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

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 assessment
• 4. Background
• 5. Findings
• 6. Closing meeting
• 7. Conclusions and recommendations
• 8. Recommendations
• 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

Abbreviations and special terms used in the report

ACHIPIA

Chilean Agency for Food Safety and Nutrition

ASOEX

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

BRC

British Retail Consortium

CA

Competent Authority

CFIA

Canadian Food Inspection Agency

DIRECON

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

EU

European Union

FDF

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

GAP

Good Agricultural Practice

GMP

Good Manufacturing Practice

HACCP

Hazard Analysis Critical Control Points

INFOSAN

World Health Organization International Food Safety Authorities Network

INN

Instituto Nacional de Normalizacion (National Standardization Institute)

MINSAL

Ministerio de Salud (Ministry of Health)

MRL

Maximum Residue Limit

PRMP

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

SAG

Servicio Agrícola y Ganadero (Agriculture and Livestock Service)

SEREMI

Secretarías Regionales Ministeriales de Salud (Regional Ministerial Health Secretariats)

US

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:

• were applied to the production and export of fresh fruits
• achieved outcomes to meet
  • Canadian import requirements
  • Canadian public health expectations

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:

• an established regulatory framework
• defined training requirements
• communication methods
• a laboratory network

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

• food safety requirements
• requirements for operators
  • authorization
  • registration (traceability)
• national monitoring programs for chemical and microbiological hazards

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.

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:

• give an opportunity to proactively find gaps
• recommend to strengthen a country's food safety control system
• support relationships to enhance food safety

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:

• interviews with Chile's CAs (Ministry of Health (MINSAL) and SAG) involved in:
  • the design, implementation and oversight of the food safety controls for fresh fruit
• visits to farms and facilities involved in:
  • the primary production, packaging, storage and export of various species of fresh fruit
• visits to government and private laboratories engaged in testing samples taken under the national sampling plans
• discussions with the Association of Exporters of Chile (ASOEX) and its research partner, the Foundation for the Development of Fruit (FDF)

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:

• summarize the team's observations
• present recommendations to further strengthen the national food safety system

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:

• Canadian import requirements
• Canadian public health expectations

The scope of the audit was limited to:

• relevant national laws and provisions
• design of the official system of controls
• controls for apples, blueberries, kiwis, stone fruit (plums and nectarines) and grapes
• controls for the export of apples, blueberries, kiwis, stone fruit (plums and nectarines) and grapes

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:

• verify CFIA's understanding of Chile's food safety controls:
  • laws
  • program design
• assess Chile's food safety control program implementation by observing:
  • verification activities conducted by national and regional CAs
  • primary producer (grower) conditions
  • packer/exporter establishment conditions
  • general level of operator compliance with the program requirements
    • corrective and follow-up actions

Information was collected at:

• 4 growers
• 4 packer/exporters or partners
• 1 government laboratory
• 2 private laboratories
• presentations and interviews with representatives of the CAs and trade associations (as outlined in Table 1)

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.

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:

• Safe Food for Canadians Regulations, section 8(1)
• Food and Drugs Act, section 4(1)

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 Pacific Ocean to the west
• Peru to the north
• Bolivia and Argentina to the east
• the South Pole

The Chilean fruit sector encompasses over 9,000 growers and exporters and ships to more than 70 markets^Footnote 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 commodities^Footnote 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:

• constitution
• international treaties ratified by Chile
• laws
• decrees
• resolutions enacted by administrative authorities such as Ministers, chiefs of public services, etc.

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

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

• Technical standard 174 Requirements for Application of Hazard Analysis System and Critical Control Points (HACCP) in Establishments of Foods
  • replaces Technical Standard 158 (Spanish only)
  • obliges establishments which are needed to carry out HACCP (see Technical Standard 187) to implement it (Point 4)
• Technical Standard 187 (Spanish only) Determination of Implementation of HACCP in Food Establishments that are required to implement Hazard Analysis System and Critical Control Points (HACCP)
  • Note: this document does not show fresh fruit establishments as being needed to carry out HACCP

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.

5.2.1.1 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:

• develop, update, harmonize and coordinate laws, standards, and policies about food safety
• design national surveillance programs
  • Note: no specific surveillance programs for fresh fruit
• coordinate policies in food sanitation
• notify of foodborne diseases
• manage:
  • the notification of domestic issues
  • alerts from other countries

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:

• food establishment:
  • approvals (including food service establishments)
  • sanitary inspection
  • control
• control and surveillance of food
  • Note: no specific surveillance programs for fresh fruit
• control of food imports
• monitoring, investigation and control of foodborne diseases
• control of labelling
• HACCP audits
  • Note: HACCP is not required for fresh fruit establishments

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).

5.2.1.2 SAG

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

• promote agricultural development of the country through the protection of animal and plant health, resources
• control agriculture inputs and products

SAG has the role and powers to:

• inspect
• supervise
• control regulated parties
• conduct surveillance
• monitor

SAG's activities include:

• propose laws and policies that support their goals
• verify the fitness for human consumption of primary agricultural products for export
  • via bacteriological analyses, etc.
• establish procedures to verify that the requirements of laws and specific destination markets^Footnote 3 are met
  • including food safety
• respond to reports of contamination
• approve pesticides
• control the use and sale of pesticides and fertilizers
• authorize third party laboratories
• supervise courses on pesticide use and management:
  • given by training entities that have an operational agreement signed with SAG
• grant credentials to applicators who have completed these courses on managing official notifications of non-compliance

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:

• Plant Protection Division
• Livestock Protection Division
• Natural Resources Protection Division
• Seeds Division
• International Affairs Division

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:

• Department of Laboratories and Quarantine Stations
• Department of Commercial Transactions and Authorization of Third Parties

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).

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.

5.2.2.1 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:

• the review and update of technical standards, indicators and goals
• to distribute resources by region and program

5.2.2.2 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 :

• would include aspects of food safety
• was developed with the Pontifical Catholic University of Chile and the Countries of the Southern Cone (Argentina, Peru and Uruguay)
• must be passed by regional supervisors and export coordinators
• will be evaluated to decide whether inspectors must pass this course before they can conduct export certification activities

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):

• must be either an agronomist or an agronomy technician
• take a 3-day training on sampling and a 2-day training on pests
• are continuously evaluated by regional SAG supervisors or coordinators

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:

• consists of safe handling, use, storage, disposal, etc.
• content is defined by SAG Central (Spanish only) - PDF (3.5 MB)
• normally delivered by third party providers that are audited by SAG

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

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

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)):

• designs, implements, coordinates and innovates the national food safety and quality system supported by the Minister of Agriculture
• serves a coordination function between the parties in the food system:
  • growers, industry, the state, the scientific community and consumers
• serves as Chile's representative and secretariat for Codex Alimentarius

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

5.2.3.1 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:

• coordinates its activities with Chile's public sector
• take part in SAG Commissions
• learns about SAG requirements
• has formal agreements with SAG for mutually beneficial projects
  • for example, export statistics
• helps carry out SAG's requirements by:
  • developing policies on best practices
  • providing information and technical guidance related to topics such as GAPs, GMPs, and foreign country requirements to the sector in coordination with SAG and MINSAL

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.

5.2.3.2 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.

5.3 Food safety control program

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

• requirements in national laws
  • GMPs, pesticide use and handling (see Table 2)
• registration systems
• SAG's Agricultural Registry System (SRA)
  • MINSAL's Health Resolutions systems
  • a national laboratory network that is qualified to conduct analyses
• verification and monitoring programs
• inspection and certification programs
• management of official notifications of non-compliance

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:

• CSG = grower
• CSP = packinghouse
• CSE = exporter

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:

• pesticide applicators
• laboratories (authorized to conduct analyses)
• entities who are authorized to take samples and inspect (SAG)

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:

• on farms
• in fresh fruit packing
• in exporting establishments

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:

• pesticide residues
• heavy metals
• microbiological contaminants

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

• makes sure that compliance to export market requirements is verified
• establishes the design and technical guidelines to perform the Official Monitoring System for:
  • chemical and microbiological contaminants
  • verification programs (the pesticide use control program)

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.

5.3.1.1 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:

• export and distribution volumes
• inherent risk
• history of detection or non-compliance
• specific market requirements (Indonesia, European Union (EU), Russia, US)

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:

• official SAG laboratories
  • in the case of samples for heavy metals and microbiology
• SAG-authorized laboratories
  • contracted for this purpose by SAG
  • in the case of pesticide residues

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:

• sample size
• volumes
• historical rates of non-compliance
• risk factors related to compliance

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.

5.3.1.2 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:

• production
• commercialization
• use (see Table 2)

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:

• pesticides
• pesticide ingredients
  • both imported and domestically-manufactured
• people who apply pesticides ('pesticide applicators')

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.

5.3.1.3 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:

• by a dedicated company employee
  • certified by SAG to conduct phytosanitary analysis
• according to the requirements which are available in the SRA

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:

• a certification body that is accredited to Chile's National Standardization Institute (INN)
• another internationally recognized accreditation body

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

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:

• according to a risk-based control procedure and inspection plan
• in response to issues:
  • for example, notification from foreign countries, complaints, or illnesses

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.

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:

• licences
  • for pesticide applicators
• sampling
  • in the case of food safety samples taken by SAG

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

• general requirements and infrastructure
• hygiene
• training and skills development
• traceability and recall
• validation procedures and sampling
• records
  • standard operating procedures
  • flow diagrams
  • other records to support that their food safety programs were being carried out

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:

• all packing facilities visited had a valid MINSAL health resolution
• all operators had 1 or more valid third party certifications
  • for example, GlobalG.A.P. and BRC where GAPs, GMPs and HACCP must are carried out
  • Note: these aren't a government requirement but rather, a market requirement
• grounds, premises and equipment are generally well-maintained
• infrastructure is generally proper for the activities conducted
  • included the control of entry and exit for workers and visitors
• operators had sanitation, hygiene and pest controls in place
• operators had proper washroom facilities with sufficient supplies
• employment is solicited mainly through the local communities
  • many workers return on a seasonal basis
• employee entry procedures (hand washing, no jewellery, wounds, etc.) are clearly posted in strategic areas (for example, entry point of the farm, packing facility, etc.)
• employees must wear proper PPE during production
• employees are trained on:
  • general topics like hygiene, internal procedures, good handling practices of agro-chemicals, use of PPE, etc.
  • other topics like specific procedures as needed
• operators implement traceability systems
  • allows operators to trace a product back to the farm and lot of origin, and in many cases, to a group of pickers
• pesticides and agro-chemicals are stored in secure areas accessible only by designated trained staff
  • controls are in place for the disposal of empty agro-chemical containers
  • agro-chemicals are handled only by trained staff
• farms had systems in place to alert staff and visitors of any pesticides applied to a field
  • alerts included product applied, date of use, date of withdrawal, and any special measures needed
    • for example, "no entry for pregnant or lactating women" in each field as needed by SAG
• packer/exporters only sourced input from farms that had GAPs in place
• operators conducted internal audits of their food safety program
  • and sometimes that of their supplying farms
  • as needed by their third party food safety certification(s)

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:

• MINSAL
• SAG
• the National Fisheries and Aquaculture Service
• DIRECON
• the Office of Agricultural Studies and Policies
• ACHIPIA

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.

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:

• Organic Law of SAG No. 18.755 (1989) (Article 14)
• Decree Law No. 3.557 of 1980 (see Table 2)

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.

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:

• morbidity surveillance related to foodborne diseases
• laboratory surveillance of etiological agents
• environmental surveillance for food control

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:

• involve primary export fruit and vegetable products
• need to be notified to the competent authorities
  • in the case that the products have been exported to those markets

For its part, MINSAL reports through INFOSAN.

5.5 SAG laboratory controls

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

• analyzes pesticide and heavy metal samples for exports under SAG
• analyzes private samples for a fee
• confirms private sample analyses
• develops new analytical methods
• audits, authorizes and supervises private laboratories
  • those that would like to work for SAG
• analyzes agricultural soils
• monitors fertilizers
• establishes technical guidelines for:
  • the SAG network of regional laboratories
  • the network of authorized external laboratories for the official programs and activities of SAG
• is a member of the Inter-American Network of Food Analysis Laboratories (Red Interamericana de Laboratorios de Análisis de Alimentos)

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:

• typically have multiple accreditations
  • INN
  • American Association for Laboratory Accreditation
  • Entidad Nacional de Acreditación (The National Accreditation Body of Spain)
• offer more services to meet the needs of their customers
  • for example, Listeria testing

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:

• general understanding of Chile's food safety program for fresh fruits
• foundation for good working relations with the CAs involved

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