Canadian Food Inspection Agency On-Site Assessment Report of Guatemala's Food Safety Control System for Fresh Blackberries, Raspberries and Peas - 2016
8. Closing meeting

8.1 Observations

During the closing meeting the following observations were shared with the CA:

1. Guatemala has in place a food safety control system which is shared across the MAGA and the PIPAA, and supported by the export community.
2. All exporters of fresh unprocessed foods must have an OSL before they can export. The OSL - which is based on GAPs, GMPs, and Codex norms - is granted by the MAGA following a company's annual on-site inspection which confirms compliance with the MAGA's requirements.
3. The checklist currently used by the MAGA was developed in the 1990s by the PIPAA in collaboration with the US FDA. It was adopted by the MAGA in 2004. The current version of the checklist was dated 2006. It does not include minimum acceptability criteria for sampling and testing.
4. It is expected that any corrective actions resulting from these activities will be addressed within 30 days or, by an agreed upon schedule (up to 2 months). However, during 1 of the visits, the team noticed that several corrective actions had not been implemented despite the fact that the MAGA re-issued their OSL.
5. Companies are not required to notify the MAGA of complaints/recalls/potential food safety issues other than the finding of E. coli in water.
6. There is no regulatory requirement for a company to initiate a trace-back in the event of a potential food safety risk, for example, an ill employee.
7. A Phytosanitary Certificate is issued for unprocessed foods of plant origin on the condition that the operator has a valid OSL and proof of export shipment inspection issued by the PIPAA. Results of analysis (microbiological, chemical, and physical) are attached to the documentation package if they are required by the importing country.
8. Companies often have multiple third party certifications, for example, Global GAPs, Primus GFS, Costco, Tesco, etc. which require annual on-site inspections. They are also audited regularly by other country authorities, for example, the US FDA. Some exporters participate in the US FDA 'green list' program which grants them access to the US market without being subject to detention for physical examination.
9. The industry appears to rely on chlorination (which is not reliably effective for parasites, viruses) and annual water testing for indicator organisms only, that is, E. coli and other coliforms to mitigate the microbial contamination of the water supply. Even so, reliable implementation of chlorination was acknowledged as an ongoing challenge.
10. Companies have not developed comprehensive sampling plans for their sites and therefore have limited capacity to conduct trend analysis.
11. No routine sampling and testing for Cyclospora is conducted by companies or the CA.
12. There are no oversight controls in place specifically for Cyclospora or, for other protozoan parasites.
13. Private laboratories also receive multiple third party audits each year (for example, from the US FDA, EU, OGA, etc.) to verify compliance with ISO 17025.
14. Although the food laboratories visited have limited capacity for Cyclospora testing, they have signalled their interest in expanding their scope of analyses to include Cyclospora.
15. Although the MAGA has the authority to conduct surveillance activities, collect samples and submit for testing, etc., they do not routinely do so. They appear to accept results which are required by international third party certification schemes.
16. Although the outcome of the MAGA's investigation into a previous concern regarding fresh Guatemalan produce conducted at the request of CFIA identified the opportunities for improvement. However, during the visit, the team did not observe the implementation of any additional control measures that could mitigate the risk of Cyclospora contamination.
17. One (1) of the farms visited does not filter their water except for the purpose of removing physical debris. This farm also uses unchlorinated well water for irrigation.
18. Given the season, it was only possible to observe companies that were handling beans.
19. In discussion with the CA during the on-site visit the assessment team realized that the information provided in the Canadian Assessment Standards tool did not mention that the MAGA has 2 laboratories involved in the testing of foods, nor that small cooperative farms without basic services are involved in the export of fresh berries and peas. Therefore, activities to observe these sites were not included in the assessment plan. In addition, due to operational requirements, and security policies established by the Embassy of Canada to Guatemala, we were unable to meet with other the MAGA inspectors.

8.2 Recommendations

The CFIA assessment team identified the following areas where Canada could offer recommendations for improvement:

1. Develop and implement a process for the continuous improvement of the MAGA's oversight systems (for example, ensure routine updates of their checklist based on current knowledge, international standards, etc.), add minimum acceptability criteria, optimize documentation maintenance procedures, avoid overstock of outdated versions.
2. Develop and implement a system to validate the effectiveness of industry's recall capabilities.
3. Strengthen documentation of corrective actions and the process of issuing of an OSL.
4. Develop capacity and expertise at the national level in the detection of, bacteria, parasites including Cyclospora, viruses, and including organisms that are antimicrobial resistant. This will facilitate the surveillance of the human population necessary to better inform risk-based decisions for microbiological control, and enable more effective monitoring of the effectiveness of those measures.
5. Encourage industry to enhance their routine random sampling and initiate monitoring programs, trend analysis, verification of controls, etc.
6. Include filtration as an integral part of all food safety plans as the only effective means of control of Cyclospora and other protozoa. Standardized procedures for the use, maintenance (including replacement) and verification of the effectiveness of these filters should be developed, based on available international standards.
7. Take caution when interpreting negative results of analysis, particularly for chlorinated samples, since most of the testing performed for E. coli and coliforms appears to employ culture-based assays which rely on the presence of live bacteria in order to detect their presence. In such cases negative results can only be used to demonstrate the effectiveness of chlorination for killing susceptible bacteria, but not to demonstrate whether fecal contamination has occurred or not. This would require detection methods that do not rely on viable bacteria in the samples, such as polymerase chain reaction.
8. Explore other available test methods for the analysis of water and produce for Cyclospora and Cryptosporidium, for example, the US FDA method to provide a more suitable indicator model for both untreated and chlorinated water.

8.3 Conclusions and next steps

As a result of this visit, the CFIA assessment team has established a general understanding of Guatemala's food safety control systems and a foundation for future working relations with our Guatemalan counterparts, including channels for open communication and information-sharing.

The representative from the MAGA acknowledged the observations presented by the CFIA team and expressed their future interests in collaboration.

The team also indicated that they would advise CFIA's Technical Assistance group of Guatemala's interest in working together to identify potential opportunities for targeted technical assistance.