|
|
| Agenda Item 4.5 | GF 02/8a |
second fao/who global forum of food safety regulators
Bangkok, Thailand, 12-14 October 2004
(Paper prepared by Ms Shashi Sareen, Director, Export Inspection Council, India)
The establishment of the WTO gives opportunities to all countries to benefit from greater access to world markets. The global trade is expanding rapidly and significantly due to increase in consumer demands linked to growing education and awareness of consumers, internationalization of tastes and habits, developments in science and technology, and improvement in communications and transportation. Coupled with the breaking down of tariff barriers and quantitative restrictions, quality and safety have become very important in international trade. Not only have consumers all over the world become conscious of quality, but at the same time governments have realized their role in protecting the health and safety of their populations by imposing stringent regulations based on health, safety and environmental considerations.
The TBT and the SPS Agreements, while permitting countries to impose standards to protect their populations and ensure fair trade, require that certain rules and disciplines are maintained so that standards and regulations do not create unnecessary barriers to trade. Both the Agreements also encourage member countries to recognize each other’s conformity assessment systems based on international standards so that products certified in one country are accepted without need for further inspection/testing by the other through ‘equivalence’ or ‘Mutual recognition’ Agreements.
The need for a strong import control mechanism is quite obvious. The need for an equally strong export control mechanism is a natural corollary of such import control systems of importing countries, which have to have a provision for recognition of export certification systems of their trading partners through equivalence agreements.
In recognizing that quality and safety can be assured through application of proper or well designed food control systems (exports and imports), the Codex Alimentarius Commission established the Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS) to develop principles and guidelines in this area.
Although food control should cover both export and import as is evident from the terms of reference of this Committee and most of the documents it developed, most governments have emphasized on development and strengthening of import control systems with a view to protecting their populations and to prevent dumping of inferior quality products into their country. However, the situation in India and some other exporting countries has been somewhat different, with export inspection and certification being compulsory in certain food items.
In this paper, the importance of food export control and certification, broad concepts to be followed, the experiences in the area of export control including the systems being implemented in India, observations regarding export control systems being developed in other countries and lessons to be learnt or issues of focus are highlighted.
The SPS Agreement permits member countries to impose measures to protect human, animal and plant life or health. Furthermore, the Agreement, through its provision for adherence/adoption of Codex standards, which in turn provide for legislative framework for imports and the role for official/government inspection/certification agencies and recognition of such agencies at the exporting country’s end through equivalence agreements, permits members to establish formal systems of import control to ensure the appropriate degree of protection for their populace.
Taking strength from these Agreements, developed and developing countries have installed strong import control systems in the food sector. Many of these countries also maintain export inspection systems, but these are very minimal and basically cater for providing sanitary, phytosanitary or health certificates when desired by the importing country.
The need to have a well-developed food quality control system for export is more important for countries that are major exporters. Some of the benefits of such export control systems are highlighted below:
Export food control activity is a multi-disciplinary activity covering a number of aspects such as food science, microbiology, analytical chemistry, plant pathology, veterinary science, etc. A number of agencies would normally be involved in any country including various departments of government, control organizations, promotional bodies, research institutions, agricultural institutions, farming community, trade associations, non-governmental organizations (NGOs), consumers etc. There needs to be a suitable documented export control food strategy with clear objectives, including the countries of focus, well designed plan of action with role clarity provided for different players and clear networking of the organizations within the country.
Food legislation includes acts, regulations, and requirements or procedures prescribed by the government relating to export of foodstuffs to meet requirements of the importing country while ensuring conditions of fair trade. Food control needs to be simple, complete, covering various aspects of the food chain as needed and address requirements of importing country - both issues of safety and quality. It should provide authority to carry out controls at all stages of the food chain. Furthermore, it should be flexible to allow taking into account new technologies, developments and changing trade needs. It also needs to be WTO compatible and as far as possible based on Codex standards, guidelines and recommendations, but depending on importing country’s requirements. Legislation may also include provisions for registration of establishments or listing of certified processing plants, establishment approval, licensing or registration of traders or agents, equipment design approval, penalties, coding requirements and charging of fees. Necessary provisions need to be included for ensuring integrity, impartiality and independence of the official and officially recognized inspection and certification systems.
Inspection services should design control programmes based on precise objective and appropriate risk analysis. HACCP or a similar quality and safety assurance and management system based approach should be encouraged with responsibility for meeting the food quality and safety regulatory requirements of importing country resting with the food industry with all segments of the food chain having responsibility for establishing food safety and quality controls. The responsibility of food control regulators is to ensure, through a surveillance system of industry and other components of the food chain that they meet the requirements specified by the importing country.
Elements of a control programme should include the following:
An administrative procedure should ensure that controls by the inspection systems are carried out regularly proportionate to the degree of risk, where non-compliance is suspected and in a coordinated manner between different authorities (if several exist).
Control should also cover, as appropriate, the establishment, installations, means of transport, equipment and material; raw materials and ingredients for preparation and production of food stuffs; semi-finished and finished products; cleaning and maintenance products; processes for manufacture or processing of foodstuffs; preservation methods; labelling integrity and claims etc. Formal documentation of the export control programmes is also necessary.
Control programmes should target the appropriate stages of operation depending on specific objectives. The frequency and intensity of controls should be designed to take into account the risk as well as the reliability of controls already carried out by those handling the products at various other stages i.e. production, manufacturing, etc. In case of rejected products, information should be sought by the export food control authority from the importing country as per CAC/GL 25-1997 – Codex Guidelines for the Exchange of information between countries on rejections of imported foods. Such information on rejections should be provided at the earliest opportunity, by the export control authority, to the exporter, the manufacturer, producer and any related department depending on the situation.
Adequate facilities including equipment, transportation and communication facilities should be available to ensure delivery of export inspection and certification services.
Laboratories are the backbone of the inspection and certification activity. In order to test to requirements prescribed by the importing countries, the laboratories should have state-of-the-art equipment and manpower that is qualified and trained to operate such equipment. The laboratories used by the export inspection and certification services need to be accredited as per international standard ISO 17025 under officially recognized programmes to ensure that adequate quality controls are in place to provide for reliability of test results. Internationally accepted quality assurance techniques should be implemented to ensure reliability of analytical results.
Official inspection and certification services should have access to a sufficient number of qualified personnel in food science, technology, chemistry, biochemistry, microbiology etc. The personnel should be trained in areas of inspection and certification systems, audit techniques, risk analysis techniques, testing, technological aspects etc. and have a status that ensures impartiality and no direct commercial interest in the products or establishments being inspected or certified.
Certification should provide assurance of conformity of a product to importing country requirements by checks on each product or a batch of products or by approval of the system being implemented by the processor with regular checks by the inspection and certification service on various aspects of the system being implemented. The competent authorities should take all necessary steps to ensure the integrity, impartiality and independence of official or officially recognized certification systems.
Export inspection or certification bodies may be officially accredited to provide services on behalf of official agencies. These bodies shall comply with criteria laid down in international standards such as ISO/IEC 17020, ISO Guides 62 and 65, as well as Codex Guidelines for the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems with specific reference to competence, independence and impartiality of personnel. The performance of such inspection and certification bodies should be regularly assessed by the competent authority.
The export inspection and certification system should be subject to audit separate from routine inspection, may be self-evaluation or by third parties. Internationally recognized assessment and verification procedures should be used. Guidelines for conducting assessment and verification of an exporting country by an importing country have been given in the Annex to CAC/GL 26-1997 and an importing country may undertake a review of the exporting country’s systems, if so agreed.
For decisions relating to food export control systems, both developmental as well as implemental, there is a need to have information as well as data that is scientifically collected, shared with decision makers and implementers as well as processors. This would include information on regulatory requirements of importing countries; data on residues and other parameters which would help in framing regulatory requirements as well as being used for decision making on implementation actions to prevent food borne hazards, plan food control activities etc. While ensuring transparency, any constraint of professional and commercial confidentiality should be respected.
India has been operating export control systems since 1963 which have been well-defined and established under the Export (Quality Control and Inspection) Act, 1963. The Act empowers the Central Government to notify commodities for pre-shipment inspection and certification, specify the minimum standards (generally recognizing international, importing countries’ standards and contractual specifications), and prescribe the manner of export inspection and certification, whether compulsory or voluntary.
The export control system is operated by the Export Inspection Council of India (EIC), India’s official export certification body, through its field organizations, the Export Inspection Agencies, having head offices in Chennai, Delhi, Kochi, Kolkata and Mumbai with 41 sub-offices including laboratories around the country.
Over the years, under the provision of the Act, nearly 1000 commodities have been notified by the government for pre-shipment inspection and certification covering such sectors as chemicals, pesticides, rubber products, engineering products, food and agricultural products, textiles, footwear etc. However, presently only sensitive items such as marine products, egg products, dairy products, poultry products and honey are under compulsory export certification by the Export Inspection Council of India. In the case of other food products, although many of these are notified under the Act, there is no compulsory certification and in many cases, and in case required by an importing government, EIC certifies the products. An example is the case of black pepper exported to USA, or basmati rice to the EC for duty benefits, etc. However, if required by the buyer or government, these food items may be certified by private inspection agencies. Details of export control systems being operated by the Export Inspection Council of India are given in the Conference Room Document prepared by India.
Implementation of export control systems strengthens a country’s infrastructure of food control and, streamlines trade between countries. During the course of operation of export control systems, India has encountered varying experiences, some of which are highlighted so that these may be taken note of and consciously addressed for capacity building in the country as well as addressing problems and removing hurdles.
(i) Equivalence Agreements/ MOUs
The concept of equivalence has been recognized in both the SPS and the TBT Agreements and is also being encouraged at the international level by the Codex Alimentarius Commission with a view to using pooled resources more effectively, avoiding duplication of inspection and testing, and ensuring that health and safety requirements are met effectively. These also serve as an important means of facilitating trade by recognition of the standards and certification systems of the exporting country to provide for an equivalent level of protection against health risks as those of the importing countries and also lead to reduced rejection rates and provide for reduced inspection of export products in overseas markets. Such Agreements are possible only if there is a strong export control system being maintained by the exporting country.
India has been seeking recognition of its export certification from the importing regulatory authorities of India’s trading partners through MOUs/Mutual Recognition Agreements (MRAs). The EIC has been recognized by the European Commission, USFDA, AQIS (Australia) and Sri Lanka Standards Institution for various products.
With countries where Agreements have been signed or where the export certification system has been recognized, there is a smooth trade flow and any issues identified are sorted out through mutual discussions. However importing countries often avoid such Agreements, with varying arguments such as - this is not a priority for them, import controls are a means of income and by signing such Agreements they would lose financially, or the administrative burden of entering into these is not justified or they do not want to lose control over imports. At times it is seen that important components are not addressed in such Agreements as these are not in the interest of the importing country such as provision for retesting and appeal in case of rejections. Other countries have appointed Private Inspection Agencies to carry out this task rather than recognizing the official certifying body. It may be mentioned that such an Agreement would benefit exporters in a ‘developing’ country as the financial burden as well as risk of rejection would be reduced.
(ii) Information on Requirements of Importing Country
Export certification has to cater to the level of protection specified by the importing country. Many countries specify levels more stringent than international ones. There are two issues here – a) certifying to different standards and b) need to have information on the SPS requirements of various importing countries in terms of their standard and legislation. The former cannot be questioned as the SPS Agreement permits members to fix their ALOP. However, scientific justification is not always forthcoming. With regard to the latter, there is often absence of information on the regulations and the procedural norms, such as methods of sampling, inspection and testing. New regulations are brought out and implemented without even giving the producers in the exporting country a chance to become familiar with these. Often standards are available only in the language of the importing country or are presented in a very complicated manner. The result is that neither the exporters nor the export certification authorities are clear about the specific requirements that they need to meet or certify against. This has, at times, led to rejection at the point of import.
(iii) Imposition of Infrastructure Requirements
In building up export certification systems, in addition to end product criteria, a food safety assurance and management systems approach to include GMP/GHP/GAP/HACCP is increasingly being implemented in the food sector especially for more risk prone products such as marine, meat, poultry, egg and dairy products, etc. Under this approach, the focus is on assessment of hazards and establishing control systems which address preventive measures instead of relying primarily on end product testing for certifying health and safety aspects.
Although under this system, flexibility of implementation has been provided for, some countries are insisting on installation of specific infrastructural requirements such as milking machines for milk production, a large number of change rooms, flake ice machines, etc. by the exporters. The exporting country is thereby forced to cover the needs of each importing country. This has resulted in the whole concept of equivalence getting lost. Implementation of such systems at the primary production level becomes difficult in a country such as India, which has a large number of small farms with their own inherent systems.
(iv) Traceability/Product Tracing
Traceability/Product tracing is an important concept. Codex has adopted a definition of Traceability/Product tracing and is working on this in its various committees. In a large country like India, where farms are of small size and raw materials are procured by processing units or exporters through traders, the concept of Traceability/Product tracing to the farm is sometimes not possible. Export certification therefore takes into account the concept of equivalence and alternatively requires a strong raw material control system at the point of entry into the factory. Such concepts addressing the area of equivalence are sometimes not accepted by importing countries and these need to be specifically addressed in documents being developed by Codex on principles for the application of Traceability/Product tracing.
(v) Rejection and Destruction of Consignments
One would expect that with an export certification system based on international established guidelines, rejections should not take place at all, or even if they do, these should be absolutely minimal based on chance factors. However, it has been observed that rejections normally continue. An assessment of these rejections shows that on a number of occasions, the importing country is adopting different methods for sampling and testing and also testing for parameters/contaminants, which are not notified; which can become reasons for rejections.
Another increasingly important issue is that of destruction of consignments. Certain Health Authorities have recently started destroying contaminated consignments (either because of biological or chemical contamination) instead of returning them to the exporting countries as requested by the exporters/importers or even the Official Certification Body on the grounds that if the contaminant is harmful to one country it would be harmful to another. With the implementation of official export certification, return of consignments to the exporting country needs to be formally accepted, if desired by the exporting country so that it can, under its responsibility, take a decision on the fate of the consignment. It is important that, the competent authority of the exporting country has an opportunity to retest the consignments and ascertain whether it is contaminated and if so, analyze the cause before any decision is taken on destruction of the consignment. There have been instances of consignments having tested positive in one laboratory of the importing country and negative in another laboratory, or negative in the laboratory of the exporting country. Therefore, unless there is uniformity in methods of testing being followed, such rejections and destructions would not be justified. Further, in cases, where contamination can be taken care of through reprocessing as in the case of Salmonella contamination, the exporting country may decide to proceed with the same.
vi) Non-recognition of Health Certificates of Export Certification Body
An issue that has recently been faced is non-recognition of ‘health certificate’ of the official export certifying body by the import control authorities in the importing countries. An example can be cited where an importing country insisted on a health certificate for egg powder by the Ministry of Agriculture in India and would not accept the health certificate of the official certifying body, namely Export Inspection Council of India, as the same was under Ministry of Commerce. As mentioned, the export quality was under control of EIC so the option was to either get an endorsement on the certificate by Ministry of Agriculture in India, which in effect would have no meaning or convince the importing country of the situation in the country. The latter course was the more logical one and is currently under discussion.
(vii) Accreditation of certification bodies as per international standards
World over, the requirement today is that certification bodies implement international criteria such as ‘Codex Guidelines on Design, Operation, Assessment & Accreditation of Food Import & Export Inspection & Certification Systems’ (GL 26-1999), ISO/IEC Guide 65 for product certification, ISO/IEC Guide 62 for system certification etc. It is further necessary that these certification bodies are accredited against these standards. Implementation of such systems helps in building transparency in inspection and certification activities, bringing about clarity in the procedures being followed and overall strengthening the inspection and certification activities. The need to implement such formal systems has recently been felt with the initiation of agreements for recognition of the export certification. As a result, India has recently started working towards implementing such systems by its official export certification body and aims to further seek accreditation against international standards.
(viii) Strengthening laboratories
Export control and certification have to be supported by test facilities meeting the requirements of the importing country. By carrying out export certification against the requirements of countries such as the EC, India has been able to build up its test capabilities to test against the most stringent requirements. For example, while certifying marine products, egg products etc for the EC markets, veterinary drug residues had to be tested at less than 1 ppb levels, for which testing had to be done with HPLC MS MS. The equipment was procured and around 11 laboratories were strengthened in the first instance. All the laboratories being used, specifically for export testing, are now gearing up for accreditation against ISO 17025. Export certification has thereby led to strengthening test facilities and bringing them at par with those in the most developed countries.
(ix) Identifying areas that need to be addressed
A well-defined export certification activity has helped in identifying areas to be addressed to strengthen the food control activities in the country. For example, an assessment of the export control system by the European Commission for residues showed that although veterinary drug residues were being controlled in the processing units, control at the farm level was not very effective. The reason was that the Official Certification Body, under the Ministry of Commerce, did not have the legislative authority to implement controls at farm level. The Ministry of Agriculture, has authority over farms and the Ministry of Health over drug stores. It was necessary to develop coordination between the three ministries for effective control over the final end product. New legislation to cover all areas was developed and the flow of information between the Ministries of Health and Agriculture and EIC was strengthened. This has now led to effective controls on the use of veterinary drugs at farm level and also controls on veterinary drug stores leading to fewer rejections.
(x) Strengthening sectors of industry
Compulsory export certification has been gradually introduced in marine, dairy, egg products, poultry products, etc. In all these sectors, a systematic approach is mandatory. Before introduction of compulsory certification for exports, most processing units had not been implementing GMP/GHP/ HACCP. However, due to the mandatory need for such systems, they started implementing the systems and the benefits became obvious to management in terms of workers following better hygienic practices, strengthened raw material controls, effective record keeping, training of manpower etc which led to overall improvement of quality and supporting systems. Today, the areas in which compulsory export certification has been introduced, has processing units that can match the best in the world.
(xi) Data Availability
Export certification has led to streamlining activities and systematizing testing of products and raw material in production units as well as by the export certification body. Further, residue monitoring plans have been developed and implemented, which has resulted in considerable data generation. With such supporting data, it has become possible to take up issues at international fora as well as with importing countries on issues of rejections, SPS limits fixed by them etc.
(xii) Empowering Personnel
As a result of export certification, the weaknesses in the capabilities of personnel both in conformity assessment activities (inspection, certification and testing) as well as in processing units and at farm level have been observed and based on this, training needs identified with focus on developing and upgrading skills of not only officials with regard to certification and testing, but also empowering industry to implement quality and safety as per international requirements. A Human Resource and Quality Development Centre was established in EIC to intensify training activities. A pool of eighty trainers was initially created through an FAO project on 'Manpower Development in Food Safety and Quality' which was further utilized for training. This has resulted in not only empowering personnel within the country for inspection and testing, but has generally helped in creating awareness and knowledge on health and safety issues even within the industry.
Although guidelines have been established for the design, operation, assessment and accreditation of food import and export inspection and certification systems, many countries are not effectively using the guidelines. Some observations on the export control systems implemented in different countries are given below.
6.1 For export, a clear policy needs to be developed taking into account issues like - are all exports to be controlled or specific products, type of parameters (health and safety or quality also), the need to build in any voluntary requirements along with mandatory ones, who would be the authority, what are the systems of inspection and certification to be followed, is the country looking at signing MRAs or equivalence Agreements for recognition of its export certification or is the aim only to ensure that a safe and good quality product is exported.
6.2 Transparency - All specifications, inspection and testing methods and procedures need to be documented. In fact, the entire inspection and certification system for exports needs to be documented. The operative part of the legislation needs to be clearly laid down in the form of regulations or executive instructions, and given to each inspecting official so that they are available at the point of use. All specifications, inspection and testing methods should also be accessible to interested parties overseas to enable ‘transparency’ in line with Article 7 of the SPS Agreement.
6.3 Self-certification by industry needs to be encouraged. Exporting units should be approved based on their following a total quality management approach i.e. implementing GMP/GHP/HACCP as well as conformance to the requirement of international specifications and those of the importing country. Periodic surveillance of the unit should be done wherein the aspects that need to be specifically checked include sanitation and hygiene of the plant, process control, implementation of HACCP plan, records, observation of testing in the laboratory of the plant, drawing of samples from various stages in the plant for testing. The certification should also take into account the varying requirements of importing countries so that rejections at importing end are reduced. This is one of the issues which have been expressed as being of concern to the exporters.
6.4 Legislation needs to be simplified to have a single legislation for food quality control preferably to include both export and import. This should contain clear defined roles of various authorities with a view to avoiding overlap.
6.5 Inspection systems followed by different inspection and certification agencies need to be aligned with ISO 17020/Guide 65 and the Codex Guidelines for the Design, operation, assessment and accreditation of food import and export inspection and certification systems.
6.6 Equivalence agreements - The importing governments should enter into equivalence agreements with governments of other countries for recognition of each other’s food export inspection and certification systems in line with Article 4 of the SPS Agreement. Such Agreements would provide an enhanced means of assuring that exported foods conform to importing country’s requirements, avoid duplication of activities and use collective resources more effectively and efficiently, provide a mechanism for cooperative exchange of expertise, assistance and information to help assure and enhance conformity with requirements. uch Agreements should include in addition provisions for transparency of legislation relating to specifications, sampling, inspection and testing methods etc; retesting and appeal in case of rejections; return of rejected consignments; technical assistance etc. Such Agreements would facilitate exports and reduce inspections and rejections of products in overseas markets.
6.8 Accreditation – A system of accreditation needs to be developed in all countries for both inspection bodies (ISO 17020) and certification bodies (ISO Guides 62 and 65) as well as laboratories (ISO 17025) and all organizations performing such activities would need to become accredited. This would result in much-needed credibility to inspection and certification activities.
6.9 Training - Personnel need to be trained within the country as well as overseas on a regular and systematic basis to bring about awareness on the scenario for inspection and testing in the country as well as the latest testing techniques, methods of sampling, risk analysis, HACCP, document and record control, auditing techniques, etc.
6.10 Computerization – All organizations need to be networked so that information can be coordinated and accessed by all organizations. Websites need to be developed to contain information on standards as well as export inspection and certification systems and procedures to enable transparency for internal & outside personnel.
6.11 Promotion and market development – These activities need to be strengthened to create a market for the country’s products. Export promotion needs to be given priority and some schemes developed to assist exporters. These could be in terms of financial/technical assistance to exporting units to set up in-house laboratories with basic test facilities, for implementing ISO 9000/14000 or HACCP. A logo may be developed and brand promotion campaigns launched in various countries. Participation in trade fairs may be intensified.
6.12 Guidelines for Exporters/ Importers - A guideline document for exporters needs to be developed which gives an overview of the system of exports and imports as well as broadly the role of different organizations as also clearly laid down steps which an exporter would need to follow for exports.
6.13 Capacity Building - Clear areas need identifying for ‘Capacity Building’ of domestic, import and export inspection and certification systems to meet international requirements to include:
Advantage needs to be taken of Article 9 of the SPS Agreement and technical assistance sought on these areas from importing developed partners.
6.14 In case of rejections, an export control body should enter into dialogue with importing authorities to resolve problems that may arise due to rejection of a consignment in the importing country. Issues due to rejections have been differing standards/conformity assessment procedures, lack of transparency etc. This would be facilitated as due to export certification, the entire data and background is available with the export certification body.
Although the significance of export certification systems have not been fully recognized by many countries, these can play a very important role in the present day scenario of rapidly expanding global trade in food. These would be useful for both importing and exporting countries and would help to utilize pooled resources more effectively while ensuring that the food exported is safe and meets the sanitary requirements of the importing country as well as any voluntary requirements, which can also be built into the system. However care needs to be taken that such export control systems are established based on the Codex Guidelines for the Design, Operation, Assessment and Accreditation of Food Import & Export Inspection and Certification Systems.