Syed Wajid H. Pirzada
The Uruguay Round (UR) of Multilateral Trade Negotiations, which ended in 1994, established WTO to replace the General Agreement on Tariff and Trade (GATT).
The UR negotiations were the first to deal with the liberalization of trade in agricultural products, an area earlier excluded from previous rounds of negotiations. The UR also included negotiation on reducing non-tariff barriers to international trade in agricultural products and led to two binding agreements:
1. The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement).
2. The Agreement on Technical Barriers to Trade (TBT Agreement).
Both these Agreements recognize the standards, guidelines and other recommendations of Codex Alimentarius Commission (CAC) as the specially identified baseline for consumer protection. This paper, therefore, seeks to address the issues related to SPS and TBT, including CAC standards and their implications for Pakistan, as these agreements are to be applied by all WTO members including Pakistan.
These are even applicable to countries that are not WTO members. With this background, we would like to discuss CAC standards and their application in relation to SPS and TBT Agreements.
The SPS Agreement
The SPS Agreement confirms the right of WTO member countries to apply measures necessary to protect human, animal and plant life and health.
Notwithstanding the need for application of national measures to protect human, animal and plant life and health, the national SPS measures had become, by design or accident, effective trade-barriers.
And as the UR negotiations address the issue of non-tariff barriers, as such, the SPS Agreement sets new rules to ensure that national SPS measures are consistent with obligations prohibiting arbitrary or unjustifiable discrimination on trade between countries. The SPS Agreement requires that, with regard to food safety measures, WTO Members base (as discussed above) their national measures as adopted by FAO/WHO Codex Alimentarius Commission where they exist. Furthermore, the SPS Agreement calls for programme of harmonization of national requirements based on CAC standards. This work is guided by WTO Committee on SPS measures, to which the representative of CAC, the International Office of Epizootics (OIC) and the International Plant Protection Convention (IPPC) are invited.
The SPS covers all food-hygiene measures and food-safety measures, such as control of veterinary residues, pesticide residues and other chemical/food additives used in food production.
The TBT Agreement
The objective of the Agreement is to prevent the Member countries using national or regional technical requirements, or standards in general, as unjustified technical barriers to trade. The TBT Agreement basically provides that all technical standards and regulations must have a legitimate purpose and that the impact or cost of implementing the standard must be proportional to the purpose of the standard. It provides that:
If there are two or more ways to achieving the same objectives, the least trade-restrictive alternative should be followed.
The TBT Agreement places emphasis on international standards, the WTO Members being obliged to use international standards, or parts of them, except where the international standards would be ineffective or inappropriate in the national situation.
The Agreement covers standards relating to all types of products, including industrial and agricultural products, with the exception of aspects of food-standards relating to SPS measures, such as products contents-requirements quality packaging and labeling, etc. this Agreement includes numerous measures to protect the consumers against deception and economic fraud.
The CAC
In the aforementioned context, the CAC standards, guidelines and other recommendations take on unprecedented prominence and importance, with respect to both consumer protection and international food-trade. It is therefore, advisable to understand both the CAC's working and its standards, guidelines and recommendations in greater detail. The CAC is an intergovernmental body established by FAO in 1961. Since 1962, it has been responsible for implementing the joint FAO/WHO Food Standards Programme, whose primary aims are to protect the health of consumers and to ensure fair practices in the food trade. It has 158 Member Governments, as on August 31, 1997.
The Codex
The Codex Alimentarius (a Latin word meaning "Food Code" or "Food Law") is a collection of food standards, codes of practice and other recommendations, presented in a uniform way. Codex standards, guidelines and other recommendations ensure that food products are not harmful to consumers and can be traded safety between countries or, in world; it facilitates international trade in food.
As discussed above the food safety standards are defined in SPS Agreement as those relating to food additives, microbiological norms, veterinary drugs and pesticide residues, contaminants, hygienic practices. Codex food-safety standards are to be used by WTO as the reference point for the WTO in this area.
There are more than 300 codex standards, guidelines and other recommendations relating to food, whether processed, semi-processed or raw, quality, composition and safety. It evaluates the safety of over 760 food-additives and contaminants, setting more than 2,500 maximum limits for pesticide-residues and more than 150 veterinary drug residues. In addition, CAC has established a number of guideline levels for a number of environmental and industrial contaminants in food. The first Codex was published in 1981 and the 2nd in 1998. The 2nd edition is now being revised and updated to take into account decisions made by the 21st session of CAC, July 1995.
The standards and maximum limits for residues of pesticides and veterinary drugs in food and feeds: IT has taken a number of years to develop the Codex. Maximum Residue Limits (MRL) and Extraneous Maximum Residue Limits (EMRL) are generally consistent with the recommendations of the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). The JMPR is composed of independent scientists who serve in their individual capacities as experts, but not as representatives of their governments or organizations. The standards and maximum limits for residues of pesticides and veterinary drugs in foods and feeds, accompanied by an appropriate communication, are sent for action to Ministries of Agriculture or Ministries of Foreign Affairs, as appropriate, of Member Nations of FAO and the Ministries of Health of Member States of WHO.
These standards and maximum limits of CAC for residues of pesticides and veterinary drugs in food and feeds are the product of a wide measure of co-operation and international agreements. Moreover, they are compatible with the norms considered by FAO and WHO as best guaranteeing the protection of the health of consumers as well as facilitation of international trade in food. It, therefore, would be in the fitness of things that Pakistan builds its capacity and ability to not only apply the international standards adopted by CAC, but also harmonize its national standards with international standards, which shall help facilitate her trade with the countries of the region and globally.
The Basis for Establishment of Codex MRL:
The codex MRLs are established only where there is supporting evidence concerning the safety/danger to humans of the resulting residues, as determined by the Joint FAO/WHO Meeting on Pesticide Residues and this implies that Codex MRLs represent residue-levels, which are toxicologically acceptable. The Codex MRLs are recommended on the basis of appropriate residue data obtained mainly from supervised trials. The residue-data, thus obtained, reflect registered or approved usage of the pesticide in accordance with "good agricultural practices".
As Codex MRLs cover a wide spectrum of use-patterns and "good agricultural practices" and need to reflect residue-levels closely following harvest, they may occasionally be higher than the levels of residues found in national surveillance programmes.
Basis for Establishment of Codex EMRLs:
The MRL refers to residues of compounds, which were used as pesticides, arising from environmental contaimination (including former use of agricultural pesticides or uses of these compounds for other than agricultural uses). These residues are treated as contaminants. Codex MRLs need to cover widely varying residue-levels in food, reflecting differing situations in respect of contamination of food by environmental and persistent pesticide-residues. For this reason, Codex EMRLs cannot always reflect strictly the actual situation of residue existing in given countries or regions. Codex EMRLs, therefore, represent acceptable residue levels, which are intended to facilitate trade in food while protecting the health of the consumers. They are established only when there is supporting evidence concerning the safety to humans of the residues, as determined by the Joint FAO/WHO Meeting on Pesticide Residues.
Codex MRLs/EMRLs and Consumer Protection - Determination of Total Daily Intake of Pesticide Residues:
The primary purpose of setting maximum limits for pesticide-residues in or on food and (in some cases) in animal feeds, is to protect the health of consumers. Codex MRLs and EMRLs serve that purpose, as they help to ensure that the maximum amount of pesticide applied to food is consistent with real pest-control needs. Codex MRLs are based or residue-data from supervised trials and not directly derived from Acceptable Daily Intakes (ADIs). Which are quantitative expressions of acceptable daily amounts of residues which persons may ingest on a log-term basis and which are established on the basis of appropriate toxicological data, mainly from animal studies.
Codex MRLs/EMRLs for Milk and Milk Products:
Codex MRLs/EMRLs for fat-soluble pesticide-residues in milk and milk products are expressed on whole-product basis.
For a "milk product" with a fat-content less than 2%, the MRL applied should be half those specified for milk. The MRL for "Milk products" with a fat-content of 2% or more should be 2.5 times the MRL specified for milk, expressed on a fat basis.
Codex MRLs/EMRLs for Processed Foods:
As a rule, Codex MRLs and EMRLs are established for new agricultural commodities. However, where it is considered necessary of consumer protection and facilitation of trade, MRLs and EMRLs are established for certain processed foods on a case-by-case basis, taking into consideration information on the influence of processing on residues.
Residue Data and the Developing Countries:
JMPR in its meeting held at FAO, Rome recognized the limitation in expertise and resources prevailing in many developing countries. It concluded that, within a relatively short period of time, reliable residue data could be generated in several developing countries having appropriate laboratory capacity, by providing assistance for the introduction and implementation of quality control and quality-assurance principles in their laboratories, and for execution of supervised field trials, in compliance with Good Laboratory Practices (GLP).
The major part of this assistance would be related to the transfer of accumulated knowledge and experience, and interested countries should explore their possibilities of obtaining the necessary support. For theoretical and practical training in this subject, the JMPR recommended the use of recently established FAO/IAEA Training and Reference Center, for which FAO and other organizations could provide the necessary assistance, if interested countries so request.
Veterinary Residues:
Veterinary residues that remain in the tissues of food-predicting animals, after treatment, create on the major problems associated with the veterinary use of such drugs. This problem stems from the difficulty of defining "safe concentratin" of the agents in meat or milk for human consumption, and is compounded by the increasing sensitivity of detecting methods. In addition, milk for processing to cheese and similar products must not contain drugs that inhibit bacterial growth.
Public Health/Consumer Protection:
The human-health risks from the ingestion of small quantities of antibiotics are hypersensitivity reactions, other toxic effects, and possible effects on microflora. According to a report, even in a developed country like USA, it was estimated that 14% of all meat and poultry samples, tested over a two years period, contained illegal and potentially harmful residues of pesticides and other drugs.
About 4% to 7% of the human population is hypersensitive to penicillin; about 0.04% develops acute anaphylactic shock when the drug is encountered and there are reports of hypersensitivity reactions after the ingestion of penicillin-contaminated milk. Nondose-related a plastic anemia caused by choloramphenicol in humans is another potential hazard of antibiotic contamination.
The effect of low concentration of antibiotic ingested in contaminated meat on the resistance and composition of human microbial flora is probably negligible. Whereas certain antibiotics are degraded by freezing, cooking or storage, such degradation is not completed, and for some antibiotics it is minimal. The toxic effects of antibiotics it is minimal. The toxic effects of antibiotics in humans increases with the concentration and duration of exposure; the small quantities likely to be consumed by the average person over the course of a year, as a result of ingesting animal products contaminated with antibiotics, are unlikely to have any significance, with rare possible exceptions, as discussed above, of penicillin and chloramphenicl. Nevertheless, it is difficult to define these risks because antibiotics and their degradation products may have carcinogenic, mutagenic and teratogenic, or other effects.
Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF):
In response to a growing concern about mass-medication of food producing animals and the implications, as discussed above, for human health and international trade, a Joint FAO/WHO Expert Consultation on Residues of Veterinary Drugs was convened in Rome, in Nov. 1984. This led to establishment of a specialized CCRVDF, which at its first session in Washington, DC, in November 1986, made a number of recommendations and suggestions for consideration by Joint FAO/WHO Expert Committee on Food Additives (JEFCA). Consequently, the 32nd JEFCA meeting was entirely devoted to the evaluation of residues of veterinary drugs in foods; subsequently a series of nine meetings of JEFCA were also dedicated to evaluation of veterinary drugs.
Methods of Detecting Veterinary Residues:
The methods used for detection of antibiotic residues are mainly microbiologic, with confirmation by electrophoresis and chemical methods (mainly high-performance liquid chromatography). Such methods employ sensitive bacterial strains (e.g. sarcina Lutea, Bacillus subtitis). The 10th session of the CCRVDF held in San Jose, Costa Rica (Oct-Nov, 1996) revised the priority list of veterinary drugs requiring evaluation. The drugs evaluated during the 48th meeting of JEFCA included these compounds except Gentamicin. The evaluation appraisals take into account the results of pharmacokinetics, metabolism and tissue residue depletion studies.
Coping Strategies: Coping strategies will rely heavily on judicious and rational use of agricultural pesticides and veterinary drugs. This, in turn, warrants regulatory interventions, on the one hand, and institutional arrangements for monitoring and testing, on the other.
For instance, USA established a computerized Residue-Avoidance Data (FARAD) Bank for food-animals. The Pharmacokinetics data is available to veterinarians on inquiry. Rational therapeutic decisions by veterinarians offer a key to control veterinary residues in food and safeguard public health and thus protect consumers.
Recommendations
i. Capacity building in the area of testing and monitoring of pesticides and veterinary drugs.
ii. Development of core human-resource in the area of food-safety and quality control/Veterinary Public Health.
iii. Rational policy for import and use of agricultural pesticides and veterinary drugs.
iv. Training/advocacy in the area of rational therapeutics for veterinarians and good agricultural practices for agronomists.
v. Institutionalizing the optimization of drug, therapy, through Therapeutic Drug Monitoring (TDM) service in veterinary medicine TDM laboratories require:
- Understanding of the pharmacology of the drug being administered.
- Some information on the Pharma cokinetics of the drug in the normal animal.
- The effect of various clinical conditions on drug-disposition. TDM is a complex service and several individuals, including clinical chemist, veterinary clinical pharmacologist and veterinary clinician/practitioner, need to be involved in the proper collection and interpretation of data.
vi. Research studies on pesticide/veterinary drug residues.
vii. Consumers protection associations.
viii. Consumers educating programme.
ix. Harmonization of standards with international standards/CAC.
x. GO-NGO-Private sector partnership in the area of food-safety and quality control.
xi. Structural adjustments in agriculture, in the context of WTO regime.
(The author has recently joined as consultant in Pakistan Council for Science & Technology, Islamabad).
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