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CFIA's Assessment of Chile's Food Safety System for Fresh Fruit - 2019

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Abbreviations and special terms used in the report


Chilean Agency for Food Safety and Nutrition


Asociación De Exportadores de Chile (The Association of Exporters of Chile)


British Retail Consortium


Competent Authority


Canadian Food Inspection Agency


Dirección General de Relaciones Económicas Internacionales (General Directorate of International Economic Relations)


European Union


Fundacion Para El Desarrollo Fruiticola (Foundation for the Development of Fruit)


Good Agricultural Practice


Good Manufacturing Practice


Hazard Analysis Critical Control Points


World Health Organization International Food Safety Authorities Network


Instituto Nacional de Normalizacion (National Standardization Institute)


Ministerio de Salud (Ministry of Health)


Maximum Residue Limit


Programa de Monitorio Residuos de Plaguicidas, Metale Pesados (National Chemical Residue Monitoring Program)


Servicio Agrícola y Ganadero (Agriculture and Livestock Service)


Secretarías Regionales Ministeriales de Salud (Regional Ministerial Health Secretariats)


United States of America

Executive summary

This report describes an assessment of Chile's food safety system for fresh fruit. The assessment was conducted in Chile by the Canadian Food Inspection Agency (CFIA) from March 4 to 15, 2019.

The main goals of the assessment were to verify how the Chilean competent authority's (CA) food safety controls:

The assessment included meetings with/visits to CAs, industry and laboratories.

Chile has several key food safety requirements in place for the production, packing, and exportation of fresh fruits to Canada including:

Chile has a foundation for a comprehensive national food safety control system. This is made up of:

The national monitoring programs are carried out by well-trained, competent individuals who are dedicated to their work.

Although Chile does not ask growers to carry out Good Agricultural Practices (GAPs), it does ask establishments to carry out Good Manufacturing Practices (GMPs). To satisfy customer needs, most operators are certified under third party food safety programs like GlobalG.A.P. and the British Retail Consortium (BRC). Chile's Agriculture and Livestock Service (SAG) verifies the presence of valid third party certifications as evidence of GAPs and GMPs. This is done as needed by specific agreements. SAG does not have a program to completely verify that proper food safety controls are in place, on farms or in establishments, for the packing of fruit for export.

This report recommends some opportunities to enhance the existing system and its programs.

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.

1. Introduction

CFIA has a broad mandate that includes food safety, animal health, plant protection and international market access. CFIA's main priority is protecting the health and safety of Canadians. 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. These activities:

The results of this assessment will inform CFIA's import controls. They will also help CFIA direct oversight resources to areas of highest risk. This can lead to increased consumer confidence in imported products from Chile. It will also contribute to market access.

The assessment was conducted in Chile from March 4 to 15, 2019 by a team from CFIA's Food Import and Export Division. The 10-day mission included:

An opening meeting was held in Santiago, Chile on March 4, 2019. Representatives from CAs, ASOEX and the Canadian Embassy in Chile were present. During this meeting, the CFIA team explained the goals and technical aspects of the assessment. The CAs then gave an overview of the program, roles and responsibilities.

From March 5 to 14, the team visited firms that grow, pack and/or store fresh fruit for export. They were accompanied by both national and regional representatives of SAG.

A closing meeting was held in Santiago on March 15, 2019 with CAs, ASOEX, and FDF. The goal of the meeting was to:

2. Audit objective, scope and methodology

The main objective of the assessment was to verify how Chilean food safety controls were applied by the CA to the production and export of fresh fruits. Do these controls achieve proper food safety outcomes to meet:

The scope of the audit was limited to:

CFIA gathered their information with different methods. This included a review of information on the relevant laws and the design of the food safety control program given by SAG. An on-site visit was then conducted to:

Information was collected at:

The number and variety of operators visited gave a representative sample of the commodities of focus. It also gave a diversity in size, complexity and geographical locations. This allowed the CFIA team to draw an unbiased conclusion about how the whole system is carried out. Although blueberries weren't in season at the time, the CFIA team visited a blueberry packer. This allowed them to tour the establishment, review documentation, and interview staff.

Table 1: Summary of sites visited
Meeting and site visits Number of visits Locations or species
National representatives of the CA 2 SAG and MINSAL
Regional representatives of the CA 3 O'Higgins, Metropolitan and Maule
Trade associations 2 ASOEX and FDF
Laboratories 3 SAG Laboratory + 2 private laboratories authorized by SAG
Growers 4 Grapes, plums, apples, kiwis
Packers and exporters 4 Multiple species

3. Legal basis for the audit

This assessment was carried out in agreement with the Chilean CAs and under the Safe Food for Canadians Act and Regulations and the Food and Drugs Act. In particular:

4. Background

Chile, officially the Republic of Chile, is a South American country with a land area of about 756,000 km² and population of about 17.5 million. It is bordered by:

The Chilean fruit sector encompasses over 9,000 growers and exporters and ships to more than 70 marketsFootnote 1 . In 2017, Chile exported 101,043,723 kg ($347,284,738 CAN) to Canada - fresh grapes and apples representing the first and second largest exported commoditiesFootnote 2. Fresh fruit is typically exported to Canada directly from Chile or via the United States of America (US).

An analysis of import data conducted by the CFIA showed that Chile is the sixth largest exporter of fresh fruits to Canada. They are behind the US, Mexico, Costa Rica, Guatemala and Ecuador. Between 2014 and 2017, the CFIA detected 19 pesticide residue violations in fresh fruit and vegetable imports from Chile. These were found through routine monitoring.

5. Findings

5.1 Regulatory foundation

The sources of Chile's regulatory instruments relevant to fresh fruit include:

The framework for fresh fruit food safety in Chile is established by legislative instruments (see Table 2).

Table 2: Key Chilean food safety laws and topics
Law Key food safety topic(s)
Sanitary (Health) Code Decree No. 725 (1968) (Spanish only) MINSAL The main official regulatory document on sanitary matters. Assigns responsibilities and authorities to the different regulatory health bodies (including MINSAL). Makes up the basis for more specific laws:
  • assigns authority to the laws to decide the characteristics that food must meet during import, processing, packaging, labelling, storage, distribution and sale (Article 105)
  • gives the authority to impose fines, order the closing of establishments, cancel operating licenses/permits, stop work, suspend distribution, withdraw, forfeit, destroy or denature objects implicated (Title III, Article 174)
  • gives the authority, as a sanitary measure, to order the closing, prohibition of operation of houses, premises or establishments, to stop tasks, seizure, destruction and denaturing of products (Annex Title III Article 178 (169))
Food Sanitary (Health) Regulation Supreme Decree No. 977 MINSAL Regulates all matters about the manipulation, storage and manufacture of food products:
  • requires production, preparation, preservation and food packaging establishments to meet good food practices (GMPs) in a systematic and auditable way (Article 69)
  • prohibits the manufacture, import, possession, distribution, marketing or transfer of foods that are altered, contaminated, adulterated or falsified (Title II Article 102)
  • specifies the maximum levels of chemical (Title 4 – although none are specifically identified for fruit) and biological residues (Title 5) permitted in food
  • gives authorities for MINSAL monitoring programs
  • gives authorities on inspection, search and seizure (Annex Title I)
Organic Law of SAG No. 18.755 (1989) - PDF (640.6 kb) Describes the organization, powers, and authorities of the Agriculture and Livestock Service (SAG). Includes SAG powers to:
  • enforce and oversee compliance with statutory and regulatory provisions on the production and trade of pesticides and fertilizers and to certify that primary agricultural products for export are fit for human consumption (Article 3, clause m)
  • know, resolve and sanction violations of laws, actions that are of competition of the regional directors within the territory of their respective jurisdictions (Article 11)
  • enter to discharge inspector's duties (Article 13)
  • order the temporary retention or transfer of the elements, supplies, products or vehicles, or their immobilization or the apposition of seals on movable or immovable property (Article 14)
  • close an establishment (Article 25)
Decree Law No. 3.557 of 1980 (Spanish only) – PDF (69.8 kb) and its amendments (Law 20,308 / 2008) Ministry of Agriculture Establishes provisions on agriculture protection, including:
  • general framework for the law, marketing and use of pesticides and fertilizers (Title III)
  • powers to take samples of pesticides (Article 32) and fertilizers (Article 39, 40)
  • procedures for pesticides and other agricultural treatments (Article 34)
  • powers to regulate, restrict or prohibit the manufacture, import, export, distribution, sale, possession, and use of agricultural pesticides and, order the retention, confiscation or destruction of pesticides (Article 35)
  • authority to enter premises for the purpose of inspection, and authority to prohibit the use and sale of contaminated products (Article 34)
  • powers to seize and take other sanctions (Title IV)
Resolution No. 1557 of 2014 (Spanish only) and its amendments SAG Describes requirements for pesticide authorization
Resolution 33 (Spanish only) and its amendments (Spanish only), resolution No. 762 of 2011 (entered into force in 2012) MINSAL Defines maximum permitted levels of pesticide residues in food
Decree 158 (2004) (Spanish only) - PDF (2.6 MB) MINSAL Deals with Notifiable diseases including foodborne diseases

A series of technical standards further define the scope and technical requirements. For example:

Conclusion: Chile has a legal framework that lets regulatory authorities carry out and oversee a national food safety control program for fresh fruits.

5.2 Government oversight

5.2.1 Roles and responsibilities

Several ministries are responsible for food safety in Chile through SAG. In particular, MINSAL and the Ministry of Agriculture. MINSAL

In general, MINSAL assures the safety and quality of food for domestic consumption (including imported food). In the area of food safety, MINSAL protects consumer's health. This promotes healthy nutritional habits, and reduces contaminants in foods to assure their safety and quality. To fulfill this role, MINSAL oversees sanitary controls and inspection measures at each stage of the food chain.

At the central level, MINSAL carries out the following:

MINSAL has presence across Chile's 16 regions through its Regional Ministerial Health Secretariats (SEREMIs). Regional staff are responsible for food safety and other aspects of public health (for example, fire safety). At this level, MINSAL carries out the following:

Oversight is delivered according to a risk-based control process. This decides the inspection plan.

Food facility inspection activities may be delegated by MINSAL to other ministries through official agreements.

MINSAL is supported by a national reference laboratory (the Public Health Institute). SAG

SAG is the key CA responsible for the food safety of primary agricultural products for export. In general, SAG's purpose is to:

SAG has the role and powers to:

SAG's activities include:

SAG is comprised of a central level with a normative or regulatory role. The SAG central level is made up of the following technical management divisions:

This central level also has 2 technical support units. The units give services and advice to the technical management divisions. The 2 technical units are:

SAG has a regional and sectoral level in all regions of Chile. This is represented by 16 regional offices and 66 sectoral offices. It also has 16 official diagnostic laboratories across 11 regions. SAG has a presence at 96 border control points, including ports through which fresh and frozen fruit are exported (for example, Valparaiso, San Antonio, Talchhuano Seaport Complex and Airport Arturo Merino Benitez).

Conclusion: Both SAG and MINSAL have well-defined roles and responsibilities pertaining to fresh fruit.

5.2.2 Program resources

The CFIA team didn't conduct a detailed review of staffing procedures. They did note that SAG appears to have sufficient inspectors and laboratory staff to meet the inspection frequencies and analytical capacity required under their system. SAG quality management

SAG has a quality management system in place that meets the requirements of International Standards Organization ISO 9001:2008. The quality management system is accredited by SGS S.A.(formerly Société Générale de Surveillance). All SAG units plan their work annually in a technical-budgetary programming process. The process is coordinated by the central level through the Strategic Management Division. Planning begins in the last quarter of each year and ends in January of the following year. The process includes: Training

SAG has a national training program in place. The program makes sure that the staff has competencies and skills needed for their respective roles and responsibilities. This includes basic induction training needs for inspectors.

Training needs are managed by SAG Academy and coordinated at the national level. SAG Central defines the training needs for inspectors and approves the content of courses. Training may be delivered at the national or the regional level. SAG tracks the training and checks the effectiveness of training via regional director surveys.

Chile planned to roll out an on online training for the Diploma for Phytosanitary Certification by April, 2019. This diploma :

Ongoing training needs are identified by the regions, assessed and selected for delivery by a SAG Academy Committee. The performance of SAG staff is assessed twice a year.

SAG technicians (inspectors):

At least 1 representative from each export company also receives training from SAG to become a SAG counterpart. This allows them to help inspections conducted by SAG at their establishment. SAG counterparts are also supervised by a SAG technician. Results of oversight activities of both the SAG technician and the SAG counterpart are documented in a report log book. A log book is maintained at each plant.

Part-time inspectors are fully retrained on basic requirements if they have not worked in that role for more than 2 years.

SAG sponsors Chile's fruit export association (ASOEX) to deliver training on their behalf. Also, SAG offers a tax benefit to exporters for every employee trained by ASOEX on SAG's requirements.

SAG pesticide applicator licensing

Fresh fruit pesticide applicators must complete a training program:

SAG checks test results and issues applicator certifications which are valid for 5 years as defined by Resolution 2.029 of 2017 (Spanish only). The team observed that this requirement was met across the operators visited.


Laboratory analysts are certified by their respective department head following a 2 to 3 month training period.

Conclusion: SAG appears to have sufficient inspectors and laboratory staff to meet the inspection frequencies and analytical capacity required under their system.

SAG has implemented a process for the development of annual programing and, continuous improvement.

SAG has systematic training requirements and programs in place. These are for SAG staff and others involved in the delivery of fresh fruit programs to make sure that the training needs are met. Ongoing training needs are identified throughout the year.

5.2.3 Industry, community and international relations

MINSAL is the designated emergency contact point for foreign food safety notifications to/from the World Health Organization International Organization of Food Safety Authorities Network (INFOSAN). INFOSAN assists members in managing food safety risks. This ensures rapid sharing of information during food safety emergencies to stop the spread of contaminated food from one country to another.

Notifications of non-compliance from other countries come to MINSAL via Chile's General Directorate of International Economic Relations (DIRECON). MINSAL conducts/coordinates investigations with other ministries responsible for the implicated product (SAG in the case of fresh fruit). MINSAL also communicates the results back to the foreign country via DIRECON.

The Chilean Agency for Food Safety and Nutrition (ACHIPIA (Spanish only)):

Authorized laboratories take part in annual technical meetings with SAG to discuss topics such as new requirements. ASOEX

ASOEX is the largest Chilean industry association for fresh fruit. Its main goal is to help exports. Members include fresh fruit growers and exporters - representing 90% of the exported volume and 57% of the crop.


ASOEX works directly with exporters to develop voluntary programs. This includes standards for packing houses and farms. The voluntary programs ensure that fruit meets quality and food safety requirements of the destination markets. ASOEX visit farms to verify GAPs and water quality. They carry out national microbiological monitoring programs for fruit and water. ASOEX also gives support in the event of alerts and notifications. Additional support is given to industry through training, technical seminars, industry guidelines and extension materials.

The team observed that ASOEX is the main source of information for Chilean exporters on foreign country import requirements. For example maximum residue limits (MRLs), including those from Canada. FDF

FDF is a private non-profit organization. It was founded in 1992 by a group of growers and exporters. FDF gives research and development to support the sector and strengthen its international competitiveness. By agreement, ASOEX members make a financial contribution to FDF for every box of fruit shipped. FDF partners with SAG, universities, and other organizations for various projects. This is to develop and deliver information on applied research. Topics include climate change issues, new technologies, and food safety.

Conclusion: Chile has delegated contacts for INFOSAN (MINSAL) and Codex (ACHIPIA). They also have procedures to manage notification of issues from foreign countries (DIRECON).

Support from ASOEX and FDF helps industry's implementation of Chile's food safety system.

5.3 Food safety control program

Chile's food safety control program for fresh fruit exports consists of multiple components:

The following sections give an overview of these controls.

5.3.1 SAG

Before they can operate, all growers, packers and exporters must be registered by SAG through their SRA (Spanish only). They are registered and assigned corresponding codes:

This process gives SAG the ability to effectively trace products back through the supply chain. Although outside the scope of this assessment, the CFIA team learned that raspberry exporters must register under a special control program for raspberries.

The SRA system shows all registered:

The CFIA team observed that SAG's laws do not have any requirements for fresh fruit farms, packers or exporters to have food safety programs in place. However, to satisfy customer and supply chain needs, most operators are certified under third party programs such as GlobalG.A.P. and BRC in the least. These certifications require initial and ongoing maintenance audits of GAP and GMP-based systems by third party certifiers.

SAG does not conduct routine food safety oversight or inspection activities:

SAG's inspection and certification system for fresh fruit exports focuses on phytosanitary and traceability requirements. In response to market requirements, SAG has carried out national sampling and monitoring plans for:

The SAG Plant Protection Division develops and updates technical guidelines and procedures for the fresh fruit phytosanitary certification process. This process:

Interviews with operators in the regions visited confirmed that SAG's verification activities are generally limited to phytosanitary and traceability requirements. 'Market requirements' are defined as those outlined in formal agreements such as those with Indonesia (Spanish only) - PDF (940 kb), Russia, Taiwan and China. Customers rely on industry's third party certifications as evidence of GAPs and GMPs. Furthermore, industry relies on their customers, and information given by ASOEX, to inform them of other market requirements. As a result, companies may not be fully aware of all requirements of their destination markets. SAG monitoring programs

SAG's monitoring plans are developed at the central level. They are distributed to regional and sectoral offices to be carried out as described in Information about the Monitoring Plan for Chemical Residues and Microbiological Contaminants in Fresh Fruits for Export. The monitoring program procedures for pesticide residues are described in Guide - Monitoring Program for Pesticide Residues in Fruits and Vegetables Products.

The design of the annual national monitoring plan considers factors such as:

Sampling under the chemical, heavy metal, and microbiological plans is typically conducted at packing houses. This sampling is also done at the same time as sampling for phytosanitary requirements. Sampling methods are given in a series of technical guidelines and norms. The technical guidelines and norms are based on international protocols (EU, Codex Alimentarius). They are also based on Chilean technical standards and needs for specific markets such as Indonesia. These monitoring plans focus on meeting market requirements.

Samples taken by SAG under these plans are submitted to 1 of the following:

SAG uses an electronic program called Delfos to check the progress of the delivery of the plans. The region puts monthly reports in Delfos which are reviewed by SAG Central.

Chemical residue monitoring program

SAG delivers the National Chemical Residue Monitoring Program (PRMP) for domestic and exported foods. The PRMP is an annual chemical residue (pesticide) monitoring plan. First started in 2009, it only included pesticide residues. The program was expanded in 2017 to include heavy metals (lead (Pb) and cadmium (Cd)). The number of samples planned for 2019 for pesticide residues (2,000) and heavy metals (150) are reasonable numbers based on export volumes.

The scope of residues monitored includes substances that are authorised, prohibited, and registered (authorised, but restricted in foreign markets). The scope does not include unapproved substances. The program is designed on a statistical basis with confidence limits that depend on:

Confidence levels can vary from 75 to 99%. This is because of Canadian (Codex Alimentarius) requirements. The sample size is chosen to achieve detection (of the non-compliance) exactly to a 1% violation rate with 95% level of confidence. Chile plans to expand the current number of analytes tested under the PRMP from 178 to 223 in 2020.

Chile's MRLs are set according to Chilean laws (MINSAL resolutions 33/2010 (Spanish only) and 762/2012 (Spanish only)). These laws are largely based on EU/Codex Alimentarius requirements. Chile and Canada have an established MRL for 41 of the same residues. Of these 41 residues, Chile's residue limits may be the same, higher or lower than Canadian limits. Chile has not established MRLs for all chemicals for which MRLs have been established by Codex Alimentarius and/or other countries (for example, Canada). Therefore these residues aren't in the scope of the PRMP. Canada has established MRLs for about 44 chemicals that are not included in the PRMP.

While both domestic and exported foods are monitored for residues, only exports are monitored for heavy metals. The plan for heavy metals started in 2017 as a requirement for Indonesia. It includes lead (Pb) and cadmium (Cd) for certain commodities only (table grapes, apples, pears, blueberries, cherries and kiwis). There are no plans to expand the program to include heavy metals related to the mining industry (arsenic (As), chromium (Cr), mercury (Hg)). This is because the orchards aren't located in proximity to mines/areas of mine run-off.

Chile does not have established requirements for heavy metals of their own. All results are assessed against Indonesia's requirements - regardless of the destination market. Because of this gap, Chile does not feel that they have the regulatory authority to stop exports if a problem is detected. That said, SAG has said that they would ask the exporter(s) not to export, and to give an action plan to prevent future problems.

As of November 2018, Chile has systems recognition with Indonesia and Russia. The agreement with Russia was established in 2008 and signed in 2009. Before these agreements, Chile needed to send a certificate of analysis of results with each shipment. Now they only need to send summary reports on an agreed frequency.

Microbiological monitoring program

SAG is also developing a microbiological monitoring program for E.coli and Salmonella in fresh fruit. The first 7 samples of apples and blueberries were taken under this program in early 2019. Of these 7 samples, 1 was rejected. SAG plans to deliver 500 samples nationally. They are considering expanding the program to other species once it is fully implemented. Pesticide and fertilizer control program

Organic Law of SAG No. 18.755 (1989) (Article 3, section m) requires SAG to oversee the norms and laws pertaining to pesticide and fertilizer:

SAG is responsible for agricultural products for agricultural use while MINSAL is responsible for products for lawns, garden and industrial use. Authorities designated to SAG by Decree Law of Agricultural Production are supported by a series of resolutions.

SAG must register all:

A list of authorized pesticides (Spanish only) is posted on SAG's external website. Information about certified pesticide applicators is maintained by SAG.

SAG has implemented an inspection program (which includes sampling) to verify compliance with the requirements. SAG typically conducts more than 3,300 pesticide inspections each year. Export control program

The foundation of SAG's export control program for fresh fruit destined for Canada is based in verifying phytosanitary requirements (Spanish only).

Before each export of fresh fruit, operators place a request in the online SRA system for SAG to inspect the lot. The applications are processed through the Service Scheduling System (Spanish only) available on the SAG website. The fresh fruit for export is prepared:

The requirements are available in the "Phytosanitary Requirements Finder" through the SAG website. A SAG export unit verifies traceability as per the protocol. The unit proceeds to inspect the lot for plant pests before approving/rejecting the lot. Results of the inspection are documented in a log book which is maintained at the company. Any safety concerns are flagged to the SAG Safety Unit to investigate.

At the time of phytosanitary inspection, samples may be taken under the annual sampling plans for chemistry and/or microbiology. This follows the guidance in technical norms or guidelines such as the Food Safety Guidelines for Exporting Fresh Fruit to Indonesia. Chemical and microbiological sampling as needed is mandatory only for Indonesia. Only SAG safety inspectors (supervisors who have received training for this purpose) can take chemistry and microbiology samples. Shipments can proceed pending results of analysis.

Samples are typically analyzed by a laboratory which has the contract to conduct that analysis. New methods must be validated by the SAG's Department of Laboratories and Quarantine Stations before they can be 'transferred' to contracted labs. SAG charges a fee per box inspected for this service.

If the lot is compliant, SAG approves the lot for export in the Multipuerto (Spanish only) system. A phytosanitary certificate is issued. A dispatch form for the lot may be entered into the system by SAG, or by SAG's inspection counterpart at the establishment.

SAG verifies GMPs (only) if needed by a destination market such as Indonesia. Evidence collected on site indicates that SAG does not conduct GAP or GMP inspections. Instead, they rely on industry's third party certifications as evidence of GAPs and GMPs. The agreement with Indonesia requires SAG to check that establishments that pack, store and inspect fruit for export to Indonesia have valid GMP certificates (including GAP certificates for their source growers). The GMP certificates should be issued by 1 of these:

The team recommended that SAG develop a procedure to verify GAPs and GMPs for all destination markets going forward.

Conclusion: SAG has started a national monitoring program for pesticide residues, heavy metals and microbiological contaminants. SAG does not verify compliance to market requirements unless they are specified in a formal agreement. Operators rely on their customers and ASOEX for information on market requirements.

SAG's compliance activities focus on phytosanitary requirements. At the moment, they don't conduct oversight of GMPs to verify compliance to Food Sanitary (Health) Regulation Supreme Decree No. 977 Article 69.

5.3.2 MINSAL

Food Sanitary (Health)Regulation Supreme Decree No. 977 Article 69 requires all establishments of production, preparation, preservation and food packaging to comply with good food practices (GMPs) in a systematic and auditable manner.

Before an establishment can operate, it must be authorized by MINSAL through a "Formalization of Food Facilities" health resolution. The resolution process is designed to verify compliance to the sanitary requirements established in the Food Sanitary (Health) Regulation. The health resolution is issued once before the first operation. It includes an attestation to carrying out GMPs as well as other non-food safety requirements. HACCP may also be needed, depending on the nature of food handled and size of the facility as defined in Technical Standard 187 (Spanish only). This standard does not show HACCP to be needed by fresh fruit packers or exporters. The health resolution is valid for 3 years. It is automatically renewed unless there is a change in the operation, for example an expansion of the facility.

The CFIA team didn't see evidence in the field of supervision or verification of ongoing sanitary requirements. This includes GMPs conducted by MINSAL. The CFIA team understands that verification may be conducted based on 1 of the following:

MINSAL delivers national and regional surveillance programs. These programs evaluate the safety and compliance of food according to their corresponding laws. This does not apply to fresh fruit. Although MINSAL indicated the need to check the risk for heavy metals in fresh fruit.

Conclusion: Chile's laws require all food establishments to be authorized by MINSAL and to carry out GMPs. In their field verification, the CFIA team didn't see any evidence of ongoing sanitary requirements by MINSAL.

5.3.3 Food safety controls and government oversight at the farms, packers, and exporters

The CFIA team visited farms, packers and exporters. During these visits, the CFIA team observed government requirements for:

The CFIA team focused on verifying that the following GAP and GMP elements were in place:

The team visited 8 fresh fruit operators (4 farms and 4 packing/exporting facilities). The fresh fruit products included apples, blueberries, kiwis, stone fruit (plums and nectarines) and grapes. Major export markets for these operators include US, Japan, China, Southeast Asia, Canada and Europe. The team observed that the operators are committed to the carrying out of GAPs and GMPs.

The CFIA team made the following general observations about the operators visited:

Conclusion: The implementation and monitoring of food safety controls at growers, packers and exporters of fresh fruit is mainly driven by industry requirements for third party certifications along the supply chain. All growers/packers/operators visited had GAPs and GMPs in place. Oversight is routinely conducted by third party certifying bodies as well as their buyers.

5.3.4 Traceability and recall

As outlined in section 5.3.1, all growers, packers, exporters, and pesticide applicators must be registered by SAG. SAG registers them with their Agricultural Registry System (SRA) (Spanish only). This process gives SAG the ability to effectively trace products back through the supply chain. Traceability of some products is further enhanced by the needs of special programs such as the special control program for raspberries.

ACHIPIA manages the online food alert (recall) system Red de Información y Alertas Alimentarias (Spanish only). The system is a portal for the rapid exchange of information between the ministries responsible for food safety for food for human or animal consumption:

This helps the rapid management of food safety events. It also helps a rapid response to countries that let Chile know of issues. The portal is available to the public. It gives information about events to consumers, market operators, academics, researchers and the general public. The portal has information on the Food Information and Alert Network.

MINSAL has authority to recall products which are distributed domestically. Their recall procedure is described in MINSAL's Manual of Procedures of the exchange of Information in Situations Related to Food Safety. The manual details the process described above for receiving and responding to international food safety issue notifications. MINSAL and its SEREMIs conduct follow-up activities and carry out actions as appropriate. This includes checks on recall effectiveness conducted by SEREMIs. In general, MINSAL takes a proactive approach and prevents exports when a product doesn't meet international requirements. These products may be diverted to the domestic market if they meet domestic requirements.

SAG has authority to both block (in the SRA system) and recall products for export. In the event of any non-compliance with national laws, SAG Central sends a letter to the regional director. The letter outlines the issue and instructs the regional director to visit the operator. A letter asking for an explanation of the issue is also sent to the operator by the SAG inspector. The operator is summoned to present their evidence to a "SAG Court". An official appointed by the regional director chairs the "SAG Court". If the infraction is found true, the official sends a report to the regional director who determines what sanctions are needed. The regional director must also inform the local SEREMI.

Conclusion: Chile has established procedures to follow up on non-compliances. This includes a system to recall and prevent export.

5.3.5 Sanctions

Each ministry has their own provisions and processes on fines, other sanctions, and appeals. For SAG, these are set out in:

Sanctions could even be decided by civil or criminal court depending on the nature and severity of the issue.

In general, SAG inspectors can't implement sanctions by themselves. They must first receive direction from the regional director. If an issue is considered an immediate food safety one, SAG inspectors can contact the local SEREMI. The local SEREMI may choose to carry out immediate measures to protect public health. The CFIA team was advised that SAG always coordinates sanction actions with MINSAL.

Conclusion: Chile has authorities and procedures for the determination and issuance of sanctions. The sanctions deal with non-compliances with regulatory or other requirements.

5.4 Food related illness and outbreak investigation

MINSAL monitors, controls and investigates etiological agent outbreaks. These activities are coordinated at the national level and carried out at the regional level by SEREMIs.

According to Decree 158 (2004) (Spanish only) - PDF (2.6 MB) (Regulation on Notification of Communicable Diseases of Compulsory Declaration), MINSAL must be notified of any foodborne diseases detected in Chile. Although public network laboratories must notify MINSAL, industry is not required to notify detection of foodborne disease agents.

MINSAL has surveillance systems that aim to control foodborne communicable diseases. These systems include:

In some instances, MINSAL collaborates with other ministries to conduct food safety investigations. For example, in 2018 SAG and MINSAL cooperated to investigate some table grapes. An incorrectly-formulated pesticide was used during the pruning of the grapes. The investigation was conducted by SAG. The affected product was seized and sent to a SAG laboratory for analysis. It was also restricted from being exported. The table grapes were only released after the operator demonstrated (through sampling) that they met requirements. This was confirmed through testing conducted by SAG. MINSAL ordered the destruction of the affected grapes because they were also destined for the domestic market. Had the product been exported, MINSAL would have advised DIRECON of the issue. DIRECON would have shared the issue with foreign CAs.

The CFIA team was told of another incident which involved the misuse of an authorized pesticide. The incident was detected through SAG's routine monitoring program. An investigation was conducted which resulted in a monetary sanction. There was no recall since all of the impacted product had been exported. The exporter was advised of the non-compliance. Although not a requirement, SAG expects that exporters will let their clients know of any non-compliances. Also, the pesticide manufacturer was fined and suspended pending verification that corrective actions were effective.

SAG communicates notifiable safety events to the Undersecretariat of International Economic Relations (SUBREI, former DIRECON). These safety events are those that:

For its part, MINSAL reports through INFOSAN.

Conclusion: Chile has defined authorities and procedures in place to report, investigate, and take action to mitigate risks associated with situations which may represent a risk to human health.

5.5 SAG laboratory controls

The Department of Laboratories and Quarantine Stations ('the department'):

In Chile, third party laboratories that are evaluated and approved ('authorized') by SAG can bid on government contracts. These contracts are to conduct analyses for official programs such as the PRMP. The Department of Commercial Transactions and Authorization of Third Party administers the National System for the Third Party Authorization. The PRMP is carried out under specific comprehensive requirements, conditions and obligations. SAG signs an agreement with authorized parties. At least once a year, the department is required to conduct supervision activities and audits of the laboratories authorized under the system. This happens even if some, or all, of those laboratories don't have a current contract to conduct analyses for SAG. Laboratory authorization can be suspended or revoked if there is a lack of compliance to requirements.

SAG, and some authorized third party, laboratories involved in testing SAG samples must be accredited to International Standards Organization ISO:17025. SAG laboratories are accredited by INN (Spanish only). INN is a signatory of the International Laboratory Accreditation Cooperation. INN accreditation is granted for 3 years. Some private laboratories are accredited by bodies other than INN, for example, American Association for Laboratory Accreditation.

SAG does not dictate the methods to be used. The methods should be validated and meet national requirements established by INN.

There are no national methods for pesticide residue analysis. All pesticide residue methods are validated against EU requirements (2002/657/EC).

Newly developed methods are maintained within the SAG laboratories network until they are fully 'developed'. This normally takes 2 years. Examples of these methods are ones for heavy metals, E. coli and Salmonella.The methods can then be 'transferred' to SAG laboratories and SAG-authorized laboratories. This makes the other laboratories in the network eligible to conduct/bid on the contract to conduct the analyses.

The department confirms any positive results generated by their laboratory network. The review of traceability and instrument needs is an example. In general, results are checked by SAG Central according to the criteria established by Chile such as Food Sanitary (Health) Regulation Supreme Decree No. 977, Resolution No. 1557 of 2014 and its amendments, and Resolution 33 and its amendments 762/2012 (see Table 2). Or, according to specific market requirements such as Indonesia (heavy metals).

The department reports to MINSAL when a pesticide result has an impact on public health. They plan to implement the same protocol for heavy metals. The requirement to report microbiological results to MINSAL already exists (Decree 158 (2004)).

Private laboratories can be fined if they don't meet the service standards defined in their contract. The service standard is normally 10 working days for pesticide residues.

Private laboratories in the system:

Conclusion: SAG's laboratory network consists of accredited private and public laboratories. These laboratories are authorized to analyze samples related to fresh fruit for export.

6. Closing meeting

On March 15, 2019, a closing meeting was held in Santiago with representatives of SAG, MINSAL, ASOEX and FDF. The CFIA team thanked SAG for their efforts in supporting the mission. They also thanked all participants for their openness and transparency. This facilitated an understanding of Chile's food safety system. An open discussion gave participants the opportunity to explain the CFIA team's observations and recommendations. This reinforced the good relations that CFIA has with Chile on the safety of fresh fruit exported to Canada.

SAG, MINSAL, ASOEX and FDF representatives acknowledged the CFIA team's observations and recommendations. They expressed their interest in future collaboration.

7. Conclusions

As a result of this visit, CFIA has established a:

8. Recommendations

  1. Ensure that the information pertaining to Canadian requirements on ASOEX's website is up-to-date, complete, accurate, and communicated to stakeholders in a timely manner.
  2. Conduct a risk assessment to consider increasing the scope of heavy metals to include arsenic (As), chromium (Cr), and mercury (Hg) to reflect the 5 priority heavy metals in Canada due to toxicity. Possibly also include less toxic heavy metals such as aluminum (Al), selenium (Se) and titanium (Ti).
  3. Continue to develop, expand and implement SAG's national microbiological monitoring program. Develop a baseline for pathogens in fresh fruit from Chile and monitor trends to help verify the effectiveness of the controls implemented by industry. Consider expanding the national monitoring program to include significant viruses and parasites. This information could be shared with ASOEX, FDF and MINSAL, and further correlated with animal health data.
  4. Modify SAG's PRMP sample size to achieve detection of non-compliances accurate to a 1% violation rate with 95% confidence as per Codex Alimentarius guidelines for residue monitoring programs in order to be compliant with the Canadian residue monitoring program.
  5. Design and implement a SAG program to verify the ongoing implementation of GMPs in packers and exporters and GAPs on farms to enhance confidence in the food safety systems implemented by industry. This would complement SAG's current monitoring and surveillance programs, and better position SAG to certify the fitness for human consumption of primary agricultural products for export.
  6. Review SAG's program requirement for full annual audits of all authorized third party laboratories regardless of whether the laboratory is currently under contract. For example, a randomized system of audits might achieve the desired assurance that appropriate controls are in place while reducing SAG's resource requirements to conduct annual audits.

Annex 1: Summary of the Canadian Food Inspection Agency (CFIA) recommendations/findings from the 2019 CFIA Assessment of Chile's Food Safety System for Fresh Fruit Final Report

Number CFIA recommendation Chile's action plan/comments
1. Ensure that the information pertaining to Canadian requirements on ASOEX's website is up-to-date, complete, accurate, and communicated to stakeholders in a timely manner. By March 2020, SAG and ASOEX will define and implement a coordination scheme to ensure that Canadian regulatory updates regarding MRLs are included in the Pesticide Agenda that ASOEX has available through its website and that such updates are communicated in a timely manner to interested parties.
2. Conduct a risk assessment to consider increasing the scope of heavy metals to include arsenic (As), chromium (Cr), and mercury (Hg) to reflect the 5 priority heavy metals in Canada due to toxicity. Possibly also include less toxic heavy metals such as aluminum (Al), selenium (Se) and titanium (Ti). The Department of Laboratories and Quarantine Stations of the SAG currently conducts Cadmium and Lead analysis in export fruit matrices. As part of the action plan, by 2020 the implementation and validation of the analysis of As, Cr, Hg in fruits and / or vegetables will begin. Next, the implementation of less toxic metals such as Al, Se and Ti will be evaluated from 2021.
3. Continue to develop, expand and implement SAG's national microbiological monitoring program. Develop a baseline for pathogens in fresh fruit from Chile and monitor trends to help verify the effectiveness of the controls implemented by industry. Consider expanding the national monitoring program to include significant viruses and parasites. This information could be shared with ASOEX, FDF and MINSAL, and further correlated with animal health data.

The baseline developed by SAG through the Department of Laboratories and Quarantine Stations, considers the analysis of Salmonella spp. and E. coli in export fruit. The fruit matrices verified to date are pome fruits, (apple and pear), berries (blueberry and frozen raspberry), table grapes and cherry. During 2020 the techniques in the nectarine and plum matrices will be verified.

The monitoring plan currently considers the analysis of 90 annual samples, distributed during the year and covering the different verified matrices. Thus, considering a n = 5 per sample, and the two bacteria to be analyzed, 450 analyzes will be performed for Salmonella spp. and 450 analyzes for E. coli. Progressively it is intended to analyze 200 samples, covering the different verified matrices, distributed during the year.

For the year 2020 it is expected to carry out, in addition, the verification of the technique for Listeria monocytogenes in pome fruits, and in 2021 it will be planned to verify the other fruit matrices that are in the baseline. By 2022, it is considered to complete the implementation of the monitoring plan for Salmonella spp., Listeria monocytogenes and E. coli.

With respect to viruses, it will be considered to start its implementation once reliable, validated and at an affordable cost analysis techniques are developed.

4. Modify SAG's PRMP sample size to achieve detection of non-compliances accurate to a 1% violation rate with 95% confidence as per Codex Alimentarius guidelines for residue monitoring programs in order to be compliant with the Canadian residue monitoring program.

The SAG since 2011 is working on a statistical validation of the sample size, which adjusts to the budgetary availability of each fiscal year. For the elaboration of the statistical design of the PMRP, information is used that allows obtaining the required representativeness of the system.

According to the volumes exported to Canada, during the 2017-2018 and 2018-2019 seasons, the main species are table grapes (37%), apple (21%) and blueberries (21%), which were 2019 represented in the PMRP with 344, 279 and 128 samples, respectively. By the year 2020, a similar samples number are being defined in the sampling plan for table and apple grapes and an increase in the sample size for blueberries. Other species that are exported to Canada, but in smaller volumes than those just mentioned, are plums (3.9%), mandarins (3.7%), nectarines (3.3%), kiwis (3.1%) and peaches (2.7%), which in the year 2019 were sampled in quantities of 74, 45, 83 and 45 samples, respectively. These defined quantities are consistent with the detections of residues found in these species, and that have a high compliance with the MRL standards of Chile and Canada, so that their sampling sizes will remain at similar values for the year 2020.

Considering that the number of samples and species is reviewed annually to determine the need for updating for the following year, the SAG during the year 2020 will study modifying the sample size in a stratified manner for the main export species, in order to ensure that in these species the detection of non-compliances accurate to a 1% violation rate with 95% confidence, according to Codex guidelines. Notwithstanding the foregoing, the history of PMRP detections in previous years will be taken into consideration, as well as notifications of non-compliance by importing countries of Chile's fresh fruits.

5. Design and implement a SAG program to verify the ongoing implementation of GMPs in packers and exporters and GAPs on farms to enhance confidence in the food safety systems implemented by industry. This would complement SAG's current monitoring and surveillance programs, and better position SAG to certify the fitness for human consumption of primary agricultural products for export. The SAG during the year 2020 will design and implement a pilot program to verify regulatory compliance in terms of safety, which will be applicable at the level of primary production and processing establishments / packers of fresh export fruit, which will focus on the main species that are exported to Canada, among other destinations. The results of this pilot program will be evaluated, in order to define its incorporation permanently within the official control actions that the SAG performs in the field of safety of primary fruit and vegetable products destined for export and which will be complementary to the monitoring plans existing.
6. Review SAG's program requirement for full annual audits of all authorized third party laboratories regardless of whether the laboratory is currently under contract. For example, a randomized system of audits might achieve the desired assurance that appropriate controls are in place while reducing SAG's resource requirements to conduct annual audits.

According to the "Specific Regulations for the Authorization of analysis / test laboratories", Code: D-GF-CGP-PT-012, Point N ° 9: Supervision of Authorized Laboratories, indicates that:
The SAG performs audits of "all" authorized laboratories through annual supervisions, at least one (1) visit per year. Similarly, the Service performs capacity tests (Interlaboratory Rounds), according to the programming required by the SAG, to verify that they continue to comply with performance standards, and in general all the conditions that allowed their authorization.

Thus, the Department of Laboratories and Quarantine Stations of the SAG, annually supervises / audits all authorized laboratories independently if they have a contract for the provision of services in force with the SAG. As evidence of this, the annual supervision program to the authorized laboratories executed in 2019 is attached. The supervision program for the year 2020 is under development.

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