La sobrexpresión de NTRK3 incrementa la actividad basal de

For decades now many countries especially developed countries are changing the way the regulate food safety. This can be seen as a change in perception or shift in the balance of food

safety strategies away from reliance on inspection, sampling and end-product testing towards prevention strategy that requires holistic approach. This is exactly the terminology used by this study in its title ---“ A Whole Chain Approach to the National Fisheries Food Safety Management System of Sierra Leone”. This shift or change in perception towards a whole- chain approach is an increased emphasis on prevention than cure (Aragrande, Segre, et al., 2005; Fulponi, 2006). Similarly, EU Regulation 178/2002, usually referred to as the General Food Law, comprises of similar terminology such as ‘risk assessment, risk management, and risk communication’ including but not limited to the reduction to an acceptable level or elimination of hazards that are significant to food safety and health (Henson and Reardon, 2005). Such terminology are part of the broader changes or shift in whole-chain preventive food safety management system (Fulponi, 2006; Aragrande, Segre, et al., 2005; Henson and Reardon, 2005) Whole-chain preventive approach reflect ideas about food safety-at-source and quality management including ISO 9000 standards relating to manufacturing production , such as ISO 9000 (Nadvi and Waltring, 2004). The author argues that there is growing adoption and implementation of prevention of hazards approach in the food businesses, but the success of such system depends on the level of management practices that encourage a whole-chain approach that focuses on prevention and control of food safety hazards from the source. Laboratory testing is an expensive process and as result many food businesses in LDCs such as Sierra Leone may not pay good attention to testing, there by allowing these to enter food chain across production harvesting, processing, transport, distribution and final consumption. Therefore, whole-chain approach designed to prevent or control hazards is becoming more acceptable to be the most cost-effective strategy than the traditional end-product testing (Plunkett and DeWaal, 2008). Though traditional end-product testing is essential for verification purposes to establish good process controls, it can never be practical as the only means of monitoring safety (Plunkett and DeWaal, 2008).

This change in perception can be characterised as a process of identification and controlling of the problem from the source, means a holistic or whole-chain approach that involves all the players in order to shift from product controls to process controls (Nadvi and Waltring, 2004). Product controls focused on traditional inspection, sampling and testing and since it is not

possible to do 100% sampling and testing, there is no guarantee that the section sampled is the one affected or infected (Kane and Taylor, 2003). In contrast, process controls describe the method of production, processing, handling, distribution and intended uses, and there requires the participation of all actors in the whole food chain across regulatory, enforcement, businesses and consumers. This study focuses on preventive control measures and specific responsibilities across the whole-chain to ensure that the product is produced correctly and safely.

In food safety management system this change in perception can be argued to be the difference between traditional end-product testing at only a certain point along the food chain whilst leaving behind more critical areas in the food chain unchecked. On the other using the whole-chain approach requires all actors to develop procedures at different points in the food safety management system designed to provide proper laws and monitoring mechanism in order to identify hazards to food safety and put in place appropriate procedures that prevent the hazards from occurring or reduce their occurrence to an acceptable level. HACCP in a whole-chain approach is designed to achieve this. The other advantage of this process-based approach is that traceability is put in place to identify product so that products can be traced as whether is coming from well-regulated food safety management system or not.

Nadvi and Waltring, 2004, made a wide comparison between product controls (traditional end- product testing) and process controls (preventive approach) and this led to a clear distinction between the two approaches in food safety management system. However, Nadvi and Waltring, 2004, fall short of providing a sufficiently strong analytical basis for understanding and interpreting the main options about the selection and designing of food safety regulations and standards. The author argues that preventive options to a larger extent can effectively influence the way in which the activities of regulators, enforcement officials, businesses and consumers affect food chain if it involves a whole-chain approach.

This study further attempted to use the analytical framework provided by Coglianese and Lazer (2003) for the discussion of the HACCP and a whole-chain regulatory strategy. Coglianese and Lazer, 2003, provided three approaches to regulatory strategies instead of focusing on two approaches. The focus of the three approaches developed by Coglianese and Lazer, 2003, is on a

preventive approach, but could be used to justify a whole-chain strategy. Firstly, a ‘Performance- based regulation’ is proposed which allows the regulatory authorities (law makers and law enforcers) specify expected outcomes. For instance, certain food can be specified not to contain maximum residue limits (MRLs) of pesticides or should be free of Salmonella or E.coli

contamination. The key focus here is the achievement of particular food safety outcomes and therefore no limitation is given on specific methodology in this achievement because no method is recommended or disqualified. Moreover, ‘performance-based regulation’ is not product specific and for example, absence of Salmonella can be applied to beef and beef products, poultry and poultry products, fish and fishery products, plants and plant products. However, this study believes that the success of Coglianese and Lazer ‘performance-based regulation’ depends not only the participation of regulatory authorities but also the businesses that implement the regulation and the consumers that may serve as pressure group on regulators to enforce and businesses to comply.

The second part is the ‘Technology-based regulation’, which specifies the type of technology to

be used or followed (Coglianese and Lazer 2003). This relates to the major distinctions between HACCP and good agricultural practices (GAPs) especially in the control of

external environment. In the controlled environment where hazards are identified, critical control point identified and critical limit established HACCP is the most effective method to use, but in the environment where hazards are unpredictable such production of fresh fruits and vegetables in farms, it is recommended for farmers to use GAPs which is often considered as HACCP-based approach. The role of businesses, farmers or fishermen falls under here within the whole-chain approach. However, it can be argued that the compliance from businesses depend on the adequacy of law and the effectiveness of enforcement to achieve food safety objective. This also requires the pressure from the consumers on regulators and businesses to carry out their mandates. The role of businesses in ‘Technology-based regulation’ requires the use of specific technology such as HACCP or GAPs.

Thirdly, the ‘Management-based regulation’ is not specific output oriented (Coglianese and Lazer, 2003). What is required here is for the businesses to produce a plan in order to comply with generic criteria designed to promote targeted social goal required by law. For example, a

business can design a food safety management plan such as HACCP plan based on required regulation. In this case the specific outputs, processes and technological requirement depend on the HACCP procedures (Coglianese and Lazer, 2003). However, the author argues that the success of such a plan depends to a larger extent on the adequacy of elements or components to achieve food safety objective, and these need to be verified by auditing from regulatory authorities. The decision to implement HACCP and the choice of elements and tools to achieve is the management decision and therefore ‘management-based regulation’, but needs to be audited by regulators or third party that means a whole-chain strategy is required.

According to Coglianese and Lazer, 2003, legislation demanding business for management- based regulation might simply require same business to conduct a risk assessment and subsequently, develop a realistic food safety plan that can prevent, eliminate or reduce the risk to an acceptable level. Furthermore, the enforcement officials might specify detailed procedures to enforce the legislation. The enforcement officers might further request the HACCP plan to be documented for further in-depth verification and, subsequently, the regulatory authority might complement the risk assessment with stringent inspections system to specify, verify and monitor compliance with specific technical requirements. One can see that the achievement of all these requires the participation of all the actors in the whole-chain across regulatory, enforcement and businesses and implications on how compliance to the regulation is to be achieved.

The increase in enforcement activity by the regulatory authorities subsequently increases business compliance, and a result the level of prescription increases. Consumers as pressure group may serve as referee in the whole-chain approach. Consequently, this narrows or diminishes the gap between management- based regulation and technology-based regulation. In Table 2 below, Coglianese and Lazer, 2003, discussed the situations in which particular type of regulation becomes more effective than the other.

Table 2: Regulatory Model by Coglianesa and Lazer, 2003, Modified by the Author to Reflect a Whole-chain Approach in Sierra Leone

Type of regulation Most Appropriate at a Particular Time Trend of Sierra Leone Fishery Products

Performance-based Outcomes clear, achievable and measurable when all actors are involved

It is unlikely that 100% sampling and testing of fishery products can take place. Hence there is no guarantee that the batch sampled is the one affected. Whole-chain approach addresses the problem from the source, thus fishery safety is guaranteed and fishery trade is maximised through access to developed markets. Potential hazards such as microbiological, chemical, and physical can be identified at a particular point in the whole-chain and preventive measures taken.

Technology-based Private businesses operate in similar manner with own technology that stabilises after sometimes (Coglianesa and Lazer, 2003). The validity of machinery used including compliance with technology need verification by regulatory authorities and pressure from consumers.

Improvement in Science and technology leads to the availability of a wide range of technology as you move from one business to another. Therefore, development of specifications of technology should involve a whole-chain approach so that multidisciplinary team provides detailed specifications that can be generalised. Specification provided by a whole-chain team has the chances to eliminate many potential hazards from different sources in complex environment in real time.

Management-based Appropriate technology undefined and it is unlikely to measure output.

Increase fishery products trade requires definition of appropriate management-based practice across national boundaries. The author argues that the success of this depends on the involvement of a whole-chain. That is, regulatory authorities develop holistic regulation, while businesses implement appropriate food safety tool and consumers as pressure group for compliance.

The author argues that the success of food safety management system has a lot to do with the regulatory strategies and have direct impact on the national food safety system for both public and private sectors. This can be seen in the approaches taken in this study for the formulation of whole-chain strategy that requires the role of all stakeholders across regulatory, enforcement, business and consumers through the combination of all the three types of regulation described by Coglianesa and Lazer, 2003.