Case Study - Indian Experience: How the Change of Analytical Methods and the Lowering of Detection Levels Had Impact on the Trade with Animal Derived Food

J. K. Malik, Izatnagar, U.P., India

With the increased awareness of the safety and quality it becomes imperative for the countries to maintain the safety standards of the food for human consumption. This becomes all the more essential to meet the requirements under the World Trade Organization (WTO), the regional trade agreements and the Sanitary and Phytosanitary (SPS) Agreement. The active involvement of livestock producers, veterinarians, food technologists, microbiologists and food biochemists in food safety risk assessment and risk management is imperative, since prevention of contamination on the farm is a viable hazard reducing strategy. In addition, livestock producers and veterinarians need to be aware of changing requirements for farm animal food safety as Hazard Analysis Critical Control Point (HACCP) and other risk reduction activities become more common.

Food Safety Standards

Under the SPS Agreement certain international standards set by the Codex Alimentarius Commission (hereafter referred to as Codex) need to be scrupulously adopted by the member countries. Accordingly, due to increased international trade, as well as domestic trade, India is now gearing itself to maintain the international standards by adopting the guidelines and recommendations under WTO Agreement. In India, the Codex standards/guidelines are taken into consideration for harmonization of national standards. To facilitate acceptance of Indian products in international trade, the Export Inspection Council of India is developing standards based on Codex standards as well as importing country standards, taking into consideration the data generated in the country on risk assessment and risk analysis. The Bureau of Indian Standards has already accepted HACCP approach of Codex and is considering other food hygiene standards for the food processing units for implementation.

As export certification is mandatory for products like marine, milk, meat, poultry, eggs etc. Government of India has set up Export Inspection Council of India (EIC) as the Official Certifying Body, to certify the quality of products for export. The export certification process covers a TQM approach to cover both the systems aspects, including Good Management Practices (GMP), Good hygiene Practices (GHP) and HACCP. This organization is gearing itself to implement International Organization for Standardization (ISO) "General Criteria for the Operation of Various Types of Bodies Performing Inspection" as well as the Codex "Guidelines for the Design Operation Assessment and Accreditation of Food Import and Export Inspection and Certification Systems" for improving its own in house system as well as end product requirements.

Nitrofuran Residues in Poultry and Marine Products

Nitrofuran residues in egg powder

There are four egg processing plants operating in the country and exporting egg products to countries including European countries, Japan and Korea. The products include whole egg powder, yolk powder, albumin powder and one of the plants also supplies these products in liquid frozen conditions. Prior to 2003, there were no residues found in the Indian products and the business was going on smoothly. However, in 2003, a Rapid Alert was issued by European Commission based on detection of nitrofuran metabolites by authorities of a member country in some of the products. There was some confusion on the batches which were designated to India but since further rapid alerts were issued; the Indian industry became quite alert. Reason for the sudden reference has been that earlier the egg products were tested only for nitrofuran (parent drug) residues and not for nitrofuran metabolites or that testing was done by less sensitive methods prior to exports. The testing of samples had been done locally by exporters and also authenticated by foreign laboratories in Germany. It was found later on that the RIKILT Laboratory had started applying some method using extremely selective LC-MS/MS technique which was not in operation earlier either in India or abroad. This technique excludes the chances of false positive results or in other words a positive result obtained by this technique has the highest degree of certainty that can be obtained. This technique, therefore, was seen suitable for confirmatory analysis. It was argued that for metabolites there are no microbiological or immuno-chemical screening methods available and for compulsory analysis of the residues of the banned substances, the LC/UV method has proven insufficiently sensitive to achieve the minimum required performance limit (MRPL) of 1.0 µg/kg set for nitrofurans. The LC-MS/MS technique was found to be a valuable tool to detect up to the level of one part per billion of these compounds and/or their metabolites.

In the year 2003, nitrofuran metabolites residues were detected in nine consignments of egg powder exported from India to the European Union (Table 1). Consequently, such consignments were rejected and some were destroyed leading to economic losses to the exporters. The argument given by European Union was that nitrofurans are banned substances and hence should be completely absent from food products. Regulatory laboratories were, therefore, obliged to try and find residues of these substances at the lowest technically possible concentration.

For poultry, the most likely causes of residues are either administration via feed, drinking water or exposure to the contaminated feed. Accordingly, the Indian export industry started monitoring their primary production farms from where the eggs were supplied and at the governmental level a mechanism in the form of a residue monitoring plan was developed to ensure that these residues do not occur in the final products. This residue monitoring plan is strictly implemented under the provisions of the Export (Quality Control and Inspection) Act,1963 and under the supervision of Export Inspection Council through the Agricultural and Processed Food Products Export Development Authority (APEDA) and presently no further alerts have been issued against India for any such drugs or other residues.

Table 1: Rejection of consignments of egg powder exported from India to the European Union as a result of detection of nitrofuran metabolites during 2003

Nitrofuran residues in fish and fish products

Some consignments of fish and fish products exported from India to the European Union during 2003 and 2004 were rejected as a result of detection of nitrofuran residues. The details of rejections are given in Tables 2 and 3. It is apparent from the data presented in two tables that heavy economic losses were incurred as a result of rejection of the consignments by the importing countries.

Table 2 Rejection of consignments of fish and fish products exported from India to the European Union as a result of detection of nitrofuran metabolites during 2003

AOZ= 3-Amino-2-oxazolidinone (Furazolidone); SEM = Semicarbazide (Nitrofurazone); NF= Nitrofuran metabolite

[Source: EIC, New Delhi]

Table 3 Rejection of consignments of fish and fish products exported from India to the European Union as a result of detection of nitrofuran metabolites during 2004

AOZ= 3-Amino-2-oxazolidinone (Furazolidone); SEM = Semicarbazide (Nitrofurazone)

[Source: EIC, New Delhi]

Current Issues

For substances including nitrofurans for which no permitted level has been established, the minimum required performance limit (MRPL) of analytical method is to be used. MRPL is the minimum content of an analyte in a sample which at least has to be detected and confirmed. It is intended to harmonise the analytical performance of methods for substances for which no permitted limit has been fixed. Threshold or safety level of a drug based on scientific risk assessment is better option than MRPL which is mainly based on performance of an analytical instrument. Thus, risk-based approach instead of a precautionary approach may be more appropriate to preclude trade barriers. It becomes imperative to generate sufficient information and the safe threshold limits of drugs without ADI and MRLs. Based on the generated scientific data, their MRLs may be fixed and such approach should be transparent and flexible. Recently, the carcinogenic effects of furazolidone and its metabolites were evaluated in two fish species^[79]. The results of this study did not support the established viewpoint that furazolidone must be banned from the trophic chain based on its potential carcinogenic properties. On the other hand, semicarbazide (SEM) which is a marker for nitrofurazone abuse can occur naturally in shrimps and eggs and is formed from natural substances such as arginine and creatine. A significant formation of SEM occurs in samples treated with hypochlorite commonly used in food processing for disinfection or bleaching^[80]. Such findings need to be considered for formulating future strategies relating to nitrofuran residues in foods of animal origin. There is a need that risk assessment studies be conducted in developing countries and the data so generated be taken into consideration while framing Codex standards.

Some developed countries are imposing newer and stricter residue limits for veterinary drugs as compared to those set by Codex. These levels are not necessarily based on proper risk assessment and scientific data generated out of the epidemiological surveillance/clinical studies, but on the detection limits of the highly sophisticated testing equipment which are very expensive. There is suggestive evidence that standards often raise costs and thereby serve to restrain trade. Additionally, standards, stronger than necessary for achieving optimum level of social protection, impose excessive costs on consumers and reducing net welfare. The additional costs incurred on meeting different standards and technical regulations, along with the cost of testing and certification, by developing countries is relatively much higher. For developing countries, all this imposes considerable additional costs and works as a big non-tariff barrier for their exports.

The different sets of standards of MRLs of veterinary drugs established in the EU as compared to those set by Codex are not appropriate and justified. It is, therefore, essential to have uniform policy for implementation of Codex MRLs with adequate legal provisions.

In order to implement Good Veterinary Practices and facilitate export of animal derived food, it would be appropriate to compile a list of veterinary drugs that are being used in different Codex member countries. Such list should also include veterinary drugs for which JECFA/Codex MRLs have not been established so far.

It has also been observed that on a number of occasions, the importing countries are adopting different methods of sampling and testing and also testing for parameters/contaminants in imported foods, which are not notified in their standards. These at times become reasons for rejections. There are cases of consignments that have been tested positive in one laboratory of the importing country and negative in another laboratory. Therefore, unless there is uniformity in methods of testing being followed i.e. Codex recommended methods, such rejections would not be justified.

Developed countries, introducing new SPS measures, mostly do not provide longer time frames for application of such new SPS measures by developing countries, as provided in the SPS Agreement. New regulations are brought out and implemented without even giving producers in the exporting country a chance to get familiar with these.

Implementation of standards involves costs that arise from testing and certification (conformity assessment) procedures to determine a product meets standardized requirements, in particular varying national technical regulations. Invariably, the test certificates issued by Indian laboratories are not accepted in the EU and other developed countries, although the Indian laboratories follow the same testing methods and protocol for testing the samples. Furthermore, growth of mandatory third party certification of conformity with technical requirements puts an inflated cost burden on the exporter.

Although every country has its own policy to fix the residue levels in the commodities in their own country, such limit should comply with SPS and WTO protocols in order to facilitate hurdle free international trade. Approach should be consistent and uniform in determining the Appropriate Level of Protection (ALOP). ALOP should be determined on the basis of scientific evaluation of risk to human health and not on the level which could be detectable or achievable. ALOP should be based on the minimum necessary level which may ensure health safety to the majority of population, scientific data generated globally with due consideration to the data generated from developing countries and risk analysis. It should be with respect to a particular identified risk and should not exceed the level necessary to overcome that risk and without negative trade effects. The options available should be technically and economically feasible with special emphasis on the conditions prevailing in developing countries. While doing so, the technical and economic needs of these nations would have to be properly addressed to achieve the appropriate level of protection.

As is obvious from the above, continuous changes in analytical methods resulting in lowered limit of detection had significant impact on trade with animal derived food. Further, the impositions of unjust measures which conflict with Codex by some importing countries are impeding the international trade. These may include application of more stringent measures than Codex without valid scientific data on risk analysis, destruction of rejected consignments, imposition of new standards without notification or prior information and application of quality testing procedures different from internationally accepted ones.

Conclusion

The advancement in analytical methods and lowering of detection levels of veterinary drugs without ADI and MRLs had significant impact on international trade with foods of animal origin. Developing countries need to make their own efforts to address such obstacles in order to facilitate the trade. To safeguard its interest in trade and gain further access to global markets, India is gearing up to meet the requirements of stringent standards imposed by some importing countries. The testing laboratories are being strengthened in terms of man power, equipment and other facilities, especially to facilitate testing of antimicrobial agents and/or their metabolites. Human resource is being developed by imparting training and technical assistance to update themselves with latest advancements in certification process. Efforts are also being made to create awareness amongst the persons related to industry on issues like HACCP, testing, quality of produce, etc. Technical assistance is being sought from EC to generate database on regulations and specifications with respect to sampling, inspection and testing procedures available in the country. India is also seeking clarification from importing governments with regards to enforcement of guidelines other than those specified in Codex, which is adversely affecting the trade.

There is a need to have uniformity in methods of testing and Codex recommended methods should be followed by different countries. Reasonable longer time frame is required to be given to producers in the exporting country by the importing country while implementing a new SPS measure. Appropriate level of protection should be based on scientific evaluation of risk to human health and not on the level which could be detectable or achievable.

It is good to prohibit veterinary drugs in animal production which have genotoxic and carcinogenic potential keeping in view the consumer health. However, prohibition of drugs as a precautionary measure in the absence of supporting scientific data is unrealistic. A list of veterinary drugs, including those for which no JECFA/Codex MRLs exist, being used by Codex member countries and the European Union should be compiled and circulated as it may facilitate in implementation of Good Veterinary Practices and in turn would ensure better food safety. Global community should make efforts to balance international trade, consumer protection and animal health while considering residues of veterinary drugs in animal/marine products. Lack of uniformity in MRLs of veterinary drugs between Codex and EU is causing unreasonable difficulties and is acting as strong non-tariff barrier for exports from developing countries like India to the EU. All Nations should accept Codex standards in Food safety and trade.