Canadian Food Inspection Agency's On-site Assessment Report of Mexico's Food Safety Control System for Fresh Fruit and Vegetables – 2017
6. The CRRS

6.1 Background

The first set of food safety laws for FFV was published following the creation of SENASICA in 2001. This led to the development of a food safety program in 2003 under which the first recognition was issued to an avocado producer in 2005. The program served as the foundation for the CRRS which came into being in 2013 with the publication of the legal framework to establish food safety programs. The purpose of the framework was to build a productive agriculture and fisheries sector, strengthen food safety and health of the population, and to increase the competitiveness of the agricultural sector.

Although the system is largely a voluntary one^Footnote 2, it has grown to 7,263 recognized operators in the primary production of fruits and vegetables (2016). SENASICA encourages the industry to participate in the program as a way of ensuring that they meet the import requirements of other countries (for example, The US Food Safety Modernization Act, etc.).

SENASICA is developing a new regulation in order to make it mandatory. Some existing modules from the current CRRS will be incorporated in the new regulation.

6.2 Overview of the program

The CRRS is based on GAPs and Good Manufacturing Practices (Hazard Analysis Critical Control Point principles). It is comprised of 15 core modules:

• Registration
• Infrastructure
• Hygiene
• Domestic and Wild Fauna Management
• Training and Skills Development
• Internal Evaluation
• Procedure Validation
• Traceability
• Production History
• Water Management
• Fertilization
• Good Use and Management of Agrochemicals
• Harvest
• Packaging
• Transport

The phases and activities in the CRRS recognition process include:

1. Diagnosis
   • Know the production conditions in which the hazard assessment and the food safety technical plan is developed.
2. Planning
   1. Implementation of the CRRS requirements
   2. Initial internal audit
      • Operators interested in obtaining CRRS recognition identify a person who will be responsible for food safety (Food Safety Technician; FST) who has appropriate training and/or experience.
      • As a first step, the operator engages a TPP (who may be associated with a CB or, an independent contractor) to assist them in meeting the requirements of the program and, to prepare them for a third party audit of their system.
      • A diagnosis (pre) audit is conducted while the operator is in the process of implementing the requirements of the CRRS to determine the level of readiness to proceed in the process.
3. Initial application for recognition
   1. Granting of a control number
      • Once the operator is ready, they submit a request to SENASICA's CRO which includes all of the documentation to support their application. SENASICA assigns them a control (identification) number.
4. Evaluation
   1. External audit (by a TPS)
   2. Review of CAs
      • A third party audit is conducted by a TPS to verify that the company has met the requirements of the CRRS. The TPS communicates their audit findings to the operator at the closing meeting and, captures them in an audit report. The report is sent to the CRO for evaluation. The CRO notifies the operator that they have 45 days to address non conformities by providing a corrective action plan. Operators must submit their corrective action plan to the CRO along with evidence of CAs taken for their assessment and verification.
      • Both the pre-audit and the third party audit are conducted using a common checklist which was developed by SENASICA.
5. Recognition (valid for 2 years)
   1. Decision to recognize
   2. Publication on SENASICA's website (Spanish only)
      • The CRO evaluates the CAs implemented by the operator as a result of the third party audit. If the operator is determined to meet the requirements of the program, a certificate of recognition is issued and the operator becomes part of the CRRS. The company is then listed on SENASICA's website (Spanish only).
6. Maintenance
   1. Internal audit (maintenance)
   2. Random inspection by SENASICA
      • Once an operator has been recognized, they are subject to an annual internal audit, conducted by a TPP who is different from the TPP who helped the operator to implement the system. Non conformities are issued by the TPP. A copy of the internal audit report is sent to the CRO for evaluation to maintain recognition. The same approach is taken to addressing non-conformities as for third party audits.
      • SENASICA also conducts random inspections of operators recognized under the CRRS to verify ongoing compliance.
7. Re-application for recognition (every 2 years) and renewal
   • Every 2 years the operator must complete the same phases as the initial process in order to renew their recognition.

6.3 Auxiliary parties involved in the implementation of the CRRS

Although the CRRS is a government program, its delivery is dependent on the work of various third party entities that are authorized by SENASICA to conduct the work. These include:

CBs

CBs are organizations of producers who support SENASICA in the development and delivery of phytosanitary and CRRS measures. There is 1 CB in each of Mexico's 32 states.

Each CB has a Technical Manager, a Food Safety Coordinator (FSC), several TPPs and Technical Assistants who support the delivery of the CRRS in each state.

Funding for the CBs comes from both SENASICA and the state government.

The main activities of the CBs and their TPPs are to:

• provide advice to operators on how to comply with the CRRS
• train operators and their staff on GAPs and Good Manufacturing Practices
• take samples
• conduct internal audits
• provide equipment and other physical support, for example, signage, portable washrooms, personal protective equipment, etc. (if financing is available)

Authorized third party professionals independents

These are TPPs who are not employed by CBs. They work independently.

Third Party Specialists (TPSs)

TPSs are independent professionals who verify the implementation of the CRRS by operators.

As of February 2017, 333 TPPs and 75 TPSs were recognized in the system. A current list of recognized (auxiliary) personnel is available on SENASICA's website.

6.4 Resources and training of parties involved in the implementation of the CRRS

The delivery of the CRRS relies on resources from the following organizations who need to maintain their technical skills and credentials:

SENASICA staff who work in the implementation of the CRRS

There are 63 SENASICA officers involved in the implementation of the CRRS. They are required to have a degree in agronomy, veterinary science, chemistry, or biology. Once hired, they complete hands-on training by shadowing an experienced inspector during verifications and inspections. They then conduct their own verifications and inspections under the supervision of an experienced inspector until they are considered to be fully trained. They can then conduct the work independently.

In order to maintain their competencies, they are required to receive 40 hours of training on relevant topics each year. Training is delivered by universities, specialized organizations, and research institutes. Training records are maintained. In addition, every officer undergoes an annual performance evaluation as per the requirements of the Professional Career Service Law on Federal Public Health.

Authorized third parties (TPPs, TPSs)

As of January, 2017 there were 333 authorized TPPs and 75 TPSs. Authorized third parties, for example, TPPs, TPSs must also have a degree in agronomic, biological, biochemical or agri-food-related sciences. They must demonstrate knowledge in topics such as GAPs, toxicology, good use and management of agrochemicals, Hazard Analysis Critical Control Point System, traceability and recalls, principles of microbiology, and sampling procedures and, they need to have at least 1 year of experience in a related field. TPSs are also required to have specific training in audit processes.

TPPs and TPSs are required to attend relevant training offered by SENASICA or external providers every year. FSCs maintain records of training received by TPPs and TPSs while the Manager of the CB maintains training received by the FSC.

6.5 Recognition/authorization and oversight of auxiliary parties

SENASICA conducts various activities under their authorities:

CBs

SENASICA oversees the CBs once they are granted recognition by SAGARPA. Through this recognition, SAGARPA delegates financial support and certain authorities for the delivery of the CRRS and other programs (aquaculture, etc.). The recognition is valid for 2 years.

The CBs are subject to both document and on-site reviews by the Safety Programs, Regulatory and International Affairs Office of DIAOOPA. Annual plans are prepared by each CB. They are reviewed and authorized by SENASICA before funding is provided.

The CBs are subject to both document and on-site reviews by SENASICA. Each month, SENASICA reviews the financial reports of each CB to ensure that program spending is on track. In addition, the CB submits an annual report on their activities to SENASICA for their review. This is complemented by on-site assessments (every 2 years) of the delivery of the program activities using a checklist which was developed by SENASICA. In this way, SENASICA can confirm that the CBs are delivering their mandate and, that enrolment in the system is increasing. SENASICA issues a report of their assessment of each CB which includes observations and a deadline to address them. In general, the CB is given 10 days to address observations.

CBs have systems in place to prevent conflict of interest, for example, TPPs who inspect a farm/packing unit will not be assigned to audit that operator; TPPs are rotated to avoid getting too familiar with a site; TPPs who are related to, or are friends, with an operator will not be assigned to that operator, if possible.

TPPs and TPSs

Candidates apply to become a TPP or TPS by submitting a documentation package in to DGIAOOPA's AAO. The application package includes training records, a log of experience, and a conflict of interest declaration. Following successful review of the information submitted, authorization is granted by the AAO through an agreement between the 2 parties. It is valid for 2 years. Renewal is subject to re submission of the same application package.

Although both TPPs and TPSs are authorized by SENASCIA, their performance is overseen by different parties, as indicated in Table 2. For example, TPPs who are employed by CBs are monitored and assessed by the FSC of their CB, whereas TPSs are evaluated by the AAO.

With respect to TPPs who work with a CB: the approach to monitoring their work varies in type, frequency and type of documentation used for the assessment and, for documenting the outcome of the evaluation. For instance, some CBs monitor the work of their TPPs on a yearly basis, focusing on the number of visits and quality of their work, while other CBs conduct on-site visits at operators to observe the work of the TPP.

TPSs are subject to supervision and performance evaluation by SENASICA at any time. The evaluation of TPSs consists of document reviews and on-site observations. SENASICA plans to evaluate 10% of TPSs each year. Candidates are selected through an annual draw.

As part of the document review process, each TPS is required to submit a monthly report of their activities to the AAO. It includes dates of evaluations, products involved, duration of the audit, and observations made. The AAO assesses the reports to identify training needs, and if needed, modifies existing tools and templates.

In addition, the CRO reviews the quality of the third party audit reports generated by the TPSs. Any inconsistencies are shared with the DIAOOPA's Federal Inspection and Verification Office and the AAO for assessment as part of the ongoing monitoring and evaluation of the TPS. AAO can suspend or cancel authorization of a TPS as a result of their evaluation.

SENASICA requires that TPSs are rotated to ensure third party audits are conducted by a different TPS each time.

Laboratories

Laboratories can be directly accredited by the national accreditation body Entidad mexicana de acreditación, a.c (Mexico's national accreditation body) or, they can be authorized to conduct various analyses by SENASCIA. The process of accreditation and authorization are different, however, operators under CRRS must use a laboratory that meets International Organization for Standardization (ISO) 17025 for the testing of official samples.

In collaboration with the NRCPC, SENASICA's AAO authorizes private laboratories based on the requirements of ISO 17025. There are 11 authorized laboratories. They are subject to oversight by SENASICA in collaboration with the NRCPC.

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

All of the operations visited had implemented the CRRS and 1 of them was in the process of implementing it.

The assessment team focused on verifying the implementation of the following core requirements of the CRRS:

• general requirements and infrastructure
• hygiene
• training and skills development
• internal audits
• good harvesting practices
• traceability
• validation procedures and sampling
• records
  • food safety plans
  • Standard Operating Procedures
  • flow diagrams
  • other records to support the implementation of the CRRS

General observations

The CFIA team observed that operators were committed to the effective implementation of the CRRS and, that the companies visited had the general requirements and infrastructure in place to support the CRRS.

Each operator had a Manual of Procedures which detailed the hazard analysis, critical controls, process and employee flows, field and facility maps, roles and responsibilities, procedures, templates and other tools, training records, employee health and hygiene, and production-related elements of the CRRS.

All operations had a FST who is responsible for the implementation of the CRRS at their operation (which could include more than 1 farm and/or 1 or more packing facilities).

The FST coordinates several activities including the development, implementation and maintenance of the Manual of Procedures. The FSTs are supported by an appropriate number of staff which depends on the size of operation.

Employee entry procedures (hand washing, no jewellery or wounds, etc.) were clearly posted in strategic areas (entry point of the farm, packing facility, etc.) – in pictures and often, in multiple languages.

Operators had sanitation and hygiene controls in place in the fields and packing facilities.

Infrastructure was generally appropriate for the activities conducted and included systems in place to control exit and entry of workers, visitors, and wildlife.

CRRS requirements for water to be supplied from deep water wells and, to for access to be restricted to designated trained staff were met.

Pesticides and agro-chemicals were stored in secure areas accessible only by designated trained staff. Controls were in place for the disposal of empty agro-chemical containers. Agro-chemicals were handled only by trained staff.

Operators implemented annual surveillance plans and maintained detailed records for the analysis of water, workers' hands, surfaces, product, soil, etc. Plans varied between operators but generally included analysis of basic microbiological indicators (fecal coliforms, Salmonella species and Escherichia coli and chemical contaminants (heavy metals, pesticides, etc.). Samples were taken by CBs, external contractors, or an accredited laboratory contracted to conduct the analysis.

Although operators are required to maintain a sampling database on the indicator's behaviour of products, water sources and contact surfaces records were generally not maintained in a way that would facilitate trend analysis or investigation of an issue.

Employees were trained on general topics every year, for example, hygiene, internal procedures, good handling practices of agro-chemicals, use of personal protective equipment, etc. and on additional topics, for example, specific procedures as required. Training was provided TPPs, FSTs/their staff, SENASICA, and external training providers.

Employee hygiene was monitored and documented routinely, for example, at start up, after breaks, etc. Procedures are in place to remove employees if they don't meet the general health/hygiene requirements and, to retrain staff if appropriate.

Operators had implemented documented sanitation and pest control programs.

Operators implemented detailed traceability systems which allowed them to trace a product back to the farm and lot of origin, and in many cases, to the picker, packing line, implements used, etc.

All operators had documented traceability procedures. Mock recalls are conducted at least once a year to test the effectiveness of their plans. Records demonstrated that although the procedure is implemented, there are some areas for improvement to ensure that operators are able to respond to real life situations.

Although the operators visited were recognized/in the process of being recognized, not all of their suppliers were recognized. Nevertheless, measures were implemented in the packing houses to mitigate risk of contamination. For example, 1 packer sourced product from over 100 suppliers, only some of which were recognized under the CRRS.

Some operators were actively encouraging their suppliers to become recognized by funding training, etc. It is also our understanding that SENASICA is moving toward making core modules of the program mandatory for all operators of all sizes (small, medium, and large) and levels of trade (domestic, import and export).

All operators visited had CB-associated TPPs assigned to them to support their ongoing implementation of the CRRS. Some companies engaged an independent TPP to conduct additional internal audits to validate the work of their CB-associated TPP.

Each operator had been subject to: and internal audit (conducted by a TPP) and, a third party audit (conducted by a TPS), both of which were conducted using SENASICA's checklist.

Operators typically submitted evidence of CAs taken as a result of a third party audits to the CRO before they received CRO's request for CAs.

Only a few operators visited had been inspected by SENASICA's Federal Inspection and Verification Office for activities other than the special programs (cantaloupes, papayas, cilantro and avocadoes).

Most of the operations visited held third party certifications to various food safety schemes but these were not considered to be a factor in their recognition process.

Not all of the laboratories engaged by the operators visited were authorized directly by SENASICA. Instead, they were accredited by the Entidad mexicana de acreditación, a.c (Mexico's National Accreditation Body).