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FAO and WHO. 2019. Food control system assessment tool: Dimension A – Inputs and resources. Food safety and quality series No. 7/2. Rome.

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CONTENTS

A.1 POLICY AND LEGAL FRAMEWORKS

A.1.1 Policy and legal drafting process

A.1.2 Institutional framework

A.1.3 Elements of food control legislation

A.2 INFRASTRUCTURE AND FINANCES

A.2.1 Financial resources

A.2.2 Infrastructure and equipment

A.2.3 Analytical resources

A.3 HUMAN RESOURCES

A.3.1 Qualification of personnel

A.3.2 Capacity development of personnel

A.3.3 Staff management & staff motivation

DIMENSION A aims at mapping the fundamental elements necessary for the system to operate. These range from legal and policy instruments to financial assets, equipment and infrastructure and human resources.

SUB-DIMENSION A.1

POLICY AND LEGAL FRAMEWORKS

This sub-dimension explores the policy and legal foundation of the food control system. Three main elements are assessed here: the quality of the policy and legislation drafting processes; the conduciveness of the institutional framework to an efficient use of the CAs’ resources and skills; and the incorporation of key technical elements into the legislation, aligned on internationally agreed good practices.

Competency A.1.1 (Policy and legal drafting process) analyses the existence of a food safety and quality policy and legislation of high quality, appropriate for its context, comprehensive and transparent. Two key areas are reviewed: first, an appropriate policy framework, where clearly articulated food safety and quality policies exist and are implemented through strategic plans that spell out CAs actions; and second, the existence of formal procedures for the policy and legal drafting processes and for the accessibility and publication of the legislation. The procedures should endorse comprehensive and participatory drafting processes, ensuring that the resulting food control system is inclusive, appropriate for the national context and clear on rights and responsibilities of CAs and on their technical independence and impartiality.

Competency A.1.2 (Institutional framework) features the elements that contribute towards an effective and efficient institutional framework for food control. A comprehensive, coherent and consistent distribution of mandates among CAs to ensure food safety and quality throughout the whole food chain should be complemented by mechanisms that ensure relevant and timely communication to exchange relevant information, as well as coordination among CAs to develop a common vision of food control. CAs, and their key staff, should also have all the necessary powers and responsibilities to carry out their mandates, while sufficient safeguards and appeal mechanisms should be in place to prevent abuse of power.

Competency A.1.3 (Elements for food control legislation) ensures that the legislation includes all the technical provisions necessary to implement food control activities and achieve the overarching objectives set in the food safety and quality policy. For this to happen, the food control legislation should apply to all steps of the food chain in a coherent manner. FBOs should have the primary responsibility for food safety and should be registered to enable proper oversight by CAs. The principle of risk analysis should be used as a basis for establishing food safety measures, while CAs should be legally empowered to provide regulatory oversight both on food production and on food imports, and to adjust their controls according to the level of risk. CAs should also be legally responsible for setting up efficient rapid alert, emergency preparedness and response systems, in line with international commitments and for surveillance of priority FBDs.

SUB-DIMENSION A.2

INFRASTRUCTURE AND FINANCES

This sub-dimension screens the fundamental inputs that should feed into the system to make it work properly, from the financial resources to sustain the system to the infrastructure to enable the food control activities to take place and the analytical resources to support official controls over food.

Competency A.2.1 (Financial resources) reviews the approach to allocating budget, its connections to the CAs’ strategic plans and the existence of key budgetary items. Financial allocations for CAs should be easily accessible to enable the achievement of established strategies. They should guarantee the hiring and retention of skilled staff in sufficient numbers as well as appropriate office space and necessary equipment for staff to properly conduct their work. Funding should also be secured for science-based activities, for the sampling activities related to monitoring of priority food safety risks, as well as for human health surveillance and food-related emergencies. CAs should also be enabled to participate meaningfully in strategically selected international events and an accountable and appropriate use of funds should be secured through budget audit and review processes.

Competency A.2.2 (Infrastructure and equipment) maps the suitable infrastructure and equipment that are necessary for CAs to perform their work effectively and according to the strategic food control plan as well as to ensure that data generated by food control can be used for risk analysis and enforcement purposes. To this end, food control staff should be provided with suitable accommodation and special facilities, including: vehicles to support inspections, sample collection and staff transportation; IT systems for recording, analysing and sharing the data collected; reliable and modern technologies for communication; and suitable sampling equipment, space and facilities for monitoring or surveillance activities.

Competency A.2.3 (Analytical resources) looks at the suitable analytical services necessary for CAs to carry out the analyses required by the food control system. Accredited laboratories should be able to provide an excellent standard of analytical services as requested by the CAs and should have the technical capabilities to address priority hazards as well as the capacity to respond to emergencies. Official methods and quality management systems should be in place and CAs and laboratories should work jointly to plan the analytical workload for servicing routine inspections, sampling programmes for monitoring of food safety risks, FBD surveillance and other scientific related activities.

SUB-DIMENSION A.3

HUMAN RESOURCES

This sub-dimension analyses the issues related to food control personnel and the importance of their qualifications, professional development and motivation to contribute towards the achievement of the food control policy outcomes.

Competency A.3.1 (Qualification of personnel) verifies whether CAs have a system in place to ensure they have access to suitably qualified personnel. CAs should engage properly qualified staff through selective recruitment and the prescribed requirement for properly qualified staff should also extend to the professional employees of contractor agencies.

Competency A.3.2 (Capacity development of personnel) focuses on the training programmes that should be in place to ensure staff can carry out the necessary range of food controls. Newly recruited staff should be provided with formal orientation courses and mentoring programmes should ensure a complementary programme allowing new staff to learn from more experienced and senior staff. Food control staff in general should be provided with periodic training update events while CAs should actively facilitate the professional development of staff. Continuous training would also ensure that staff take a uniform and updated approach to control issues. Training needs assessment of the staff at all levels should be at the basis of the training framework.

Competency A.3.3 (Staff management & staff motivation) explores the systems CAs have in place to ensure staff are properly compensated, motivated and protected. On time and correct payment of salaries supports staff motivation, performance and probity. Regular staff appraisals and opportunities for career progression increase good work performance of staff. Staff should also have a safe possibility to report wrongdoing of colleagues or officers of other institutions without exposure to adverse reactions. While political changes will occur periodically, mechanisms should be in place to maintain sustainability of programmes and internal stability.

A.1
POLICY AND LEGAL FRAMEWORK

A.1.1

POLICY AND LEGAL DRAFTING PROCESS

The policy framework and legal drafting processes allow the legislation of the country to be of high quality, fit for purpose and transparent (Ref. para 31 of CAC/GL 82-2013).

A.1.1.1

ASSESSMENT CRITERION:

Clear policy guidance is available for food safety and quality.

GUIDANCE

Countries should have a policy document explaining the national goals, objectives, priorities and responsibilities for ensuring food safety and quality, with a clear statement of commitment to achieve those goals and overarching objectives (Ref. para 30, 34, 35 and 38 of CAC/GL 82-2013). This would provide an enabling environment for the different stakeholders involved in the food control system and would guide subsequent actions, including the establishment of strategic plans for food control, legislation and regulations.

Such a policy document would require a careful assessment of options and should include the identification and clear articulation of expected outcomes (Ref. para 30 of CAC/GL 82-2013). It should affirm the precedence of protection of consumers, and that in the event of conflict with other interests, the health of consumers is considered as the priority in driving the course of actions under a national food control system (Ref. para 8 of CAC/GL 82-2013).

A food safety and quality policy should also place emphasis on prevention, as a general approach to be taken by both CAs and FBOs. This focus on prevention should be supplemented by capacities of intervention and response (Ref. para 19 of CAC/GL 82-2013).

Factors that are likely to shape a food safety and quality policy include: the national context; food production and consumption patterns; consumer concerns; stakeholder interests; an assessment of risks and/or benefits; effectiveness and efficiency of various controls and methods of oversight; existing and planned government structures; coordination among authorities along the food chain; technical and scientific information; the roles of government and food business operators; and best practices/models (Ref. para 25 and 33 of CAC/GL 82-2013).

Stakeholders, including FBOs and consumers, should be actively involved in this policy setting process.

POSSIBLE OUTCOME

Sustainable and clearly articulated policies are published and publicly available, and drive CAs’ courses of action, contributing to the national outcomes of the food control system.

POSSIBLE INDICATORS

> A clear policy document:

i. Outlining the national goals, overarching objectives, priorities and activities to ensure food safety and quality;

ii. Stating the commitment to achieve these goals;

iii. Giving precedence to consumer protection, in particular consumers’ health;

iv. Highlighting a preventative approach by FBOs and CAs, supported by adequate capacities of intervention and response.

> The document takes into account national specificities (e.g. in areas such as food production and consumption patterns, consumer concerns, stakeholder interests, existing and planned government structures).

> Evidence that there are resources assigned to food control.

> Evidence of stakeholders’ involvement in the development process of the food safety and quality policy.

SOURCES OF EVIDENCE

> Policy document.

> Documented commitment to food safety and quality (e.g. activity by CAs such as workshops, activities, records, recent legislation).

SEE ALSO

A.3.3.5 [CAs maintain sustainability of programmes and internal stability even in times of political change]

A.1.1.2

ASSESSMENT CRITERION: Food control strategic plans are prepared by Competent Authorities (CAs) and translate into action the overarching objectives set out in the food safety and quality policy.

GUIDANCE

While the policy document sets out goals or desired outcomes for food safety and quality at national level, CAs need to design and strategize their course of action into strategic implementation plans where detailed operational outcomes for food control activities are prioritized. This is key to demonstrate and support policy coherence, by providing overarching guidance on implementation.

These plans should specify priorities and time frame for implementation and deliverables, as well as responsibilities. They will also be the basis to ensure alignment between objectives and resources (financial, human, equipment, transportation, etc.) This can be used as a negotiation basis for overall resource allocation. It will also be useful to ensure matching numbers, qualifications and training of staff with specific missions and allow planning and ensuring proper stakeholder engagement (Ref. para 42, 59 and 69 of CAC/GL 82-2013).

In some countries, such documents exist at a consolidated level, directly related as a strategic subset of the policy framework; in others, each CA would have its own strategic plan. In these cases, it is important to check that there is coherence and complementarity among these strategic plans, as they should all contribute to meeting the overarching objectives set out by the policy. These plans should also ensure consolidated reporting, thus supporting monitoring of outputs and outcomes. The next planning cycle should take into account results and lessons learned from implementation in previous years. This should also inform subsequent policy review cycles.

POSSIBLE OUTCOME

Implementation of food safety and quality policy is supported by an instrument demonstrating accountability of Competent Authorities.

POSSIBLE INDICATORS

> Existence of one or several complementary strategic plans for food control activities.

> Consolidated results deriving from implementation plans documented and analysed.

SOURCES OF EVIDENCE

> Documented plans.

> Implementation reports.

SEE ALSO

A.2 [Infrastructure and finances]

A.3.1 [Qualification of personnel]

A.3.2 [Training of personnel]

A.3.3.5 [CAs maintain sustainability of programmes and internal stability even in times of political change]

B.1.1.4 [Periodic inspection plans developed by CAs are based on an articulated rationale and are implemented]

B.1.1.9 [Official controls implemented by various CAs at all levels of the food chain are organized to be continuous, joined-up, comprehensive and strategically complementary]

B.2 [Monitoring, surveillance and response functions]

A.1.1.3

ASSESSMENT CRITERION: Food safety and quality policy and legislation are developed on the basis of written principles and procedures that enable comprehensive and participatory processes and ensure “fit for purpose” results.

GUIDANCE

Countries should have written principles and procedures guiding the process for drafting or updating policy and legislation that can be applied to food control. These principles and procedures should meet the following criteria:

> Take into consideration the different food safety and quality interests (including health, economic development and trade), represented by the relevant public and private actors, including international organizations.

> Be participatory; enable participation of different public and private stakeholders and take their feedback into consideration (Ref. para 32 and 41 of CAC/GL 82-2013). Besides food business operators (FBOs) and consumer associations, which are potentially more structured, participation of specific and/or more vulnerable groups potentially affected by the legislation (such as indigenous communities, women, specific consumer groups) should be taken into consideration from early stages of the preparation of the policy or legal reform. This will help to create consensus in favour of the law, which improves compliance and fosters a sense of “ownership”.

> Ensure that policy/legislation measures are focusing on addressing the root cause(s) of the issue/s and not its/their manifestations.

> Entail at least some elements of a regulatory impact assessment. This includes an assessment that the proposed food safety and quality policy or legislation fits its purpose and is adapted to the national context, legal system and traditions, as well as to the overall national policy and economic contents. The impact assessment should integrate monitoring and surveillance data, including information on the food chain, and should take into consideration the impact on consumers, food operators and trade partners.

> Facilitate consideration of emerging food safety-related issues and include mechanisms to enable regular revision and updates of policy and legislation.

> Foresee specific mechanisms to ensure transparency so that participation can occur effectively (e.g. public hearings, disclosure of the text to other countries before adoption and publication in accordance with WTO transparency requirements, etc.).

POSSIBLE OUTCOME

The legal and policy basis of the food control system is inclusive, appropriate for the national context and forward-looking.

POSSIBLE INDICATORS

> Existence of written principles and procedures guiding the process for drafting/updating food safety and quality policy and legislation and reflecting the elements cited above.

> Inter-agency involvement and approvals, perspectives and interests are taken into account.

> Existence and practice of regulatory impact assessment: all major consequences of particular policy or legal options are considered and, if necessary, researched when a policy or legislation is being decided.

> Broad consultations are carried out and stakeholders are involved in food safety and quality policy and legal formulation, including in the field with people directly affected and not only in a distant capital city.

> Upon enactment of the law, such stakeholders have a formal role in the institutional structures for policy and legal formulation and review established (e.g. they may be included among the members of the country’s food board or council).

> There is a clear provision in legislation/regulations providing for periodic review, and ex-ante and post-factum regulatory impact assessments.

SOURCES OF EVIDENCE

> Documented principles and procedures for policy and legal writing and updates.

> Texts of the policies/legislation.

> Written or verbal confirmation on how the procedures were followed in development of food policy and legislation.

> Interviews with the groups/stakeholders consulted (including central and local authorities, producers, consumers, scientific and academic staff, the tourism industry and private sector organizations).

SEE ALSO

C.2.1.3 [Through the WTO, Member countries notify other countries of any new or changed food safety and quality requirement that affects trade]

A.1.1.4

ASSESSMENT CRITERION: Legislation recognizes the stakeholders’ right to have access to information on food control measures (including sanitary and quality requirements) and includes provisions on publicizing them.

GUIDANCE

Transparency is a key principle in the Codex (Ref. para 10 of CAC/GL 82-2013) and is at the basis of relevant international agreements such as the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and the Technical Barriers to Trade (TBT) Agreement of the WTO.

At national level, transparency translates into stakeholders’ rights to have access to information and to be informed of all food control measures. This enables FBOs to prepare themselves for, contribute to the establishment of, and implement such measures and contributes to their justification and proportionality.

In addition, policies and legislation should expressly recognize and regulate the responsibility of governments and stakeholders to communicate potential food risks or the presence of hazards, and to have access to information on related measures taken, particularly in case of emergency.

At international level, the obligation of transparency requires countries to provide trading partners with reliable and rapid access to all information regarding food safety and quality requirements for trade. In addition, under the International Health Regulations (IHR), countries should keep records and notify INFOSAN of the occurrence of food safety-related incidents.

POSSIBLE OUTCOME

Stakeholders and international partners are adequately informed and have access to information on food control measures, requirements and legislation, to take action if necessary.

POSSIBLE INDICATORS

At national level:

> Policies and legislation that expressly recognize and regulate the responsibility for governments and stakeholders to communicate potential food hazards and to have access to information, particularly in case of emergency.

> Clear procedures for publicizing food safety measures, requirements and legislation.

> Conferences, workshops and publications for professional groups.

> Mechanism for stakeholders to request access to information regarding food control legislation (in preparation or enacted).

> Protocol/procedure for risk communication.

At international level:

> Clear procedure for notification to international partners and organizations, including IHR and WTO.

> Mechanism for stakeholders to request access to information.

SOURCES OF EVIDENCE

> Legislation.

> Records of notifications to the WTO (under the SPS and TBT agreements), WHO (INFOSAN) and trade partners.

> Registry of information, records.

> Educational resources.

SEE ALSO

A.1.3.10 [Legislation includes a provision for a rapid alert system, emergency preparedness and response]

C.1.2 [Information flows and integration of FBOs into risk management]

C.2.1.2 [Trading partners have easy access to up-to-date information regarding food safety and quality requirements and controls]

A.1.1.5

ASSESSMENT CRITERION: Legislation is unambiguous, and allows for evolution over time

GUIDANCE

Poorly drafted laws give rise to ambiguity in interpretation and poor implementation. Whether a law is clear or not affects implementation and compliance with it. Legislation should reflect the intended policy outcomes and clearly distribute obligations and rights (Ref. para 37 and 38 of CAC/GL 82-2013). The rules of style aim to support precision, accuracy and clarity of drafting. Access to expertise and capacities to analyse and draft legislation, from both a legal and technical point of view, should be available to ensure the quality of texts produced.

Good legislation also presents the right distribution between primary and secondary legislation. Primary legislation should include basic legal provisions establishing mandates and functions or relating to fundamental rights. Secondary legislation should provide operational, administrative and technical details that build on and remain within the authority of primary legislation. Therefore, details that may be subject to frequent review and amendment should be included in secondary legislation. This allows legislation to evolve globally over time without having to be re-examined by Parliament, and to be responsive to specific issues related to new food safety hazards, emerging frauds, etc.

When required, additional guidance should be prepared to facilitate implementation – for example, at local level – to ensure a harmonized approach to implementation.

Countries may have specific rules that guide legislation drafting style and different legal uses and practices concerning the amount of detail to be included in primary and secondary legislation.

POSSIBLE OUTCOME

All stakeholders of the national food control system are clear about their rights and responsibilities, are in a position to implement them and can refer to legislation which is responsive to the situation.

POSSIBLE INDICATORS

> Core obligations are easily found in legislation.

> Definitions in legislation are not mixed up with substantive obligations.

> Each article in food safety legislation has normative value (i.e. a reason to be there, not serving as filler).

> Terms defined in the main act are not repeated and do not have divergent definitions in the regulations.

> There is good distribution between primary and secondary legislation.

> Basic legal provisions establishing mandates and functions or relating to fundamental rights are found in primary legislation.

> Subsidiary instruments serve the purposes and objectives of the main act and do not create powers or procedures.

> Style and form of legislation, as well as the drafting process, are consistent with the expectations of national stakeholders.

> Resources are provided to enable implementation by CAs.

> Number of court cases related to discrepancies in interpretation of the legislation is recorded.

SOURCES OF EVIDENCE

> Primary and secondary legislation, administrative decisions, inspection reports.

> Appeals and court cases (to assess difficulties in interpretation).

> Food inspectors` views of the clarity of the law (e.g. level of understanding, consistency of implementation).

> Stakeholders` views regarding clarity, understanding and implementation of the law.

A.1.1.6

ASSESSMENT CRITERION: CAs make decisions in a consistent and impartial manner and are free of improper or undue influence or conflicts of interest.

GUIDANCE

To be respected and credible, and to play their role in an effective national food control system, CAs need to be protected from undue or improper influence (Ref. para 16 of CAC/GL 82-2013), such as political or commercial influence. The technical basis for decision-making, coherent with relevant international binding commitments (for example, IHR) or memberships (such as Codex), should be respected by all levels of government and other stakeholders. In some countries, there are examples of evidence-based or scientifically based decisions made by CAs being overruled by non-scientific considerations. These considerations may be commercial, financial, hierarchical and/or political. When CAs delegate some tasks (e.g. inspection, audit, certification and accreditation) to other parties (other CAs or third parties) it is important that mechanisms are in place to ensure that these principles of integrity and impartiality are equally embedded in the behaviour of the bodies that are receiving such delegation (Ref. para 16 and 75 of CAC/GL 82-2013).

The food safety and quality policy should contain statements anchoring CAs’ technical independence, impartiality and integrity.

Safeguards against corruption from an institutional perspective should also be incorporated (corruption at the individual level is addressed in A.3.3); clear guidance on what to achieve and how, for staff at all levels, supported by clear statements of outcomes (as stated in the strategic plans) are elements of these safeguards. Standard good management practices, such as audits, and transparency rules should further support institutions to fight corruption.

POSSIBLE OUTCOME

The technical independence and impartiality of CAs is protected and corruption is actively prevented.

POSSIBLE INDICATORS

> Food safety and quality policy statement anchoring CAs’ technical independence, impartiality and integrity.

> CAs’ technical decisions supported by evidence and sound scientific information and, when appropriate, risk-based.

> Statements or evidence of respect for CAs’ technical decisions.

> Mechanisms to ensure equal and impartial behaviour of bodies receiving delegation of tasks.

> No reports of reversal of CAs’ decision for illegitimate reasons.

SOURCES OF EVIDENCE

> Policy document.

> Documentation of CAs’ decision-making process.

> Interviews with staff.

> Records in the media.

SEE ALSO

A.1.1.2 [Food control strategic plans are prepared by Competent Authorities (CAs) and translate into action the overarching objectives set out in the food safety and quality policy]

A.3.3.4 [CAs enable confidential reporting of wrongdoing by colleagues and officers without exposure to adverse reactions]

D.1.3.1 [CAs demonstrate sound understanding of risk analysis principles and commitment to the risk management framework in processes and outputs, as appropriate, pertaining to legislation, standard setting, policies, guidance, etc.]

D.1.3.9 [Units conducting risk assessment and risk management are functionally separated and CAs and experts involved in risk assessment are not subject to any conflicts of interest]

A.1.2

INSTITUTIONAL FRAMEWORK

The allocation of powers and responsibilities, as well as the coordination mechanism among CAs, enable an effective and efficient institutional framework for food control.

A.1.2.1

ASSESSMENT CRITERION: Mandates of CAs involved in food control, at central and decentralized levels, are clearly defined in legislation and ensure an efficient distribution of roles and responsibilities among CAs, over the entire food chain.

GUIDANCE

Mandates for controlling food safety and quality along the entire food chain should be enshrined in law. The roles and responsibilities of each CA should be formulated unambiguously, preventing gaps and minimizing overlaps and duplication of functions (e.g. multiple agencies inspecting an FBO) and bureaucracies (e.g. when a food producer must apply to multiple agencies for a license or permit) (Ref. para 11, 27 and 38, 2nd point, of CAC/GL 82-2013). Conflicting relationships among CAs lead to diminished effectiveness and efficiency.

Clear allocation of functions and responsibilities should cover the whole spectrum of CAs involved in food control, including domestic, import and export controls, over different types of production, processing, marketing and distribution activities (agriculture, livestock, fisheries, etc.)

The distribution of responsibilities should be clear between central and local authorities to ensure an appropriate distribution of tasks (production of technical guidance, methods, global planning, monitoring and evaluation, implementation, reporting, early detection, rapid response to local events and wider scale emergencies, etc.) and related distribution and use of resources. This can follow different models depending on the country’s global policy with regard to decentralization.

Within a CA, the chain of command should be clearly described from central to local levels, to ensure that the tasks allocated to each level are effectively implemented as planned and reported upon when and to whom they should be.

In some jurisdictions, regional or local authorities (at the supranational or the subnational level – for example, in federations) may also have a role in food inspections. This may be in parallel with local offices of technical CAs, and the relationships and collaboration may vary to an important extent. A duty to report from regional or local level to the central technical authorities is a way to ensure that all relevant national information about food safety and quality can be gathered and analysed at national level. This is necessary to support a national vision, a capacity to provide response to international partners in a consolidated manner and to ensure that the international obligations for reporting for example are fulfilled.

POSSIBLE OUTCOME

All products at each step of the chain are under effective and efficient supervision of relevant CAs.

POSSIBLE INDICATORS

> National legislation includes a clear allocation of the functions and responsibilities of CAs, including:

i. Central and decentralized entities, including regional/local authorities (subnational level);

ii. Domestic, import and export controls over different types of production and processing (agriculture, livestock, fisheries, etc.).

> The roles and responsibilities of each CA are formulated unambiguously to:

i. Prevent gaps;

ii. Minimize overlaps and duplication of functions and resources (e.g. multiple agencies inspecting an FBO);

iii. Avoid duplicative bureaucracies (e.g. application to multiple agencies required for obtaining a license or permit).

> Where local (subnational) authorities contribute to food safety, they have clear roles and procedures to implement legislation and clear reporting channels.

SOURCES OF EVIDENCE

> Legislation (food safety, pesticides, customs, local authorities, veterinary).

> Interviews with different government entities at the central and decentralized levels.

A.1.2.2

ASSESSMENT CRITERION: A formal communication mechanism is in place between CAs and other stakeholders involved in food control, to exchange relevant information over the entire food chain, from primary production to human health.

GUIDANCE

Food control is highly multidisciplinary, requiring the exchange of information and views from a wide range of stakeholders. It involves different CAs (e.g. in agriculture, health, trade) but also stakeholders from the private sector, civil society and academia, among others (Ref. para 9 and 65 of CAC/GL 82-2013). The exchange of information can be strictly enchained among CAs when outputs produced by one CA serve as an input to the activities of another CA. For example, information produced by the FBD surveillance system should feed into the prioritization process of control over certain food products, particularly those related to a specific disease.

To enable this exchange of information and to allow substantive discussions for building a common vision, a formal and functional communication mechanism needs to be in place and its participants should be clearly identified. In addition, this communication mechanism should identify:

i. Which information should be shared;

ii. When the information should be shared;

iii. Who needs to report the information;

iv. How the information should be shared and with whom.

For further guidance, refer to the publications reported in the footnote (FAO and WHO, 2006; WHO, 2017).

In some countries, there may be more than one information mechanism. In this case, it would be important that an overarching system allows relevant information to flow from one mechanism to another if the need arises.

POSSIBLE OUTCOME

CAs and stakeholders in food control have access to information which is relevant for them to implement their role in the overall system, and actively contribute to feed the information-sharing mechanism.

POSSIBLE INDICATORS

> Track record of information officially shared through one mechanism that allows different stakeholders in the food control system to share information they generate as useful input for other stakeholders.

> List of stakeholders involved in this information-sharing mechanism.

> Documented agreement on:

i. Which information should be shared;

ii. When the information should be shared;

iii. Who needs to report the information;

iv. How the information should be shared and with whom.

> Evidence that this mechanism is in operation (e.g. written communication plans, reports from an outbreak debrief about how the teams will work better together, etc.).

SOURCES OF EVIDENCE

> Documents, reports, documented communication exchanges.

SEE ALSO

B.1.1.9 [Official controls implemented by various CAs at all levels of the food chain are organized to be continuous, joined-up, comprehensive and strategically complementary]

A.1.2.3

ASSESSMENT CRITERION: Legislation includes coordination mechanisms that enable CAs to develop a common vision of food control, to facilitate multi-sectoral planning and implementation of food control measures, and to promote communication.

GUIDANCE

In addition to the clear allocation of roles and responsibilities, legislation should consider the need for dedicated provisions or legal instruments to facilitate and ensure coordination.

Coordination is key to:

> Allow complementary mandates to be implemented in an effective manner (e.g. when some issues need concerted action along the food chain);

> Support efficiency gain (e.g. coordinated actions making it possible to mobilize staff jointly for common actions);

> Develop an integrated perspective on food control issues;

> Match public health or trade issues with regulatory action;

> Refine the set-up of priorities;

> Improve courses of action over time;

> Solve common issues of concern;

> Collaboratively respond to food safety incidents or outbreaks where different agencies are responsible for human health and food safety;

> Facilitate data sharing.

Coordination should take place at the levels of planning, implementation and reporting, and should take into account the different authorities directly and indirectly related to the food production chain. Coordination mechanisms should involve, as appropriate, the authorities in charge of agricultural inputs, customs, trade and other areas. They should also take into consideration the decentralization of functions.

The distribution of functions and duties among all these actors and the duty of ensuring coordination should be described in legislation, in Memoranda of Understanding (MoUs) or in agreements between institutions, which may contain delegated functions. These agreements should describe who will do what and how it will be done. MoUs and agreements do not substitute for legislation. They are a tool to help in understanding how the legal obligations will be implemented in practice.

Information flow and reporting duties (as described in A.1.2.2) could also be part of the coordination mechanism.

The designation of an entity or body to monitor and facilitate such coordination can be extremely helpful. Such a body requires coordinating functions, a specific mandate and the capacity to monitor the activities of the different CAs in the various stages of the food chain.

Some countries do include in their legislation instruments and mechanisms that facilitate coordination and integrated reporting (e.g. the approval of an integrated food safety strategy, or an integrated food safety inspection control plan on a plurennial basis).

POSSIBLE OUTCOME

An overall vision and coordination mechanisms for food control support the achievement of the goals set up by the policy.

POSSIBLE INDICATORS

> MoUs, inter-ministerial working groups, specific bodies or entities, or other coordination mechanisms that involve:

i. Authorities in charge of agricultural inputs, customs, trade, human health and other areas;

ii. Decentralized functions;

iii. Delegated functions;

iv. Distribution of functions and duties among all these institutions.

> Regulated procedures for the collection and sharing of information.

> Inspection procedures and manuals that include provisions on the flow of information.

> Institution with the responsibility to monitor food safety across the food chain.

> Legislation referring to a common document that explains how food safety will be monitored and controlled in a coordinated manner in all stages of the food chain (food safety strategy/control plan).

> Local authorities having clear procedures to report back the information.

> Good communication between CAs in the areas of food production and human and animal health.

> Evidence of communication exchanges among CAs during the implementation of food control measures.

SOURCES OF EVIDENCE

> Legislation (food safety, pesticides, customs, local authorities, veterinary).

> MoUs or other legal mechanisms that facilitate coordination.

> Focal points for communication between CAs.

> Interviews with different government entities at central and decentralized levels.

> Instruments related to the food safety and quality policy (such as food safety strategy, food safety inspection plan).

> Documented coordinated food control measures carried out in the past.

SEE ALSO

A.1.3.5 [Legislation includes provision for inspection, monitoring and control of the food supply for hazards]

B.1.1.9 [Official controls implemented by various CAs at all levels of the food chain are organized to be continuous, joined-up, comprehensive and strategically complementary]

A.1.2.4

ASSESSMENT CRITERION: Legislation provides the CAs with all the necessary powers and responsibilities to implement the law, within their mandate.

GUIDANCE

All the powers and responsibilities necessary for CAs to meet food control objectives should be anchored in legislation. These related provisions should take into consideration all the different functions related to food control and should consider the ability of the authority to implement and enforce the law. These powers and responsibilities might be in one comprehensive food law or in different laws regulating food safety and quality-related areas (public health law, veterinary law, standard setting, etc.)

A non-exhaustive list (Ref. para 39 of CAC/GL 82-2013) of the responsibilities and powers that should be recognized in the legislation includes ability to:

i. Develop food safety and quality mandatory standards and requirements, including the possibility to prohibit or set limits for food additives usage, pesticide and veterinary drug residues, chemical and microbiological contaminants, and irradiation of food and other substances or processes.

ii. Approve implementing regulations.

iii. Monitor and enforce these standards (performing audits, verifications, inspections and investigations).

iv. Develop measures based on science and risk analysis.

v. Regulate and implement systems for the approval, licensing, registration and inspection of FBOs.

vi. Identify FBDs for mandatory notifications.

vii. Collect and analyse samples, evidence and technical data for incidence and prevalence of risks and food-borne illnesses.

viii. Designate official and reference laboratories.

ix. Improve infrastructure for human health surveillance relevant to FBDs and monitoring of priority food safety risks.

x. Control food imports and exports and designate points of entry and exit for food.

xi. Enter into bilateral or multilateral agreements for food trade.

xii. Build capacity in food control through training and awareness of food inspectors under the CA.

xiii. Regularly disseminate information to the public, consumers and other stakeholders and take steps to ensure that stakeholders receive rapid, reliable and objective information through appropriate media.

xiv. Develop guidelines and technological and industrial practices for food control systems.

xv. Collect fees.

POSSIBLE OUTCOME

CAs are adequately empowered to achieve the overarching objectives set up by the policy.

POSSIBLE INDICATORS

> Legislation includes the power of the CAs to implement the list of tasks described in para 39 of CAC/GL 82-2013 (also indicated in the guidance above).

> Legislation clarifies the powers and responsibilities of local food control authorities and how these are coordinated with the food control authorities at the central level.

SOURCES OF EVIDENCE

> Legislation.

> Information and feedback received from the government, different agencies, local authorities and public and private stakeholders.

A.1.2.5

ASSESSMENT CRITERION: If appropriate, legislation allows the CAs to delegate some functions to other public or private entities.

GUIDANCE

CAs should be provided with a certain degree of flexibility in implementing their mandates to adjust to evolving or exceptional circumstances. Delegation is one tool for achieving this flexibility (Ref. para 58 of CAC/GL 82-2013). Delegation should be considered as a possibility to be assessed for its appropriateness given the specific circumstances. The law should offer this possibility and this should be explicit, with a clear designation of who can be commissioned to do what, the timeframe and purpose of the delegation, and the reporting obligations (Ref. para 39, 8th point, of CAC/GL 82-2013). For example, it should be possible to authorize or delegate a public or private laboratory to perform official analyses, or to delegate private organizations to conduct inspection and audit activities, as well as certification and accreditation.

In addition, delegation does not mean that the CAs are not ultimately responsible for what is done under delegation. Delegation should only be given to competent structures, whose competence is officially recognized (Ref. para 26 of CAC/GL 82-2013). Therefore, prior to delegation, competence should be assessed against objective criteria (Ref. para 75 of CAC/GL 82-2013).

Delegation should not be motivated by a lack of technical capacity or knowledge to implement a task. Activities that represent the sovereignty of the State (such as the signature of official certificates) should not be delegated.

POSSIBLE OUTCOME

The possibility to delegate specific functions provides CAs with the necessary flexibility to exercise their overall responsibilities.

POSSIBLE INDICATORS

> Legislation on delegation of specific functions (e.g. inspection, audit, certification, accreditation, risk assessment and other scientific work), clearly designating who can be commissioned to do what, the timeframe and purpose of the delegation, and reporting obligations.

> Legislation conferring on the CAs the power to authorize public or private laboratories to carry out official analyses on their behalf.

SOURCES OF EVIDENCE

> Legislation.

> Information and feedback received from the government, different agencies, local authorities and public and private stakeholders.

SEE ALSO

A.3.1.4 [The prescribed requirement for properly qualified staff also extends to the professional employees of agencies engaged by CAs]

A.1.2.6

ASSESSMENT CRITERION: Legislation provides designated officials with the necessary authority to carry out their mandates, and sets sufficient safeguards to prevent abuse of power.

GUIDANCE

Legislation should include a clear provision on both the designation of food inspector, and recognition of the powers of food inspectors. The designation of inspector is particularly important in countries where there are different authorities playing a role in food safety monitoring and food control (both at central and at local levels). All food inspectors should be vested by law with similar powers, to be granted following their designation as food inspectors. Inspectors’ powers, such as the power to enter into private property or the power to collect samples, can be in conflict with fundamental rights to privacy and property; hence, these powers must be recognized in primary legislation.

A non-exhaustive list of the powers that should be conferred to inspectors includes:

i. Power to enter any food business or other premises – except dwellings – in which any food is being or is suspected of being produced, manufactured, treated, graded, packed, packaged, labelled, stored, handled, prepared, served or sold, or in which any other operation or activity in connection with food is being or suspected of being carried out.

ii. Power to inspect or search such premises for the purpose of determining whether the food safety law is being violated.

iii. Power to weigh, count, measure, mark, open and take samples in the prescribed manner of any food, product, material, object or substance or its package or container, or to lock, secure, seal or close any door giving access to it.

iv. Power to examine, make copies of or take extracts from any book, statement or other document found at such premises which refers to or is suspected of referring to such food, and to demand from the owner or any person in charge of the premises an explanation of any entry in it.

v. Power to inspect any operation or process carried out on such premises.

vi. Power to demand any information regarding such operation or process from the owner or person in charge of such premises or from any person carrying out such operation or process.

vii. Power to take any photographs.

viii. Power to seize any food, appliance, product, material, object, substance, book, statement or document which appears to provide proof of a contravention of any provision of the food law, providing a signed receipt in the prescribed form which shall be countersigned immediately by the owner or other person in charge of such premises or object.

ix. Power to stop and search any vehicle in which food is being or is suspected of being transported, produced, manufactured, treated, graded, packed, packaged, stored, handled, prepared, served or sold or in which any other operation or activity in connection with food is being or is suspected of being carried out.

x. Power to stop, search and detain any person who is suspected of committing an offence under the food law.

xi. Power to apply fines and sanctions.

xii. Power to share information with other CAs to allow food safety incident investigations.

In addition to outlining the powers to be exercised, the law must also establish guidelines for the exercise of these powers, identify any limitations on them, and describe training requirements for anyone who will receive delegation. The law should further include different safeguards to minimize the risk for corruption, such as written receipts, two-person patrols, etc.

POSSIBLE OUTCOME

Inspectors can effectively enforce food control provisions and conduct investigations, without generating abuse of power.

POSSIBLE INDICATORS

> Clear provision exists on the designation of food inspectors.

> Clear provision exists on recognition of the powers of food inspectors in primary legislation (as indicated in points (i) to (x) in the above guidance).

> Powers are accompanied by the necessary safeguards to help prevent abuses of power and corrupt practices.

> Inspectors must hold a valid identification card and identify themselves prior to an inspection.

> An FBO’s right and obligation to accompany the authorized inspector during an inspection is recognized.

> Inspectors must send a written report, including any justification, for a required corrective action, providing notice to operators in case of adverse findings or actions.

SOURCES OF EVIDENCE

> Legislation.

> Inspection reports, complaint and investigation reports.

> Appeals, court cases.

> Discussions with stakeholders, inspectors.

A.1.2.7

ASSESSMENT CRITERION: Legislation provides an array of effective enforcement provisions as well as the right to appeal decisions made by the CAs.

GUIDANCE

Legislation should include measures to ensure enforcement in cases of non-compliance, including a clear list of offences and effective, dissuasive and proportionate sanctions (Ref. para 39, 9th point, and 57 of CAC/GL 82-2013). According to a general principle of law, offences and sanctions must be established in legislation. Offences must be defined, along with the penalties that may be imposed and the procedures applicable once an offence has been committed. Deciding what activities are to be considered offences under the law is a decision to be made in the formulation of the law and is highly influenced by the national legal tradition. Having defined the offences, the law must then outline the applicable penalties, whether applied by the CA or taken through the courts. Economic penalties (fines) should be set up at an appropriate level, and can be accompanied by administrative measures such as removal of a licence (Ref. para 81, 2nd point, of CAC/GL 82-2013), detention or recall of food, closure of plant operations, etc., in an immediate manner. Such administrative measures are generally limited in time, open for re-evaluation as circumstances change or evolve, and may lead to permanent sanctions.

Legislation should also contain provisions on the right to appeal all governmental decisions. Procedures regarding notice, the right to a hearing, and the right to appeal a negative decision are designed to protect the rights of individuals, particularly the right to due process and to a proper defence. Any person aggrieved by a government decision should be granted the right to appeal a decision of the executive authority to a higher authority or to civil or administrative courts, within a specified period. In addition, once a violation has been committed, notice should be served upon the offender to inform him or her of the facts, the date and nature of the offence and the assessed sanction. Notice is served prior to the imposition of a penalty to afford the accused a reasonable opportunity to object, either in writing or in person. It should be noted that, according to different legal systems, this could also include standard legal safeguards or processes (not limited only to formal appeal).

POSSIBLE OUTCOME

Appeals provisions and enforcement measures for non-compliance are regulated and they are effective and proportionate.

POSSIBLE INDICATORS

> There is a clear provision in legislation/regulations listing:

i. Enforcement provisions

ii. Offences

iii. Penalties for non-compliance

> There is a provision stating that any person aggrieved by an action or decision of an authorized officer or an official analyst may appeal to a designated entity within the prescribed time frame.

SOURCES OF EVIDENCE

> Legislation.

SEE ALSO

B.1.1.11 [Clear documentation containing enforcement sanctions and procedures (including reference to legal instruments) is available to official control staff]

A.1.3

ELEMENTS OF FOOD CONTROL LEGISLATION

Legislation provides all the technical provisions necessary to implement food control activities and achieve the overarching objectives set in the food safety and quality policy (Ref. para 37 of CAC/GL 82-2013).

A.1.3.1

ASSESSMENT CRITERION: National legislation recognizes the primary responsibility of food business operators (FBOs) for food safety and quality and lays out their specific obligations, including placing only safe food on the market and recalling products that do not meet the prescribed standards.

GUIDANCE

Food business operators (FBOs) have the primary responsibility for ensuring the safety and quality of the food they provide for consumption (Ref. para 12 and 38, of CAC/GL 82-2013). This should be accompanied by a clear prohibition for FBOs and other participants in the food chain to put unsafe food on the market (Ref. para 39, last point, of CAC/GL 82-2013). For this purpose, private and public entities (e.g. government, charities, churches or community organizations), international organizations (e.g. United Nations, international non-governmental organizations) or others should also be considered FBOs when they deliver or distribute food, including food brought by participants for sharing.

To exercise this responsibility, modern food safety legislation requires FBOs not only to make sure that food is prepared, treated and sold in a hygienic way but also to identify food safety hazards and ensure that internal safety controls (self-controls) are implemented, maintained and reviewed. For specific categories of FBOs, this self-control system could be a HACCP (Hazard Analysis and Control of Critical Points) system or HACCP-based system (Ref. para 54 of CAC/GL 82-2013).

Other obligations of FBOs include record-keeping obligations, notification in case of non-compliance or suspicion of non-compliance, and the obligation to facilitate inspections and to contribute to the implementation of the law.

FBOs also have the primary responsibility to recall from the market products that do not meet the prescribed standards (Ref. para 63 of CAC/GL 82-2013).

Implementing legislation may set up different procedures and time requirements for recall responsibilities according to different categories of risk. If the FBO fails to recall the product as necessary, the concerned CA should take action. In these cases, the CA will have the possibility of charging the costs to the responsible FBO.

POSSIBLE OUTCOME

Legislation is framed so that FBOs have the primary responsibility for food safety, and CAs have an enabling and oversight role.

POSSIBLE INDICATORS

> Food control legislation expressly recognizes the primary responsibility of FBOs for food safety and quality.

> Food control legislation expressly prohibits FBOs and other actors in the food chain from putting unsafe food on the market for consumption.

> Food control legislation recognizes the obligations of food operators to:

i. Notify regarding potential food safety hazards, keep records, introduce self-control schemes, etc.

ii. Recall from the market products that do not meet the standards (and provides CAs with the power to mandate recalls).

> Legislation includes a reference to mechanisms for the government to “control” FBOs, starting with identifying and recording them, using registration or other licensing schemes.

SOURCES OF EVIDENCE

> Legislation.

A.1.3.2

ASSESSMENT CRITERION: Food control legislation applies to all steps of the food chain in a coherent and coordinated manner.

GUIDANCE

An effective modern food control system requires a comprehensive and coherent national legal framework that covers all aspects of the food chain. Food control legislation must therefore refer to all legislation that incorporates any food safety and quality-related activities, “from farm to fork”. This broad range of activities is frequently spread through a number of different laws, from agriculture (including livestock, fisheries, etc.) to industrial and trade legislation.

Food control legislation should cover: all food, including commodities, processed and unprocessed food; all potential hazards that may affect food safety; all activities and operators along the food chain through to consumer, both at domestic and at import level. Public health issues should also be considered in relation to food safety (Ref. para 9 of CAC/GL 82-2013).

Over time, legislation is frequently updated or amended with multiple laws that may lead to gaps, duplication, outdated requirements or contradictions. Legal fragmentation, outdated and duplicative provisions, or gaps in legislation can be detrimental to the implementation of a comprehensive food control programme and hinder the accessibility and transparency of the legislation.

In addition, if not managed with a perspective of “user-friendliness”, the successive amendments or revisions to the legal texts can lead to difficulties for FBOs without solid legal background in accessing these, finding the necessary references, or identifying what is applicable to them. This can also affect other stakeholders (other international partners, or CA staff overseeing implementation of the requirements). As a consequence, this can hamper proper implementation of the requirements, in particular from the perspective of FBOs without solid legal background.

Countries may have one food law or multiple laws addressing food safety and quality, but these should be consistent and coordinated in a manner that minimizes gaps, duplication and contradictions and ensures comprehensive coverage and coordination. Furthermore, different laws in the agricultural realm (such as pesticide or veterinary legislation) may have an impact on food safety. These laws should not create duplications or contradictions and should contribute to the common purpose of protecting public health and fair practices in food trade.

POSSIBLE OUTCOME

Food safety and quality regulatory requirements applying to each step of the food chain are easy to identify and readily available to FBOs.

POSSIBLE INDICATORS

> Evidence that the legal texts (one or several) cover all aspects and stages of the food production chain.

> Evidence of coherence in the legal provisions applying to the food chain.

> Legislation is “user-friendly” in terms of accessibility.

> No evidence (e.g. stakeholder, FBO reports) of gaps, duplication, contradictions or outdated measures.

> Food control legislation is not in conflict with any other legislation relevant to food safety and quality and does not result in duplication or ambiguity in the functions of relevant institutions.

SOURCES OF EVIDENCE

> Legislation.

SEE ALSO

A.1.1.5 [Legislation is unambiguous and allows for evolution over time]

A.1.3.3

ASSESSMENT CRITERION: The definitions used in food control legislation are clear, unambiguous and consistent with internationally recognized standards (e.g. Codex Alimentarius).

GUIDANCE

Definitions employed in legislation affect the scope of legislation, and hence may influence its implementation, including for international trade. The list of definitions in the food law is not a glossary of food control terms in general, but rather an explanation only of those terms that appear in the law.

Some key terms are defined in the Codex Alimentarius:

Food means “any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drink, chewing gum and any substance which has been used in the manufacture, preparation or treatment of ‘food’ but does not include cosmetics or tobacco or substances used only as drugs.”

Hazard refers to a “biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.”

Risk refers to a “function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.”

POSSIBLE OUTCOME

There is a national consensus on a number of key terms and concepts that are also consistent with international definitions and conflicts due to misinterpretation are minimized.

POSSIBLE INDICATORS

> The definitions in the law cover the key terms.

> The definitions correspond to key Codex definitions when they exist (e.g. food, hazard, risk).

> Definitions do not include terms with different interpretations.

SOURCES OF EVIDENCE

> Legislation.

A.1.3.4

ASSESSMENT CRITERION: Legislation introduces the principle of risk analysis and this is used as a basis for establishing food safety measures.

GUIDANCE

Risk analysis allows for focusing food control resources where they are most likely to exert the greatest impact on the public. Therefore, it is of interest to governments that decisions be based on risk analysis principles and transparency should be the rule when communicating about risks with the various stakeholders (Ref. para 17 and 28 of CAC/GL 82-2013).

The SPS Agreement requires that all sanitary measures be based on an assessment of the risks that takes into consideration risk assessment techniques developed by the relevant international organizations (Article 5.1 of the SPS Agreement).

Codex guidelines CAC/GL 62 2007 present in more detail the working principles for food safety risk analysis for application by governments. In particular, national government decisions on risk management should have as their primary objective the protection of the health of consumers. Unjustified differences in the measures selected to address similar risks in different situations should be avoided. These principles apply equally to issues of national food control and food trade situations and should be applied consistently and in a non-discriminatory manner (Ref. para 3 and 30 of CAC/GL 62 2007).

The risk management framework entails a comparison of the different options to manage risks; control measures should be adapted to the effective level of risk.

Implementation of risk analysis principles should have a legal basis; hence the risk analysis principles, as included in Codex standards, should be incorporated into national legislation.

POSSIBLE OUTCOME

CAs are legally empowered to implement a risk-based approach to food control.

POSSIBLE INDICATORS

> Legislation expressly refers to the principle of risk analysis.

> Legislation includes a mechanism for incorporating Codex guidance on risk assessment and management.

> Food control and inspection legislation introduce approaches based on risk analysis.

> Evidence exists that risk assessment or scientific advice has influenced operational approach, supporting decisions on the choice of risk management options and the expenditure of resources (money, staff time).

SOURCES OF EVIDENCE

> Legislation.

> Feedback from government officials.

> Communications commissioning risk assessment from risk assessors.

> Risk assessment reports.

SEE ALSO

A.1.1.6 [CAs make decisions in a consistent and impartial manner and are free of improper or undue influence or conflicts of interest]

A.1.3.5 [Legislation includes provision for inspection, monitoring and control of the food supply for hazards]

A.1.3.6 [Legislation includes provisions for setting import requirements]

B.1.1.5 [Inspection plans are based on a well-documented risk categorization framework]

A.1.3.5

ASSESSMENT CRITERION: Legislation includes provision for inspection, monitoring and control of the food supply for hazards.

GUIDANCE

Activities related to inspection (also including oversight, auditing and monitoring) need to have a legal basis as they will require FBOs to cooperate – for example, by providing samples, access to information, analytical results, etc. The purpose of these activities may be routine work; investigation of food-borne outbreaks, incidents or FBOs; or surveys to better understand the magnitude of a risk and to generate data to support risk-based approaches (e.g. risk assessments) (Ref. para 26 of CAC/GL 82-2013). For many of these purposes, a legislative mandate may be required to ensure compliance by FBOs and access to samples, but also to adapt the control pressure based on risk (Ref. para 50 CAC/GL 82-2013). As explained in A.1.3.4, many of these activities may be modulated by the effective risk, so it should be clear to all that the pressure in inspection activities, or in sampling for example, may be adapted to the actual level of risk.

POSSIBLE OUTCOME

CAs are legally empowered to undertake a range of control activities, including inspection and sample-taking, and adjust these controls according to the level of risk.

POSSIBLE INDICATORS

> Risk-based controls (e.g. inspection, audit, verification); sampling and analysis explicitly mentioned in legislation, providing powers for food inspection and implementing monitoring programmes (A.1.2.3).

> Legislation authorizing CAs to perform public health functions, including surveillance (A.1.3.12), and including the authority to take and analyse samples as part of food-borne outbreak and incident investigations.

SOURCES OF EVIDENCE

> Legislation.

SEE ALSO

A.1.2.3 [Legislation includes coordination mechanisms that enable CAs to develop a common vision of food control, to facilitate multi-sectoral planning and implementation of food control measures, and to promote communication]

A.1.3.4 [Legislation introduces the principle of risk analysis and this is used as a basis for establishing food safety measures]

A.1.3.12 [Legislation includes provisions for surveillance of priority FBDs, guided by the food safety and quality policy]

A.1.3.6

ASSESSMENT CRITERION: Legislation includes provisions for setting import requirements.

GUIDANCE[1]

The CAs should have the legal mandate to approve import requirements. They should have the legal capacity to control food imported into the country and, for the purposes of analysis or inspection thereof, to take samples of any such food. Import requirements may differ from each other and may include: providing specific information about consignments; certificates of analysis; information (and assurances) about the controls performed at the time of production; information on the quality assurance systems put in place by the importer; provision of advance notice; pre-clearances; etc.

Import controls should monitor compliance with the import requirements, including the safety and quality of food products. They should be proportionate to risk, and non-discriminatory. This also means that control procedures on imports cannot be more stringent than the ones applied on domestic production (Ref. para 5 and 15 of CA/GL 47-2003). These requirements are also set forth by the WTO SPS Agreement.

There are many options available for setting controls over imports, which may be selected and combined to best fit the national situation, depending on flows of products and control infrastructure. These can include: requirements for notifications; pre-notification for specific food products; application for permits prior to import; submission of a set of specific documents and certificates; use of dedicated border inspection posts for specific food products; etc.

As noted in A.1.3.4, control measures need to be adapted to the effective level of risk, so for import requirements, this means that different control procedures can be applied to different products, depending on their nature, origin and other relevant factors. It is therefore important that the array of measures selected for risk management be accurately reflected in the legislation, to provide CAs with the required legal authority to exercise the appropriate controls and ensure transparency with stakeholders.

General import control systems are often located within the ministry responsible for customs, while the import and export of food products may fall within the ambit of the basic food safety enforced by the CAs. Collaborative mechanisms should therefore be established, with a legal basis. The CAs may also have the power to perform inspections in the countries of origin, as part of trade and equivalence agreements.

POSSIBLE OUTCOME

CAs are legally empowered to provide regulatory oversight on food imports as appropriate to the situation and effective risk.

POSSIBLE INDICATORS

> Clear provision in legislation/regulations stating that no article of food shall be imported unless it meets the import requirements, is accompanied by the prescribed documents, and is offered up for inspection by the CA at the port of entry.

> Legislation including provisions for collaboration with other border agencies to ensure the efficacy and efficiency of import controls.

> Import requirements and monitoring designed on the basis of risk.

> Legal provision enabling controls in countries of origin, equivalence and trade agreements.

> Legislation enabling the CA to require relabelling or reconditioning prior to import, as well as to destroy, detain or re-ship items that do not comply with their import requirements.

> Requirement that importers apply for the relevant permits from the appropriate authority.

SOURCES OF EVIDENCE

> Legislation.

> Trade agreements.

SEE ALSO

A.1.3.4 Legislation introduces the principle of risk analysis and this is used as a basis for establishing food safety measures]

A.1.3.7

ASSESSMENT CRITERION: Legislation includes a mechanism that enables CAs to identify all FBOs throughout the food chain.

GUIDANCE

Knowledge of the “universe” of FBOs (producers, processors, distributors, importers, food retailers, caterers, etc.) is required to have a fully functioning risk-based food control programme. This knowledge facilitates supervision and control, helps CAs to improve planning and favours interactions (including capacity development activities) between government and FBOs. Therefore, some jurisdictions set legal obligations for registration or licensing, requiring notification or approval of FBOs prior to operation (Ref. para 40 of CAC/GL 82-2013).

In some systems, different categories of FBOs would have to comply with different obligations and responsibilities, which should be reflected in the specific licensing schemes. Legislation may therefore include one single registration or licensing scheme for all FBOs or different licensing schemes specific to the different types of FBOs.

CAs can also obtain and cross-check information about FBOs from other entities (e.g. authorities issuing business/trade licences, customs or the census).

POSSIBLE OUTCOME

CAs are enabled to exercise regulatory oversight over food production through knowledge of FBOs.

POSSIBLE INDICATORS

> Specific provision in legislation regarding authorization/registration/licensing of FBOs.

> Legislation including one single registration or licensing scheme for all FBOs or different license schemes for different types of FBOs.

> Mechanisms allowing CAs to obtain information about FBOs from other entities such as authorities issuing business/trade licences, customs or the census.

SOURCES OF EVIDENCE

> Legislation.

> Information collected from the CAs and from other entities (trade, business registration).

SEE ALSO

B.1.1 [Domestic controls]

A.1.3.8

ASSESSMENT CRITERION: National food standards, regulations and guidelines provide an appropriate foundation for food control, and these are based on Codex or other international reference standards.

GUIDANCE

Legislation should provide the CAs with the capacity to “establish, monitor and enforce standards or other management options to prevent and control food-borne hazards such as disease-causing organisms, contaminants, veterinary drug and pesticide residues” (Ref. para 39, 1st and 2nd points, of CAC/GL 82-2013). At national level, sanitary or technical standards and other requirements are the benchmarks that provide FBOs with clear indications ranging from product specifications related to hazards, quality and integrity, positive or negative lists of substances or contaminants, and procedures such as food hygiene practices. This benchmark also practically supports the achievement of overarching objectives as outlined in the food safety and quality policy. National food standards (intended as mandatory and including other regulations such as guidelines, etc.) are necessary to implement the various activities related to food control. They should be developed taking into account the needs of the country (diversity of food produced and offered to consumers, including imported products) and they should be based on the standards approved by the Codex Alimentarius Commission (Ref. para 23 and 39, 6th point, of CAC/GL 82-2013). When incorporating Codex standards into national legislation, CAs should pay attention to adapting Codex provisions into clear obligations and responsibilities appropriate to the national context (e.g. using more specific wording, instruments, processes, technological approaches corresponding to national situation). These can be implemented by a variety of different legal instruments, including subsidiary legislation or sanitary/technical standards. CAs should also verify that there is national capacity (technical and resource-wise) of FBOs to implement the obligations and responsibilities resulting from such legislation. Standards will serve as a reference for food control activities performed by a variety of institutions at the central and the local level (local authorities). These authorities should be fully informed and should understand the content of the standard to make it enforceable.

It is important that CAs have a clear role in the development and approval of these standards, as well as a preeminent role in their implementation. It is also important that CAs recognize other CAs’ standards at the appropriate stages of the food chain (Ref. para 39, 3rd point, CAC/GL 82-2013).

POSSIBLE OUTCOME

CAs have the regulatory instruments to exercise regulatory oversight over food production consistent with internationally agreed standards and provide FBOs with guidance to achieve food safety objectives.

POSSIBLE INDICATORS

> Standards are based on Codex standards.

> Standards are adapted in language and content to the national legal drafting style, and create clear obligations and responsibilities.

> Standards are developed taking into account the needs of the country (diversity of food produced and offered to consumers, including imported products).

> Standards are consistent with national enforcement and implementation capacities (technical capacity and resource availability, for CAs and other personnel).

SOURCES OF EVIDENCE

> Legislation.

> Guidelines.

A.1.3.9

ASSESSMENT CRITERION: Legislation includes an obligation to ensure food traceability from farm to fork.

GUIDANCE

Legislation should set up the basis for the development and implementation of a traceability system (Ref. para 39, 12th point, of CAC/GL 82-2013). This refers to the capacity to identify food products and to be able to trace a product backward and forward through all stages of production, manufacture and distribution. This includes the origin and the final destination of a food product, a food-producing animal, food ingredient or substance intended to be or expected to be incorporated into a food. As part of their obligations under the law, FBOs should be primarily responsible for implementing this system in all stages of the production chain. Responding to food safety incidents and emergencies requires a consistent system of being able to trace back and trace forward the source or final destination of food products and their ingredients. CAs may have a shared responsibility for the traceability system, particularly in countries where the private sector may have limited capacities.

POSSIBLE OUTCOME

CAs have a legal instrument to require tracing backward and forward of food products or ingredients.

POSSIBLE INDICATORS

> Clear provision in legislation requiring the establishment of a system for traceability (e.g. obligation for FBOs to establish and implement a system enabling them to identify any person who supplied or to whom they supplied a food-producing animal, food or substance intended to be or expected to be incorporated into a food).

> Subsidiary legislation that sets out the features of the traceability system (e.g. type of information to be kept as records, allocation of batch/lot numbers, and labelling requirements relevant to traceability).

SOURCES OF EVIDENCE

> Legislation, subsidiary legislation.

SEE ALSO

B.1.1.16 [Mechanisms for withdrawal and recall of contaminated products are in place in collaboration with the food industry]

A.1.3.10

ASSESSMENT CRITERION: Legislation includes a provision for a rapid alert system, emergency preparedness and response.

GUIDANCE

An efficient response to a food safety emergency relies heavily on anticipation and preparation well before the emergency actually happens. This will require a number of steps and elements to be in place, such as: a national food safety emergency plan, supported by a coordination mechanism linking to public health authorities and clear communication procedures; a rapid alert system creating capacity to detect and take appropriate action upon signals (notification of suspect cases of illness and hazards, access to relevant scientific advice); supporting tools and systems (i.e traceability systems, recall systems); and response capacities (supported by clear procedures), through CAs. Legislation should support the setting up of such a system, including clear obligations and responsibilities to establish a rapid alert system that encompasses emergency preparedness and response. Legislation should also require FBOs to notify CAs of food safety issues and for CAs to adopt emergency response measures and communicate risk in an effective manner

Food safety events that constitute a Public Health Emergency of International Concern (PHEIC) should be reported through the appropriate channels as required by the International Health Regulations (IHR).[2] These are an international legal instrument that aims at helping the international community prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide.

National legislation may require authorities of the public health sector to designate an IHR focal point and adhere to IHR reporting obligations.

POSSIBLE OUTCOME

Food safety legislation includes a legal responsibility for the CAs to set up coordinated and efficient rapid alert, emergency preparedness and response systems, in line with international commitments.

POSSIBLE INDICATORS

> CAs are required by legislation to approve and implement a food safety emergency plan that sets out a system to respond to food safety events and outbreaks of FBD, which involves a multidisciplinary response team and coordination among CAs.

> Legal provisions exist to require FBOs, where appropriate, to notify CAs of food safety issues and implement preventive measures.

> Legal provision is made for communication of food safety events between the public health authorities and other CAs in charge of food safety.

> Legislation includes clear responsibilities for accurate risk communication with the public in case of food emergency, and with trading partners if the emergency is of potential international nature.

SOURCES OF EVIDENCE

> Legislation and regulations.

> Food safety emergency plan.

SEE ALSO

A.1.1.4 [Legislation recognizes the stakeholders’ right to have access to information on food control measures (including sanitary and quality requirements) and includes provisions on publicizing them]

B.2.3 [Management of food safety emergencies]

A.1.3.11

ASSESSMENT CRITERION: Legislation contains requirements for food packaging, labelling and advertising.

GUIDANCE

Food labelling information is essential to handle, maintain and use food products in a safe manner. CODEX STAN 1-1985, on general rules for labelling of pre-packaged foods, gives provisions for key labelling information, such as name of food, ingredients list and quality indications, weight or volume, name and address of manufacturer, country of origin, instructions for use, storage instructions, date marking and details that enable traceability. Food labelling should not mislead the consumer as to the product’s characteristics or effects (Ref. para 50, 2nd point, of CAC/GL 82-2013) nor should it attribute to a product properties for the prevention, treatment or cure of a human illness (see, for example, CAC/GL 23-1997 providing guidelines on nutrition and health claims).

Although details on food labelling requirements are most often stipulated in subsidiary food legislation, additional labelling rules may occasionally appear in other types of legislation:

> In most countries, separate legislation governs the use of weights, volumes, measures and numbers.

> Nutrition labelling is a cause of rejections (non-food safety-related) in international trade, because of varying requirements (see CAC/GL 2-1985, guidelines on nutrition labelling).

> Advertising includes any representation – written, pictorial, visual or otherwise – made for promoting directly or indirectly the sale or placement on the market of any food or any substance represented as food. The regulation of food labels and advertising varies widely among countries and regions.

> Food hygiene regulations also encompass the safety of those materials and articles intended to come into contact with food. Inappropriate packaging and re-packaging can pose specific food safety hazards and enable contamination.

POSSIBLE OUTCOME

CAs have a legal instrument to prevent fraudulent or misleading food labelling and advertising, and risks associated with food packaging are considered alongside other hazards.

POSSIBLE INDICATORS

> Clear provisions in legislation:

i. Stating that every package of food intended for sale in the country shall bear a label which sets out such particulars as may be prescribed (at the minimum: name of the food, ingredients list and quality indications, weight or volume, name and address of the manufacturer, country of origin, instructions for use, storage and date marking).

ii. Stating that these particulars should be indicated in a language easily understood by the consumer.

iii. Containing food safety requirements for material intended to come into contact with food products, including food packaging.

iv. Regarding nutritional labelling.

v. Regarding basic requirements for food advertising to protect the consumer (e.g. rules prohibiting false health claims, rules prohibiting and penalizing the marketing of unhealthy foods – particularly those high in saturated fat, salt and free sugars, to children – with misleading claims and allegations).

SOURCES OF EVIDENCE

> Legislation.

> Advertisements, labels and packages.

> Feedback collected from consumer protection organizations, government and other stakeholders.

A.1.3.12

ASSESSMENT CRITERION: Legislation includes provisions for surveillance of priority FBDs, guided by the food safety and quality policy.

GUIDANCE

Timely access for relevant CAs to adequate information relating to the surveillance, investigation and response to food-borne illness and food-related incidents, is critical. Such information can identify the risks or issues that need to be addressed by CAs and also whether or not the controls or measures in place are effective.

Surveillance of FBDs should include, as appropriate, both Event-Based Surveillance (EBS) and Indicator-Based Surveillance (IBS). Surveillance and response systems for FBD should be built on the existing mechanisms that are part of the core capacity requirements of the IHR, in order to promote and strengthen multidisciplinary and inter-agency coordination for surveillance, risk assessment and response.

As a foundational basis for effective detection of, investigation of and response to food safety events, legislation should include the responsibility for the government to develop a system of surveillance, including the development and periodic update of a priority list of FBDs or syndromes for surveillance and regulated procedures for surveillance and reporting.

POSSIBLE OUTCOME

Legislation recognizes the power and the responsibility of the CAs to put in place surveillance, including reporting, of priority FBDs or syndromes, which inform food control priorities so they remain relevant to prevalent hazards and risks.

POSSIBLE INDICATORS

> A priority list of FBDs or syndromes for mandatory surveillance, including reporting.

> Procedures for surveillance and reporting.

SOURCES OF EVIDENCE

> Legislation.

> List of priority diseases.

> Procedures for surveillance and reporting.

SEE ALSO

A.1.3.5 [Legislation includes provision for inspection, monitoring and control of the food supply for hazards]

B.2.2.1 [There is a fully functional Indicator-Based Surveillance (IBS) system in place that can successfully monitor trends and detect food-borne disease (FBD) outbreaks]

A.2
INFRASTRUCTURE AND FINANCES

A.2.1

FINANCIAL RESOURCESS

Sufficient budget is secured to implement the strategic food control plan[5] at all levels of government and to respond to food safety emergency and events (Ref. para. 24 of CAC/GL 82-2013).

A.2.1.1

ASSESSMENT CRITERION: Preparation of budget allocations for CAs is carried out in a participatory and transparent manner that reflects a strategic plan for food control at national and subnational levels.

GUIDANCE

Allocating public finances within Ministries and within CAs that have a shared mandate can be challenging. The allocation should be managed in a transparent and inclusive manner, with a view to consistency, and based on planning for the required outcomes. Budgeting processes should be based on a strategic process that federates individual CAs around a common goal for specific outcomes, results and activities. This is important, for example, when food control activities previously carried out by technical ministries are transferred to local authorities. In the absence of a common planning process, individual strategic plans should be available to justify budgetary allocations for each CA according to results-based management principles. This process must also take into account the obligations created by legislation on CAs and be realistic about what should be achieved. When CAs are located within a broader embracing ministry, funds should be clearly earmarked for food control.

POSSIBLE OUTCOME

Financial allocations for CAs are consistent with a national strategic vision for food control.

POSSIBLE INDICATORS

> Clear and effective strategic processes for budget preparation (that federate individual CAs around a common goal), OR:

> Individual strategic plans that justify budgetary allocations for each CA on results-based principles.

> Clearly identifiable budget lines for food control.

> Clear and effective processes for management of funds.

> Clearly identifiable units within CAs responsible for management of funds.

> Oversight, training, support or advice provided for personnel deciding budgets and preparing budgets (i.e. budget managers).

SOURCES OF EVIDENCE

> Documentary reports of budget allocations explaining the rationale behind the allocations.

> Financial planning/annual budget reports, documents or reviews.

SEE ALSO

A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy]

A.2.1.2

ASSESSMENT CRITERION: CAs can easily access the allocated funds, including any recovery of fees, commensurate with the controls to be carried out as per the strategic plan.

GUIDANCE

The CAs will make annual application to government for budgetary allocations based upon their official food control strategies and their financial estimates. These applications should be realistic. If so, the CAs should require equally realistic budgetary sums to be able to implement the strategies. When government responds by positively allocating funds according to the sums outlined in the applications, then the situation is conducive to implementing satisfactory official controls (Ref. para 58 of CAC/GL 82-2013). On the contrary, when the allocations fall short of the application or are not easily accessible, CAs have to find ways to reduce expenditures – for example, by prioritizing activities, cutting staff, etc. As a result, official food controls may not be expedited properly and the original risk-based strategy could be compromised, possibly endangering public health or raising risk.

If it is foreseen that some CAs get partial funding through the collection of fees, these fees should be easily recovered by the CAs (some countries direct them towards the general treasury where they are subsequently difficult to access for the CAs).

POSSIBLE OUTCOME

The achievement of established strategies is supported by adequate funding.

POSSIBLE INDICATORS

> The actual allocations for food control activities are in line with the annual budgetary applications (no deviations during the last 5-year period).

> When CAs are expected to get partial funding through the perception of fees, these fees are easily recovered by the CAs (e.g. if the fees are directed towards general treasury it might be difficult for CAs to access them).

SOURCES OF EVIDENCE

> Budgetary applications.

> Budgetary allocation documents.

> The opinions of CAs’ managers and key staff.

> Annual reports from the CAs.

SEE ALSO

A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy]

A.2.1.3

ASSESSMENT CRITERION: An analysis of the cost of the relevant scientific services has been reflected in budget allocations.

GUIDANCE

Modern food control governance is evidence- and risk-based, which means that CAs should be able to access scientists and experts (either hired internally or commissioned externally) to support their priority-setting and decision-making processes. This criterion is about assessing if prioritized science-based work, risk-based work (and any associated analytical resources specifically related to these) have been financially catered for. This includes covering costs associated with scientists (analysts, but also modelling experts, statisticians, or any other expert necessary to support risk analysis work).

Note: Resources for the scientific services differ from the resources allocated to monitoring programmes (reviewed under A.2.1.7), and to regular support to analytical structures (subject of A.2.3).

POSSIBLE OUTCOME

Science-based activities to support risk- and evidence-based approaches are financially supported.

POSSIBLE INDICATORS

> An analysis of the cost (estimate) of the most pressing science-based and risk-based activities (including: specific analytical resources, specific experts – e.g. modelling, exposure assessment, statisticians).

> Reflection of this analysis in the final and formal budget allocations.

> Budget includes provision for subcontracting of specialist scientific services.

SOURCES OF EVIDENCE

> Strategic analysis report.

> Financial planning/annual budget reports, documents or reviews.

SEE ALSO

A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy]

A.2.1.4

ASSESSMENT CRITERION: The financial resources required to hire, pay and retain sufficient and skilled staff are secured and accounted for in financial planning and budgeting.

GUIDANCE

The implementation of a national food control strategy is based on technical activities and enforcement being properly implemented by skilled staff in sufficient numbers (Ref. para 59, 2nd point, of CAC/GL 82-2013). Different types of activities (e.g. enforcement, audits, surveys, regulation drafting) will require a mix of different skills, and their administrative deployment in different areas with specified frequencies will affect numbers. Budgetary allocation must provide adequate funding for the mix of staff required to operate each CA programme.

POSSIBLE OUTCOME

Skilled staff in sufficient numbers support the implementation of CAs’ strategic food control plans.

POSSIBLE INDICATORS

> Funding of staff positions secured in the annual budget.

> Skilled staff in sufficient numbers across all sectors.

SOURCES OF EVIDENCE

> Financial planning/annual budget reports, documents or reviews.

> Interviews with CAs.

SEE ALSO

A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy]

A.3.1 [Qualification of personnel]

A.2.1.5

ASSESSMENT CRITERION: Training and ongoing development of food control staff is financially secured in CAs’ budgets.

GUIDANCE

The government’s successful delivery of official food controls is largely a function of the competence of the staff, and the development of their skills in relation to scientific and technical developments. For this reason, as well as to offer career development opportunities, and to keep staff motivation high, the ongoing training and development of food control staff is of great importance, and has to be funded and supported financially by budgetary allocations (Ref. para 59, 1st point, and 72 of CAC/GL 82-2013).

POSSIBLE OUTCOME

Planned training for staff can occur.

POSSIBLE INDICATORS

> Funding of on-going training and development of food control staff secured in the annual budget.

> Realistically high budget.

SOURCES OF EVIDENCE

> Financial planning/annual budget reports, documents or reviews.

SEE ALSO

A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy]

A.3.2 [Training of personnel]

A.2.1.6

ASSESSMENT CRITERION: The financial resources required to purchase, renew and maintain essential infrastructure and equipment (office, logistics, transportation, IT, etc.) are financially secured in CAs’ budgets.

GUIDANCE

Food control staff require appropriate office space, essential office equipment and specific facilities to conduct their work; appropriate budgetary provisions should be made to allow access to these facilities and equipment (for proper maintenance if owned, for rental or other arrangements otherwise). Beside the physical working space (office and technical facilities for inspection, storage of samples, etc.), basic equipment to record data, communicate and access information are essential for the work of food control staff (Ref. para 59, 1st point, of CAC/GL 82-2013).

Documentation, including records, certificates, samples and other admissible evidence, must be kept secure from removal or interference. Transportation is also to be ensured, either through access to vehicles (whether official vehicles, or provisions for rental) or through specific agreements for use of personal vehicles if appropriate to the task to be performed. The issue of how much is “adequate” is connected to the targets specified in CAs strategic plans.

POSSIBLE OUTCOME

Appropriate office spaces and necessary equipment and facilities allow food control staff to properly conduct their work.

POSSIBLE INDICATORS

> Funding for essential infrastructure and equipment secured in the annual budget (offices, logistics, transportation, IT, etc.).

> Breakdown of costs for: physical space/offices, facilities, supporting laboratories, IT and office equipment, etc.

SOURCES OF EVIDENCE

> Financial planning/annual budget reports, documents or reviews.

SEE ALSO

A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy]

A.2.2.1 [Food control services are provided with suitable accommodation and with special facilities at all locations where official food control work is carried out]

A.2.2.2 [There are suitable and sufficient vehicular assets adequately maintained for the implementation of the food control programme by CAs]

A.2.2.3 [There is an IT system in place for recording, analysing and sharing the data collected during food controls and surveillance of FBDs]

A.2.2.4 [Staff operating inspection, monitoring and surveillance activities have access to reliable modern technologies for rapid communications in central and local offices]

A.2.2.5 [Suitable sampling equipment, space and facilities (such as temperature-controlled storage and infrastructure for transportation of samples to laboratories), are provided for monitoring or surveillance activities]

B.1.2.8 [Sufficient inspection facilities are available to inspection staff, of appropriate design, layout and capacity, in the relevant sites]

A.2.1.7

ASSESSMENT CRITERION: Funding for the sampling activities related to monitoring of priority food safety risks, as well as human health surveillance relevant to FBDs, is financially secured in the CAs’ budgets.

GUIDANCE

The activities of monitoring priority food safety risks are key to the CA’s science-based and risk-based strategies for official food controls. Human health surveillance of FBDs is also fundamental for detecting outbreaks and incidents, and attributing food vehicles. The activities should provide sound scientific results, upon which can be based risk assessment, official controls and enforcement work but also a review of the food safety and quality policy and CAs’ strategies. For this reason, these activities have to be conducted well and therefore must be properly financed (Ref. para 59, 3rd point, of CAC/GL 82-2013).

POSSIBLE OUTCOME

Enforcement work and review of food safety and quality policies and official controls are informed by data and analysis of monitoring of food products for priority risks and results of human health surveillance activities related to FBDs.

POSSIBLE INDICATORS

> Operating budget for sampling activities supporting monitoring of food risks (including human health surveillance) secured in the annual budget (collection of samples, storage and transport, analysis, processing and communication of data, etc.).

> Risk analysis activities and strategic national sampling/surveillance plan reflected in the operating budget for sampling and surveillance.

> Estimated costs of the sampling and surveillance strategy are in line with the actual budgetary allocations.

SOURCES OF EVIDENCE

> Financial planning/annual budget reports, documents or reviews.

SEE ALSO

A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy]

A.2.2.5 [Suitable sampling equipment, space and facilities (such as temperature-controlled storage and infrastructure for transportation of samples to laboratories), are provided for monitoring or surveillance activities]

A.2.3.1 [CAs and laboratories work jointly to plan the analytical workload for servicing routine inspections, sampling programmes for monitoring of priority food safety risks, FBD surveillance and other scientific related activities]

B.1.2.8 [Sufficient inspection facilities are available to inspection staff, of appropriate design, layout and capacity, in the relevant sites]

B.2.1 [Monitoring programmes in relation to the food chain]

A.2.1.8

ASSESSMENT CRITERION: In the event of a national food-related emergency, there is sufficient and realistic financial allocation secured in the budgets to support the mobilization of the national emergency plan.

GUIDANCE

When food-related emergencies arise (whether of a food safety or quality nature or through fraud), great political pressure is applied to government and to the CAs from consumers and from the private sector alike. At these times, it is of great importance that resources are readily accessible to mobilize the government’s response and effective official controls within the country’s emergency plan. For these reasons, it is important that sufficient financial resources be pre-allocated for the government’s response to food-related emergencies. The funds may be within central government budgets or within individual CA budgets.

In the absence of specific dedicated funds, emergencies would be dealt with using the “regular budget” and this might cause disruptions in the regular control activities.

POSSIBLE OUTCOME

Official government response to food-related emergencies is financially supported.

POSSIBLE INDICATORS

> Sufficient financial resources pre-allocated for responses to food-related emergencies (the funds may be within central government budgets or within individual CA budgets).

> Correspondence between the budgetary estimate and the actual financial allocations for food-related emergencies.

> Easy access to the funds secured for emergency management.

SOURCES OF EVIDENCE

> Financial planning/annual budget reports, documents or reviews.

SEE ALSO

A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy]

A.2.3.4 [In case of a food safety emergency, food control laboratories have the capabilities and versatility to adapt to the resulting changes/surges in demand of tests to be performed]

B.2.3 [Management of food safety emergencies]

A.2.1.9

ASSESSMENT CRITERION: Staff preparation for, and attendance at, selected international scientific and policy-makers’ meetings and conferences relevant for food safety and quality is financially secured in the CAs’ budgets.

GUIDANCE

Relationships with food control CAs of trading countries often happen through selected meetings of international organizations that have a mandate relevant to food control. Participation in these meetings is important for several reasons: new food control concepts and threats are discussed; new knowledge and new ideas are shared; access to expertise and advice is secured. As a result, food trading relations may benefit and cooperation between countries (for instance in food safety emergencies) may be supported. Participation in regional conferences/meetings or in Codex committees strategically relevant for the country is a good example. Such international networking is important for successful implementation of the food control strategic plan. For that purpose, it is expected that CAs make an analysis of their strategic needs in that regard to justify the budgetary allocation requested. It should be noted that participation in Codex meetings means more than just “physical attendance” at the meeting. To be meaningful it requires, among other actions, sharing of information, national consultations and preparation of positions, and, if necessary, awareness-raising among stakeholders to facilitate their input to the national consultations.

It is understood that choices will inevitably be made, as attendance to all regional/international meetings and conferences would not be possible (nor even desirable). The purpose of this criterion is to understand whether: (i) meetings are identified with a strategic vision; and (ii) the meetings deemed strategically important could be attended (with the relevant level of preparation) from the funding perspective.

POSSIBLE OUTCOME

CAs are enabled to participate meaningfully in strategically selected international events.

POSSIBLE INDICATORS

> The budget for staff attendance at international meetings takes into account:

i. Documented process to determine strategic meetings to attend, with communication between CAs to avoid duplication.

ii. Number of key staff who require consideration of this nature.

iii. Conference fees, travel costs, and subsistence costs.

iv. For Codex Committees: attendance matching country needs and priorities as identified and selected by CAs.

> Documents attesting participation to relevant regional/international meetings in the past.

SOURCES OF EVIDENCE

> Financial planning/annual budget reports, documents or reviews.

SEE ALSO

A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy]

C.2.2.1 [The country is an active member of Codex and other relevant IOs with mandates in food safety and quality]

C.2.2.3 [The country provides Codex and related scientific advice bodies with relevant scientific and technical information]

A.2.1.10

ASSESSMENT CRITERION: Post-expenditure audit of the budget and review of management performance in relation to the budgetary expenditure are performed.

GUIDANCE

It is important to check the performance of the budget and expenditures (post-expenditure) on a periodic basis. This allows CAs to verify whether the allocations were appropriate and also if the management of the budget was carried out properly. This will ascertain whether the budget was accurate in the estimate and in reality, whether there was sufficient or insufficient allocation in the actual budget and whether the budget was handled properly. It will also determine if there are any lessons to be learned and what actions or new approaches are suggested by the review process. This should support a feedback loop allowing CAs not only to properly implement their programmes of work for the coming budgetary exercises, but also to progressively invest in missing assets, training of staff, etc.

POSSIBLE OUTCOME

Budget audit and review process secure effective, accountable, and appropriate use of funds.

POSSIBLE INDICATORS

> Periodic (annual?) financial audit of the budget.

> Periodic financial performance review.

> Checks performed by independent competent authorities.

SOURCES OF EVIDENCE

> Financial planning/annual budget reports, documents or reviews.

> Reports and other outputs from the financial audit and performance review.

SEE ALSO

A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy]

A.2.2

INFRASTRUCTURE AND EQUIPMENT

Suitable and sufficient infrastructure and equipment are available for CAs to perform their work effectively and according to the strategic food control plan[6] (Ref. para 24 of CAC/GL 82-2013).

A.2.2.1

ASSESSMENT CRITERION: Food control services are provided with suitable accommodation and with special facilities at all locations where official food control work is carried out.

GUIDANCE

The CAs should have rented, arranged, or been provided with suitable accommodation at locations where work for official controls is performed. Food control services operating in specific locations (e.g. cities), by selected FBOs or infrastructures (e.g. slaughterhouses) and at border inspection points (airports, seaports, road crossings, etc.) require secure and suitable accommodation and special facilities that allow the staff to conduct their work. Documentation including records, certificates, samples and other admissible evidence must be kept secure from removal or interference. At such locations where work is infrequent, the staff should have at their disposal facilities that meet the work and security criteria.

POSSIBLE OUTCOME

Suitable accommodation with special facilities allows food control staff to properly conduct their work.

POSSIBLE INDICATORS

> The accommodations and facilities themselves, allowing, for example, secured storage of documents.

SOURCES OF EVIDENCE

> Written or photographic data about facilities provided at key inspection locations, and also at lesser inspection locations (based on several facilities in different regions and with different functions).

SEE ALSO

A.2.1.6 [The financial resources required to purchase, renew and maintain essential infrastructure and equipment (office, logistics, transportation, IT, etc.) are financially secured in CAs’ budgets]

B.1.2.8 [Sufficient inspection facilities are available to inspection staff, of appropriate design, layout and capacity, in the relevant sites]

A.2.2.2

ASSESSMENT CRITERION: There are suitable and sufficient vehicular assets adequately maintained for the implementation of the food control programme by CAs.

GUIDANCE

Effective food control services throughout a country’s territory require mobility of staff, equipment, and all other items that require relocation, such as (biological) samples, food products, or protective clothing. Remote locations can be reached with a good road infrastructure supported by vehicles that can be relied upon to traverse the roads in adverse weather conditions. Vehicular assets must be mechanically sound and in all ways maintained to be reliable and safe. Functional road transport requires reliable and available fuel resources. There must be drivers available who can safely use the vehicles and the roads. The notion of “sufficient” is closely connected to the implementation of activities and to the targets set in the food control strategic plan(s) or in the CAs programmes of work deriving from this plan(s).

POSSIBLE OUTCOME

Availability of vehicles supports inspections, sample collections and staff transportation for the achievement of targets of the food control strategic plan.

POSSIBLE INDICATORS

> Availability of vehicles that:

i. Can be relied upon for traversing roads in adverse conditions of weather.

ii. Are mechanically sound and maintained to be reliable and safe.

> Availability of reliable fuel resources.

> Availability of drivers who can safely use the vehicles and the roads.

> Evidence that availability of vehicles and their support systems do not affect negatively or impose any limitations on reaching the food control strategic plan targets.

SOURCES OF EVIDENCE

> Formal lists of vehicular assets.

> Interviews with food control CAs and officers.

SEE ALSO

A.2.1.6 [The financial resources required to purchase, renew and maintain essential infrastructure and equipment (office, logistic, transportation, IT, etc.) are financially secured in CAs’ budgets]

A.2.2.3

ASSESSMENT CRITERION: There is an IT system in place for recording, analysing and sharing the data collected during food controls and surveillance of FBDs.

GUIDANCE

Traditional paper-based information and data recordings do not lend themselves well to the processing and dissemination of information. Electronic recording of information means that the information can be processed, copied, saved, collated and transmitted much more efficiently than through traditional paper-based systems. Such systems should have national coverage, and facilitate exchange of information between laboratories as well as CAs. Since IT systems can be vulnerable to physical damage and breakdown, the presence of a valid technical support system is also mandatory for success.

POSSIBLE OUTCOME

Data generated by food controls can be analysed for risk analysis and enforcement purpose.

POSSIBLE INDICATORS

> Electronic system in place for the recording of data and information.

> Existence of support functions for protection and maintenance of the system.

> Internet and/or intranet available, functional and reliable.

> Modern devices for supporting official food controls and inspections (available and utilized effectively).

> Information stemming from surveillance of FBDs and monitoring of priority food safety risks can be exchanged between CAs and laboratories.

SOURCES OF EVIDENCE

> Reports generated using the system.

SEE ALSO

A.2.1.6 [The financial resources required to purchase, renew and maintain essential infrastructure and equipment (office, logistics, transportation, IT, etc.) are financially secured in CAs’ budgets]

A.2.2.4

ASSESSMENT CRITERION: Staff operating inspection, monitoring and surveillance activities have access to reliable modern technologies for rapid communication in central and local offices.

GUIDANCE

Key staff should have the facility of communicating regardless of where they are. The capacity to talk or message (e.g. by cell phones, radio or computers/laptops with access to Web-based services) supports the delivery of a food control inspection service. Officers should be able to communicate to colleagues or to FBOs at all times and in all places and to check information and arrangements. The instruments are either personally owned with an allowance provided for office use or they should be supplied by the office with an arrangement for private use. The CAs should ensure that the performance of food control services is not jeopardized by difficulties in communicating. Access by CAs to confidential information should have safeguards to protect information and commercial sensitivity.

POSSIBLE OUTCOME

Operational and reliable modern technologies for communications support delivery of food control services.

POSSIBLE INDICATORS

> Food control officers have appropriate instruments to be able to communicate in all places and at all times (cell phones, radio, computers/laptops with Internet access, etc.).

> CAs support food control staff to use modern communication equipment and services (e.g. cell phones).

> If the instruments are personally owned, the staff is satisfied with the arrangements.

SOURCES OF EVIDENCE

> Evidence from food control officers who operate at central and also provincial level.

SEE ALSO

A.2.1.6 [The financial resources required to purchase, renew and maintain essential infrastructure and equipment (office, logistics, transportation, IT, etc.) are financially secured in CAs’ budgets]

B.1.2.8 [Sufficient inspection facilities are available to inspection staff, of appropriate design, layout and capacity, in the relevant sites]

B.2.3.4 [Functional arrangements are in place for communication and implementation of response in the event of a food safety emergency]

B.2.3.5 [Strategies and guidance for communicating with partners, stakeholders, general public and international organizations are in place]

C.1.2 [Information flows and integration of FBOs into risk management]

A.2.2.5

ASSESSMENT CRITERION: Suitable sampling equipment, space and facilities (such as temperature-controlled storage and infrastructure for transportation of samples to laboratories), are provided for monitoring or surveillance activities.

GUIDANCE

In sampling locations (such as FBOs, infrastructures like slaughterhouses, border inspection points), it is important that samples of food products for monitoring can be collected in a professional manner that ensures their representability and integrity. This entails proper sampling equipment (e.g. gauges, probes, thermometers), temperature-controlled facilities for storage, visual inspection and transportation to the laboratories. This would also include any device and facility that protects the sampling operation and the sample itself from adverse environmental contamination. Biological samples must be kept securely in physical conditions of containment, temperature control or refrigeration, and the accommodation must provide these facilities as required.

POSSIBLE OUTCOME

Samples are received by laboratories in a state that ensures results are valid.

POSSIBLE INDICATORS

> Information collected by visiting locations where such samples are collected and by interviewing appropriate staff.

> Few or no instances where the laboratory reports that samples cannot be processed due to contamination or deterioration of quality.

SOURCES OF EVIDENCE

> Interviews with appropriate staff upon visits to locations where samples are collected.

> Data regarding validity of laboratory findings.

SEE ALSO

A.2.1.6 [The financial resources required to purchase, renew and maintain essential infrastructure and equipment (office, logistics, transportation, IT, etc.) are financially secured in CAs’ budgets]

A.2.1.7 [Funding for the sampling activities related to monitoring of priority food safety risks, as well as human health surveillance relevant to FBDs, is financially secured in the CAs’ budgets]

B.1.2.8 [Sufficient inspection facilities are available to inspection staff, of appropriate design, layout and capacity, in the relevant sites]

B.1.1.14 [Authoritative and clear guidance on sampling techniques is available to inspectors and samples taken during inspections are appropriate]

A.2.3

ANALYTICAL RESOURCES

Suitable and sufficient analytical services are available and accessible by CAs to carry out the analysis required by the food control system (Ref. para 43, 9th point, of CAC/GL 82-2013).

A.2.3.1

ASSESSMENT CRITERION: CAs and laboratories work jointly to plan the analytical workload for servicing routine inspections, sampling programmes for monitoring of priority food safety risks, FBD surveillance and other scientific related activities.

GUIDANCE

Laboratories operate as managed entities that provide services of analysis and scientific investigation. A government food control laboratory (or a contracted private laboratory) has a specified role and a mandate to accomplish. The operations of the laboratory/ies must be fully integrated with the operations of the field services that are deployed by the CAs. Close communication and liaison between the managers of food control field operations and the laboratory operations should be supported by joint planning. The existence of a strategic food control plan (see A.1.1.2) provides support when planning analytical upcoming needs by CAs and therefore would facilitate discussions with laboratories.

POSSIBLE OUTCOME

Laboratory services are available to CAs when requested.

POSSIBLE INDICATORS

> Liaison mechanisms between the managers of the field operations (official food controls) and the managers of the food control laboratory/ies for joint work planning.

SOURCES OF EVIDENCE

> Meeting plans and meeting reports, or documents that:

i. Indicate that strong liaison and coordination between the managers occur predictably.

ii. Include the identification of the labs where samples should be sent, depending on needs, for specific analysis (e.g. accredited labs).

SEE ALSO

A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy]

A.2.1.7 [Funding for the sampling activities related to monitoring of priority food safety risks, as well as human health surveillance relevant to FBDs, is financially secured in the CAs’ budgets]

A.2.3.2

ASSESSMENT CRITERION: The laboratory capacities meet the country’s strategic analytical needs with appropriate geographical coverage across the country, including for import and export.

GUIDANCE

CAs must define analytical needs with sufficient precision to allow laboratories to invest in development of methods, purchase of equipment and training of staff. Laboratories (or, more generally, access to laboratory services – for small countries where having a public dedicated food control laboratory is not strategic or feasible) should be located in a way to best serve the CAs’ most important needs, according to the locations for sampling (BIPs, important areas of concentration of FBOs, important cities etc.) Countries’ specific transportation challenges and CAs’ equipment to transport samples (both means for maintaining sample integrity) should also be taken into account when deciding where and how many laboratories (and of what capacity) are necessary.

POSSIBLE OUTCOME

Laboratories are providing effective analytical services to the CAs.

POSSIBLE INDICATORS

> Definition of analytical needs by the CAs.

> Appropriate geographical coverage of laboratories (or access to laboratory services) as per CAs’ needs.

> Evidence that laboratories meet the demand placed upon them.

> Evidence of capacity for sample transportation and maintenance.

SOURCES OF EVIDENCE

> Documentary evidence of laboratory effectiveness (mission statement, strategy or internal policy document, routine reports, etc.).

A.2.3.3

ASSESSMENT CRITERION: The national system of laboratories has sufficient technical capabilities to address priority hazards and quality parameters for food analysis, and the analysis of clinical samples for detection of FBDs.

GUIDANCE

Some laboratories are capable only of basic tasks of food analysis due to limited resource availability or low investment in equipment and staff. Other laboratories can address tasks that are more complex. The CAs should be able to demonstrate that analytical tasks to support official controls over food products can be addressed, as mandated by legislation and indicated in the food control strategic plan, within the system of laboratories in the country. If some important analysis cannot be addressed somewhere in the country, food control managers should be able to access laboratory services in foreign countries. The demands placed upon the laboratories in terms of their technical capabilities (i.e. whether they can address and perform complex or unusual analyses) must be commensurate with the equipment and technical expertise of the staff. In practice, the laboratories’ capabilities are a function of the demands placed upon the service, the policy “drivers” or forces that are behind the operation, the investments that the government or CA has been able to secure and the aspirations of the laboratory managers.

POSSIBLE OUTCOME

Priority analytical aspects of food control are adequately covered by laboratories.

POSSIBLE INDICATORS

> Laboratories have equipment and methodologies to perform credible and reliable analyses for priority aspects of food control.

> The demands placed upon the food safety and quality laboratory system in terms of its technical capabilities are commensurate with the equipment and technical expertise of the staff.

> The normal output of the laboratories meets the expectations of the stakeholders, including the government sector and the private sector.

SOURCES OF EVIDENCE

> List of food control laboratories and their capabilities (plus the throughput statistics for each of the tests that are performed).

> Interviews with laboratory staff.

SEE ALSO

A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy]

A.2.3.4

ASSESSMENT CRITERION: In case of a food safety emergency, food control laboratories have the capabilities and versatility to adapt to the resulting changes/surges in demand of tests to be performed.

GUIDANCE

Versatility of the food control laboratories is important because there may be gradual changes in the demand for certain services. Sometimes the change in demand may be sudden. Changes can affect the number or the type of tests required. Essentially this criterion is to assess the technical capacity of the food control laboratories to adapt to surges of demand for analytical services. This versatility may be dependent upon the type of test, the physical space or the availability of equipment and/or reagents, but also upon financial resources, political will and (very importantly) the technical capabilities of the staff.

POSSIBLE OUTCOME

Laboratories have capacity to respond to emergencies.

POSSIBLE INDICATORS

> Labs can raise all performance capacities as needed to support expanding food control priorities and emerging issues.

> “Versatility” as a concept is addressed in government reports or contingency planning for the food safety laboratory/ies.

> There are no indications that there is (or has been) demand for services that has not been met with versatility by the government.

SOURCES OF EVIDENCE

> Any document or report that deals with contingency planning for the food safety laboratory sector.

SEE ALSO

A.2.1.8 [In the event of a national food-related emergency, there is sufficient and realistic financial allocation secured in the budgets to support the mobilization of the national emergency plan]

B.2.3.1 [A suitable national food safety emergency plan has been developed in a participatory way and food safety emergencies have been defined to serve as a trigger for escalating appropriate response]

B.2.3.3 [A functional central coordination mechanism includes all relevant CAs to address food safety emergencies]

A.2.3.5

ASSESSMENT CRITERION: Codex and other official recommended methods of analysis and sampling are implemented.

GUIDANCE

Along with setting up maximum levels of microbiological criteria or defining specific parameters, regulations should indicate which reference testing method should be used to sample and test for a specific parameter. At international level, Codex Alimentarius specifies reference methods submitted by recognized bodies (e.g. ISO, AOAC). It is therefore important that the laboratories use official methods as prescribed by regulations and that these official methods are relevant.

POSSIBLE OUTCOME

Methods used by laboratories are relevant to food control, and based on official methods.

POSSIBLE INDICATORS

> Labs utilize the Codex Recommended Methods of Analysis and Sampling (CODEX STAN 234-1999) or other official methods where appropriate.

SOURCES OF EVIDENCE

> Standard Operating Procedures (SOPs).

> Evidence of tests performed in the past.

A.2.3.6

ASSESSMENT CRITERION: Laboratories are following Good Laboratory Practices and have quality management systems in place.

GUIDANCE

The reliability of analytical results calls, at minimum, for the observance of Good Laboratory Practices and a quality assurance system in place. Besides a documentation system, this includes, among other requirements, procedures for sample management and registration, periodic and routine calibration service and maintenance of equipment, and personnel health and safety measures (Ref. para 76 of CAC/GL 82-2013). Codex Alimentarius has adopted, among other texts related to analysis and sampling, recommendations for internal quality control and analytical chemistry laboratories (CAC/GL 65-1997) and food control management (CAC/GL 28-1995).

Laboratories handle pathogens, toxins and other food safety hazards. Some of these (most especially infectious agents) can be dangerous to personnel in the laboratory or to others in the area of the laboratory. All scientific procedures and work conducted in the laboratory should be done in a manner that is safe for the staff and also for the public at large. In addition, the availability of a national metrology system to support calibration should be ascertained.

POSSIBLE OUTCOME

Laboratories’ quality management systems ensure the quality of scientific tests for food control analyses, while staff health and safety are protected.

POSSIBLE INDICATORS

> Calibration performed by reliable service providers subject to quality assurance controls.

> Access to satisfactory maintenance contracts.

> Evidence that the laboratory considers health and safety very seriously.

> Evidence that staff have been trained and are very aware of health and safety during their work.

> Availability of protective clothing, uniforms, badges, stamps, etc.

> Written guidance for staff about safety procedures.

> Quality assurance manual for the laboratory, including procedures for sample registration and management.

SOURCES OF EVIDENCE

> Records generated by the quality assurance system.

> The laboratory’s health and safety manual, along with any formal report that deals with safety performance of the laboratory.

> The management’s internal policy statements regarding equipment maintenance and calibration, reports and accounts.

A.2.3.7

ASSESSMENT CRITERION: Designated food control laboratories are accredited ISO 17025[7] (testing laboratories) and ISO 15189[8] (clinical laboratories) by internationally recognized bodies.

GUIDANCE

Confidence in the standard of food control laboratory service is important for the stakeholders who rely upon the accuracy and quality of the results that are used to inform control decisions about food safety and quality for consumers. If the laboratory services are conducted to stringent quality standards and accredited as having achieved these standards, and if continuing achievement of the standards is verified periodically, this provides assurances about the quality provided to the users of the laboratory services. ISO 17025 offer an internationally agreed basis for accreditation for testing laboratories, while ISO 15189 are relevant for clinical laboratories (Ref. para 77 of CAC/GL 82-2013). For the accreditation to be valid at international level, it is important that the accrediting body be internationally recognized (e.g. International Laboratory Accreditation Cooperation, ILAC).

POSSIBLE OUTCOME

An excellent standard of service is offered and is accredited.

POSSIBLE INDICATORS

> ISO 17025 and/or ISO 15189 accreditation by internationally recognized accrediting body. (Evidence of engagement in the process for achievement of ISO 17025 and/or ISO 15189 accreditation would give a partially achieved score).

> Certificates of accreditation for the laboratory standard ISO 17025 or ISO 15189 as appropriate, by an internationally recognized accrediting body.

SEE ALSO

D.2.1.6 [The CAs responsible for official controls for food safety have written policies to use external audit of business processes to improve public services and these policies are implemented]

A.3
HUMAN RESOURCES

A.3.1

QUALIFICATION OF PERSONNEL

CAs implement a systematic approach to ensure that they have access to suitably qualified personnel[9] in sufficient numbers.

A.3.1.1

ASSESSMENT CRITERION: A duty is placed upon the State to ensure that CAs have access to sufficient and suitably skilled personnel with adequate qualifications and ability.

GUIDANCE

Legislation should stipulate that only persons who are suitably qualified should be designated as food control officers – for example, inspectors – to work for the service and support the mandate. The numbers outlined by the strategic plan.

POSSIBLE OUTCOME

CAs engage properly qualified staff.

POSSIBLE INDICATORS

> Physical evidence that only qualified persons are engaged as food inspectors – for example, records of qualification of personnel.

SOURCES OF EVIDENCE

> Legal texts at national level and, if possible, at provincial or local level.

SEE ALSO

A.1.2 [Institutional Framework]

A.2.1.4 [The financial resources required to hire, pay and retain sufficient and skilled staff are secured and accounted for in financial planning and budgeting]

B.1.1.4 [Periodic inspection plans developed by CAs are based on an articulated rationale and are implemented]

A.3.1.2

ASSESSMENT CRITERION: CAs have clear internal policy guidelines addressing the prerequisite qualifications for the various employees supporting food control activities.

GUIDANCE

Food control is a technical subject that involves a wide range of biological and scientific disciplines. The work of different categories of officers (including food inspectors, meat inspectors, laboratory technicians or laboratory managers and border inspection officers) involves different sets of knowledge and skills and different processes/procedures. Core education in food science-related disciplines is important for almost all of these posts. Laboratory technicians must be able to successfully run analytical laboratory tests according to official methods. Food inspectors need to be able to collect information that they recognize as important, to analyse the information, to communicate with business operators, to understand risk as it pertains to food safety, and to be able to contemplate and communicate corrective solutions to situations where the food safety of a process has deviated so that it is no longer safe. If necessary, these officers need to have the skills to collect evidence and to use formal enforcement procedures to ensure compliance and safe food production. For these reasons, core tertiary education for such posts is required, and the CAs must have a clear set of policy guidelines addressing the prerequisite qualifications for the various employed positions that supply support to food control services.

POSSIBLE OUTCOME

Staff with relevant qualifications are hired for specific duties.

POSSIBLE INDICATORS

> The lists of personnel and the roles that they are qualified to perform, justified by a note of their qualifications.

> The actual internal policy guidelines, which outline the prerequisite qualifications required for various food control-related technical or professional posts.

> Evidence that food inspectors, laboratory technicians (and all staff with roles requiring subject-specific tertiary education) are properly qualified.

SOURCES OF EVIDENCE

> Internal policy guidelines.

> Records/documentation on staff employment and hiring process.

> Job descriptions.

A.3.1.3

ASSESSMENT CRITERION: CAs base recruitment on clear job descriptions and transparent processes.

GUIDANCE

Within the governance of food control, there are many different technical roles. For example, laboratory technology and meat inspection are contrasted in terms of the differences in responsibilities, skills required, qualifications required and work environment. During a job search, applicants for jobs with specific skills or experience levels should be able to understand the exact requirements of a post in terms of the goals, methods, qualifications required and experience required. The job description should focus on the important criteria that support the work function. This will mean that (in general) only suitable applications are received for consideration and that the best applicants will closely match the terms of reference (ToRs).

POSSIBLE OUTCOME

Recruitments are selective.

POSSIBLE INDICATORS

> Food control-related public sector posts are publicly advertised.

> Sufficiently detailed ToRs are used for food control-related public sector posts.

SOURCES OF EVIDENCE

> Documented hiring process.

> Justification notes for the candidates selected.

A.3.1.4

ASSESSMENT CRITERION: The prescribed requirement for properly qualified staff also extends to the professional employees of agencies engaged by CAs.

GUIDANCE

Government services sometimes engage contractors to perform operational roles that are technical but, in effect, are not executive. For example, in the case of food inspection and meat inspection, private sector agencies are provided with business contracts to supply qualified staff to buffer the availability of directly employed staff in cities, towns or provincial areas, especially to cover leaves, sickness, etc. The agency staff should have the same educational background as the directly employed staff, and should have the same potential to deliver quality food control services. This requirement should be legally prescribed along with the required qualifications needed for particular official roles. The performance of officially authorized bodies should be regularly assessed by the CAs. The CAs should initiate procedures to correct deficiencies and, if appropriate, enable withdrawal of official authorization (Ref. para 75 CAC/GL 82-2013).

POSSIBLE OUTCOME

CAs engage properly qualified contactor agencies as required.

POSSIBLE INDICATORS

> The legally prescribed requirement for properly qualified staff also extends to the professional employees of agencies engaged by CAs.

> Evidence exists that all staff engaged in official food controls (both directly and indirectly employed staff) have the correct educational qualifications for their role.

> The overall performance of officially authorized bodies is assessed.

> Procedures exist to withdraw official authorization in case of need.

SOURCES OF EVIDENCE

> The legally prescribed requirement.

> Lists of qualifications required for food control technical and professional roles mapped against the actual written legal requirements.

SEE ALSO

A.1.2.5 [If appropriate, legislation allows the CAs to delegate some functions to other public or private entities]

A.3.2

CAPACITY DEVELOPMENT OF PERSONNEL

CAs have clear and comprehensive capacity development programmes in place to ensure staff can carry out the necessary range of food control[10] (Ref. para 72 of CAC/GL 82-2013).

A.3.2.1

ASSESSMENT CRITERION: Newly recruited staff are provided with formal orientation courses, allowing them to enter on duty in an effective manner.

GUIDANCE

“New-start” staff who work in support of official food control will be qualified in the appropriate technical subjects and will have a tertiary education. However, very often, educational institutions such as universities cannot provide practical or vocational training in food control enforcement work. CAs should therefore ensure that sufficient capacity exists in terms of knowledge and experience to train, motivate and provide technical support to new staff regarding their role in food control, including enforcement. Formal training should aim at equipping staff with knowledge, procedural understanding and judgment regarding their official role in food control and in enforcement work. The benefits are orientation, familiarization, networking, communication and institutionalization. Useful elements to be included in formal orientation courses could be (Ref. para 71 CAC/GL 82-2013):

i. Information about organizational charts of the official food control system;

ii. Roles of each level in the hierarchy, including other jurisdictions (e.g. provincial);

iii. Job functions and operating procedures (e.g. methods of audit, verification, inspection and control, sampling plans, testing);

iv. Relevant legislation and requirements, processes and procedures relevant to enforcement;

v. Arrangements for coordination with relevant CAs and stakeholders;

vi. Procedures for dealing with food safety emergencies, recalls and investigations.

In some countries, this type of training is actually provided directly and formally by the CAs themselves, while other countries prefer to have a partnership with a training institution (e.g. university or equivalent) where a curriculum is specially designed for the needs of the CAs.

POSSIBLE OUTCOME

Newly recruited staff receive appropriate training to be authorized and designated for work as food control officers.

POSSIBLE INDICATORS

> Training is available and implemented for the principal roles in official food control.

> The curricula of such trainings are available, which should be adequate in terms of scope, content and potential to support professionals to engage with their new roles.

SOURCES OF EVIDENCE

> Training documentation.

> Handbooks, notes and reference materials.

A.3.2.2

ASSESSMENT CRITERION: CAs encourage active exchange of knowledge and skills among staff.

GUIDANCE

Interaction among staff members should be actively encouraged by management in CAs to promote development of staff in different categories – for example, mentoring between junior and more experienced staff, or between staff of the same levels in decentralized and centralized locations.

Groups of people working in a dynamic environment of change and development can benefit each other by sharing experiences, ideas and proposals. This will not only result in exchanges of information, but it can also establish a strong team ethic or bond. Regular opportunities for people to exchange such ideas can be used beneficially in all countries within the official food control work environment.

Long careers cause individuals to gain experience and knowledge that is inaccessible to less-experienced individuals unless specific opportunities are created for sharing practical experience and “knowledge gained by doing”. Traditional apprenticeships are based upon this concept. In the workplaces where staff are responsible for official controls it is of great value if more experienced practitioners are enabled to share their experiences by way of induction training, or mentoring learning in a direct “on the job” situation, (or even using remote communication possibilities to check work, essays, reports, etc.) Succession planning also allows CAs to avoid problems following departure of key staff.

POSSIBLE OUTCOME

Team spirit and learning by doing under the guidance of experienced practitioners allow individuals to grow in stature and confidence.

POSSIBLE INDICATORS

> Work culture that encourages, promotes, or insists upon “learning by doing” under the guidance of experienced practitioners, allowing junior individuals to grow in stature and confidence.

> Events organized to facilitate exchange between staff, bringing together different categories.

> Supporting tools created to facilitate exchange between staff.

> Any evidence of the results of this practice (e.g. improvement in staff performance, uptake of new tasks or responsibilities).

SOURCES OF EVIDENCE

> Any internal policy document that refers to this practice.

> Any records of mentoring or similar activities designed to assist junior or inexperienced staff to gain from the advice and views of experienced staff.

> Any record of assignment of new tasks/responsibilities following the mentoring.

> Records of events organized to facilitate exchange of experience.

> Interviews with staff.

SEE ALSO

D.1.1.2 [Staff are supported to share new knowledge with work colleagues and work teams]

A.3.2.3

ASSESSMENT CRITERION: CAs supply or facilitate periodic update training events for staff with responsibilities in food control.

GUIDANCE

The government must be seen to be taking uniform measures across the country in the context of official food controls. Variances in the way that FBOs are treated will be quickly exploited by those who are opposed for any reason to the measures being used by the government or CAs; in any event, control measures should be uniformly applied to ensure the intended outcome. While written working procedures support this uniformity of approach, all operational staff with responsibilities for food control should receive periodic update training or orientation to ensure that adoption of new legislation (or new procedures) is successful, to support uniform application of official controls and to bridge gaps revealed during implementation of field work.

POSSIBLE OUTCOME

Staff show a uniform and updated approach to control issues.

POSSIBLE INDICATORS

> The update training events themselves, including a history of these.

> The relevance of the content of these events to ensure uniform application of official controls.

> The frequency at which the events are delivered.

SOURCES OF EVIDENCE

> Annual/biannual training plan for staff.

> Training reports and records.

> Interviews with staff.

SEE ALSO

B.1.1.6 [There are documented procedures for performing inspections of the same food category]

A.3.2.4

ASSESSMENT CRITERION: CAs actively facilitate continuing professional development of food control staff, at both central and remote locations.

GUIDANCE

Continuing professional development (CPD) is a means to ensure that professionals are developing their uptake of new knowledge in their own technical or professional fields. This is important for maintenance of the service standards that the individual can deliver, which in turn reflects upon the employer. CPD can include role orientation training and update training. However, CDP is more than simply those training events, which are institutionally driven. CPD is broad-based knowledge uptake that develops the academic basis of the individual, or develops skills that are supportive of greater efficiency or output. CPD generally involves personal reading, or formal courses. A supportive employer would provide resources (including time) for employees to improve their knowledge and skills base. For staff working in areas that are remote from centres of excellence and teaching institutions, CAs should facilitate the use of online technologies.

POSSIBLE OUTCOME

Staff actively develop their professional abilities.

POSSIBLE INDICATORS

> The CA provides support for career development for official control staff including:

i. Training attendance at conferences, workshops, courses.

ii. Facilities and resources (including time).

iii. Remote learning opportunities/online learning (especially for officers working in remote areas).

> All staff with professional and technical responsibilities provided with opportunities.

> Guidance about suitable learning opportunities that may exist.

> Formal requirements of individual staff for evidence of learning.

> Any changes in responsibility/efficiency/outputs/SOPs following specific training activities.

SOURCES OF EVIDENCE

> Annual/biannual training plan for staff.

> Records of staff attendance at training events, workshops.

> Records of staff effort to expand capacities though personal initiative.

> Record of any changes in responsibility/efficiency/outputs/SOPs, as a result of the training activities.

A.3.2.5

ASSESSMENT CRITERION: CAs have an internal policy to conduct internal review of the capacity development needs of the staff at all levels within the workplace, at both central and remote locations.

GUIDANCE

Institutions succeed (or fail) due to the quality of work of the staff and the way in which staff are managed. Institutions therefore need to understand whether staff are able to deliver the outputs expected from them, taking into account the full background, qualification and experience of the staff. CAs with responsibility for food control are no exception. Employers and managers should assess whether their staff require skills development, either for routine work outputs or for particular projects.

Training needs assessments are a way of getting this knowledge. Depending upon political will, such needs assessments can be implemented to help strengthen the outputs of the institution. Staff could record the CPD activities they undertake in an institutional format. This could be helpful for employers who are interested in how staff set out to develop themselves and how the institution can help staff to develop in order to support the role of the institution.

POSSIBLE OUTCOME

CAs are aware of staff competences and needs at all levels.

POSSIBLE INDICATORS

> Deployment of training needs assessments for staff.

> CPD records maintained by the individual staff member and used in an institutional context of internal audit, skills review, training needs analysis, etc.

> Existence of an institutional format for recording CPD activities.

> Evidence of implementation of needs assessment.

SOURCES OF EVIDENCE

> CPD records.

> Reports on the result of the training needs assessment/analysis.

A.3.3

STAFF MANAGEMENT & STAFF MOTIVATION

CAs have systems in place to ensure staff are properly compensated, motivated and protected.

A.3.3.1

ASSESSMENT CRITERION: Staff salary is sufficient, commensurate with duties and supplied on time and regularly.

GUIDANCE

People work to provide themselves with a living income to support themselves and their families. Staff salaries should correspond to reasonable expectations for professionals at their respective levels, allowing retention of skilled staff over time. In addition, being paid on time and in the expected amount underpins staff morale. The failure to be paid a living wage or to be paid on time, or being paid the incorrect amount de-motivates staff and could encourage situations of bribery or corruption.

POSSIBLE OUTCOME

On time and correct salary payment supports staff motivation, performance and probity.

POSSIBLE INDICATORS

> Evidence that staff have been paid regularly and at the level that they expect per contract.

> Any record of staff complaint in this respect (staff can also be interviewed).

SOURCES OF EVIDENCE

> Payroll records.

> Records of staff compliance.

> Interviews with staff.

A.3.3.2

ASSESSMENT CRITERION: Staff competence and performance are assessed routinely by means of formal appraisal.

GUIDANCE

At all stages of a staff member’s career, the employer needs to be assured that the employee is delivering the work that he or she is being paid for. CAs with responsibilities for food control are no exception. This is especially important for staff members who work individually or remotely, and who may be involved in work that can be difficult to assess because of a lack of easily determined indicators. Any job role should be subject to a system of institutional performance appraisal, which is applied regularly. Such assessments can be regarded as an opportunity for managers to have a structured conversation with staff members. The goal should be a meaningful yet constructive exchange of views that should aim to achieve consensus about past performance and about future plans for work and work outputs. In theory, this should assist both the staff member and the manager.

POSSIBLE OUTCOME

Competent performance is supported by regular staff appraisals.

POSSIBLE INDICATORS

> Evidence that staff who have responsibility for key roles in the governance of food control are subject to appraisal processes.

> Evaluation periods have been set.

> Evidence that the process is adhered to and considered to be of value.

SOURCES OF EVIDENCE

> Performance evaluation records.

A.3.3.3

ASSESSMENT CRITERION: CAs encourage good work performance, which is linked to opportunities for career development.

GUIDANCE

Individuals who possess tertiary educational qualifications and a professional or technical record of accomplishment generally tend to expect to gain promotion by devoting themselves to their work. If an institution can demonstrate that career progression is possible and feasible, that good work conditions and support for development are provided, then individuals will tend to work hard and to demonstrate that they are employable for the longer term. However, they will expect to be rewarded with promotion and if this is delayed, or the individual is overlooked, the tendency will be for the staff member to seek other employers.

POSSIBLE OUTCOME

Staff are encouraged to offer good work performance through opportunities for career progression.

POSSIBLE INDICATORS

> Good record of retaining good staff.

SOURCES OF EVIDENCE

> The opinion of managers and staff.

> Facts and figures provided by institutions, such as the average length of service of employees.

A.3.3.4

ASSESSMENT CRITERION: CAs enable confidential reporting of wrongdoing by colleagues and officers without exposure to adverse reactions.

GUIDANCE

In some situations, staff may need to report wrongdoing that is occurring in the course of their work or that is in some way connected with their work. Staff may witness (or believe they witness) peers or more senior staff performing in a manner that is in some way wrong (morally wrong rather than simply by mistake or error). In other situations, staff may consider that the way a particular internal policy is being implemented is not in the spirit in which it is intended and thereby construe that either a favour is being provided or malice is intended (neither of which are permissible behaviours for civil servants). In yet other instances, staff may witness criminal acts, under which many forms of corruption may be listed. Staff who hold sensitive information about activities inside the institution may be fearful of their employed position if they were to confront the issue directly; they may fear that they will be dismissed or sidelined or otherwise discriminated against. Such staff and such situations warrant an institutional policy for “whistle-blowing” whereby the individual who believes wrongdoing has occurred in the institution can make a complaint or explanation in confidence and without public identification. While protecting the whistle-blower from retaliation measures, the policy should avoid offering money or rewards to whistle-blowers, to avoid any lucrative or bad practice that would lead to negative ethical behaviour.

POSSIBLE OUTCOME

Staff have a safe possibility to report wrongdoing of colleagues or officers of other institutions.

POSSIBLE INDICATORS

> Any evidence of the actual enactment of such policy.

SOURCES OF EVIDENCE

> A published “whistle-blower” policy.

A.3.3.5

ASSESSMENT CRITERION: CAs maintain sustainability of programmes and internal stability even in times of political change.

GUIDANCE

To maintain a course of action over time, CAs need a certain degree of stability; staff are trained and committed to a strategic framework, which should be periodically revisited and improved. Constant changes at CAs’ level driven by, for example, a fragile and volatile political situation, can be very harmful to the effectiveness of CAs’ action, as well as to staff motivation and performance. Therefore, while political changes will occur periodically, mechanisms should be in place to ensure that a relevant level of stability allows the achievement of outcomes for the national food control system, as outlined in the Food Safety and Quality Policy, and implementation of strategic plans over their natural lifespan. Staffing changes may well occur as a result of political changes, but they should be planned and not implemented in a manner that causes disruption to the mandate and technical relevance of CAs.

POSSIBLE OUTCOME

The achievement of policy outcomes and the implementation of a strategic framework at CAs’ level are made possible by a sustainable and stable food control leadership.

POSSIBLE INDICATORS

> Civil servant status, protecting staff from political changes.

> Internal policy of change of staff after political changes.

> Strategic framework milestones consistently achieved.

SOURCES OF EVIDENCE

> List of staffing changes.

> Any policy addressing this issue.

SEE ALSO

A.1.1.1 [Clear policy guidance is available for food safety and quality]

A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy]

1 See also: FAO (2016) Risk Based Imported Food Control Manual

2 The International Health Regulations (IHR) is binding on 196 countries across the globe, including all the Member States of WHO.

3 See A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy].

4 See A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy].

5 The strategic food control plan makes it possible to achieve targets described in A.1.1., and integrates activities described in B, C and D. See A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy].

6 The strategic food control plan makes it possible to achieve targets described in A.1.1 and integrates activities described in B, C and D. See A.1.1.2 [Food control strategic plans are prepared by CAs and translate into action the overarching objectives set out in the food safety and quality policy].

7 ISO 17025: General requirements for the competence of testing and calibration laboratories

8 ISO 15189: Medical Laboratories – Requirements for Quality and Competence

9 See also: A.2.1.4 [Financial resources to hire, pay and retain staff]

10 See also: A.2.1.5 [Training and ongoing development of food control staff is financially secured]