Legal And Food Safety System Requirements Gaps Construction Essay

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Malaysia fishery products (FP) export is valued between RM 2200 to RM 2600 million per year from 2004 to 2008 (refer to Figure 1) and average about 48% of Malaysia fishery products are exported to the European Union (EU) and United States of America (USA) (DOF, 2004; DOF, 2005; DOF, 2006; DOF, 2007; DOF, 2008)

Figure Malaysia Fishery Export Value in RM (million) from 2004 to 2008

Major FP export to the EU in 2007 (refer to Figure 2) includes Shrimps and Prawn (frozen), Cuttlefish and Squid (frozen), Shrimps and Prawn (prepared or preserved), octopus (frozen), other fish (prepared or preserved) and others (DOF, 2007).

Figure Types of Fishery Products Export to the EU in 2007

32.2%

23.3%

30.3%

4.2%

Literature Review

EU Fishery Import Requirements

"The European Commission's Directorate - General for Health and Consumer Protection (SANCO) is responsible for food safety in the European Union. Our import rules for fishery products and shellfish (bivalve molluscs) seek to guarantee that all imports fulfil the same high standards as products from the EU Member States - with respect to hygiene and consumer safety and, if relevant, also the animal health status." (European Commission, 2007).

The pre-requite for a country to export to the EU is to have a recognition of Competent Authority (CA) by the European Commission. Malaysia has multi-agencies Competent Authorities (CAs) to carry out inspection and controls throughout the fishery product chain. The Ministry of Health (MOH), Malaysia, Food Safety and Quality Division (FSQD) is the central CA and responsible to carry out inspection at downstream of the supply chain, middlemen, ice factories and also imported EU approved materials; the Department of Fisheries (DOF) is the CA and responsible to carry out inspection on aquaculture farms and fishing vessels and Lembaga Kemajuan Ikan Malaysia (LKIM) is the CA and responsible to carry out inspection on landing sites of capture fish (FSQD, 2009A). These CAs should have legal powers and resources to carry out inspection and controls throughout the fishery production chain in terms of Hygiene, Public Health (PH) and Animal Health (AH).

Recognized CA/CAs are one of the specific key elements (European Commission, 2007) for the export of FP to the EU. Other specific key elements for Malaysia to export FP to EU include demonstrate that Malaysia Food Act 1983, Food Regulations 1985 and Food Hygiene Regulations 2009 are equivalent to the EU Health Legislation; CAs have carried out inspection along the fishery supply chain and ensure compliance to Good Practices, Traceability and HACCP requirements; CAs have published fishery establishments inspected which meet the EU requirements; CAs have demonstrated compliance during FVO inspection mission and provide guarantee to Public Health (PH) and Animal Health (AH) attestations in the certificate to accompany fishery products that were destined for the EU. Finally, FP arrived at the EU borders will be to inspected for Health Certificate (HC), physical, chemical and microbiological analysis. Refer to Figure 3 for summary description of specific key elements for the export of FP to the EU.

Figure Specific Key Elements for the Export of Fishery Products to the EU

Issues Highlighted in the FVO Mission Inspections

There were four missions carried out by the FVO since 2005 (EUROPA, 2005A; EUROPA, 2008A; EUROPA, 2009A; EUROPA, 2010A), these four missions were carried out in 2005, 2008, 2009 and 2010.

Figure FVO Mission Reports in 2005, 2008, 2009 and 2010

In FVO mission report 2005 (EUROPA, 2005A), FVO mission team had highlighted many gaps in the Malaysia control systems and shortcomings in the residues and environmental contaminants monitoring program and also major shortcomings in Animal Health (AH) certificates were issued which were based on diagnostic techniques performed by laboratory with inadequate facilities. FVO has concluded that Malaysian CA cannot currently guarantee compliance of fishery and aquaculture products originating in Malaysia.

In FVO mission report 2008 (EUROPA, 2008A), FVO mission team had found that Fishery establishments inspected by FVO did not comply with EU legislations and requirements. FVO had concluded that the Malaysian CA was not competent to provide guarantee to public health and animal health attestations in the certificate to accompany fishery products that were destined for the EU. As a result of the 2008 mission, Malaysia had voluntarily de-listed all establishments in June, 2008. No establishments were allowed to export to the EU after the de-listing.

In 2009, FVO (EUROPA, 2009A) had carried out another mission and found that there were still weaknesses in enforcement related to the national residue control plan. However, FVO recognized that public health guarantees were ensured by systematic and regular official controls and the intensive own checks performed by the food business operators in the sector. FVO acknowledged that in general the system of public health controls for Fishery Products intended for export to the EU can be considered to offer guarantees equivalent to those foreseen under EU Health legislation. As a result of 2009 mission, total 6 establishments were re-listed and Malaysia resumed export of Fishery Products to the EU in May, 2009.

The latest mission carried out by FVO was in 2010 (EUROPA, 2010A) and FVO mission team only found minor shortcomings related to vessels registration, inspection of establishments, histamine testing and training. On the other hand, FVO has acknowledged that CA has demonstrated commitment to strengthen the capability of the CA involved in the official controls with regard to financial allocations, organizational restructuring, and recruitment of additional staff.

Summary of major findings, conclusions and status of the mission reports were summarized in Table 1.

Table Summary of FVO Mission Reports for 2005, 2008, 2009 and 2010

Year

March, 2005

April, 2008

March, 2009

April - May, 2010

Scope of Audit

- Evaluate control system of the production of Fishery Products implemented by the Competent Authorities (CAs)

- Evaluate health certificates issued by CAs for live fish is harmonized with the EU

- Follow up on 2005 mission

- Production from aquaculture and from imported raw material and follow up on 2008 mission

- Production from wild caught raw materials &follow up on 2009 mission

Findings

- Found gaps in the control systems and shortcomings in the residues and environmental contaminants monitoring program

- Animal Health certificates issued were based on diagnostic techniques performed by laboratory with inadequate facilities and procedures

- Fishery establishments inspected by FVO did not comply with EU legislations and requirements

- Issues highlighted by FVO in 2005 have not been addressed in 2008

- Weaknesses in enforcement related to the national residue control plan

+ Public health guarantees are ensured by systematic and regular official controls and the intensive own checks performed by the food business operators in the sector

- Minor shortcomings related to vessels registration, inspection of establishments, histamine testing and training were identified

+ Demonstrated commitment to strengthen the capability of the CA involved in the official controls with regard to financial allocations, organizational restructuring, and recruitment of additional staff

Conclusion

- Malaysian CA cannot currently guarantee compliance of fishery and aquaculture products originating in Malaysia

- Malaysian CA was not competent to provide guarantee to public health and animal health attestations in the certificate to accompany fishery products that were destined for the EU

- In general the system of public health controls for Fishery Products intended for export to the EU can be considered to offer guarantees equivalent to those foreseen under EU Health legislation

- Significant improvements in the implementation of official controls

Status

- Total 15 establishments out of 76 were removed from the approval list

-Malaysia voluntarily de-listed all establishments in June, 2008. No establishments were allowed to export to the EU after the de-listing

- Total 6 establishments were re-listed and Malaysia resumed export of Fishery Products to the EU in May, 2009.

- Establishments listed can continue to export to the EU

The number of fishery establishments listed in the third country approved list (Figure 5) had reduced from 77 in March, 2008 to 58 in May, 2008 (EUROPA, 2008B; EUROPA, 2008C) after the FVO mission team carried out audit in March, 2008 and the number of Malaysia fishery establishments had further reduced to zero when Malaysia voluntarily delisted all fishery establishments in June, 2008.

After FVO inspection in March, 2009, total 6 fishery establishments were re-listed (EUROPA, 2009A) and the number has increased to 9 in December, 2009 (EUROPA, 2009B) and 19 in December, 2010 (EUROPA, 2010A).

Figure Number of Fishery Establishments in Malaysia with EU Registration Number

Statement of Problem

The voluntary delisting of fishery establishments had caused major economic impact to Malaysia fishery industry and economic losses to the country has yet to recover. The following are specific statement of problem for each chapter:

Chapter 1:

What are the gaps between the Malaysia fishery products safety control system and the EU fishery products import requirements? and what are the possible solutions to address gaps identified?

Chapter 2:

What are the hazards identified in Malaysia fishery products rejected by the Border Inspection Post (BIP)? And what are possible control measures to minimize reoccurrences?

Chapter 3:

What are the perceived benefits and difficulties faced during implementing and operating of the Food Safety system in Malaysia fishery establishments and what are major barriers during the adoption of Food Safety system?

Chapter 4:

What are costs incurred during implementing and operating Food safety system? and what are the annualized total Food Safety system costs per unit of turnover in Malaysia fishery establishments?

Justification

Many research related to national Food Safety Control System had been carried out in different countries and published in academic journals. These research on the national food control system were carried out in the State of Kuwait (Alomirah, et al., 2010), in sub-Sahara Africa (Bagumire, Todd, Muyanja, & Nasinyama, 2009; Nguz, 2007) in Arab Gulf Cooperation Council (GCC) countries (Al-Kandari & Jukes, 2009), in Croatian (Antunovic, Mancuso, Capak, Poljak, & Florijančić, 2008), in Greece (Varzakas, Tsigarida, Apostolopoulos, Kalogridou-Vassiliadou, & Jukes, 2006) and in Spain (Garcia & Jukes, 2004).

Many research related to HACCP system adoption benefits, difficulties, barriers, motivating factors and costs had been carried out in different countries and published in academic journals. For example, motives and external effect on the HACCP adoption (Jin, Zhou, & Ye, 2008) and incentives of implementing HACCP in China food businesses (Bai, Ma, Yang, Zhao, & Gong, 2007); costs, benefits and problems associated with HACCP implementation in New Zealand meat industry (Cao & Scrimgeour, 2004) in India seafood, dairy, spices and fruit and vegetables sector (Deodhar, 2003) and in the UK dairy sector (Henson, Holt, & Northen, 1999); difficulties and barriers of HACCP implementation in Turkey (BaÅŸ, Yüksel, & ÇavuÅŸoÄŸlu, 2007) and in Spain food businesses (Vela & Fernández, 2003); and cost analysis case study of HACCP implementation in Brazilian pasteurized milk plant (Roberto & Brandão, 2006) in USA oyster sector (Hinson & Whitley, 2003) in airline catering (Bata, Drosinos, Athanasopoulos, & Spathis, 2006).

There was only one qualitative research paper (Merican, 2000) published in academic journal on the role of Ministry of Health Malaysia and development of HACCP Certification Scheme for the benefits of food businesses in Malaysia in 2000.

Significant of Study

This research will provide valuable insight to Malaysia Competent Authorities in terms of understanding of EU import requirements, weakness in Malaysia fishery products safety control system and possible solutions to close the gaps, and barriers faced by Malaysia fishery establishments during adoption of Food Safety system so that appropriate supports can be provided.

This research will also being benefits to Malaysia fishery establishments in terms of understanding of EU import requirements, hazards identified in Malaysia fishery products rejected by the EU and also quantitative value on benefits, difficulties, barriers and costs of implementing and operating Food Safety system so that fishery establishments can evaluate the magnitude of benefits and costs before adoption of Food Safety system.

General Objective

To evaluate gaps on the legal and Food Safety system requirements for the export of Malaysia Fishery Products to the European Union (EU).

Specific Objectives

Each of the chapters in this research will have specific objective. The following are objectives of each chapters:

Chapter 1:

To identify gaps between the Malaysia fishery products safety control system and the EU fishery products import requirements and propose solutions to close gaps identified.

Chapter 2:

To analyze hazards in Malaysia fishery products rejected by the Border Inspection Post (BIP) and propose possible control measures to address hazards identified and minimize reoccurrences.

Chapter 3:

To identify major perceived benefits and difficulties faced during the implementing and operating of Food Safety system and major barriers of adoption of Food Safety system in Malaysia fishery establishments.

Chapter 4:

To calculate estimated costs incurred on implementing and operating Food Safety system and annualized total Food Safety system costs per unit of turnover in Malaysia fishery establishments.

Research Hypotheses

The following are hypotheses to be tested for each chapter in this research:

Chapter 1:

Malaysia has comprehensive fishery safety control system in terms of food control management, legislation, inspection and official control laboratories to meet the EU import requirements but the implementation of such control system is not stringent.

Chapter 2:

Major chemical hazards detected in Malaysia fishery products rejected by the BIP are unauthorized substances, histamine and benzo(a)pyrene (BaP) and major biological hazards detected are Salmonella and V. Cholera.

Chapter 3:

There are 3 hypotheses to be tested in Chapter 3:

Gaining access to international market, retaining existing and attracting new customers are major perceived benefits of Food Safety system adoption

Training, retraining and motivation of staff are major difficulties encountered during Food Safety system adoption

Lack of financial supports and incentives from government are major barriers encountered by the Malaysia fishery establishments during Food Safety system adoption

Chapter 4:

There are also 3 hypotheses to be tested in Chapter 4:

Investing in new machine and equipment and structural changes to the plant are major implementing costs incurred during the implementation of Food Safety system

Product testing and time spent on recording and verification are major operating costs incurred during the operation of Food Safety system

The implementation of Food Safety system in Malaysia fishery establishments has incurred high annualized total costs per unit of turnover and this has significant impact on small establishments operating on a narrow profit margin.

Definition of Terminology

The following is the definition of terminology used in this research:

Good Practices:

Food hygiene (or pre-requisite program)

HACCP:

Hazard Analysis Critical Control Point

Traceability:

The ability to trace backward to the origin or source of fishery products and the ability to track forward the location of the fishery products.

Food Safety system:

Food Safety system includes implementation of Good Practices, HACCP and Traceability.

Methodology

This section will describe location, design, sampling, sample, data collection, instrument, reliability and validity for each chapters.

Figure Research Methodology Used

Chapter 1: Competent Authorities

Location

Chapter 1 will be carried out in Malaysia.

Design

The objective for this chapter is to identify gaps between Malaysia fishery products control system versus the EU import requirements. Thus, the design of Chapter 1 will focus to obtain assessment from CAs. Questionnaire will be designed and adapted from Bagumire at al. (2009) and pilot study will be carried out with 5% of the CAs from MOH, DOF and LKIM by randomly selected participants from database. Questionnaire will be reviewed based on pilot participants comment before distributing to the remaining participants in the database. This is a non-experimental quantitative research.

Sampling

CAs list is available at the MOH, DOF and LKIM. Purposive sampling technique will be used and sample will be obtained from the CAs list.

Sample

Since the number of CAs involved in the credible inspection along the fishery supply chain is not large, all CAs in the list will be the target sample for the research.

Data Collection

Questionnaire will be used to collect research data. Beside the questionnaire, cover letter explaining objectives of the research and a postage-paid, coded return envelop will be mailed to participants. A softcopy will also be emailed to participants. Participants can revert by hardcopy or softcopy.

Reminder postcards / emails will be sent 3 weeks after the initial mailing to encourage participation.

Instrument

Questionnaire with close end questions and Likert scales will be used to obtain assessment from CAs on Malaysia fishery safety control system versus the EU in terms of food control management, legislation, inspection and official control laboratories. A subjective question will be placed at the end of each sections which allow participants to add or elaborate their opinions.

Validity and Reliability

Face validity will be carried out during pilot and results obtained from CAs will be cross checked with results obtained from fishery establishments on Malaysia Fishery Safety control system and Food Safety system implementation.

Chapter 2: Fishery Products

Location

Chapter 2 will be carried out in Malaysia.

Design

The objective for this chapter is to identify hazards in Malaysia fishery products rejected by the Border Inspection Post (BIP). A case study approach will be used based on official data published in the EU SANCO webpage - Rapid Alert System for Food and Feed (RASFF).

Sampling

No sampling will be carried out. All official data reported in RASFF from 2004 to current will be used for analysis.

Sample

The sample for the research will be fishery products rejected by the EU produced by Malaysia fishery establishments.

Data Collection

Data from RASFF will be compiled from 2004 to current and hazards identified will be categorized into Chemical, Microbiological and Physical. Major hazards for each category of fishery products will be identified for further analysis.

Instrument

Not applicable.

Validity and Reliability

Cross check results obtained from RAFF with questionnaire results obtained from fishery establishments on products rejected.

Chapter 3: Fishery Establishments

Location

Chapter 3 will be carried out in Malaysia.

Design

The objective for this chapter is to identify perceived benefits, difficulties faced by Malaysia fishery establishment during implementing and operating Food Safety system and major barriers during adoption of Food Safety system. Thus, the design of Chapter 3 will focus to obtain assessment from fishery establishments. Questionnaire will be designed and adapted from adapted from Cao & Scrimgeour (2004), Deodhar (2003) and Henson, Holt, & Northen (1999) and pilot study will be carried out with 5% of the fishery establishments listed in the third country approval list in March, 2008. Questionnaire will be reviewed based on pilot participants comment before distributing to the remaining fishery establishments in the data base. This is a non-experimental quantitative research.

Sampling

Fishery establishments listed in the third country establishment list were downloaded from EUROPA webpage on 1 March, 2008 (EUROPA, 2008B). Purposive sampling technique will be used and sample will be obtained from the third country approval list.

Sample

Since there was only 77 fishery establishment listed in the third country approval list in the EUROPA webpage on 1 March, 2008, all fishery establishments in the list will be the target sample for the research.

Data Collection

Questionnaire will be used to collect research data. Besides the questionnaire, cover letter explaining objectives of the research and a postage-paid, coded return envelop will be mailed to participants. A softcopy will also be emailed to participants. Participants can revert by hardcopy or softcopy.

Reminder postcards / emails will be sent 3 weeks after the initial mailing to encourage participation.

Target respondents of the questionnaire will be personnel holding Quality Assurance Manager or Director position in the fishery establishments.

Instrument

Questionnaire with close end questions and Likert scales will be used to obtain assessment from fishery establishments on perceived benefits and difficulties faced during implementing and operating of Food Safety system and major barriers during adoption of Food Safety system. A subjective question will be placed at the end of each sections which allow participants to add or elaborate their opinions.

Validity and Reliability

Face validity will be carried out during pilot and results obtained from fishery establishments will be cross checked with results obtained from CAs on Malaysia fishery control system and Food Safety system implementation.

Chapter 4: Fishery Establishments

Location

Chapter 4 will be carried out in Malaysia.

Design

The objective for this chapter is to identify perceived costs during implementing and operating Food Safety system and to calculate estimated costs of implementing and operating Food Safety system and annualized total costs per unit of turnover. Thus, the design of Chapter 4 will focus to obtain assessment and estimated costs from fishery establishments. Questionnaire will be designed and adapted from adapted from Bata, Drosinos, Athanasopoulos, & Spathis (2006), Cao & Scrimgeour (2004), Deodhar (2003), Henson, Holt, & Northen (1999). Pilot study will be carried out with 5% of the fishery establishments listed in the third country approval list in March, 2008. Questionnaire will be reviewed based on pilot participants comment before distributing to the remaining fishery establishments in the data base. This is a non-experimental quantitative research.

Sampling

Fishery establishments listed in the third country establishment list were downloaded from EUROPA webpage on 1 March, 2008 (EUROPA, 2008B). Purposive sampling technique will be used and sample will be obtained from the third country approval list.

Sample

Since there was only 77 fishery establishment listed in the third country approval list in the EUROPA webpage on 1 March, 2008, all fishery establishments in the list will be the target sample for the research.

Data Collection

Questionnaire will be used to collect research data. Besides the questionnaire, cover letter explaining objectives of the research and a postage-paid, coded return envelop will be mailed to participants. A softcopy will also be emailed to participants. Participants can revert by hardcopy or softcopy.

Reminder postcards / emails will be sent 3 weeks after the initial mailing to encourage participation.

Target respondents of the questionnaire will be personnel holding Production / Operation Manager or Director position in the fishery establishments.

Instrument

Questionnaire with close end questions and Likert scales will be used to obtain assessment from fishery establishments on perceived costs faced during implementing and operating of Food Safety system and estimated costs on implementing, operating, maintenance and certification costs of Food Safety system. A subjective question will be placed at the end of each sections which allow participants to add or elaborate their opinions.

Validity and Reliability

Face validity will be carried out during pilot to ensure validity and reliability of data. Estimated costs obtained from different fishery establishments will be compared to ensure validity and reliability of data.

Data Analysis

Different data analysis techniques will be used for different chapters in this research.

Chapter 1:

Data obtained on from survey on food control management, legislation, inspection and official control laboratories will be entered and analysis using the Statistical Package for Social Science (SPSS) (version 12.0).

Chapter 2:

Hazards identified in Malaysia fishery products rejected by the EU will be categorized for further analysis and identify possible causes for each of the hazards and each fishery product types before propose possible solutions to minimize the re-occurrences.

Chapter 3:

Data obtained on from survey on perceived benefits, difficulties faced and major barriers will be entered and analysis using the Statistical Package for Social Science (SPSS) (version 12.0). t-tests will be carried out to determine if any significant differences between fishery establishments listed in third country approval list and de-listed.

Chapter 4:

Data obtained on from survey on perceived costs barriers will be entered and analysis using the Statistical Package for Social Science (SPSS) (version 12.0). Annual costs on implementing, operating, maintenance and certification of Food Safety system will be tabulated and annualized total costs per unit of turnover will be calculated. At the end, relationships between annualized total costs per unit of turnover and establishment sizes will be established.

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