference laboratory for:
- fish quarantine
- safety of fishery products
- actively develops and standardizes testing methods
- administers a PT program for the TIU and provincial laboratories
- offers control and other reference materials to various private and government laboratories
- conducts method validation
- develops laboratory technical guidance
- delivers technical guidance training to TIU and provincial laboratory staff
- develops the national standard methods (referred to as the Technical Guidelines)
- a total of 19 draft national standards and 7 national standards
FQI SEL is accredited for methods and other activities within their scope, for example, proficiency testing. They are accredited by both KAN and the Indonesian Food Testing Laboratory Network (Jejaring Laboratorium Pengujian Pangan Indonesia). Accreditation for competent fisheries human resources is conducted by the national Certification Institution for Pest, Disease, and Fish Quality Control (Lembaga sertifikasi profesi Pengendali hama, penyakit dan mutu ikan Lsp; LSP PHMI). Accreditation for quality management systems is by QA International (ISO 17025:2008 and ISO 17043:2010).
The scope of FQI SEL analyses include:
- microbiological parameters
- Escherichia coli
- Vibrio parahaemolyticus
- total plate count
- Anisakis sp.
- Gnathostoma sp.
- chemical parameters
- shellfish toxins
On occasion, FQIA may tell FQI SEL to develop a method for a specific parameter. An example is the response to the 2016 Hepatitis A outbreak in Hawaii. Indonesia proactively required products for export to the US to be tested for Hepatitis A. But first, they needed a method. This was developed by FQI SEL. The US has not rejected any Indonesian product for Hepatitis A since the program was started. Note that no evidence was given to suggest that it was an existing hazard in Indonesian waters in the first place.
FQI SEL isn't usually engaged in supporting outbreak investigations. BPOM laboratories offer those laboratory needs. Taking part in a new laboratory network may change that in future.
Analyses are typically conducted by the regional laboratories. But FQI SEL will analyze if a regional lab is unable to. FQI SEL also receives samples from private companies (paid service). They conduct confirmatory testing for both regional and private labs. At the time of the visit, FQI SEL had processed about 120 microbiology samples in 2018. Sampling is conducted by the regional offices/private companies.
FQI SEL is contracted by DG Aquaculture to conduct National Chemical Residue Monitoring Program analyses of only lead, cadmium and mercury. All other National Chemical Residue Monitoring Program analyses are conducted by the national reference laboratory for DG Aquaculture. The assessment team didn't have an opportunity to visit this laboratory or, provincial laboratories involved in the system.
FQI SEL's PT program has been expanding progressively since it was started in 2012. It now includes Salmonella sp., Escherichia coli, total plate count, Aspergillus flavus, Gnathostoma and, several fish parasites and viruses.
The assessment team wasn't able to visit any BPOM laboratories during this visit. This could be an opportunity to explore in the future.
Provincial government laboratories
Provincial government laboratories are contracted by TIUs to offer more services where needed. For example, for analysis of microbiological and heavy metal parameters. They are also accredited by KAN.
The assessment team visited 1 private laboratory with multiple locations in Indonesia. The laboratory offers a comprehensive range of:
- paid testing
- certification services
- microbiological swabbing in production facilities to pre-shipment testing
- antibiotics chemical residues and microbiological parameters
- foodservice and retail audits/inspections
- conducting second-party audits for social programs
- for example, worker overtime and child labour standards
The laboratory maintains multiple accreditations including from KAN (ISO 17025: 2017, 17065), BAP, the Ministry of Industry, and the Marine Stewardship Council. The facility is modern and well-equipped and well-staffed to process work within its scope. It has a well-developed quality management program. This includes a Laboratory Information Management System and an annual PT program to keep sample result integrity, traceability and confidentiality. It also hosts an onsite training academy for lab skills.
The laboratory processes both private and government samples. They are contracted by agreement with MMAF to test shrimp and tilapia for:
- chemical residues
- malachite green
- heavy metals
Note: microbiological parameters are not tested.
It wasn't clear how many private laboratories are contracted by MMAF for similar or complementary services.
Most of their more than 300 private fish and seafood clients test their products to satisfy buyer requirements, such as the European Union or the US. Laboratory staff indicated that they had not been asked to test any samples against Canadian requirements.
Note: The laboratories are contracted to test samples against buyer requirements. They could not confirm whether any of the products they test are destined for Canada.
Concerns were expressed that the analytical methods routinely used in Indonesia for certain analyses might not be sensitive enough to show compliance to Canadian requirements. Should Indonesia be aware of an issue related to products exported to Canada, they should use appropriate testing methods. This should include scope of testing and methods sensitive enough to meet the Canadian requirements (in terms of limits of quantification). For instance, in the case of banned substances where sensitive methods must prove absence.
Reportable diseases/potentially hazardous foods
The assessment team was told that government and private laboratories are not required to report samples containing pathogens or chemical toxins to a central health agency. The reports might be for action, preventative measures or trend analysis. In some circumstances, there was evidence that laboratories may share some information, but it didn't seem to be consistent.
Both public and private laboratories support Indonesia's food safety control program for fish and seafood. They are generally well-resourced for the activities within their scope and have well-trained employees. The laboratories have started quality management programs to ensure the quality of their work. Both private and public laboratories are typically accredited by KAN. KAN is a signatory to International Laboratory Accreditation Cooperation. The laboratories are therefore recognised as having a system in place to consistently deliver quality results.
Indonesia should confirm that the methods they are using are appropriate for the scope of analysis needed. And, when aware of an issue about products exported to Canada, that methods are sensitive enough to show compliance with Canadian requirements.
6. Closing meeting
A closing meeting was held at the MMAF HQ in Jakarta on December 7, 2018. It was attended by:
- the Canadian assessment team
- representatives from MMAF HQ
- regional TIUs
- FQI SEL
- the port of Jakarta
- the Ministry of Finance
- the Canadian Embassy
The assessment team thanked the MMAF for their planning efforts to support the assessment and their overall professionalism. They also thanked them for their openness to questions and responsiveness to the assessment team's needs. The assessment team presented a summary of their understanding of the system as well as their findings and recommendations. The assessment team indicated that they planned to give a draft report to the MMAF within 60 working days from the closing meeting.
7. Conclusions and recommendations
MMAF is committed to quality assurance of the fish products they export. Indonesia has started a system for the safe production and export of fish and seafood products. The system is generally being carried out as written by well-trained and competent professionals at both the state and federal level. The assessment team made several recommendations which are summarized in Annex 1.
Annex 1: Summary of the Canadian Food Inspection Agency (CFIA) recommendations/findings from the Canadian Audit of Indonesia's Fish and Seafood Program Draft Report - 2018
Summary of CFIA recommendations/findings from the Canadian Audit of Indonesia's Fish and Seafood Program
- Recommendation 1: Consider implementing a programme of voluntary control requirements (the HC process) for exports to all countries that could become mandatory over time.
- Recommendation 2: Conduct an annual national review of all HACCP and HC-related activities to capture national trends, gaps, training needs etc. related to the quality of program delivery.
- Recommendation 3: Describe the process, including rationale and criteria that is used to determine which B-rated UPIs are eligible to ship to Canada.
- Recommendation 4: Provide national training to general TIU staff to ensure that all officers are aware of the enforcement tools under their authority and the process to exercise them.
- Recommendation 5: Revise the Sampling Technical Guide and any other tools and processes that provide guidance on Canadian import requirements to national and regional CAs, laboratories and industry.
- Recommendation 6: Confirm that laboratories are using methodology appropriate for the scope of testing and, sensitive enough to demonstrate compliance with Canadian requirements in terms of limits of quantification.
- Recommendation 7: Confirm that appropriate authorities and processes are in place to support a full traceback investigation to identify the point source and root cause of food safety issues related to fish and seafood products.
- Recommendation 8: Re-evaluate the role of re-sampling in situations where sample results exceed the acceptable limits for chemical and microbiological parameters.
Consider implementing a programme of voluntary control requirements (the HC process) for exports to all countries that could become mandatory over time.
MMAF action plans / comments
January 15, 2020:
Control requirements (the HC process) for exports to all countries (stuffing) are scheduled as required in accordance with technical instructions
NUMBER 59 / KEP-BKIPM / 2016:
To ensure the correctness and suitability of the data stated in the HC draft with the products exported, the quality inspector or competent officer must be conduct an stuffing at the time of loading. Organoleptic tests are carried out using a score sheet on the product to be exported. The results of stuffing including organoleptic tests are documented, and if:
- the results showed the truth and suitability with the data as listed on the HC draft as well as the organoleptic test results according to the requirements so the HC can be issued;
- the results do not showed the truth and non-compliance with the data as listed on the HC draft and the organoleptic test results are not in accordance with the requirements so the HC cannot be issued.
However, after a technical meeting, stuffing was formulated periodically in accordance with letter reference number 1326/BKIPM/XII/2018.
RFQIA plans and conducts stuffing based on "risk analysis" adjusted to the export plan and the commitment to apply HACCP, export frequency and volume, to guarantee products that are loaded in accordance with yield specifications fisheries contained in HC.
For information, Since January 2020, surveillance online already can be used to do the surveillance.
August 19, 2020:
Currently, surveillance in the framework of official control is being added in to the HACCP Online System (HONEST) application. So that in the future it is expected that official control activities to all establishment, starting from planning to reporting, will be carried out by the online system.
Conduct an annual national review of all HACCP and HC-related activities to capture national trends, gaps, training needs etc. related to the quality of program delivery.
MMAF action plans / comments
January 15, 2020:
Competent Authority has conducted an annual national review for food safety control system including HACCP and HC. The national review has been carried out on 25 - 27 November 2019 in Bogor. Regarding on the result of the review, CA should conduct the training for the quality inspectors to develop and increase their competency. CA should have an adequate number of the quality inspector to control the implementing of HACCP system on 909 UPIs.
On 2020, CA will be conducting the training of HACCP system for the quality inspectors, such as:
- Training for Registration of The Quality Inspector
- An Annual Technical Meeting of The Quality Inspector
- Technical guidance for quality inspector
FQIA has conducted annual evaluations for HC issued. Based on the results of the HC evaluation for year 2018-2019 showed a positive trend. There has been an increase with amount of HC in 2018 377 HC and in 2019 353 HC (per September 2019). With the most product to export is shrimp.
After evaluating, there is a result that organoleptic training needs to be conducted which reaches more RFQIA.
Describe the process, including rationale and criteria that is used to determine which B-rated UPIs are eligible to ship to Canada.
MMAF action plans / comments
January 15, 2020:
Based on Annex II on The "Arrangement on the Mutual Recognition of Fish and Fishery Products Inspection and Control Systems" is all establishments registered or licensed for export by the Competent Authority under the HACCP Based Integrated Quality Management Program for Fishery Products are recognized under this arrangement.
Regarding on article 15 on "Regulation of Minister for Marine Affairs and Fisheries (MMAF) No. 51/Permen-KP/2018 concerning Requirements of and procedure for issuance the certificate of implementation of integrated quality management program/Hazard analysis and critical control point", there is a HACCP rating scale based on the maximum number of non-compliances.
|Rating||Maximum Number of Non-Compliances||Maximum Number of Non-Compliances||Maximum Number of Non-Compliances||Maximum Number of Non-Compliances|
|A||0||0||0-5 Table Note a||0-6|
|B||0||1-2 Table Note b||6-10||≤ 7|
|C||0||3-4||≤ 11||≥ 7|
- Table Note a
Major category and minor category with maximum value of 11 (eleven) as well as with the major category value of maximum 5 (five).
- Table Note b
Serious category and major category with the maximum value of 10 (ten) as well as with the serious category value of maximum 2 (two).
August 19, 2020:
Basically, grades A and B have met the quality assurance system requirements. Grading is determined based on unconformity found during the audit. The establishment negligence at the time of inspection must be corrected for these findings within a period of 1 month, if the corrective action is not made then the HACCP certificate will be suspended and given a period of 1 month again, if it not followed up then the HACCP certificate will be revoked.
The list of establishments has been provided.
Provide national training to general TIU staff to ensure that all officers are aware of the enforcement tools under their authority and the process to exercise them.
MMAF action plans / comments
January 15, 2020:
|1. Training for Registered Fish Inspectors||Manado, 11-15 February, 2019||
|1. Training for Registered Fish Inspectors||Bogor, 28 October – 1 November, 2019||40 participants
|2. Inspectors Technical Meeting||Bogor, 1-4 October, 2019||48 Participants (Appendix 4), inspector from FQIA||
|3. Review of Food Safety Standard||Jakarta, 20-22 November, 2019||30 Participants Inspector from Centre of Quality and Safety Control
|4. Technical Meeting of Inspection for Traceability System Implementation for Fish Inspector||Jakarta, 22-24 April, 2019||52 participants
|5. Technical Guidance on Organoleptic Testing of Fishery Products||Jakarta, 26-29 Maret, 2019||70 participants
|6. Workshop Kasus Penahanan / Penolakan Produk Perikanan||Bogor, 13-16 Agustus, 2019||60 Participants||
Organoleptic training at least 1 time per year with speakers from BUSKIPM and participants from RFQIAs:
- Fisheries Product Quality and Safety Control Policies;
- Microbiology Sampling and Testing for Food Quality and Safety
- Principles of Organoleptic Sensory Testing
- Sample Handling and Sample Preparation Techniques for Fisheries Product Analysis
- Theory and Practice, which consists of: basic test of organoleptic testing (Ishihara, color, and odor; sample preparation; differentiating test of organoleptic testing; testing, calculation and reporting of organoleptic results with a score sheet; formation of trained panelists; field visits to UPI.
- Preparation of reports and presentations per group, namely: reports on the results of visits to the Fish Processing Unit (UPI) and reports on the results of the panelist calculation.
Snapper and Grouper Identification Training:
- Fisheries Product Quality and Safety Control Policy
- Fish Observation based on morphological and coloring differences in the same species
- Practice of fish identification based on fish species, fish morphology, pre-test and post-test
Crab DNA training (Scylla serrata and Portunus pelagicus):
Subject: Principles and Testing of Crab DNA
On 2020, CA will be conducting the training of HACCP system for the quality inspectors, such as:
- Training for Registration of The Quality Inspector
- Technical Meeting of The Quality Inspector
- Technical Meeting of Inspection for Traceability System Implementation for Quality Inspectors
- Technical Guidance for Quality Inspectors
August 19, 2020:
- Implementation of Ministerial Regulation No.51/2018 regarding Requirements of and Procedure for Issuance the Certificate of Implementation of Integrated Quality Management Program/Hazard Analysis and Critical Control Point.
- Policy of Quality Assurance System for Fish and Fishery Product
- Criminal Act for SJMKHP Based on Fisheries Law No. 31 / 2004 Jo No. 45 / 2009
- The Technique of Identifying Fishery Products as a result of Destructive Fishing
- HACCP Inspection
- Audit Technique
Dissemination related surveillance, sampling and issuing of Health Certificate activities.
Revise the Sampling Technical Guide and any other tools and processes that provide guidance on Canadian import requirements to national and regional CAs, laboratories and industry to include:
- the complete Canadian import requirements and
- clear guidance regarding the sampling and testing expectations for products destined for Canada (as outlined in 5.3.3)
For example: the Technical Guidelines Surveillance, Technical Guideline Publishing HC, training materials, other tools used by the TIUs to conduct export-related activities, communication materials with laboratories, industry etc.
MMAF action plans / comments
January 15, 2020:
Technical Guidelines for the Issuance of HC Certificates in Regulation Number 59/2016:
- Issuance of HC;
- Sampling procedures; and
Technical Guideline 59 is still in the process of revision.
August 19, 2020:
Revision of the Technical Guideline No. 59/2016 and will finished in October 2020.
The link of Canadian Import requirements will be inserted in the new Technical Guideline.
Confirm that laboratories are using methodology appropriate for the scope of testing and, sensitive enough to demonstrate compliance with Canadian requirements in terms of limits of quantification.
Communicate any changes to all parties involved, and evidence collected to demonstrate that the changes have been implemented.
MMAF action plans / comments
January 15, 2020:
Laboratories involved in NRMP have used methodologies and instruments that are appropriate and sensitive enough to meet Canadian requirements.
For example for forbidden compounds (chloramphenicol, Nitrofuran and Dyes both Limit of Detection (LoD) and Limit of Quantification (LoQ) below the Minimum Requirement Performance Limit (MRPL). MRPL means the minimum content of an analysis in a sample which has to be detected and confirmed .
For pesticide, Anthelmintic, contaminant and other veterinary drugs that have Maximum Residue Limit (MRL) Laboratory designed for Indonesia NRM Programs are capable of performing Limit of Quantification are way below Requirement MRL.
Confirm that appropriate authorities and processes are in place to support a full traceback investigation to identify the point source and root cause of food safety issues related to fish and seafood products. This includes consideration of closures of harvest areas implicated in an outbreak until the safety of products from that area can be confirmed.
MMAF action plans / comments
January 15, 2020:
In case the food safety incidents occur, the Competent Authority will conduct:
- Investigation to find the root cause from the case occur
- The Competent Authority will conduct sampling and traceability to the product affected by the case
- The establishment should conduct the corrective action from the root cause
- If the corrective action meets the requirements, the Competent Authority will inform to the notify country as measures taken by the establishment
- If the corrective action doesn't meet the requirements, the establishment do not allow to export until the corrective action is fulfilled.
August 19, 2020:
Regulation of Investigation procedure still under process in review and will be completed in the end of this year.
Previously, investigation procedure refers to ISO Management systems document that one of the technical guidance contain work instruction to do the investigation of food businesses operators to find the root cause of the non-conformity of the food safety case.
Re-evaluate the role of re-sampling in situations where sample results exceed the acceptable limits for chemical and microbiological parameters.
MMAF action plans / comments
January 15, 2020:
Regulation 59/2016 concerning Sampling no. 14, mention that:
- The test result report is evaluated whether it meets the national or importing country standards, if the test results do not meet the standards, it must be immediately submitted to UPI for investigation and corrective action.
- If UPI does not take corrective actions, then the Head of UPT conducts a temporary suspension until UPI corrects the non-conformity.
August 19, 2020:
In the new regulation, will be added an explanation if the test results do not meet the standards then the results will be immediately submitted to the establishment for investigation and corrective action.
Then the Inspector will carry out an investigation and re-sample the products whose test results do not meet the standards.
- Date modified: