Canadian Food Inspection Agency On-Site Assessment Report of Guatemala's Food Safety Control System for Fresh Blackberries, Raspberries and Peas - 2016
5. CA and official controls

5.1 Overview of roles and responsibilities

The responsibility for the oversight of food safety is shared between 3 government departments (see Appendix A):

• the Ministry of Public Health and Social Assistance (MSPAS)
• the Ministry of the Economy
• the MAGA

The specific jurisdiction, authorities and requirements are defined by a series of decrees (official orders issued by legal authority) and intergovernmental agreements (also legally binding) such as the National Snow Pea Committee, comprised of representatives from the MAGA, the Ministry of the Economy, and the Exporters Committee from the Guatemalan Exporter's Association (AGEXPORT).

The Ministry of the Economy is responsible for tariffs. They are also the Guatemalan representative to international trade organizations such as the World Trade Organization.

In addition to being responsible for public health in general, the MSPAS is responsible for the oversight of the safety and quality of processed products of plant origin. Decree 90-97 "Health Code of the Republic of Guatemala" confers upon the MAGA the authority and responsibility for the oversight of food safety controls including for fresh (unprocessed) products of plant origin for export. In 2004 the MAGA's Food Safety Directorate (FSD) was established specifically to address this responsibility. Appendix B provides an overview of the MAGA's current organizational structure.

Furthermore, Guatemala's Government Agreement No. 455-2013, Article 1 confers upon the MAGA the regulatory authority to delegate food safety inspection for the purpose of export. Through this agreement, the MAGA has delegated some of the export-related responsibilities to the Comprehensive Program for Agricultural and Environmental Protection (PIPAA), a public-private alliance which is responsible for issuing phytosanitary certificates, delivering of training programs and supporting industry's implementation of GAPs and GMPs. The PIPAA is the primary consultative interface between industry and the MAGA.

The PIPAA is governed by an Advisory Board and an Executive Directorate. The Advisory Board is comprised of a Chair (Deputy Minister of the MAGA), 4 representatives from the MAGA, 3 representatives from AGEXPORT, 1 member from each of the Association of the Chemical and Agricultural Guild, the Association of Users of the PIPAA, and the PIPAA. The functions of the Executive Directorate are proposed by the Advisory Board.

5.2 Overview of food safety controls

In order to export fresh unprocessed foods of plant origin, a company requires a valid Operating Sanitary License (OSL) which is issued by the FSD of the MAGA (the CA). The MAGA has the regulatory authority to grant or renew the OSL based on the legal provisions of Guatemala's Government Agreement No. 72-2003.

The CA has regulatory authority to inspect, investigate and verify compliance with good agricultural, good handling practices and other food safety requirements under Guatemala's Government Agreement No. 969-99.

Exporters must apply to the CA for an OSL for the activities which they are conducting (for example, growing, packing, storage, and transportation of fresh unprocessed foods of plant origin) in order for the product(s) to be eligible for export. The OSL is issued by the CA once it has been determined that the exporter complies with the relevant regulatory requirements and after an on-site verification. The OSL is valid for 1 year and is issued only after compliance with the food safety requirements is confirmed by an on-site inspection by the MAGA.

The MAGA conducts their on-site annual inspection using the check list that was developed by the PIPAA in collaboration with the US Food and Drug Administration (US FDA). The checklist, which is based on GAPs and GMPs, defines the MAGAs baseline food safety requirements. Although the original checklist has been revised several times to reflect updates to various regulations, the current version of the check list dates back to 2006.

Deviations from the check list requirements are classified into 2 categories: low or high risk each of which has a specified or agreed upon time frame for implementation of corrective action(s) (up to 2 months for low risk deviations). Effective implementation is subsequently verified by the CA through document review when it involves low risk deviations and an on-site verification when a high deviation is involved.

The PIPAA plays a key role in assisting small, medium and large farms and cooperatives in meeting the food safety requirements and in preparing for, and responding to, the MAGA's annual inspections. The PIPAA visits the approximately 970 registered producers every 3 months to help operators meet GAP requirements including records maintenance. If a producer does not meet the GAP food safety requirements, the producer is removed from the PIPAA's registry of export eligible producers and is no longer eligible to export until corrective actions have been effectively implemented.

In addition, in order to export a company must have a valid Phytosanitary Certificate for every shipment exported. This is issued by the PIPAA only when the exporter holds a valid OSL.

5.3 Program resources and training

Currently, the MAGA's FSD has 4 inspectors assigned to conduct annual inspections to verify compliance with baseline food safety requirements; however staff from other directorates can be cross-utilized if necessary. All of the MAGA's personnel are trained as agronomists, veterinarians or zootechnicians. Most have a food safety background and complete a university-accredited course(s) in food safety when they join the MAGA. Training is delivered by a third party provider (for example, the US Department of Agriculture, the US FDA, and Hazard Analysis Critical Control Point Alliance) and may be sponsored by, for example, the US Department of Agriculture, US FDA, EU, and others. In addition, before being authorized to conduct inspections, new inspectors must be supervised by a senior inspector for 3 to 5 months. The FSD has an internal procedure to verify that their inspectors are following the appropriate procedures.

With more than 450 companies currently registered with the FSD over 80% of the FSD inspector's time is spent in the field conducting annual inspections to facilitate the issuance of OSL's. The inspector's schedule is designed to ensure impartiality by rotating inspectors. The MAGA maintains inspection-related records for 10 years.

The PIPAA has 50 employees who are dedicated to various phytosanitary and food safety activities such as facilitating training of growers, providing technical support, developing guidelines, and collecting samples for testing. There were 14 inspectors/auditors trained by the US FDA in GAPs and GMPs.

5.4 Traceability and recall

Every company is required to have an effective traceability system before they are issued an OSL which certifies them for export.

When the MAGA is notified by another CA of a food safety incident/outbreak involving Guatemalan produce, they conduct a comprehensive investigation into the implicated farm(s) and packer(s). This includes a document review of the farm/packer's production history and food safety programs, and an on-site inspection. Evaluation of any test results generated related to the event (food, water, and environmental samples, etc.) also falls within the scope of the investigation.

5.5 Microbiological testing and laboratory controls

The MAGA does not prescribe any microbiological sampling or testing except for an annual water analysis for generic E. coli. Samples for this purpose are collected by the PIPAA. In addition, PIPAA collects 1 sample per grower per season for analysis of chemical residues to meet the MAGA's requirements. There is no requirement for physical analysis. In the case of a non-compliance and /or food safety investigation, the MAGA requests the implicated company to collect samples for testing at their expense. However, although the MAGA has a laboratory, it does not currently have the capacity to perform this testing. Therefore, sampling is typically conducted either by trained company personnel or, by a contracted sampler who is employed by a private third party testing laboratory.

Each company is responsible for any additional analysis of water, food and environment in accordance with requirements for third party certification, that is, Global Good Agricultural Practices (Global GAPs), Primus, Costco, Tesco, etc. Water used for cleaning, personal hygiene, processes etc. must comply with the standards of Guatemala's water normative: COGUANOR NGO 29001. The MAGA reviews reports of analysis as part of their annual on-site inspections. In addition, the PIPAA takes a food sample to be analyzed for chemical contamination from each producer at the beginning and end of the production season.

All sampling and testing is performed by International Organization for Standardization (ISO) 17025 accredited laboratories. At the time of the assessment there were 38 member laboratories in AGEXPORT's Laboratory Commission. The number and scope of accredited laboratories is increasing each year. While most routine testing is conducted in Guatemala, external laboratories may be contracted for specialized analyses.

5.6 Implementation of food safety controls at the farm, packing and exporter levels

The CFIA team visited 2 farms and 2 packers/exporters in order to observe and assess how the CA verifies the implementation of Guatemala's food safety requirements. These visits focused on:

• premises of the farms and packing facilities
• transportation/receiving/shipping/storage
• equipment
• personnel
• sanitation and pest control
• recall and traceability
• oversight by the CA

During the visit the assessment team interviewed the Field Managers of both farms as well as key field staff, Production Managers of both packing/export facilities and their Food Safety Managers/Coordinators. The team reviewed a range of documents including their:

• Food Safety Plan
• Manual of Procedures
• Hazard Analysis and Critical Control Point diagrams
• training records
• employee health records
• third party audit reports and certificates
• results of internal audits
• the MAGA's inspection reports
• recall and traceability procedures including records of complaints
• sampling and testing plans and results
• pest control program
• sanitation program
• maintenance records

Overview of farm number 1 and packing facility number 1

This family business has been in operation for over 30 years and is currently responsible for over 50% of the blackberries exported from Guatemala. It also has operations in Mexico and Chile, and a head retail office in Florida, US. They grow and market a variety of produce under various trade names, with blackberries and French beans the most important fruit and vegetable crop, respectively. Their markets include the US, EU, Mexico, Canada and Japan.

The company employs approximately 25 staff across the 4 farms that they manage in Guatemala. During 2 peak harvest seasons, the number increases from 80 to 120 employees. Produce from the farms is packaged in a packing facility which is located in close proximity to the farms.

French (green) beans are trimmed by hand instead of being cut with a knife. To minimize handling damage and spoilage due to excessive moisture, the product is not washed.

The company owns its own transport vehicles to convey the product for export. Most of the product is shipped by air, but alternative shipping options by sea are being pursued.

The company has had a food safety system in place since 1997. They have a valid OSL for the harvesting, processing, storage and transportation of fresh fruits and vegetables. They also hold certification from Global GAPs and Primus Global Food Safety (Initiative) – a Global Food Safety Initiative Variant (Primus GFS). The company is subject to annual audits to maintain these certifications. Copies of their current certificates were observed by the assessment team.

Overview of farm number 2 and packing facility number 2

Established in 1998, this company consists of 4 farms: 2 certified organic, and 2 conventional. They share a common processing facility. They grow and market a variety of produce under various trade names, with French beans the most important vegetable crop at the time of the visit. Their markets include the US, Canada, Japan and the United Kingdom. This company was implicated in the 2015 Ontario outbreak of cyclosporiasis which was linked to snow peas.

The company employs approximately 16 to 26 field workers and 35 to 45 packing plant employees depending on seasonal needs.

French beans are trimmed using a knife, washed in a flume and dried in a centrifuge.

The company owns its own transport vehicles to convey the product from the farms to the packing facility.

The company has implemented a documented food safety (Hazard Analysis Critical Control Points) system based on Global GAPs, Primus GFS, and the Equitable Food Initiative.

The company has an OSL for growing and packing, and third party certifications from Global GAPs, Primus GFS, Costco and the US National Organic Program. The requirements of these schemes generally exceed the MAGA's baseline requirements.

5.7 Summary of observations at farm and packing facilities

The facilities visited have implemented and maintain food safety systems in accordance with the MAGA's requirements. They maintain valid OSLs for the activities they conduct.

Both operators have a Field Manager who is responsible for the implementation of the food safety system at the field level including training, worker health and hygiene, and overall production. The quality of the water, soil, fertilizers and the plants themselves are managed by a qualified agronomist. While 1 farm does not use manure on the fields (they use chemical fertilizers which are delivered via a drip irrigation system), the other uses compost and chicken manure which are applied 65 days before harvest. Neither farm uses human sewage to fertilize their farms.

The farms meet the MAGA's requirement to have deep water wells for irrigation. Entrance to the facilities is physically controlled with access limited to authorized personnel. Employees are trained to monitor chlorination equipment and levels and to maintain the filtration system (where one is in place). Microbiological analysis of water for E. coli and coliforms is routinely conducted twice per year (once each in the dry and rainy seasons), more frequently if necessary, for example, when filters are changed. Drip irrigation lines are flushed routinely to prevent clogging with soil and minerals.

The food safety management systems for packing and export are implemented and managed at both packing/exporting facilities by a Quality Manager who is a food safety specialist by profession. The Manager is supported by a quality team.

The food safety management systems are subject to annual internal audit and management review. In addition, they are subject to annual inspection by the MAGA and food safety audits by third party certification bodies. Corrective actions resulting from these activities are addressed within 30 days or, by an agreed upon schedule up to 2 months (in the case of low-risk issues identified by the MAGA).

As part of their food safety systems, both packing/export facilities have documented procedures to monitor raw materials, cleaning and sanitation, equipment, personnel hygiene, training, storage, waste disposal, transportation, traceability and complaints.

Employees must be trained before they can work at these packing facilities. Regular training sessions on food safety, personal hygiene, internal procedures and processes, etc. are also held throughout the year. Training is provided internally by the quality team and externally by third parties, for example, the PIPAA and various contracted services.

Company hygiene and health policies require staff to have a valid government health card which attests to the absence of a variety of illnesses/infections. It is renewed annually. Employee health and hygiene is monitored and documented routinely. Procedures are in place to remove an employee from handling produce if they don't meet health/hygiene requirements. In addition, employees have to attest in writing to their fitness to work each day prior to entering the packing facility.

Both operations have adequate hand washing stations and toilet facilities on the farm and in the packing facilities. Employees are required to wear personal protective equipment (for example, masks, aprons, gloves, hairnets, etc.) which is provided by their employers.

Written procedures are implemented for daily, weekly and other scheduled cleaning of the premises and equipment, including personal protective equipment.

Pests are managed by an integrated pest management system which includes various types of traps and deterrents. Monitoring of controls is conducted by a third party pest control company and by internal staff.

The companies have developed detailed traceability systems that allow them to trace back to the level of the farm, and lot. Even the picker can be identified by 1 farm. Mock recalls are conducted at least twice a year to test their system. While there are still challenges in maintaining records, companies are working to address this by developing standard forms and procedures, and applying to private certification schemes.

These companies manage complaints following their respective documented complaint procedure. They are not required to inform the MAGA of complaints unless there is an outbreak. However, companies are required to notify the MAGA when results relative to food safety are obtained, for example, the presence of E. coli. In the event of a complaint/recall/outbreak which implicates a fresh product from Guatemala, the exporter's client notifies the exporter directly. The exporter then initiates a follow up.

Each operation is visited once a year by the MAGA in order to renew their OSL; and every 3 months by the PIPAA. Third party certification bodies also audit annually. The assessment team confirmed that the implementation of the operations' written procedures is verified by the MAGA and the PIPAA during their on-site activities.